Chemicals From China

ENVIRONMENT IMPACT ASSESSMENT (EIA)
REPORT FOR
APIs & INTERMEDIATES MANUFACTURING
INDUSTRY
At
Plot No. 1A, 1A"P", 1B, 2, 2A, 2B, 3A to 3E,
4A, 4B, 4C, 5A & 5B,
Deosugar Industrial Area, Raichur, Karnataka
For
M/s. SHILPA MEDICARE LIMITED – UNIT I
Proposal number: IA/KA/IND2/75276/2018
Prepared by
SAMRAKSHAN
F- 4, I Floor, Swastik Manandi Arcade,
S C Road, Sheshadripuram,
Bangalore - 560 020
Ph.: 080-41466009
E mail id: [email protected]; [email protected]
CONTENTS
Index no. Description Page no.
Executive summary 01 - 10
CHAPTER 1
INTRODUCTION
1.1 Purpose of the report 11
1.2 Identification of project and project proponent 13
1.3 Brief description of nature, size, location of the project and its 15
importance to the country, region
1.3.1 Nature, size and location of the project 15
1.3.2 Importance of the project to the country, region 16
1.4 Scope of study – details of regulatory scoping carried out (as 18
per terms of reference)
1.4.1 Scope of study 18
1.4.2 Details of the study 18
1.4.3 Methodology of the study 19
1.4.4 Study area details 19
1.4.5 Terms of Reference (TOR) 19
CHAPTER 2
PROJECT DESCRIPTION
2.1 Type of project 32
2.2 Need for the project 32
2.3 Location (maps showing general location, specific location, 32
project boundary and project site layout)
2.4 Size or magnitude of operation 38
2.5 Proposed schedule for approval and implementation 38
2.6 Technology and process description 39
2.6.1 Products with production capacities 39
2.6.2 List of raw materials required and their source along with 40
mode of transportation
2.6.2.1 Raw materials, sources and supply 49
2.6.2.2 Storage facilities for raw materials, products 56
2.6.3 Reactor details 57
2.6.4 Manufacturing process description 57
2.6.4.1 Acebrophylline 58
2.6.4.2 Ambroxol HCl 64
2.6.4.3 Buflomedil HCl 71
2.6.4.4 Nifedipine 80
2.6.4.5 Phenyl ephrine HCl 89
2.6.4.6 Sildenafil citrate 104
2.6.4.7 Ticlopidine HCl 113
2.6.4.8 Ursodeoxycholic acid 123
2.6.4.9 Anastrozole 139
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2.6.4.10 Bendamustine HCl 149
2.6.4.11 Bicalutamide 153
2.6.4.12 Bortezomib 158
2.6.4.13 Capecitabine 168
2.6.4.14 Carboplatin 179
2.6.4.15 Cisplatin 186
2.6.4.16 Docetaxel trihydrate 192
2.6.4.17 Epirubicin HCl 201
2.6.4.18 Gefitinib 210
2.6.4.19 Gemcitabine HCl 217
2.6.4.20 Imatinib mesylate 226
2.6.4.21 Irinotecan HCl trihydrate 232
2.6.4.22 Lenalidomide 241
2.6.4.23 Letrozole 248
2.6.4.24 Oxaliplatin 256
2.6.4.25 Paclitaxel 263
2.6.4.26 Pemetrexed 273
2.6.4.27 Temozolomide 282
2.6.4.28 Thalidomide 289
2.6.4.29 Topotecan HCl 294
2.6.4.30 Zoledronic acid 301
2.6.5 Green chemistry 308
2.7 Project description including drawings showing project layout, 308
components of the project etc.
Schematic representations of the feasibility drawings which
give information important to EIA purpose
2.7.1 Project drawing 308
2.7.2 Schematic representations of the feasibility drawings which 308
give information important to EIA purpose
2.8 Mitigation measures to meet environmental standards, 309
environmental operating conditions or other EIA requirements
2.8.1 Source of water supply 309
2.8.2 Water demand and wastewater discharge 310
2.8.2.1 Flow chart of ETP at Unit II 314
2.8.3 Product-wise process water consumption and effluent 316
discharge
2.8.4 Effluent characteristics 319
2.8.5A A solvent recovery and recycling 319
2.8.5.1 Solvent recovery system 324
2.8.5.2 Solvents storage 325
2.8.5.3 Solvents management 326
2.8.5.4 Measures to control evaporation losses and fugitive emissions 327
for few raw materials and solvents
2.8.5B Rainwater management 328
2.8.6 Air pollution sources and their management 329
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2.8.6.1 Ambient air quality and stack emission monitoring 333
2.8.6.2 Specifications of air pollution control units provided 333
2.8.6.3 Power requirement 335
2.8.7 Noise generation and its management 335
2.8.8 Solid waste generation and its management 335
2.8.9 Hazardous waste generation and its management 336
2.8.9.1 Storage and disposal of hazardous waste 337
2.8.10 By- products generation and management 338
2.8.10.1 Other materials generated during manufacturing process 342
2.9 Assessment of new and untested technology for the risk of 343
technological failure
CHAPTER 3
DESCRIPTION OF THE ENVIRONMENT
3.1 Study area, period, components and methodology 344
3.2 Status of environmental attributes 346
3.2.1 Meteorological data 346
3.2.1.1 Temperature 348
3.2.1.2 Relative humidity 348
3.2.1.3 Rainfall 348
3.2.1.4 Atmospheric pressure 348
3.2.1.5 Wind 348
3.2.1.6 Cloud cover 354
3.2.2 Geology of the study area 354
3.2.3 Hydrogeology of study area 354
3.2.4 Drainage pattern of the study area 355
3.3 Monitoring of environmental attributes 359
3.3.1 Sampling locations 359
3.3.2 Air quality 361
3.3.3 Noise environment 369
3.3.4 Water environment 376
3.3.4.1 Surface water 376
3.3.4.2 Ground water 385
3.3.5 Soil and geology 390
3.3.6 Ecology 394
3.3.6.1 Anticipated impacts 394
3.3.6.2 Flora 394
3.3.6.3 Fauna 396
3.3.7 Socio-economic environment 397
3.3.7.1 Demographic structure 397
3.3.7.2 Economic environment 398
3.3.8 Social infrastructure available 399
3.2.8.1 Connectivity 400
3.2.8.2 Surrounding industries 405
3.3 Base maps of all environmental components 406
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CHAPTER 4
ANTICIPATED ENVIRONMENTAL IMPACTS & MITIGATION MEASURES
4.1 Details of investigated environmental impacts due to project 410
location, possible accidents, project design, project
construction, regular operations, final decommissioning or
rehabilitation of completed project measures for minimizing
and/or offsetting adverse impacts identified
4.1.1 Environmental impacts due to project location, possible 410
accidents, project design and mitigation measures
4.1.2 Environmental impacts due to regular operations and 422
mitigation measures
4.1.2.1 Scope 423
4.1.2.2 Actions likely to affect the environment during operation phase 423
4.1.2.3 Measures for minimizing & / or offsetting adverse impacts 424
identified - mitigation measures
4.1.2.4 Implementation schedule 428
4.1.3 Environmental impacts due to final decommissioning and 428
mitigation measures
4.2 Irreversible & irretrievable commitments of environmental 428
components
4.3 Assessment of significance of impacts (criteria for determining 428
significance, assigning significance)
4.3.1 Impact matrix 429
CHAPTER 5 431
ANALYSIS OF ALTERNATIVES (TECHNOLOGY & SITE)
CHAPTER 6
ENVIRONMENTAL MONITORING PROGRAM
6.1 Technical aspects of monitoring the effectiveness of mitigation 431
measures (including measurement methodologies, frequency,
location, data analysis, reporting schedules, emergency
procedures, detailed budget and procurement schedules)
6.1.1 Measurement methodology 431
6.1.2 Frequency, location, data analysis, reporting schedules 431
6.1.3 Emergency procedures 433
6.1.4 Budget and procurement schedules 433
CHAPTER 7
ADDITIONAL STUDIES
7.1 Public consultation 434
7.2 Risk assessment 436
7.2.1 Introduction 436
7.2.2 HAZOP analysis 436
7.2.3 Introduction to risk assessment 436
7.2.4 Evaluation of risks 436
7.2.5 Minimization / avoidance of the risk 437
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7.2.6 Quantitative risk analysis 437
7.2.7 Hazard identification 437
7.2.8 Risk assessment 438
7.2.9 Risk assessment for storage of materials 450
7.2.10 Major risk assessment 453
7.2.11 Worst case analysis-control measures 455
7.2.12 Hazard and severity mapping for hazardous raw materials 458
7.2.13 Mitigation measures for storage of hazardous raw materials 464
7.2.14 Safety precautions during solvents storage, handling, 465
transportation and recovery
7.2.14.1 MDC handling and precautions against anticipated hazards 465
7.2.14.2 MDC transportation 465
7.2.15 General safety measures / precautions 466
7.2.16 Safety measures taken in hydrogenation process 467
7.2.17 Occupational health & safety 468
7.3 Air pollution dispersion modeling studies 475
7.3.1 Introduction 475
7.3.2 Air modeling study 476
7.7.2 Meteorological data 477
7.7.3 Presentation of results 477
7.4 Social impact assessment, R&R action plans 488
CHAPTER 8
PROJECT BENEFITS
8.1 Improvements in the physical infrastructure, social 489
infrastructure
8.2 Tangible benefits 489
8.3 Intangible benefits 489
8.4 Other benefits 490
CHAPTER 9
ENVIRONMENTAL COST BENEFIT ANALYSIS
9.1 Natural resources 496
9.2 Air environment 499
9.3 Water environment 499
9.4 Soil environment 500
9.5 Socio-economic environment 500
9.6 Assessment of ecological damage to the environment 501
CHAPTER 10
ENVIRONMENTAL MANAGEMENT PLAN (EMP)
10.1 Introduction 502
10.2 Mitigation measures 502
10.3 Monitoring plans 502
10.4 Roles, responsibilities and resource allocation for monitoring 502
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CHAPTER 11
SUMMARY & CONCLUSION
11.1 Measures adopted to mitigate the impacts 503
CHAPTER 12
DISCLOSURE OF CONSULTANTS ENGAGED
CHAPTER 13
ASSESSMENT OF ECOLOGICAL DAMAGE WITH RESPECT TO AIR, WATER,
LAND AND OTHER ENVIRONMENTAL ATTRIBUTES. EMP COMPRISING
REMEDIATION PLAN & NATURAL & COMMUNITY RESOURCE AUGMENTATION
PLAN VIS-À-VIS ECOLOGICAL DAMAGE ASSESSED & ECONOMIC BENEFITS
DERIVED
13.1 Introduction 509
13.1. A. Historical and Current activities at the site 509
13.2 Preamble to assessment of ecological damage if any, EMP 510
comprising remediation plan & natural & community resource
augmentation plan & economic benefits due to violation
13.3 Brief description of the site 511
13.4 Assessment of ecological/ environmental damage 512
13.4.A. Introduction 512
13.4.B Present scenario 512
13.4.C Zone of influence 513
13.4.D. Environmental status of study 513
13.4.E. Impacts & mitigation measures for sources of pollution during 519
operation
13.4.F. Assessment of ecological damage and suggested remediation 522
measures
13.4.G Concerns raised during public consultation & response 528
13.5 Natural and community resource augmentation plan 545
13.6 Economic benefits derived due to violation 546
13.7 Cost of remediation & measures to improve surrounding areas 547
13.8 Implementation schedule of planned activities and related 547
bank guarantee
13.9 Conclusion and recommendation 548
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List of tables
Table Description Pg.
no. no
1.1 Terms of Reference (TOR) 20
2.1 Co-ordinates (latitude-longitude) of all four corners of the site 32
2.2 Immediate surroundings of project site 33
2.3 Land-use pattern 34
2.4 Value of the company as per CA certificate 38
2.5 APIs manufactured 39
2.6 A Raw materials requirement 40
2.6 B List of raw materials, their sources and mode of transportation 50
2.6 C Storage facilities for raw materials and products 56
2.7 Water consumption and wastewater discharge 310
2.8 Wastewater treatment and disposal 311
2.9A Product-wise water consumption and effluent discharge 316
2.9B Combined effluent characteristics 319
2.10 Solvent recovery 319
2.11 Measures to control evaporation losses and fugitive emissions for 327
few raw materials and solvents
2.12 Air pollution sources, fuel consumption and chimney height details 330
2.13 Solid waste generation & management 336
2.14 Summary of the total quantity of hazardous wastes 336
2.15 Storage and disposal of hazardous wastes 337
2.16 Quantity of by-products generated 339
2.17 Other products generated during manufacturing process 342
3.1 Meteorological data of Raichur for the year 2017 347
3.2 Predominant wind directions in different seasons 348
3.3 Sampling locations for environmental attributes 359
3.4 Ambient air quality data, analysis results 361
3.4A Ambient air quality – summary 366
3.5 Ambient air quality standards – MoEF as per the notification dated 367
16th November 2009 for industrial, residential & rural areas
3.6 A Noise level monitoring, data analysis results – March 2018 370
3.6 B Noise level monitoring, data analysis results –April 2018 371
3.6 C Noise level monitoring, data analysis results – May 2018 373
3.7 Equivalent noise levels 375
3.8 A Surface water analysis – March 2018 377
3.8 B Surface water analysis –April 2018 378
3.8 C Surface water analysis – May 2018 380
3.8 D Designated best use of surface water 382
3.8 E Class of surface water analysed – March 2018 383
3.8 F Class of surface water analysed – April 2018 383
3.8 G Class of surface water analysed – May 2018 384
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3.9 A Ground water analysis – March 2018 385
3.9 B Ground water analysis – April 2018 386
3.9 Ground water analysis – May 2018 388
3.10A Physico-chemical characteristics of soil –March 2018 390
3.10 B Physico-chemical characteristics of soil – April 2018 391
3.10 C Physico-chemical characteristics of soil –May 2018 392
3.10 D Soil classification 393
3.11 Flora in the study area 395
3.12 Fauna in the study area 396
3.13 Summary of demographic structure 397
3.14 List of infrastructural facilities in the surroundings 399
3.15 Connectivity from the project site 400
3.16 Surrounding industries 405
3.17 Existing land-use pattern 406
4.1 Air quality management during operation phase 425
4.2 Noise management during operation phase 426
4.3 Water quality management during operation phase 427
4.4 Land quality management during operation phase 428
4.5 Impact matrix 430
6.1 Monitoring schedule for environmental parameters 432
6.2 Financial allocation/budgetary provisions for environmental 433
management aspects
7.1 Probable hazards in the plant 438
7.2 Data considered for calculation of GLC 476
7.3 Predicted incremental short-term concentrations 477
7.4 Resultant Maximum 24 hourly concentrations 487
8.1 CSR activity - windmills 490
8.2 Other CSR activities 491
9.1 Production – consented vs actual (for last 3 consecutive years) 497
9.2 Water consumption - comparison between consented versus actual 499
water consumption (for last 2 consecutive years)
9.3 Hazardous waste generation - comparison between authorized 500
versus actual water consumption (for last 2 consecutive years)
9.4 Summary of CBA (Cost Benefit Analysis) 501
11.1 Measures adopted to mitigate the impacts 505
13.1 Land-use pattern 511
13.2 Immediate surroundings of project site 511
13.3 Groundwater quality in the immediate vicinity of the industry 516
13.4 Mitigation measures 519
13.5 Budgetary provisions for EMP 521
13.6 Assessment of environmental / ecological damage, remediation 522
measures & cost suggested
13.7 Economic benefits derived due to violation 546
13.8 Financial allocation for remediation 547
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List of figures
Fig. Description Pg. no
No.
2.1 General and specific location of industry 34
2.2 Google map with site boundary 35
2.3 Plant layout 36
2.4 Site Photographs 37
2.5 Photographs of raw materials storage area 56
2.6 Green chemistry – continuous flow reactors 308
2.7 Schematic representation of the overall feasibility and 309
environmental assessment process
2.8 Wastewater storage tanks at Unit I (20 KL capacity for each) 311
2.9 Effluent Treatment Plant at Unit II 312
2.10 Water balance chart 313
2.11 Solvent recovery system 324
2.12 Solvent storage area 325
2.13 Condenser system to reactors for solvent management 326
2.14 Centrifuge connected to scrubber 327
2.15 Rainwater harvesting tank and groundwater recharge pits 329
2.16 Photographs of air pollution sources and control equipments 331
2.17 Hazardous waste storage area 338
3.1 Topo map 345
3.2 Wind rose diagrams 349
3.3 A Hydrogeology of Raichur District 356
3.3 B Hydrogeology of Mahbubnagar District 357
3.4 Drainage pattern of Raichur District 358
3.5 Google map showing sampling locations for environmental 360
attributes
3.6 Wind rose diagram – March (sampling period) 368
3.7 Google map showing infrastructural facilities and connectivity 401
3.8 Google map 1 km radius 402
3.11 Google map showing surrounding industries 405
3.12 Existing land-use pattern 407
3.13 Google map showing surrounding water bodies 409
4.1 Personal with safety PPEs in work area 411
4.2 Eye and body showers 411
4.3 ISO 18001:2007 (Occupational Health and Safety Management 413
System) certification
4.4 Health and safety policy 414
4.5 Firefighting facilities 416
4.6 ISO 14001:2015 (Environmental Management System) 418
x
certification
4.7 Environment policy 419
4.8 A Spill control kits provided at various locations 421
4.8 B Green-belt 422
6.1 Continuous online monitoring system 433
7.1 Screenshot from KIADB website 435
7.2 Particulate matter (PM10) isotherms for proposed project 478
7.3 Sulfur di-oxide (SO2) isotherms for proposed project 481
7.4 Oxides of nitrogen (NOx) isotherms for proposed project 484
8.1 Photographs of CSR activities 493
10.1 Organization chart of Environment Cell 503
13.1 Google map showing sampling locations within and in the 515
immediate vicinity of the project site
13.2 Historical google maps 518
13.3 Photographs 544
List of enclosures
Enclosure Details Pg no.
no.
1 1. Borewell water analyzed at 550-554
Wells in Growth Centre (by KSPCB).
Yedlapur
2. Konan halla water at the outlet of surface water drain from
Deosugur industrial area
2 Dismissal order dated 05-10-2018 for complaint file case No: 33/2014- 555-557
15
3 1. Medical report regarding health status of people in the surrounding 558-563
areas obtained from the Department of Health and Family Welfare,
Government of Karnataka.
2. Sample health reports of workers at Shilpa Medicare Ltd. Unit I.
STAY ORDER 564-568
ANNEXURES (569-858)
xi
M/s. Shilpa Medicare Ltd. Unit I
EXECUTIVE SUMMARY
1. INTRODUCTION
COMPANY HISTORY
M/s. Shilpa Medicare Limited (SML), 312-6-214/A1, Hyderabad Road,

Raichur 584135, Karnataka, is a Public Limited Company and has two units
at Raichur.
Unit I is located at Plot No. 1A, 1A"P", 1B, 2, 2A, 2B, 3A to 3E, 4A, 4B, 4C,
5A & 5B, Deosugar Industrial Area, Raichur, Karnataka.
Raichur Thermal Power Plant of Karnataka Power Corporation is the
neighbouring unit producing 1,720 MW of power.
Unit I is manufacturing APIs and intermediates. It has been classified as a
red category by KSPCB. The said Company is manufacturing lifesaving anti-
cancer drugs which are made available at an affordable price and is also
exporting the same to various countries and hitherto it has earned foreign
exchange equivalent to Rs. 1500 Crores from one Unit.
This activity is covered under the EIA notification S.O.1533(E) dated
14-09-2006 under schedule 5(f).
The said Company also has another unit called as Unit II at Plot No. 33, 33A,
40 to 47, Industrial Growth Centre, Chicksugur Village, Raichur District. This
Unit was established in the year 2008 with prior Environmental Clearance
from MoEF under the EIA notification.
As permitted under the consent conditions, the effluent from Unit I is taken
to Unit II for necessary treatment in accordance with law.
The Company is incorporated under the Indian Companies Act and has
undergone various changes in its constitution as follows:
a) Originally one M/s. Green Leaves Organics Pvt. Ltd., which was a small scale
industry was established prior to 1994.
b) One M/s. Shilpa Antibiotics Private Limited which was also a small scale
industry was established in the year 1987 and commissioned during 1989. Later
on the said Shilpa Antibiotics Private Limited became Shilpa Antibiotics
Limited. Public issues were called and became a public limited company in the
year 1995.
c) The name of M/s. Shilpa Antibiotics Limited was later changed as Shilpa
Medicare Limited with effect from 13-12-2002.
d) As the said M/s. Green Leaves Organics Pvt. Ltd., was sick and was not in
operation the said company was taken over by one M/s. Shilpa Oragincs Pvt.
Ltd. on 28-06-2000 through the Karnataka State Finance Corporation and the
and the name of the said company was changed as M/s. Shilpa Organics Pvt.
Ltd.
e) Subsequently both M/s. Shilpa Organics Pvt. Ltd. and Shilpa Medicare454
Ltd. were merged and became M/s. Shilpa Medicare Limited on 01-04-2007.
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PRODUCTION HISTORY
Prior to 2006, the then Shilpa Organics Pvt. Ltd. was manufacturing 4
products viz. Trimethoprim, Sulphmethoxazole, 1,3,5-Trimethoxy benzene
and Terfinadine of total capacity 9.4 MT per month. Prior to the merger of
Shilpa Organics Pvt. Ltd., the Company Shilpa Medicare Ltd. was also
manufacturing 4 products viz. Trimethoprim, Sulphamethoxazole, Nifedine
and Atenaol with a total production capacity of 20 MT per month.
After merger, Shilpa Medicare Ltd. had a Consent to Manufacture 6 products
of capacity 29.4 MT per month, viz., Trimethoprim, Sulphamethoxazole,
Nifedine, Atenalol, 1,3,5- Trimethoxy Benzene and Terfinadine.
During 2010, the industry conceptualized for change in product mix.
Karnataka State Pollution Control Board (KSPCB), after appraising the
project before the Technical Advisory Committee (TAC) has granted the
Consent to Establish (CTE) on 7-5-2011 for modification of existing products
without increase in pollution load. Subsequently Consent to Operate under
the Water and the Air Act was accorded by Karnataka State Pollution
Control Board for 30 products with a total capacity of 26.44 MT/month, in`
the process 5 of the old products were dropped and 25 new products w
ere added, without increase in the pollution load and quantity of
production.
This was renewed subsequently upto 30-06-2016. Consent application for
further period is made.
The Company was carrying on its activities and was operating by securing
necessary consent for operation from time to time ever since its
commencement from earlier to 1994 and lastly vide CTO issued by the
Board on 08-10-2015 which was valid till 30-06-2016.
The application made for consent renewal is held back by KSPCB. The
Company has been directed to obtain environmental clearance for the
change in product mix. Therefore, it is proposed to obtain Environment
Clearance for these 30 products with a total production capacity of 26.44
MT/month.
2. PURPOSE OF STUDY
Application was made to MoEFCC with project report for obtaining

Environmental Clearance (EC) as the project falls under category 5(f) - bulk
drugs and intermediates.
By virtue of MoEF notification no. S.O.804(E) dated 14.3.2017 application
was made to MoEFCC under violation category seeking environmental
clearance. The report was appraised by Expert appraisal Committee
related to violation of the EIA notification, 2006 on 16th Jan 2018. ToR was
issued by the Committee, accordingly environment impact assessment
study is carried out and the report is prepared.
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3. EXTENT OF STUDY AND AREA COVERED
The broad scope of this EIA study includes detailed characterization of

environmental parameters/attributes (ambient air, water, soil, noise) in of 10
km radius from the project site. This EIA is prepared, based on studies carried
out during March to May 2018 and duly addressing the TOR laid down by
MoEFCC.
4. PROJECT AT A GLANCE
Name of the industry M/s. Shilpa Medicare Limited (SML)

Description of the industry Active Pharmaceutical Ingredients (APIs) and
intermediates manufacturing industry
Location of the industry Plot No. 1A, 1A"P", 1B, 2, 2A, 2B, 3A to 3E, 4A,
4B, 5A & 5B, Deosugar Industrial Area, Raichur,
Karnataka.
GPS coordinates and elevation Latitude 16°20'44.97"N
of the project site with Longitude 77°20'37.07"E and at
respect to MSL 358 m above MSL.
Address for correspondence 312-6-214/A1, Hyderabad Road,
Raichur 584 135, Karnataka
Constitution of the company Public Limited Company
Year of establishment of the Established in the year 1987 and commissioned
existing industry during 1989.
Products manufactured with Sl. APIs and intermediates Production
production capacities no. capacity
(MT/annum)
1 Acebrophylline 36
2 Ambroxol HCl 72
3 Buflomedil HCl 12
4 Nifedipine 12
5 Phenyl ephrine HCl 18
6 Sildenafil citrate 12
7 Ticlopidine HCl 24
8 Ursodeoxycholic acid 108
Oncology products
9 Anastrozole 0.06
10 Bendamustine HCl 0.06
11 Bicalutamide 2.4
12 Bortezomib 0.012
13 Capecitabine 12
14 Carboplatin 0.6
15 Cisplatin 0.6
16 Docetaxel trihydrate 0.6
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17 Epirubicin HCl 0.24

18 Gefitinib 0.12
19 Gemcitabine HCl 3
20 Imatinib mesylate 1.2
21 Irinotecan HCl trihydrate 0.12
22 Lenalidomide 0.012
23 Letrozole 0.06
24 Oxaliplatin 0.06
25 Paclitaxel 0.12
26 Pemetrexed 0.12
27 Temozolomide 1.2
28 Thalidomide 0.6
29 Topotecan HCl 0.06
30 Zoledronic acid 0.06
TOTAL 317.304
Total value of industry Rs. 13,038.51 Lakhs
(Rupees One Hundred and Thirty Crores Thirty
Eight Lakhs Fifty One Thousand Only)
as on 31st March 2017 as per the Chartered
Accountant (CA) certificate.
Total people employed 150 (both permanent and contract)
5. ENVIRONMENTAL EVALUATION
ENVIRONMENTAL STATUS
Three months data during the period of March to May 2018 has been collected
for environmental attributes like air, water, soil, noise etc., within a radius of
10 km to assess the environmental status around the industry area. Secondary
data from different government, semi-government and private agencies and
other sources are collected, interpreted, compiled and presented to
authenticate and draw conclusion/s regarding the status of the environment in
the study area.
PUBLIC AMENITIES
Water supply
Most of the villages in the study area are provided with basic civic amenities.
Water sources are Krishna river, open wells and bore wells.
Transportation and communication

The project site is well connected with roadways, NH-167 / SH 51 is adjacent
to the industry towards east, enabling easy transportation of materials to and
from the industry.
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Electricity
Electricity is supplied from GESCOM for various needs such as domestic,
industrial and agricultural requirements in the study area.
Health, medical and educational facility

Few health and medical facilities are available.
AIR ENVIRONMENT
The ambient air quality status around the industry is characterized using the
following sources of data.
Ambient air quality monitoring data for selected locations within 10 km
radius of study area.
Meteorological data
Air quality
To evaluate the status of the ambient air quality, a short-term survey was
conducted at seven locations around the proposed project site for three
months during March to May 2018. Ambient air quality standards MoEF as per
the notification dated 16th November 2009 for industrial, residential and rural
areas were considered as the standard. During the study period, concentrations
of SPM (PM10 & PM2.5), SO2, NOx , CO were measured. From the observations, it
has been concluded that the concentration of pollutants under consideration
are within the specified limits of NAAQS for industrial and residential areas.
NOISE ENVIRONMENT
Noise level monitoring was conducted at seven locations within the study area
representing industrial and residential areas. The field observations during the
study period indicate that the ambient noise levels in both industrial and
residential areas are within the CPCB limits during most time of the day and
night. However on few days, at certain times the noise levels exceed the limits
stipulated due to truck/vehicular movement.
WATER ENVIRONMENT
Seven groundwater samples were collected in the study zone including project
site and surroundings and analyzed for their physico- chemical characteristics
to evaluate the existing status of water quality. The ground water analysis
results indicate that the parameters are within the permissible limits of the
Drinking Water Standards (IS: 10500-1991) except Muraharidoddi in Telangana.
Nitrates at Muraharidoddi in Telangana after crossing river Krishna are more
than the acceptable & permissible limit of 45 mg/L specified ranging from 96-
99 mg/L. This village is surrounded by agricultural fields where there is
extensive use of fertilizers.
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In addition, surface water sources analyzed for water quality are Krishna river
(both upstream & downstream), Rajasab Talav/ Merched Kere and Konad Halla
all located within 10 km distance form the industry. All the samples of surface
water analyzed come under class C (Drinking water source after conventional
treatment and disinfection) & D (Propagation of wildlife and fisheries).
The required water for this industry area is from KIADB (Krishna river).
SOIL ENVIRONMENT
The soil in the study area is moderately to strongly alkaline. Potassium,

nitrogen and phosphorous content is very less.
FLORA and FAUNA
There are naturally growing plants, vegetation and grass. Land within the study
zone is moderately dry, barren with few trees & bushes surrounding the rural
village settings. Tree species attaining moderate to considerable height are
found to be present in sparsely distributed area. The biodiversity of vegetation
in the area is not very high due to industries, brick industries and agro
ecosystem.
In the industry, an area of 33,591.25 SQM i.e. 35% of the total plot area is open
space and landscape/green-belt. About 50 native indigenous trees such as
Neem (Azadirachta indica) and Pongamia (Millettia pinnata) are present.
The fauna found in the region does not show much diversity since the forests in
the district are of mixed dry deciduous type consisting of open scrub jungles.
Plenty of snakes, scorpions and lizards are found. Few water birds such as
Indian pond heron, grey heron, river tern are found near the Krishna river.
SOCIO-ECONOMIC ENVIRONMENT
The industry has generated direct employment opportunities for 150 people out
of which 70% (105) are local people. The main occupation of the people in the
study area is agriculture. Paddy is extensively cultivated. As there was
apprehensions expressed by few participants during the public hearing on
13-11-2018 about the contamination of Konad/Konnan halla a natural stream,
monitoring was carried out. Inference that can be drawn from monitoring are
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Konad/ Konnan halla

After joining of
Sl. Class Close to WTP Class
Parameters Units surface drain
No. of area being used of
from Deosugur
water for paddy fields water
industrial area
MPN/
Total coliform
1 100 150 120
organisms
mL
2 pH -- 7.67 7.32
C D
3 Dissolved oxygen mg/L 4.5 3.9
Biochemical Oxygen
4 Demand (BOD) 5 mg/L 5.2 5.6
days 20 C
Konad/Konnan halla water analysed during March to May 2018 comes
under class C&D of surface water before joining of storm water drain
from Deosogur industrial area.
6. ENVIRONMENTAL MANAGEMENT PLAN (EMP) OPERATION PHASE
AIR EMISSIONS
The sources of air pollution in the industry are
Process section provided with column scrubbers and stack of adequate
heights.
Two boilers of 4 TPH capacity each provided with multicyclones and
combined stack of 30 m height.
DG setsof 325 kVA capacity each provided with stacks of 5 m ARL height
and acoustic enclosures.
Impact on air quality

No adverse impact on air environment is envisaged as adequate measures are
adopted. The same is substantiated in the monthly monitoring reports of
ambient air quality within the industry premises.
WATER POLLUTION
The sources of water pollution are domestic sewage and industrial effluent.
Wastewater treatment and disposal details

The treatment methods and the final disposal of each type of wastewater
generated is shown in the table below
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Sewage/wastewater treatment and discharge

Effluent
Treatment Final disposal point
(wastewater)
units provided
generated from
Septic tank
(a) Domestic Septic tank and soak pit.
and soak pit
After pre-treatment, the effluent, i.e.,
neutralized effluent is sent to Shilpa Medicare Unit
The effluent II for final treatment and disposal.
generated Two 20 KL wastewater storage tanks provided at
from the Unit I.
(b) Industrial industry is At Unit II, Multi Effect Evaporator and Agitated
treated in Thin Film Drier are provided. The capacity of the
neutralization system is good enough to handle effluent from Unit
tank. I & II. The condensate from the MEE is again
treated in Biological ETP and RO, at Unit II. RO
permeate is reused for cooling tower and boilers.
Impact on water environment

No adverse impact on the water environment is observed as adequate facilities
are provided for treatment and disposal of effluent.
NOISE
Sources of noise
DG sets are the major noise generating sources for which acoustic
enclosures are present.
Handling and conveying of raw materials and semi-finished
components to different operations can be a source of noise
pollution. This is controlled by regular maintenance.
Impact on noise level

Monthly monitoring reports show the ambient noise levels within the industry
premises are within the stipulated limits for industrial areas.
SOLID WASTE
The solid waste generated from the industry is of 2 types non-hazardous solid
waste and hazardous solid waste. The total quantity of waste generated with
disposal & management options are detailed below.
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Non-hazardous solid waste
Solid waste generation and management

Domestic solid waste
Total no. of employees 150
Assuming per capita solid waste generation rate as 0.25 kg/capita/day
Quantity of solid waste generated 37.5 kg/day
Organic solid waste : 60 % of the 22.5 kg/day
total waste
Inorganic solid waste : 40 % of the 15 kg/day
total waste
Disposal of domestic solid waste Segregated at source, collected in
bins and disposed to waste
collection system of the
Municipality.
Boiler ash
Quantity of boiler ash generated 500 kg/day
Storage Stored in covered shed.
Disposal Handed over to local brick
manufacturers.
Hazardous solid waste

The quantities of hazardous waste generated from various processes their
management are tabulated below
Hazardous wastes
Sl. Storage Name of disposal
Source Quantity Mode of disposal
No. container facility
Sent to KSPCB
Used oil from Leak proof authorized spent oil re-
1 0.2 KL/annum KM Oils Pvt. Ltd.
DG sets containers processors for
regeneration & re-use.
Handed over to KSPCB
Panchamukhi
Spent 39.6 Leak proof authorized
2 Pharma Chem,
solvents KL/annum containers recyclers/re-
Ramanagara
processors.
Distillation HDPE carboys E Nano Incitech,
3 2 MT/annum Sent for incineration.
residue / LDPE bags Ramanagara
Process HDPE carboys E Nano Incitech,
4 2 MT/annum Sent for incineration.
residue / LDPE bags Ramanagara
Discarded 200 Handed over to KSPCB Hajira Enterprises,
5 --
containers No.s/annum authorized recyclers. Ramanagara
E Nano Incitech,
6 Spent carbon 1 MT/annum Polybags Sent for incineration.
Ramanagara
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7. ENVIRONMENTAL IMPACTS AND MANAGEMENT PLAN (EMP) - OPERATION PHASE

Detailed in Chapter 4, Section 4.3.1 of this EIA report.
8. POST-PROJECT MONITORING PLAN

Monitoring program currenty being followed in the industry is detailed in
Chapter 6, Section 6.1.2 of this EIA report.
9. CONCLUSION
The overall impact of the project is beneficial as the impacts on air, noise,
water, soil and biological environment are not significant and socio-economic
impacts are predominantly positive. All the relevant safety norms &
precautionary measures are incorporated in the system, to ensure that the
project is environmentally viable.
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CHAPTER 1
INTRODUCTION
1.1 PURPOSE OF THE REPORT
M/s. Shilpa Medicare Limited, Unit I is located at Plot No. 1A, 1A"P", 1B, 2, 2A,
2B, 3A to 3E, 4A, 4B, 4C, 5A & 5B, Deosugar Industrial Area, Raichur,
Karnataka. The Company is manufacturing Active Pharmaceutical Ingredients
(APIs) and Intermediates. This activity is covered under schedule 5(f) of the EIA
notification S.O.1533(E) dated 14-09-2006.
Company manufactures lifesaving anti-cancer drugs which are made available

at an affordable price. Also, some of it is being exported to other countries and
hitherto it has earned valuable foreign exchange equivalent to Rs. 1500 Crores
from one Unit.
The Company (Unit I) was carrying on its activities and was operating by
securing necessary consent for operation from time to time ever since its
commencement as issued by the Karnataka State Pollution Control Board
(KSPCB).
The Company is incorporated under the Indian Companies Act and has
undergone various changes in its constitution as follows:
Originally M/s. Green Leaves Organics Pvt. Ltd., which was a small scale
industry, was established prior to 1994.
M/s. Shilpa Antibiotics Private Limited which was also a small scale industry
was established in the year 1987 and commissioned during 1989. Later on
the said Shilpa Antibiotics Private Limited became Shilpa Antibiotics
Limited. Public issues were called and became a public limited company in
the year 1995.
The name of M/s. Shilpa Antibiotics Limited was later changed as Shilpa
Medicare Limited with effect from 13-12-2002.
As the said M/s. Green Leaves Organics Pvt. Ltd. was sick and was not in
operation the said company was taken over by one M/s. Shilpa Organics Pvt.
Ltd. on 28-06-2000 through the Karnataka State Finance Corporation and
the name of the said company was changed as M/s. Shilpa Organics Pvt. Ltd.
Subsequently both M/s. Shilpa Organics Pvt. Ltd. and Shilpa Medicare
Limited were merged and became M/s. Shilpa Medicare Limited on
01-04-2007.
The Company, Shilpa Organics Pvt. Ltd., prior to 2006 was manufacturing 4
products by name Trimethoprim, Sulphmethoxazole, 1,3,5-Trimethoxy
benzene & Terfinadine of total capacity 9.4 MT per month. Prior to the
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merger of Shilpa Organics Pvt. Ltd., the said Company was also
manufacturing 4 products by name Trimethoprim, Sulphamethoxazole,
Nifedine and Atenaol with a total production capacity of 20 MT per month.
The Company prior to the said merger had consent from the Karnataka State
Pollution Board to manufacture 6 products of capacity 29.4 MT per month.
On 07-05-2011 consent to establish for the change in product mix was issued
by the Board for 30 products with a total capacity of 26.44 MT per month.
During the issue of the said consent 25 new products were added by
dropping 5 old products without increasing the pollution load which fact is
disclosed in the consent to establish issued to the company. A true copy of
the said CTE is enclosed as Annexure A2.
Subsequently the Consent to Operate was issued on 30-03-2012 valid up to
30-06-2012, renewed subsequently upto 30-06-2016. Consent application is
made for further renewal.
The said Company also has another unit called as Unit No. II at Plot No. 33,
33A, 40 to 47, Industrial Growth Centre, Chicksugur Village, Raichur District.
The said Unit No. II was established in the year 2008. Unit II has obtained prior
EC and consent to establish in accordance with law. As permitted under the
consent conditions, the effluent from Unit I is taken to Unit II for necessary
treatment in accordance with law. The treated effluent is reused.
As regard to air pollution control, industry has complied with the regulatory
norms as per consent conditions.
The hazardous waste generated is being stored in the premises in a secured

manner and disposed to authorized persons.
Originally the activity of the Company was covered under the EIA Notification
No. S.O. 60(E) dated 27-01-1994 issued by the MOEF. As the Unit was
established prior to EIA notification 1994 and thereafter upto 2011 there was
no change in product, hence there was no requirement to obtain Environmental
Clearance (EC) from the Central Government or the State Government. In 2011
when the product mix was done it was within the earlier manufacturing
capacity and there was no increase in pollution load which was certified by
KSPCB and CTE and CTO was granted valid upto 30.6.2016. Thereafter, when
the application was made for renewal of consent under the Water and the Air
Act to KSPCB it was informed in letter dated 18th Jan 2017 to obtain
Environmental Clearance for the change in product mix.
In the mean-time the Ministry of Environment, Forest and Climate change

issued another notification bearing No. S.O.804 (E) dated 14-03-2017. By virtue
of the said notification opportunity was given to industries to set activities in
order by obtaining necessary permissions as required under the Environment
Protection Act and EIA notifications. Accordingly, application was made to
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MoEFCC seeking environmental clearance under the violation category in April

2017.
The Company has fully complied with all the previous consent conditions and
operated in accordance with law except that it has to secure EC from MOEFCC
which has been made mandatory by virtue of the 2006 notification and the
time is extended by virtue of the 14.3.2017 notification.
In the 2nd meeting of Expert Appraisal Committee (EAC) for the proposal
involving violation of EIA Notification, 2006, held on 16 th January, 2018 the
proposal was appraised.
In the Minutes of 3rd meeting of Expert Appraisal Committee for projects

related to violation of the EIA Notification, 2006 held on 30-31 January, 2018
Terms of Reference (ToR) was issued for conducting study and preparation of
Environment Impact Assessment (EIA) report.
The EIA report is prepared duly incorporating the terms of reference given by
the Ministry of Environment, Forest & Climate Change.
1.2 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT
PROJECT
M/s. Shilpa Medicare Limited (SML)., Unit I, is located at Plot No. 1A, 1A"P", 1B,
2, 2A, 2B, 3A to 3E, 4A, 4B, 4C, 5A & 5B, Deosugar Industrial Area, Raichur,
Karnataka. The unit is in operation since 1989. Deosugar Industrial Area is a
designated industrial area established by Karnataka Industrial Area
Development Board (KIADB) on 27-04-1987.
PROJECT PROPONENT
M/s. Shilpa Medicare Limited (SML), No. 10/80, Rajendra Gunj, Raichur
584 102, Karnataka, a public limited company has two units at Raichur. Unit I is
Active Pharmaceutical Ingredients (APIs) & Intermediates manufacturing
industry with R & D activity at Plot No. 1A, 1A"P", 1B, 2, 2A, 2B, 3A to 3E, 4A,
4B, 4C, 5A & 5B, Deosugar Industrial Area, Raichur, Karnataka. Unit I initially
started producing Trimethoprim IP/BP with in-house developed technology.
The Company started manufacturing both for export and domestic markets in
the year 1992.
The Company was listed on Bombay Stock Exchange on Jun 19, 1995 and
National Stock Exchange (NSE) on Dec 03, 2009. Subsequently, Shilpa Medicare
has gained World Health Organization-Good Manufacturing Practices (GMP)
Certificate recognition. In the relentless efforts for growth-Shilpa Medicare
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successfully set up a 100% EOU project in at Raichur Growth Center in 2008

incurring a capital expenditure of nearly Rs.1000 million.
Today, Shilpa Medicare has carved a niche in the exceedingly competitive and
quality-conscious field of pharmaceuticals manufacturing. The aim is to be
amongst global leaders in generic APIs & pharmaceutical products
manufacturers, finding innovative ways to make affordable medicines
accessible to every section of the society. SML is committed to its mission of
achieving affordable healthcare, which shall be available to more and more
- is the motto.
-
Oncology APIs and intermediates. Further, to consolidate in field of generic
APIs and formulations, we are striving for achieving excellence by putting our
relentless efforts in field of Novel Drug Delivery Systems (NDDS) and peptides,
along with widening our focus to other therapy areas. Shilpa Medicare aims for
ensuring affordable healthcare without compromising quality standards.
Shilpa Medicare is an ISO 14001: 2015, ISO 18001:2007 certified organization
and committed to implement, maintain and improve the environmental
management system so as to assure its conformity with the stated
environmental policy. A broad and integrated portfolio of products and services
(CRAMS) are offered to the global pharmaceutical industry. In recognition of
the outstanding performance, Shilpa Medicare has received many awards &
recognitions
First Prize, National Energy Conservation award in Drugs & Pharmaceutical
Sector received from Shri. Pranav Mukharji President of India on
14-12-2012.
National Small scale Entrepreneurs Award in 1994, from the President of
India.
Consistently winning the best Exporter award from the Govt. of Karnataka
year on year since 1994.
Consistently earning Foreign Exchange for the country to the tune of
Rs.3,500 Crores so far.
Being proactive in approach, Shilpa Medicare continuously seeks out avenues

and available opportunities for development of new products, drawing strength
from the zeal to provide affordable healthcare to everyone. Shilpa Medicare
has state-of-the-art infrastructure, more than 2 decades of experience, and
rigorous across-the-board quality standards which contributes to the
commitment of - Quality Healthcare at a price which everyone can afford. Few
subsidiary organizations of Shilpa Medicare companies which share the same
vision and business plans are:
Loba Finechem
Raichem Life Sciences
Nu Therapeutics
Reva Pharma
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The products of Shilpa Medicare are exported to USA, Canada, Australia, Japan
and European Countries viz., Germany, Switzerland, Netherlands, Belgium,
Spain, Greece, Cyprus, Italy, United Kingdom etc. and also to South American
Countries like Mexico, Brazil, and Columbia etc.; African Countries like Kenya,
Nigeria and West Indies etc. and Asian Countries like Singapore, Taiwan, China,
Malaysia, Thailand, etc.
ave received key regulatory approvals for its

facilities as well as for the products from EDQM, UK-MHRA, TGA, USFDA, PMDA
and KFDA. With diverse regulatory recognized manufacturing set ups and
excellent scientific manpower, Shilpa has been on a consistent growth path,
thus defining - Shilpa Medicare-
At Shilpa Medicare, every effort is made to create an environment of openness

and transparency and believe in maintaining the trust and respect of all
stakeholders and customers by acting with integrity at all times. The ultimate
goal is to help all levels of society in living healthier lives.
Unit-II
Unit-II of Shilpa Medicare Ltd. is a 100% Export Oriented API Unit established
during 2008. This unit is at at a distance of 4.2 km from Unit I in the south east
direction. It is also well connected to state highway as being located just
adjacent to Hyderabad-Raichur state highway. This unit is certified by ISO
14001 and approved by WHO-GMP/EUGMP.
This unit has expertise in:

Isolation, purification, separation techniques
Asymmetric synthesis
Chiral technology
Reduction reactions
Customized synthesis/CRAMS activities
1.3 BRIEF DESCRIPTION OF NATURE, SIZE, LOCATION OF THE PROJECT AND ITS
IMPORTANCE TO THE COUNTRY, REGION
1.3.1 NATURE, SIZE AND LOCATION OF THE PROJECT
M/s. Shilpa Medicare Limited Unit I is an Active Pharmaceutical Ingredients

(APIs) and intermediates manufacturing industry. APIs and intermediates
manufacturing industries are classified into red category both by Central
Pollution Control Board (CPCB) and Karnataka State Pollution Control Board
(KSPCB).
The total value of Unit I is Rs. 13,038.51 Lakhs as on 31st March 2017.
Location of the project site is in Chapter 2, Section 2.3 of this report.
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1.3.2 IMPORTANCE OF THE PROJECT TO THE COUNTRY, REGION
Drugs have become a part of our life for sustaining many of our day-to-day
activities, preventing and controlling diseases. Bulk drugs manufacturing sector
in India is well established and has recorded a steady growth in the overall
Indian industrial scenario. The bulk drugs and allied industries have been
amongst the fastest growing segments of the Indian industry.
The Indian pharmaceuticals market is the third largest in terms of volume and
thirteenth largest in terms of value. It accounts for 20 percent in the volume
terms and 1.4 percent in value terms of the Global Pharmaceutical Industry as
per a report by Equity Master. India is the largest provider of generic drugs
globally with the Indian generics accounting for 20 percent of global exports in
terms of volume. Of late, consolidation has become an important characteristic
of the Indian pharmaceutical market as the industry is highly fragmented.
Presently over 80 percent of the antiretroviral drugs used globally to combat

AIDS (Acquired Immuno Deficiency Syndrome) are supplied by Indian
pharmaceutical firms.
MARKET SIZE
Indian pharmaceutical sector is estimated to account for 3.1 3.6 percent of

the global pharmaceutical industry in value terms and 10 percent in volume
terms. The market is expected to grow to US$ 55 billion by 2020, thereby
emerging as the sixth largest pharmaceutical market globally by absolute size,
as stated by Mr. Arun Singh, Indian Ambassador to the US. Branded generics
dominate the pharmaceuticals market, constituting nearly 80 percent of the
market share (in terms of revenues). The sector is expected to generate 58,000
additional job opportunities by the year 2025.
$16.8 billion in 2016-17 and are

expected to grow by 30 percent over the next three years to reach US $20
billion by 2020, according to the Pharmaceuticals Export Promotion Council of
India (PHARMEXCIL).
Indian companies received 304 Abbreviated New Drug Application (ANDA)

approvals from the US Food and Drug Administration (USFDA) in 2017. The
country accounts for around 30 percent (by volume) and about 10 percent
(value) in the US$ 70-80 billion US generics market.
GOVERNMENT INITIATIVES
Some of the initiatives taken by the government to promote the

pharmaceutical sector in India are as follows:
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The Government of India is planning to set up an electronic platform to

regulate online pharmacies under a new policy, in order to stop any
misuse due to easy availability.
The Government of India unveiled 'Pharma Vision 2020' aimed at making
India a global leader in end-to-end drug manufacture. Approval time for
new facilities has been reduced to boost investments.
The government introduced mechanisms such as the Drug Price Control
Order and the National Pharmaceutical Pricing Authority to deal with the
issue of affordability and availability of medicines.
ROAD AHEAD
The Indian pharmaceutical market size is expected to grow to US $100 billion

by 2025, driven by increasing consumer spending, rapid urbanization and
expected to grow by 9 percent year-on-year through fiscal 2020.
Going forward, better growth in domestic sales would also depend on the
ability of companies to align their product portfolio towards chronic therapies
for diseases such as such as cardiovascular, anti-diabetes, anti-depressants and
anti-cancers that are on the rise.
The Indian government has taken many steps to reduce costs and bring down
healthcare expenses. Speedy introduction of generic drugs into the market has
remained in focus and is expected to benefit the Indian pharmaceutical
companies. In addition, the thrust on rural health programs, lifesaving drugs
and preventive vaccines also augurs well for the pharmaceutical companies.
Reference source: Indian Brand Equity Foundation
Karnataka is one of the fastest growing states in terms of the pharmaceutical

sector in India. The state occupies the fifth position in the pharmaceutical
The state contributes about 10% to the pharmaceutical export revenues of the
country. At present Karnataka is home to more than 230 pharma and biotech
companies.
International pharma majors have preferred many companies from the State.
When large companies offer their services on contractual basis to global MNCs,
they want to outsource drug production for the domestic market from quality
small-medium manufacturers in State. Here the small-medium units ideally fit
into slot as third party manufacturers and serve as major hubs for
pharmaceutical outsourcing. In fact, two of Indian pharma sectors top five
brands, are already outsourced from Karnataka. The units have been
recognized for stringent regulatory enforcement and known to manufacture
quality products.
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PROJECT NEED
Cancer cases in India are on the rise with more than 3.5 million prevalent cases
& a million new cancer cases being diagnosed every year. Among men, the
cancer of the head and neck and in women cancer of cervix and breast are
leading forms of cancer. The oncology segment in India is now witnessing
increasing domestic presence with a large number of Indian companies entering
into the foray. Not only are these companies competing for the existing
portfolio but are also actively pursuing research for introduction of newer &
improved specialty products. The sale of cancer drugs is expected to grow at
nearly twice the rate of the rest of pharmaceuticals. With a large number of
patents for many oncology products due to expire shortly, there is a lot of
scope in oncology segment. Therefore, SML proposes to manufacture 22
oncology products to take advantage of the growing demand in this sector and
also to ensure availability of life saving drugs.
1.4 SCOPE OF STUDY DETAILS OF REGULATORY SCOPING CARRIED OUT (AS

PER TERMS OF REFERENCE)
The purpose of EIA/EMP is to critically analyse the environmental impacts due

to APIs and intermediates manufacturing industry and to suggest mitigation
measures to reduce the pollution and to delineate an Environmental
Management Plan along with recommendations and suggestions.
1.4.1 SCOPE OF STUDY
Environmental baseline monitoring has been carried out for three months i.e.
March to May 2018. Chapter 13 i.e. Assessment of ecological damage w.r.t.
various environmental attributes has been prepared in line with the ToR.
1.4.2 DETAILS OF THE STUDY
The scope of study broadly includes:

To conduct literature review and collect data relevant to the study area.
To undertake environmental monitoring so as to establish the baseline
environmental status of the study area.
To evaluate the likely impacts on the various environmental attributes in
the study area by using scientifically developed and widely accepted
environmental impact assessment methodologies.
Assessment of ecological damage with respect to air, water, land and
other environmental attributes.
To prepare an EMP outlining the remediation plan and natural and
community resource augmentation plan corresponding to the ecological
damage assessed and economic benefits derived due to violation.
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To identify critical environmental attributes required to be monitored

monitoring program.
Remediation plan and the natural & community resource augumentation
plan.
The literature review includes identification of relevant articles from various
publications, collection data from various government agencies and other
sources.
1.4.3 METHODOLOGY OF THE STUDY
Reconnaissance was conducted by the monitoring team and concerned officials

from the project proponent. Sampling locations were identified by considering
the following factors.
Existing topography, drainage pattern and location of surface water
bodies like ponds, canals, rivers and sea.
Location of villages/towns/sensitive areas.
The field observations are used to,
Identify extent of negative impacts on community / natural resources
and
Identify mitigation measures and monitoring requirements.
1.4.4 STUDY AREA DETAILS
The study area for the present EIA study is the area covered within the 10 km
radius from the plant boundary.
1.4.5 TERMS OF REFERENCE (TOR)
have been considered for preparation of Environment Impact Assessment

studies for the project. Scope of present study is in line with the Terms of
Reference as indicated stipulated by MoEFCC vide letter no. F.No.J-
11011/191/2017-IAII(I) dated 14th June 2018. Also, the Standard Terms of
Reference for category 5(f) projects stipulated by MoEFCC in April 2015 are
considered.
All these are tabulated below
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Table 1.1: Terms of Reference (TOR)

1) STANDARD TERMS OF REFERENCE AS STIPULATED BY MOEFCC IN APRIL 2015
Sl. Terms of Reference Details provided in
No. Chapter/Section
1 Executive summary Executive summary is
provided prior to Chapter
1.
2 Introduction --
i Details of the EIA Consultant including NABET EIA consultant is
accreditation. Samrakshan, Bangalore.
The EIA report is prepared
by Mr. S. Nanda Kumar and
Mr. Hanumantharaj Urs
and team who are working
in the capacity of Chief
Executive Officer and
Senior Manager, Projects
respectively. They have
filed writ petitions before
Karnataka on file W.P.No.

12624 and 12625 /2017
(GM-RES) on the
Notification in no. S.O.648
(E) dated 03.03.2016
issued by Ministry of
Environment, forest and
Climate Change. the
the notification. Details in

Chapter 12.
ii Information about the project proponent. Chapter 1, Section 1.2
iii Importance and benefits of the project. Chapter 1, Section 1.3.2 &
Chapter 8
3 Project description --
i Cost of project and time of completion. Chapter 2, Section 2.4 &
2.5
ii Products with capacities for the proposed project. Chapter 6, Section 2.6.1
iii If expansion project, details of existing products This is the first application
with capacities and whether adequate land is for Environmental
available for expansion, reference of earlier EC if Clearance by M/s Shilpa
any. Medicare Ltd. - Unit I.
Application is made under
violation category.
iv List of raw materials required and their source Chapter 2, Section 2.6.2
along with mode of transportation.
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v Other chemicals and materials required with Chapter 2, Section 2.8.5

quantities and storage capacities.
vi Details of emission, effluents, hazardous waste Chapter 2, Section 2.8
generation and their management.
vii Requirement of water, power, with source of Water, power: Chapter 2,
supply, status of approval, water balance Section 2.8
diagram, man-power requirement (regular and Manpower: Chapter 8,
contract). Section 8.2
viii Process description along with major equipments Chapter 2, Section 2.6.4
and machineries, process flow sheet
(quantitative) from raw material to products to
be provided.
ix Hazard identification and details of proposed Chapter 7, Section 7.2
safety systems.
Expansion/modernization proposals: --
x c. Copy of all the Environmental Clearance(s) This is the first application
including Amendments thereto obtained for the for Environmental
project from MOEF/SEIAA shall be attached as an Clearance by M/s Shilpa
Annexure. A certified copy of the latest Medicare Ltd. - Unit I.
Monitoring Report of the Regional Office of the Application is made under
Ministry of Environment and Forests as per violation category.
circular dated 30th May, 2012 on the status of
compliance of conditions stipulated in all the
existing environmental clearances including
Amendments shall be provided. In addition, status
of compliance of Consent to Operate for the
ongoing /existing operation of the project from
SPCB shall be attached with the EIA-EMP report.
d. In case the existing project has not obtained Chapter 1, Section 1.1
environmental clearance, reasons for not taking
EC under the provisions of the EIA Notification
1994 and/or EIA Notification 2006 shall be Compliance report to the
provided. Copies of Consent to Establish/No latest CTO dated 8th Oct
Objection Certificate and Consent to Operate (in 2015 vide combined
case of units operating prior to EIA Notification consent order no.
2006, CTE and CTO of FY 2005-2006) obtained PCB/HPI/053/2015-16 and
from the SPCB shall be submitted. Further, CTE dated 7th May 2011
compliance report to the conditions of consents vide no.
from the SPCB shall be submitted. KSPCB/HPI/053/Shilpa-
I/CFEx/2010-11/86 is
appended as Annexure A3.
4 Site details --
i Location of the project site covering village, Chapter 2, Section 2.3
Taluka/Tehsil, District and State, Justification for
selecting the site, whether other sites were
considered.
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ii A topo sheet of the study area of radius of 10 km Annexure A11

and site location on 1:50,000/1:25,000 scale on
an A3/A2 sheet. (including all eco-sensitive areas
and environmentally sensitive places)
iii Details w.r.t. option analysis for selection of site NA as it is an existing
industry.
iv Co-ordinates (lat-long) of all four corners of the Chapter 2, Table 2.1
site.
v Google map-Earth downloaded of the project site. Chapter 2, Fig 2.2
vi Layout maps indicating existing unit as well as Chapter 2, Fig 2.3
proposed unit indicating storage area, plant area, Annexure A11
greenbelt area, utilities etc. If located within an
Industrial area/Estate/Complex, layout of
Industrial Area indicating location of unit within
the Industrial area/Estate.
vii Photographs of the proposed and existing (if Chapter 2, Fig 2.4
applicable) plant site. If existing, show Chapter 4, Fig 4.8 B
photographs of plantation/greenbelt, in
particular.
viii Land use break-up of total land of the project site Chapter 2, Table 2.3
(identified and acquired), government/ private -
agricultural, forest, wasteland, water bodies,
settlements, etc. shall be included (not required
for industrial area).
ix A list of major industries with name and type Chapter 3, Section 3.2.8.2
within study area (10 km radius) shall be
incorporated. Land use details of the study area.
x Geological features and Geo-hydrological status Chapter 3, Section 3.2.2 &
of the study area shall be included. 3.2.3
xi Details of drainage of the project upto 5 km Drainage pattern of the
radius of study area. If the site is within 1 km area is in Chapter 3,
radius of any major river, peak and lean season Section 3.2.4.
river discharge as well as flood occurrence
frequency based on peak rainfall data of the past Krishna river is at a
30 years. Details of Flood Level of the project site distance of 4.22 km.
and maximum Flood Level of the river shall also Hence NA.
be provided (mega green field projects).
xii Status of acquisition of land. If acquisition is not NA as it is an existing
complete, stage of the acquisition process and industry.
expected time of complete possession of the
land.
xiii R&R details in respect of land in line with state NA as it is an existing
Government policy. industry in the notified
industrial area of
government of Karnataka.
5 Forest and wildlife related issues (if applicable): There is no forest and wild
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life sanctuary in the study

area.
i Permission and approval for the use of forest land NA
(forestry clearance), if any, and recommendations
of the State Forest Department (if applicable).
ii Land use map based on high resolution satellite NA
imagery (GPS) of the proposed site delineating
the forestland (in case of projects involving forest
land more than 40 ha).
iii Status of Application submitted for obtaining the NA
stage I forestry clearance along with latest status
shall be submitted.
iv The projects to be located within 10 km of the NA
National Parks, Sanctuaries, Biosphere Reserves,
Migratory Corridors of Wild Animals, the project
proponent shall submit the map duly
authenticated by Chief Wildlife Warden showing
these features vis-à-vis the project location and
the recommendations or comments of the Chief
Wildlife Warden-thereon.
v Wildlife Conservation Plan duly authenticated by NA
the Chief Wildlife Warden of the State
Government for conservation of Schedule I fauna,
if any exists in the study area.
vi Copy of application submitted for clearance under NA
the Wildlife (Protection) Act, 1972, to the
Standing Committee of the National Board for
Wildlife.
6 Environmental status --
i Determination of atmospheric inversion level at Chapter 3, Section 3.2.1
the project site and site-specific
micrometeorological data using temperature,
relative humidity, hourly wind speed and
direction and rainfall.
ii AAQ data (except monsoon) at 8 locations for Environmental study for
PM10, PM2.5, SO2, NOX , CO and other parameters ambient air (PM10, PM2.5,
relevant to the project shall be collected. The SO2, NOx & CO) is carried
monitoring stations shall be based CPCB out for three months at 7
guidelines and take into account the pre- locations in the study area
dominant wind direction, population zone and of 10 km. In the specific
sensitive receptors including reserved forests. TOR issued by MoEFCC vide
letter no. F.No.J-
11011/191/2017-IAII(I)
dated 14th June 2018 it is
stipulated to carry out
monitoring at 5 locations.
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Details are in Chapter 3,

Section 3.3.2.
iii Raw data of all AAQ measurement for 12 weeks of Same as in 6 (ii) above.
all stations as per frequency given in the NAQQM
Notification of Nov. 2009 along with - min., max.,
average and 98% values for each of the AAQ
parameters from data of all AAQ stations should
be provided as an annexure to the EIA Report.
iv Surface water quality of nearby river (100m No wastewater is
upstream and downstream of discharge point) and discharged into the river
other surface drains at eight locations as per or in to any water body.
CPCB/MoEF&CC guidelines. The effluent is pre-treated
and sent to Shilpa
Medicare Unit II for
treatment of effluent as
per the consent granted by
KSPCB.
Krishna River analysis
reports are in Chapter 3,
Section 3.3.4.1.
v Whether the site falls near to polluted stretch of No
river identified by the CPCB/MoEF&CC, if yes give
details.
vi Ground water monitoring at minimum at 8 As per the specific ToR
locations shall be included. issued by MoEFCC vide
letter no. F.No.J-
11011/191/2017-IAII(I)
dated 14th June 2018,
environmental study for
groundwater at 5 locations
in the study area of 10 km
is required to be carried
out.
However, analysis has
been done at 7 locations.
Section 3.3.4.2.
vii Noise levels monitoring at 8 locations within the Environmental study for
study area. noise levels at 7 locations
in the study area of 10 km
is taken up. In the specific
TOR issued by MoEFCC vide
letter no. F.No.J-
11011/191/2017-IAII(I)
dated 14th June 2018 it is
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specified to monitor at 5
locations.
Section 3.3.3.
viii Soil characteristic as per CPCB guidelines. Chapter 3, Section 3.3.5.
ix Traffic study of the area, type of vehicles, Chapter 4, Section 4.1.2.3,
frequency of vehicles for transportation of subsection III.
materials, additional traffic due to proposed
project, parking arrangement etc.
x Detailed description of flora and fauna (terrestrial Chapter 3, Section 3.3.6.
and aquatic) existing in the study area shall be
given with special reference to rare, endemic and
endangered species. If Schedule-I fauna are found
within the study area, a Wildlife Conservation
Plan shall be prepared and furnished.
xi Socio-economic status of the study area. Chapter 3, Section 3.3.7
7 Impact and Environment Management Plan. --
i Assessment of ground level concentration of Chapter 7, Section 7.3
pollutants from the stack emission based on site-
specific meteorological features. In case the
project is located on a hilly terrain, the AQIP
Modeling shall be done using inputs of the specific
terrain characteristics for determining the
potential impacts of the project on the AAQ.
Cumulative impact of all sources of emissions
(including transportation) on the AAQ of the area
shall be assessed. Details of the model used and
the input data used for modeling shall also be
provided. The air quality contours shall be plotted
on a location map showing the location of project
site, habitation nearby, sensitive receptors, if
any.
ii Water Quality modeling - in case of discharge in Not applicable as no
water body wastewater treated /
untreated is discharged
into any water body.
iii Impact of the transport of the raw materials and Chapter 2, Section 2.6.1 &
end products on the surrounding environment 2.6.2
shall be assessed and provided. In this regard,
options for transport of raw materials and
finished products and wastes (large quantities) by
rail or rail-cum road transport or conveyor cum
rail transport shall be examined.
iv A note on treatment of wastewater from different Chapter 2, Section 2.8.2
plant operations, extent recycled and reused for
different purposes shall be included. Complete
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scheme of effluent treatment. Characteristics of

untreated and treated effluent to meet the
prescribed standards of discharge under E (P)
Rules.
v Details of stack emission and action plan for Chapter 2, Section 2.8.6
control of emissions to meet standards.
vi Measures for fugitive emission control. Chapter 2, Section 2.8.5.4
vii Details of hazardous waste generation and their Chapter 2, Section 2.8.9
storage, utilization and management. Copies of
MOU regarding utilization of solid and hazardous
waste in cement plant shall also be included. EMP
shall include the concept of waste-minimization,
recycle/ reuse/ recover techniques, Energy
conservation, and natural resource conservation.
viii Proper utilization of fly ash shall be ensured as Boiler ash is handed over
per Fly Ash Notification, 2009. A detailed plan of to brick manufacturers.
action shall be provided.
ix Action plan for the green belt development plan Chapter 4, Section 4.1.1,
in 33 % area i.e. land with not less than 1,500 Subsection C.
trees per ha. Giving details of species, width of
plantation, planning schedule etc. shall be
included. The green belt shall be around the
project boundary and a scheme for greening of
the roads used for the project shall also be
incorporated.
x Action plan for rainwater harvesting measures at Chapter 2, Section 2.8.5B
plant site shall be submitted to harvest rainwater
from the roof tops and storm water drains to
recharge the ground water and also to use for the
various activities at the project site to conserve
fresh water and reduce the water requirement
from other sources.
xi Total capital cost and recurring cost /annum for Chapter 6, Section 6.1.4
environmental pollution control measures shall be
included.
xii Action plan for post-project environmental Chapter 6, Section 6.1.2
monitoring shall be submitted.
xiii Onsite and offsite disaster (natural and Man- On-site emergency plan is
made) Preparedness and Emergency Management prepared and made readily
Plan including Risk Assessment and damage available to the concerned
control. Disaster management plan should be persons in case of
linked with District Disaster Management Plan. emergency.
8 Occupational health --
i Plan and fund allocation to ensure the Chapter 6, Section 6.1.4
occupational health & safety of all contract and
casual workers.
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ii Details of exposure specific health status Enclosure 3

evaluation of worker. If the workers' health is
being evaluated by pre designed format, chest x
rays, Audiometry, Spirometry, Vision testing (Far
& Near vision, colour vision and any other ocular
defect) ECG, during pre-placement and periodical
examinations give the details of the same. Details
regarding last month analysed data of above
mentioned parameters as per age, sex, duration
of exposure and department wise.
iii Details of existing Occupational & Safety Hazards. Chapter 7, Section 7.2.9
What are the exposure levels of hazards and
whether they are within Permissible Exposure
Level (PEL)? If these are not within PEL, what
measures the company has adopted to keep them
within PEL so that health of the workers can be
preserved.
iv Annual report of health status of workers with Enclosure 3
special reference to Occupational Health and
Safety.
9 Corporate Environment Policy --
i Does the company have a well laid down Chapter 7, Section 7.2.9
Environment Policy approved by its Board of
Directors? If so, it may be detailed in the EIA
report.
ii Does the Environment Policy prescribe for Chapter 7, Section 7.2.9
standard operating process / procedures to bring
into focus any infringement / deviation / violation
of the environmental or forest norms /
conditions? If so, it may be detailed in the EIA.
iii What is the hierarchical system or Administrative Chapter 10, Section 10.4
order of the company to deal with the
environmental issues and for ensuring compliance
with the environmental clearance conditions?
Details of this system may be given.
iv Does the company have system of reporting of Yes, the company has the
non-compliances / violations of environmental reporting system of
norms to the Board of Directors of the company violations of
and / or shareholders or stakeholders at large? environmental norms to its
This reporting mechanism shall be detailed in the Board of Directors,
EIA report. shareholders & stake
holders of the company &
as good corporate citizens
the company will intimate
any violations of the
environmental norms to
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SEBI and publish in the

annual report.
10 Details regarding infrastructure facilities such as Toilets are provided to the
sanitation, fuel, restroom etc. to be provided to casual workers including
the labour force during construction as well as to truck drivers.
the casual workers including truck drivers during
operation phase.
11 Enterprise Social Commitment (ESC) Details of CSR activities
i. Adequate funds (at least 2.5 % of the project carried out by the
cost) shall be earmarked towards the Enterprise Company in the last few
Social Commitment based on Public Hearing issues years are in Chapter 8,
and item-wise details along with time bound Section 8.4.
action plan shall be included. Socio-economic Public hearing issues are
development activities need to be elaborated addressed and a separate
upon. time bound action plan is
included in Chapter 13.
12 Any litigation pending against the project and/or No
any direction/order passed by any Court of Law
against the project, if so, details thereof shall
also be included. Has the unit received any notice
under the Section 5 of Environment (Protection)
Act, 1986 or relevant Sections of Air and Water
Acts? If so, details thereof and compliance/ATR to
the notice(s) and present status of the case.
13 A tabular chart with index for point wise Provided
compliance of above TOR.
SPECIFIC TERMS OF REFERENCE
1 Details on solvents to be used, measures for Chapter 2, Section 2.8.5A
solvent recovery and for emissions control.
2 Details of process emissions from the proposed Chapter 2, Section 2.8.6
unit and its arrangement to control.
3 Ambient air quality data should include VOC, Annexure A3
other process-specific pollutants* like NH3*,
chlorine*, HCl*, HBr*, H2S*, HF*, etc. (*-as
applicable).
4 Work zone monitoring arrangements for hazardous Annexure A3
chemicals.
5 Detailed effluent treatment scheme including Chapter 2, Section 2.8.2
segregation of effluent streams for units adopting
'Zero' liquid discharge.
6 Action plan for odour control to be submitted. Chapter 4, Section 4.1.1,
Subsection B
7 A copy of the Memorandum of Understanding Contract copies with
signed with cement manufacturers indicating different vendors for
clearly that they co-process organic disposal of hazardous
solid/hazardous waste generated. waste are appended as
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Annexure A10.
8 Authorization/Membership for the disposal of Chapter 2, Section 2.8.2
liquid effluent in CETP and solid/hazardous waste Trade effluent is collected,
in TSDF, if any. neutralized and sent to
sister concerShilpa
Medicare Ltd. Unit II for
further treatment in ETP.
The treated effluent is
then reused.
9 Action plan for utilization of MEE/dryers salts. NA
10 Material Safety Data Sheet for all the Chemicals Annexure A12
are being used/will be used.
11 Authorization/Membership for the disposal of Annexure A10
solid/hazardous waste in TSDF.
12 Details of incinerator if to be installed. No incinerator is installed.
13 Risk assessment for storage and handling of Chapter 7, Section 7.2
hazardous chemicals/solvents. Action plan for
handling & safety system to be incorporated.
14 Arrangements for ensuring health and safety of Chapter 7, Section 7.2.17
workers engaged in handling of toxic materials.
2) TERMS OF REFERENCE AS PER LETTER F.No.J-11011/191/2017-IAII(I) BY

MOEFCC (IA DIVISION) DATED 14TH JUNE 2018
Sl. Terms of Reference Details provided in
No. Chapter/Section
GENERAL
1 Grant of Terms of Reference for undertaking EIA EIA & EMP prepared as per
and preparation of Environment Management ToR granted.
Plan (EMP) as enumerated in Annexure I, along Public consultation report
with public hearing. along with response & plan
of action to address the
concerns is included in
Chapter 13, Section
13.4.G.
2 The project proponent shall be required to Accepted.
submit a bank guarantee equivalent to the
amount of remediation plan and natural and
community resource augumentation plan with
SPCB prior to the grant of EC. The quantum shall
be recommended by the EAC and finalized by the
regulatory authority. The bank guarantee shall be
released after successful implementation of the
EMP followed by recommendations of the EAC
and approval of the regulatory authority.
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3 Submit the proposal for Environment Clearance EIA & EMP prepared as per
as per the ToRs to the concerned regulatory ToR granted.
authority, incorporating all the issues raised Public consultation report
during Public hearing/consultation. is included in Chapter 13,
Section 13.4.G.
ANNEXURE
4 Project description, its importance and benefits. Chapter 1, Section 1.2 &
1.3
5 Project site details (location, toposheet of the Chapter 2, Section 2.3
study area of 10 km, coordinates, google map, Annexure A11
layout map, land use, geological features and Chapter 3, Section 3.2.2,
geo-hydrological status of the study area, 3.2.3, 3.2.4
drainage).
6 Land acquisition status, R&R details. Annexure A10
7 Forest and Wildlife and eco-sensitive zones, if None within 10 km radius
any in the study area of 10 km - Clearances
required under the Forest (Conservation) Act,
1980, the Wildlife (Protection) Act, 1972 and/or
the Environment (Protection) Act, 1986.
8 Baseline environmental study for ambient air Chapter 3, Section 3.3.2
(PM10, PM2.5, SO2, NOx & CO), water (both surface
and ground), noise and soil for one season
(except monsoon period) as per MoEF&CC / CPCB
guidelines at minimum 5 locations in the study
area of 10 km.
9 Details on flora and fauna and socio-economic Chapter 3, Section 3.3.6

aspects in the study area.
10 Likely impact of the project on the Chapter 4, Section 4.1.2
environmental parameters (ambient air, surface
and ground water, land, flora and fauna and
socio-economic, etc.).
11 Source of water for different identified purposes Chapter 2, Section 2.8.1
with the permissions required from the
concerned authorities.
12 Wastewater management (treatment, reuse and Chapter 2, Section 2.8.2
disposal) for the project and also the study area.
13 Management of solid waste and the construction Chapter 2, Section 2.8.8
& demolition waste for the project vis-à-vis the
Solid Waste Management Rules, 2016 and the
Construction & Demolition Rules, 2016.
14 Energy efficient measures (LED lights, solar Chapter 2, Section 2.6.5
power, etc.) during construction as well as during Chapter 8, Section 8.4
operational phase of the project.
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15 Assessment of ecological damage with respect to Chapter 13

air, water, land and other environmental
attributes. The collection and analysis of data
shall be done by an environmental laboratory
duly notified under the Environment (Protection)
Act, 1986, or an environmental laboratory
accredited by NABL, or a laboratory of a Council
of Scientific and Industrial Research (CSIR)
institution working in the field of environment.
16 Preparation of EMP comprising remediation plan Chapter 10 & 13
and natural and community resource
augmentation plan corresponding to the
ecological damage assessed and economic
benefits derived due to violation.
17 The remediation plan and the natural and Chapter 13
community resource augmentation plan to be
prepared as an independent chapter in the EIA
report by the accredited consultants.
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CHAPTER 2
PROJECT DESCRIPTION
2.1 TYPE OF PROJECT
Active Pharmaceutical Ingredients (APIs) & intermediates manufacturing

industry with R&D activity. It is classified as synthetic organic chemicals
industry category 5(f) of EIA notification 2006.
2.2 NEED FOR THE PROJECT
Detailed in Chapter 1, Section 1.3.2.
2.3 LOCATION (MAPS SHOWING GENERAL LOCATION, SPECIFIC LOCATION,

PROJECT BOUNDARY AND PROJECT SITE LAYOUT)
M/s. Shilpa Medicare Limited, Unit I is located at Plot No. 1A, 1A"P", 1B, 2, 2A,
2B, 3A to 3E, 4A, 4B, 4C, 5A & 5B, Deosugar Industrial Area, Raichur,
Karnataka.
The general and specific location is shown in fig 2.1.

Google map with site boundary is shown in fig 2.2.
Plant layout is shown in fig 2.3.
Site photographs are shown in fig 2.4.
Co-ordinates (latitude-longitude) of all four corners of the site are shown in

table 2.1.
Land use pattern is shown in table 2.3.
Table 2.1: Co-ordinates (latitude-longitude) of all four corners of the site

Sl. Directions Co- ordinates
No.
1 North East 16°20'50.68"N, 77°20'54.17"E
2 North West 16°20'42.45"N, 77°20'18.87"E
3 South East 16°20'46.47"N, 77°20'53.74"E
4 South West 16°20'40.20"N, 77°20'20.28"E
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Table 2.2: Immediate surroundings of project site

Particulars Orientation
w.r.t. project
site
Raichur Thermal Power Plant North
12 m Road South
NH-167 & SH 51 East
Vacant area (railway track) West
Note:
Karnataka Telangana boundary is at a distance of 4.5 km towards North.
Shilpa Medicare Ltd. Unit II is at at a distance of 4.2 km in the south east
direction.
Table 2.3: Land-use pattern

Sl. Particulars Area (SQM) Percentage (%)
No.
1 Total plot area 95,975.34 100
2 Ground coverage area 21,441.43 22.3
3 Hard paved area 11,706.26 12.2
4 Landscape & green-belt area 33,591.25 35
5 Provision for future expansion 29,236.4 30.4
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Fig 2.1: General and specific location of industry
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Fig 2.2: Google map with site boundary
Latitude: 16°20'44.97"N; Longitude: 77°20'37.07"E; Elevation above MSL: 359 m
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Fig 2.3: Plant layout
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Fig 2.4: Site photographs
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2.4 SIZE OR MAGNITUDE OF OPERATION
M/s. Shilpa Medicare Ltd. Unit I has a total value of Rs. 13,038.51 Lakhs
(Rupees One Hundred and Thirty Crores Thirty Eight Lakhs Fifty One Thousand
Only) as on 31st March 2017. The total production capacity is 317.304 ton per
annum.
The details of capital investment on the project is in the table 2.4
Table 2.4: Value of the company as per CA certificate

Sl. Description Cost, INR
No. in Lakhs
1 Plant and machinery 5,162.38
2 Land and building 3,173.73
3 Windmill 3,843.03
4 Computer and software 177.44
5 Vehicles 170.9
6 Intangible assets 188.63
7 Other assets 322.4
TOTAL 13,038.51
2.5 PROPOSED SCHEDULE FOR APPROVAL AND IMPLEMENTATION
The industry is in operation since 1989.
Now it is proposed to secure EC from MOEFCC which has been made mandatory
by virtue of the 2006 EIA notification for the change in product mix without
increasing the pollution load which has taken place during 2011.
The application for EC is made on 18.04.2017 as per MoEFCC notification dated

14.03.2017.
EAC for projects related to violation of EIA notification was appraised. The
proposal and resolved to grant ToR vide proceedings dated 30-31st Jan 2018.
The impact assessment study is carried out as per the ToR mentioned above
along with the standard ToR for schedule 5(f) activity
under the said notification.
Once the EC is granted, the conditions in the EC will be implemented.
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2.6 TECHNOLOGY AND PROCESS DESCRIPTION
Active Pharmaceutical Ingredients (APIs) and intermediates are manufactured

using raw materials like chemicals, solvents and catalysts. The reactions are
carried out in closed reactors made of glass lined/SS, depending on the nature
of the reaction viz. acidic/alkaline. There will be different stages of reaction
involving distillation, solvents separation and centrifugation and
intermediates/APIs are formed. The final product produced may take multiple
intermediatery stages or it may be formed in one reaction based on the
formation of final molecule. Shilpa Medicare Ltd. will manufacture only the
intermediates or APIs based on the market demand.
2.6.1 Products with production capacities
The list of products currently being manufactured with production capacities

are tabulated below. This is in accordance with the Consent to Operate (CTO)
no. PCB/HPI/053/2015-16/1245 dated 8th October 2015.
Table 2.5: APIs manufactured

Sl. APIs & intermediates Production capacity
no. MT/month MT/annum
1 Acebrophylline 3 36
2 Ambroxol HCl 6 72
3 Buflomedil HCl 1 12
4 Nifedipine 1 12
5 Phenyl ephrine HCl 1.5 18
6 Sildenafil citrate 1 12
7 Ticlopidine HCl 2 24
8 Ursodeoxycholic acid 9 108
Total 24.5 294
Oncology products
9 Anastrozole 0.005 0.06
10 Bendamustine HCl 0.005 0.06
11 Bicalutamide 0.2 2.4
12 Bortezomib 0.001 0.012
13 Capecitabine 1 12
14 Carboplatin 0.05 0.6
15 Cisplatin 0.05 0.6
16 Docetaxel trihydrate 0.05 0.6
17 Epirubicin HCl 0.02 0.24
18 Gefitinib 0.01 0.12
19 Gemcitabine HCl 0.25 3
20 Imatinib mesylate 0.1 1.2
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21 Irinotecan HCl 0.01 0.12

trihydrate
22 Lenalidomide 0.001 0.012
23 Letrozole 0.005 0.06
24 Oxaliplatin 0.005 0.06
25 Paclitaxel 0.01 0.12
26 Pemetrexed 0.01 0.12
27 Temozolomide 0.1 1.2
28 Thalidomide 0.05 0.6
29 Topotecan HCl 0.005 0.06
30 Zoledronic acid 0.005 0.06
Total 1.942 23.304
TOTAL 26.442 317.304
Note:
The products are exported to Europe/Latin American
countries/Japan/Korea by air/sea and to the Indian markets by
train/road.
Out of 30 products at a time maximum of 6 products could be
manufactured.
2.6.2 List of raw materials required and their source along with mode of
transportation
The raw materials required for the manufacture of APIs & intermediates are
appended in the table 2.6A below. Raw materials as listed will be procured as
per the production requirement.
The per month quantities tabulated in 2.6A are required for maximum
allowable production quantity as per CTO no. PCB/HPI/053/2015-16/1245
dated 8th October 2015 is achieved. However, this is seldom the case as seen
from the actual production records of the last 3 years. Details are in Chapter 9,
Section 9.1 of this EIA report.
Recent photographs of raw material storage area is show n in figure 2.5
Table 2.6 A: Raw materials requirement

No. of
Sl.
Product Stage Raw material kg/batch batches kg/month
No.
/month
2 amino 3,5-dibromo
150 1800
benzaldehyde
Trans-4-amino cyclohexanol 62.5 750
1 Acebrophylline I 12
Sodium borohydride 22.5 270
Methanol 910 10920
Water 700 8400
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Dimethyl formamide (DMF) 1065 12780

Ethyl acetate 5350 64200
II
Thiophylline-7-acetic acid
128 1536
2 amino 3,5 dibromo
400 4000
benzaldehyde
Trans -4- amino cyclohexanol 250 2500
I
Sodium borohydride 75 750
Methanol 3000 30000
2 Ambroxol HCl 10
Water 2000 20000
Acetone 2780 27800
Hydrochloric acid 150 1500
II
Carbon 50 500
Water 25 250
4-chloro butyryl chloride 177 1239
Aluminum chloride 183 1281
1,3,5-trimethoxy benzene 111 777
I
Methylene di-chloride (MDC) 500 3500
Water 2000 14000
Ethyl acetate 300 2100
3 Buflomedil HCl II Pyrrolidine 125 7 875
Iso propyl alcohol (IPA) HCl 257 1799
IPA 600 4200
C.S. (caustic) lye 100 700
Carbon 11 77
III
Toluene 300 2100
IPA HCl 180 1260
Water 500 3500
Methyl aceto acetate 435 428.91
I Methanol 435 428.91
Ammonia (25% solution) 435 428.91
Ortho nitrobenzaldehyde 250 500
4 Nifedipine Isopropyl alcohol 1500 2 3000
II Piperidine catalyst 4.5 9
Methyl aceto acetate 217.5 435
Acetic acid 7 14
III Methanol 2700 5400
Metahydroxy acetophenone 337 2022
Toluene 2847 17082
Phenyl ephrine Ethyl acetate 1005 6030
5 I 6
HCl Liq. bromine 442 2652
Liq. ammonia 442 2652
N-methyl benzyl amine 543 3258
EIA
- 41 -
Aluminum chloride 8 48
Sodium bicarbonate 67 402
n-Hexane 670 4020
Water 5025 30150
IPA HCl 551 3306
Methanol 1820 21840
Pd. carbon 6.5 78
II Hydrogen 26 312
Liq. ammonia 700 8400
Water 2600 31200
Isopropyl alcohol (IPA) 672 4032
Tartaric acid 336 2016
Acetic anhydride 1545 9270
III
Liquor ammonia 772 4632
Sulfuric acid 90 540
Water 1682 10092
Methanol 670 4020
Carbon 3.5 21
IV
Acetone 840 5040
IPA HCl 200 1200
4-amino-1-methyl-3-n-
propylpyrazolo-5- 125 500
carboxamide
I
2-ethoxy benzoyl chloride 125 500
Sildenafil
6 Water 1250 4 5000
citrate
Chlorosulfonic acid 375 1500
II n-methyl piperazine 250 1000
Water 1250 5000
Acetone 1500 6000
III
Citric acid 75 300
Thiophene-2-ethanol 222.5 1780
Trimethyl amine 202.5 1620
I
Benzene sulfonyl chloride 345 2760
Toluene 650 5200
Ortho chloro benzylamine 375 3000
II
7 Ticlopidine HCl Acetone 2475 8 19800
Water 250 2000
Formaldehyde 162.5 1300
III Toluene 600 4800
Isopropyl alcohol (IPA) HCl 200 1600
Methanol 155 1240
EIA
- 42 -
Carbon 10 80
Cholic acid 590.835 21270.06
I Methanol 945.733 34046.388
Methane sulphonic acid 3.972 142.992
Ethyl acetate 1071.4 38570.4
II Sodium carbonate 238 8568
Acetic anhydride 357 12852
Sodium hypochloride 952.4 34286.4
III Acetic acid 76 2736
Water 600 21600
2-methoxy ethanol 3809 137124
Ursodeoxycholic
8 HzHz 500 36 18000
acid IV
KOH 357 12852
Water 250 9000
Sodium bromate 95 3420
V MDC 512 18432
Water 300 10800
Sodium metal 333.3 11998.8
Hydrochloric acid 130.95 4714.2
VI Butanol 4523.8 162856.8
Water
300 10800
a,a,a,a,-tetramethyl-5-
(methyl)-1,3- benzenedi- 8 16
acetonitrile
Acetonitrile 30 60
I
N- bromosuccianmide 6.6 13.2
Ethyl acetate 30 60
Water 10 20
Cyclohexane 5 10
1,2,4-triazole 2.5 5
9 Anastrozole 2
Potassium carbonate 5 10
Acetone 40 80
II
Water 4 8
Ethyl acetate 10 20
Hydrochloric acid 0.5 1
Water 10 20
Sodium carbonate 2 4
III
Ethyl acetate 10 20
Cyclohexane 5 10
Ethyl-4-(5-(bis(2-hydroxy
ethyl) amino)-1-methyl-1H-
Bendamustine 5 20
10 I benzoid) imidazol-2- 4
HCl
yl)butanoate
Thionyl chloride 20 80
EIA
- 43 -
Water 40 160
N-[4-cyano-3-trifluoromethyl
phenyl]-3-[4-fluorophenyl
12 240
thio]-2-hydroxy-2-methyl
11 Bicalutamide I propanamide 20
Acetonitrile 100 2000
Potassium permanganate 5 100
Isopropyl alcohol 10 200
3- phenyl -2-[(pyrazine-2-
carbonyl)-amino] propionic 0.1 1.2
acid
R-borolex-(+)-pinanediol
0.115 1.38
trifluoro acetic acid
I n-hydroxy succinamide 0.09 1.08
MDC 0.27 3.24
Disopropyl amine 0.11 1.32
1N HCl 0.12 1.44
Saturated sodium bicarbonate 0.57 6.84
12 Bortezomib 12
Methanol 0.67 8.04
Methanol 0.17 2.04
Isobutyl boronic acid 0.085 1.02
n-Heptane 2.07 24.84
II 1N HCl 0.57 6.84
MDC 0.27 3.24
Ethyl acetate 0.57 6.84
Sat. sodium bicarbonate 0.57 6.84
Methanol 0.109 1.308
III
Water 0.109 1.308
5-methyl tetrahydrofuran-
150 1500
2,3,4-triyl triacetate
Toluene 300 3000
Hexa methyl disaline (HMDS) 150 1500
5-fluorocytosine 100 1000
Tetra methyl silyl chloride
I 5 50
(TMSC)
13 Capecitabine Sodium bicarbonate 150 10 1500
Water 300 3000
Stannic chloride 160 1600
Isopropyl alcohol 300 3000
Methylene di chloride (MDC) 250 2500
N-pentyl chloroformate 110 1100
II Pyridine 60 600
Heptane 500 5000
Water 300 3000
EIA
- 44 -
Methanol 350 3500

MDC 250 2500
Toluene 900 9000
III
Sodium hydroxide 20 200
Water 300 3000
Water 50 250
Potassium
17 85
I tetrachloroplatinate
Potassium iodide 40 200
Ammonium hydroxide (25%) 10 50
14 Carboplatin 5
Water 1000 5000
Silver oxide 9 45
II 1,1-cyclobutane dicarboxylic
6 30
acid
Carbon 2 10
Potassium
17 85
tetrachloroplatinate
I Potassium iodide 40 200
Water 50 250
15 Cisplatin 5
Ammonium hydroxide (25%) 10 50
Water 50 250
II Silver nitrate 9 45
Potassium chloride 7 35
CN1 20 100
Acetonitrile 200 1000
6N HCl 8.4 42
Saturated sodium bicarbonate
I solution in water 10 kg in 12 440 2200
L water
Docetaxel Ethyl acetate 300 1500
16 5
trihydrate Sodium chloride 6 30
Sodium sulfate 20 100
Methylene di chloride (MDC) 240 1200
II Acetone 240 1200
Petroleum ether 600 3000
Methanol 240 1200
III
Water 240 1200
EPI-i 2 160
Ethanol 7.89 631.2
MDC 26.4 2112
17 Epirubicin HCl I Acetone 3.95 80 316
Sodium hydroxide 0.5 40
Hydrochloric acid 2.36 188.8
Sodium borohydride 0.1 8
EIA
- 45 -
Water 10 800
MDC 26.4 2112
Water 10 800
II
Sodium hydroxide 0.2 16
n-Hexane 6.54 523.2
Hydrobromic acid 1.5 120
Acetone 9.48 758.4
Sodium bicarbonate 0.1 8
Water 10 800
III
Methanol 7.9 632
Dioxane 7 560
MDC 26.4 2112
n-Hexane 9.8 784
7-methoxy-6-(3-morphalino
5 15
I propyl) quinazolin-4 (3H)-one
Thionyl chloride 10 30
18 Gefitinib 3
3-chloro-4-fluoroaniline 4.3 12.9
II Ethyl acetate 90 270
Potassium carbonate (K2CO3) 1.2 3.6
G Intermediate 330 3300
I Methanol 975 9750
Ammonia 25% 565 5650
Methanol 750 7500
Gemcitabine
19 II Carbon 10 10 100
HCl
HCl 40 400
Water 30 300
III Acetic acid 2000 20000
HCl 40 400
4-methyl-N3-(5-pyridin-3yl
pyrimidine-2-yl) benzene-1,3- 10 100
diamine
4-(4-methyl-piperazin-1-yl-
ethyl)benzoic acid 10 100
Imatinib dihydrochloride
20 I 10
mesylate Methylene dichloride (MDC) 100 1000
Triethyl amine 20 200
Hydroxy benzotriazole 6 60
Methanol 50 500
Methane sulphonic acid 2 20
Carbon 1 10
7-ethyl-10-hydroxy
2 10
camptothecin
Irinotecan HCl
21 I 1,chlorocarbonyl-4-piperidino 5
trihydrate 2.4 12
piperidine hydrochloride
Pyridine 80 400
EIA
- 46 -
Chloroform 140 700

Water 20 100
Hexane 20 100
Ethanol 2 10
II Dimethyl formamide (DMF) 2 10
Water 8 40
Water 18 90
III
Carbon 0.2 1
Methanol 4 4
4-nitropthalide 1 1
I
Raney nickel catalyst 0.1 0.1
Hydrogen gas 2 2
22 Lenalidomide Dimethyl sulphoxide 5 1 5
L-glutamine 1 1
II N,N, carbomyl diimidazole 3 3
Water 25 25
Carbon 0.1 0.1
p-tolunitrile 3 15
n-bromosuccinamide 2.5 12.5
I
Aceto nitrile 15 75
Hexane 3 15
23 Letrozole 1,2,4-triazole 1 5 5
Dimethyl formamide 3 15
II Potassium carbonate 3 15
Ethyl acetate 10 50
Water 10 50
Potassium
1.7 8.5
I Trans-1,2-diamino
0.51 2.55
cyclohexane
24 Oxaliplatin Water 5 5 25
Water 75 375
Silver oxide 0.93 4.65
II
Oxalic acid 0.47 2.35
Carbon 0.14 0.7
TxL RM 2 20
Zinc 3.75 37.5
I Methanol 15.6 156
Acetic acid 20 200
25 Paclitaxel Ethyl acetate 22.5 10 225
MDC 17.45 174.5
II Acetone 5.27 52.7
Petroleum ether 32.7 327
III Methanol 9.36 93.6
EIA
- 47 -
Water 12 120
MDC 4.85 48.5
IV Acetone 1.38 13.8
Petroleum ether 7.7 77
L-glutamic acid diethyl ester
1.14 11.4
HCl
4-[2-(2-amino-4,7-dihydro-4-
oxo-1H-pyrrolo[2,3-
1.56 15.6
d]pyrimidin-5-
yl)ethyl)benzolic acid
I
N-methyl morphalane 1.16 11.6
DMF 10.2 102
MDC 38.5 385
26 Pemetrexed Water 38.5 10 385
2-chloro-4,6-dimethoxy-
1 10
1,3,5-triazine
II Sodium hydroxide 1 10
Water 25 250
Acetone 30.78 307.8
III
Sodium hydroxide 1 10
Water 25 250
5-amino-1-(n-methyl
carbomyl) imidazole-4- 100 400
carboxamide
I
Water 600 2400
27 Temozolomide Sodium nitrite 40 4 160
Acetone 400 1600
II Water 150 600
Carbon 5 20
Phthalic anhydride 10 50
L-glutamine 10 50
Dimethyl sulphoxide (DMSO) 50 250
28 Thalidomide I 5
N,N-carbomyl diimidazole 15 75
Carbon 1 5
Water 100 500
10-hydroxy camptothecin 1 10
Dimethyl amine 0.5 5
I Formaldehyde 0.67 6.7
29 Topotecan HCl Acetic acid 10 10 100
Water 10 100
Water 10 100
II
Hydrochloric acid 0.3 3
EIA
- 48 -
Carbon 0.1 1
Imidazole 10 10
Toluene 50 50
Potassium carbonate 15 15
I Methyl chloroacetate 22 22
Isopropyl alcohol
30 30
hydrochloride
30 Zoledronic acid 1
Water 25 25
Phosphoric acid 14 14
Chlorobezene 40 40
II Phosphorous trichloride 20 20
Water 20 20
Carbon 1 1
2.6.2.1 Raw materials, sources and supply
The raw materials are either obtained from the local suppliers or imported
transportation mode is by road & sea. List of raw materials, their sources and
mode of transportation are given in table 2.6 B below.
EIA
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Table 2.6 B: List of raw materials, their sources and mode of transportation
Sl.
List of raw materials Vendor Name Place Mode of Transportation
No.
1 1,1-cyclobutane dicarboxylic acid HEFEI Home Sunshine Pharmaceutical China By sea/ By road
2 1,2,4-triazole Riddhi Pharma Ankleshwar By road through transport by sharing
3 1,3,5-trimethoxy benzene Inogent Laboratories Pvt. Ltd. Hyderabad By road through transport by sharing
1,chlorocarbonyl-4-piperidino
4 Vasuha Pharma Chem Vizag By road through transport by sharing
5 10-hydroxy camptothecin Avra Labs Hyderabad By road through transport by sharing
6 1N HCl TGV Sraa Ltd. Kurnool By road through transport by sharing
2 amino 3,5-dibromo
7 Riddhi Pharma Ankleshwar By road through transport by sharing
benzaldehyde
2-chloro-4,6-dimethoxy-1,3,5-
8 Eastar Technology Development Co. L Hong Kong By road through transport by sharing
triazine
9 2-ethoxy benzoyl chloride Urmi Chemicals Mumbai By road through transport by sharing
10 2M enol Dynamic (Hong Kong) Ind Co. Ltd. Hong Kong By road through transport by sharing
3- phenyl -2-[(pyrazine-2-carbonyl)-
11 Brilliant Top Corporation Limited China By sea / By road
amino] propionic acid
12 3-chloro-4-fluoroaniline Spectrochem Pvt. Ltd. Mumbai By road through transport by sharing
13 HEFEI Home Sunshine Pharmaceutical China By sea / By road
ethyl)benzoic acid dihydrochloride
4-[2-(2-amino-4,7-dihydro-4-oxo-
14 1H-pyrrolo[2,3-d]pyrimidin-5- HEFEI Home Sunshine Pharmaceutical China By sea / By road
propylpyrazolo-5-carboxamide
16 4-chloro butyryl chloride Transpek Industry Vadodara By road through transport by sharing
4-methyl-N3-(5-pyridin-3yl
17 pyrimidine-2-yl) benzene-1,3- HEFEI Home Sunshine Pharmaceutical China By sea / By road
diamine
EIA
- 50 -
18 4-nitropthalide Spectrochem Pvt. Ltd. Mumbai By sea / By road

5-amino-1-(n-methyl carbomyl)
19 Dalian Wistha Pharma China By sea / By road
imidazole-4-carboxamide
Nantong Haiers Pharmaceutical Co.
20 5-fluorocytosine China By sea / By road
Ltd.
5-methyl tetrahydrofuran-2,3,4-
triyl triacetate
22 6N HCl Prepared internally
23 7-ethyl-10-hydroxy camptothecin Avra Laboratories Pvt. Ltd. Hyderabad By road through transport by sharing
7-methoxy-6-(3-morphalino propyl)
quinazolin-4 (3H)-one
a,a,a,a,-tetramethyl-5-(methyl)-
1,3- benzenedi- acetonitrile
26 Acetic acid R Nandlal And Sons Mumbai By road
27 Acetic anhydride Jubilant Life Sciences Limited Pune By road
28 Acetonitrile Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road through transport by sharing
29 Acetone Sonkamal Enterprises Pvt. Ltd. Mumbai By road
30 Acetonitrile Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road
31 Aluminum chloride Hemant Chemicals Dharangaon By road
32 Ammonia Teja Ammonia Hyderabad By road
33 Ammonium Hydroxide -- -- Prepared internally
34 Benzene sulfonyl chloride Urmi Chemicals Mumbai By road
35 Butanol Cetex Petrochemicals Chennai By road
Sree Rayalaseema Hi Strength Hypo
36 C.S. (caustic) lye Karnool By road
Ltd.
37 Carbon Universal Chemicals Punjab By road through transport by sharing
38 Chlorobezene Spectrochem Pvt. Ltd. Mumbai By road through transport by sharing
39 Chloroform Urmi Chemicals Mumbai By road through transport by sharing
40 Chlorosulfonic acid TGV Sraa Ltd. Kurnool By road
41 Cholic acid Ice spa Italy By sea/ By road
EIA
- 51 -
42 Citric acid Mahalaxmi Dyes And Chemicals Ltd. Mumbai By road through transport by sharing
43 CN1 Spectrochem Pvt. Ltd. Mumbai By road through transport by sharing
44 Cyclohexane R R Innovative Pvt. Ltd. Mumbai By road through transport by sharing
45 Dimethyl amine Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road through transport by sharing
46 Dimethyl formamide (DMF) Lok Chemicals Mumbai By road
47 Dimethyl sulphoxide (DMSO) Mahalaxmi Dyes And Chemicals Ltd. Mumbai By road through transport by sharing
48 Dioxane Urmi Chemicals Mumbai By road through transport by sharing
49 Disopropyl amine Urmi Chemicals Mumbai By road through transport by sharing
50 EPI-i NA
51 Ethanol Shree Venkatesh Scientific Systems Gulbarga By road through transport by sharing
52 Ethyl acetate Laxmi Organics Mahad By road
Ethyl-4-(5-(bis(2-hydroxy ethyl)
53 amino)-1-methyl-1H-benzoid) Brilliant Top Corporation Limited China By sea / By road
imidazol-2-yl)butanoate
54 Formaldehyde Urmi Chemicals Mumbai By road through transport by sharing
55 G Intermediate By road through transport by sharing
56 HCl Durga Industries Hyderabad By road through transport by sharing
57 Heptane Vipul Life Science Ltd. Mumbai By road
58 Hexa methyl disaline (HMDS) Xinyaqiang silicon chemistry co., L China By sea/ By road
Pon Pure Chemical India Private
59 Hexane Hyderabad By road through transport by sharing
Limited
60 Hydrobromic acid Mody Chem Mumbai By road through transport by sharing
61 Hydrogen Kurnool By road through transport by sharing
Ltd.
62 Hydrogen gas Kurnool By road
Ltd.
63 Hydroxy benzotriazole Snap Intermediates Mumbai By road through transport by sharing
64 HzHz Chori Co. Ltd. Japan By sea / By road
65 Imidazole Spectrochem Pvt. Ltd. Mumbai By road through transport by sharing
66 IPA R R Innovative Pvt. Ltd. Mumbai By road through transport by sharing
EIA
- 52 -
67 IPA HCl Durga industries Hyderabad By road through transport by sharing

68 Iso propyl alcohol (IPA) HCl Durga industries Hyderabad By road through transport by sharing
69 Isobutyl boronic acid Denisco Ltd. Hyderabad By road through transport by sharing
70 Isopropyl alcohol R R Innovative Pvt. Ltd. Mumbai By road through transport by sharing
71 Isopropyl alcohol hydrochloride Durga industries Hyderabad By road through transport by sharing
72 Isopropyl alcohol (IPA) R R Innovative Pvt. Ltd. Mumbai By road
73 Isopropyl alcohol (IPA) HCl Durga industries Kurnool By road
74 KOH TGV Sraac Limited Kurnool By road
75 L-glutamic acid diethyl ester HCl Gaoyuan International Co. Limited China By sea / By road
76 L-glutamine Navpad Trade Impex Mumbai By road through transport by sharing
77 Liq. ammonia Tej Ammonia Hyderabad By road
78 Liq. bromine Mody Chem Mumbai By road
79 MDC Shandong Dongyue Fluo-Silicon Mater China By sea / By road
80 Metahydroxy acetophenone Mahalaxmi Dyes And Chemicals Ltd. Mumbai By road
81 Methane sulphonic acid Lok Chemicals Mumbai By road through transport by sharing
82 Methanol Neha Chemicals Mumbai By road
83 Methyl aceto acetate Mahalaxmi Dyes And Chemicals Ltd. Mumbai By road
84 Methyl chloroacetate Spectrochem Pvt. Ltd. Mumbai By road through transport by sharing
85 Methylene di-chloride (MDC) Shandong Dongyue Fluo-Silicon Mater China By sea / By road
86 N- bromosuccianmide Mody Chem Mumbai By road through transport by sharing
87 N,N, carbomyl diimidazole Changzhou Chongkai Chemical Co.Ltd. China By sea / By road
N-[4-cyano-3-trifluoromethyl
88 phenyl]-3-[4-fluorophenyl thio]-2- Brilliant Top Corporation Limited China By sea / By road
hydroxy-2-methyl propanamide
89 n-bromosuccinamide Mody Chem Mumbai By road through transport by sharing
90 n-Heptane Vipul Life Science Ltd. Mumbai By road through transport by sharing
Pon Pure Chemical India Private
91 n-Hexane Mumbai By road
Limited
92 n-hydroxy succinamide Spectrochem Pvt. Ltd. Bangalore By road through transport by sharing
93 N-methyl benzyl amine Spectrochem Pvt. Ltd. Bangalore By road through transport by sharing
EIA
- 53 -
94 N-methyl morphalane Spectrochem Pvt. Ltd. Bangalore By road through transport by sharing
95 n-methyl piperazine Spectrochem Pvt. Ltd. Bangalore By road through transport by sharing
96 N-pentyl chloroformate M/s Vandemark Chemcials Inc. New York, USA By sea / By road
97 Ortho chloro benzylamine Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road through transport by sharing
98 Ortho nitrobenzaldehyde Hangzhou longshan Chemical Co. Ltd. China By sea / By road
99 Oxalic acid Jaya Scientific Enterprises Raichur By road through transport by sharing
100 Pd. carbon Evonik Catalyst Mumbai By road through transport by sharing
101 Petroleum ether Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road
Panchiao,
102 Phosphoric acid Hiforce Chemical Co Limited By sea / By road
Taiwan
103 Phosphorous trichloride Sandhya Groups Mumbai By road through transport by sharing
104 Phthalic anhydride Sonkamal Enterprises Pvt. Ltd. Mumbai By road through transport by sharing
105 Piperidine catalyst Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road through transport by sharing
106 Potassium carbonate (K2CO3) Unid Korea Korea By sea / By road
107 Potassium chloride Jaya Scientific Enterprises Raichur By road
108 Potassium iodide Avra Synthesis Pvt. Ltd. Hyderabad By sea / By road
109 Potassium permanganate Piyush Chemicals Mumbai By sea / By road
110 Potassium tetrachloroplatinate Ravindra Heraeus Pvt. Ltd. Udaipur By road through transport by sharing
111 p-tolunitrile Naveep Chemicals Gujrat By road through transport by sharing
112 Pyridine Arthasri Impex Hyderabad By road
113 Pyrrolidine Spectrochem Pvt. Ltd. Bangalore By road through transport by sharing
114 Raney nickel catalyst Namokar Specialty Chemicals Indore By road through transport by sharing
R-borolex-(+)-pinanediol trifluoro
115 Suzhou Lixin Pharmaceutical Co. Ltd. China By sea / By road
acetic acid
116 Saturated sodium bicarbonate TATA Chemicals Mithapur By road through transport by sharing
117 solution in water 10 kg in 12 L Spectrochem Pvt. Ltd. Mumbai By road
water
118 Silver nitrate Silver White Chemicals Ahmedabad By road through transport by sharing
119 Silver oxide Hindustan Platinum Pvt. Ltd. Mumbai By road through transport by sharing
EIA
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120 Sodium bicarbonate Shika Enterprises Secunderabad By road

Shandong Guobang Pharmaceuticals
121 Sodium borohydride China By sea / By road
Ltd.
122 Sodium bromate Windia Chemicals Chennai By road through transport by sharing
123 Sodium carbonate Shika Enterprises Secunderabad By road
124 Sodium chloride Gayathri Salt Hyderabad By road through transport by sharing
125 Sodium hydroxide Merck Ltd. Mumbai By road through transport by sharing
126 Sodium hypochloride TGV SRAAC Limited Kurnool By road
127 Sodium metal Wanji Global Singapor Singapore By sea / By road
128 Sodium nitrite Shika Enterprises Secunderabad By road through transport by sharing
129 Sodium sulfate Shika Enterprises Secunderabad By road through transport by sharing
130 Stannic chloride Mithila Rasyan TARAPUR By road through transport by sharing
131 Sulfuric acid Kurnool By road through transport by sharing
Ltd.
132 Tartaric acid Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road through transport by sharing
133 Tetra methyl silyl chloride (TMSC) Chemcon Speciality Pvt. Ltd. EOU Vadodara By road through transport by sharing
134 Thionyl chloride Jeevandas Laljee And Sons Hyderabad By road through transport by sharing
135 Thiophene-2-ethanol Sanjay Chemicals (India) Pvt. Ltd. Mumbai By road through transport by sharing
136 Thiophylline-7-acetic acid Bajaj Healthcare Ltd. Mumbai By road through transport by sharing
137 Toluene Neha Chemicals Mumbai By road
138 Trans -4- amino cyclohexanol Hangzhou Longshan Chemical Co. Ltd. China By sea / By road
139 Trans-1,2-diamino cyclohexane Hangzhou Longshan Chemical Co. Ltd. China By sea / By road
140 Trimethyl amine Balaji Amines Limited Solapur By road through transport by sharing
141 TxL RM Hangzhou Longshan Chemical Co., Ltd. China By sea / By road
142 Water -- -- In-house
143 Zinc Jaya Scientific Enterprises Raichur By road
EIA
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2.6.2.2 Storage facilities for raw materials, products
Table 2.6 C: Storage facilities for raw materials and products

Sl. Storage Facility for Facility
No.
1 Raw materials Solid chemicals are stored in warehouse. Solvents
are stored in solvent tank farm and underground
storage tank as per PESO norms with necessary
approvals from regulatory bodies.
2 Finished products Finished goods store / Warehouse.
Fig 2.5: Photographs of raw materials storage area
EIA
- 56 -
2.6.3 Reactor details
Details of all reactors used in the manufacturing process are listed in the
following table
Table 2.7: Reactor details
Sl. Capacity of the Stainless Glass Lined All Glass (Round
no. reactors Steel (SS) (GL) Reactor Bottom - RB flask)
Reactor (No.s) (No.s)
(No.s)
1 1L 0 0 1
2 2L 0 0 1
3 3L 0 0 1
4 8L 0 0 1
5 10 L 0 0 1
6 20 L 0 0 1
7 63 L 0 2 0
8 100 L 0 5 0
9 160 L 0 5 0
10 250 L 0 2 0
11 500 L 2 7 0
12 1.0 KL 1 1 0
13 1.6 KL 2 5 0
14 2.0 KL 5 2 0
15 2.5 KL 7 5 0
16 3.0 KL 4 2 0
17 4.0 KL 12 4 0
18 6.3 KL 0 3 0
19 8.0 KL 4 5 0
Total 36 48 6
2.6.4 Manufacturing process description
The manufacturing process for each of the APIs proposed to be produced is

described with stoichiometric and gravimetric balances along with process
description and material balance flow charts as under.
EIA
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2.6.4.1 Acebrophylline
REACTION SCHEME
EIA
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RAW MATERIAL CONSUMPTION
1st stage
Sl. Raw material used Qty./batch

No. (kg)
1 2 amino 3,5-dibromo
150
benzaldehyde
2 Trans-4-amino cyclohexanol 62.5
3 Sodium borohydride 22.5
4 Methanol 910
5 Water 700
2nd stage
Production batch size 250 kg

No. (kg)
1 Dimethyl 1065
formamide (DMF)
2 Ethyl acetate 5350
3 Thiophylline-7- 128
acetic acid
EIA
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PROCESS FLOW CHART
1st & 2nd stages
2-amino-3,5-dibromo benzaldehyde Methanol

150 kg 910 kg
Trans 4 amino cyclohexanol
62.5 kg
SS Reactor
Methanol
Water 24 hrs reflux recovered
100 kg 895 kg
Sodium borohydride SS Reactor Distillation loss
22.5 kg 15 kg
Water Process
Centrifuge
600 kg wastewater
735 kg
Ambroxol base
200 kg
DMF Thiophylline-7- acetic acid

1065 kg 128 kg
SS Reactor
Ethyl acetate
Filter Ambroxol base
5350 kg
78 kg DMF
recovered
Centrifuge Distillation 1050 kg
loss
15 kg
Ethyl acetate
Drier Recovered
5310 kg
Loss
40 kg
Acebrophylline
250 kg
EIA
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GRAVIMETRIC MATERIAL BALANCE
1st stage
Input Qty/batch Output Qty/batch

Reactors
(kg) (kg)
2 amino 3,5- Output from 1st stage 200
150
dibromo Solvent methanol
benzaldehyde recovered from 895
SS
Trans-4-amino reaction
62.5 Reactor
cyclohexanol loss 15
3 KL 2
Sodium borohydride 22.5 Process wastewater 735
no.s
Methanol 910
Water 700
Total input 1845 Total output 1845
Qty./batch
Output (kg)
Input Qty./batch Reactor Output from 200
(kg) 1st stage
2 amino 3,5 dibromo
benzaldehyde 150
Trans-4-amino 62.5 Solvent methanol

cyclohexanol
recovered from 895
Sodium 22.5 reaction
borohydride loss 15
Methanol 910
Water 700
Wastewater 735
EIA
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2nd stage

Reactors
(kg) (kg)
st
Output from 1 stage 200 Acebrophylline 250
Dimethyl formamide 1065 By product: ambroxol 78
(DMF) base
Ethyl acetate 5350 Solvent
Thiophylline-7-acetic 128 1) DMF
acid SS recovered from 1050
Reactor reaction
8 KL 2 loss 15
no.s
2) Ethyl acetate
recovered from 5310
reaction
loss 40
Qty./batch
Output (kg)
Qty./batch Reactor Acebrophylline 250
Input
(kg)
Output from 1st
stage 200
By product
DMF 1065 Ambroxol base 78
Ethyl acetate 5350

Solvent
1) DMF
Thiophylline-7- 128 1050
recovered from
acetic acid
reaction
loss 15
2) Ethyl acetate
recovered from 5310
reaction
loss 40
EIA
- 62 -
PROCEDURE
The process involves 2 steps.
1st stage
2-amino-3,5-dibromobenzaldehyde is reacted with trans-4-amino cyclohexanol

in the presence of methanol for 24 hrs (reflux) to give in situ trans -4- [(2-
amino-3,5-dibromobenzyl) amino] cyclohexanol. This in situ product is further
reduced with sodium borohydride in the presence of water to give ambroxol
base.
2nd stage
Ambroxol base is dissolved in dimethyl formamide at room temperature.

Theophylline-7-acetic acid is charged and stirred to dissolve the reaction
mixture completely at 10°C which is then filtered. The product is recrystallized
with ethyl acetate and dried to give acebrophylline.
CYCLE TIME
Time (hrs)
Particulars
1 stage 2nd stage
st
Reaction 24 - 26 12 - 14
Isolation & centrifugation 4-6 8 - 10
Solvent recovery 8 - 10 5-6
Total process time 36 - 42 25 - 30
APPLICATIONS
Acebrophylline is used as bronchodilator. It is an airway mucus regulator with

anti-inflammatory action
EIA
- 63 -
2.6.4.2 Ambroxol HCl
REACTION SCHEME
EIA
- 64 -
1st stage

No. (kg)
1 2 amino 3,5 dibromo benzaldehyde 400
2 Trans amino cyclohexanol 250
3 Sodium borohydride 75
4 Methanol 3000
5 Water 2000
2nd stage

No. (kg)
1 Acetone 2780
2 Hydrochloric acid 150
3 Carbon 50
4 Water 25
EIA
- 65 -
PROCESS FLOW CHART

st
1 stage
2-amino-3,5-dibromo benzaldehyde Methanol

400 kg 3000 kg
Trans -4- amino cyclohexanol Sodium borohydride
250 kg 75 kg
Water Distillation
SS Reactor
2000 kg
Solvent methanol
recovered from reaction
Process wastewater Centrifuge 2920 kg
2190 kg recovered from scrubber
70 kg
loss
Ambroxol HCl base 10 kg
535 kg
Acetone Carbon
2nd stage 2780 kg 50 kg
SS Reactor
By product: carbon
Filter 50 kg
Hydrochloric acid
150 kg
GL Reactor
Solvent acetone
recovered from
reaction
Centrifuge Mother liquor 2700 kg
recovered from
Water
scrubber
25 kg 70 kg
Drier loss
Slurry
10 kg
Ambroxol HCl Centrifuge

585 kg
Process wastewater
EIA 125 kg
- 66 -
1st stage

Reactors
(kg) (kg)
2 amino 3,5 dibromo 400 Output from 1st stage 535
benzaldehyde Solvent methanol
Trans -4- amino 250 recovered from 2920
SS
cyclohexanol reaction
Reactor
Sodium borohydride 75 recovered from 70
4 KL 2
Methanol 3000 scrubber
no.s
loss 10
Water 2000 Process wastewater 2190
Qty./batch
Output (kg)
Qty./batch
Input Reactor Output from 535
(kg)
1st stage
2 amino 3,5 dibromo
benzaldehyde 400
Solvent methanol
Trans -4- amino 250
cyclohexanol recovered from 2920
reaction
Sodium 75 recovered from 70
borohydride scrubber
loss 10
Methanol 3000
Water 2000 Wastewater 2190
EIA
- 67 -
2nd stage

Reactors
(kg) (kg)
Output from 1st stage 535 SS Ambroxol HCl 585
Acetone 2780 Reactor Carbon 50
Hydrochloric acid 150 4 KL Solvent acetone
Carbon 50 recovered from 2700
Water 25 reaction
GL recovered from 70
Reactor scrubber
4 KL loss 10
Process wastewater 125
Qty./batch
Output (kg)
Qty./batch Reactor
Input Ambroxol HCl 585
(kg)
Output from 1st
stage 535
Carbon 50
Acetone 2780
Solvent acetone
Hydrochloric 150 recovery from 2700
acid
reaction
50 recovered from 70
Carbon
scrubber
Water 25 10
loss
Wastewater 125
EIA
- 68 -
PROCEDURE
1st stage
2-amino-3,5-dibromobenzaldehyde is condensed with trans-4-amino

cyclohexanol in the presence of solvent methanol to get trans-4-[(2-amino-3,5-
dibromobenzyl)amino] cyclohexanol of ambroxol hydrochloride. The above
trans-4-[(2-amino-3,5-dibromobenzyl)amino] cyclohexanol on reaction with
sodium borohydride & in the presence of water forms ambroxol HCl base.
2nd stage
Ambroxol base is converted into crude ambroxol HCl in the presence of acetone
and carbon which is then purified to get ambroxol HCl pharma grade. HCl is
used for pH adjustment.
CYCLE TIME
Particulars Time (hrs)

1st stage 2nd stage
Reaction 24 - 26 10 - 12
Isolation and centrifugation 4-6 4-6
Solvent recovery 8 - 10 8 10
EIA
- 69 -
APPLICATIONS
Ambroxol is a secretolytic agent used in the treatment of respiratory diseases

associated with viscid or excessive mucus. It is the active ingredient of
Mucosolvan, Lasolvan or Mucoangin. The substance is a mucoactive drug with
several properties including secretolytic and secretomotoric actions that
restore the physiological clearance mechanisms of the respiratory tract which
synthesis and release of surfactant by type II pneumocytes. Surfactants act as

an anti-glue factor by reducing the adhesion of mucus to the bronchial wall, in
improving its transport and in providing protection against infection and
irritating agents.
associated with abnormal mucus secretion and impaired mucus transport. It

promotes mucus clearance, facilitates expectoration and eases productive
cough, allowing patients to breathe freely and deeply.
Ambroxol also provides pain relief in acute sore throat. Pain in sore throat is
the hallmark of acute pharyngitis. Sore throat is usually caused by a viral
infection. The infection is self-limited and the patient recovers normally after
a few days. What is most bothering for the patient is the continuous pain in the
throat maximized when the patient is swallowing. The main goal of treatment
is thus to reduce pain. The main property of Ambroxol for treating sore throat
is the local anaesthetic effect, described first in the late 1970s, but explained
and confirmed in more recent work.
Ambroxol is a very potent inhibitor of the neuronal Na+ channels. This property
led to the development of a lozenge containing 20 mg of ambroxol. Many state-
of-the-art clinical studies have demonstrated the efficacy of Ambroxol in
relieving pain in acute sore throat, with a fast onset of action and a long
duration of effect of at least 3 hours. Additional anti-inflammatory properties
of Ambroxol are of clinical relevance since treatment lead to a marked
EIA
- 70 -
2.6.4.3 Buflomedil HCl
REACTION SCHEME
EIA
- 71 -
1st stage
No. (kg)
1 4-chloro butyryl chloride 177
2 Aluminium chloride 183
3 1,3,5-trimethoxy benzene 111
4 Methylene di-chloride (MDC) 500
6 Water 2000
2nd stage
No. (kg)
1 Ethyl acetate 300
2 Pyrrolidine 125
3 Iso propyl alcohol (IPA) HCl 257
3rd stage
Production yield per batch 130 kg
No. (kg)
1 IPA 600
2 C.S. lye 100
3 Carbon 11
4 Toluene 300
5 IPA HCl 180
6 Water 500
EIA
- 72 -
PROCESS FLOW CHART
1st stage
4-chloro butyryl chloride Methylene di-chloride

177 kg 500 kg
Aluminum chloride 1,3,5-trimethoxy benzene
183 kg 111 kg
GL Reactor
Hydrochloric acid
250 kg Process wastewater
Water GL Reactor 2571 kg
2000 kg
Crystallizer Distillation
Methylene dichloride
Recovered
Output from 1st stage 490 kg
Loss
150 kg 10 kg
EIA
- 73 -
2nd stage
Ethyl acetate Output from 1st stage

300 kg 150 kg
Pyrrolidine
125 kg
Reactor
Ethyl acetate
IPA HCl recovered
257 kg Reactor 290 kg
loss
10 kg Process
ML residue
Centrifuge Distillation
3 kg
Pyrrolidine IPA recovery

Output from 2nd stage 231 kg
100 kg
198 kg
EIA
- 74 -
3rd stage
Output from 2nd stage

C.S. lye 198 kg Water
100 kg 500 kg
C.S. lye
Reactor
100 kg
Toluene
Reactor Process wastewater
300 kg 555.3 kg
Carbon Organic layer
11 kg
Spent carbon
Filter 11 kg
IPA HCl Reactor IPA

180 kg recovered 90 kg
loss 1.86 kg
1,3,5 -
Centrifuge Distillation trimethoxy
benzene
Toluene 50 kg
recovered 295 kg
loss 5 kg
IPA IPA
600 kg Reactor recovered 635 kg
loss 13.14 kg
Process
Centrifuge Distillation residue
2.7 kg
Drier
Buflomedil HCl
130 kg
EIA
- 75 -
1st stage
Input Qty/batch Reactor Output Qty/batch

(kg) (kg)
4-chloro butyryl 177 Output from 1st stage 150
chloride Solvent MDC
Aluminium chloride 183 recovered from 480
1,3,5-trimethoxy 111 GL reaction
benzene Reactor recovered from 10
Methylene di- 500 4 KL 2 chiller
chloride (MDC) no.s loss 10
Hydrochloric acid 250 Process wastewater 2571
Water 2000
Qty./batch
Input Reactor Qty./batch
(kg) Output
4-chloro butyryl (kg)
chloride 177
Output from 150
1st stage
Aluminum 183
chloride
1,3,5-trimethoxy Solvent MDC

111 recovered from 480
benzene
reaction
MDC 500 recovered from 10
chiller
Hydrochloric 250 loss 10
acid
Water 2000
Wastewater 2571
EIA
- 76 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 150 Output from 2nd stage 198
stage SS
Ethyl acetate 300 Reactor By product: 100
Pyrrolidine 125 2 KL pyrrolidine
Iso propyl alcohol 257 Solvent ethyl acetate
(IPA) HCl recovered from 290
reaction
GL
loss 10
Reactor
IPA recovery 231
2.5 KL
Process residue 3
Qty./batch
Output
(kg)
Qty./batch
(kg)
2nd stage
Output from 1st
150
stage
300 By product pyrrolidine 100
Ethyl acetate
Pyrrolidine 125
Solvent ethyl acetate
IPA HCl 257 recovered from 290
reaction
loss 10
IPA recovery 231
Process residue 3
EIA
- 77 -
3rd stage

Reactors
(kg) (kg)
Output from 198 Buflomedil HCl 130
2nd stage SS By product: 1,3,5 - 50
IPA 600 Reactor trimethoxy benzene
C.S. (caustic) 100 2 KL Carbon 11
lye Caustic lye 100
Carbon 11 Solvent
Toluene 300 1) IPA
Water 500 reaction
loss 15
GL
Reactor 2) Toluene
2.5 KL recovered from 295
reaction
loss 5
Process residue 2.7
Process wastewater 555.3
Qty./batch
Output (kg)
Qty./batch Reactor Buflomedil HCl
Input 130
(kg)
Output from 2nd
stage 198 By product: 1,3,5 - 50
trimethoxy benzene
Isopropyl alcohol 600
Carbon 11
C.S. (caustic) lye 100
11 Caustic lye 100
Carbon
Toluene 300 Solvent
1) IPA
reaction
Water 500 loss 15
2) Toluene
recovered from 295
reaction
loss 5
Process residue 2.7

EIA 555.3
Wastewater
- 78 -
PROCEDURE
1st stage
1,3,5-trimethoxy benzene is reacted with chloro butyryl chloride in presence of

aluminium chloride and in solvent methylene dichloride (friedel craft reaction)
to get the output from 1st stage.
2nd stage
The output from 1st stage is condensed with pyrrolidine in the presence of ethyl
acetate at 800C to 850C and subsequently with isopropyl alcohol/HCl to produce
buflomedil hydrochloride (crude output from 2nd stage).
3rd stage
The crude buflomedil hydrochloride is purified by regeneration of free base

in sodium hydroxide solution (lye), in the presence of toluene and carbon
and converted it into pure buflomedil hydrochloride by isopropyl
alcohol/HCl.
CYCLE TIME

1 stage 2nd stage
st
3rd stage
Reaction 20 - 22 14 - 16 10 - 12
Isolation and centrifugation 8 - 10 8 - 12 4-6
Solvent recovery 2-3 4-6 4-6
Total process time 30 - 35 26 - 34 18 - 24
APPLICATIONS
It is used for the treatment of disease of peripheral blood vessel and symptom
which is caused by chronic brain blood vessel offering blood not enough.
EIA
- 79 -
2.6.4.4 Nifedipine
REACTION SCHEME
H H H H2N CH3
+H2O
H C C C C O C H NH3 Mol. Wt. 18
O
Ammonia CH3
H O H O H Mol. Wt. 17.03
Methyl acetoacetate O
C5H8O3
Methyl 3-aminobut-2-enoate
Mol. Wt.: 116.12
C5H9NO2
Mol. Wt.: 115.13
H3C O
+H2O
O Mol. Wt. 18
H3C
NO2
H H H O NO2
CHOH H C C C C O C H
H O H O H
O-Nitrobenzaldehyde Methyl acetoacetate methyl 2-(2-nitrobenzylidene)-3-oxobutanoate

C7H5NO3 C5H8O3 C12H11NO5
Mol. Wt.: 151.12 Mol. Wt.: 116.12 Mol. Wt.: 249.22
H3C O
H2N CH3 OCH3
O CH3
O
H3C O
CH3 NH
O NO2
O NO2 O CH3
Methyl 3-aminobut-2-enoate OCH3
C5H9NO2 +H2O
Mol. Wt.: 115.13
Mol. Wt. 18
Nifedipine
methyl 2-(2-nitrobenzylidene)-3-oxobutanoate C17H18N2O6
C12H11NO5 Mol. Wt.:346.33
Mol. Wt.: 249.22
EIA
- 80 -
1st stage
Sl. Raw materials used Qty./batch

No. (kg)
1 Methyl aceto acetate 435
2 Methanol 435
3 Ammonia (25%) 435
2nd stage

No. (kg)
1 Ortho nitrobenzaldehyde 250
2 Isopropyl alcohol (IPA) 1500
3 Piperidine catalyst 4.5
4 Methyl aceto acetate 217.5
5 Acetic acid 7
3rd stage
Production yield/batch 450 kg

No. (kg)
1 Methanol 2700
EIA
- 81 -
PROCESS FLOW CHART
1st stage
Methyl aceto acetate Ammonia

435 kg 435 kg
Methanol
435 kg
SS Reactor
Centrifuge Process wastewater

930 kg
Drier
Output from 1st stage

375 kg
EIA
- 82 -
2nd stage
Ortho nitro benzaldehyde Methyl aceto acetate

250 kg 217.5 kg
Isopropyl alcohol Acetic acid
1500 kg 7 kg
Piperidine catalyst
4.5 kg SS Reactor
Methyl aceto acetate
(recovered)
99.5 kg
IPA recovered
1485 kg
IPA loss
15 kg
Piperidine catalyst residue
4.5 kg
Drier

375 kg
EIA
- 83 -
3rd stage
Output from 1st stage Output from 2nd stage

185 kg 375 kg
Methanol
2700 kg
SS Reactor
Filter
SS Reactor Methanol loss

20 kg
Methanol
Centrifuge recovered &
Distillation
recycled
2680 kg
Drier Hazardous
waste (process
Centrifuge residue)
5 kg
Sifter
Nitro phenyl pyridine

105 kg
Nifedipine
450 kg
EIA
- 84 -
1st stage
Qty/batch Qty/batch
Input Reactor Output
(kg) (kg)
Methyl aceto acetate 435 Output from 1st stage 375
SS
Methanol 435 Process wastewater 930
Reactor
Ammonia (25%
435 (SSR) -
solution)
2 KL
Qty./batch
Qty./batch Output (kg)
Input
(kg)
Reactor Output from 375
Methyl aceto 1st stage
acetate 435
Methanol 435
Ammonia 435
EIA
- 85 -
2nd stage
Qty/batch Qty/batch
(kg) (kg)
Ortho Output from 2nd stage 375
250
nitrobenzaldehyde By product:
Methyl aceto acetate 99.5
(recovered)
SS Piperidine catalyst
Piperidine catalyst 4.5 4.5
Reactor (recovered)
Methyl aceto 3 KL Solvent IPA
217.5
acetate recovered & 1485
recycled
Acetic acid 7
loss 15
Output Qty./batch
(kg)
Output from 375
Input Qty./batch
Reactor 2nd stage
(kg)
Ortho
nitrobenzaldehyde 250 By-product
1500 Methyl aceto acetate 99.5
Isopropyl alcohol
(recovered)
Piperidine 4.5
catalyst
Piperidine catalyst
4.5
(recovered)
Methyl aceto 217.5
acetate
Solvent IPA
Acetic acid 7
recovered 1485
loss 15
EIA
- 86 -
3rd stage
Qty/batch Qty/batch
(kg) (kg)
Methanol 2700 Nifedipine 450
Output from 1st Nitro phenyl pyridine 105
185
stage Solvent methanol
Output from 2nd 375 SS recovered & 2680
stage Reactor recycled
4 KL 2 loss 20
no.s Hazardous waste
5
(process residue)
Qty./batch
Input Qty./batch Reactor Output (kg)
(kg)
Nifedipine 450
Methanol 2700
Nitro phenyl 105

Output from 1st
185 pyridine
stage
Hazardous waste 5
Output from
2nd stage 375
Solvent methanol
recovered 2680
loss 20
EIA
- 87 -
PROCEDURE
The process involves 3 stages.
1st stage
Methyl aceto acetate is treated with ammonia solution and methanol to form
an intermediate compound (A).
2nd stage
Ortho nitro benzaldehyde is treated with methyl aceto acetate in presence of

isopropyl alcohol, acetic acid and piperidine catalyst to form an intermediate
compound (B).
3rd stage
Intermediate compound A is condensed with B in presence of methanol to

obtain the final product nifedipine.
CYCLE TIME

st
1 stage 2nd stage 3rd stage
Reaction 10 - 12 14 16 24 26
Isolation & centrifugation 4-6 4 6 8 10
Solvent recovery - 10 - 12 8 - 10
Total process time 14 - 18 28 34 40 46
APPLICATIONS
Nifedipine (brand name Adalat, Nifedical, and Procardia) is a dihydropyridine

calcium channel blocker. Its main uses are
As an antianginal (especially in Prinzmetal's angina) and antihypertensive.
A large number of other uses have recently been found for this agent, such
as Raynaud's phenomenon, premature labour, and painful spasms of the
oesophagus in cancer and tetanus patients.
It is also commonly used for the small subset of pulmonary hypertension
patients whose symptoms respond to calcium channel blockers.
The approved uses for nifedipine are the long-term treatment of
hypertension (high blood pressure) and angina pectoris.
EIA
- 88 -
2.6.4.5 Phenyl ephrine HCl
REACTION SCHEME
EIA
- 89 -
Route of Synthesis for Phenyl Ephrine
Stage-III
HO CH3 HO CH3
H2 H2
H C C NH.HCl H C C NH2
IPA
L (+) tartaric acid
OH OH
DL-Phenyl ephrine HCl DL-Phenyl ephrine HCl
C9H14ClNO2 C9H14NO2
Mol. Wt.: 203.67 Mol. Wt.: 168.21
Stage-IV
HO CH3 HO CH3
H2 H2
H C C NH2 H C C NH2
Methanol
IPA HCl / Acetone HCl
OH OH
DL-Phenyl ephrine HCl Phenyl ephrine HCl
C9H14NO2 C9H15ClNO2
Mol. Wt.: 168.21 Mol. Wt.: 204.67
EIA
- 90 -
1st stage
No. (kg)
1 Metahydroxy acetophenone 337
2 Toluene 2847
3 Ethyl acetate 1005
4 Liq. bromine 442
5 Liq. ammonia 442
6 N-methyl benzyl amine 543
7 Aluminium chloride 8
8 Sodium bicarbonate 67
9 n-Hexane 670
10 Water 5025
11 IPA (isopropyl alcohol) HCl 551
2nd stage
No. (kg)
1 Methanol 1820
2 Pd. carbon 6.5
3 Hydrogen 26
4 Liq. ammonia 700
5 Water 2600
3rd stage
No. (kg)
1 Isopropyl alcohol (IPA) 672
2 Tartaric acid 336
3 Acetic anhydride 1545
4 Liquor ammonia 772
5 Sulfuric acid 90
6 Water 1682
4th stage
No. (kg)
1 Methanol 670
2 Carbon 3.5
3 Acetone 840
4 IPA HCl 200
EIA
- 91 -
PROCESS FLOW CHART
1st stage
Metahydroxy acetophenone Toluene

337 kg 2847 kg
Liq. bromine
442 kg
Reactor
Water Liq. ammonia
1436 kg 442 kg
Sodium bicarbonate Sodium carbonate solution
Reaction mass 2677 kg
67 kg
Solvent toluene
recovered 2820 kg Distillation Organic layer
spent 17 kg
loss 10 kg
Ethyl acetate N-methyl benzyl amine

1005 kg 543 kg
Aluminum chloride Filter Salt N-mehtyl benzyl amine
8 kg 540 kg
Water Aqueous layer (process wastewater)
Filtrate
3589 kg 3381 kg
IPA HCl
Organic layer
551 kg
recovered 950 kg
loss 55 kg
Spent IPA+hexane
110 kg
n-hexane Recovered IPA

Centrifuge Mother liquor 425 kg
670 kg
Process residue Recovered n-hexane

12 kg recovered 645 kg
loss 15 kg
280 kg
EIA
- 92 -
2nd stage

280 kg
Methanol Pd. carbon
1820 kg 6.5 kg
Hydrogen gas
26 kg
SS Reactor
Water Recovered Pd. Carbon

Filter 6.5 kg
2600 kg
Liq. Ammonia
Filtrate
700 kg
Methanol
Centrifuge Mother recovered 1750 kg
liquor spent (methanol
+toluene comes
from process)
150 kg
loss 9 kg
Process wastewater
Cake 3349 kg
Drier (cake drying)

168 kg
EIA
- 93 -
3rd stage

336 kg
Isopropyl alcohol Tartaric acid
448 kg 336 kg
Water
202 kg
SS Reactor
Isopropyl alcohol
224 kg
Centrifuge
Liquor ammonia Water
604 kg 168 kg
Salt
SS Reactor (MLR) Process wastewater
274 kg
Water Centrifuge
471 kg
Solvent IPA
Process recovered 330 kg
Centrifuge Cake spent 336 kg
wastewater
1646 kg loss 6 kg
Drier Drier
Output from 3rd stage Acetic anhydride Sulfuric acid

235 kg 1545 kg 90 kg
Acetic anhydride +
SS Reactor ammonia + tartaric acid
recovered 1450 kg
Liq. ammonia Water
168 kg 673 kg
Reaction mass
Water
Centrifuge 1156 kg
EIA
- 94 -
4th stage
Output from 3rd stage

235 kg
Methanol Acetone
670 kg 756 kg
Carbon
3.5 kg
SS Reactor
Spent carbon
Filter 6.5 kg
Methanol recovery
IPA HCl 500 kg
200 kg SS Reactor
Methanol ML
Acetone
Centrifuge
84 kg
Acetone ML
Acetone recovery
180 kg
Spent solvent mixture
991 kg
Phenyl ephrine isomer
Drier salt
21 kg
Phenyl ephrine HCl

250 kg
EIA
- 95 -
1st stage
Qty/batch Qty/batch
(kg) (kg)
Metahydroxy Output from 1st stage 280
337
acetophenone By product: n-methyl
540
Toluene 2847 benzyl amine
GL
Ethyl acetate 1005 Sodium carbonate
Reactor 2677
Liq. bromine 442 3 KL
solution
Liq. ammonia 442 Solvent
N-methyl benzyl 1. Toluene
543 2820
amine recovery
17
Aluminium chloride 8 spent (from
SS scrubber)
Sodium bicarbonate 67
Reactor loss 10
n-Hexane 670
3 KL
Water 5025 2. Ethyl acetate
IPA HCl 551 recovery 950
loss 55
3. n- Hexane
recovery
loss 645
SS 15
4. IPA
Reactor
Recovered 425
6.3 KL
5. Spent IPA + hexane 110
Hazardous waste
12
(process residue)
EIA
- 96 -
Output Qty./batch
(kg)
Output from 280
1st stage
By-product
Input Qty./batch
(kg) Reactor n-methyl benzyl 540
amine
Metahydroxy
acetophenone 337
Sodium carbonate 2677
Toluene 2847 solution
Ethyl acetate 1005 Solvent
Liq. bromine 442 1. Toluene

recovery 2820
442 spent 17
Liq. ammonia
loss 10
N-methyl 2. Ethyl acetate
543 950
recovery
benzyl amine loss 55
3. n- Hexane
Aluminum recovery 645
8
chloride loss 15
Sodium 67
bicarbonate Spent IPA +
110
hexane
n-Hexane 670
Hazardous waste 12
5025 (process residue)
Water

IPA HCl 551
EIA
- 97 -
2nd stage
Qty/batch Qty/batch
(kg) (kg)
Output from 1st SS
280 Output from 2nd stage 168
stage Rector
Methanol 1820 4 KL 1 Pd. carbon 6.5
Pd. carbon 6.5 no. Solvent methanol
Hydrogen 26 recovery
1750
spent (methanol+
150
SS toluene comes from
Liq. ammonia 700
Rector process)
9
6.3 KL loss
1 no. Process wastewater
Water 2600 3349
(neutral pH)
Total input 5432.5 Total output 5432.5
Output Qty./batch
Qty./batch (kg)
Input
(kg) Output from 168
Reactor
st 2nd stage
Output from 1
stage 280
Methanol 1820 Pd. carbon 6.5
Pd. carbon 6.5 Solvent methanol

recovery 1750
Hydrogen 26 spent (methanol+ 150
toluene comes
Liq. ammonia 700 from process) 9
loss
Water 2600 Process
3349
wastewater
EIA
- 98 -
3rd stage
Qty/batch Qty/batch
(kg) (kg)
Output from 2nd SS Output from 3rd stage 235
stage (2 times x 336 Reactor
output) 2 KL
Solvent IPA
SS
Isopropyl alcohol recovery 330
672 Reactor
(IPA) spent 336
3 KL
loss 6
Tartaric acid 336 SS
Acetic anhydride 1545 Reactor
Liquor ammonia 772 1 KL Acetic anhydride recovered 1450
+ ammonia liquid + tartaric
Sulfuric acid 90 SS acid
Reactor
Water 1682 Process wastewater 3076
2.5 KL
Output Qty./batch
Qty./batch (kg)
Input Reactor
(kg) Output from 235
3rd stage
Output from 336
2nd stage
Isopropyl alcohol 672 Solvent IPA

recovery 330
spent
Acetic loss 6
anhydride 1545
Liquor ammonia 772
Sulfuric acid Acetic anhydride + 1450

90
ammonia liquid +
Water tartaric acid
1682
recovered
Process
3076
wastewater
EIA
- 99 -
4th stage
Qty/batch Qty/batch
(kg) (kg)
Output from 3rd Phenyl ephrine HCl 250
235
stage Phenyl ephrine isomer
21
Methanol 670 salt
Carbon 3.5 Carbon (wet) 6.5
Acetone 840 SS Solvent
IPA HCl 200 Reactor 1. Methanol
500
2 KL 2 recovery
no.s 2. Acetone
recovery 180
3. Spent acetone,
methanol & IPA 991
mixture
EIA
- 100 -
Output Qty./batch
(kg)
Phenyl
250
ephrine HCl
Input Qty./batch Reactor

(kg)
Phenyl ephrine 21
Output from 3rd 235 isomer salt
stage
Methanol 670
3.5 6.5
Carbon Carbon
Acetone 840
IPA HCl 200 Solvent

1. Methanol
recovery 500
2. Acetone
recovery 180
3. Spent
acetone,
methanol & 991
IPA mixture
EIA
- 101 -
PROCEDURE
1st stage
Meta hydroxyl aceto phenone reacts with bromine in the presence of toluene to
form bromo aceto phenone. The reaction mass is then treated with liquor
ammonia, sodium bi-carbonate & water. This further reacts with n-methyl
benzyl amine and aluminium chloride in presence of solvent ethyl acetate. The
reaction mass is then treated with IPA HCl & n-hexane to form 3-hydroxy
methyl benzyl amine aceto phenone HCl.
2nd stage
The output from 1st stage is hydrogenated using palladium carbon in presence
of solvent methanol, liquor ammonia and water. The resultant reaction mass
forms DL-phenyl ephirine HCl obtained after isolation.
3rd stage
The output from 2nd stage on racemization with tartaric acid and acetic
anhydride and in the presence of solvent isopropyl alcohol and water forms L(-
_) phenyl ephirine.
4th stage
The output from 3rd stage is purified in methanol by addition of carbon. The
reaction mass is then filtered, isolated and crystallized with acetone in the
presence of solvent IPA to form pure phenyl ephirine HCl.
CYCLE TIME

1st stage 2nd stage 3rd stage 4th stage
Reaction 18 - 20 10 - 12 12 - 14 30 - 35
Isolation and centrifugation 4-6 4-6 6-7 12 - 14
Solvent recovery 6-8 8 - 10 5-7 4-6
Total process time 28 - 34 22 - 28 23 - 28 46 - 55
EIA
- 102 -
APPLICATIONS
Phenylephrine or Neo-Synephrine is a -adrenergic receptor agonist used

primarily as a decongestant, as an agent to dilate the pupil, and to increase
blood pressure.
1. Decongestant: Phenylephrine is used as a decongestant sold as an oral

medicine, as a nasal spray, or as eye drops. Phenylephrine is now the most
common over-the-counter (OTC) decongestant in the United States.
Phenylephrine is less likely to cause side effects such as central nervous
system stimulation, insomnia, anxiety, irritability, and restlessness.
Phenylephrine's effectiveness as a decongestant stems from its
vasoconstriction of nasal blood vessels, thereby decreasing blood flow to
the sinusoidal vessels, leading to decreased mucosal edema. Some popular
cold remedies containing phenylephrine include Codral Cold & Flu (New
Formula), Demazin PE, Kapryl (Kaptab Pharmaceuticals), Lemolate, Dristan,
Theraflu, Benadryl Allergy & Sinus Headache, Excedrin Sinus Headache etc.
2. Decolgen/Bioflu: As a nasal spray, phenylephrine is available in 1 percent

and 0.5 percent concentrations. It causes some rebound congestion effects,
similar to oxymetazoline, although possibly to a lesser degree.
3. Mydriatic: Phenylephrine is used as an eye drop to dilate the pupil in order

to facilitate visualization of the retina. It is often used in combination with
tropicamide. Narrow-angle glaucoma is a contraindication to phenylephrine
use.
4. Vasopressor: Phenylephrine is sometimes used as a vasopressor to increase

the blood pressure in unstable patients with hypotension. Such use is more
common in anaesthesia or critical-care practices; phenylephrine is
especially useful in counteracting the hypotensive effect of epidural and
subarachnoid anaesthetics. It also has the advantage of not being inotropic
or chronotropic, and so it strictly elevates the blood pressure without
increasing the heart rate or contractility (reflex bradycardia may result
from the blood pressure increase, however). This is especially useful if the
heart is already tachycardic and/or has a cardiomyopathy. The elimination
half-life of phenylephrine is about 2.5 to 3 hours.
5. Detumescent: Phenylephrine is used by Urologists to abort priapism. It is

diluted significantly and injected directly into the corpora cavernosa. The
mechanism of action is to cause constriction of the blood vessels entering
into the penis thus breaking the pathophysiologic cycle that continues the
priapism.
EIA
- 103 -
2.6.4.6 Sildenafil citrate
REACTION SCHEME
EIA
- 104 -
1st stage

no. (kg)
1 4-amino-1-methyl-3-n- 125
propylpyrazolo-5-
carboxamide
2 2-ethoxy benzoyl chloride 125
3 Methylene di-chloride 500
(MDC)
4 Water 1250
2nd stage

No. (kg)
1 Chlorosulfonic acid 375
2 n-methyl piperazine 250
3 Water 1250
3rd stage

No. (kg)
1 Acetone 1500
2 Citric acid 75
EIA
- 105 -
PROCESS FLOW CHART
1st stage
propylpyrazolo-5-carboxamide Methylene di-chloride
125 kg 500 kg
2-ethoxy benzoyl
chloride Water
125 kg 1250 kg
GL Reactor
MDC
Recovered
loss
100 kg
Process wastewater
1325 kg
Drier

175 kg
EIA
- 106 -
2nd & 3rd stage

175 kg
Chlorosulfonic acid
375 kg
n-methyl piperazine DM water
250 kg 1250 kg
Reactor
Process wastewater
Centrifuge 1857.5 kg
Drier

192.5 kg
Citric acid Acetone
75 kg 1500 kg
Sildenafil base
SS Reactor 17.5 kg
Acetone
recovered
loss
20 kg
Drier
Multimill
Sifter
Sildenafil citrate
250 kg
EIA
- 107 -
1st stage

Reactors
(kg) (kg)
4-amino-1-methyl-3- 125 Output from 1st stage 175
n-propylpyrazolo-5-
carboxamide Solvent MDC
2-ethoxy benzoyl 125 GL recovery 400
chloride Reactor loss 100
Methylene di- 500 2.5 KL
chloride (MDC)
Water 1250
Input Qty./batch
(kg) Reactor
4-amino-1- Qty./batch
125 Output
methyl-3-n- (kg)
propylpyrazolo- Output from
5-carboxamide 175
1st stage
2-ethoxy benzoyl 125

chloride Solvent MDC
recovery 400
Methylene di- 500 loss 100
chloride

Water 1250
EIA
- 108 -
2nd stage

Reactors
(kg) (kg)
Output from 1st GL
175 Output from 2nd stage 192.5
stage Reactor
Chlorosulfonic acid 375 2.5 KL
n-methyl piperazine 250 SS Process wastewater 1857.5
Water 1250 Reactor
Total input 2050 3 KL Total output 2050
Input Qty./batch Reactor Qty./batch

(kg) Output
(kg)
Output from 1st Output from
stage 175 192.5
2nd stage
Chlorosulfonic 375
acid
n-methyl
piperazine 250 1857.5
Wastewater
Water 1250
EIA
- 109 -
3rd stage

Reactors
(kg) (kg)
Sildenafil citrate 250
Output from 2nd
192.5 By product: sildenafil
stage 17.5
SS base
Acetone 1500 Reactor Solvent acetone
Citric acid 75 2 KL recovery 1480
loss 20
Qty./batch
Output (kg)
Input Qty./batch Reactor Sildenafil 250

(kg) citrate
Output from 192.5
2nd stage By product
Sildenafil base 17.5
Acetone 1500
Solvent acetone
Citric acid 75
recovery 1480
loss 20
EIA
- 110 -
PROCEDURE
1st stage
4-amino-1-methyl-3-n-propylpyrazolo-5-carboxamide is condensed with 2-

ethoxy benzoyl chloride in the presence of methylene di chloride and water to
form [5-[2-ethoxy-phenyl] -1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]
pyrimidin - 7-one].
2nd stage
The output from 1st stage is converted into sildenafil base [5-[2-ethoxy-5-(4-
methylpiperazinyl sulfonyl) phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-
pyrazolo[4,3-d]pyrimidin-7-one] by reacting with chlorosulfonic acid n-methyl
piperazine & water and the resultant intermediate is condescend with n-methyl
piperazine.
3rd stage
Sildenafil base is treated with citric acid in the presence of acetone to get
sildenafil citrate.
CYCLE TIME

st
Reaction 12 - 14 10 12 6 8
Isolation & centrifugation 4-6 4 6 4 6
Solvent recovery 4-6 - 8 - 10
Total process time 20 - 26 14 18 18 24
EIA
- 111 -
APPLICATIONS
Sildenafil citrate is sold as Viagra, Revatio and under various other trade
names. It was developed and is being marketed by the pharmaceutical
company Pfizer. Since becoming available in 1998, sildenafil has been the
prime treatment for erectile dysfunction.
1. Sexual dysfunction: The primary indication of sildenafil is treatment of

erectile dysfunction (inability to sustain a satisfactory erection to complete
intercourse). Its use is now standard treatment for erectile dysfunction in
all settings, including diabetes.
2. Pulmonary hypertension: Sildenafil citrate is also effective in the rare

disease- pulmonary arterial hypertension (PAH). It relaxes the arterial wall,
leading to decreased pulmonary arterial resistance and pressure. This, in
turn, reduces the workload of the right ventricle of the heart and improves
symptoms of right-sided heart failure. Because PDE-5 is primarily
distributed within the arterial wall smooth muscle of the lungs and penis,
sildenafil acts selectively in both these areas without inducing vasodilation
in other areas of the body. Pfizer submitted an additional registration for
sildenafil to the FDA, and sildenafil was approved for this indication in June
2005. The preparation is named Revatio, to avoid confusion with Viagra.
3. Altitude sickness: Sildenafil has been shown to be useful for the prevention
and treatment of high-altitude pulmonary edema associated with altitude
sickness such as that suffered by mountain climbers.
4. Use in sports: Professional sports players have been documented using drugs
such as Viagra, with the thinking that the opening of their blood vessels will
enrich their muscles. In turn, they believe that it will enhance their
performance.
EIA
- 112 -
2.6.4.7 Ticlopidine HCl
REACTION SCHEME
EIA
- 113 -
1st stage
No. (kg)
1 Thiophene-2-ethanol 222.5
2 Trimethyl amine 202.5
3 Benzene sulfonyl chloride 345
4 Toluene 650
2nd stage
No. (kg)
1 Ortho chloro benzylamine 375
3 Acetone 2475
4 Methylene di-chloride (MDC) 700
3rd stage
No. (kg)
1 Water 250
2 Formaldehyde 162.5
3 Toluene 600
4 Isopropyl alcohol (IPA) HCl 200
5 Methanol 155
6 Carbon 10
EIA
- 114 -
PROCESS FLOW CHART
1st stage
Thiophene-2-ethanol Benzene sulfonyl chloride

222.5 kg 345 kg
Trimethyl amine Toluene

202.5 kg 650 kg
GL Reactor
Centrifuge Trimethyl amine HCl

545 kg
Toluene
Mother Liquor (ML) recovered
640 kg
loss
10 kg
225 kg
EIA
- 115 -
2nd stage

225 kg
Ortho chloro benzylamine MDC

375 kg 700 kg
Reactor
Benzene sulphonic acid

Centrifuge
565 kg
HCl Mother Liquor (ML)

275 kg MDC
recovered
685 kg
Centrifuge
loss
15 kg
Acetone
Cake
2475 kg Acetone
recovered
2450 kg
Centrifuge
loss
25 kg
Drying

310 kg
EIA
- 116 -
3rd stage

310 kg
Formaldehyde
162.5 kg
Toluene Water
600 kg 250 kg
Reactor
Process wastewater
Layer separation
510 kg
Carbon
Organic layer
10 kg
Spent carbon
Filtration
10 kg
IPA HCl
Filtrate
200 kg
IPA recovered 160.5 kg
Toluene
recovered 595 kg
Centrifuge loss 5 kg
Process residue
1.5 kg
Methanol
Cake
155 kg
Methanol
recovered 152 kg
Centrifuge
loss 3 kg
Process residue
0.5 kg
Drier
Ticlopidine HCl
250 kg
EIA
- 117 -
1st stage
Input Qty/batch Reactors Output Qty/batch

(kg) (kg)
Output from 1st 225
Thiophene-2-ethanol 222.5
stage
Trimethyl amine 202.5 By-product: triethyl 545
Benzene sulfonyl GL amine HCl
345
chloride Reactor Solvent toluene
Toluene 650 3 KL recovered from 640
reaction
loss 10
Qty./batch Reactor Qty./batch

Input Output
(kg) (kg)
Thiophene-2- Output from
222.5 225
ethanol 1st stage
Trimethyl 202.5
amine By-product
Triethyl amine HCl 545
Benzene sulfonyl 345
chloride
Solvent toluene
Toluene 650 recovered 640
loss 10
EIA
- 118 -
2nd stage

Reactors
(kg) (kg)
Output from 1st Output from 2nd 310
225
stage stage
Ortho chloro 375 By product: Benzene 565
benzylamine SS sulphonic acid
Reactor
Hydrochloric 275
2 KL
acid Solvent
Acetone 2475 1) Acetone
Methylene di- 700 recovered from 2450
chloride (MDC) reaction
loss 25
GL 2) MDC
Reactor recovered from 685
3 KL reaction
loss 15
Output Qty./batch
(kg)
Qty./batch
(kg)
st 2nd stage
Output from 1 225
stage By product
Ortho chloro Benzene sulphonic acid 565
375
benzylamine
Hydrochloric 275 Solvent
acid 1) Acetone
recovered from 2450
Acetone 2475
reaction
loss 25
MDC 700
2) MDC
recovered from 685
reaction
loss 15
EIA
- 119 -
3rd stage

Reactors
(kg) (kg)
Output from 310 Ticlopidine HCl 250
2nd stage By product: carbon 10
GL
Water 250 Solvent
Reactor
Formaldehyde 162.5 1) Toluene
2.5 KL
Toluene 600 recovered from 595
Isopropyl 200 reaction
alcohol (IPA) loss 5
HCl
Methanol 155 2) Methanol
reaction
SS loss 3
Reactor
2.5 KL 3) IPA recovered from 160.5
reaction
Process residue 2
Qty./batch
Output
(kg)
Qty./batch
Input Reactor Ticlopidine HCl 250
(kg)
Output from
2nd stage 310
By product
Carbon 10
Water 250
Formaldehyde 162.5 Solvent
1) Toluene
Toluene 600 recovered from 595
reaction
IPA HCl 200
loss 5
Methanol 155
2) Methanol
Carbon recovered from 152
10
reaction
loss 3
3) IPA recovered from 160.5

reaction
Process residue 2
EIA Wastewater 510

- 120 -
PROCEDURE
1st stage
Thiophene 2-ethanol is reacted with benzenesulphonyl chloride in presence of

triethylamine and toluene to get thiophene-2-ethylphenylsulphonyl ester.
2nd stage
Thiophene-2-ethylphenylsulphonyl ester is reacted with orthochlorobenzyl

amine in the presence of MDC to be converted into N-(2-chlorobenzyl)-2-
(thiophen-2-yl) ethanamine hydrochloride.
3rd stage
N-(2-chlorobenzyl)-2-(thiophen-2-yl) ethanamine hydrochloride is converted

into ticlopidine base by using formaldehyde in the presence of toluene and
water. Further it is converted to ticlopidine HCl crude by using isopropanol /
HCl in the presence of carbon catalyst and purified by re-crystallizing in
methanol to get ticlopidine HCl.
CYCLE TIME

1st stage 2nd stage 3rd stage
Reaction 12 - 14 22 - 24 22 - 24
Isolation and centrifugation 4-6 8 - 12 8 - 12
EIA
- 121 -
APPLICATIONS
Ticlopidine (trade name Ticlid) is an antiplatelet drug in the thienopyridine

family. It is an adenosine diphosphate (ADP) receptor inhibitor. It is used in
patients in whom aspirin is not tolerated, or in whom dual antiplatelet therapy
is desirable. Because it has been reported to increase the risk of thrombotic
thrombocytopenic purpura (TTP) and neutropenia, its use has largely been
supplanted by the newer drug, clopidogrel, which is felt to have a much lower
hematologic risk. The usual dose is 250 mg twice daily by the oral route.
Action
Inhibits platelet aggregation by altering the function of platelet membranes
by blocking ADP receptors. This prevents the conformational change of
glycoprotein IIb/IIIa which allows platelet binding to fibrinogen.
Prolongs bleeding time.
Decreased incidence of stroke in high-risk patients.
EIA
- 122 -
2.6.4.8 Ursodeoxycholic acid
REACTION SCHEME
COOH
OH OH
STEP 1 STEP 2
95% 74%
Practical yield Practical yield
HO OH HO OH
Cholic acid M. Wt. 408 Cholic acid methyl ester M. Wt. 422 COOH
CH3
COOCH3 COOCH3 CH3
OH O
STEP 4
CH3
STEP 3
75%
70% Practical
Practical yield yield
HO OH
OOCCH3 H3 CCOO OOCCH3
H3 CCOO
3 , 7 -diacetyl,12 -hydroxy- methyl cholanate 3 , 7 -diacetyl-12-keto-methyl cholanate 3 , 7 -dihydroxy-5 -Cholanic acid

M. Wt. 504 M. Wt. 502 M. Wt. 392.6
EIA
- 123 -
CH3 COOH
CH3 COOH
CH3
STEP 5 CH3
STEP 6
CH3
80% 75% CH3
HO O
HO
3 , hydroxy-7-keto-Cholanic acid OH
M. Wt. 390.6
Ursodeoxycholic acid
M. Wt. 392.6
EIA
- 124 -
1st stage

No. (kg)
1 Cholic acid 595
2 Methanol 952.4
3 Methane sulphonic 4
acid
2nd stage

No. (kg)
1 Ethyl acetate 1071.4
2 Sodium carbonate 238
3 Acetic anhydride 357
3rd stage

No. (kg)
1 Sodium hypochloride 952.4
2 Acetic acid 76
3 Water 600
4th stage

No. (kg)
1 2-methoxy ethanol 3809
2 HzHz 500
3 KOH 357
4 Water 250
EIA
- 125 -
5th stage

No. (kg)
1 Sodium bromate 95
2 MDC 512
3 Water 300
6th stage

No. (kg)
1 Sodium metal 333.3
2 Hydrochloric acid 130.95
3 Butanol 4523.8
4 Water 300
EIA
- 126 -
PROCESS FLOW CHART
1st stage
Cholic acid Methanol
595 kg 952.4 kg
Methane sulphonic acid

4 kg SS Reactor Reused methyle cholonate
54 kg
Methanol recovered
935 kg
Methanol spent
17.4 kg
Drier
Methylcholonate
545 kg
Ethyl acetate Acetic anhydride

2nd stage 1071.4 kg 357 kg
Sodium carbonate
238 kg
Diacetyl compound
Reused methyle cholonate 50 kg
50 kg SS Reactor
Ethyl acetate
recovered
Process wastewater 1065.5 kg
Centrifuge
containing acetic acid Distillation
415 kg Ethyl acetate
loss
5.9 kg
Sodium acetate
180 kg
- - hydroxy- methyl cholanate
(Diacetylate intermediate) 545 kg
EIA
- 127 -
3rd stage Output from 2nd stage

545 kg
Sodium hypochloride Water
952.4 kg 600 kg
Acetic acid
76 kg
Diacetyl compound Cholic acid

50 kg SS Reactor 72 kg
Process wastewater
Centrifuge
1628.4 kg
Drier
- diacetyl, 12 keto- methyl cholanate

523 kg
Hydrazine hydrate (HzHz) 2-methoxy ethanol (2 M enol)

th
4 stage 500 kg 3809 kg
Potassium hydroxide Water
357 kg 250 kg
Dihydroxy cholanic
acid 94 kg
SS Reactor
Caustic potash lye
606 kg
2 M enol + water + Hzhz
recovered
4298 kg
Distillation Loss
12 kg
- - cholanic acid
429 kg
EIA
- 128 -
5th stage
- - cholanic acid
429 kg
Sodium bromate MDC

95 kg 512 kg
Water
300 kg
Hydroxy keto
SS Reactor cholonic acid
95.3 kg
MDC recovered
495 kg
Distillation MDC loss
17 kg
Process wastewater
395 kg
hydroxyl-7-keto-cholanic acid
6th stage 333.3 kg
Sodium metal Butanol

333.3 kg 4523.8 kg
HCl Water
130.95 kg 300 kg
Dihydroxy
cholanic acid
SS Reactor 83.3 kg
Cautic soda lye
595 kg
Butanol recovered
4476.6 kg
Butanol loss
Distillation
47.6 kg
Process wastewater
169.25 kg
250 kg
EIA
- 129 -
PROCESS FLOW CHART FOR MANUFACTURE OF URSODEOXYCHOLIC ACID
3 , 7 dioxy cholanic acid (exported from

SHILPA)
First purification
Reactor
Centrifuge
Purification
done
Drying at
ICE S.r.l., Italy
Second purification
Reactor
Ursodeoxycholic acid USP / Ph.Eur
EIA
- 130 -
1st stage
Qty/batch Qty/batch
(kg) (kg)
Cholic acid 595 Methylcholonate 545
Reused methyl
SS 54
cholonate
Methanol 952.4 Reactor Solvent methanol
2 KL 4 recovery 935
Methane sulphonic 4 no.s
acid spent 17.4
Qty./batch
Output (kg)
Qty./batch Reactor
Input
(kg) Methylcholonate 545
Cholic acid 595

Reused methyl 54
cholonate
Methanol 952.4
Solvent methanol
Methane 4
recovery 935
sulphonic acid
loss 17.4
EIA
- 131 -
2nd stage
Qty/batch Qty/batch
(kg) (kg)
Methylcholonate 595 Diacetylate 545
(including reused) intermediate
Diacetylate compound 50
Ethyl acetate 1071.4 By-product: 180
SS Sodium acetate
Rector Process wastewater 415
4 KL containing acetic acid
Sodium carbonate 238 Solvent ethyl acetate
Acetic anhydride 357 recovery 1065.5
loss 5.9
Qty./batch
Output (kg)
Diacetylate 545
Qty./batch intermediate
Input Reactor
(kg)
Diacetylate 50
Methylcholonate 595 compound
Ethyl acetate 1071.4 By-product
Sodium acetate 180
Sodium carbonate 238
Process wastewater
Acetic 357 containing acetic 415
anhydride acid

recovered 1065.5
loss 5.9
EIA
- 132 -
3rd stage
Qty/batch Qty/batch
Inputs Reactor Output
(kg) (kg)
Output from 2nd GL Output from 3rd stage 523
stage (including 595 Reactor
By product: Cholic acid 72
compound) 4 KL
Sodium hypochloride 952.4 1 no.
Acetic acid 76 SS
Reactor
Water 600
2 KL 1
Total input 2223.4 no. Total output 2223.4
Qty./batch Qty./batch
Input Reactor Output (kg)
(kg)
Output from 523
Output from 595 3rd stage
2nd stage
Sodium 952.4 By product 72

hypochloride Cholic acid
Acetic acid 76
Process 1628.4
wastewater
Water 600
EIA
- 133 -
4th stage
Qty/batch Qty/batch
(kg) (kg)
Output from 3rd 523 Output from 4th stage 429
stage By product:
2-methoxy ethanol 3809 Dihydroxy cholanic 94
SS acid
Reactor caustic potash lye 606
HzHz 500 6 KL 2 Solvent
KOH 357 no.s 2-methoxy ethanol +
Water 250 water + HzHz 4298
recovered 12
Loss
Qty./batch
Output (kg)
Input Qty./batch
(kg)
Reactor Output from 429
Output from 3rd 523.8 4th stage
stage
2-methoxy 3809
ethanol By product
500 Dihydroxy cholanic 94
HzHz
acid
caustic potash lye 606
KOH 357
Solvent
Water 250 2-methoxy
ethanol + water
+ Hz Hz 4298
recovery 12
loss
EIA
- 134 -
5th stage
Qty/batch Qty/batch
(kg) (kg)
Output from 4th 429 GL Output from 5th stage 333.3
stage Reactor By product: hydroxy keto 95.3
3 KL 2 cholonic acid
Sodium bromate 95 no.s Solvent MDC
MDC 512 recovery 495
SS loss 17
Water 300
Reactor
2 no.s
Output Qty./batch
(kg)
Output from
Input Qty./batch 333.3
(kg) Reactor 5th stage
Output from 4th 429

stage By product
Hydroxy keto 95.3
Sodium bromate 95 cholonic acid
MDC 512 Solvent MDC

recovery 495
loss 17
Water 300
Process
wastewater 395
EIA
- 135 -
6th stage
Qty/batch Qty/batch
(kg) (kg)
Output from 5th 333.3 Ursodeoxycholic acid 250
stage (UDCA)
By product:
Sodium metal 333.3 SS Dihydroxy cholanic 83.3
Reactor acid
8 KL 2 Caustic soda lye 595
Hydrochloric acid 130.95 no.s Solvent butanol
Butanol 4523.8 recovery 4476.2
Water 300 loss 47.6
Output Qty./batch
(kg)
Input Qty./batch Reactor Ursodeoxycholic
(kg) 250
acid (UDCA)
Output from 5th 333.3
stage
By product
Sodium metal 333.3 Dihydroxy 83.3
cholanic acid
Hydrochloric Caustic soda lye 595
130.95
acid
Solvent butanol
Butanol 4523.8 recovery 4476.2
loss 47.6
Water 300
Process 169.25
wastewater
EIA
- 136 -
PROCEDURE
1st stage
Cholic acid is esterified in presence of methanol at 40 to 50°C for 10 hrs to get

methylcholonate.
2nd stage
Methylcholonate is reacted with acetic anhydride at 15 to 25°C in presence of

ethyl - - hydroxy-
methyl cholanate.
3rd stage
- - hydroxy- methyl cholanate is oxidized with sodium

hypochloride at 60 to 70°C for 8 hrs in the presence of solvent and water to get
- diacetyl, 12 keto- methyl cholanate.
4th stage
- diacetyl, 12 keto- methyl cholanate is reduced with hydrazine hydrate

at 100 to 120°C in presence 2-methoxy ethanol in the presence of potassium
- - cholanic acid.
5th stage
- - cholanic acid oxidized with sodium bromate at 80 to

-7-keto-
cholanic acid.
6th stage
-7-keto-cholanic acid is reduced with sodium metal in presence of

2 butanol, hydrochloric acid and water at 10 to 20°C to get raw
ursodeoxycholic acid.
EIA
- 137 -
CYCLE TIME

st nd rd
1 2 3 4th 5th 6th
stage stage stage stage stage stage
Reaction 8 - 10 12 - 14 8 - 10 16 - 18 12 - 14 8 - 10
Centrifugation 4-6 6-8 6-8 8 - 10 4-6 8 - 10
Solvent recovery 4-6 4-6 - 4-6 6-8 6-8
Total process time 16 - 22 22 - 28 14 - 18 28 - 34 22 - 28 22 - 28
APPLICATIONS
Ursodiol, also known as ursodeoxycholic acid and the abbreviation UDCA, is one
of the secondary bile acids, which are metabolic by-products of intestinal
bacteria.
Ursodeoxycholic acid goes by the trade names Actigall, Ursosan, Ursofalk, Urso,
and Urso Forte.
It can be chemically synthesized and was brought to market by the Montreal-
based Axcan Pharma in 1998, which continues to market the drug.
The drug reduces cholesterol absorption and is used to dissolve
(cholesterol) gallstones in patients who want an alternative to surgery.
The drug is very expensive, however, and if the patient stops taking it,
the gallstones tend to recur if the condition that gave rise to their
formation does not change. For these reasons, it has not supplanted
surgical treatment by cholecystectomy.
It is the only FDA approved drug to treat primary biliary cirrhosis.
A Cochrane review to evaluate if ursodeoxycholic acid has any beneficial
effect in primary biliary cirrhosis patients included 16 randomized clinical
trials with a total of 1447 patients. The primary outcome measures were
mortality and mortality or liver transplantation. Although treatment with
ursodeoxycholic acid showed a reduction in liver biochemistry, jaundice,
and ascites, it did not decrease mortality or liver transplantation.
In children, its use is not licensed, as its safety and effectiveness are not
established.
In double the recommended daily dose ursodeoxycholic acid reduces
elevated liver enzyme levels in patients with primary sclerosing
cholangitis, but its use was associated with an increased risk of serious
adverse events (the development of cirrhosis, varices, death or liver
transplantation) in patients who received ursodeoxycholic acid compared
with those who received placebo). After adjustment for baseline
stratification characteristics, the risk was 2.1 times greater for death,
transplantation, or minimal listing criteria in patients on ursodeoxycholic
acid than for those on placebo (P = 0.038). Serious adverse events were
more common in the ursodeoxycholic acid group than the placebo group
(63% versus 37% [P < 0.01])).
EIA
- 138 -
2.6.4.9 Anastrozole
REACTION SCHEME
EIA
- 139 -
1st stage
No. (kg)
1 , , , ,-tetramethyl-5- 8
(methyl)-1,3- benzenedi-
acetonitrile
2 Acetonitrile 30
3 N- bromosuccianmide 6.6
4 Ethyl acetate 30
5 Water 10
6 Cyclohexane 5
2nd stage
No. (kg)
1 1,2,4-triazole 2.5
2 Potassium carbonate 5
3 Acetone 40
4 Ethyl acetate 10
6 Water 4
3rd stage
No. (kg)
1 Water 10
2 Sodium carbonate 2
3 Ethyl acetate 10
4 Cyclohexane 5
EIA
- 140 -
PROCESS FLOW CHART
1st stage
, , , ,-tetramethyl-5-(methyl)-
1,3- benzenedi- acetonitrile N- bromosuccianmide
8 kg 6.6 kg
Acetonitrile Ethyl acetate
30 kg 30 kg
Water
10 kg GL Reactor
Hydrobromic acid -
succinamide 4.6 kg
Process wastewater
Layer separation 12 kg
Organic layer
Acetonitrile
Distillation recovered 28 kg
loss 2 kg
Cyclohexane Cyclohexane
Reaction mass
5 kg recovered 4.5 kg
loss 0.5 kg
Ethyl acetate
recovered 28 kg
Drying
loss 2 kg

8 kg
EIA
- 141 -
2nd stage
1,2,4-triazole Output from 1st stage

2.5 kg 8 kg
Potassium carbonate Acetone
5 kg 40 kg
GL Reactor
, , , ,-tetramethyl-
5-(methyl)-1,3-
benzenedi- acetonitrile
2.5 kg
Filter Potassium bromide
1 kg
Acetone
recovered 34 kg
Ethyl acetate loss 6 kg
10 kg
HCl
Distillation
0.5 kg GL Reactor
Ethyl acetate
recovered 8 kg
loss 2 kg
Water Process wastewater

Centrifuge
4 kg 12 kg
Drying

4.5 kg
EIA
- 142 -
3rd stage
Water Output from 2nd stage

10 kg 4.5 kg
Sodium carbonate Ethyl acetate
2 kg 10 kg
GL Reactor
Sodium chloride
2.5 kg
Process wastewater
Layer separation
12 kg
Ethyl acetate layer Distillation
Cyclohexane Ethyl acetate

Reaction mass recovered 9 kg
5 kg
loss 1 kg
Cyclohexane
Drying recovered 4.5 kg
loss 0.5 kg
Anastrozole
2 kg
EIA
- 143 -
1st stage

(kg) (kg)
, , , ,- 8 Output from 1st stage 8
tetramethyl-5- Hydrobromic acid - 4.6
(methyl)-1,3- succinamide
benzenedi- Solvent
GL
acetonitrile 1) Ethyl acetate
Reactor
Acetonitrile 30 recovered from reaction 28
160 L loss 2
N- 6.6
bromosuccianmide 2) Cyclohexane
Ethyl acetate 30 recovered from reaction 4.5
Water 10 loss 0.5
Cyclohexane 5 3) Acetonitrile
GL recovered from reaction 28
Reactor loss 2
250 L Process wastewater 12
Output Qty./batch
(kg)
Input Qty./batch Reactor Output from
(kg) 1st stage 8
, , , ,-
tetramethyl-5- 8 4.6
By product
(methyl)-1,3-
Hydrobromic acid -
benzenedi-
succinamide
acetonitrile
Acetonitrile 30 Solvent
1) Ethyl acetate
N- recovered 28
bromosuccianmide 6.6 loss 2
Ethyl acetate 30 2) Cyclohexane

Water recovered 4.5
10
loss 0.5
Cyclohexane 5
3) Acetonitrile
recovered 28
loss 2
Wastewater 12
EIA
- 144 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 8 Output from 2nd stage 4.5
stage By-products
1,2,4-triazole 2.5 GL Reactor , , , ,-tetramethyl-5- 2.5
Potassium 5 160 L (methyl)-1,3-
carbonate benzenedi- acetonitrile
potassium bromide 1
Acetone 40 Solvent
Water 4 1) Acetone
Ethyl acetate 10 recovered from reaction 34
Hydrochloric 0.5 loss 6
acid
GL Reactor 2) Ethyl acetate
250 L recovered from reaction 8
loss 2
Output Qty./batch
Qty./batch (kg)
Input (kg) Reactor Output from
4.5
2nd stage
Output from 1st
stage 8
, , , ,-tetramethyl- 2.5
1,2,4-triazole 2.5 5-(methyl)-1,3-
benzenedi- acetonitrile
Potassium carbonate 5
potassium bromide 1
Acetone 40
Solvent
Water 4 1) Acetone
recovered from 34
Ethyl acetate 10 reaction
loss 6
Hydrochloric 0.5
acid 2) Ethyl acetate
recovered from 8
reaction
loss 2
EIA
- 145 -
3rd stage

Reactors
(kg) (kg)
Output from 4.5 Anastrozole 2
2nd stage By product: sodium 2.5
chloride
Water 10 Solvent
Sodium 2 1) Ethyl acetate
carbonate GL recovered from 9
Ethyl acetate 10 Reactor reaction
Cyclohexane 5 160 L 2 loss 1
no.s
2) Cyclohexane
recovered from 4.5
reaction
loss 0.5
Qty./batch
Output (kg)
Anastrozole 2
(kg)
Output from By product 2.5
2nd stage 4.5
sodium chloride
Water 10
Solvent
Sodium 2 1) Ethyl acetate
carbonate recovered from 9
reaction
Ethyl 10 loss 1
acetate
2) Cyclohexane
Cyclohexane 5
recovered from 4.5
reaction
loss 0.5
Wastewater 12
EIA
- 146 -
PROCEDURE
1st stage
, , , , tetra methyl-5-(methyl)-1,3-benzene diacetontrile is charged in

acetonitrile. N-bromosuccinimide is then added to the reaction mass & heated
to 50 600 C for 4 hrs to complete the reaction. Then the product is extracted
in ethyl acetate followed by washing with water. Ethyl acetate is distilled and
product (1st stage) is crystallized in cyclohexane, centrifuged and dried to get
the output from 1st stage.
2nd stage
The output from 1st stage is dissolved in acetone to which potassium carbonate
and 1,2,4 triazole are added at 40 500 C for 2 hrs to complete the reaction.
Potassium bromide salt formed is filtered; acetone is distilled to get the
residue. Ethyl acetate is added to dissolve completely. Anastrozole
hydrochloride is formed by adding hydrochloric acid which is cooled and
filtered to get HCl salt of anastrozole.
3rd stage
Anastrozole hydrochloride is basified in water and sodium carbonate. It is then

extracted in ethyl acetate, & then washed with water. Ethyl acetate is
separated and distilled and the product is isolated by adding cyclohexane. The
product is then centrifuged and dried to get pure anastrozole.
CYCLE TIME
Time (hrs)
Particulars
Reaction 8 - 10 6 8 6 8
Isolation & centrifugation 8 - 12 6 8 8 - 12
EIA
- 147 -
APPLICATIONS
Anastrozole (Arimidex®) is a prescription medication used to treat breast

cancer in postmenopausal women. Specific anastrozole uses include treating
postmenopausal women with:
Early breast cancer that is hormone receptor-positive. It is used after breast
cancer surgery with or without radiation. This is known as adjuvant therapy,
or treatment that is used to help prevent the cancer from returning (see
Adjuvant Therapy for Breast Cancer).
Advanced or metastatic breast cancer that is either hormone receptor-
positive or the hormone receptor status is not known.
Advanced breast cancer that has not responded to tamoxifen (Nolvadex®,
Soltamox®).
EIA
- 148 -
2.6.4.10 Bendamustine HCl
REACTION SCHEME
Production yield per batch 1.2 kg

No. (kg)
1 Ethyl-4-(5-(bis(2-hydroxy 5
ethyl) amino)-1-methyl-
1H-benzoid) imidazol-2-
yl)butanoate
2 Thionyl chloride 20
3 Water 40
EIA
- 149 -
PROCESS FLOW CHART
Ethyl-4-(5-(bis (2-hydroxy Thionyl chloride

ethyl) amino)-1-methyl-1H- 20 kg
benzoid) imidazol-2-yl)
butanoate Water
40 kg
5 kg
GL Reactor
Process residue
0.1 kg
Process wastewater
63.7 kg
Bendamustine HCl
1.2 kg
EIA
- 150 -

(kg) (kg)
Ethyl-4-(5-(bis(2- 5 Bendamustine 1.2
hydroxy ethyl) amino)-1- HCl
methyl-1H-benzoid) GL Process residue 0.1
imidazol-2-yl)butanoate Reactor Process 63.7
160 L wastewater
Thionyl chloride 20
Water 40
Input Reactor
(kg) Output (kg)
Ethyl-4-(5-(bis(2-
hydroxy ethyl) Bendamustine 1.2
5 HCl
amino)-1-methyl-
1H-benzoid)
imidazol-2-
yl)butanoate Process residue 0.1
Thionyl chloride 20
Wastewater 63.7
Water 40
EIA
- 151 -
PROCEDURE
Ethyl-4-(5-(bis(2-hydroxy ethyl) amino)-1-methyl-1H-benzoid) imidazol-2-

yl)butanoate is reacted with thionyl chloride at 10 -15°C in GL reactor. After
the reaction is complete the reaction mass is distilled out at 65°C to get semi-
solid material. The reaction mass is cooled to 25 to 30°C & centrifuged to get
the final product.
CYCLE TIME
Time
Particulars
(hrs)
Reaction 8 - 10
Isolation & centrifugation 2 2.5
Total process time 10 12.5
APPLICATIONS
Bendamustine HCl is a chemotherapy agent that is effective in treating patients

with various diseases, including non-Hodgkin's lymphoma, multiple myeloma,
and breast cancer. It was recently approved for the treatment of chronic
lymphocytic leukaemia. In addition, small studies from Eastern Europe have
shown that bendamustine HCl is likely effective for treating HL.
EIA
- 152 -
2.6.4.11 Bicalutamide
REACTION SCHEME
EIA
- 153 -

No. (kg)
1 N-[4-cyano-3- 12
trifluoromethyl phenyl]-3-
[4-fluorophenyl thio]-2-
hydroxy-2-methyl
propanamide
2 Acetonitrile 100
3 Potassium permanganate 5
4 Isopropyl alcohol 10
EIA
- 154 -
PROCESS FLOW CHART
N-[4-cyano-3-trifluoromethyl Acetonitrile
phenyl]-3-[4-fluorophenyl thio]-2- 100 kg
hydroxy-2-methyl propanamide
Potassium permanganate
12 kg 5 kg
GL Reactor
Manganese dioxide
Filtration 5 kg
IPA Filtrate Distillation

10 kg
Acetonitrile
recovered 97 kg
loss 3 kg
Impurity-A (2,3-epoxy-2-methyl-N-[4-cyano-
3-trifluoromethyl)phenyl] propanamide
2 kg
IPA
recovered 8 kg
loss 2 kg
Bicalutamide
10 kg
EIA
- 155 -

(kg) (kg)
N-[4-cyano-3- 12 Bicalutamide 10
trifluoromethy By-product: manganese 5
l phenyl]-3-[4- dioxide
fluorophenyl Solvent
thio]-2- 1) Acetonitrile
hydroxy-2- GL recovered from reaction 97
methyl Reactor loss 3
propanamide 160 L 2 2) IPA
Acetonitrile 100 no.s recovered from reaction 8
Potassium 5
loss 2
permanganate
Impurity-A (2,3-epoxy-2- 2
Isopropyl 10 methyl-N-[4-cyano-3-
alcohol trifluoromethyl)phenyl]
propanamide
Qty./batch
Input (kg) Reactor Qty./batch
Output (kg)
N-[4-cyano-3-
trifluoromethyl Bicalutamide 10
12
phenyl]-3-[4-
fluorophenyl thio]-
2-hydroxy-2- By-product
methyl Manganese dioxide 5
propanamide
100 Solvent
Acetonitrile
1) Acetonitrile
recovered 97
Potassium 5 loss 3
permanganate
2) IPA
Isopropyl 10 recovered 8
alcohol loss 2
Impurity-A (2,3-
epoxy-2-methyl-N- 2
[4-cyano-3-
trifluoromethyl)phe
nyl] propanamide
EIA
- 156 -
PROCEDURE
Acetonitrile is charged in the reactor into which N-[4-cyano-3-trifluoromethyl

phenyl]-3-[4-fluoro phenyl thio]-2-hydroxy-2-methyl propanamide is dissolved
and heated to 40 50°C. Potassium permanganate is then added into the
reaction mass and maintained for 4 hrs to complete the reaction. The reaction
mass is then filtered to remove manganese dioxide formed during reaction. The
filtrate is evaporated and isopropyl alcohol is added to isolate the product
which is centrifuged and dried to get the final product.
CYCLE TIME
Time
Particulars
(hrs)
Reaction 6 8
Isolation & centrifugation 10 12
Solvent recovery 1 2
Total process time 17 22
APPLICATIONS
Bicalutamide belongs to a group of medications known as nonsteroidal

antiandrogens. Nonsteroidal antiandrogens such as bicalutamide block the
effect of the male hormone testosterone in the body.
Bicalutamide is used in combination with another treatment that reduces the
amount of testosterone in the body (either with medications called luteinizing
hormone releasing hormone analogues (LHRH) or with surgery to remove the
testicles) for the treatment of late stage (metastatic) prostate cancer.
EIA
- 157 -
2.6.4.12 Bortezomib
REACTION SCHEME
EIA
- 158 -
1st stage
No. (kg)
1 3- phenyl -2-[(pyrazine-2- 0.1
carbonyl)-amino] propionic
acid
2 R-borolex-(+)-pinanediol 0.115
3 n-hydroxy succinamide 0.09
4 MDC 0.27
5 Disopropyl amine 0.11
6 1N HCl 0.12
7 Saturated sodium bicarbonate 0.57
8 Methanol 0.67
2nd stage
No. (kg)
1 Methanol 0.17
2 Isobutyl boronic acid 0.085
3 n-Heptane 2.07
4 1N HCl 0.57
5 MDC 0.27
7 Saturated sodium bicarbonate 0.57
3rd stage
No. (kg)
1 Methanol 0.109
2 Water 0.109
EIA
- 159 -
PROCESS FLOW CHART
1st stage
3- phenyl -2-[(pyrazine-2- R-borolex-(+)-pinanediol trifluoro

carbonyl)-amino] propionic acid acetic acid
0.1 kg 0.115 kg
n-hydroxy succinamide Disopropyl amine
0.09 kg 0.11 kg
MDC Methanol
0.27 kg RB Flask 0.67 kg
Filter
1N HCl Process wastewater

MDC filtrate
0.12 kg 0.4 kg
Saturated sodium Process wastewater

MDC layer
bicarbonate 0.57 kg 1.225 kg
MDC layer Distillation
MDC recovered
0.22 kg
Process residue
Filtration
0.07 kg

0.13 kg
EIA
- 160 -
2nd stage
Output from 1st stage n-Heptane

0.13 kg 2.07 kg
Isobutyl boronic acid 1N HCl

0.085 kg 0.57 kg
Sat. sodium bicarbonate
RB Flask
0.57 kg
Process wastewater
Layer separation 1.542 kg
Heptane layer Distillation
Ethyl acetate
Recovered n-heptane
0.57 kg Residue 1.57 kg
Methanol
0.17 kg
MDC Process
Filter Distillation
residue
0.27 kg
0.27 kg
Output from 2nd stage Recovered heptane,
MDC, methanol
0.083 kg
0.97 kg
EIA
- 161 -
3rd stage
Methanol Output from 2nd stage

0.109 kg 0.083 kg
Water
0.109 kg
RB Flask Process wastewater

0.112 kg
Filter Distillation
Recovered methanol
0.109 kg
Drying
Bortezomib
0.08 kg
EIA
- 162 -
1st stage

(kg) (kg)
3- phenyl -2-[(pyrazine- 0.1 Output from 1st 0.13
2-carbonyl)-amino] stage
propionic acid RB Flask MDC recovered 0.22
R-borolex-(+)-pinanediol 0.115 2L Process residue 0.07
trifluoro acetic acid Process 1.625
n-hydroxy succinamide 0.09 wastewater
MDC 0.27
Disopropyl amine 0.11
1N HCl 0.12
RB Flask
Saturated sodium
0.57 3L
bicarbonate
Methanol 0.67
Qty./batch Reactor
Input
(kg) Qty./batch
3- phenyl -2-[(pyrazine-2- Output (kg)
carbonyl)-amino] 0.1 Output from
propionic acid 0.13
1st stage
R-borolex-(+)-pinanediol
0.115 MDC recovered 0.22
n-hydroxy succinamide 0.09 Process residue 0.07
MDC 0.27
Wastewater 1.625
Disopropyl amine 0.11
1N HCl 0.12
Saturated sodium 0.57

bicarbonate
Methanol 0.67
EIA
- 163 -
2nd stage

Reactors
(kg) (kg)
Output from 1st stage 0.13 Output from 2nd 0.083
stage
Methanol 0.17 RB Flask Recovered heptane, 0.97
2L 2 MDC, methanol
Isobutyl boronic acid 0.085
no.s
n-Heptane 2.07 Recovered n-heptane 1.57
1N HCl 0.57 Process residue 0.27
MDC 0.27 Process wastewater 1.542
Ethyl acetate 0.57 RB Flask
Sat. sodium 0.57 5L 2
bicarbonate no.s
Input (kg) Reactor Output
(kg)
Output from 1st Output from 0.083
stage 0.13
2nd stage
Methanol 0.17
Isobutyl boronic acid 0.085 Recovered heptane, 0.97

MDC, methanol
n-Heptane 2.07
1N HCl 0.57 Recovered n-heptane 1.57
MDC 0.27
Process residue 0.27
Ethyl acetate 0.57
Sat. sodium 0.57 Wastewater 1.542

bicarbonate
EIA
- 164 -
3rd stage

Reactors
(kg) (kg)
Output from 2nd 0.083 Bortezomib 0.08
stage RB Flask
Recovered methanol 0.109
1L 2
Methanol 0.109 Process wastewater 0.112
no.s
Water 0.109
Qty./batch
Input Reactor
(kg)
Output from Bortezomib 0.08
2nd stage 0.083
Methanol 0.109 Recovered methanol 0.109
Water 0.109
Wastewater 0.112
EIA
- 165 -
PROCEDURE
1st stage
MDC, 3-pheyl-2-[(pyrazine-2-carbonyl)-amino] propionic acid, R-borolex-(+)

pinanediol trifluroacetic acid, n-hydroxy succinamide, methanol &
disoproylamine are charged into cleaned & dried reactor at 25-30°C and
maintained for 2 hrs. The cake so formed is collected & filtered. MDC layer is
washed with 1N HCl solution & then saturated with sodium bicarbonate solution
& evaporated. Methanol is then added & redistilled to remove MDC layer & to
get output from 1st stage.
2nd stage
Methanol, N-heptane, isobutyl boromic acid & 1N HCL are charged into a clean
dry reactor and stirred for 2 hrs. Organic layer is separated. HCl layer is taken
& product is extracted in MDC & washed. Saturated sodium bicarbonate
solution & MDC are added & the reaction mass is distilled to which ethyl
acetate is added to crystallize the output from 2nd stage, which is filtered &
dried to get crude bortezomib.
3rd stage
Crude product from 2nd stage is dissolved in methanol & water is added to
crystallize the final product. The final product is filtered & dried to get pure
bortezomib.
CYCLE TIME
Time (hrs)
Particulars st
Reaction 6-8 6-8 4-6
Isolation & centrifugation 2-3 6-8 10 - 14
EIA
- 166 -
APPLICATIONS
Bortezomib belongs to a class of drugs known as antineoplastic agents. The

medication is used to treat patients with certain types of cancer such as
multiple myeloma and mantle cell lymphoma. Bortezomib works by inhibiting
the digestion of proteins in cancer cells, which consequently disrupts the
internal stability of the cells. These actions ultimately lead to cell death and
help delay tumour growth.
Bortezomib is used to treat a type of bone marrow cancer known as multiple
myeloma. Bortezomib is also used to treat patients with a type of lymph node
cancer known as mantle cell lymphoma who has not responded to alternative
treatment options.
EIA
- 167 -
2.6.4.13 Capecitabine
REACTION SCHEME
EIA
- 168 -
1st stage
No. (kg)
1 5-methyl tetrahydrofuran-
150
2,3,4-triyl triacetate
2 Toluene 300
3 Hexa methyl disaline
150
(HMDS)
4 5-fluorocytosine 100
5 Tetra methyl silyl
5
chloride (TMSC)
6 MDC 500
7 Sodium bicarbonate 150
8 Water 300
9 Stannic chloride 160
10 Isopropyl alcohol 300
2nd stage
No. (kg)
1 Methylene di chloride (MDC) 250
2 N-pentyl chloroformate 110
3 Pyridine 60
4 Heptane 500
5 Water 300
3rd stage
No. (kg)
1 Methanol 350
2 MDC 250
3 Toluene 900
5 Sodium hydroxide 20
6 Water 300
EIA
- 169 -
PROCESS FLOW CHART
1st stage
Sodium bicarbonate
150 kg
5-methyl tetrahydrofuran-2,3,4-
triyl triacetate TMSC
150 kg 5 kg
Toluene MDC
300 kg 500 kg
HMDS
150 kg Stannic chloride
5-fluorocytosine GL Reactor 160 kg
100 kg Trimethyl silane
15 kg
Sodium bicarbonate
Filtration
+stannous chloride
+ silyl chloride
350 kg
MDC layer
300 kg 496 kg
Toluene
recovered 290 kg
loss 10 kg
Organic layer Distillation
MDC
recovered 470 kg
Isopropyl alcohol loss 30 kg
Organic layer
300 kg
Process residue
4 kg
IPA
recovered 280 kg
Output from 1st stage loss 20 kg
150 kg
EIA
- 170 -
2nd stage
MDC Output from 1st stage

250 kg 150 kg
N-pentyl chloroformate Pyridine
110 kg 60 kg
GL Reactor
Pyridine HCl
Filter
64 kg
Water
Layer separation
375 kg
Heptane
500 kg
MDC
recovered 200 kg
loss 50 kg
Process residue
1 kg
Heptane
recovered 470 kg
Drying
loss 30 kg

180 kg
EIA
- 171 -
3rd stage

180 kg
Methanol Sodium hydroxide
350 kg 20 kg
MDC Hydrochloric acid
250 kg 50 kg
GL Reactor
Sodium acetate
Layer separation
78 kg
Water
Organic layer
300 kg
Process wastewater
Layer separation
370 kg
MDC
recovered 220 kg
loss 30 kg
MDC layer Distillation
Methanol
recovered 330 kg
Toluene loss 20 kg
Reaction mass
900 kg
Process residue
2 kg
Toluene
Drying recovered 870 kg
loss 30 kg
Capecitabine
100 kg
EIA
- 172 -
1st stage

(kg) (kg)
Output from 1st stage 150
5-methyl By product:
tetrahydrofuran- Trimethyl silane 15
150 GL
2,3,4-triyl Sodium bicarbonate + 350
triacetate Reactor stannous chloride + silyl
3 KL chloride
Toluene 300 Solvent
Hexa methyl 1) MDC
150
disaline (HMDS) recovered from reaction 470
5-fluorocytosine 100 loss 30
Tetra methyl silyl 2) Toluene
5 recovered from reaction 290
chloride (TMSC)
Methylene di- loss 10
500 3) IPA
chloride (MDC)
Sodium bicarbonate 150 Reactor loss 20
Water 300 2 KL Process residue 4
Stannic chloride 160 Process wastewater 496
Total input 2,115 Total output 2,115
EIA
- 173 -
Qty./batch
Output (kg)
Qty./batch Output from 150
Input Reactor
(kg)
1st stage
5-methyl
tetrahydrofuran- 150
2,3,4-triyl By product
trimethyl silane 15
triacetate
Sodium bicarbonate 350
Toluene 300 + stannous chloride
+ silyl chloride
HMDS 150
100 Solvent
5-fluorocytosine
1) MDC
TMSC recovered 470
5
loss 30
MDC 500
2) Toluene
Sodium 150 290
recovered
bicarbonate 10
loss
Water 300 3) IPA

recovered 280
Stannic chloride 160 loss 20
Isopropyl 300 Process residue 4

alcohol
Wastewater 496
EIA
- 174 -
2nd stage

Reactors
(kg) (kg)
stage By product: pyridine HCl 64
Methylene di Solvent
250
chloride (MDC) 1) MDC
N-pentyl recovered from reaction 200
110 GL Reactor
chloroformate loss 50
Pyridine 60 2 KL 2
Heptane 500 no.s 2) Heptane
recovered from reaction 470
loss 30
Water 300
Process residue 1
Qty./batch
Output (kg)
Qty./batch
Input (kg) Reactor Output from 180
Output from 1st 2nd stage
150
stage
By product
MDC 250 Pyridine HCl 64
N-pentyl
110 Solvent
chloroformate
1) MDC
recovered from 200
Pyridine 60
reaction
Heptane 500 loss 50
Water 300 2) Heptane

recovered from 470
reaction
loss 30
Process residue 1
EIA
- 175 -
3rd stage

Reactors
(kg) (kg)
Output from 180 Capecitabine 100
2nd stage By product: sodium acetate 78
Methanol 350 Solvent
MDC 250 GL 1) Toluene
Toluene 900 Reactor recovered from reaction 870
Hydrochloric 3 KL loss 30
50
acid
Sodium 2) MDC
20 recovered from reaction 220
hydroxide
loss 30
3) Methanol
SS recovered from reaction 330
Water 300
Reactor loss 20
3 KL Process residue 2
Qty./batch
Output (kg)
Capecitabine 100
Input Qty./batch
Reactor
(kg)
Output from By product:
180
2nd stage 78
Sodium acetate
Methanol 350
Solvent
MDC 250 1) Toluene
recovered 870
Toluene 900 loss 30
Hydrochloric 50
2) MDC
acid
recovered 220
Sodium 20 loss 30
hydroxide
3) Methanol
Water 300 recovered 330
loss 20
Process residue 2
Wastewater 370
EIA
- 176 -
PROCEDURE
1st stage
Toluene, hexa methyl disaline, 5-fluorocytosine and tetra methyl silyl chloride
are added and heated to reflux at 128°C for 2 hrs to dissolve completely. Then
toluene is distilled and cooled. 5-methyl tetrahydrofuran-2,3,4-triyl triacetate,
MDC and stannic chloride are added to the reaction mixture and maintained for
2 hrs. Then sodium bicarbonate is added and maintained 1 hr and filtered.
Filtrate MDC is collected and given water wash. MDC layer is separated and
distilled and crystallized in IPA, centrifuged and dried to get 1st stage output.
2nd stage
1st stage output is dissolved in MDC to which pyridine is added. Then added n-
pentyl chloroformate is added slowly to the reaction mixture which is
maintained as such for 2 hrs to complete the reaction. Then MDC layer is
washed with water, separated, distilled and isolated in heptane, centrifuged
and dried to get 2nd stage output.
3rd stage
The output from 3rd stage is dissolved in methanol and cooled to 0-5°C. 1N
NaOH solution is then slowly added to the reaction mixture in 1-2 hrs and
maintained for 2 hrs to complete the reaction. Reaction mass is adjusted to pH
range 4.5 to 5.5 with HCl 30% and product is extracted in MDC. MDC layer is
water washed and distilled and crystallized in toluene, centrifuged and dried to
get capecitabine.
CYCLE TIME
Time (hrs)
Particulars
Reaction 25 - 30 15 - 20 15 - 20
Isolation & centrifugation 10 - 14 10 - 14 12 - 16
EIA
- 177 -
APPLICATIONS
Capecitabine (Xeloda®) is a prescription medication used to treat breast cancer

and colorectal cancer (cancer of the colon or rectum). It is an oral
chemotherapy medication. Specifically, capecitabine is approved to be used:
Alone to prevent the return of colon cancer (that had spread to at least one
lymph node) after surgery has removed the tumour.
Alone to treat metastatic colorectal cancer (cancer that spread to other
parts of the body).
In combination with docetaxel (Taxotere®) to treat metastatic breast
cancer in people whose tumours are resistant to anthracycline
chemotherapy medications.
Alone to treat metastatic breast cancer in people whose tumours are
resistant to both paclitaxel (Onxol®, Taxol®) and anthracycline
chemotherapy medications (or cannot take any more anthracycline
medications).
EIA
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2.6.4.14 Carboplatin
REACTION SCHEME
EIA
- 179 -
1st stage

No. (kg)
1 Water 50
2 Potassium tetrachloroplatinate 17
3 Potassium iodide 40
4 Ammonium hydroxide (25%) 10
2nd stage

No. (kg)
1 Water 1000
2 Silver oxide 9
3 1,1-cyclobutane
6
dicarboxylic acid
4 Carbon 2
EIA
- 180 -
PROCESS FLOW CHART
1st stage
Potassium iodide
40 kg
Potassium tetrachloroplatinate Ammonium hydroxide (25%)

17 kg 10 kg
GL Reactor
Potassium chloride
Filtration
41.5 kg

Centrifuge
50 kg 57.5 kg
Drying

18 kg
EIA
- 181 -
2nd stage
Silver oxide Output from 1st stage

9 kg 18 kg
Water 1,1-cyclobutane dicarboxylic acid
1000 kg 6 kg
GL Reactor
Silver iodide
Filter
22.84 kg
Carbon Spent carbon

Filtrate 2 kg
2 kg
Filtrate Distillation
Water
750 kg
Process residue
0.16 kg
Water
250 kg
Drier
Carboplatin
10 kg
EIA
- 182 -
1st stage

Reactors
(kg) (kg)
Water 50 Output from 1st stage 18
Potassium 17 Potassium chloride 41.5
tetrachloroplatinate GL Process wastewater 57.5
Potassium iodide 40 Reactor
Ammonium hydroxide 500 L
10
(25%)
Qty./batch
(kg)
Water 50 Output from 18
1st stage
Potassium 17
tetrachloroplatinate 41.5
Potassium chloride
Potassium 40
iodide
Wastewater 57.5
Ammonium 10
hydroxide (25%)
EIA
- 183 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 18 Carboplatin 10
stage
Water 1000 GL Silver iodide 22.84
Silver oxide 9 Reactor Spent carbon 2
1,1-cyclobutane 2000 L Water 1000
6
dicarboxylic acid 2 no.s Process residue 0.16
Carbon 2
Qty./batch
(kg)
Output from 1st Carboplatin 10
stage 18
1000 Silver iodide 22.84

Water
Silver oxide 9 Spent carbon 2
1,1-cyclobutane 6 Water 1000

dicarboxylic acid
Carbon 2
EIA
- 184 -
PROCEDURE
1st stage
Potassium tetrachloroplatinate, potassium iodide are charged into the reactor

and maintained 40-50°C for 30 min. The reaction mass is then cooled to room
temperature and ammonium hydroxide 25% solution is added to crystallize the
output from 1st stage which is then filtered and dried to get the output from 1st
stage.
2nd stage
Silver oxide and 1,1-cyclobutane dicarboxylic acid are reacted in presence of

water at 50-60°C for 1 hr. 1st stage output is then added to the reaction
mixture and maintained at 40-50°C for 6-8 hrs to complete the reaction. Silver
iodide so formed is separated by filtration. The filtrate is treated with carbon
and concentrated, cooled and filtered to get pure carboplatin.
CYCLE TIME

st
1 stage 2nd stage
Reaction 6-8 18 - 20
Isolation and centrifugation 8 - 10 8 - 12
Solvent recovery 2 3 1-2
APPLICATIONS
Carboplatin is a chemotherapy drug. It targets fast dividing cells, like cancer

cells, and causes these cells to die. This medicine is used to treat ovarian
cancer and many other cancers.
It is also used to treat certain types of lung cancer, testicular cancer, head and
neck cancer, Wilms' tumour, brain tumours, bladder cancer, and
retinoblastoma.
EIA
- 185 -
2.6.4.15 Cisplatin
REACTION SCHEME
EIA
- 186 -
1st stage

No. (kg)
1 Potassium tetrachloroplatinate 17
2 Potassium iodide 40
3 Water 50
4 Ammonium hydroxide (25%) 10
2nd stage

No. (kg)
1 Water 50
2 Silver nitrate 9
3 Potassium chloride 7
EIA
- 187 -
PROCESS FLOW CHART
Potassium tetrachloroplatinate
17 kg
Potassium iodide Ammonium hydroxide (25%)
40 kg 10 kg
GL Reactor
Filtration Potassium chloride

41.5 kg
Crystallization

Filtration
50 kg 57.5 kg
Drying

18 kg
Water Silver nitrate

50 kg 9 kg
GL Reactor
Silver iodide
Filter
24 kg
Potassium chloride
Filtrate
7 kg
Process wastewater
Centrifuge
50 kg
Drying
Cisplatin
10 kg
EIA
- 188 -
1st stage
Input Qty/batch Output Qty/bat

Reactors
(kg) ch (kg)
Potassium 17 Output from 1st stage 18
tetrachloroplatinate By product: potassium 41.5
Potassium iodide 40 GL chloride
Water 50 Reactor Process wastewater 57.5
Ammonium hydroxide 10 500 L
(25%)
Qty./batch
Output (kg)
(kg) Output from 18
Potassium 1st stage
17
Potassium iodide 40 By product: 41.5
Water 50 potassium chloride
Ammonium 10
hydroxide (25%) Wastewater 57.5
EIA
- 189 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 18 Cisplatin 10
stage (chloride Silver iodide 24
intermediate) GL Process wastewater 50
Water 50 Reactor
Silver nitrate 9 250 L
Potassium chloride 7
Input Qty./batch (kg) Reactor

Output Qty./batch (kg)
Output from 1st
stage 18
Cisplatin 10
Water 50
Silver iodide 24
Silver nitrate 9
Wastewater 50
Potassium 7
chloride
EIA
- 190 -
PROCEDURE
1st stage
Potassium tetrachloroplatinate is dissolved in water to which potassium iodide

is added. The reaction mixture is maintained at 40-500C for 30 minutes, cooled
to room temperature and ammonium hydroxide 25% solution is added to
crystallize the material. The material is then filtered and dried to get the 1st
stage output.
2nd stage
Silver nitrate is dissolved in water to which the output from 1st stage is added
and the mixture is maintained for 30 min at 50 600C. Silver iodide formed
during the reaction is isolated by filtration. The filtrate is collected and
potassium chloride is added to crystallize cisplatin. The material is filtered and
dried to get cisplatin.
CYCLE TIME
Time (hrs)
Particulars st
1 stage 2nd stage
Reaction 6 8 6 8
Isolation & centrifugation 8 10 8 12
Total process time 14 18 14 20
APPLICATIONS
Cisplatin is a chemotherapy drug. It targets fast dividing cells, like cancer cells,
and causes these cells to die.
Cisplatin is approved by the Food and Drug Administration (FDA) to treat

metastatic testicular cancer and metastatic ovarian cancer.
It is also approved for late-stage bladder cancer and has been used to treat
other types of cancer including head and neck cancer, esophageal cancer,
stomach cancer, lung cancer, skin cancer, prostate cancer, lymphoma and
others (breast, neuroblastoma, sarcoma, bladder, cervical, myeloma,
mesothelioma, osteosarcoma).
EIA
- 191 -
2.6.4.16 Docetaxel trihydrate
REACTION SCHEME
EIA
- 192 -
1st stage
No. (kg)
1 CN1 20
2 Acetonitrile 200
3 6N HCl 8.4
4 Saturated sodium 440
bicarbonate solution in
water 10 kg in 12 L water
5 Ethyl acetate 300
6 Sodium chloride 6
7 Sodium sulfate 20
2nd stage
No. (kg)
1 MDC 240
2 Acetone 240
3 Petroleum ether 600
3rd stage
No. (kg)
1 Methanol 240
2 Water 240
EIA
- 193 -
PROCESS FLOW CHART
1st stage
CN1
20 kg
solution in water Ethyl acetate
440 kg 240 kg
Acetonitrile 6N HCl
200 kg 8.4 kg
GL Reactor
Filter
Process wastewater
Filtrate
440 kg
Ethyl acetate
Distillation Sodium chloride
6 kg
Filter
Sodium chloride Process residue

6 kg 12.4 kg
Sodium sulfate
Organic layer
20 kg
Sodium sulfate
Filter
20 kg
Aceto nitrile
recovered 140 kg
loss 60 kg
Ethyl acetate
st recovered 260 kg
Output from 1 stage
loss 40 kg
16 kg
EIA
- 194 -
2nd stage

240 kg 16 kg
Acetone Petroleum ether
180 kg 600 kg
GL Reactor MDC
recovered 200 kg
loss 40 kg
Acetone
ML Distillation recovered
Centrifuge
170 kg
loss 10 kg
Petroleum ether
Acetone Residue recovered 560 kg
60 kg loss 40 kg
Drying
Filter Process residue

4 kg
Output from 2nd stage Acetone
recovered
12 kg Distillation 50 kg
loss 10 kg
EIA
- 195 -
3rd stage
Methanol Output from 2nd stage

240 kg 12 kg
GL Reactor
Filter
Water
Filtrate
240 kg
Process wastewater
242 kg
Methanol
loss 40 kg
Docetaxel trihydrate
10 kg
EIA
- 196 -
1st stage

(kg) (kg)
CN1 20 Output from 1st stage 16
Acetonitrile 200 By product:
6N HCl 8.4 Sodium chloride 6
Saturated sodium 440 Sodium sulfate 20
bicarbonate GL Solvent
solution in water Reactor 1) Aceto nitrile
10 kg in 12 L water 2 KL & recovered from reaction 140
Ethyl acetate 300 GL loss 60
Sodium chloride 6 Reactor 2) Ethyl acetate
Sodium sulfate 20 1.5 KL recovered from reaction 260
loss 40

Qty./batch
(kg) 1st stage
CN1 20
By product
Acetonitrile 200 Sodium chloride 6
Sodium sulphate 20
6N HCl 8.4
Solvent
Saturated sodium 1) Aceto nitrile
440
bicarbonate recovered 140
solution in water loss 60
2) Ethyl acetate
Ethyl acetate 300 recovered 260
loss 40
Sodium chloride 6
Sodium
20 Process residue 12.4
sulfate
Wastewater 440
EIA
- 197 -
2nd stage

Reactors
(kg) (kg)
stage Solvent
Methylene di 240 1) MDC
chloride (MDC) recovered from reaction 200
Acetone 240 loss 40
Petroleum 600
ether GL 2) Acetone
Reactor recovered from reaction 220
2000 L loss 20
3) Petroleum ether
loss 40
Process residue 4
Qty./batch
Output
(kg)
Input Qty./batch (kg) Reactor Output from 12
2nd stage
Output from 1st
16
stage
Solvent
MDC 240
1) MDC
Acetone 240 recovered 200
loss 40
Petroleum 600
ether 2) Acetone
recovered 220
loss 20
3) Petroleum ether
recovered 560
loss 40
Process residue 4
EIA
- 198 -
3rd stage

Reactors
(kg) (kg)
Output from 12 Docetaxel trihydrate 10
2nd stage Solvent methanol
Methanol 240
Reactor
Water 240 loss 40
1 KL
Qty./batch
Output (kg)
Docetaxel trihydrate 10
Input Qty./batch
Reactor
(kg)
Output from Solvent methanol
12
2nd stage recovered 200
loss 40
Methanol 240
Water 240
Wastewater 242
EIA
- 199 -
PROCEDURE
1st stage
CN1 is dissolved in acetonitrile at room temperature and cooled to 10-15°C. 6N

HCl is slowly added at a temperature of 10 to 15°C in 1 hr and maintained for 30
min to complete the reaction. Ethyl acetate is then added to extract the product.
Ethyl acetate layer is washed with saturated sodium bicarbonate and then with
sodium chloride. The ethyl acetate layer is dried over sodium sulfate and
evaporated to get the output from 1st stage.
2nd stage
The output from 1st stage is dissolved in MDC and acetone. Petroleum ether is then
added slowly in 1 to 2 hrs at room temperature. After complete addition, the
reaction mixture is maintained for 1 hr at room temperature, filtered and dried to
get crude docetaxel (output from 2nd stage).
3rd stage
Docetaxel crude (2nd stage) is dissolved in methanol and water is added in 1 to 2

hrs to crystallize the product. The mass is maintained for 1 hr at room
temperature and filtered and dried to get pure docetaxel trihydrate.
CYCLE TIME
Time (hrs)
Particulars
Reaction 6-8 4-6 4-6
Isolation & centrifugation 4-6 4-6 12 - 16
APPLICATIONS
Docetaxel (trade name Taxotere) is a clinically well established anti-mitotic

chemotherapy medication (that is, it interferes with cell division). It is used
mainly for the treatment of breast, ovarian, and non-small cell lung cancer.
Docetaxel has an FDA (US Food & Drug Administration) approved claim for
treatment of patients who have locally advanced or metastatic breast or non-
small-cell lung cancer who have undergone anthracycline based chemotherapy and
failed to stop cancer progression or relapsed and a European approval for use in
hormone-refractory prostate cancer.
EIA
- 200 -
2.6.4.17 Epirubicin HCl
REACTION SCHEME
EIA
- 201 -
1st stage
No. (kg)
1 EPI-i 2
2 Ethanol 7.89
3 MDC 26.4
4 Acetone 3.95
5 Sodium hydroxide 0.5
7 Sodium borohydride 0.1
8 Water 10
2nd stage
No. (kg)
1 MDC 26.4
2 Water 10
3 Sodium hydroxide 0.2
4 n-Hexane 6.54
3rd stage
No. (kg)
1 Hydrobromic acid 1.5
2 Acetone 9.48
3 Sodium bicarbonate 0.1
4 Water 10
5 Methanol 7.9
6 Dioxane 7
7 MDC 26.4
8 n-Hexane 9.8
EIA
- 202 -
PROCESS FLOW CHART
1st stage
Sodium hydroxide
0.5 kg
EPI-i Hydrochloric acid

2 kg 2.36 kg
Ethanol Sodium borohydride
7.89 kg 0.1 kg
RBF
MDC
Reaction mass
26.4 kg
Sodium acetate
Layer separation
1 kg
MDC + ethanol +
acetone recovered
36 kg
Acetone Distillation
Reaction mass
3.95 kg

Centrifuge
10 kg 15.1 kg

1.1 kg
EIA
- 203 -
2nd stage

26.4 kg 1.1 kg
Water Sodium hydroxide
10 kg 0.2 kg
RBF
n-Hexane Process wastewater

Layer separation
6.54 kg 0.2 kg
MDC
recovered 24 kg
loss 2.4 kg
Process residue
10.1 kg
n-Hexane
loss 1.54 kg

1 kg
EIA
- 204 -
3rd stage

1 kg
Hydrobromic acid Sodium bicarbonate
1.5 kg 0.1 kg
Acetone MDC
9.48 kg 26.4 kg
GL Reactor
Process wastewater
Layer separation
11.1 kg
Methanol
7.9 kg
Dioxane
7 kg
Water Spent recovered acetone
Organic layer
10 kg + methanol + dioxane +
n-hexane + MDC
58 kg
n-Hexane
9.8 kg
Process residue
3.83 kg
Drying
Epirubicin HCl
0.25 kg
EIA
- 205 -
1st stage
Input Qty/batch Reactors Output Qty/batc

(kg) h (kg)
EPI-i 2 Output from 1st stage 1.1
Ethanol 7.89
By-product: sodium acetate 1
MDC 26.4
Acetone 3.95 Spent solvent MDC + 36
GL
Sodium hydroxide 0.5 ethanol + acetone
Reactor recovered
Hydrochloric acid 2.36
250 L
Sodium Process wastewater 15.1
0.1
borohydride
Water 10
Input Qty./batch Reactor Qty./batch

(kg) Output (kg)
EPI-i 2 Output from 1.1
1st stage
Ethanol 7.89
MDC 26.4 By product

1
Sodium acetate
Acetone 3.95
Spent solvent MDC + 36
Sodium 0.5 ethanol + acetone
hydroxide recovered
Hydrochloric 2.36 Wastewater 15.1

acid
Sodium 0.1
borohydride
Water 10
EIA
- 206 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 1.1 Output from 2nd stage 1
stage Solvent
MDC 26.4 1) MDC
Water 10 recovered from 24
Sodium 0.2 reaction 2.4
hydroxide loss
GL
n-Hexane 6.54 Reactor
2) n-Hexane
63 L
recovered from 5
reaction
loss 1.54
Qty./batch
Output (kg)
Qty./batch Reactor
Input Output from 1
(kg)
2nd stage
Output from 1st
stage 1.1
Solvent
MDC 26.4 1) MDC
recovered 24
Water 10 loss 2.4
0.2 2) n-Hexane
Sodium hydroxide
recovered 5
n-Hexane 6.54 loss 1.54
EIA
- 207 -
3rd stage

Reactors
(kg) (kg)
Output from 2nd stage 1 Epirubicin HCl 0.25
Hydrobromic acid 1.5 GL Spent solvent 58
Acetone 9.48 Reactor recovered acetone
Sodium bicarbonate 0.1 160 L 1 + methanol +
no. dioxane + n-hexane
Water 10 + MDC
Methanol 7.9
GL
Dioxane 7 Reactor Process wastewater 11.1
MDC 26.4 250 L 1
n-Hexane 9.8 no.
Qty./batch
Input Reactor
(kg)
Output from
1
2nd stage
Hydrobromic 1.5 Output Qty./batch (kg)

acid
Epirubicin HCl 0.25
Acetone 9.48
Sodium
Spent recovered
bicarbonate 0.1
acetone + methanol + 58
10 dioxane + n-hexane +
Water
MDC
Methanol 7.9 3.83

Process residue
Dioxane 7 11.1
Wastewater
MDC 26.4
n-Hexane 9.8
EIA
- 208 -
PROCEDURE
1st stage
N-((2R,3R,4R,6R)-6-(((1S,3S)-3-acetyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-
1,2,3,4,5a,6,11,11a-octahydrotetracen-1-yl)oxy)-3-hydroxy-2-methyltetrahydro-
2H-pyran-4-yl)-2,2,2-trifluoroacetamide reacts with sodium borohydride in
ethanol, in the presence of HCl & NaOH to form the 1st stage output.
2nd stage
N-((2R,3S,4R)-6-(((1S,3S)-3-acetyl-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-
1,2,3,4,5a,6,11,11a-octahydrotetracen-1-yl)oxy)-3-hydroxy-2-methyltetrahydro-
2H-pyran-4-yl)-2,2,2-trifluoroacetamide reacts with aqueous sodium hydroxide in
the presence of dichloromethane to form the 2nd stage output.
3rd stage
8S,10S)-8-acetyl-10-(((4R,5S,6R)-4-amino-5-hydroxy-6-methyltetrahydro-2H-pyran-
2-yl)oxy)-6,8,11-trihydroxy-1-methoxy-7,8,9,10-tetrahydrotetracene-
5,12(5aH,11aH)-dione reacts with hydrobromic acid and MDC in methanol and
dioxane in presence of sodium bicarbonate in water and acetone to get the
required product.
CYCLE TIME
Time (hrs)
Particulars
Reaction 4-6 4 6 4-6
Isolation & centrifugation 5-8 8 - 12 6-8
APPLICATIONS
Epirubicin hydrochloride is approved by the Food and Drug Administration (FDA) to

treat early-stage breast cancer that has spread to the lymph nodes under the arm.
It is used together with other chemotherapy after breast cancer surgery.
Epirubicin hydrochloride is also being studied in the treatment of other types of

cancer.
EIA
- 209 -
2.6.4.18 Gefitinib
REACTION SCHEME
EIA
- 210 -
1st stage

No. (kg)
1 7-methoxy-6-(3-morphalino propyl) 5
2 Thionyl chloride 10
2nd stage

No. (kg)
1 3-chloro-4-fluoroaniline 4.3
2 Ethyl acetate 90
3 Potassium carbonate
1.2
(K2CO3)
EIA
- 211 -
PROCESS FLOW CHART
7-methoxy-6-(3-morphalino propyl) Thionyl chloride

quinazolin-4 (3H)-one 10 kg
5 kg
GL Reactor
Scrubbed water
HCl Scrubber
consisting of HCl
5 kg
Thionyl chloride
recovered 4 kg
Process residue
1 kg
5 kg
3-chloro-4-fluoroaniline Ethyl acetate

4.3 kg 90 kg
Potassium carbonate
1.2 kg
GL Reactor
Potassium chloride
Filtration 1.2 kg
Ethyl acetate
recovered 88 kg
loss 2 kg
HCl
Centrifuge Distillation 5.9 kg
Process residue
0.4 kg
Gefitinib
3 kg
EIA
- 212 -
1st stage
Input Qty/batch Output Qty/bat

Reactors
(kg) ch (kg)
7-methoxy-6-(3- Output from 1st stage 5
morphalino propyl) 5 (chloride intermediate)
quinazolin-4 (3H)- GL Thionyl chloride
4
one Reactor recovered
Thionyl chloride 10 63 L HCl gas scrubbed 5
Process residue 1
Qty./batch
Output (kg)
(kg) Output from 5
7-methoxy-6-(3- 1st stage
morphalino propyl) 5
quinazolin-4 (3H)-
one Thionyl chloride 4
10 recovered
Thionyl chloride
HCl gas scrubbed 5
Process residue 1
EIA
- 213 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 5 Gefitinib 3
stage (chloride By product:
intermediate) HCl 5.9
Potassium 1.2
3-chloro-4- GL
4.3 chloride
fluoroaniline Reactor
160 L 2
Ethyl acetate 90 recovered from 88
no.s
reaction
Potassium
1.2 loss 2
carbonate (K2CO3)
Process residue 0.4
Qty./batch
Output (kg)
Qty./batch Gefitinib 3
Input (kg) Reactor
Output from 1st

stage 5 By product:
HCl 5.9
Potassium chloride 1.2
3-chloro-4- 4.3
fluoroaniline
Solvent ethyl
90 acetate
Ethyl acetate
recovered 88
Potassium loss 2
1.2
carbonate
Process 0.4
id
EIA
- 214 -
PROCEDURE
The process involves 2 steps and solvent recovery.
1st stage (production of chloride intermediate)
7-methoxy-6-(3-morphalino propyl) quinazolin-4 (3H)-one is reacted with thionyl

chloride at 50-60°C. The reaction mass is then cooled to room temperature and
centrifuged to obtain the output from 1st stage.
2nd stage (isolation of gefitinib)
The solid mass from the centrifuge is taken in GL reactor and treated with 3-
chloro-4-fluoroaniline and K2CO3 in solvent ethyl acetate, under heating centrifuge
at 55-60°C for 3 hrs. The reaction mass is then filtered and dissolved K2CO3 is
removed. The filtrate is cooled in the same reactor at 5-10°C for 2 hrs. The
material is then centrifuged and dried. The mother liquor is transferred for
recovery of solvent.
Solvent recovery
The mother liquor in GLR reactor is distilled to recover ethyl acetate which is
recycled.
CYCLE TIME
1st stage
Reaction 10 15
Centrifugation 2 3
Solvent recovery 2
2nd stage
Reaction 3 4
Filtration 4 5
Centrifugation 1 1.5
Solvent recovery 1 1.5
EIA
- 215 -
APPLICATIONS
Gefitinib is a prescription drug used to treat lung cancer. It belongs to a family of

anti-cancer drugs called tyrosine kinase inhibitors. The U.S. Food and Drug
Administration approved gefitinib in May 2003. Gefitinib is marketed by Astra
Zeneca under the brand name Iressa. Gefitinib is indicated as a stand-alone
therapy for the continued treatment of advanced non-small cell lung cancer that
may or may not have spread (metastasized) to other tissues. It is used when
treatment with both platinum-based and docetaxel (Taxotere) chemotherapies are
ineffective.
EIA
- 216 -
2.6.4.19 Gemcitabine HCl
REACTION SCHEME
EIA
- 217 -
1st stage
No. (kg)
1 G Intermediate 330
2 Methanol 975
3 Ammonia 25% 565
2nd stage
No. (kg)
1 Methanol 750
2 Carbon 10
3 Hydrochloric acid (HCl) 40
3rd stage
No. (kg)
1 Water 30
2 Acetic acid 2000
3 HCl 40
EIA
- 218 -
PROCESS FLOW CHART
1st & 2nd stages
G Intermediate Ammonia 25%

330 kg 565 kg
Ammonia
Methanol
benzoate 300 kg
975 kg
Wastewater
Distillation
SS Reactor 420 kg
Methanol
recovered 925 kg
Output from 1st stage loss 50 kg
175 kg
Methanol Carbon
750 kg 10 kg
Reactor
HCl Carbon
Filter
40 kg 10 kg
Filtrate
Methanol
recovered 700 kg
Centrifuge loss 50 kg
Wastewater
177.5 kg
Drying

37.5 kg
EIA
- 219 -
3rd stage
Water Output from 2nd stage

30 kg 37.5 kg
GL Reactor
Acetic acid HCl

2000 kg 40 kg
Filter
Crystallization
Acetic acid recovered
1975 kg
ANFD
(Filtration & Drying)
Wastewater
107.5 kg
Gemcitabine HCl
25 kg
EIA
- 220 -
1st stage

(kg) (kg)
G Intermediate 330 Output from 1st stage 175
Methanol 975 By product: ammonia 300
Ammonia 25% 565 SS benzoate
Reactor Solvent methanol
2.5 KL recovered from reaction 925
loss 50
Output
Qty./batch (kg)
Output from 175
1st stage

By product
300
ammonia benzoate
G Intermediate 330
Methanol 975
Solvent methanol
Ammonia 25% 565 recovered 925
loss 50
Wastewater 420
EIA
- 221 -
2nd stage

Reactors
(kg) (kg)
stage SS
Spent carbon 10
Reactor
Methanol 750 Solvent methanol
1 .6KL
HCl 40 reaction
GL loss 50
Reactor
1.6 KL
Qty./batch
Output (kg)
Qty./batch
Input Reactor Output from 37.5
(kg)
2nd stage
Output from 1st 175
stage
Methanol 750 Spent carbon 10
Carbon 10
40 Solvent methanol
HCl
recovered 700
loss 50
EIA
- 222 -
3rd stage

Reactors
(kg) (kg)
Output from 37.5 GL Gemcitabine HCl 25
2nd stage Reactor Acetic acid recovered 1975
Water 30 160 L Process wastewater 107.5
Acetic acid 2000 GL with acetic acid
HCl 40 Reactor
Total input 2107.5 3 KL Total output 2107.5
Qty./batch
Qty./batch (kg)
Output
Input (kg) Reactor
Output from Gemcitabine 25
2nd stage 37.5 HCl
Water 30 Acetic acid 1975

Acetic acid 2000 recovered
HCl 40 Wastewater 107.5

with acetic
acid
EIA
- 223 -
PROCEDURE
1st stage
G intermediate is dissolved in methanol at room temperature and then cooled to

0-5°C. Ammonia is then added slowly to the reaction mixture maintaining the
temperature between 0-5°C for 4 hours. Methanol and water are distilled out to
form a thick residue (output from 1st stage).
2nd stage
Output from 1st stage is dissolved in methanol. Carbon is then added to the
reaction mixture, maintained for 30 minutes and filtered. Filtrate is collected in
GLR to which HCl is added at room temperature. The reaction mixture is
maintained at 20-25°C for 24 hours, centrifuged and dried to obtain output.
3rd stage
Output from 2nd stage is dissolved in water at 50-55°C and filtered. The filtrate is
quenched in acetic acid and maintained for 2 hours at room temperature and for
20 hr at 15-25°C to crystallize the product. The product is then filtered and dried
in ANFD to get gemcitabine HCl.
CYCLE TIME
Time (hrs)
Particulars
Reaction 20 30 30 32 28 32
Isolation & centrifugation 8 10 10 12 16 18
Solvent recovery 6 8 6 8 8 10
Total process time 34 48 46 52 52 60
EIA
- 224 -
APPLICATIONS
Gemcitabine hydrochloride is approved by the Food and Drug Administration (FDA)

to be used by itself to treat pancreatic cancer that is advanced or has
metastasized (spread to other parts of the body). It is used in patients who cannot
be treated with surgery and have already been treated with other chemotherapy.
Gemcitabine hydrochloride is approved to be used with other drugs to treat the

following:
Ovarian cancer that is advanced and has not gotten better with other
chemotherapy.
Breast cancer that has metastasized (spread to other parts of the body) and has
not gotten better with other chemotherapy.
Non-small cell lung cancer (NSCLC) that is advanced, cannot be treated with
surgery, or has metastasized (spread to other parts the body).
Gemcitabine hydrochloride is also being studied in the treatment of other types
of cancer.
EIA
- 225 -
2.6.4.20 Imatinib mesylate
REACTION SCHEME
EIA
- 226 -

No. (kg)
1 4-methyl - N3 - (5-pyridin-3yl 10
pyrimidine-2-yl) benzene-1,3-
diamine
2 4- (4- methyl-piperazin -1- yl- 10
ethyl) benzoic acid
dihydrochloride
3 Methylene dichloride 100
4 Triethyl amine 20
5 Hydroxy benzotriazole 6
6 Methanol 50
7 Methane sulphonic acid 2
8 Carbon 1
EIA
- 227 -
PROCESS FLOW CHART
4-methyl-N3-(5-pyridin-3yl pyrimidine-
2-yl) benzene-1,3-diamine
10 kg
ethyl)benzoic acid dihydrochloride Triethyl amine
10 kg 20 kg
MDC Hydroxy benzotriazole
100 kg 6 kg
GL Reactor
Methanol Methane sulphonic acid

50 kg 2 kg
Triethylamine HCl
Carbon
Filter salt 25 kg
1 kg Carbon 1 kg
Crystallization MDC
recovered 95 kg
loss 5 kg
Hydroxy
Centrifuge Distillation benzotriazole
Methanol 13 kg
recovered 47 kg
Drier loss 3 kg
Imatinib mesylate
10 kg
EIA
- 228 -

Reactors
(kg) (kg)
4-methyl-N3-(5- 10 Imatinib mesylate 10
pyridin-3yl By product
pyrimidine-2-yl) Triethylamine 25
benzene-1,3-diamine HCl salt
4-(4-methyl- 10 Hydroxy 13
GL
piperazin-1-yl- benzotriazole
Reactor
ethyl)benzoic acid
500 L Spent carbon 1
dihydrochloride
Solvent
Methylene dichloride 100 1) MDC
(MDC) recovered from 95
reaction
Triethyl amine 20
loss 5
Hydroxy 6
benzotriazole 2) Methanol
GL
Methanol 50 recovered from 47
Reactor
Methane sulphonic 2 reaction
500 L 2
acid loss 3
no.s
Carbon 1
EIA
- 229 -
Qty./batch Reactor
Input
(kg)
4-methyl-N3-(5- Qty./batch
10 Output (kg)
pyridin-3yl
pyrimidine-2-yl) Imatinib mesylate 10
benzene-1,3-
diamine
By product
4-(4-methyl- Triethylamine 25
piperazin-1-yl- HCl salt
ethyl)benzoic acid 10 Hydroxy 13
dihydrochloride benzotriazole
MDC 100 Solvent

1) MDC
recovered 95
Triethyl 20 loss 5
amine
2) Methanol
Hydroxy 6 recovered 47
benzotriazole loss 3
Methanol 50
Spent carbon 1
Methane 2
sulphonic acid
Carbon 1
EIA
- 230 -
PROCEDURE
Methylene dichloride, 4-methyl-N3-(5-pyridin-3yl pyrimidine-2-yl) benzene-1,3-

diamine, -(4-methyl-piperazin-1-yl-ethyl)benzoic acid dihydrochloride,
triethylamine and hydroxy benzotriazole are charged and maintained for 4 hrs at
30 to 35°C to complete the reaction. Triethylamine hydrochloride salt formed is
then isolated by filtering. MDC layer is collected and evaporated. Methanol and
methane sulphonic acid are added to the reaction mixture and heated to 50-60°C
in order to dissolve. Carbon is then charged into the mixture which is filtered. The
mixture is stirred for 2 hrs at room temperature to isolate imatinib mesylate.
CYCLE TIME

Reaction 12 - 15
Isolation, centrifugation & 12 - 16
solvent recovery
Total process time 24 - 31
APPLICATIONS
Imatinib (originally STI571) is a drug used to treat certain types of cancer. It is

currently marketed by Novartis as Gleevec (USA) or Glivec (Europe/Australia/Latin
America) as its mesylate salt, imatinib mesilate (INN).
Imatinib is the first member of a new class of agents that act by specifically
inhibiting a certain enzyme that is characteristic of a particular cancer cell, rather
than non-specifically inhibiting and killing all rapidly dividing cells, and served as a
model for other targeted therapy modalities through tyrosine kinase inhibition.
Imatinib is used in the treatment of chronic myelogenous leukaemia (CML),
gastrointestinal stromal tumours (GISTs) and a number of other malignancies. One
study demonstrated that imatinib mesylate was effective in patients with systemic
mastocytosis, including those who had the D816V mutation in c-Kit. Experience has
shown, however, that imatinib is much less effective in patients with this
mutation, and patients with the mutation comprise nearly 90% of cases of
mastocytosis. Early clinical trials also show its potential for treatment of
hypereosinophilic syndrome and dermatofibrosarcoma protuberans.
EIA
- 231 -
2.6.4.21 Irinotecan HCl trihydrate
REACTION SCHEME
EIA
- 232 -
1st stage
No. (kg)
1 7-ethyl-10-hydroxy
2
camptothecin
2 1,Chlorocarbonyl-4-piperidino
2.4
3 Pyridine 80
4 Chloroform 140
5 Water 20
6 Hexane 20
2nd stage
No. (kg)
1 Ethanol 2
2 Dimethyl formamide (DMF) 2
3 Water 8
3rd stage
No. (kg)
1 Water 18
2 Carbon 0.2
EIA
- 233 -
PROCESS FLOW CHART
1st stage
1,chlorocarbonyl-4-piperidino
piperidine hydrochloride 7-ethyl-10-hydroxy camptothecin
2.4 kg 2 kg
Pyridine Pyridine recovered
80 kg 78 kg
Distillation
GL Reactor
Chloroform
140 kg Pyridine
Water hydrochloride
Reaction mass
20 kg 3.6 kg
Process wastewater
20 kg
Chloroform layer Distillation
Chloroform
Hexane recovered 136 kg
Residue
20 kg loss 4 kg
Hexane
Centrifuge recovered 19 kg
loss 1 kg

2.8 kg
EIA
- 234 -
2nd stage
Ethanol Output from 1st stage

2 kg 2.8 kg
DMF
2 kg
GL Reactor
Process wastewater
8 kg
Ethanol & DMF
Water recovered 3.6 kg
8 kg Ethanol loss
0.4 kg
Process residue
Drying 0.4 kg

2.4 kg
EIA
- 235 -
3rd stage

2.4 kg
Carbon Water
0.2 kg 17 kg
GL Reactor
Carbon
Filter
0.2 kg
Process residue Water

Distillation
0.8 kg GL Reactor 4.4 kg
Water wash ANFD Process wastewater

1 kg (Filtration & Drying) 3.6 kg
Irinotecan HCl trihydrate

2 kg
- 236 -
1st stage

(kg) (kg)
7-ethyl-10- Output from 1st stage 2.8
hydroxy 2 By product: pyridine 3.6
camptothecin GL hydrochloride
1,chlorocarbonyl- Reactor Pyridine recovered 78
4-piperidino 500 L Solvent
2.4 1) Chloroform
piperidine
hydrochloride recovered from 136
reaction
Pyridine 80 loss 4
Chloroform 140
Water 20 2) Hexane
GL
Hexane 20 recovered from 19
Reactor
500 L reaction
loss 1
Input Qty./batch (kg) Reactor Output from 2.8

1st stage
7-ethyl-10-hydroxy
camptothecin 2
By product 3.6
1,Chlorocarbonyl Pyridine hydrochloride
-4-piperidino
piperidine 2.4
Pyridine recovered 78
hydrochloride
Solvent
Pyridine 80 1) Chloroform
recovered 136
Chloroform 140 loss 4
Water 20
2) Hexane
Hexane 20 recovered 19
loss 1
Wastewater 20
- 237 -
2nd stage

Reactors
(kg) (kg)
st nd
Output from 1 stage 2.8 Output from 2 stage 2.4
Ethanol 2 Ethanol & DMF 3.6
Dimethyl formamide 2 recovered
GL Ethanol loss 0.4
(DMF)
Reactor
Water 8 Process residue 0.4
63 L
including DMF
Qty./batch
Output (kg)
Qty./batch
Input (kg) Reactor Output from 2.4
2.8
stage
2 Ethanol & DMF 3.6
Ethanol
2 recovered
DMF
Ethanol loss 0.4
Water 8
Process residue 0.4
including DMF
- 238 -
3rd stage

Reactors
(kg) (kg)
Output from 2.4 Irinotecan HCl trihydrate 2
2nd stage GL Spent carbon 0.2
Water 18 Reactor Pure water recovered 9.8
Carbon 0.2 160 L 2 Process residue 0.8
no.s Process wastewater 7.8
Qty./batch
Output (kg)
Irinotecan HCl 2
Qty./batch trihydrate
Input Reactor
(kg)
Output from
2nd stage 2.4 Spent carbon 0.2
Water 18
Pure water recovered 9.8
Carbon 0.2
Process residue 0.8
Wastewater 7.8
- 239 -
PROCEDURE
1st stage
7-ethyl-10-hydroxy (20S) camptothecin is reacted with 1-chloro carbonyl-4-

piperidino piperidine hydrochloride in solvent pyridine. After the reaction is
complete pyridine is distilled out, the residue is dissolved in chloroform. Further it
is extracted into hexane and the organic layer is distilled out to get crude
irinotecan base (1st stage).
2nd stage
The crude irinotecan base is purified in ethanol and dimethyl formamide to get
irinotecan base of 99.0% HPLC purity.
3rd stage
Irinotecan base from 3rd stage is purified in water in the presence of carbon to get
irinotecan HCl. Further it is crystallized in water to get irinotecan HCl trihydrate
of 99.5% HPLC purity.
CYCLE TIME
Time (hrs)
Particulars
Reaction 30 - 32 28 - 32 12 - 20
Isolation & centrifugation 10 - 12 16 - 18 12 - 16
Solvent recovery 6-8 8 - 10 -
Total process time 46 - 52 52 - 60 24 36
APPLICATIONS
Irinotecan belongs to the group of cancer-fighting medications known as

antineoplastics. It kills cancer cells by interfering with the genetic material DNA,
which is necessary for their growth and reproduction. Irinotecan is usually used in
combination with other medications to treat colon or rectal cancer.
- 240 -
2.6.4.22 Lenalidomide
REACTION SCHEME
- 241 -
1st stage

No. (kg)
1 Methanol 4
2 4-nitropthalide 1
3 Raney nickel catalyst 0.1
4 Hydrogen gas 2 m3
2nd stage

No. (kg)
1 Dimethyl sulphoxide 5
2 L-glutamine 1
3 N,N, carbomyl diimidazole 3
4 Water 25
5 Carbon 0.1
- 242 -
PROCESS FLOW CHART
1st stage
Methanol
4 kg
4-nitropthalide Raney nickel catalyst

1 kg 0.1 kg
Hydrogen gas Hydrogen gas vented
Hydrogenator through steam
2 m3
2 m3
Raney nickel catalyst

Filter
0.1 kg
RB Flask Methanol
recovered 3 kg
loss 1 kg
Process residue
st 0.1 kg
Output from 1 stage
0.9 kg
- 243 -
2nd stage

0.9 kg
Dimethyl sulphoxide N,N, carbomyl diimidazole

5 kg 3 kg
L-glutamine Carbon
1 kg 0.1 kg
GL Reactor
Spent carbon
Filter
0.1 kg
Filtrate
Cooling (100 C)
Process residue
Filter 2 kg
Water
25 kg Filtrate
DMSO
recovered 4.9 kg
loss 0.1 kg
Process wastewater
26.9 kg
Lenalidomide
1 kg
- 244 -
1st stage

Reactors
(kg) (kg)
Methanol 4 Output from 1st stage 0.9
Methanol
Hydrogenator
4- 1 recovered from 3
10 L
nitropthalide reaction
loss 1
Raney nickel 0.1 Raney nickel 0.1
catalyst RB Flask recovered & recycled
10 L Process residue 0.1
Hydrogen gas 2 m3 Hydrogen gas vented 2 m3
through steam
Qty./batch
Output (kg)
Output from 0.9

Qty./batch 1st stage
Input (kg) Reactor
4 Methanol
Methanol
recovered 3
loss 1
4-nitropthalide 1
Raney nickel 0.1 Raney nickel

catalyst 0.1
recovered & recycled
Hydrogen gas 2 m3
Process residue 0.1
Hydrogen gas vented 2 m3

through steam
EIA
- 245 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 0.9 Lenalidomide 1
stage GL Spent carbon 0.1
Dimethyl 5 Reactor DMSO
sulphoxide 63 L recovery 4.9
L-glutamine 1 loss 0.1
N,N, carbomyl 3 Process residue 2
GL
diimidazole
Reactor
Water 25 Process wastewater 26.9
20 L - 2
Carbon 0.1
no.s
Input Qty./batch (kg) Reactor Lenalidomide 1

st
Output from 1
stage 0.9
Spent carbon 0.1
Dimethyl 5 DMSO
sulphoxide recovery 4.9
loss 0.1
L-glutamine 1
N,N, carbomyl 3
diimidazole Process residue 2
Water 25
Wastewater 26.9
Carbon 0.1
EIA
- 246 -
PROCEDURE
1st stage
Methanol, 4-nitrophthalide and raney nickel catalyst are charged into a clean 5 L
hydrogenator and the manhole is tightened. The hydrogenator is first flushed with
nitrogen and then with hydrogen (not shown in material balance). Hydrogen
pressure is maintained at 4.0 kg and at a temperature of 40 to 50°C for 4 hrs. TLC
is checked for completion of reaction. The catalyst is filtered and methanol is
distilled out to get the output from 1st stage.
2nd stage
The output from 1st stage is charged along with dimethysulphoxide, L-glutamine
and N,N, carbomyl diimidazole and maintained for 4 hrs at a temperature of 25 to
30°C for completion of reaction, monitored by TLC. Carbon is then added and
filtered. The filtrate is quenched in water to crystallize the product which is
centrifuged and dried to get the final product lenalidomide.
CYCLE TIME
Time (hrs)
Particulars
1st stage 2nd stage
Reaction 4-6 4-6
Isolation & centrifugation 2-3 12 - 16
Solvent recovery 0.5 - 1 2-3
Total process time 6.5 - 10 18 - 25
APPLICATIONS
Lenalidomide is approved by the Food and Drug Administration (FDA) to treat

anaemia caused by a certain type of myelodysplastic syndrome (MDS). It is only
available as part of a special program called RevAssist. Lenalidomide is also
approved to treat multiple myeloma.
Lenalidomide is also being studied in the treatment of other types of cancer.
EIA
- 247 -
2.6.4.23 Letrozole
REACTION SCHEME
EIA
- 248 -
1st stage

No. (kg)
1 p-tolunitrile 3
2 n-bromosuccinamide 2.5
3 Aceto nitrile 15
4 Hexane 3
2nd stage

No. (kg)
1 1,2,4-triazole 1
2 Dimethyl formamide 3
4 Ethyl acetate 10
5 Water 10
EIA
- 249 -
PROCESS FLOW CHART
1st stage
n-bromosuccinamide Aceto nitrile

2.5 kg 15 kg
p-tolunitrile Hexane
3 kg 3 kg
GL Reactor
Succinamide
Filter
2.5 kg
Aceto nitrile
recovered 14.5 kg
loss 0.5 kg
Process residue
0.2 kg
Hexane
Output from 1st stage recovered 2.5 kg
3 kg loss 0.3 kg
EIA
- 250 -
2nd stage

3 kg
Dimethyl formamide Potassium carbonate

3 kg 3 kg
1,2,4-triazole Ethyl acetate
1 kg 10 kg
Water Hydrobromic
Scrubber
10 kg GL Reactor acid
0.7 kg
Process wastewater
Ethyl acetate
recovered 9.5 kg
loss 0.5 kg
Potassium bromide
Filter 3.2 kg
Filtrate (cooled & chilled)
Dimethyl formamide
recovered 2.7 kg
loss 0.3 kg
Process residue
0.1 kg
Letrozole
1 kg
EIA
- 251 -
1st stage

Reactors
(kg) (kg)
p-tolunitrile 3 Output from 1st stage 3
n- 2.5 By product: succinamide 2.5
bromosuccinamide Solvent
Aceto nitrile 15 1) Aceto nitrile 14.5
Hexane 3 recovered from
GL reaction 0.5
Reactor loss
160 L 2
no.s 2) Hexane
recovered from 2.5
reaction
loss 0.3
Process residue 0.2
Qty./batch
Output
(kg)
Output from 3
1st stage
(kg)
3 By product
p-tolunitrile
succinamide 2.5
n-
bromosuccinamide 2.5
Solvent
1) Aceto nitrile
Aceto nitrile 15 recovered 14.5
loss 0.5
Hexane 3 2) Hexane
recovered 2.5
loss 0.3
Process residue 0.2
EIA
- 252 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 3 Letrozole 1
stage By product:
1,2,4-triazole 1 Hydrobromic acid 0.7
Dimethyl 3 Potassium bromide 3.2
formamide Solvent
Potassium 3 1) Ethyl acetate
carbonate recovered from 9.5
GL
Ethyl acetate 10 Reactor reaction
Water 10 63 L 2 loss 0.5
no.s
2) Dimethyl formamide
recovered from 2.7
reaction
loss 0.3
Process residue 0.1
Qty./batch
Output (kg)
Qty./batch
Input Reactor Letrozole 1
(kg)
st
Output from 1
stage 3 By product:
Hydrobromic acid 0.7
1,2,4-triazole 1 Potassium bromide 3.2
Dimethyl 3 Solvent
formamide 1) Ethyl acetate
recovered 9.5
Potassium 3 loss 0.5
carbonate
2) Dimethyl formamide
10 recovered 2.7
Ethyl acetate
loss 0.3
Water 10
Process residue 0.1
Wastewater 12
EIA
- 253 -
PROCEDURE
1st stage
p-tolunitrile is reacted with n-bromosuccinamide in aceto nitrile at 70 to 85°C for

2 hrs. The reaction completion is monitored by TLC for absence of p-tolunitrile.
Then the mass is cooled to room temperature and hexane is added to crystallize
the product which is filtered and dried to get the 1st stage output.
2nd stage
The output from 1st stage is condensed with 1,2,4-triazole in presence of

potassium carbonate and DMF for 3 hrs. The reaction is monitored by TLC. Water is
then added to the reaction mass and the product is extracted in ethyl acetate.
The ethyl acetate layer is separated & the reaction mass is concentrated to 80%.
The reaction mass is then cooled, filtered & dried to get the final product.
CYCLE TIME
Time (hrs)
Particulars st
1 stage 2nd stage
Isolation & centrifugation 8 - 12 10 - 12
Solvent recovery 0.5 - 1 0.5 - 1
Total process time 14.5 - 21 20.5 - 25
EIA
- 254 -
APPLICATIONS
Letrozole is approved by the Food and Drug Administration (FDA) to be used alone
to treat postmenopausal women who have any of the following types of breast
cancer:
Early-stage, hormone receptor positive (HR+) breast cancer in women who have
already received other treatment.
Early-stage breast cancer that has been treated with tamoxifen for at least five
years.
Breast cancer that is locally advanced or has metastasized (spread to other
parts of the body) and is hormone receptor positive (HR+).
Breast cancer that is locally advanced or has metastasized and it is not known
whether the cancer is HR+ or hormone receptor negative (HR-).
Advanced breast cancer that has gotten worse after anti-estrogen therapy.
Letrozole is also used with a drug called lapatinib to treat postmenopausal women
who need hormonal therapy to treat metastatic breast cancer that is:
hormone receptor positive (HR+); and

HER2 positive (HER2+).
Letrozole is also being studied in the treatment of other types of cancer.
EIA
- 255 -
2.6.4.24 Oxaliplatin
REACTION SCHEME
EIA
- 256 -
1st stage

No. (kg)
1 Potassium tetrachloroplatinate 1.7
2 Trans-1,2-diamino cyclohexane 0.51
3 Water 5
2nd stage

No. (kg)
1 Water 75
2 Silver oxide 0.93
3 Oxalic acid 0.47
4 Carbon 0.14
EIA
- 257 -
PROCESS FLOW CHART
1st stage
Potassium tetrachloroplatinate Water

1.7 kg 5 kg
Trans-1,2-diamino cyclohexane
0.51 kg
GL Reactor
Process wastewater
5.01 kg
Potassium chloride
Drying 0.8 kg

1.4 kg
EIA
- 258 -
2nd stage

1.4 kg
Silver oxide
Oxalic acid
0.93 kg
0.47 kg
Water
75 kg
Reactor
Silver oxide
Carbon Spent carbon
Reactor
0.14 kg 0.14 kg
Distillation
Filtrate (water)
Process wastewater
Silver chloride
Filtration 1.73 kg
Mother liquor
Drier
Process residue
Distillation 0.07 kg
Oxaliplatin Process wastewater

10 kg
1 kg
EIA
- 259 -
1st stage

Reactors
(kg) (kg)
Potassium 1.7 Output from 1st stage 1.4
tetrachloroplatinate Potassium chloride 0.8
GL
Trans-1,2-diamino 0.51 Process wastewater 5.01
Reactor
cyclohexane
20 L
Water 5
Qty./batch
Qty./batch Output
(kg)
Input (kg) Reactor
Output from 1.4
Potassium 1st stage
tetrachloroplatinate 1.7
Trans-1,2-diamino 0.51 0.8

Potassium chloride
cyclohexane
Water 5
Wastewater 5.01
EIA
- 260 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 1.4 Oxaliplatin 1
stage
Water 75 GL Silver chloride 1.73
Reactor
Silver oxide 0.93 Spent carbon 0.14
160 L
Oxalic acid 0.47 Process residue 0.07
3 no.s
Carbon 0.14 Process wastewater 75
Qty./batch
Output (kg)
Input Qty./batch Reactor Oxaliplatin 1

(kg)
Output from 1st
stage 1.4
Silver chloride 1.73
Water 75
Spent carbon 0.14
Silver oxide 0.93
Oxalic acid 0.47 Process residue 0.07
Carbon 0.14
Wastewater 75
EIA
- 261 -
PROCEDURE
1st stage
Potassium tetrachloroplatinate is dissolved in water to which trans-1,2-

diaminocyclohexane is added and maintained for 6 hrs at room temperature. The
material is centrifuged and dried to get output from 1st stage.
2nd stage
Silver oxide and oxalic acid are added to water and maintained at 50-60°C for 15
min to form silver oxalate. This is then reacted with the output from 1st stage at
50-60°C for 6 hrs. Silver chloride is formed which is filtered and collected. The
water layer is treated with carbon, concentrated and filtered to get the product
which is washed with water to get pure oxaliplatin.
CYCLE TIME

1st stage 2nd stage
Reaction 8 - 10 10 - 12
Solvent recovery - -
APPLICATIONS
Oxaliplatin is approved by the Food and Drug Administration (FDA) to be used

together with other drugs as adjuvant treatment for stage III colon cancer in
patients who have had surgery to remove the cancer. It is also approved to be
used with other drugs to treat colorectal cancer that has advanced or recurred
after earlier chemotherapy.
Oxaliplatin is also being studied in the treatment of other types of cancer.
EIA
- 262 -
2.6.4.25 Paclitaxel
REACTION SCHEME
EIA
- 263 -
1st stage
No. (kg)
1 TxL RM 2
2 Zinc 3.75
3 Methanol 15.6
4 Acetic acid 20
2nd stage
No. (kg)
1 MDC 17.45
2 Acetone 5.27
3 Petroleum ether 32.7
3rd stage
No. (kg)
1 Methanol 9.36
2 Water 12
4th stage
No. (kg)
1 MDC 4.85
2 Acetone 1.38
3 Petroleum ether 7.7
EIA
- 264 -
PROCESS FLOW CHART
1st stage
TxL RM Methanol
2 kg 15.6 kg
Zinc Acetic acid
3.75 kg 20 kg
GL Reactor
Spent zinc dust

Distillation 3.75 kg
Acetic acid recovered

19.7 kg
Ethyl acetate
22.5 kg
Methanol
recovered 15 kg
loss 0.6 kg
Process residue
0.3 kg
Filter Distillation
Ethyl acetate
Drier recovered 22 kg
loss 0.5 kg

2 kg
EIA
- 265 -
2nd & 3rd stages
Output from 1st stage Acetone

2 kg 5.27 kg
MDC Petroleum ether

17.45 kg 32.7 kg
GL Reactor Process residue

2.2 kg
Filter ML
Spent solvent MDC + acetone +

petroleum ether 54 kg
Drying

1.2 kg
Methanol Water
9.36 kg 12 kg
GL Reactor
Methanol
recovered 8 kg
loss 1.36 kg
Reaction mass Distillation
Process wastewater
Filter
12.1 kg
Drying
Output from 3rd stage

1.1 kg
EIA
- 266 -
4th stage
Output from 3rd stage Acetone

1.1 kg 1.38 kg
MDC
4.85 kg
Glass vessel
L- isomer of paclitaxel
Filter 0.1 kg
Petroleum ether
Filtrate
7.7 kg
MDC
recovered 4.5 kg
loss 0.35 kg
Filter ML Distillation
L- isomer of Acetone + petroleum ether

Drier paclitaxel recovered 8.9 kg
0.1 kg loss 0.18 kg
Paclitaxel
1 kg
EIA
- 267 -
1st stage

(kg) (kg)
TxL RM 2 Output from 1st stage 2
Zinc 3.75 Spent zinc dust 3.75
Methanol 15.6 Solvent
Acetic acid 20 1) methanol
Ethyl 22.5 recovered from reaction 15
acetate loss 0.6
GLR
160 L
2) ethyl acetate
loss 0.5
Acetic acid recovered 19.7
Process residue 0.3
Output
Qty./batch (kg)
Output from 2
1st stage

Spent zinc dust 3.75
TxL RM 2
Solvent
3.75 1) Methanol
Zinc recovered 15
loss 0.6
Methanol 15.6
2) Ethyl acetate
Acetic acid 20 recovered 22
loss 0.5
Ethyl 22.5
acetate
Acetic acid recovered 19.7
Process residue 0.3
EIA
- 268 -
2nd stage

Reactors
(kg) (kg)
stage Spent solvent MDC + 54
MDC 17.45 GLR acetone + petroleum
Acetone 5.27 100 L ether
Petroleum ether 32.7 Process residue 2.2
Input Qty./batch (kg) Reactor Output from 1.2

2
stage
MDC 17.45 Spent solvent MDC + 54

acetone +
Acetone 5.27
petroleum ether
Petroleum ether 32.7
Process residue 2.2
EIA
- 269 -
3rd stage

Reactors
(kg) (kg)
rd
Output from 1.2 Output from 3 stage 1.1
2nd stage Solvent methanol
Methanol 9.36 recovered from 8
GLR
reaction
63 L
loss 1.36
Water 12 Process wastewater 12.1
Qty./batch
Input Reactor
(kg)
Output from Output from 1.1
2nd stage 1.2 3rd stage
Methanol 9.36 Solvent methanol

recovered 8
Water 12
loss 1.36
Wastewater 12.1
EIA
- 270 -
4th stage

Reactors
(kg) (kg)
Output from 3rd 1.1 Paclitaxel 1
stage By products: L- isomer 0.1
MDC 4.85 of paclitaxel
Acetone 1.38 Solvent
Petroleum ether 7.7 1) MDC
recovered from 4.5
Glass reaction
vessel loss 0.35
63 L
2) Acetone +
petroleum ether
recovered from 8.9
reaction
loss 0.18
Qty./batch
Output (kg)
Qty./batch
Input (kg) Reactor Paclitaxel 1
Output from 3rd
1.1
stage
By products: L- 0.1
4.85
MDC isomer of paclitaxel
Acetone 1.38
Petroleum ether 7.7

Solvent
1) MDC
recovered 4.5
loss 0.35
2) Acetone +
petroleum ether
recovered 8.9
loss 0.18
EIA
- 271 -
PROCEDURE
1st stage
TxL RM is dissolved in methanol to which acetic acid & zinc powder are added &
heated to 40-50°C for 2 hrs. The reaction is monitored by TLC. The reaction
mixture is then filtered & methanol, acetic acid is evaporated until residue
formed. The residue is crystallized in ethyl acetate, filtered and dried to get 1st
stage output.
2nd stage
The output from 1st stage is dissolved in MDC & acetone, which is then re-
crystallized in petroleum ether. The resultant mass is filtered and dried to get the
output from 3rd stage.
3rd stage
The output from 2nd stage is dissolved in methanol and re-crystallized, filtered and
dried to get the output from 3rd stage.
4th stage
The output from 3rd stage is dissolved in MDC and acetone and re-crystallized in
petroleum ether. The reaction mass is then filtered and dried to get pure
paclitaxel.
CYCLE TIME
Time (hrs)
Particulars st nd
1 stage 2 stage 3rd stage 4th stage
Reaction 8-9 6-8 8 - 10 6-8
Isolation & centrifugation 6-7 6-8 10 - 12 6-8
Solvent recovery 1-2 Nil 0.5 - 1 1-2
Total process time 15 - 18 12 - 16 18.5 - 23 13 - 18
APPLICATIONS
Paclitaxel is approved by the Food and Drug Administration (FDA) to treat ovarian
and breast cancer, and AIDS-related Kaposi sarcoma. It is also approved to be used
together with a drug called cisplatin to treat advanced ovarian cancer and non-
small cell lung cancer (NSCLC).
Paclitaxel is also being studied in the treatment of other types of cancer.

EIA
- 272 -
2.6.4.26 Pemetrexed
REACTION SCHEME
EIA
- 273 -
1st stage
No. (kg)
1 L-glutamic acid diethyl ester HCl 1.14
2 4-[2-(2-amino-4,7-dihydro-4-oxo- 1.56
1H-pyrrolo[2,3-d]pyrimidin-5-
3 N-methyl morphalane 1.16
4 DMF 10.2
5 MDC 38.5
6 Water 38.5
7 2-chloro-4,6-dimethoxy-1,3,5- 1
triazine
2nd stage
No. (kg)
3 Water 25
3rd stage
No. (kg)
1 Acetone 30.78
4 Water 25
EIA
- 274 -
PROCESS FLOW CHART
1st stage
DMF
10.2 kg 4-[2-(2-amino-4,7-dihydro-4-oxo-1H-
pyrrolo[2,3-d]pyrimidin-5-
L-glutamic acid diethyl ester HCl yl)ethyl)benzolic acid
1.14 kg 1.56 kg MDC
recovered 30.8 kg
N-methyl morphalane MDC loss 7.7 kg
1.16 kg 38.5 kg
2-chloro-4,6-dimethoxy- Distillation
1,3,5-triazine 1 kg GL Reactor
DMF
recovered 9.5 kg
loss 0.7 kg

Centrifuge
38.5 kg 41.49 kg

1.87 kg
EIA
- 275 -
2nd& 3rd stages
Output from 1st stage Sodium hydroxide

1.87 kg 1 kg
Hydrochloric acid Water
1 kg 25 kg
GL Reactor
Centrifuge Process wastewater

27.47 kg

1.4 kg
`
Acetone Sodium hydroxide
30.78 kg 1 kg
Hydrochloric acid Water
1 kg 25 kg
Distillation
GL Reactor
Acetone
recovered 30 kg
loss 0.78 kg
Pemetrexed
Centrifuge
1 kg
Distillation Process wastewater

27 kg
Process residue
0.4 kg
EIA
- 276 -
1st stage

(kg) (kg)
L-glutamic acid diethyl 1.14 Output from 1st 1.87
ester HCl stage
4-[2-(2-amino-4,7- 1.56 Solvent
dihydro-4-oxo-1H- 1) MDC
pyrrolo[2,3- recovered from 30.8
d]pyrimidin-5- reaction
yl)ethyl)benzolic acid GL loss 7.7
N-methyl morphalane 1.16 Reactor
DMF 10.2 250 L 2) DMF
MDC 38.5 recovered from 9.5
reaction
Water 38.5
loss 0.7
2-chloro-4,6- 1
dimethoxy-1,3,5- Process 41.49
triazine wastewater
Qty./batch
Input Reactor
(kg) Qty./batch
L-glutamic acid Output (kg)
diethyl ester HCl 1.14
Output from 1.87
4-[2-(2-amino-4,7- 1st stage
dihydro-4-oxo-1H-
pyrrolo[2,3- 1.56
d]pyrimidin-5- Solvent
yl)ethyl)benzolic 1) MDC
acid recovered 30.8
loss 7.7
N-methyl
1.16 2) DMF
morphalane
recovered 9.5
DMF 10.2 0.7
loss
MDC 38.5
Water 38.5
Wastewater 41.49
2-chloro-4,6- 1
dimethoxy-
1,3,5-triazine
EIA
- 277 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 1.87 Output from 2nd stage 1.4
stage
GL
Hydrochloric acid 1 Process wastewater 27.47
Reactor
Sodium hydroxide 1
100 L
Water 25
Qty./batch
Input (kg) Reactor
Qty./batch
Output from 1st Output (kg)
1.87
stage
Output from 1.4
Hydrochloric 1 2nd stage
acid
Sodium 1
hydroxide Process wastewater 27.47
including DMF
Water 25
EIA
- 278 -
3rd stage

Reactors
(kg) (kg)
Output from 1.4 Pemetrexed 1
2nd stage Solvent acetone
Acetone 30.78 recovered from 30
Hydrochloric 1 GL reaction
acid Reactor loss 0.78
Sodium 1 100 L Process residue 0.4
hydroxide Process wastewater 27
Water 25
Qty./batch
Output (kg)
(kg) Pemetrexed 1
Output from
2nd stage 1.4
Acetone Solvent acetone

30.78
recovered 30
Hydrochloric loss 0.78
acid 1
Sodium Process residue 0.4

1
hydroxide
25 Wastewater 27
Water
EIA
- 279 -
PROCEDURE
1st stage
Benzolic acid is reacted with glutamic acid in presence of n-methylmorpholine and

triazine in DMF media in the presence of 2-chloro-4,6-dimethoxy-1,3,5-triazine &
DMF at an evaluated temperature 45-50°C in GLR reactor. Coater is formed during
the reaction, after the reaction is complete. The reaction mass is cooled to 25-
30°C and the product centrifuged.
2nd stage
The output from 1st stage is dissolved in coater to which sodium hydroxide is added
and stirred at 25-30°C for 2 hrs. To this reaction mixture hydrochloric acid is
added and the material is centrifuged.
3rd stage
The output from 2nd stage is dissolved in acetone and water to which sodium
hydroxide is added and stirred at a temperature of 25-30°C. To this reaction
mixture hydrochloric acid is added. After the reaction is complete, the product is
centrifuged.
CYCLE TIME
Time (hrs)
Particulars
Reaction 5-7 5 - 5.5 4 - 4.5
Isolation & centrifugation 3 - 3.5 2 - 2.5 2-3
Total process time 8 - 10.5 7-8 6 - 7.5
Solvent recovery 2-3 - 2-3
EIA
- 280 -
APPLICATIONS
Pemetrexed disodium is approved by the Food and Drug Administration (FDA) to be

used alone to treat non-squamous cell non-small cell lung cancer (NSCLC). It is
used in patients whose cancer is locally advanced or has metastasized (spread) and
who have already had other chemotherapy.
Pemetrexed disodium is also approved to be used with cisplatin to treat:
Malignant pleural mesothelioma in patients who cannot be treated with

surgery.
Non-squamous cell non-small cell lung cancer (NSCLC) that is locally advanced
or has metastasized (spread). The combination is used in patients who have not
already had other chemotherapy.
Pemetrexed disodium is also being studied in the treatment of other types of
cancer.
EIA
- 281 -
2.6.4.27 Temozolomide
REACTION SCHEME
EIA
- 282 -
1st stage

No. (kg)
1 5-amino-1-(n-methyl carbomyl) 100
imidazole-4-carboxamide
2 Water 600
3 Sodium nitrite 40
4 Tartaric acid 80
2nd stage

No. (kg)
1 Acetone 400
2 Water 150
3 Carbon 5
EIA
- 283 -
PROCESS FLOW CHART
1st stage
5-amino-1-(n-methyl carbomyl) Sodium nitrite

imidazole-4-carboxamide 40 kg
100 kg
Water Tartaric acid
600 kg 80 kg
SS Reactor
Process wastewater
646 kg
Filtration Distillation
Drying
Sodium tartrate Process residue
120 kg 4 kg

50 kg
EIA
- 284 -
2nd stage

50 kg
Acetone
Carbon
400 kg
5 kg
Water
150 kg
Reactor
Spent carbon
Filter
8 kg
Solvent acetone
recovered 385 kg
loss 15 kg
0 50 C for 2 hrs
Process wastewater
Centrifuge ML Distillation
147 kg
Drier Azahypoxanthine & 5-

aminoimidazole -4-carboxamide
25 kg
Temozolomide
25 kg
EIA
- 285 -
1st stage

Reactors
(kg) (kg)
5-amino-1-(n-methyl 100 Output from 1st stage 50
carbomyl) imidazole- By product: sodium 120
4-carboxamide SS tartrate
Water 600 Reactor Process wastewater 646
Sodium nitrite 40 2 KL Process residue 4
Tartaric acid 80
Qty./batch
Output (kg)
Qty./batch
Input Reactor
(kg) Output from 50
5-amino-1-(n-methyl 1st stage
carbomyl) 100
imidazole-4-
carboxamide By product: 120
sodium tartrate
Water 600
40
Sodium nitrite Wastewater 646
Tartaric acid 80
Process residue 4
EIA
- 286 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 50 Temozolomide 25
stage By product: 25
Acetone 400 azahypoxanthine &
Water 150 5-aminoimidazole-4-
Carbon 5 SS carboxamide
Reactor Spent carbon 8
1.6 KL Solvent acetone
recovered from 385
reaction
loss 15
Qty./batch
Output
(kg)
Temozolomide 25
Qty./batch By product:
Input Reactor
(kg) azahypoxanthine
Output from 1st & 5- 25
stage 50 aminoimidazole-4-
carboxamide
Acetone 400
Water 150 Spent carbon 8
Carbon 5
Solvent acetone
recovered 385
from reaction
loss 15
EIA
- 287 -
PROCEDURE
1st stage
Water and 5-amino-1-(n-methyl carbomyl) imidazole-4-carboxamide are charged

into the reactor and cooled at 20 250 C. Sodium nitrite and then tartaric acid are
added to the reaction mixture and maintained for 8-10 hrs to complete the
reaction. Material is centrifuged and dried to give 1st stage output (crude
temozolomide).
2nd stage
Acetone & water are charged into the reactor. Then the output from 1st stage is
charged into the reactor and heated to 35 - 450C. Carbon is then charged & after
complete dissolution carbon is filtered and the reaction mass is cooled to 0 - 50 C
for 2 hrs and centrifuged and dried to get temozolomide.
CYCLE TIME

st
1 stage 2nd stage
Reaction 12 14 4 -6
Isolation & centrifugation 16 20 12 -16
Total process time 28 34 16 -22
Solvent recovery The time required for
solvent recovery is
included in the stage
cycle time
APPLICATIONS
Temozolomide is approved by the Food and Drug Administration (FDA) to treat two
different types of brain tumour in adults: anaplastic astrocytoma and glioblastoma
multiforme (GBM).
Temozolomide is also being studied in the treatment of other types of cancer.
EIA
- 288 -
2.6.4.28 Thalidomide
REACTION SCHEME
EIA
- 289 -

No. (kg)
1 Phthalic anhydride 10
2 L-glutamine 10
3 Dimethyl sulphoxide 50
4 N,N-carbomyl diimidazole 15
5 Carbon 1
6 Water 100
EIA
- 290 -
PROCESS FLOW CHART
Carbon
1 kg
Phthalic anhydride DMSO
10 kg 50 kg
L-glutamine N,N-carbomyl diimidazole
10 kg 15 kg
GL Reactor
Spent carbon
Filter
1 kg
Water
Filtrate
100 kg
Cooling & chilling
Phthalic acid &
Filter imidazole
24.92 kg
DMSO
recovered 40 kg
loss 10 kg
Process
residue
0.08 kg
Process wastewater
100 kg
Drier
Thalidomide
10 kg
EIA
- 291 -

Reactors
(kg) (kg)
Phthalic anhydride 10 Thalidomide 10
Spent carbon 1
L-glutamine 10
By product: phthalic 24.92
Dimethyl sulphoxide GL acid & imidazole
50
(DMSO) Reactor Solvent DMSO
N,N-carbomyl 15 160 L recovered from 40
diimidazole reaction
Carbon 1 loss 10
Water 100 Process 0.08
residue/Hazardous
GL waste
Reactor
500 L
Qty./batch
Input Reactor
(kg)
Thalidomide 10
Phthalic anhydride 10
By products: 24.92
L-glutamine 10
phthalic acid &
imidazole
Dimethyl 50
sulphoxide Spent carbon 1
Solvent DMSO
N,N-carbomyl 15 recovered 40
diimidazole from reaction
loss 10
Carbon 1
Water 100
EIA
- 292 -
PROCEDURE
Phthalic anhydride and L-glutamine are charged in dimethyl sulphoxide and

maintained at 50 to 60°C for 4 hrs to form an intermediate which is crystallized to
form crude thalidomide by using N,N-carbomyl dimidazole at 35 to 40°C for 4 hrs.
After the reaction is complete carbon is charged into the reaction mixture which is
filtered and re-crystallized in water, centrifuged and dried to get pure
thalidomide.
CYCLE TIME

Reaction 10 - 14
Isolation, centrifugation 10 - 14
Solvent recovery 2-3
Total process time 22 - 31
APPLICATIONS
Thalidomide is approved by the Food and Drug Administration (FDA) to treat a

painful skin disease related to leprosy. It is also approved to treat multiple
myeloma in patients who have just been diagnosed with the disease. It is only
available as part of a special program called S.T.E.P.S. Thalidomide is used
together with another drug called dexamethasone.
Thalidomide is also being studied in the treatment of other types of cancer.
EIA
- 293 -
2.6.4.29 Topotecan HCl
REACTION SCHEME
EIA
- 294 -
1st stage

No. (kg)
1 10-hydroxy camptothecin 1
2 Dimethyl amine 0.5
3 Formaldehyde 0.67
4 Acetic acid 10
5 Water 10
2nd stage
Production batch size 0.5 kg

No. (kg)
1 Water 10
3 Carbon 0.1
EIA
- 295 -
PROCESS FLOW CHART
1st stage
10-hydroxy camptothecin Formaldehyde

1 kg 0.67 kg
Dimethyl amine Water

0.5 kg 10 kg
GL Reactor
Formic acid
0.63 kg
Filter Distillation
Process wastewater
10.24 kg
Acetic acid
10 kg GL Reactor
Acetic acid
recovered 8 kg
loss 2 kg
Filter Distillation
Process wastewater
0.3 kg
Drying

1 kg
EIA
- 296 -
2nd stage

1 kg
Water
10 kg Carbon
0.1 kg
Hydrochloric acid
0.3 kg
GL Reactor
Spent carbon
Filter 0.1 kg
Filtrate
Centrifuge ML
Chill to 00 C Isomer of topotean
& 10-hydroxy
camptothecin
Drier Filtration 0.2 kg
Process wastewater
Topotecan HCl 10.6 kg
0.5 kg
EIA
- 297 -
1st stage

Reactors
(kg) (kg)
10-hydroxy 1 Output from 1st stage 1
camptothecin By product: formic 0.63
Dimethyl amine 0.5 acid
GL
Formaldehyde 0.67 Solvent acetic acid
Reactor
Acetic acid 10 recovered & 8
160 L 2
Water 10 recycled
no.s
loss 2
Qty./batch
Qty./batch Output
(kg)
Input (kg) Reactor
Output from 1
10-hydroxy 1st stage
camptothecin 1
Dimethyl amine 0.5 By product 0.63

Formic acid
Formaldehyde 0.67
10 Solvent acetic
Acetic acid
acid
10 recovered 8
Water
loss 2
Wastewater 10.54
EIA
- 298 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 1 Topotecan HCl 0.5
stage By product: isomer 0.2
Water 10 GL of topotean & 10-
Hydrochloric acid 0.3 Reactor hydroxy
Carbon 0.1 160 L 2 camptothecin
no.s Spent carbon 0.1
Qty./batch
Output (kg)
Qty./batch
Input (kg) Reactor Topotecan HCl 0.5
Output from 1st
stage 1
By product: isomer
of topotean & 10- 0.2
Water 10 hydroxy
camptothecin
Hydrochloric 0.3
acid
Spent carbon 0.1
Carbon 0.1
Wastewater 10.6
EIA
- 299 -
PROCEDURE
1st stage
10-hydroxy camptothecin is treated with dimethyl amine and formaldehyde at 10

to 15°C in water medium and maintained for 2-4 hrs at 20-25°C. The reaction
mass is then filtered through robo filter. The wet cake is treated with acetic acid
at 70-80°C to dissolve and cooled to 5-10°C for 2 hrs and filtered, dried to get the
output from 1st stage.
2nd stage
The output from 1st stage is dissolved in water and hydrochloric acid at 60-70°C, to
which carbon is added & filtered. The filtrate is cooled to 5-10°C for 12 hrs and
filtered, dried to get topotecan hydrochloride.
CYCLE TIME

1st stage 2nd stage
Reaction 14 - 16 15 - 18
Solvent recovery 1-2 -
APPLICATIONS
Topotecan hydrochloride is approved by the Food and Drug Administration (FDA) to

treat ovarian cancer and small cell lung cancer in patients whose cancer has not
gotten better with earlier chemotherapy. It is also approved to be used together
with another medicine, called cisplatin, to treat cervical cancer in some women
whose cancer has not gotten better or has recurred (come back).
Topotecan hydrochloride is also being studied in the treatment of other types of

cancer.
EIA
- 300 -
2.6.4.30 Zoledronic acid
REACTION SCHEME
EIA
- 301 -
1st stage

No. (kg)
1 Imidazole 10
2 Toluene 50
4 Methyl chloroacetate 22
5 Isopropyl alcohol hydrochloride 30
6 Water 25
2nd stage

No. (kg)
1 Phosphoric acid 14
2 Chlorobezene 40
3 Phosphorous trichloride 20
4 Water 20
5 Carbon 1
EIA
- 302 -
PROCESS FLOW CHART
1st stage
Methyl chloroacetate
22 kg
Potassium carbonate Isopropyl alcohol hydrochloride

15 kg 30 kg
Toluene Water
50 kg 25 kg
Imidazole
10 kg GL Reactor
Potassium acetate
Layer separation
21 kg
Organic layer
Chill to 00 C Process wastewater
51 kg
Toluene
ML recovered 48 kg
loss 2 kg
Process residue Isopropyl alcohol
Drying 0.1 kg recovered 21.9 kg

8 kg
EIA
- 303 -
2nd stage

8 kg
Phosphoric acid
Chlorobezene
14 kg
40 kg
Water
20 kg
GL Reactor
Carbon
Water layer
1 kg
Spent carbon
Filter 1 kg
Phosphorous
Filtrate (cooling)
trichloride 20 kg
Solvent chlorobenzene
Centrifuge Distillation recovered 38 kg
loss 2 kg
Process wastewater
Drier 57 kg
Zoledronic acid
5 kg
EIA
- 304 -
1st stage

Reactors
(kg) (kg)
Imidazole 10 Output from 1st stage 8
Toluene 50 By product: potassium 21
Potassium carbonate 15 acetate
Methyl chloroacetate 22 Solvent:
Isopropyl alcohol 1) toluene
30
hydrochloride GL recovered & 48
recycled
Reactor
loss 2
160 L
Water 25 2) isopropyl alcohol 21.9
recovered
Process residue 0.1
Qty./batch
Output (kg)
Qty./batch
Input Reactor
(kg) Output from 8
1st stage
Imidazole 10
50 By product: 21
Toluene
potassium acetate
Potassium carbonate 15
Solvent:
1) Toluene
Methyl 22 recovered 48
chloroacetate loss 2
Isopropyl alcohol 30 2) isopropyl 21.9
hydrochloride
alcohol recovered
Water 25
Process residue 0.1
Process 51
wastewater
EIA
- 305 -
2nd stage

Reactors
(kg) (kg)
Output from 1st 8 Zoledronic acid 5
stage Solvent
Phosphoric acid 14 chlorobenzene
Chlorobezene 40 GL recovered from 38
Phosphorous Reactor reaction
20 160 L 2 loss 2
trichloride
no.s
Water 20 Spent carbon 1
Carbon 1 Process wastewater 57
Qty./batch
Input Reactor
(kg)
Zoledronic acid 5
Output from 1st
stage 8
Solvent
Phosphoric acid 14 chlorobenzene
recovered 38
Chlorobezene 40 from reaction
loss 2
Phosphorous 20
trichloride
Spent carbon 1
Water 20
Carbon 1 Wastewater 57
EIA
- 306 -
PROCEDURE
1st stage
Toluene, imidazole & potassium carbonate are charged into the reactor and
cooled to 10 to 15°C. Methyl chloroacetate is then added to the reaction
mixture at 10 to 15°C & maintained for 3 hrs. The reaction completion is
monitored by TLC. Water and isopropyl chloride are then added to the
reaction mixture at a temperature of 10 to 15°C and filtered to get 1st stage
output.
2nd stage
Chlorobenzene, output from 1st stage, phosphorus trichloride &
orthophosphoric acid are heated to 80 to 90°C for 8 hrs. The reaction
completion is monitored by TLC. Water is then added and water layer is
separated. Carbon is added to the water layer and filtered in hot condition.
The reaction mixture is then cooled to 0-5°C and filtered to get zoledronic
acid.
CYCLE TIME
st
1 stage 2nd stage
Isolation & centrifugation 8 - 12 10 - 12
Solvent recovery 1-2 3-4
APPLICATIONS
Zoledronic acid is approved by the Food and Drug Administration (FDA) to

treat the following conditions:
Hypercalcemia (high blood levels of calcium) caused by malignant
tumours.
Paget disease of the bone.
Osteoporosis in postmenopausal women.
Zoledronic acid is also approved to be used together with other drugs
to treat multiple myeloma and cancers that have spread to the bone.
Zoledronic acid is being studied in the treatment of other types of cancer.
EIA
- 307 -
2.6.5 Green chemistry
Green chemistry development is a continual program to minimize the wastes

& manufacture the products with very minimal or no impurities, thereby
avoiding the subsequent purifications. This is encouraged & practiced at
M/s. Shilpa Medicare Ltd.
Continuous flow reactors with a net investment of about Rs. 3 crores is
provided to explore the possibility of minimizing waste generated during the
reaction by way of losses, by-products, purifications etc. Photograph of the
same is shown below
Fig 2.6: Green chemistry continuous flow reactors
2.7 PROJECT DESCRIPTION INCLUDING DRAWINGS SHOWING PROJECT

LAYOUT, COMPONENTS OF THE PROJECT ETC.
SCHEMATIC REPRESENTATIONS OF THE FEASIBILITY DRAWINGS WHICH GIVE
INFORMATION IMPORTANT TO EIA PURPOSE
2.7.1 Project drawing

Site plan drawing of the industry is enclosed as Annexure A11.
2.7.2 Schematic representations of the feasibility drawings which give

information important to EIA purpose
A schematic representation of the overall feasibility and environmental
assessment process is shown in Figure 2.7.
EIA
- 308 -
Fig 2.7: Schematic representation of the overall feasibility and

environmental assessment process
Existing APIs & intermediates manufacturing

industry with R&D
Site survey to study the existing conditions
Consideration by EAC committee, MoEFCC
Preparation of preliminary project report and submission to MoEFCC
Presentation before EAC
Issue of ToR by EAC
Baseline study with assessment of ecological damage

with respect to environmental attributes
Preparation of EMP comprising remediation plan and natural and

community resource augmentation plan corresponding to the ecological
damage if observed and economic benefits derived due to violation
Preparation of EIA as per TOR and guidelines in EIA notifications
Public consultation
Addressing all environmental concerns raised during public consultation in EIA report
. Submission of EIA report to MoEFCC
Presentation before EAC committee
Grant of Environment Clearance
2.8 MITIGATION MEASURES TO MEET ENVIRONMENTAL STANDARDS,

ENVIRONMENTAL OPERATING CONDITIONS OR OTHER EIA REQUIREMENTS
2.8.1 SOURCE OF WATER SUPPLY
Krishna River supplied by KIADB.
EIA
- 309 -
2.8.2 WATER DEMAND AND WASTEWATER DISCHARGE
Total number of employees: 150 people

Per capita water demand: 45 LPCD
The break-up of the consumption of water and discharge of wastewater is

presented below.
Table 2.7: Water consumption and wastewater discharge
Water consumed for Consumption Discharge
(LPD) (LPD)
PROCESS
1) Process 8,245 11,255
2) Washing/Cleaning 8,000 8,000
3) QC, R&D 700 700
Total - process 16,945 19,955
UTILITY
4) Boiler feed for 4 TPH boilers 2 no.s 12,500 2,000
(blow-down)
5) Cooling tower 2 no.s 10,000 1,000
(make-up water) (bleed off)
6) Scrubber 4 no.s 1,500 1,500
7) DM/Softener 2,000 1,500
(rejects)
Total - utility 26,000 6,000
OTHERS
8) Domestic (toilet, canteen etc.) 7,000 6,000
9) Landscaping/Green-belt 4,000 -
10) Fire services 2,000 -
Total - others 13,000 6,000
Total 55,945 31,955
Or say Or say
56 KLD 32 KLD
Note:
LPD = Litre/day
Total boiler feed as per the capacity is 1,92,000 LPD (only the initial
consumption) but the condensate recovered is 1,79,500 LPD, therefore
the net consumption of water in boiler is 12,500 LPD.
The water demand and wastewater generation tabulated above is for
peak/maximum allowable production. However the actual consumption
is usually less as detailed in Chapter 9, Section 9.1 of this EIA report.
The treatment methods and the final disposal of each type of wastewater
generated is appended in the table 2.8 below
EIA
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Table 2.8: Wastewater treatment and disposal

Effluent
Treatment Final disposal point
(wastewater)
units provided
generated from
Septic tank
(a) Domestic Septic tank and soak pit.
and soak pit
After pre-treatment, the effluent, i.e.,
neutralized effluent is sent to Shilpa Medicare Unit
II for final treatment and disposal.
The effluent
Two 20 KL wastewater storage tanks provided at
generated
Unit I.
from the
At Unit II, solvent stripper, Multi Effect Evaporator
(b) Industrial industry is
(MEE) and agitated thin film drier are provided.
treated in
The capacity of the system is good enough to
neutralization
handle effluent from Unit I & II. The condensate
tank.
from the MEE is again treated in Biological ETP and
RO. RO permeate is reused for cooling tower and
boilers. RO reject is taken back to MEE.
Note: The treatment units provided is in accordance with the Consent to
Operate (CTO) no. PCB/HPI/053/2015-16/1245 dated 8th October 2015.
Fig 2.8: Wastewater storage tanks at Unit I (20 KL capacity for each)
EIA
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Fig 2.9: Effluent Treatment Plant at Unit II
EIA
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Fig 2.10: Water balance chart
KIADB WATER SUPPLY
WATER CONSUMPTION
55945 LPD
PROCESS UTILITY OTHERS

16945 LPD 26000 LPD 13000 LPD
Fire services Gardening Domestic

DM/ Softener 2000 LPD 4000 LPD 7000 LPD
20745 LPD
(make-up
2000 LPD)
Washing/ Cooling towers Scrubber

QC, R&D Process Boiler make-up water 1500 LPD
Cleaning
700 LPD 8245 LPD 12500 LPD
8000 LPD 10000 LPD
Process DM/
Washing QC, R&D Boiler blow Scrubber Domestic
effluent Softener Cooling Tower
effluent Wastes down effluent wastewater
11255 rejects bleed off
8000 LPD 700 LPD 1500 LPD 2000 LPD 1500 LPD 6,000 LPD
LPD 1000 LPD
Septic
tank &
25,955 LPD sent to Effluent Treatment Plant of Unit II soak pit
EIA Re-used in cooling towers & boilers of Unit II

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2.8.2.1 Flow chart of ETP at Unit II
1. For High TDS stream
HTDS Effluent Collection Bar Screen

Tank (58.75 KLD+ 26 KLD
from Unit-1 =
Oil Trap
Total 84.75 KLD)
Equalization /Collection Tank

Coagulant dosing
Flash mixer
Flocculating dosing
HRSCC
Tube settler Sludge Filter press/ Sludge drying bed

**** 8400 LPD Boiler
condensate water is mixed
with MEE Condensate water Collection/Ph correction tank
Distillate High boiling reactor

Stripper column solvent
300 LPD MEE Stripper
Condensate water solvent 350 LPD Bottom Distilled Mixed solvent
Bottom concentrate
water 1600 LPD (@2%)
MEE Salt 1000 950 LPD Condensate water
KG/day ATFD MEE plant
Cooling Towers makeup Solvent
700 LPD
Salt send to TSDF Condensate water 91,450 LPD Filtrated water tank
(81,800+950+300+8400**)
PSF tank
Biological Treatment
Anaerobic digester Clarified water tank

Filter press/ Sludge drying bed
Sludge Aeration tank-1 HRSCC Sludge
Clarifier-1 Flash mixer
Aeration tank-II Clarified water tank
Extended Aeration tank-III Clarifier-2
EIA
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1. For Low TDS stream
LTDS Effluent Bar Screen

collection Tank
1, 05,500 LPD
Oil Trap
Equalization / Collection Tank

Coagulant dosing
Flash mixer
Flocculating dosing
HRSCC
Tube settler Sludge
Collection/Ph correction tank

Filter press/ Sludge drying bed
Anaerobic digester
Salt send to TSDF
Sludge
Domestic Effluent Aeration tank -1
25 ,000 LPD ATFD
Clarifier -1 Feed to Boiler
MEE plant
Aeration tank -II RO Permeate

Stripper
Extended Aeration tank -III RO plant RO rejects
Filtered water tank

Clarifier -2
Hypo Dosing
Clarified water tank Clarified water tank
Alum Dosing
Flash mixer HRSCC
Poly Dosing
EIA
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2.8.3 PRODUCT-WISE PROCESS WATER CONSUMPTION AND EFFLUENT DISCHARGE
The quantity of water required and wastewater discharged during the process of manufacture of each of the products
is tabulated below.
Table 2.9 A: Product-wise water consumption and effluent discharge
No. of WASTEWATER
WATER CONSUMPTION
Sl. batches DISCHARGE
Product Stage
No. per
kg/batch kg/month kg/batch kg/month
month
1 Acebrophylline I 700 8400 12 735 8820
I 2000 20000 2190 21900
2 Ambroxol HCl 10
II 25 250 125 1250
I 2000 14000 2571 17997
3 Buflomedil HCl 7
III 500 3500 555.3 3887.1
4 Nifedipine I 0 0 2 458.49 916.98
I 5025 30150 3381 20286
5 Phenyl ephrine HCl II 5200 31200 6 6698 40188
III 1682 10092 3076 18456
I 1250 5000 1325 5300
6 Sildenafil citrate 4
II 1250 5000 1857.5 7430
7 Ticlopidine HCl III 250 2000 8 510 4080
II 0 0 415 14940
III 600 21600 1628.4 58622.4
8 Ursodeoxycholic acid IV 250 9000 36 0 0
V 300 10800 395 14220
VI 300 10800 169.25 6093
I 10 20 12 24
9 Anastrozole II 4 8 2 12 24
III 10 20 12 24
EIA
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10 Bendamustine HCl I 40 160 4 63.7 254.8

I 0 0 1.625 19.5
11 Bortezomib II 0 0 12 1.542 18.504
III 0.109 1.308 0.112 1.344
I 300 3000 496 4960
12 Capecitabine II 300 3000 10 375 3750
III 300 3000 370 3700
I 50 250 57.5 287.5
13 Carboplatin 5
II 1000 5000 1000 5000
I 50 250 57.5 287.5
14 Cisplatin 5
II 50 250 50 250
I 0 0 440 2200
15 Docetaxel trihydrate 5
III 240 1200 242 1210
I 10 800 15.1 1208
16 Epirubicin HCl II 10 800 80 0.2 16
III 10 800 11.1 888
I 0 0 420 4200
17 Gemcitabine HCl II 0 0 10 177.5 1775
III 30 300 107.5 1075
I 20 100 20 100
18 Irinotecan HCl trihydrate II 8 40 5 8 40
III 18 90 7.8 39
19 Lenalidomide II 25 25 1 26.9 26.9
20 Letrozole II 10 50 5 12 60
I 5 25 5.01 25.05
21 Oxaliplatin 5
II 75 375 75 375
22 Paclitaxel III 12 120 10 12.1 121
I 38.5 385 41.49 414.9
23 Pemetrexed 10
II 25 250 27.47 274.7
EIA
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III 25 250 27 270

I 600 2400 646 2584
24 Temozolomide 4
II 150 600 147 588
25 Thalidomide I 100 500 5 100 500
I 10 100 10.54 105.4
26 Topotecan HCl 10
II 10 100 10.6 106
I 25 25 51 51
27 Zoledronic acid 1
II 20 20 57 57
TOTAL 24922.609 206106.308 31297 281297.6
Note:
Considering no. of working days/month = 25
1. Daily process water consumption = 2,06,106.308/25 = 8,244.25 LPD Or say 8,245 LPD
2. Daily process effluent discharge = 2,81,297.6/25 = 11,251.904 Or say 11,255 LPD.
EIA
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2.8.4 EFFLUENT CHARACTERISTICS
The combined characteristics of the effluent generated during the process of

manufacture of APIs & Intermediates are tabulated below.
Table 2.9 B: Combined effluent characteristics

Wastewater characteristics Before treatment Condensate
after
Biological
& RO
treatment
at Unit II
Biochemical Oxygen Demand (BOD), ppm 10-40 <30
Chemical Oxygen Demand (COD), ppm 12000 - 20000 <250
Total Dissolved Solids (TDS), ppm 8000 - 12000 <500
Suspended solids, ppm 500 - 1000 <100
pH 5 12.5 5.5 to 9
Latest analysis reports of raw effluent are appended as Annexure A3.
2.8.5A SOLVENT RECOVERY AND RECYCLING
Various solvents are used during the process of manufacture of APIs &
Intermediates. Details of solvents recovered and recycled are in the 2.10 table.
Table 2.10: Solvent recovery

Sl. Name of the Solvent consumption kg/month
Stage Solvent used
No. product Used Recovered Loss Spent
I Methanol 10920 10740 180 0
1 Acebrophylline DMF 12780 12600 180 0
II
Ethyl acetate 64200 63720 480 0
I Methanol 30000 29900 100 0
2 Ambroxol HCl
II Acetone 27800 27700 100 0
Methylene di-
I chloride 3500 3430 70 0
(MDC)
Ethyl acetate 2100 2030 70 0
3 Buflomedil HCl Iso propyl
II
alcohol (IPA) 1799 1617 0 0
HCl
Iso propyl
III 4200 5075 105 0
alcohol
EIA
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Iso propyl
1260 0 0 0
alcohol HCl
Toluene 2100 2065 35 0
Isopropyl
II 3000 2970 30 0
4 Nifedipine alcohol
III Methanol 5400 5360 40 0
Toluene 17082 16920 60 102
n-Hexane 4020 3870 90 0
Iso propyl
I
alcohol HCl
(recovered 3306 2550 0 660
IPA; spent
IPA+hexane)
Methanol
(spent
II methanol + 10920 10500 54 900
toluene comes
from process)
Phenyl ephrine Isopropyl
5 4032 1980 36 2016
HCl alcohol
Acetic
anhydride
(recovered
III
acetic
9270 8700 0 0
anhydride +
ammonia
liquid +
tartaric acid)
Methanol 4020 3000 0 5946
Acetone 5040 1080 0 0
IV Iso propyl
alcohol (IPA) 1200 0 0 0
HCl
Methylene di-
Sildenafil I 2000 1600 400 0
6 chloride
citrate
III Acetone 6000 5920 80 0
I Toluene 5200 5120 80 0
Acetone 19800 19600 200 0
II Methylene di-
5600 5480 120 0
chloride
7 Ticlopidine HCl
Toluene 4800 4760 40 0
Methanol 1240 1216 24 0
III
Iso propyl
1600 1284 0 0
alcohol HCl
EIA
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I Methanol 34286.4 33660 0 626.4

II Ethyl acetate 38570.4 38358 212.4 0
2-methoxy
ethanol
(recovered 2-
137124 154728 432 0
Ursodeoxycholic IV methoxy
8
acid ethanol+hz
hz+water)
Hz Hz 18000 154728 432 0
Methylene di-
V 18432 17820 612 0
chloride
VI Butanol 162856.8 161143.2 1713.6 0
I Cyclohexane 10 9 1 0
Acetonitrile 60 56 4 0
9 Anastrozole Acetone 80 68 12 0
II
III
Cyclohexane 10 9 1 0
10 Bicalutamide I Isopropyl
200 160 40 0
alcohol
Methylene di-
I 3.24 2.64 0 0
chloride
n-Heptane 24.84 18.84 0 0
Methylene di-
chloride +
methanol
11 Bortezomib
II (recovered n-
5.28 11.64 0 0
Heptane +
Methylene di-
chloride +
methanol)
III Methanol 1.308 1.308 0 0
Methylene di-
chloride 5000 4700 300 0
(MDC)
I
Toluene 3000 2900 100 0
Isopropyl
3000 2800 200 0
12 Capecitabine alcohol
Methylene di-
chloride 2500 2000 500 0
II
(MDC)
Heptane 5000 4700 300 0
III Toluene 9000 8700 300 0
EIA
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Methylene di-
chloride 2500 2200 300 0
(MDC)
Methanol 3500 3300 200 0
I
Methylene di
chloride 1200 1000 200 0
Docetaxel
13 (MDC)
trihydrate II
Acetone 1200 1100 100 0
Petroleum
3000 2800 200 0
ether
III Methanol 1200 1000 200 0
Methylene di
chloride 2112 2880 0 0
I (MDC)
Ethanol 631.2 0 0 0
Acetone 316 0 0 0
Methylene di
chloride 2112 1920 192 0
II
(MDC)
14 Epirubicin HCl
n-Hexane 523.2 400 123.2 0
Acetone 758.4 4640 0 0
Methanol 632 0 0 0
Dioxane 560 0 0 0
III n-Hexane 784 0 0 0
Methylene di
chloride 2112 0 0 0
(MDC)
Thionyl
I 30 12 0 0
15 Gefitinib chloride
II Ethyl acetate 270 264 6 0
I Methanol 9750 9250 500 0
Gemcitabine
16 II Methanol 7500 7000 500 0
HCl
III Acetic acid 20000 19750 0 0
Methylene
Imatinib dichloride 1000 950 50 0
17 I
mesylate (MDC)
Methanol 500 470 30 0
Chloroform 700 680 20 0
I
Hexane 100 95 5 0
Irinotecan HCl Ethanol 10 18 2 0
18
trihydrate Dimethyl
II
formamide 10 0 0 0
(DMF)
EIA
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I Methanol 4 3 1 0
Dimethyl
19 Lenalidomide
II sulphoxide 5 4.9 0.1 0
(DMSO)
Aceto nitrile 75 72.5 2.5 0
I
Hexane 15 12.5 1.5 0
20 Letrozole Ethyl acetate 50 47.5 2.5 0
II Dimethyl
15 13.5 1.5 0
formamide
Methanol 156 150 6 0
I
Methylene
dichloride 174.5 540 0 0
(MDC)
II
Acetone 52.7 0 0 0
21 Paclitaxel Petroleum
327 0 0 0
ether
III Methanol 93.6 80 13.6 0
MDC 48.5 45 3.5 0
Acetone 13.8 89 1.8 0
IV
Petroleum
77 0 0 0
ether
Methylene
dichloride 385 308 77 0
(MDC)
I
22 Pemetrexed Dimethyl
formamide 102 95 7 0
(DMF)
III Acetone 307.8 300 7.8 0
23 Temozolomide II Acetone 1600 1540 60 0
Dimethyl
24 Thalidomide I sulphoxide 250 200 50 0
(DMSO)
25 Topotecan HCl I Acetic acid 100 80 20 0
Toluene 50 48 2 0
Isopropyl
26 Zoledronic acid I
alcohol 30 21.9 0 0
hydrochloride
TOTAL 789151 920690 11525 10250
EIA
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2.8.5.1 SOLVENT RECOVERY SYSTEM
After the reaction is complete the solvents are recovered in the

distillation unit.
The distillation unit has two condensers (shell and tube type).
The first condenser has cooling tower water, while the second condenser
will have chilled water at 0 - 20 C as coolants.
After the vapors are condensed, the condensate along with un-
condensed vapors is passed through a trap which is cooled externally
with chilled water.
The vents of condenser and receiver are connected to scrubber system.
All the reaction vessels and centrifuges are connected to a common line.
These fumes and exhausts are sucked by ID fan and scrubbed by alkali.
The air after scrubbing is let out into the atmosphere and the scrubbed
water is sent to ETP for further treatment.
This wet scrubber absorbs acidic vapors, traces of solvents etc. and
purified gas stream is let out into the atmosphere.
Fig 2.11: Solvent recovery system
EIA
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2.8.5.2 SOLVENTS STORAGE
There are three solvent storage tanks one above the ground to store
butanol, toluene, isopropyl alcohol etc. & two below the ground level
acetone, ethyl acetate & methanol etc.
The above ground solvent storage tank farm is of 49.3 x 38.25 m. This area
has six tanks of 30 KL storage capacity each and is provided with protective
dyke wall of 18.46 X 13.26 X 1.3 m (all-around to contain leakages or
spillages if any within the designated area.
Below ground solvent storage tank farms are of 13.65 m X 14.5 m and
14.56 X 11.3 m area.
License has been obtained from PESO (Petroleum and Explosives Safety
Organization).
The spilt solvents are collected and pumped back into the tanks.
Fig 2.12: Solvent storage area
1) Above ground tanks with safety dyke
Cooling
tower of
Raichur
Thermal
Power
Plant
EIA
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2) Underground solvent storage
2.8.5.3 SOLVENTS MANAGEMENT
Solvent management is carried out as follows

Reactors and solvent handling pumps are provided with mechanical seals to
prevent leakage.
Proper earthing is provided to all electrical equipments wherever solvent
handling is done.
Condensers are provided with sufficient Head Transfer Area (HTA) and
residence time to achieve maximum recovery.
Fig 2.13: Condenser system to reactors for solvent management
EIA
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2.8.5.4 MEASURES TO CONTROL EVAPORATION LOSSES AND FUGITIVE

EMISSIONS FOR FEW RAW MATERIALS AND SOLVENTS
All centrifuge vents are connected to the scrubber for controlling of fugitive
emissions. In addition, measures taken to control fugitive emissions for raw
materials & solvents are tabulated below.
Table 2.11: Measures to control evaporation losses and fugitive emissions for
raw materials and solvents
Sl. Mode of Safety systems Measures to avoid loss and
no. storage control of evaporation
1 Above Breather valve followed by Enclosed dispensing system.
ground flame arrester. Pumps with double mechanical
Non-contact level indicator. seal.
2 Drums No dispensing in storage area. No dispensing of solvent is
Secondary containment carried out in storage area.
Spill and leak control kit Required quantities are issued
Organic vapour detectors in sealed drums.
Stored at required
temperature as per MSDS
Fig 2.14: Centrifuge connected to scrubber
EIA
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2.8.5B RAINWATER MANAGEMENT
The rainwater is diverted into infiltration pits, specially prepared for the
purpose of groundwater recharge at various locations within the campus.
Rainwater harvesting potential
The total amount/quantity of water i.e. received in the form of rainfall over an
area is called the rain water endowment of that area, out of which the amount
of water that can be effectively harvested is called the rain water harvesting
potential.
Rain water harvesting potential = rainfall (mm) x collection efficiency
The collection efficiency accounts for the fact that all the rain water falling
over an area cannot be effectively harvested due to losses on account of
evaporation, spillage or runoff etc.
According to the data available from the Indian Meteorological Department,
the average annual rainfall around month of September for the year 2017 = 264
mm
Assuming that about 85% rainfall can be effectively used for recharging
Number of rainy days = 9.3
Therefore the I.R = 264/9.3 = 24.1 mm/day or 0.0241 m/day or 0.024 m/day
The amount of storm water that the landscaped area will produce can be
determined by considering the impermeability factor to be 0.3.
Q = 0.024 x 33,591.25 m2 x 0.3
= 242 m3/day
The amount of storm water that the paved area will produce can be
determined by considering the impermeability factor to be 0.9.
Q = 0.024 x 11,706.26 m2 x 0.9
= 253 m3/day
The total amount of storm water = landscaped area + paved area

= 242 + 253 m3/day
= 495 m3/day
Groundwater recharge pits of 2.5 m deep filled with graded media comprising
of boulder at bottom and with coarse aggregates to facilitate percolation to
recharge ground water table are provided at different locations within the
premises.
Photographs are in fig 2.15.
EIA
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Fig 2.15: Rainwater harvesting tank and groundwater recharge pits

Groundwater Storm water drain Groundwater
recharging pit recharging sump
2.8.6 AIR POLLUTION SOURCES AND THEIR MANAGEMENT
The major air pollution sources from the industry are DG sets and boilers apart
from the process sections. These sources are provided with suitable air
pollution control equipments and stacks of adequate height so as to disperse
the emanating flue gases without affecting the ground level concentrations.
Details are tabulated below.
EIA
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Table 2.12: Air pollution sources, fuel consumption and chimney height details
SI. Stack attached to Fuel Fuel consumption Number Stack/s height Air pollution Predicted
no. used of control unit emissions
stacks
1 Process section - - 4 3 m ARL for each Packed Acid
column mist/
scrubbers VOCs
4 no.s
2 Steam boilers 4 TPH 2 no.s Coal/ 900 kg/hr coal 1 30 m AGL combined Multicyclone SO2, NOx ,
Briquette or stack - 2 no.s SPM
1050 kg/hr briquette
for each boiler
3 D.G. sets - 325 kVA 2 no.s HSD 76 L/hr for each DG set 2 5 m ARL for each Stack SO2, NOx ,
DG set SPM
Note:
HSD High Speed Diesel
The stack heights are provided as stipulated in the Consent to Operate (CTO) no. PCB/HPI/053/2015-16/1245 dated
8th October 2015.
EIA
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Fig 2.16: Photographs of air pollution sources and control equipments
1) Scrubbers process section
2) Scrubber line connected to reactors
EIA
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3) Mechanical dust collectors/ multicyclone for boilers
3) Provisions provided for sampling boiler stack
EIA
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4) Accoustics - DG
2.8.6.1 AMBIENT AIR QUALITY AND STACK EMISSION MONITORING
Adequate port holes with access platform are provided as per KSPCB guidelines
for flue gas analysis. The same is shown in fig 2.16.
Also all stacks are analysed monthly for the parameters stipulated in CTO no.
PCB/HPI/053/2015-16/1245 dated 8th October 2015. Sample analysis reports
are enclosed as Annexure A3.
2.8.6.2 SPECIFICATIONS OF AIR POLLUTION CONTROL UNITS PROVIDED
Scrubber
a) Scrubber details:
Type : Single stage

counter flow packed bed
Dia : 1250 mm
Height : 4000 mm
MOC : PP/FRP
PP : 5 mm
FRP : 7 mm with isopthalic resin
Packing : Polypropylene pal rings
Size : 40 mm dia x 40 mm height
Filter Plate : PP perforated - 15 mm thick
Spray : Polypropylene jet spray system
EIA
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b) Blower:
Type : Backward curve SISW
Casing : PP/FRP with isopthalic resin
Impeller : MS/FRP with bisphenol resin
Capacity : 18000 CMH
Stat. Pressure : 150 mmwg
Motor : 20 HP FLP 1440 RPM
Make : Kirloskar or CG
Drive : Belt
c) Ducting details:
MOC : PP/FRP
Sizes : 250, 350, 450 & 700 mm dia
Ducting includes straight lengths, elbows, T-sections & reducers
d) Liquid circulation tank:

Capacity : 2KL
PP : 5 mm
FRP : 7 mm with isopthalic resin
Cylindrical, vertical, flat bottom & conical top
External MS/FRP reinforcement
Necessary nozzles & manhole
e) Pump:
Make : Antico
Model : 130 CT
Drive Motor : 3 HP 2900 RPM FLP
f) Liquid circulation lines:

MOC : HDPE
Sizes : Variable from 40 mm dia to 75 mm dia
g) MS Support structure for scrubber with anti-corrosive coating
EIA
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Mechanical dust collector / Multicyclone
Output gas flow : 24000 CMH

Type of fuel : Coal/husk
Temp of flue gases : 180°C-220°C
Air quantity to be handled : 24000 CMH
Pressure drop across the system : 70-75 MMWG
Total no of cyclones :
Size of output pipe :
Thickness of cones : 10 mm
Material of construction of cones : IS 210
Thickness of outer casing & hopper : 3.15 mm
2.8.6.3 POWER REQUIREMENT
Source of power supply: Gulbarga Electricity Supply Company - GESCOM (State

Government)
Power requirement: 1800 kVA
2.8.7 NOISE GENERATION AND ITS MANAGEMENT
DG sets are the major noise generating sources for which acoustic enclosures
are present.
Handling and conveying of raw materials and semi-finished components
to different operations can be a source of noise pollution. This is
controlled by regular maintenance.
Also ambient noise levels will be ensured within the ambient standards by
inbuilt design of mechanical equipment viz. dampners, periodic maintenance,
accoustic buildings apart from vegetation (tree plantations) along the periphery
and at various locations within the industry premises.
2.8.8 SOLID WASTE GENERATION AND ITS MANAGEMENT
The details of the quantity of solid waste generated from the industry and
disposal options are shown in the following table.
EIA
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Table 2.13: Solid waste generation & management

Domestic solid waste
Total no. of employees 150
Assuming per capita solid waste generation rate as 0.25 kg/capita/day
Quantity of solid waste generated 37.5 kg/day
Organic solid waste : 60 % of the 22.5 kg/day
total waste
Inorganic solid waste : 40 % of the 15 kg/day
total waste
Disposal of domestic solid waste Segregated at source, collected in
bins and disposed to waste
collection system of the
Municipality.
Boiler ash
Quantity of boiler ash generated 500 kg/day
Storage Stored in covered shed.
Disposal Handed over to local brick
manufacturers.
2.8.9 HAZARDOUS WASTE GENERATION AND ITS MANAGEMENT
The quantities of hazardous waste generated from various processes are shown
in the table 2.14.
Table 2.14: Summary of the total quantity of hazardous wastes

Sl. Source Unit Quantity Category according
No. to Schedule I of
hazardous waste
Rules 2016
1 Used oil from DG sets KL/annum 0.2 5.1
2 Spent solvents KL/annum 39.6 28.6
3 Distillation residue MT/annum 2 28.1
4 Process residue MT/annum 2 28.1
5 Empty No.s/annum 200 33.1
barrels/containers/li
ners contaminated
with hazardous
chemicals/wastes
6 Spent carbon MT/annum 1 28.3
Note:
EIA
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The maximum quantity of hazardous waste is as per authorization by

KSPCB no. PCB/WMC/SEO/69748/2014-15 dated 23rd June 2014. The
authorization is valid from 1.7.2014 to 30.6.2019.
The quantities tabulated above are for maximum consented production
capacity as per CTO. However, the actual quantity generated is less.
This is detailed in Chapter 9, Section 9.4 of this EIA report.
The spent catalysts viz. piperidine and raney nickel are sent to E Nano
Incitech, Ramanagara and manufacturer for recharging and return
respectively.
2.8.9.1 STORAGE AND DISPOSAL OF HAZARDOUS WASTE
The hazardous wastes are stored in designated impervious structure (sealed

drums under cover roof). The details are shown below. MOU/Agreement copy
with hazardous waste disposal facilities is appended as Annexure A10.
Photographs of storage area are in fig 2.17.
Table 2.15: Storage and disposal of hazardous wastes

Sl. Storage Name of disposal
Source Mode of disposal
No. container facility
Sent to KSPCB authorized
Leak proof
1 Used oil from DG sets spent oil re-processors for KM Oils Pvt. Ltd.
containers
regeneration & re-use.
Handed over to KSPCB Panchamukhi
Leak proof
2 Spent solvents authorized recyclers/re- Pharma Chem,
containers
processors. Ramanagara
HDPE
E Nano Incitech,
3 Distillation residue carboys / Sent for incineration.
Ramanagara
LDPE bags
HDPE
E Nano Incitech,
4 Process residue carboys / Sent for incineration.
Ramanagara
LDPE bags
Hajira
Handed over to KSPCB
5 Discarded containers -- Enterprises,
authorized recyclers.
Ramanagara
E Nano Incitech,
6 Spent carbon Polybags Sent for incineration.
Ramanagara
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Fig 2.17: Hazardous waste storage area
2.8.10 BY- PRODUCTS GENERATION AND MANAGEMENT
The details of different by-products generated during the process of

manufacture of APIs & intermediates are tabulated below. All the by-products
are stored in a designated area.
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Table 2.16: Quantity of by-products generated

Sl. Mode of
Product Stage By-product kg/month Disposal by
No. storage
1 Acebrophylline II Ambroxol base 936 HDPE drums Recycled (in-house)
II Pyrrolidine 700 HDPE drums Recycled (in-house)
2 Buflomedil HCl
III 1,3,5 -trimethoxy benzene 350 HDPE drums Recycled (in-house)
Cement industry for co-
II Methyl aceto acetate 199 HDPE drums
processing in kiln
3 Nifedipine
III Nitro phenyl pyridine 210 HDPE drums
processing in kiln
Phenyl ephrine Cement industry for co-
4 I n-methyl benzyl amine 3240 HDPE drums
HCl processing in kiln
5 Sildenafil citrate III Sildenafil base 70 HDPE drums Recycled (in-house)
I Triethyl amine HCl 4360 HDPE drums Recycled (in-house)
6 Ticlopidine HCl Cement industry for co-
II Benzene sulphonic acid 4520 HDPE drums
processing in kiln
Recovered & sold to the
II Sodium acetate 6480 Storage tank industries who makes
further use
III Cholic acid 2592 HDPE drums Recycled (in-house)
Ursodeoxycholic Dihydroxy cholanic acid 3384 HDPE drums Recycled (in-house)
7
acid IV
Caustic potash lye 21816 HDPE drums Sold as spent
V Hydroxy keto cholonic acid HDPE drums Recycled (in-house)
Dihydroxy cholanic acid 2998.8 HDPE drums Recycled (in-house)
VI
Cautic soda lye 21420 Storage tank Used for neutralization
a,a,a,a,-tetramethyl-5-
(methyl)-1,3- benzenedi- 5 HDPE drums
processing in kiln
8 Anastrozole II acetonitrile
Potassium bromide
2 HDPE bags Sold as by-product
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processing in kiln along
III Sodium chloride 5 HDPE bags
with other materials which
are combustible.
Send to the manufacturer
9 Bicalutamide I Manganese dioxide 100 HDPE bags for reactivation, on
repurchase or sale basis
Trimethyl silane 150 HDPE drums Recycled (in-house)
Sodium bicarbonate +
I Sold to the recyclers for
stannous chloride + silyl 3500 MS drums
recovery of tin (Sn)
chloride
10 Capecitabine
II Pyridine HCl 640 HDPE drums Sold
Recovered & sold to the
III Sodium acetate 780 Storage tank industries who makes
further use
11 Cisplatin I Potassium chloride 207.5 HDPE bags
with other materials which
are combustible.
Docetaxel Sodium chloride 30 HDPE bags
12 I with other materials which
trihydrate
are combustible.
Sodium sulphate 100 HDPE bags Sold a spent
13 Epirubicin HCl I Sodium acetate 80 storage tank Sold a spent
HCl 17.7 HDPE drums Used for neutralization
14 Gefitinib II
Potassium chloride 3.6 HDPE bags Sold a spent
15 Gemcitabine HCl I Ammonia benzoate 3000 HDPE drums processing in kiln.
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Triethylamine HCl salt 250 HDPE drums
Imatinib processing in kiln
16 I
mesylate Cement industry for co-
Hydroxy benzotriazole 130 HDPE drums
processing in kiln
Irinotecan HCl
17 I Pyridine hydrochloride 18 HDPE drums Sold as pyridine spent
trihydrate
I Succinamide 12.5 HDPE drums
processing in kiln
18 Letrozole
Hydrobromic acid 3.5 HDPE drums Sold
II
Potassium bromide 16 HDPE bags Sold
19 Paclitaxel IV L- isomer of paclitaxel 1 HDPE drums Recycled (in-house)
I Sodium tartrate 480 HDPE drums
processing in kiln
20 Temozolomide Azahypoxanthine & 5-
II aminoimidazole-4- 100 HDPE drums Recycled (in-house)
carboxamide
21 Thalidomide I Phthalic acid & imidazole 124.6 HDPE drums
processing in kiln
I Formic acid 6.3 HDPE drums Recycled (in-house)
22 Topotecan HCl Isomer of topotean & 10- Recycled (in-house)
II 2 HDPE drums
hydroxy camptothecin
23 Zoledronic acid I Potassium acetate 21 HDPE drums Sold
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2.8.10.1 OTHER MATERIALS GENERATED DURING MANUFACTURING PROCESS
Apart from products, by-products and used solvents few other materials are also generated during manufacturing
process. They are segregated and stored in a designated area for further disposal/management. Details are tabulated
below.
Table 2.17: Other products generated during manufacturing process
Sl.
Product Stage Other output kg/month Mode of storage Disposal
No.
1 Buflomedil HCl III Caustic lye 700 HDPE drums Used for neutralization
2 Nifedipine III Nitro phenyl pyridine 210 HDPE carboys Recycled (in-house)
Sodium carbonate
I 16062 Storage tank Used for neutralization
Phenyl ephrine solution
3
HCl Phenyl ephrine isomer
IV 126 HDPE carboys Recycled (in-house)
salt
Hydrobromic acid -
4 Anastrozole I 9.2 HDPE carboys Recycled (in-house)
succinamide
Impurity-A (2,3-epoxy-
2-methyl-N-[4-cyano-3- Cement industry for
5 Bicalutamide I 40 HDPE bags
trifluoromethyl)phenyl] co-processing in kiln
propanamide
Disposed to recyclers
I Potassium chloride 207.5 HDPE sacs for making fertilizers
containing potassium
6 Carboplatin Sent for recovery of
Silver iodide 114.2 HDPE carboys
silver
II Recycled to boiler/
Water 5000 Storage tank Chilling plant brine
makeup
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Sent for recovery of

7 Cisplatin II Silver iodide 120 HDPE carboys
silver
Thionyl chloride 12 HDPE drums Recycled (in-house)
8 Gefitinib I
HCl gas scrubbed 15 HDPE drums Used for neutralization
Irinotecan HCl I Pyridine 390 HDPE drums Sold as spent pyridine
9
trihydrate III Water 49 Storage tank Recycled in utilities
Hydrogen gas vented Vented through seal
10 Lenalidomide I 2 Vented out
through seal water tank water tank
Disposed to recyclers
I Potassium chloride 4 HDPE bags for making fertilizers
11 Oxaliplatin containing potassium
Sent for recovery of
II Silver chloride 8.65 HDPE carboys
silver
2.9 ASSESSMENT OF NEW AND UNTESTED TECHNOLOGY FOR THE RISK OF TECHNOLOGICAL FAILURE
The industry is involved in the manufacture of APIs and intermediates. The manufacturing process for these products is
a tried and tested method. Therefore, there is no risk of technological failure. In addition to this, the facility is being
backed up by the R & D centre where there are continuous efforts for optimization of the process to take care of
technological failures if any.
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CHAPTER 3
DESCRIPTION OF THE ENVIRONMENT
3.1 STUDY AREA, PERIOD, COMPONENTS AND METHODOLOGY
STUDY AREA: An area, covering 10 km radial distance with the project site at the
centre is considered for study. Topo map showing study area is enclosed as
Annexure A11.
PERIOD: Three months from March to May 2018.
DESCRIPTION OF THE STUDY AREA:

The industry M/s. Shilpa Medicare Ltd. is located in Deosugar Industrial Area,
Raichur. The study area has a mixed land-use pattern industrial, agricultural,
residential and rural developments.
METHODOLOGY:
Studies were conducted to know the status of various environmental attributes, viz.
climatic and atmospheric conditions, air, water, noise, soil, land use pattern,
ecological, socio-economic environment. It involved conducting field studies, socio-
economic survey among the people. Secondary data was collected from
State/Central Government, semi-Government and public-sector organizations and
verified for correctioness.
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Fig 3.1: Topo map
Project Site
TOPO MAP NO. 56 H/7
Source: Survey of India; Scale: 1:50000
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3.2 STATUS OF ENVIRONMENTAL ATTRIBUTES
3.2.1 Meteorological data
Assessment of the micro and macro meteorology is important from the standpoint
of understanding the nature and extent of air pollution in the study area. Climate
has an important role in the build-up of pollution levels. The climatic condition of
the area may be classified as moderately or seasonally dry, tropical or temperate
savannah climate with four seasons in a year. Winter is critical for air pollution
build-up because of frequent calm conditions with temperature inversions
resulting in poor atmospheric mixing, natural ventilation and high emission loads.
The classification of months according to the seasons is given in the following table.
Season Period
Summer/Pre-monsoon March to May
Monsoon June to September
Post monsoon October to December
Winter January to February
The metrological data reflecting minimum, maximum temperature in 0C, relative

humidity in %, rainfall in mm, atmospheric pressure in mb, wind speed in m/s,
cloud cover in % for the year 2017 is shown in table 3.1.
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Table 3.1: Meteorological data of Raichur for the year 2017

Month Temperature Precipitation Relative humidity (%) Atmospheric pressure (mb) Wind Cloud
(0C) rate (mm) At 0830 At 1730 At 0830 hrs At 1730 hrs speed cover
hrs hrs (m/s) (%)
Min Max Mean Mean Mean Avg Max Avg
Jan 17.4 30.8 0 76 34 971.8 967.6 2.9 4.1 7
Feb 19.3 33.7 0 56 20 970.2 966.9 2.9 4.2 1
Mar 22.7 36.9 0 47 20 966.3 962.5 3 4.6 6
Apr 25.9 40.9 7.2 42 19 964.7 960.7 3.3 5.2 3
May 27.6 40.3 0 54 22 963.8 959 3.6 5.1 6
June 24.8 34.8 157.4 78 47 961.8 958 4.7 6.5 49
July 24.1 34.3 31 75 48 962.4 959.2 7.3 8.6 52
Aug 23.5 32.2 143 84 62 962.5 958.5 5.9 7.2 51
Sept 23.3 30.9 248.3 87 70 964.2 960.4 3.8 5.3 45
Oct 22.2 30.6 193.2 88 66 965.6 961.7 2.9 4.1 26
Nov 19.4 30.8 0 74 45 968.4 964.2 3.3 4.2 16
Dec 16.2 29.6 0 76 39 970.2 966.6 3.2 4.4 9
Source: India Meteorological Department (IMD) and
https://www.worldweatheronline.com/raichur-weather- averages/karnataka/in.aspx
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3.2.1.1 TEMPERATURE
The mean maximum temperature is observed at 40.9°C in the month of April
and the mean minimum temperature at 16.2°C is observed in the month of
December. In the summer season the mean minimum temperature is observed
during the month of March (22.7°C). During the monsoon the mean maximum
temperature is observed to be 34.8°C in the month of June with the mean
minimum temperature at 23.3°C during September. By the end of September
with the onset of post monsoon season (October - December), day
temperatures drop slightly with the mean maximum temperature at 30.8°C in
November and mean minimum temperature at 16.2°C in December. The values
are presented in table 3.1.
3.2.1.2 RELATIVE HUMIDITY

The minimum relative humidity observed at 0830 hrs is 42% in April & maximum
is 88% in October. At 1730 hrs minimum is 19% in April & maximum is 70% in
October. The values are presented in table 3.1.
3.2.1.3 RAINFALL
The maximum annual rate of precipitation over this region ranges between 0 to
248.3 mm.
3.2.1.4 ATMOSPHERIC PRESSURE

The minimum atmospheric pressure observed at 0830 hrs is 961.8 mb in June &
maximum is 971.8 mb in January. At 1730 hrs minimum is 958 mb in June &
maximum is 967.6 mb in January. The values are presented in table 3.1.
3.2.1.5 WIND
The data on wind patterns are pictorially represented by means of wind rose
diagrams for the entire year and for different seasons in fig 3.2. Predominant
wind directions in different seasons are shown in table 3.2.
Table 3.2: Predominant wind directions in different seasons

Season Period Wind direction
(towards)
Summer March to May South East
Monsoon June to September North East
Post monsoon October to November South West
Winter December to February South West
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Fig 3.2: Wind rose diagrams

1. Annual
WIND ROSE PLOT: DISPLAY:
Annual Wind Speed

Direction (blowing from)
NORTH
15%
12%
9%
6%
3%
WEST EAST
WIND SPEED
(m/s)
>= 11.1
8.8 - 11.1
5.7 - 8.8
SOUTH
3.6 - 5.7
2.1 - 3.6
0.5 - 2.1
Calms: 11.51%
COMMENTS: DATA PERIOD: COMPANY NAME:
2009 Shilpa Medicare Ltd. Unit I

Jan 1 - Dec 31
00:00 - 23:00 MODELER:
Samrakshan
CALM WINDS: TOTAL COUNT:
11.51% 8760 hrs.
AVG. WIND SPEED: DATE: PROJECT NO.:
2.79 m/s 4/11/2018
WRPLOT View - Lakes Environmental Software
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2. Summer/Pre-monsoon - March to May
March to May Wind Speed

NORTH
20%
16%
12%
8%
4%
WEST EAST
WIND SPEED
(m/s)
>= 11.1
8.8 - 11.1
5.7 - 8.8
SOUTH
3.6 - 5.7
2.1 - 3.6
0.5 - 2.1
Calms: 14.09%

Mar 1 - May 31
00:00 - 23:00 MODELER:
Samrakshan
14.09% 2208 hrs.
2.46 m/s 4/11/2018
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3. Monsoon - June to September
June to September Wind Speed

NORTH
30%
24%
18%
12%
6%
WEST EAST
WIND SPEED
(m/s)
>= 11.1
8.8 - 11.1
5.7 - 8.8
SOUTH
3.6 - 5.7
2.1 - 3.6
0.5 - 2.1
Calms: 2.22%

Jun 1 - Sep 30
00:00 - 23:00 MODELER:
Samrakshan
2.22% 2928 hrs.
3.75 m/s 4/11/2018
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4. Post monsoon - October to December
October to December Wind Speed

NORTH
25%
20%
15%
10%
5%
WEST EAST
WIND SPEED
(m/s)
>= 11.1
8.8 - 11.1
5.7 - 8.8
SOUTH
3.6 - 5.7
2.1 - 3.6
0.5 - 2.1
Calms: 10.10%

Oct 1 - Dec 31
00:00 - 23:00 MODELER:
Samrakshan
10.10% 2208 hrs.
2.58 m/s 4/11/2018
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5. Winter - January to February
January to February Wind Speed

NORTH
20%
16%
12%
8%
4%
WEST EAST
WIND SPEED
(m/s)
>= 11.1
8.8 - 11.1
5.7 - 8.8
SOUTH
3.6 - 5.7
2.1 - 3.6
0.5 - 2.1
Calms: 28.88%

Jan 1 - Feb 28
00:00 - 23:00 MODELER:
Samrakshan
28.88% 1416 hrs.
1.67 m/s 4/11/2018
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3.2.1.6 CLOUD COVER

The minimum cover measured in percentage is 1 in the month of February and
the maximum observed is 52 in the month of July.
3.2.2 Geology of the study area

The predominant geological formation in Raichur District is peninsular gneissic
complex.
Source: Central Ground Water Board
3.2.3 Hydrogeology of the study area
Raichur district. These formations are grouped under hard rock, as they do not
have any primary porosity. However, secondary porosity is developed due to
faults, fractures, joints, and due to weathering, which has improved
permeability and water yielding capacity of these rocks. Ground water occurs
under water table conditions in the weathered and jointed hard rock, and
under confined to semi confined conditions in the fractured rock. Since the
district is covered predominantly by black cotton soils, which inhibit
percolation and circulation of water, there are pockets of poor quality ground
water in the area. The hydrogeology of the district is shown in the figure 3.3.
The depth to water level in general varies from 0.65-m BGL to 10.70 m BGL in
the area during the pre-monsoon period (May) and from 0.05 m BGL to 11.00 m
BGL during the post monsoon (Nov) period.
Aquifers, the water bearing formations, in the district have been classified into
two types
1) Shallow aquifers: which constitute mostly weathered, semi weathered and

partly fractured hard rocks occurring below the semi weathered zone, up to
the approximate depth of 30 m BGL. Ground water occurs in the open spaces of
weathered and fractured rock formations under phreatic to semi-confining
condition. Ground water development seen in the district is mainly from this
zone, through dug wells, dug-cum-bore wells and shallow bore wells and filter
points. The direction of ground water movement corresponds to the drainage
on the surface. Based on the data collected from various hydro geological
surveys and yield tests carried out, the yields of dug wells varied from 10
m3/day to 250 m3/day. The recuperation was poor in the wells tapping
schistose rocks.
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2) Medium to deep aquifers: The medium to deep aquifers occurring in the

district are mostly located in the semi-weathered to fractured hard rock and
these aquifers are occurring between the depths of 30-100 m BGL and are
tapped through the bore wells. Ground water occurs under semi-confined
condition in the semi-weathered zone, but occurs under confined conditions
wherever fractures occur at depth, (generally below 40 m depth). Many
drinking and irrigation bore wells tap these aquifers. The yield from these bore
wells ranged from less than 1.0 m3/hr to 75.4 m3/hr.
3.2.4 Drainage pattern in the study area
The drainage pattern is highly dendritic in nature (as shown in fig 3.4) and has
been altered due to the irrigation practices in the area.
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Figure 3.3A: Hydrogeology of Raichur District
PROJECT SITE
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Figure 3.3B: Hydrogeology of Mahbubnagar District
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Figure 3.4: Drainage pattern of Raichur District
PROJECT SITE
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3.3 MONITORING OF ENVIRONMENTAL ATTRIBUTES
3.3.1 Sampling locations
Sampling locations were identified by considering the following factors

Existing topography, drainage pattern and location of surface water
bodies like ponds, canals, rivers and sea.
Location of villages/towns/sensitive areas.
Upwind and downwind directions
Fig 3.5 shows google map with all the sampling locations.
Details of sampling locations are tabulated in Table 3.3
Table 3.3: Sampling locations for environmental attributes

Sl. Monitoring Location Monitoring to Distance from Direction from
No. station ID be done for site (km) the site
1 Project site M1 - -
2 Hegsanhalli M2 1.08 South
3 Deosugur M3 3.24 North East
4 Chicksugur M4 Ambient air, 3.93 South East
5 Kadlur M5 noise, soil, 7.4 North West
Krishna groundwater
6 M6 7.2 North West
(Telangana)
Muraharidoddi
7 M7 7.5 North East
(Telangana)
Krishna river
North West &
8 upstream & M8 & M9 6.3 / 4.4
North East
downstream
Surface
Rajasab
water
9 Talav/ M10 9.3 South West
Merched Kere
10 Konad Halla M11 2.28 South
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Fig 3.5: Google map showing sampling locations for environmental attributes
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3.3.2 Air quality
Summary of the average concentrations of pollutants at seven locations within 10 km of the project site are given in
the table 3.4. Ambient air quality standards stipulated by MoEF as per the notification dated 16th November 2009 for
industrial, residential and rural areas is shown table 3.5.
Table 3.4: Ambient air quality data, analysis results

Sl. Parameter Sampling week 24 hrs concentration (µg/m3)
No. Monitoring station
Project Hegsanhalli Deosugur Chicksugur Kadlur Krishna Muraharidoddi
site
1 Particulate Week 1 (1st to 71.8 65.3 63.4 63.6 53.8 64.1 70.8
matter (size 10th March 2018) 75.4 64.7 65.6 62.6 54.8 64 71.8
less than 10 Week 2 (11th to 78.2 69.6 64.7 69.1 62.5 73.9 64.8
µm), (PM10), 17th March 2018) 74.8 65.5 63.1 64.2 56.6 62.2 73.8
µg/m 3 Week 3 (18th to 75.5 70 66.8 62.7 66.2 64.3 64.5
24th March 2018) 73 67.4 62.5 61.5 49.8 64.5 71.2
Week 4 (25th to 75.2 65 63.3 62.6 53.5 60.1 72.5
31st March 2018) 76.7 62.6 62.2 64.4 51.5 64.8 65.2
Week 1 (1st to 72.6 57.1 69.1 70.3 54.1 64.7 63.6
7th April 2018) 72.3 57.1 47.5 67.3 55.5 72.3 60.2
Week 2 (8th to 70 70.5 71.1 76.9 55.9 63.9 58.2
14th April 2018) 55.1 53.6 57.2 57.3 51.8 64 58.2
Week 3 (15th to 75.6 67.8 70.7 74.8 58 63.3 55.6
21st April 2018) 75.1 52.6 60 67.3 54.3 62.7 56
Week 4 (22nd to 74.3 70.9 71.8 69.5 55.1 59.5 53.7
30th April 2018) 72.3 61.2 56.1 70.5 53.3 59.8 53.8
Week 1 (1st to 71 52.5 65 70.4 51.7 57.7 73.6
8th May 2018) 73.3 53.2 45.5 65.3 52.3 58.5 72.8
Week 2 (9th to 72.5 53.6 57.2 65.9 51.8 64.7 65.6
15th May 2018) 72.3 70.5 69.3 69.2 55.9 65.4 65.9
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Week 3 (16th to 71 55.2 53.8 65.3 46.6 62.6 54.8

23r d May 2018) 71 70.6 74.6 68.8 55.2 68 65.6
Week 4 (24th to 72.9 71 69.8 69 51.1 64 63.2
31st May 2018) 73.3 52.6 52.1 68.2 49 67.9 64.4
Particulate Week 1 (1st to 38.8 35.4 33.1 34 21 27.4 30.1
matter (size 10th March 2018) 39.2 33.2 33.1 31.5 22.9 27.5 26.5
less than 2.5 Week 2 (11th to 45.2 28.7 30.6 31.9 32 23.7 27.3
µm), 17th March 2018) 40.1 31 34.2 33 22.6 26.1 23.7
3
(PM2.5),µg/m Week 3 (18th to 41.4 30.9 35.4 33 35.2 26.3 25.1
24th March 2018) 43.5 32.2 32 32.6 22.6 26.4 27.7
Week 4 (25th to 39.3 29.8 27.2 32.3 21.3 24.2 22.4
31st March 2018) 37.8 32.3 34.7 34.8 22.3 26.7 25.2
Week 1 (1st to 27.8 24.2 27.7 27.5 22.5 33.7 32.6
7th April 2018) 25.6 23.9 21.4 23.9 23.1 22.4 24.2
Week 2 (8th to 25.5 31 28.8 29.8 24.5 30.8 25.6
14th April 2018) 24.5 23.7 25 23.8 23.8 30.8 25.6
2 Week 3 (15th to 29.6 30.6 28.7 26.2 24.9 29.6 24
21st April 2018) 25.5 23 24 24 24.8 30.5 24.4
Week 4 (22nd to 26.4 26.4 25.3 28.5 22.9 26.8 24.6
30th April 2018) 26.5 23.5 26.5 26.6 23.1 25.7 24.6
Week 1 (1st to 28.6 21.5 27.4 25.9 19.4 21 38.2
8th May 2018) 26.8 20.7 20.6 20.6 24.7 20.8 25.2
Week 2 (9th to 25.5 23.7 25 25.1 23.8 33.2 33.1
15th May 2018) 23.2 31 28.6 29.8 24.5 28.3 29.1
Week 3 (16th to 27.1 25.4 21.3 27 23.3 31.5 22.9
23r d May 2018) 29.4 28.6 26.5 30.1 23.9 30.8 20.8
Week 4 (24th to 25.6 28.5 27.3 31.1 21.2 26.3 22
31st May 2018) 25.6 21.6 26 25 21.4 25.3 21.2
3 Sulfur Week 1 (1st to 14.8 12.6 12.1 13.2 8.8 14.4 12.9
dioxide (SO2), 10th March 2018) 15.5 12.2 12.8 13.3 8.7 13.5 13.5
µg/m 3
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Week 2 (11th to 15.2 12.3 14.5 14 13.9 13.3 13.7

17th March 2018) 14.4 13.3 13.8 14.1 8 13.3 13.1
Week 3 (18th to 15.1 13 12.8 12.4 8.6 15 14.8
24th March 2018) 14.6 12.4 12.4 12.6 9.1 14.5 14.2
Week 4 (25th to 14.4 13.6 12.6 12.6 8.7 13 13.2
31st March 2018) 15.2 14.4 13.2 12.6 7.2 14.5 14.7
Week 1 (1st to 9.1 9 9.1 9.3 9.5 12.6 12.4
7th April 2018) 8.6 8.4 8.5 9.1 8.7 13.2 12.9
Week 2 (8th to 8.6 9.1 8.7 9.3 9 12 12.4
14th April 2018) 8.5 8.3 9.1 8.5 9.2 12.1 12.4
Week 3 (15th to 8.6 10 9.1 10.3 9.6 13.1 11.4
21st April 2018) 8.7 8.9 9 8.5 10.1 13.3 11.2
Week 4 (22nd to 8.7 9.3 9.2 9.6 8.6 13 12.6
30th April 2018) 9.3 9.16 9.9 9.5 8.26 13.2 12.7
Week 1 (1st to 10.9 7.4 9 8.5 7.6 8.4 16.9
8th May 2018) 10.8 9.2 10.3 9.2 7.7 12.3 17.4
Week 2 (9th to 8.5 8.3 9.1 8.5 9.2 12.2 12.8
15th May 2018) 8.6 9.1 8.7 9.3 9 12.2 13
Week 3 (16th to 8.6 8.4 9.3 10.2 9.2 13.3 8.7
23r d May 2018) 9.9 10.3 8.6 8.6 8.7 13.1 9.1
Week 4 (24th to 8.5 9.3 9.2 8.1 8.9 15.3 15
31st May 2018) 9.6 9 8.6 8.4 8.2 21.1 19.3
4 Oxides of Week 1 (1st to 16.1 14.9 15 14.6 10.3 14.5 13.2

nitrogen 10th March 2018) 16.9 15.1 14.6 13.6 10.9 15 14.9
3
(NOx ), µg/m Week 2 (11th to 18.4 17.4 15.2 14.7 15.7 14 15
17th March 2018) 16.8 15.1 14.9 14.8 10.4 14.3 14.3
Week 3 (18th to 17.1 15 15.2 14.5 10.2 14.2 13.7
24th March 2018) 18 13.9 14.6 14.5 10.4 14.5 15
Week 4 (25th to 17.1 14.9 15 14.9 10.3 14.4 13.9
31st March 2018) 17.2 15.3 15.3 16.3 8.1 14.2 13.7
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Week 1 (1st to 11.4 9.7 12 12.3 10.5 13.6 13.1

7th April 2018) 11.1 11.1 10.5 10.5 11.1 13.7 14.4
Week 2 (8th to 10.2 11.1 8.5 11 10.9 12.8 12.7
14th April 2018) 10.7 10.8 10.9 10.9 10.4 12.7 12.7
Week 3 (15th to 10.8 12 10.3 11.7 10.3 13.6 11.9
21st April 2018) 10.6 10.3 10.4 10.2 10.4 13.3 12.1
Week 4 (22nd to 10.9 11.5 11.6 11.8 11.4 13.7 14.1
30th April 2018) 11.1 11.5 11.5 12.5 10.3 13.7 14.3
Week 1 (1st to 13.5 9.3 10.6 11.3 11.4 10 17.8
8th May 2018) 11.4 8.9 9.2 11.2 10.3 14.4 18.2
Week 2 (9th to 10.7 10.8 10.9 10.9 10.4 15.1 14.6
15th May 2018) 10.2 11.1 8.5 11 10.9 15.2 14.6
Week 3 (16th to 8.9 11.4 10.3 11.1 11.1 13.6 10.9
23r d May 2018) 12.5 11.6 10.4 10.3 10.3 13.1 12.6
Week 4 (24th to 9.2 11.8 10.3 10.5 9.7 13.4 14.3
31st May 2018) 11.3 11.3 11.6 11.2 10.5 13 19.9
5 Carbon Week 1 (1st to 0.18 0.15 0.3 0.1 0.19 0.14 0.2
monoxide 10th March 2018) 0.2 0.17 0.18 0.19 0.17 0.16 0.18
(CO), mg/m 3 Week 2 (11th to 0.18 0.18 0.18 0.16 0.19 0.16 0.12
17th March 2018) 0.21 0.17 0.15 0.15 0.19 0.12 0.14
Week 3 (18th to 0.2 0.16 0.22 0.16 0.14 0.14 0.15
24th March 2018) 0.21 0.16 0.17 0.15 0.13 0.15 0.15
Week 4 (25th to 0.16 0.16 0.19 0.14 0.16 0.1 0.12
31st March 2018) 0.14 0.17 0.18 0.2 0.17 0.13 0.15
Week 1 (1st to 0.16 0.18 0.12 0.22 0.2 0.18 0.14
7th April 2018) 0.22 0.18 0.19 0.21 0.19 0.16 0.15
Week 2 (8th to 0.21 0.18 0.22 0.17 0.15 0.16 0.12
14th April 2018) 0.22 0.16 0.18 0.14 0.14 0.15 0.14
Week 3 (15th to 0.23 0.19 0.2 0.18 0.17 0.19 0.16
21st April 2018) 0.2 0.18 0.15 0.16 0.15 0.14 0.15
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Week 4 (22nd to 0.15 0.17 0.21 0.15 0.15 0.18 0.14

30th April 2018) 0.16 0.18 0.19 0.22 0.18 0.16 0.15
Week 1 (1st to 0.16 0.14 0.12 0.19 0.22 0.16 0.6
8th May 2018) 0.16 0.17 0.19 0.15 0.18 0.13 0.19
Week 2 (9th to 0.22 0.16 0.18 0.14 0.14 0.17 0.18
15th May 2018) 0.21 0.18 0.22 0.17 0.15 0.17 0.19
Week 3 (16th to 0.16 0.12 0.18 0.15 0.16 0.19 0.17
23r d May 2018) 0.2 0.16 0.17 0.15 0.19 0.16 0.14
Week 4 (24th to 0.24 0.14 0.2 0.18 0.14 0.14 0.13
31st May 2018) 0.19 0.17 0.15 0.14 0.17 0.12 0.14
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Table 3.4A: Ambient air quality summary

Sl. Location Parameter Min Max Average 98
No. percentile
1 Project site PM10, µg/m3 55.1 78.2 72.7 76.7
PM2.5, µg/m3 23.2 45.2 37.2 43.5
SO2, µg/m3 8.5 15.5 11 15.2
NOx , µg/m3 8.9 18.4 13 18
CO, mg/m3 0.14 0.24 0.19 0.23
2 Hegsanhalli PM10, µg/m3 52.5 71 62.5 70.9
PM2.5, µg/m3 20.7 35.4 27.5 33.2
SO2, µg/m3 7.4 14.4 10.3 13.6
NOx , µg/m3 8.9 17.4 12.3 15.3
CO, mg/m3 0.12 0.19 0.17 0.18
3 Deosugur PM10, µg/m3 45.5 74.6 62.6 71.8
PM2.5, µg/m3 20.6 35.4 27.9 34.7
SO2, µg/m3 8.5 14.5 10.4 13.8
NOx , µg/m3 8.5 15.3 11.9 15.2
CO, mg/m3 0.12 0.3 0.19 0.22
4 Chicksugur PM10, µg/m3 57.3 76.9 66.9 74.8
PM2.5, µg/m3 20.6 34.8 28.6 34
SO2, µg/m3 8.1 14.1 10.4 14
NOx , µg/m3 10.2 16.3 12.3 14.9
CO, mg/m3 0.1 0.22 0.17 0.22
5 Kadlur PM10, µg/m3 46.6 66.2 54.2 62.5
PM2.5, µg/m3 19.4 35.2 23.8 32
SO2, µg/m3 7.2 13.9 8.9 10.1
NOx , µg/m3 8.1 15.7 10.7 11.4
CO, mg/m3 0.13 0.22 0.17 0.2
6 Krishna PM10, µg/m3 57.7 73.9 64 72.3
village PM2.5, µg/m3 20.8 33.7 27.3 33.2
SO2, µg/m3 8.4 21.1 13.4 15.3
NOx , µg/m3 10 15.2 13.8 15.1
CO, mg/m3 0.1 0.19 0.15 0.19
7 Muraharidoddi PM10, µg/m3 53.7 73.8 63.9 73.6
PM2.5, µg/m3 20.8 38.2 26.2 33.1
SO2, µg/m3 8.7 19.3 13.2 17.4
NOx , µg/m3 10.9 19.9 14.2 18.2
CO, mg/m3 0.12 0.6 0.17 0.2
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Table 3.5: Ambient air quality standards MoEF as per the notification dated
16th November 2009 for industrial, residential & rural areas
Air quality parameter Concentration
24 hrs Annual
1 Particulate matter (size less than 10 µm), 100 60
(PM10), µg/m3
2 Particulate matter (size less than 2.5 µm), 60 40
(PM2.5),µg/m3
3 Sulfur-di-oxide (SO2), µg/m3 80 50
4 Nitrogen dioxide (NO x ), µg/m3 80 40
3
5 Carbon monoxide (CO), mg/m 4 1 hr 2 8 hrs
Note:
24 hourly or 08 hourly or 01 hourly monitored values, as applicable, shall be
complied with 98% of the time in a year. 2% of the time, they may exceed the
limits but not on two consecutive days of monitoring.
Whenever and wherever monitoring results on two constitutive days of
monitoring exceed the limits specified above for the respective category, it
shall be considered adequate reason to institute regular or continuous
monitoring and further investigation.
OBSERVATIONS
The monitored values are within the limits specified by MoEF (as per the
notification dated 16th November 2009 for industrial, residential and rural
areas) at all the sampling locations.
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Fig 3.6: Wind rose diagram March to May (sampling period)
March to May Wind Speed

NORTH
20%
16%
12%
8%
4%
WEST EAST
2017
WIND SPEED
(m/s)
>= 11.1
8.8 - 11.1
5.7 - 8.8
SOUTH
3.6 - 5.7
2.1 - 3.6
0.5 - 2.1
Calms: 14.09%

Mar 1 - May 31
00:00 - 23:00 MODELER:
Samrakshan
14.09% 2208 hrs.
2.46 m/s 4/11/2018
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3.3.3 Noise environment
M/s. Shilpa Medicare Ltd. Unit I, is an APIs & Intermediates manufacturing

industry hence requires movement of raw materials, fuels, tools and tackles
required for its manufacturing process and also transportation of finished
products to its destination. The movement of personnel from their residence to
industry would also result in a moderate increase in the traffic, which would
not result in any drastic change in either the existing traffic pattern or noise
levels of the area.
Hourly noise levels are shown in table 3.6 A, B & C and day equivalent of noise
levels and CPCB standards are shown in table 3.7.
Time of the Time (in hrs)

day
Morning 6.00 AM to 12.00 PM
Afternoon 12.00 PM to 5.00 PM
(12.00 to 17.00)
Evening 5.00 PM to 10.00 PM
(17.00 to 22.00)
Night 10.00 PM to 6.00 AM
(22.00 to 6.00)
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Table 3.6 A: Noise level monitoring, data analysis results March 2018
Sl. Location Time of Time (in hrs) Noise Time (in Noise Time (in Noise Time (in hrs) Noise Std.
No. the day level hrs) level hrs) level level
in in in in
dB(A) dB(A) dB(A) dB(A)
Leq Leq Leq Leq
5-3-2018 13-3-2018 19-3-2018 24-3-2018
1 Project site Morning 9.30-9.45 72 8.15-8.30 69 8.30-8.45 74 9.45-10.00 74 75
Afternoon 13.45-14.00 70 13.00-13.15 72 13.15-13.30 72 14.30-14.45 72
Evening 17.30-17.45 73 17.15-17.30 72 17.00-17.15 70 17.45-18.00 70
Night 3.15-3.30 67 2.00-2.15 68 2.15-2.30 67 1.30-1.45 67 70
2 Hegsanhalli Morning 8.45-9.00 59 8.00-8.15 58 8.15-8.30 58 9.30-9.45 60 55
Afternoon 14.00-14.15 54 14.15-14.30 59 14.45-15.00 59 14.00-14.15 58
Evening 17.15-17.30 56 17.30-17.45 54 17.00-17.15 54 17.15-17.30 59
Night 1.30-1.45 58 1.45-2.00 59 1.30-1.45 55 1.45-2.00 55 50
3 Deosugur Morning 9.30-9.45 58 9.30-9.45 61 9.30-9.45 57 9.00-9.15 59 55
Afternoon 14.00-14.15 62 14.30-14.45 58 14.00-14.15 60 14.30-14.45 58
Evening 17.45-18.00 54 17.15-17.30 57 17.00-17.15 56 17.15-17.30 61
Night 1.45-2.00 60 1.15-1.30 59 1.45-2.00 59 1.30-1.45 54 50
4 Chicksugur Morning 9.30-9.45 61 9.30-9.45 57 8.30-8.45 59 8.00-8.15 58 55
Afternoon 14.00-14.15 58 14.00-14.15 61 14.15-14.30 57 14.45-15.00 56
Evening 17.00-17.15 54 17.30-17.45 56 17.00-17.15 58 17.15-17.30 54
Night 2.15-2.30 55 2.00-2.15 54 1.15-1.30 53 1.45-2.00 59 50
5 Kadlur Morning 8.30-8.45 57 9.30-9.45 59 9.30-9.45 63 9.30-9.45 58 55
Afternoon 14.00-14.15 56 14.15-14.30 56 14.00-14.15 53 14.45-15.00 54
Evening 17.45-18.00 54 17.00-17.15 53 16.30-16.45 54 17.15-17.30 57
Night 1.45-2.00 53 1.45-2.00 54 1.45-2.00 51 1.30-1.45 59 50
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03-03-2018 10-03-2018 17-03-2018 24-03-2018

6 Krishana Morning 8.30-8.45 56 8.30-8.45 55 8.30-8.45 58 8.30-8.45 57 55
Village Afternoon 13.15-13.30 54 13.15-13.30 57 13.15-13.30 54 14.15-14.30 54
Evening 17.00-17.15 55 17.00-17.15 55 17.00-17.15 57 17.30-17.45 58
Night 2.15-2.30 52 2.15-2.30 51 2.15-2.30 50 2.45-3.00 51 50
7 Muraharidoddi Morning 9.30-9.45 56 9.30-9.45 54 9.30-9.45 55 9.30-9.45 55 55
Afternoon 14.15-14.30 57 14.15-14.30 55 14.15-14.30 57 13.15-13.30 56
Evening 17.15-17.30 54 17.15-17.30 53 17.15-17.30 55 18.00-18.15 55
Night 2.15-2.30 52 2.15-2.30 50 2.15-2.30 51 2.30-2.45 52 50
Table 3.6 B: Noise level monitoring, data analysis results April 2018
in in in in
Leq Leq Leq Leq
2-4-2018 9-4-2018 16-4-2018 24-4-2018
Afternoon 13.15-13.30 72 13.00-13.15 72 13.15-13.30 72 14.30-14.45 72
Evening 17.00-17.15 71 17.15-17.30 72 17.00-17.15 70 17.45-18.00 70
Night 2.15-2.30 68 2.00-2.15 68 2.15-2.30 67 1.30-1.145 67 70
Afternoon 14.30-14.45 53 14.15-14.30 59 14.45-15.00 59 14.00-14.15 58
Evening 17.00-17.15 54 17.30-17.45 54 17.00-17.15 54 17.15-17.30 59
Night 1.15-1.30 59 1.45-2.00 59 1.30-1.45 55 1.45-2.00 55 50
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Afternoon 14.30-14.45 60 14.30-14.45 58 14.00-14.15 60 14.30-14.45 58
Evening 17.30-17.45 57 17.15-17.30 57 17.00-17.15 56 17.15-17.30 61
Night 1.30-1.45 60 1.15-1.30 59 1.45-2.00 59 1.30-1.45 54 50
Afternoon 14.15-14.30 61 14.00-14.15 61 14.15-14.30 57 14.45-15.00 56
Evening 17.30-17.45 57 17.30-17.45 56 17.00-17.15 58 17.15-17.30 54
Night 1.15-1.30 58 2.00-2.15 54 1.15-1.30 53 1.45-2.00 59 50
5 Kadlur Morning 9.15-9.30 56 9.30-9.45 59 9.30-9.45 63 9.30-9.45 58 55
Afternoon 14.15-14.30 54 14.15-14.30 56 14.00-14.15 53 14.45-15.00 54
Evening 17.30-17.45 52 17.00-17.15 53 16.30-16.45 54 17.15-17.30 57
Night 1.00-1.15 58 1.45-2.00 54 1.45-2.00 51 1.30-1.45 59 50
04-04-2018 11-04-2018 18-04-2018 25-04-2018
Evening 17.00-17.15 56 17.30-17.45 55 17.45-18.00 55 17.30-17.45 55
Night 2.15-2.30 51 2.30-2.45 50 2.15-2.30 51 2.00-2.15 50 50
7 Murahari Doddi Morning 9.30-9.45 58 8.30-8.45 57 8.30-8.45 56 9.45-10.00 56 55
Evening 17.15-17.30 54 17.00-17.15 56 17.45-18.00 57 17.00-17.15 54
Night 2.30-2.45 50 2.15-2.30 51 2.15-2.30 50 2.15-2.30 50 50
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Table 3.6 C: Noise level monitoring, data analysis results May 2018
in in in in
Leq Leq Leq Leq
3-5-2018 12-5-2018 21-5-2018 27-5-2018
Afternoon 13.00-3.15 71 13.00-13.15 71 13.15-13.30 72 13.30-13.45 70
Evening 17.15-17.30 69 17.15-17.30 69 17.00-17.15 70 17.30-17.45 69
Night 02.00-02.15 67 02.00-02.15 67 02.15-02.30 69 02.30-02.45 68 70
Afternoon 14.45-15.00 62 14.45-15.00 62 14.15-14.30 66 14.15-14.30 68
Evening 17.15-17.30 52 17.15-17.30 52 17.30-17.45 52 17.30-17.45 65
Night 01.30-01.45 59 01.30-01.45 69 01.15-01.30 54 01.15-01.30 55 50
Afternoon 14.45-15.00 61 14.45-15.00 61 14.30-14.45 61 14.15-14.30 66
Evening 17.00-17.15 55 17.00-17.15 55 17.15-17.30 54 17.30-17.45 67
Night 1.45-2.00 61 01.45-02.00 61 1.00-01.15 61 01.15-01.30 63 50
Afternoon 14.15-14.30 64 14.15-14.30 64 14.00-14.15 57 14.15-14.30 56
Evening 17.30-17.45 54 17.30-17.45 54 17.15-17.30 61 17.30-17.45 53
Night 1.15-1.30 66 1.15-01.30 66 1.00-1.15 58 1.15-1.30 60 50
5 Kadlur Morning 09.45 - 56 9.45-10.00 56 9.15-9.30 61 9.00-9.15 58 55
10.00
Afternoon 14.00 - 54 14.00-14.15 52 14.30-14.45 54 14.30-14.45 54
14.15
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Evening 17.15-17.30 52 17.15-17.30 54 17.00-17.15 52 17.30-17.45 53

Night 1.30-1.45 51 1.30-1.45 51 1.15-1.30 56 1.00-1.15 56 50
05-05-2018 12-05-2018 19-05-2018 25-05-2018
Evening 17.15-17.30 54 17.30-17.45 54 17.15-17.30 54 17.00-17.15 58
Night 2.30-2.45 50 2.30-2.45 52 2.00-2.15 52 2.15-2.30 51 50
9 Muraharidoddi Morning 8.00-8.15 56 8.45-9.00 55 8.30-8.45 57 8.45-9.00 55 55
Evening 17.45-18.00 55 17.15-17.30 54 17.30-17.45 56 17.15-17.30 54
Night 2.15-2.30 50 2.30-2.45 52 2.30-2.15 51 2.30-2.45 51 50
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OBSERVATIONS
The field observations during the study period indicate that the ambient noise
levels in both industrial and residential areas are within the CPCB limits during
most time of the day and night. However on few days, at certain times the
noise levels exceed the limits stipulated, the reason for exceedance is
vehicular/truck movements.
The range of noise levels observed during the monitoring period are tabulated
below
Range of
Sl. Environment Time of noise Limit
Location
No. setting day levels dB(A) Leq
dB(A) Leq
Project site Industrial Morning 68-74
Afternoon 70-72 75
1
Evening 69-73
Night 67-69 70
Hegsanhalli Morning 56-62
Afternoon 53-68 55
2
Evening 52-65
Night 54-69 50
Deosugur Morning 57-62
Afternoon 58-66 55
3
Evening 54-67
Night 54-63 50
Chicksugur Morning 54-62
Afternoon 56-64 55
4
Evening 53-61
Night 53-66 50
Residential
Kadlur Morning 56-63
Afternoon 52-56 55
5
Evening 52-57
Night 51-59 50
Krishana Morning 55-58
Village Afternoon 54-56 55
6
Evening 54-58
Night 50-52 50
Muraharidoddi Morning 54-58
Afternoon 54-58 55
7
Evening 53-57
Night 50-52 50
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3.3.4 Water environment
3.3.4.1 SURFACE WATER
The major river of Raichur district is the Krishna. This is located within the
study area. To assess the prevailing status of surface water quality, samples
from Krishna river upstream & downstream, Rajasab Talav/ Merched Kere and
Konad Halla were collected and analysed. The same is presented in tables 3.8
A, B & C.
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Table 3.8 A: Surface water analysis March 2018

Sl. Parameters Units Results
No. (Sampling date: 8.3.2018)
Krishna river upstream Krishna river downstream Rajasab Talav/ Konad Halla
of industry of industry Merched Kere
1 Colour -- Colourless Colourless Colourless Colourless
2 Odour -- Agreeable Agreeable Agreeable Agreeable
3 pH -- 8 7.8 8.42 8.2
4 Turbidity NTU 3.1 3.1 3 3.2
0
5 Temperature C 29 27 30 27
Chemical Parameter
6 Alkalinity mg/L 215.6 130.6 216.3 156.2
7 Total Dissolved Solids mg/L 840 814 668 740
8 Total Hardness as CaCO 3 mg/L 280.3 240.6 260.8 284.3
9 Calcium as Ca mg/L 70 84.8 116.2 106.3
10 Magnesium as Mg mg/L 25.3 6.9 27 26
11 Sulphate as SO4 mg/L 120.4 109.5 110.5 190.2
12 Chloride as Cl mg/L 180.3 126.2 114.8 110.5
13 Nitrate as NO3 mg/L 2.3 2.4 1 1.1
14 Iron as Fe mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
15 Fluoride as F mg/L 1 0.7 0.6 0.8
16 Copper mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
17 Manganese mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
18 Mercury mg/L BDL(<0.0006) BDL(<0.0006) BDL(<0.0006) BDL(<0.0006)
19 Cadmium mg/L BDL(<0.006) BDL(<0.006) BDL(<0.006) BDL(<0.006)
20 Lead mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
21 Chromium mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
22 Selenium mg/L BDL(<0.006) BDL(<0.006) BDL(<0.006) BDL(<0.006)
23 Zinc mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
24 Oil & Grease mg/L BDL BDL BDL BDL
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25 B.O.D mg/L 3.2 3.5 3 3.2

26 C.O.D mg/L 24 22 27 24
27 Total suspended Solids mg/L 28 12 10 13
28 Sodium as Na mg/L 58.4 59.2 55.5 58.5
29 Potassium as K mg/L 7.5 6.5 8.2 6.6
30 Acidity mg/L BDL BDL BDL BDL
31 Dissolved Oxygen mg/L 8.5 7.2 6.8 6.8
Bacteriological parameters
32 Coliform MPN/ 900 1150 3800 3500
100
mL
Table 3.8 B: Surface water analysis April 2018

Krishna river upstream Krishna river downstream Rajasab Konad Halla
of industry of industry Talav/
Merched Kere
1 Colour -- Colorless Colorless Colorless Colorless
3 pH -- 7.61 7.61 8.46 8.2
4 Turbidity NTU 3.4 2.4 2.8 3.6
0
Chemical Parameter
6 Alkalinity mg/L 324.2 192.5 223.6 252.6
8 Total Hardness as CaCO 3 mg/L 302.6 280 262.3 270.1
9 Calcium as Ca mg/L 120.1 73.2 118.2 110.2
10 Magnesium as Mg mg/L 23 41 28 27
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11 Sulphate as SO4 mg/L 210.3 106.5 114 188.6

12 Chloride as Cl mg/L 142 143.2 112.6 108.9
13 Nitrate as NO3 mg/L 0.15 0.13 1.1 1.3
14 Iron as Fe mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) (BDL(<0.01)
15 Fluoride as F mg/L 0.7 0.7 0.7 0.8
25 B.O.D mg/L 2.8 2.5 13.6 3.7
26 C.O.D mg/L 25 28 25 24
27 Total Suspended Solids mg/L 34 40 28 14
28 Sodium as Na mg/L 180 105.6 56.2 57.2
29 Potassium as K mg/L 8.8 6.6 8 6.5
31 Dissolved Oxygen mg/L 6 4.8 7.7 7.4
32 Coliform MPN/ 1150 1300 3900 4000
100
mL
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Table 3.8 C: Surface water analysis May 2018

Krishna river upstream Krishna river downstream Rajasab Talav/ Konad Halla
of industry of industry Merched Kere
1 Colour -- Colorless Colorless Colorless Colorless
3 pH -- 7.66 7.69 8.4 7.55
4 Turbidity NTU 2.5 2.5 2.8 3.3
0
Chemical Parameter
6 Alkalinity mg/L 322.9 198.5 213.2 162.5
8 Total Hardness as CaCO 3 mg/L 311.8 280 270 280.5
9 Calcium as Ca mg/L 102.2 74.5 116.9 104.2
10 Magnesium as Mg mg/L 27 42 29 28.1
11 Sulphate as SO4 mg/L 106.5 198.7 111 187.8
12 Chloride as Cl mg/L 168 157.9 113.8 112.1
13 Nitrate as NO3 mg/L 0.13 0.13 1.2 1.5
14 Iron as Fe mg/L BDL(<0.01) BDL(<0.01) BDL(<0.01) BDL(<0.01)
15 Fluoride as F mg/L 0.8 0.7 0.7 0.7
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25 B.O.D mg/L 2.6 3.7 13.6 3.2

26 C.O.D mg/L 25 28 25 24
27 Total suspended Solids mg/L 38 39 28 13
28 Sodium as Na mg/L 106.2 107.2 56.2 58.5
29 Potassium as K mg/L 8.6 6.5 8 6.6
31 Dissolved Oxygen mg/L 5.7 4.4 7.7 6.8
32 Coliform MPN/ 1500 1650 4800 4100
100
mL
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Table 3.8 D: Designated best use of surface water

Designated best use Class of Criteria
water
Drinking water source A Total coliform organisms MPN/100 mL
without conventional shall be 50 or less
treatment but after pH between 6.5 and 8.5
disinfection Dissolved oxygen 6 mg/L or more
Biochemical Oxygen Demand (BOD) 5
days 20 C 2 mg/L or less
Outdoor bathing B Total coliform organisms MPN/100 mL
(organised) shall be 500 or less
pH between 6.5 and 8.5
Dissolved oxygen 5 mg/L or more
Drinking water source C Total coliform organisms MPN/100 mL
after conventional shall be 5000 or less
treatment and pH between 6 and 9
disinfection Dissolved oxygen 4 mg/L or more
Propogation of wildlife D pH between 6.5 and 8.5
and fisheries Dissolved oxygen 4 mg/L or more
Free ammonia (as N) 1.2 mg/L or less
Irrigation, industrial E pH between 6.5 and 8.5
cooling, controlled waste Electrical conductivity at 25 C micro
disposal mhos/cm max 2250
Sodium absorption ratio max 26
Boron max 2 mg/L
Below E Not meeting A, B, C, D, E criteria
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Table 3.8 E: Class of surface water analysed March 2018

Results
(Sampling date: 8.3.2018)
Krishna
Sl. Krishna Rajasab
Parameters Units Class river Class Class
No. river Talav/ Konad Class of
of downstrea of of
upstream Merched Halla water
water m of water water
of industry Kere
industry
5 Total coliform organisms MPN/100 mL 900 1,150 3,800 3,500
6 pH -- 8 7.8 8.42 8.2
7 Dissolved oxygen mg/L 8.5 D 7.2 D 6.8 C 6.8 D
Biochemical Oxygen
8 mg/L 3.2 3.5 3 3.2
Demand (BOD) 5 days 20 C
Table 3.8 F: Class of surface water analysed April 2018

Results
Krishna
Sl. Krishna Rajasab
of downstrea of of
of industry Kere
industry
1 Total coliform organisms MPN/100 mL 1,150 1,300 3,900 4,000
2 pH -- 7.61 7.61 8.46 8.2
3 Dissolved oxygen mg/L 6 C 4.8 C 7.7 D 7.4 C
Biochemical Oxygen
4 mg/L 2.8 2.5 13.6 3.7
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Table 3.8 G: Class of surface water analysed May 2018

Results
Krishna
Sl. Krishna Rajasab
of downstrea of of
of industry Kere
industry
1 Total coliform organisms MPN/100 mL 1,500 1,650 4,800 4,100
2 pH -- 7.66 7.69 8.4 7.55
3 Dissolved oxygen mg/L 5.7 C 4.4 D 7.7 D 6.8 D
Biochemical Oxygen
4 mg/L 2.6 3.7 13.6 3.2
OBSERVATIONS
The designated best use of surface water samples analysed are tabulated below
Sl. Class of Designated best use
Surface water
No. water
1 Krishna river upstream of industry C - Drinking water source after conventional treatment and
2 Krishna river downstream of industry disinfection.
C-D
3 Rajasab Talav/ Merched Kere
4 Konad Halla D - Propogation of wildlife and fisheries
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3.3.4.2 GROUND WATER
Ground water is the major source of water in the study area, occurring under water table conditions in the weathered
mantle of granite gneisses and in the joints, cracks and crevices of the basement rock. The depth of water is also
dependent on topography and varies depending on the depth of weathering.
The results of the ground water analysis collected from the project site and other locations within the study area are
appended in tables 3.9 A, B & C.
Table 3.9 A: Ground water analysis March 2018

DW Standards Results
Sl. (IS 10500:2012) (Sampling date: 5.3.2018 & 17.3.2018)
Parameters Unit
No. Acceptable Permissible Project Krishna Muraharid
Hegsanhalli Deosugur Chicksugur Kadlur
Limit limits site Village oddi
1 Colour & --- 5 15 Colourless Colourless Colourless Colourless Colourless Colourless Colourless
Odour & & & & & & &
Agreeable Agreeable Agreeable Agreeable Agreeable Agreeable Agreeable
2 pH --- 6.5 8.5 No 7.78 7.86 7.45 7.92 7.85 7.49 7.22
relaxation
3 Turbidity NTU 1 5 2.1 3.5 2.6 0.3 2.2 <1 <1
CHEMICAL PARAMETERS
4 Calcium as Ca mg/L 75 200 46 150.4 170 38 78.3 62 57.1
5 Chloride as Cl mg/L 250 1000 420.9 280.4 350.4 355.8 240 205 275
6 Total mg/L 200 600 299 480.7 450.6 180 385.3 180 300
Hardness as
CaCO3
7 Alkalinity mg/L 200 600 485.3 200.7 341.7 540 322 430 445
8 Dissolved mg/L 500 2000 1600.4 1800 1810 1680 1750 1204 1228
Solids
9 Fluoride as F mg/L 1.0 1.5 1.2 0.8 0.4 0.65 0.68 0.8 0.01
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10 Sulphate as mg/L 200 400 370 350.6 300 354 250.4 67 144
SO4
11 Iron as Fe mg/L 0.3 No <0.01 <0.01 <0.01 <0.01 <0.01 <0.02 <0.02
Relaxation
12 Nitrate as mg/L 45 No 0.4 ND ND 1.5 ND 37 99
NO3 Relaxation
13 Sulphide mg/L 1.2 1.1 1.5 1 1 BDL BDL
14 Zinc mg/L 5 15 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01
15 Magnesium as mg/L 30 100 44.7 25.4 6.2 20.6 46 7.29 38.2
Mg
16 Lead mg/L 0.05 No BDL(<0.01) BDL(<0.01) BDL(<0.01 BDL(<0.01) BDL(<0.01) <0.01 <0.01
Relaxation )
17 Aluminium mg/L <0.01 <0.01 <0.01 <0.01 <0.01 0.01 0.01
18 Sodium as Na mg/L 10.2 11.8 8.8 12 11 265 90
19 Potassium as mg/L 5 4.8 4.2 5.2 4.6 10.7 34
K
Table 3.9 B: Ground water analysis April 2018

Parameters Unit
Odour & & & & & & &
2 pH --- 6.5 8.5 No 7.62 7.62 7.32 7.69 7.8 7.67 7.29
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relaxation
3 Turbidity NTU 1 5 2.6 3.7 2.5 0.46 2.1 <1 <1
CHEMICAL PARAMETERS
4 Calcium as Ca mg/L 75 200 42.6 149.6 168.2 40.6 83 62 60
5 Chloride as Cl mg/L 250 1000 440.2 277.9 360.8 360.4 248.9 206 279
6 Total mg/L 200 600 302 475.3 455 172.2 336.3 180 310
Hardness as
CaCO3
7 Alkalinity mg/L 200 600 470.3 219.2 340.9 528.6 310.6 435 449
8 Dissolved mg/L 500 2000 1680 1750 1820 1660 1750 1200 1230
Solids
9 Fluoride as F mg/L 1.0 1.5 1.2 0.7 0.5 0.6 0.52 0.9 0.01
10 Sulphate as mg/L 200 400 372.8 358 319.2 341.2 258.6 68 148
SO4
11 Iron as Fe mg/L 0.3 No <0.01 <0.01 <0.01 <0.01 <0.01 <0.02 <0.02
Relaxation
12 Nitrate as NO3 mg/L 45 No 0.32 ND ND 1.12 ND 39 97

Relaxation
13 Sulphide mg/L ND 0.8 1.4 1.2 ND BDL BDL
14 Zinc mg/L 5 15 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01
15 Magnesium mg/L 30 100 42.3 37.4 6 22.3 41.5 7.15 38.8
16 Lead mg/L 0.05 No BDL(<0.01 BDL(<0.01) BDL(<0.01 BDL(<0.01) BDL(<0.01) <0.01 <0.01
Relaxation ) )
17 Aluminium mg/L <0.01 <0.01 <0.01 <0.01 <0.01 0.01 0.01
18 Sodium as Na mg/L 10.9 11.7 8.6 11.8 11.3 257 92
19 Potassium as mg/L 5.3 4.5 4.6 4.3 4.3 10.9 38
K
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Table 3.9 C: Ground water analysis May 2018

Parameters Unit
Odour & & & & & & &
2 pH --- 6.5 8.5 No 7.69 7.66 7.55 7.66 7.8 7.35 7.22
relaxation
3 Turbidity NTU 1 5 2.5 3.6 2.8 0.46 2.7 <1 <1
CHEMICAL PARAMETERS
4 Calcium as Ca mg/L 75 200 45.5 159 178.2 37.8 89 62 65.5
5 Chloride as Cl mg/L 250 1000 429.6 277.4 360.7 348.4 238 209 277
6 Total mg/L 200 600 296 475.2 448 182.2 376 191 318
Hardness as
CaCO3
7 Alkalinity mg/L 200 600 473.2 200 340 545.3 329.6 432 444
8 Dissolved mg/L 500 2000 1620 1780 1790 1691 1720 1250 1242
Solids
9 Fluoride as F mg/L 1.0 1.5 1.3 0.7 0.6 0.5 0.62 0.8 0.01
10 Sulphate as mg/L 200 400 366.7 346 295.2 331.9 246.7 69 145
SO4
11 Iron as Fe mg/L 0.3 No <0.01 <0.01 <0.01 <0.01 <0.01 <0.02 <0.02
Relaxation
12 Nitrate as NO3 mg/L 45 No 0.12 ND ND 1.11 ND 37 96
Relaxation
13 Sulphide mg/L 1 1.1 1.2 1 1 BDL BDL
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14 Zinc mg/L 5 15 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01 <0.01

15 Magnesium as mg/L 30 100 37.9 38.2 44 32.3 41.5 7.18 37.6
Mg
16 Lead mg/L 0.05 No BDL BDL (<0.01) BDL BDL BDL <0.01 <0.01
Relaxation (<0.01) (<0.01) (<0.01) (<0.01)
17 Aluminium mg/L <0.01 <0.01 <0.01 <0.01 <0.01 0.01 0.01
18 Sodium as Na mg/L 10.6 11.7 8.6 11.8 11.3 250 94
19 Potassium as mg/L 5.3 4.7 4.8 4.9 4.3 10.4 35
K
OBSERVATIONS
All the parameters of the groundwater samples analysed are within the permissible limit specified under IS
10500:2012 even though few parameters such as turbidity, alkalinity, dissolved solids, total hardness, calcium,
magnesium, sulfates are more than the acceptable limits.
Fluoride at the project site is slightly higher than the acceptable limits ranging from 1.2-1.3 mg/L though less
than the permissible limit of 1.5 mg/L.
Nitrates at Muraharidoddi in Telangana after crossing river Krishna is more than the acceptable & permissible
limit of 45 mg/L specified ranging from 96-99 mg/L. Also, magnesium ranges from 37.6 38.8 mg/L which is
more than the acceptable limit of 30 mg/L though less than permissible limit of 100 mg/L. This village is
surrounded by agricultural fields where there is extensive use of fertilizers.
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3.3.5 Soil and geology
The soil of Raichur district can be classified broadly into the following four types namely: mixed red and black soils,
medium black soils, deep black soils and red sandy soils.
Results of soil analysis is tabulated in 3.10 A, B & C.
Table 3.10 A: Physico-chemical characteristics of soil March 2018

Sl. Parameter Unit Results
No. (Sampling date: 5.3.2018 & 3.3.2018)
Project Krishna
Hegsanhalli Deosugur Chicksugur Kadlur Muraharidoddi
site Village
1 pH @ 250C ---- 8.58 8.84 8.68 8.9 8.71 8.6 8.84
2 Electrical ms/cm 0.31 0.25 0.242 0.42 0.332 0.310 0.25
conductivity
3 Moisture % 2.8 3 3.2 4 3.85 2.8 3
content
4 Organic carbon % 0.88 0.9 0.98 1 0.95 0.88 0.9
5 Sodium % 0.5 0.44 0.52 0.68 0.53 0.5 0.44
6 Potassium % 0.2 0.16 0.18 0.22 0.21 0.2 0.16
7 Phosphorus kg/ha 0.018 0.02 0.022 0.03 0.02 0.018 0.02
8 Lead mg/kg <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05
9 Sulphates as % 32 38 44 40 35 32 38
SO4
10 Calcium as Ca % 61.8 72.8 78 74.2 74 61.8 72.8
11 Magnesium as % 25 22 20 18.8 21 25 22
Mg
12 Iron as Fe % 3 2.6 2.75 2.8 2 3 2.6
13 Nitrogen as N kg/ha 1 0.88 0.9 1.1 1.2 1 0.88
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Table 3.10 B: Physico-chemical characteristics of soil April 2018

No. (Sampling date: 3.4.2018 & 4.4.2018)
Project Krishna
site Village
1 pH @ 250C ---- 8.62 8.8 8.42 8.8 8.68 8.68 7.8
2 Electrical ms/cm 0.308 0.262 0.222 0.41 0.341 0.242 0.48
conductivity
3 Moisture % 2.78 3.4 3.4 4.3 3.9 3.2 6
content
4 Organic carbon % 0.82 0.89 0.99 1.5 0.98 0.98 2
5 Sodium % 0.46 0.46 0.58 0.7 0.6 0.52 0.78
6 Potassium % 0.22 0.19 0.20 0.24 0.28 0.18 0.52
7 Phosphorus kg/ha 0.02 0.027 0.026 0.045 0.029 0.022 0.06
8 Lead mg/kg <0.05 <0.05 <0.05 <0.05 <0.05 <0.05 <0.05
9 Sulphates as % 30 36 46 44 35.6 44 60
SO4
10 Calcium as Ca % 62.2 74.3 74 76.1 75.1 78 44.2
11 Magnesium as % 27 24 24 20 22.2 20 18.8
Mg
12 Iron as Fe % 3.2 2.72 2.82 2.36 2.8 2.75 2.8
13 Nitrogen as N kg/ha 1.2 0.84 0.94 1.14 1.32 0.9 1.1
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Table 3.10 C: Physico-chemical characteristics of soil May 2018

No. (Sampling date: 14.5.2018 & 3.5.2018)
Project Krishna
site Village
1 pH @ 250C ---- 8.83 8.53 8.69 8.35 8.45 8.61 8.1
2 Electrical ms/cm 0.328 0.402 0.278 0.432 0.362 0.342 0.452
conductivity
3 Moisture % 2.95 3.6 3.1 3.9 3.53 3.75 3.85
content
4 Organic carbon % 0.73 0.76 0.92 1.9 0.85 0.45 0.65
5 Sodium % 0.52 0.53 0.63 0.82 0.71 0.23 0.43
6 Potassium % 0.34 0.24 0.27 0.33 0.24 0.41 0.31
7 Phosphorus kg/ha 0.04 0.032 0.04 0.036 0.03 0.05 0.05
8 Lead mg/kg <0.05 <0.05 <0.05 <0.05 <0.05 <0.03 <0.04
9 Sulphates as % 36 32 39 37 31.2 55 45
SO4
10 Calcium as Ca % 69.6 79.4 69.4 61.4 76.4 24 64
11 Magnesium as % 29 31 31.5 23.4 28.8 11 41
Mg
12 Iron as Fe % 3.4 4.86 4.35 4.19 3.1 2 3
13 Nitrogen as N kg/ha 1.4 0.68 0.69 1.04 0.98 1.3 1.6
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Table 3.10 D: Soil classification

Sl. Soil test Classification
No.
1 pH <4.5 Extremely acidic
4.51- 5.50 Very strongly acidic
5.51-6.00 moderately acidic
6.01-6.50 slightly acidic
6.51-7.30 Neutral
7.31-7.80 slightly alkaline
7.81-8.50 moderately alkaline
8.51-9.0 strongly alkaline
>9.00 very strongly alkaline
2 Salinity Electrical Conductiv ity Upto 1.00 Average
(ppm) 1.01-2.00 harmful to germination
2.01-3.00 harmful to crops (sensitive to salts)
3 Organic Carbon Upto 0.2: very less
0.21-0.4: less
0.41-0.5 medium,
0.51-0.8: on an average sufficient
0.81-1.00: sufficient
>1.0 more than sufficient
4 Nitrogen (Kg/ha) Upto 50 very less
51-100 less
101-150 good
151-300 Better
>300 sufficient
5 Phosphorus (Kg/ha) Upto 15 very less
16-30 less
31-50 medium
51-65 on an average sufficient
66-80 sufficient
>80 more than sufficient
6 Potassium (Kg/ha) 0 -120 very less
120-180 less
181-240 medium
241-300 average
301-360 better
>360 more than sufficient
Source: Handbook of agriculture
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OBSERVATIONS
A summary of analytical results are presented below:

The pH of the soil samples ranged from 7.8-8.9 i.e. moderately to strongly
alkaline.
Nitrogen content ranged from 0.68 to 1.6 kg/ha i.e. very less
Phosphorous from 0.018 to 0.06 kg/ha i.e. very less
Potassium content ranges from 0.16 to 0.52% i.e. very less
3.3.6 Ecology
Ecology is a branch of biology that deals with the relations of organisms with one
another and to their physical surroundings. Natural flora and fauna are important
features of the environment. They are organized into natural communities with
mutual dependencies among their members and show various responses and
sensitivities to physical environment. The integrated ecological thinking and planning
process is an urgent need in the context of natural environment's deterioration which
has a direct bearing on socio-economic development.
Ecological survey of the study area was carried out by actual field visits to observe
the various species of flora and fauna. Personal enquiries/discussion with local people
and forest department officials was also conducted to get a fair idea of the existing
ecological status.
3.3.6.1 ANTICIPATED IMPACTS
The industry is located in designated industrial area of KIADB, Raichur. The impact
can be considered insignificant as the region consists of only skeletal vegetation like
grass and thorny shrubs with no rare and endangered species. The industrial activity is
limited only to the core zone and mitigative measures are implemented to contain
water, air and noise pollution. Hence, there shall be no damage to the flora and fauna
of the buffer zone.
When compared to the mega Raichur thermal power plant at the next compound, the
impact of M/s. Shilpa Medicare Ltd. Unit I is negligible in terms of wastewater, air
and solid waste pollution generation.
3.3.6.2 FLORA
Raichur district has 44 sq. km of forest area as per the State of Forest Report 2017,
published by the Forest Survey of India. This accounts for just 2.2% of the total
geographical area. Hence, the districts forest wealth is almost nil. In the study area
the weeds and climbers are found. They neither possess any economic value nor are
they nutritious. The different types of grass growth are not nourishing even to feed
the cattle, but these are used for making thatch roof for Kutcha houses in the
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villages. Bellary jali is the predominant shrub. The shrubs are mostly used for fencing
purposes.
In Mahbubnagar district, Telangana which falls in the study area, thorny shrubs,
deciduous (Hardwickia binata) and bamboo type of vegetation is found.
Floral composition in the study area is presented in the table 3.11 below.
Table 3.11: Flora in the study area

Sl. No. Botanical name Common name
SHRUBS/HERBS
1 Prosopis juliflora Bellary jali
2 Butea superba Bel Palas
3 Gardenia gummifera Dikmali
4 Zizyphus xylopyrus Gotti or Challa
5 Annona squamosa Sharifa or Seetaphal
6 Cassia auriculata Tarwad or Tangadi
7 Alysicarpus monilifer Necklace-Pod
8 Mimosa hamata Sagari mullu
9 Mimosa pudica Touch me not
10 Acalypha alnifolia Alder Leaved Cat Tail
11 Osbeckia zeylanica Akka jogi gida
TREES
12 Cassia fistula Kakka or Amaltas
13 Acacia Arabica Jali or Hunise
14 Wrightia tinctoria Hale or Palakordsha
15 Butea frondosa Pales or Muttaga
16 Anogeissus latifolia Tirman or Dindiga
17 Albizia amara Chujjalu
18 Chloroxylon swietenia Haragalu
19 Hardwickia binata Karachi or Kammara
20 Terminalia tomentosa Nallamaddi or Mati
21 Acacia farnesiana Needle bush
22 Acacia leucophloea Bellada, bili-jali, nayibela
23 Acacia nilotica Gobli mara
24 Vernonia albicans Bitter leaf tree
25 Pongamia pinnata Honge
26 Sapindus emarginatus Notched leaf soapnut
27 Acacia Sundra Karangali
28 Dodonaea viscosa Bandaru
29 Ficus benghalensis Banyan
30 Hardwickia binata Indian blackwood
Source: District Census Handbook, Raichur & Mahbubnagar validated by field visits.
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3.3.6.3 FAUNA
Since the forests in Raichur district are of mixed dry deciduous type consisting of open
scrub jungles, animals belonging to the family of big game variety are not seen. It
seems that few centuries ago, tigers and leopards had their abode in these forests and
sight of these animals was rare. Presently such encounters of these animals are
almost found nil. Animals sighted in these forests are wolves, jackals and deer. Plenty
of snakes, scorpions and lizards are found in these jungles. Among the snakes, the
cobra, Russels viper and small water snakes are found not only in the forest but also
in all regions of the district. Among the game bird, partridges and quails, along the
rivers and streams, the wild duck, teal and waterfowl are also seen in the district.
The composition of fauna in the study area is presented in the table 3.12 below.
Table 3.12: Fauna in the study area

Sl. No. Scientific name Common name
MAMMALS
1 Canis lupus Grey wolf
2 Vulpes benglensis Indian fox
REPTILES
3 Ophiophagus hannah King cobra
4 Daboia Russells viper
5 Pantherophis obsoletus Rat snake
6 Coelognathus helena Trinket snake
7 Ahaetulla nasuta Green vine snake
8 Echis carinatus Saw scaled viper snake
9 Erycinae Common sand boa
10 Telescopus fallax Common cat snake
11 Oligodon arnensis Banded common kukri
BIRDS
12 Passer domesticus House sparrow
13 Corvus splendens Crow
14 Pavo cristatus Peafowl
15 Gelochelidon nilotica Gull-billed tern
16 Coracias benghalensis Indian roller
17 Ardeola grayii Indian pond heron
18 Ardea cinerea Linnaeus Grey heron
19 Sterna aurantia River tern
20 Chrysomm a sinense Yellow-eyed babbler
21 Eremopterix griseus Ashy-crow ned sparrow-lark
22 Saxicola caprata Pied bush chat
23 Halcyon smyrnensis White-throated kingfisher
24 Cinnyris asiaticus Purple sunbird
25 Bubulcus ibis Cattle egret
26 Vanellus indicus Red-wattled lapwing
Source: Karnataka Biodiversity Board, avibase validated by field visits.
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3.3.7 Socio-economic environment
The baseline data referring to the socio-economic environment is collected by way of

secondary sources such as census records, statistical hand book and relevant official
records with the government agencies and primary sources such as the socio-economic
surveys conducted by different Govt. & Non Govt. Agencies.
The growth of industrial sectors and infrastructure development in and around the
agricultural area i.e. villages and semi-urban settings and towns is bound to create
certain socio-economic impacts on the local populace. The impacts may be either
positive or negative depending on the nature of development. To assess such impact
it is necessary to know the existing socio-economic order of the study area, which will
be helpful in improving the overall quality of life.
3.3.7.1 DEMOGRAPHIC STRUCTURE
The information collected from the secondary sources are from the district census
statistical hand books and the records of the National Informatics Centre, New Delhi
in respect of the population, infrastructure facilities available and the occupational
structures of the study area.
The socio-ecological aspect of the study include the agro based economy, industry
based economy and occupational structure of the workers.
The distribution of population in the study area as per census record of 2011 is
presented in table 3.13 below.
Table 3.13: Summary of demographic structure

Demographic parameters No.s
Hegsanhalli Deosugur Raichur Muraharidoddi
Total no. of households 377 1,315 52001 142
Total population 1,766 6,039 2,64,564 819
Males 859 3,053 1,31,899 406
Females 907 2,986 1,32,665 413
Sex ratio (No. of 1,055 978 1,005 1,017
female/thousand males)
Scheduled castes 422 1,195 58,590 77
Scheduled tribes 44 49 53,438 0
Literates (above 7 years of 1,213 3,923 1,20,070 281
age)
Main workers (among total 501 1,866 1,04,842 376
working population)
Marginal workers (among total 117 338 29,589 18
working population)
Non-workers 1,148 3,835 1,30,133 425
Source: District census handbook, Raichur & Mahbubnagar, 2011
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Literacy levels
Raichur District
Raichur district has a literacy rate of 59.6 percent and is placed at penultimate
rank in the State.
There is a substantial percentage increase in the literacy levels from 49.54% during
2001 census to 59.6% during 2011. The literacy rate has improved due to the efforts
under the D.P.E.P. programme and the literacy drive campaign. However, it is still
less when compared to the Karnataka State average of 75.6%.
The male literacy rate in the district is 70.5 percent and the female literacy rate is
48.7 percent.
The male female literacy gap is 21.8 percentage points, which is higher than the
male female literacy gap registered by the State (14.4 percentage points).
In Raichur district there are about 3,150 schools (total upto higher secondary PU
level) controlled by the Department of Education.
Mahbubnagar district
Mahbubnagar district ranks 14th in Andhra Pradesh State (during 2011 cesus, prior
to division into Telangana & Andhra Pradesh) with literacy of 55.04%.
Male literacy rate is 65.21% & female literacy is 44.72%.
Source: EMIS & DISE reports and District census handbook, Raichur & Mahbubnagar,
2011
3.3.7.2 ECONOMIC ENVIRONMENT
Raichur was economically and industrially backward district of Karnataka.

Government of Karnataka first brought a thermal power plant to this area in the year
1985 with 210 MW capacity. Thereafter, it has grown and expanded to the present
capacity of 1,720 MW.
The Government of Karnataka has also established an industrial area in the year 1987
at Deosugur and Raichur growth center industrial area in the year 2005. By this
industrialization, the town is experiencing economical growth supported by
agriculture. Off-late educational institutions have also come up. Raichur Institute of
Medical Sciences, Navodaya Medical College and Nursing college, SLN Engineering
college, Government Engineering College, Navodaya Engineering College are a
prominent few.
Mahbubnagar district, Telangana which falls under the study area of 10 km radius of
the M/s. Shilpa Medicare Ltd. Unit I, the land-use pattern is predominantly
agricultural & rural.
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3.3.8 Social infrastructure available
Infrastructure is the basic physical and organizational structures needed for the
operation of a society or enterprise or the services and facilities necessary for an
economy to function.
The term typically refers to the technical structures that support a society, such as
roads, water supply, sewers, electrical grids, telecommunications and so forth and
can be defined as "the physical components of interrelated systems providing
commodities and services essential to enable, sustain or enhance societal living
conditions.
Viewed functionally from the industrial point of view , infrastructure facilitates are
those that support the production of goods and services, the distribution of finished
products to markets, basic social services such as schools and hospitals.
List of infrastructural facilities available in the vicinity of the industry are tabulated
below. Google map of the same is in fig 3.6.
Table 3.14: List of infrastructural facilities in the surroundings

Sl. Infrastructural facility Distance from the Direction
No. industry (km) w.r.t. the
industry
1 District hospital 12.7 South
2 GPV hospital 14.3 South
3 KPCL DAV public school 2.5 North East
4 Vignan School 14.5 South East
5 Government Engineering 8.7 South East
College
6 SLN College of Engineering 11.05 South East
7 Raichur Institute of 13.05 South East
Medical Sciences
Note: All distances mentioned are aerial.
In Mahbubnagar district covered under study area only few primary schools are
present.
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3.2.8.1 CONNECTIVITY
Connectivity to the project site is detailed in the following table 3.15. Google map
showing the same is appended subsequently in fig 3.7.
Table 3.15: Connectivity from the project site

Sl. Particulars Distance from Direction
No. the project site w.r.t. project
(km) site
A. NH-167 & SH 51 Adjacent to the East
project site
B. Chiksugur railway station 1 South
C. Raichur railway station 16 South
D. Hyderabad airport 152 North East
E. Krishna railway station 7.4 North West
(Telangana)
Note: All distances mentioned are aerial
Google maps covering a radial distance of 1, 5 & 10 km are in fig 3.8, 3.9 & 3.10.
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Fig 3.7: Google map showing infrastructural facilities and connectivity
3
A
B
5
6
1
2 74
Legend:
1: District hospital; 2: GPV hospital; 3: KPCL DAV public school; 4: Vignan School; 5: Government Engineering College;
6: SLN College of Engineering; 7: Raichur Institute of Medical Sciences
A: NH-167 & SH 51; B: Chiksugur railway station; E: Krishna railway station
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Fig 3.8: Google map 1 km radius
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3.2.8.2 SURROUNDING INDUSTRIES
M/s. Shilpa Medicare Limited, Unit I is located at Deosugar Industrial Area, Raichur,
Karnataka. There are many brick industries located around the industry. In addition,
major industries located in the vicinity are tabulated below and shown in fig 3.11.
Table 3.16: Surrounding industries

Sl. Particulars Distance from Direction
No. the project site w.r.t. project
(km) site
1 Raichur Thermal Power Plant Adjacent North
2 Trimax Bio Sciences Pvt. Ltd. 3.8 South East
3 Shilpa Medicare Ltd. Unit II 4.1 South East
4 Surana Power Ltd. 4.5 South East
5 Helcon Agro Chemicals Ltd. 5.1 South
6 Madhavi Edible Oils Pvt. Ltd. 5.6 South West
7 Yermarus Thermal Power Station 5.9 South East
8 KSH Agro Foods Bangalore Pvt. Ltd. 6.5 South
Note: All distances mentioned are aerial
Fig 3.11: Google map showing surrounding industries
2
34
5
6 7
8
Legend: As per table
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3.3 BASE MAPS OF ALL ENVIRONMENTAL COMPONENTS
The major environmental components in the surroundings along with the distance &
direction from the project site are tabulated below . Google map showing the location
of the environmental parameters are appended as figure 3.13 and topo map of 10 km
radius is appended as Annexure A11. Bhuvan map showing land-use pattern in the
immediate vicinity of the industry is in fig 3.12.
Table 3.17: Existing land-use pattern

Sl. Particulars Details Distance Direction
No. from the w.r.t.
project site project
(km) site
1 Agriculture Minor activities - scattered Beyond -
industrial
area
2 National park, None within 10 km radius - -
forest
3 Water bodies Krishna river 4.22 North
Konad Halla 2.18 North West
Dodda Halla 3.25 South East
Note:
a) All distances mentioned are aerial.
b) The location of the industry is in a notified KIADB, Karnataka Govt. industrial
area.
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Fig 3.12: Existing land-use pattern
PROJECT
SITE
Source: Bhuvan, Indian geo platform of ISRO
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PROJECT
SITE
Source: Bhuvan, Indian geo platform of ISRO
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Fig 3.13: Google map showing surrounding water bodies
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CHAPTER 4
ANTICIPATED ENVIRONMENTAL IMPACTS &

MITIGATION MEASURES
4.4.1 DETAILS OF INVESTIGATED ENVIRONMENTAL IMPACTS DUE TO PROJECT
LOCATION, POSSIBLE ACCIDENTS, PROJECT DESIGN, PROJECT CONSTRUCTION,
REGULAR OPERATIONS, FINAL DECOMMISSIONING OR REHABILITATION OF
COMPLETED PROJECT MEASURES FOR MINIMIZING AND/OR OFFSETTING ADVERSE
IMPACTS IDENTIFIED
4.1.1 Environmental impacts due to project location, possible accidents, project

design and mitigation measures
A. PROJECT LOCATION
Major environmental impacts due to project location are not anticipated because the
industry is located in Deosugar Industrial Area, Raichur.
B. POSSIBLE ACCIDENTS
The possible accidents that can occur in the industry are

raw material spills
process accidents
accidents during effluent transport
accidents during hazardous waste transport
accidents during hydrogenation
Summarized data on accidents during the previous years is tabulated below

S. Yearly data
Discription
No. 2012 2013 2014 2015 2016 2017
1 No.of minor incident/accidents 9 10 8 11 4 5
2 No.of major incident/accidents 0 0 0 0 0 0
No.of occupational health
0 0 0 0 0 0
3 diseases reported
C. PERSONAL SAFETY & TRAINING
1) PPEs
All the personal are provided with adequate number of protective equipments based
on the area of work to ensure safety. Few PPEs provided are listed below.
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Helmet
Goggles
Nose masks
Uniform
Aprons
Hand gloves
Safety shoes
Face shield
Eye and body showers
Fig 4.1: Personal with safety PPEs in work area
Fig 4.2: Eye and body showers
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2) Training
Safety training for the employees on need basis depending on the work area is given
at regular intervals to ensure development and maintenance of safety mind-set
amongst the employees.
3) Mock drills and safety audit
Safety mock drills are held annually to ensure prompt and safe response during
emergencies.
Shilpa Medicare Ltd. Unit I is an ISO 18001:2007 (Occupational Health and Safety
Management System) certified company. Copy of the certificate is shown in fig 4.3.
The company has an approved health and safety policy and the same is shown in fig
4.4.
4) Health safety
Annual medical health check up is conducted and medi-claim scheme is provided for
all employees.
Sample health check-up reports are appended as Enclosure 3.
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Fig 4.3: ISO 18001:2007 (Occupational Health and Safety Management System)
certification
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Fig 4.4: Health and safety policy
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4) Fire-fighting equipments
Adequate numbers of fire extinguishers are available at necessary locations. Fire
water tank of 200 KL capacity and fire hydrant system is provided all around the
premises and other necessary locations. Photographs are shown in fig 4.5.
Fig 4.5: Firefighting facilities

Fire extinguishers Fire hydrant pumps
Fire
extinguisher
Fire hydrant
line
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5) Others
In addition,
The necessary safety documents like Material Safety Data Sheets (MSDS), risk
assessment study report, HAZOP study report, on-site emergency plan are
prepared and made readily available to the concerned persons in case of
emergency.
Electric audit is conducted regularly.
Insurance coverage is provided in case of fire (PLI)
Contact numbers in case of emergencies are displayed at prominent locations.
ENVIRONMENT SAFETY
Shilpa Medicare Ltd. Unit I is an ISO 14001:2015 (Environmental Management System)

certified company. The company has an approved environment policy. The same are
shown in fig 4.6 & 4.7 respectively.
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Fig 4.6: ISO 14001:2015 (Environmental Management System) certification
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Fig 4.7: Environment policy
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SPILL CONTROL AND MANAGEMENT
Procedure followed at M/s. Shilpa Medicare Ltd. Unit I for spill control and
management is detailed below. SOPs are in place and care is taken to prevent land,
surface and groundwater contamination.
i) Acid / caustic spills

Report the spill to the Block in-charge. EHS department/ higher-ups.
Appropriate precautions shall be taken as per Material Safety Data Sheet (MSDS)
for individual chemicals. The MSDS shall be available in the Departments.
suitable respirators to be worn when handling the spills.

Apply sodium carbonate powder or other inward from the perimeter of the spill.
Carefully mix the powder with scoops/mop.
Pick up neutralized material with scoop/mop and transfer to a disposal bag and
send to TSDF for disposal.
In case of major spill, intimate to KSPCB.
For small spills use spill control kits.
Enter the details of incident in the spill control record.
ii) Solvents spills
Report the spill to the site in-charge/EHS Department/ Higher-ups.

Do not attempt to clean up a solvent spill when an ignition source is nearby. Stop
the ignition source immediately on observing the solvent spill. The solvent spill or
leak from the solvent tank storage area is collected in the dyke wall, pump the
spilled solvent into the tank & follow the procedure as described below for
clearing the site
rubber gloves, safety goggles and shoes etc.
Spray dry sand from the perimeter covering the total spill area & cover the solvent
with foam available in fire hydrant system hydrant points.
Mix thoroughly with SS scoop until the location is dry and no traces of solvent
remains.
Transfer solvent absorbent to disposal bag and tie the bag, then send to TSDF for
disposal.
Enter the details of incidents in the spill control record.
iii) Gases
In case of leakage evacuate the area, inform the block in-charge and EHS
department/ higher-ups.
All other persons should leave the area till safe conditions return.
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In case of major leakage all persons should be warned & evacuated and KSPCB to
be intimated.
suitable cartridge respirator,
rubber gloves, safety goggles, shoes etc.
Approach from the wind wards side so that escaping gas is carried down-wind
In case of large leaks first step is try to stop the flow of gas
Ammonia leakages are controlled by spraying water which will automatically start
In case the leak is in the equipment in which it is being used, stop the valve on the
container at once.
iv) Solid material spills
Report the spill to the block in-charge.

rubber gloves, safety goggles, shoes
etc.
Pick up material with scoop and transfer to a disposal bag and then TSDF for
disposal.
Fig 4.8 A: Spill control kits provided at various locations
ODOUR CONTROL AND MANAGEMENT
Pungent odours are neutralized by using scrubbers in process section.

Breather valves & nitrogen blanketing system is provided in solvent storage area.
The Volatile Organic Compound (VOC) monitoring is carried out regular Intervals.
All the areas are covered with Air Handling Units (AHUs).
All the possible sources of leaks will be identified and plugged immediately with
an effective preventive maintenance schedule.
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C. PROJECT DESIGN
Production blocks are kept separate from storage area

Safety dyke walls are provided for solvent storage area. Details are in Chapter 2,
Section 2.8.5.2 of this report.
An area of 33,591.25 SQM i.e. 35% of the total plot area is open space and
landscape/green-belt. About 50 native indigenous trees such as Neem (Azadirachta
indica ) and Pongamia (Millettia pinnata) are present.
Fig 4.8 B: Green-belt
4.1.2 Environmental impacts due to regular operations and mitigation measures
Recognition of project specific activities for major impacts is essential for arriving at
suitable mitigation measures. This in turn will ensure maintenance of the existing
environmental quality.
Focus is mainly on operational phase as the environmental impacts will be due to

continuous operation of the project.
Impacts due to industry on six basic environmental parameters listed below are
studied.
1. Air environment
2. Noise environment
3. Water environment
4. Land environment
5. Biological environment
6. Socio-economic environment
7. Flora & fauna
The impacts on the above parameters have been identified, analysed and classified as
adverse, beneficial impacts and the impact matrix is presented later in the report.
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4.1.2.1 SCOPE
Identification and assessment of

Adverse and beneficial environmental impacts due to the project.
Mitigation measures to minimize the adverse impacts.
4.1.2.2 ACTIONS LIKELY TO AFFECT THE ENVIRONMENT DURING OPERATION PHASE
1. AIR ENVIRONMENT
Pollutants in the form of oxides of nitrogen, sulfur and SPM from generators and
boilers and acid mist/VOCs from the process section, contribute and cause certain
impacts on the ambient air quality if not controlled.
The process of manufacture of APIs & intermediates involves closed operations in

controlled reactors. The handling and operation of such activity invariably
generates small quantity of acid mist and VOCs from the process and other
physical operations which would cause impact on the environment if not
controlled.
Reactor emissions can be from the following

a) displacement of air containing VOC during reactor charging,
b) solvent evaporation during the reaction cycle
c) overhead condenser venting uncondensed VOC during refluxing,
d) purging vaporized VOC remaining from a solvent wash and
e) opening reactors during a reaction cycle to take samples, determine reaction end-
points etc.
2. NOISE ENVIRONMENT
DG sets are the major noise generating sources during the operation phase. Also
handling and conveying of raw materials and semi-finished components to
different operations & compressors can be a source of noise pollutio n.
3. WATER ENVIRONMENT
Wastewater from manufacturing process, washing/cleaning, boiler blow -down,

cooling tower, QC, R&D section, scrubber and DM/softener rejects are the
major sources. In addition small quantity of domestic sewage is also generated.
Also, a number of raw materials, products, by-products, hazardous waste are
used, generated and stored within the industry premises. Their improper
management can cause an impact on the surface and groundw ater sources.
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4. LAND AND BIOLOGICAL ENVIRONMENT
The major impacts on land environment can be due to

Discharge of wastewater
Improper storage and disposal of solid and hazardous wastes
Improper storage of raw materials and products.
5. SOCIO-ECONOMIC ENVIRONMENT
This is mainly positive impact in terms of increased employment potential by creating

direct and in-direct employment opportunities. Preference is given to the local
skilled, semi-skilled and unskilled workers.
6. FLORA & FAUNA
There are no rare, endemic or endangered species in the study area. Moreover, all
measures are taken for minimizing/offsetting adverse impacts on air, water and soil
as detailed in further sections of this Chapter.
4.1.2.3 MEASURES FOR MINIMIZING & / OR OFFSETTING ADVERSE IMPACTS

IDENTIFIED - MITIGATION MEASURES
I. AIR ENVIRONMENT
Pollutants like SPM, SO 2, NOx and CO are emitted from the industry mainly due to
burning of fuel in DGs and boilers. Exhausts from these sources are let out from stacks
of adequate height and also suitable air pollution control units are provided as
stipulated by KSPCB.
There is a possibility of plant personnel coming in contact with gaseous fumes

and prolonged exposure to such an environment can adversely affect their
health. Therefore, the management of the industry has provided to all the
personnel engaged in production operations with Personal Protective
Equipments (PPE) to protect themselves from possible occupational hazards.
Mitigation measures for air quality management during operation phase are shown in
table 4.1.
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Table 4.1: Air quality management during operation phase

Environmental Mitigation measures
impacts
Process of Process emissions from the reactors are scrubbed using
manufacture packed column scrubbers with caustic soda as the
of APIs & scrubbing media. Also stacks 3 m height ARL are provided
intermediates as stipulated.
Fugitive Also, manufacturing process involves closed operations in
emissions due various controlled reactors to minimize fugitive emissions.
to storage of Main condenser with Cooling Tower (CT) water circulation and
solvents sub condenser with chilled water circulation provided for all
Particulate the reactors to control emissions.
and gaseous Solvents are transferred from warehouse to tanks in
emissions production blocks under closed condition. Only sealed
from DG set containers are handled. From here, pumping to the reactors is
and Boiler also in closed condition.
Transportation All centrifuge vents are connected to the scrubber for
of raw controlling of fugitive emissions.
materials and The process area is provided with abundant natural light
products and ventilation and high roofs to disperse the
fumes/gases to the outside atmosphere; preventing the
dispersed.
AHUs (Air Handler Unit) are provided for circulation of
fresh air into process area which has a roof height of 5-
5.5 m.
The emissions from DGs and boilers will be let out through
stacks of height 5 m ARL and 30 m AGL respectively.
Boilers are provided with multicyclone.
Stacks and ambient air are monitored at regular intervals.
Sample analysis reports are appended as Annexure A3.
Transport vehicles will be maintained.
Ambient air Ambient air quality monitoring is carried out monthly at
quality two locations within the industry premises. Sample
analysis reports are appended as Annexure A3.
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II. NOISE ENVIRONMENT
The main sources of noise pollution in the industry are from the operation of
machineries during the manufacturing process, handling and conveying of raw
materials and semi-finished components to different operations.
The conveying system is maintained by following routine and periodic

maintenance to reduce noise generation in material handling.
High noise generating units such as DG sets are provided with acoustic enclosures.
Green belt at the project boundary further acts as noise barrier and helps in
attenuation of noise. Measures for maintaining noise levels within stipulated limits are
presented in table 4.2.
Table 4.2: Noise management during operation phase

Environmental impacts Mitigation measures
Operation of DG sets are provided with acoustic enclosure. They
machineries during are installed in dedicated utility area, where the
the manufacturing access will be restricted. Also the use of PPE (ear
process. plugs) will be mandatory in this area.
Handling and Green belt at the project boundary will further act
conveying of raw as noise barrier and help in attenuation of noise.
materials and semi-
finished components
to different
operations.
Operation of DG set.
Transportation of raw
materials, products
and hazardous waste
III. TRAFFIC DENSITY AND ITS IMPACT
Raw materials will be procured from various locations and transported to the factory
through lorries/tankers by rail/road. Similarly, the final products will be transported
by rail/road to various locations within India and by sea/air to other countries. The
vehicles will move mainly through State and National highways which are tarred
roads. Presently, the traffic on these roads is meagre and vehicle movement to and
from industry does not have any major impact on the existing environment.
Maximum number of vehicles moving in and out of the premises in one day is around
6-7.
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IV. WATER ENVIRONMENT
Water demand is met from Krishna river source supplied by KIADB.

Domestic sewage and trade effluent are generated from the industry.
Table 4.3 presents measures taken to treat wastewater to stipulated limits.
Table 4.3: Water quality management during operation phase

impacts
(a) Domestic The domestic sewage is treated in septic tank and soak pit.
sewage
(b) Trade After pre-treatment, the effluent, i.e. neutralized effluent is
effluent sent to Shilpa Medicare Unit II for final treatment and
disposal. At Unit II Multi Effect Evaporator and Agitated Thin
Film Drier is provided. The capacity of the system is good
enough to handle effluent from Unit I & II. The condensate
from the MEE is again treated in Biological ETP and RO, at
Unit II. RO permeate is reused for cooling tower and boilers.
(c) Storage of They are stored in designated, closed, hard paved area to
raw materials, prevent percolation and contamination of groundwater
products and sources or run-off to the surface water sources.
by-products Dyke wall of 18.46 X 13.26 X 1.3 m is constructed around
solvent storage area to contain spills, if any within the
premises.
Training is provided to employees concerned on safe
handling and management.
Ground water Source of water supply is from KIADB (Krishna River).
quality/ Groundwater recharging pits are provided at different
availability locations within the site.
Surface water
Water consumption is for industrial and domestic purposes.
availability
Receiving
No impact as treatment of domestic sewage and industrial
water body
effluent, storage and disposal of hazardous waste, storage and
quality
handling of raw materials and products are managed without
Drainage
causing any adverse impact on the environment.
system
V. LAND ENVIRONMENT
Mitigation measures for maintaining quality of land environment is tabulated below
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Table 4.4: Land quality management during operation phase

impacts
(a) Effluent Closed collection tanks above ground level.
management Pre-treatment facility for effluent on impervious ground,
system hence no leakage
(b) Storage of Designated hazardous waste storage area secured by proper
hazardous roofing on impervious platform.
wastes
(c) Storage of Designated storage area with proper roofing on impervious
raw materials platform.
(d) Storm Storm water drain is kept separate and there is no mixing of
water effluent or any discharges or spillages.
4.1.2.4 IMPLEMENTATION SCHEDULE
All the mitigation measures detailed in the previous section exist and are
implemented. The responsibility of implementation lies with M/s. Shilpa Medicare
Ltd. Unit I.
4.1.3 Environmental impacts due to final decommissioning and mitigation measures
Shilpa Medicare Ltd., Unit I is an operating industry and decommissioning is not

envisaged. However, in-order to minimize impacts that may arise during any
eventuality following precautions are taken
All hazardous wastes are disposed within the stipulated time frame without
stockpiling.
Raw materials are procured on need basis avoiding overstocking.
Products are manufactured based on market demand.
4.2 IRREVERSIBLE & IRRETRIEVABLE COMMITMENTS OF ENVIRONMENTAL

COMPONENTS
Adequate care is taken to prevent any major impact on the environmental parameters
as necessary mitigation measures are in place.
4.3 ASSESSMENT OF SIGNIFICANCE OF IMPACTS (CRITERIA FOR DETERMINING

SIGNIFICANCE, ASSIGNING SIGNIFICANCE)
The significance of the impacts identified in the previous sections for various
environmental parameters are detailed in this section.
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4.3.1 Impact matrix
Table 4.5 presents impact matrix for the actions identified on various environmental
parameters. A rating scale has been devised to give severity of impacts in the
following manner.
A : Strongly beneficial (positive) impact
B : Low beneficial impact
C : Strong adverse (negative) impact
D : Low adverse impact (localized in nature)
E : No conceivable impacts on environment
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Table 4.5: Impact matrix

Sl. Environmental Impact rating during operation phase Mitigation
Probable source of impact Remarks
no. components measures
Description Scale
Process of manufacture of APIs and intermediates
fugitive emissions.
Air environment Low adverse impact (localized in
Storage of raw materials and solvents.
1 - ambient air nature) D
Particulate and gaseous emissions from DG sets
quality DG sets
and boilers.
will be
Transportation of raw materials and products
used
Operation of machineries during the only
manufacturing process.
during
Handling and conveying of raw materials and power
Low adverse impact near noise
semi-finished components to different areas of
2 Noise generation sources inside the D failure.
operations.
premises. Detailed in section
Operation of DG sets.
4.1.2.3 of this
Transportation of raw materials, products &
Chapter.
hazardous waste.
Water environment
Ground water
Source of water supply is from KIADB (Krishna Water
quality/ No conceivable impact E
River). conserva
availability
tion
Surface water Water consumption for industrial and domestic
3 Low adverse impact D measure
availability purposes.
s will be
No conceivable impact as wastewater
Receiving water encourag
is completed treated and trade E Discharge of domestic sewage and industrial
body quality ed.
effluent is reused. effluent.
Drainage system No conceivable impact E Storage and disposal of hazardous waste.
No conceivable impact as good storage Storage and handling of raw materials and
4 Land and handling systems are adopted for E products. -
solid and hazardous waste.
Locally available
manpower utilized
5 Socio-economic Low beneficial impact B Employment opportunities -
to the maximum
possible extent.
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CHAPTER 5
ANALYSIS OF ALTERNATIVES
(TECHNOLOGY & SITE)
Analysis of alternatives (technology and site) was not proposed during the
scoping stage.
CHAPTER 6
ENVIRONMENTAL MONITORING PROGRAM
6.1 TECHNICAL ASPECTS OF MONITORING THE EFFECTIVENESS OF MITIGATION

MEASURES (INCLUDING MEASUREMENT METHODOLOGIES, FREQUENCY,
LOCATION, DATA ANALYSIS, REPORTING SCHEDULES, EMERGENCY PROCEDURES,
DETAILED BUDGET AND PROCUREMENT SCHEDULES)
6.1.1 Measurement methodology
Ambient air, stacks, ambient noise, water and wastewater are to be monitored
on regular basis.
Monitoring of all environmental samples shall be done as per the guidelines

provide by MoEF/CPCB/SPCB. The method followed shall be recommended /
standard method approved/recommended by MoEF/CPCB.
Monitoring is outsourced to M S V Analytical Laboratories which is

NABL/MoEFCC accredited.
6.1.2 Frequency, location, data analysis, reporting schedules
A comprehensive monitoring program is in table 6.1.
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Table 6.1: Monitoring schedule for environmental parameters

Sl. Particulars Monitoring Duration of Important parameters
No. frequency monitoring for monitoring
I Air quality
1 Ambient air Once in a 48 hours (2 PM10, PM2.5,H2S, NOx,
monitoring - project month consecutive SOx
premises 2 locations. days)
2 Ambient air - VOC Once in 3 As per VOC
months standard
procedures
3 Stack monitoring Once in a Grab As stipulated by KSPCB
process section, month in Consent to Operate.
boilers, DG.
4 Hazardous air Once in 6 As per As stipulated by KSPCB
pollutants benzene, months standard in Consent to Operate.
carbon tetra procedures in
chloride, methanol, National
toluene etc. Ambient Air
Quality
Standards.
II Water and wastewater quality
a Water quality
i. Groundwater at two Twice a year Before & As per KSPCB
locations (up- after stipulations
gradient and down- monsoon
gradient)
b Wastewater quality
i. Raw effluent Once in a Grab As per KSPCB
month stipulations
III Soil quality
1. Within project Once in a year Composite As per KSPCB
premises at 1 sample stipulations
location
IV Noise monitoring
1. Project premises Once in a Day time and As per KSPCB
month night time stipulations
V Hazardous waste monitoring
1. Hazardous waste Annually Grab As per KSPCB
characterization stipulations
In addition to the above schedule of monitoring carried out by external

laboratory, continuous online monitoring system is provided to measure flow of
wastewater/effluent outlet and linked to CPCB website. Camera is provided to
monitor the effluent collection & disposal. Photographs are shown in fig 6.1
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Fig 6.1: Continuous online monitoring system
6.1.3 Emergency procedures
Approved on-site emergency plan is available and is available and is approved

by the Inspector of Factories.
6.1.4 Budget and procurement schedules
The financial allocation/budgetary provisions for environmental management

are detailed in table 6.2.
Table 6.2: Financial allocation/budgetary provisions for environmental

management aspects
Sl. Description Financial provision
No. in Lakhs/annum -
recurring cost
1 Personal protection safety gadgets and health care 48
2 Tree plantation and landscaping measures 12
3 Environmental monitoring plan (air, noise, water 48
and hazardous waste)
4 Effluent Treatment and hazardous waste 180
management
TOTAL 288
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CHAPTER 7
ADDITIONAL STUDIES
7.1INTRODUCTION
7.1 PUBLIC CONSULTATION
The Deosugar Industrial Area, i.e., the Raichur Growth Center of KIADB,
Government of Karnataka was established on 27-4-1987. Screenshot from
Karnataka Industrial Areas Development Board (KIADB) is in fig 7.0. This is prior
to EIA Notification 2006. The total extent of this industrial area is 214.86 acres.
Point (7) of letter issued by MoEFCC vide no. F.No.J-11011/191/2017-IAII(I)

dated 14th June 2018 specifically states that EIA report has to be prepared
incorporating all issues raised during Public hearing/consultation. Accordingly
public consultation was conducted on 13th November 2018. Details with action
plan to address the environmental concerns expressed during the process are
addressed in Chapter 13.
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Fig 7.1: Screenshot from KIADB
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7.2INTRODUCTION
7.1 RISK ASSESSMENT
7.2.1 Introduction
APIs & Intermediates manufacturing industries are generally associated with

use of raw materials and chemicals which are hazardous in nature. The process
activities of these industries are also associated with certain risks. Therefore,
HAZOP analysis and risk assessment are addressed in detail as additional
studies.
7.2.2
7.2 HAZOP
HAZOP analysis
ANALYSIS
Detailed step-wise HAZOP analysis studies describing process, operation,

possible hazard failure and remedial actions for each of the product
manufactured is given in Annexure A9.
7.2.3 Introduction to risk assessment
Risk assessment is a term used to describe the overall process or method where
hazards and risk factors that have the potential to cause harm are
identified (hazard identification).
the risk associated with that hazard (risk analysis, and risk evaluation)
are analysed and evaluated.
appropriate ways to eliminate the hazard, or control the risk when the
hazard cannot be eliminated (risk control) are determined.
7.2.4 Evaluation of risks
The recognized method for evaluation and management of risk are -

Adherence to good practices in design, construction, operation,
maintenance, organization.
Predictive hazard and risk analysis by studies like HAZOP, HaZan, failure
mode and effect analysis, event/fault tree analysis, effects and damage
calculation, risk contours etc. Dispersion models which try to predict
concentrations at ground level and other attitudes of emissions after taking
into account atmospheric conditions.
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7.2.5 Minimization / avoidance of the risk
Providing the necessary warning system and automatic quick action.

Minimizing inventories of hazardous raw material.
Quick isolation and release of contents to flare, detoxification etc.
Training of personnel on emergency procedures, mock drill & table top
discussions and updating the disaster management plan.
Providing green belt around factory.
Monitoring of air quality in the area and of emission and effluents arising
out of normal operation.
Analyzing the risks (fire, explosion gas cloud, leak) and consequences arising
out of abnormal operation.
Identifying the impact on environment and neighboring population due to
operations as well as other activities and suggest measures to bring down
the risks and environmental pollution.
7.2.6 Quantitative risk analysis
Quantitative risk analysis is used for

Plant location, layout, tank and equipment, predicting areas which may be
affected by toxic gas release or fire and explosion.
Analyzing the risks (fire, explosion gas cloud, leak) and consequences arising
out of abnormal operation.
Suggest measures to bring down the risks and environmental pollution.
7.2.7 Hazard identification
The technique used for the hazard identification is Maximum Credible Accident
(MCA) analysis, which allows identification of an accident with probable
maximum damage distance.
Apart from the solvents, diesel fuel will also be stored in plant premises. The
solvent storage tanks are designed as per the safety norms. Apart from the tanks
small quantities of solvents are stored in flame proof barrels in designated
storage area in a secured manner under cover. The solvent and fuel requirement
for the industry/plant on monthly basis is based on the production schedule.
Probable hazards in the Plant are shown in table 7.1.
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Table 7.1: Probable hazards in the plant

Hazard type Description
Solvent use Spillage of chemicals while handling.
Spillage of chemicals or baths into trench.
Fuel storage Diesel oil spill and fire.
The drawing indicating areas earmarked for storage of solvents is shown in the
plant layout of the industry.
7.2.8 Risk assessment
Hazards and risks associated with manufacture of ursodeoxy cholic acid, above
ground storage tanks housing flammable solvents, drum storage shed, solvents
loading and unloading, equipments and reactors with existing controls available
are detailed below
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Name of Person Undertaking Assessment Date Conducte d Department / Are a (including description of what is be ing asse sse d)
A.M.KULKARNI 04-04-2018 3alpha,7beta-Dihydroxy Cholanic acid / Urso deoxychlolic acid
Re f No Haz ard under re vie w No & Description of Existing Controls Asse sse d Le ve l Furthe r Action Re quire d By (Date )
staff involve d of Risk* + Re vie w
Date
L M H
1 Fire and Explosion Staff -5 Certifying reactor to ensure free of water and X Ensuring of earthing and
-Air and vapour mixture formation while Workmen-10 moisture bonding through recording in
handling Butanol due to spillage, leaks. Casuals-5, Practicing chemical compatibility to avoid butanol BMR
-Air ingress during Butanol distillation. In the entire and Sodium bromate during staging of RM Ele ctrostatic bonding and
-Water/moisture contact with Na Production Block Effective PMP for FLP fixtures and SRV e arthing.
-Contact of Sodium bromate with Butanol LEL detectors instead of smoke detectors. Avoid and prevent personnel
-Failure of FLP fixtures. Non sparking tools acquiring electro static charges
-Non provision of FLP fixtures. Ensuring and recording of Nitrogen blanketing and Re lease of vacuum through
-Formation and discharge of static oxygen monitoring nitrogen
charges. Charging powdered raw materials through Hopper.
-Usage of sparking tools. Effective works permit system.
-External ignition sources. Vents fixed with flame arresters.
-Absence of hot work permits system.
2. Pressure Staff -5 Recording of vent opening in BMR X Effe ctive PMP of SRV
-Closure of vent. Workmen-10 Periodical recording of PG re adings in BMR High pressure alarms and self-
-Nonfunctioning of vent. Casuals and visitors-5 SO P to ensure absence of water in reactor after correcting systems
-Water contact with Sodium metal In the entire cleaning. Use of non-aqueous coolant for
-Absence of coolant in condenser. Production Block jacket and condenser.
3. Exothe rmic Staff -5 Checking of moisture content of the contents before X O rde r of charge to be maintained
Water or aqueous solution contact with Workmen-5 charging Sodium metal strictly.
Sodium. Casuals
In the entire
Production Block
4. Toxicity Staff -5 Supplied air mask while handling Ammonia. X Spill control training.
Due to spillage, leakage, emissions or Workmen-10 Avoidance of employees with premedical conditions Haz ard communication training
reactor pressurization. Casuals-5 for handling Ammonia/Methylene chloride
-Methylene Chloride, Carcinogen(2B) In the entire Respirators approved by NIOSH. EN or equivalent IS
-Ammonia Production Block Spill control materials like sorbent pads and booms.
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Name of Person Undertaking Assessment Date De partment / Area (including de scription of what is being asse sse d)
Conducted
A.M.KULKARNI 04-04-2018 ABO VE GROUND STORAGE TANKS HO USING FLAMMABLE SO LENTS
Re f No Haz ard unde r revie w No & Existing Controls Asse ssed Level of Risk* Furthe r Action Re quire d By
De scription (Date
of staff )
involve d +
Re vie
L M H
w
Date
1 SO P for various operations inside the tank X Ide ntification of flammables for air vapours mixture
Fire and Explosion Staff -1 are a to highlight fire safety issues and inside the tank.
-Air and vapour mixture formation while Workmen-1 corrective actions. Vapour space to be filled with inert gas.
loading, unloading sampling and dispensing of Casuals-1 Installation of flame arrester in Ensuring complete discharge of electrostatic
solvents. combination with breather arrangement. accumulation from the tanker using earthrite.
-Formation of air+vapour mixture inside the Tanker unloading permit procedure. LEL dete ctors.
storage tank. Fire protection by sprinkler system around Ele ctrostatic bonding
-Poor control of external ignition sources inside the storage tank and tanker. Avoid and prevent personnel acquiring e lectro static
the tank area. Distances maintained as per statutory charges
-In adequate separation distances from the tank regulations Re lease of vacuum through nitrogen.
are a and adjacent buildings. Se lection of e lectrical installations as per IS-
-Electrical installations not as per haz.area 2148 or any other international body.
classification. Effe ctive PMP for FLP fixtures.
-Failure of FLP fixtures. Ensuring of earthing and bonding through
-Non provision of FLP fixtures. recording in BMR
-Formation and discharge of static charges. Non sparking tools
-Usage of sparking tools. Effe ctive works permit system.
-External ignition sources. Ve nts fixed with flame arresters.
-Absence of hot work permits system. Display of prohibition of spark producing
materials in to tank farm.
2. Pre ssure Staff -1 Sprinkler system with heat detector. X Solvents with high evaporation rate should have
-extreme heat Workmen-1 Adequate maintenance of pressure relieving cooling arrangement.
-sudden cooling Casuals and systems Ine rtising pre ssure regulated.
-choking of flame arrester and breather valve. visitors-2 PMP for breather and flame arresters. Re sidues with potential for de composition to be
-sudden increase in inertising pressure. De sign of tank adequate to sustain pressure avoided.
-impingement of heat due to external fire. and vacuum.
-Nonfunctioning of sprinkler or other cooling
arrangement.
-Decomposition of the product.
3. Exposure hazards. Staff -1 Re spirators approved by NIOSH. EN or X
De rmatitis with prolonged contact with solvents. Workmen-1 equivalent IS. Spill control training.
Severe chemical burns due to splashing of Casuals-1 Full face protection. Hazard communication training
solvents. Eme rgency shower and eye wash
Spill control materials like sorbent pads and
booms.
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Name of Person Undertaking Assessment Date De partment / Area (including description of what is be ing asse sse d)
Conducted
A.M.KULKARNI 04-04-2018 DRUM STO RAGE SHED
Re f No Haz ard unde r revie w No & Existing Controls Asse ssed Level of Risk* Furthe r Action Re quire d By (Date )
De scription + Re vie w Date
of staff
involve d
L M H
1 Fire and Explosion Non sparking tools. X LEL dete ctors instead of smoke detectors.
-Air and vapour mixture formation while Staff -2 Effe ctive works permit system. Ele ctrostatic bonding
sampling and dispensing of flammable materials. Workmen-2 Avoid and prevent personnel acquiring
-Usage of air for dispensing solvent from the Casuals-1 e lectro static charges
drum. Usage of extremely low pressure Nitrogen
- dropping and rolling of solvent drums. for dispensing.
-Chemical compatibility not observed.
-Failure of FLP fixtures.
-Non provision of FLP fixtures.
-Formation and discharge of static charges.
-Usage of sparking tools.
-External ignition sources.
2. Pre ssure Staff -2 -Air moisture sensitive materials stored in X -mechanical arrangements to place the
-Decomposition of the product. Workmen-2 controlled conditions. drums.
-use of uncontrolled pressure of air/nitrogen for Casuals and -He at from external sources prevented. -Integrity of the container maintained
dispensing. visitors-2 -The storage place checked periodically and after sampling.
-exposure to external source of heat. containers for pressure regularly. -Use of low pressure nitrogen.
-admittance of air or moisture in to the drums
containing sensitive materials.
3. Exposure hazards. Staff -2 Re spirators approved by NIOSH. EN or X
De rmatitis with prolonged contact with solvents. Workmen-2 equivalent IS. Spill control training.
Severe chemical burns due to contact of corrosive Casuals-2 Extra-long acid alkali gloves while handling Hazard communication training
che micals. corrosive solids and liquids.
Severe respiratory problems due inhalation of Spill control materials like sorbent pads and
corrosive fumes. booms.
While de aling with spills and similar e mergency Chemical emergencies handled with SCBA
conditions. Water reactive materials stored separately.
Life threatening situations while de aling with
che micals releasing toxic gases like H2S.
4. Re action e xotherm. Staff -2 Mate rials stored as per compatibility. X Hazard communication.
Water reactive materials Workmen-2 Storage conditions mentioned in MSDS are
Air se nsitive materials Casuals-2 obse rved.
Incompatible materials Haz ard display.
Unstable materials
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Conducte d
A.M.KULKARNI 04-04-2018 PRO CESS EQ UIPMENT-REACTO RS
Re f No Haz ard unde r review No & Existing Controls Asse ssed Level of Risk* Furthe r Action Re quire d By (Date )
Description + Re vie w
of staff Date
involved
L M H
1 Effe ctive PMP for FLP fixtures and SRV X

Fire and Explosion Staff -1 MO C suiting the chemicals involved in the LEL detectors instead of smoke detectors.
-Air and vapour mixture formation during Workmen-1 process. Ele ctrostatic bonding
che mical processing. Casuals-1 Proper selection of agitator type and speed. Re lease of vacuum through nitrogen.
-agitator failures. DQ protocol complete with safety
-wrong MOC requirements.
-Failure of FLP fixtures. Non sparking tools
-Non provision of FLP fixtures. Ve nts fixed with flame arresters.
-Formation and discharge of static charges.
2. Pre ssure Staff -1 Effe ctive PMP of SRV X

-Closure of vent. Workmen-1 Re cording of ve nt opening in BMR Use of Efficient Coolant to the jacket and condenser.
-Nonfunctioning of vent. Casuals and Pe riodical recording of PG readings in
-flame arresters choke visitors-2 BMR
-Absence of coolant in condenser. High pressure alarms and self-correcting
-Decomposition of the product. systems
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Name of Person Undertaking Assessment Date De partment / Area (including de scription of what is being a sse sse d)
Conducte d
A.M.KULKARNI 04-04-2018 PRO CESS EQ UIPMENT-CENTRIFUGE& Filtration equipment like Nutch Filters Cum driers
of staff Date
involved
L M H
1 Effe ctive PMP for FLP fixtures and SRV X

Fire and Explosion Staff -1 Ensuring of earthing and bonding through LEL detectors instead of smoke detectors.
-Formation of air+vapour mixture in the Workmen-1 recording in BMR Ele ctrostatic bonding
basket Casuals-1 Non sparking tools Avoid and prevent personnel acquiring e lectro static
-vapour+air mixture in the room. Ensuring and recording of Nitrogen charges
-Failure of FLP fixtures. blanketing and oxygen monitoring
-Non provision of FLP fixtures. Effe ctive works permit system.
-Formation and discharge of static charges. Ve nts fixed with flame arresters.

-Closure of vent. Workmen-1 Re cording of ve nt opening in BMR
-Nonfunctioning of vent. Casuals and
visitors-1
3. Physical injuries Staff -1 Good house keeping X Inte rlocks
-Contact with rotating parts Workmen-1 Circuit breakers
-Slip, trip and falls Casuals-1 Effe ctive work permit system
-electric shocks Maint.crew-
1
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Name of Person Undertaking Assessment Date Conducte d Departme nt / Are a (including description of what is be ing asse sse d)
A.M.KULKARNI 04-04-2018 SO LVENT UNLO ADING AND LO ADING
Re f No Hazard under revie w No & Description of staff Existing Controls Asse ssed Le ve l of Furthe r Action Re quire d By (Date )
involve d Risk* + Re vie w
Date
L M H
1 Fire and explosion hazard Staff -1 Dematching at the gate X Drum unloading to be done using scissors lift
Workmen-1 Fire and Explosion signs displayed only
Casuals- - Compatibility followed while storing Bonding and e arthing to be ensured.
Drive r -1 Spark arresters e nsured at the gate.
Cleaner -- Spark arresters fixed to the vehicles at
the gate.
Work men training
Hazard communication
Inspection program for earthing and
bonding cable integrity.
Spark arresters inspection and
maintenance.
Spark proof tools to be used.
2. Chemical exposure Staff -1 Caution displayed X Prote ction against inhalation, contact and
Workmen-1 Work men training ingestion to be provided by providing specific
Casuals- Hazard communication RA
Drive r -1 Provision of PPE Staff to e nsure using the same and record
Cleaner - Annual health check up
3. Physical injuries Workmen-1 All workers to be provided with shoes X
Hit by Casuals-1 with toe guards. Present methodology of rolling the drums to be
Crush injuries avoided.
4. Ergonomic hazards Staff -1 None X Risk assessment of manual handling

Workmen-1 Training on proper manual handling
Casuals-2 techniques.
Emphasis on postures leading to sprains and
strains
5. Vehicle movement Staff -1 None X Wheel chokes should be used while parking
Workmen-1 vehicles on slopes.
Casuals-2 Ve hicles should be e nsured for road worthy
conditions.
Traine d drivers should be e nsured for the
vehicles.
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6. Lone worker Staff -1 None X Lone worker policy to be installed.

Workmen-1 Lone worker risk assessment to be done to
Casuals-1 provide necessary controls for identified risks.
7. Emergency communication Staff -1 None X Eme rgency communication facilities like siren,
Workmen-1 PA system to be installed
Casuals-1
Emergency Evacuations Staff -5 None X Evacuation routes to be identified and marked
9. Workmen-5 Training
Casuals-4 Allocated assembly points.
Eme rgency lighting
Vehicle movement Staff -1 None X Wheel chokes should be used while parking
Workmen-1 vehicles on slopes.
Casuals-1 Ve hicles should be e nsured for road worthy
conditions.
Traine d drivers should be e nsured for the
vehicles.
7. Lone worker Staff -1 None X Lone worker policy to be installed.
Workmen-1 Lone worker risk assessment to be done to
Casuals-1 provide necessary controls for identified risks.
8. Emergency communication Staff -1 None X Eme rgency communication facilities like siren,
Workmen-1 PA system to be installed
Casuals-1
Emergency Evacuations Staff None X Evacuation routes to be identified and marked
9. Workmen Training
Casuals Allocated assembly points.
Eme rgency lighting
10. Manual Handling Workmen -1 None X Risk assessment of manual handling
and Casuals-1 Training on proper manual handling
techniques.
Emphasis on postures leading to sprains and
strains
11. Insects and other harmful creatures like Staff -1 Anti-snake venom kept in dedicated X All staff and workmen should be made aware of
snakes Workmen-2 place. the antidote location.
Casuals-1 Staff and workmen to be trained and first aid to
treat the injuries specific to the work and
harmful creatures.
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Conducte d
A.M.KULKARNI 05-04-2018 PRO CESS EQ UIPMENT-RCVD, RVPD, Vacuum Tray Drier,
of staff Date
involved
1 Fire and Explosion Staff -1 Effe ctive PMP for FLP fixtures and SRV X LEL detectors instead of smoke detectors.
-Air and dust mixture formation inside and Workmen-1 Ensuring of earthing and bonding through Ele ctrostatic bonding
around the eqpt. Casuals-1 recording in BMR Avoid and prevent personnel acquiring e lectro static
-Air ingress during vacuum drying Non sparking tools charges
-Failure of FLP fixtures. Ensuring and recording of Nitrogen Re lease of vacuum through nitrogen
-Non provision of FLP fixtures. blanketing and oxygen monitoring
-Formation and discharge of static charges. Charging powdered raw materials through
-Usage of sparking tools. Hopper.
-External ignition sources. Effe ctive works permit system.
-Absence of hot work permits system. Ve nts fixed with flame arresters.
-
2. Pre ssure Staff -1 Effe ctive PMP of SRV X Earth interlocks.

-Closure of vent. Workmen-1 Re cording of ve nt opening and closing in
-Nonfunctioning of vent. Casuals -1 BMR
-Ignition inside High pressure and vacuum failure alarms
and self-correcting systems
3. Physical injuries Staff -1 Effe ctive safe work system. X Inte rlocks to prevent contact of rotating part.
-Contact of rotating parts Workmen-1 Good house keeping
-Electric shocks Casuals Circuit breakers
-Slip, trip and falls Maint.crew
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Conducte d
A.M.KULKARNI 05-04-2018 PRO CESS EQ UIPMENT-TRAY DRIER
of staff Date
involved
1 Fire and Explosion Staff -1 Blowers are Kept outside the drying X LEL detectors instead of smoke detectors.
-Air and dust mixture formation inside and Workmen-1 Chambers keeping HEPA Filters as Ele ctrostatic bonding
around the eqpt. Casuals-1 barriers to avoid the contact of Moving Avoid and prevent personnel acquiring e lectro static
-Air ingress during vacuum drying parts in the Drying chamber charges
-Failure of FLP fixtures. Effe ctive PMP for FLP fixtures and SRV/ Re lease of vacuum through nitrogen
-Non provision of FLP fixtures. EXPLO SIO N VENT
-Formation and discharge of static charges. Ensuring of earthing and bonding through
-Usage of sparking tools. recording in BMR
-External ignition sources. Non sparking tools
-Absence of hot work permits system. Ensuring and recording of Nitrogen
- blanketing and oxygen monitoring
Charging powdered raw materials through
Hoppe r.
Effe ctive works permit system.
Ve nts fixed with flame arresters.
2. Pre ssure Staff -1 Effe ctive PMP of exhaust dampner X Earth interlocks.
-Closure of Exhaust dampner. Workmen-1 High pressure and vacuum failure alarms
-Nonfunctioning of vent. Casuals -1 and self-correcting systems
-Ignition inside
-Slip, trip and falls Maint. crew
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Conducte d
A.M.KULKARNI 05-04-2018 PRO CESS EQ UIPMENT-Multimill & Sfter
of staff Date
involved
1 Fire and Explosion Staff -1 Effe ctive PMP for FLP fixtures & X LEL detectors instead of smoke detectors.
-Air and dust mixture formation inside and Workmen-1 e quipment Ele ctrostatic bonding
around the eqpt. Casuals-1 Ensuring of earthing and bonding through Avoid and prevent personnel acquiring e lectro static
-Air ingress during vacuum drying recording in BMR charges
-Failure of FLP fixtures. Non sparking tools
-Non provision of FLP fixtures.
-Formation and discharge of static charges. Charging powdered raw materials through
-Usage of sparking tools. Hopper.
-External ignition sources. Effe ctive works permit system.
-Absence of hot work permits system. Ve nts fixed with flame arresters.
-
2. Pre ssure Staff -1 Effe ctive PMP of the Rotating Parts, X Earth interlocks.
. Workmen-1 the reby avoiding the sparks
-Ignition inside Casuals -1
-Slip, trip and falls Maint. crew
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Conducte d
A.M.KULKARNI 5-04-2018 PRO CESS EQ UIPMENT-Boiler 4 TPH @10.54 Kg /Cm2
of staff Date
involved
L M H
1 Effe ctive PMP for SRV, IBR Lines& Boiler X

Fire and Explosion Staff -2 Parts, Installed VFD’s To RUN the ID LEL detectors instead of smoke detectors.
-Air Q ty Draft Imbalance. Workmen-5 Fan&FD Fan as per the loads, thereby Ele ctrostatic bonding
-agitator failures. Casuals-5 pre venting the Back Firing From the
-wrong MOC Furnace
-Failure of FLP fixtures. Effe ctive PMP for water generation System,
-Formation and discharge of static charges. Installing auto Blow downs
-Absence of hot work permits system. DQ protocol complete with safety
requirements.

-Closure of Discharge Line to plant & Workmen-1 Re cording of SRV opening in Log Book
Continuation of Firing the furnace. Casuals and Pe riodical recording of PG readings in Log
-Nonfunctioning of SRV. visitors-2 Book
Low water levels High pressure alarms and self-correcting
systems
Effe ctive mobari Control is kept, to trip the
FD & Id fans
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7.2.9 Risk assessment for storage of materials
Name of Person Undertaking Assessment Date Conducted

A.M.KULKARNI 03/04/2018
Conducted For: Shilpa Medicare Ltd Unit-1,

Plot No-1A,1B,2,2A,3A to3E&4Ato4C ,5A,5B,Deosugur
Industrial area, Raichur- Taluk & District
Ref MATERIAL IN HAZARD REVIEW EXISTING CONTROLS RISK LEVEL SUGGESTED ACTION PLAN
No. STORE/ LOCATION
01
L M H
1 Dispensing room Fire SOP X FLP maintenance as per IS-
Ground floor, ware Exposure to chemicals FLP fittings SOP to be reviewed
House PPE Policy to prevent dispensing of
highly reactive materials having
rating of Nr 3,4 Nf 3,4 Oxidizing
and water reactive materials.
Smoke detectors.
Non-sparking tools.
2. Charcoal store. Dust explosion FLP fittings. X FLP fittings should be dust tight.
Ground floor, ware Self-heating. SOP Heat detectors.
house PPE Respirators with N98 filter.
3. Sodium room Fire SOP X Humidity control to maintain dry
Ground floor, Explosion. RCC room air.
Hazardous material Hydrogen detectors
store Special DCP extinguishers.
Warehouse Double door opening.
Non-sparking tools.
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4. Cold storage room. Fire SOP X FLP fittings

Ground floor. Ware Toxic release. Emergency exit.
house Heat/Smoke detectors.
5. Sampling room Fire SOP X FLP maintenance as per IS-
warehouse Toxic release. FLP fittings SOP to be reviewed
PPE Policy to prevent sampling of
highly reactive materials having
rating of Nr 3,4 Nf 3,4 Oxidizing
and water reactive materials.
Smoke detectors.
Non-sparking tools.
6. MCC Shock Earthing X Review earthing as per IS-3043
Ground floor Fire ELCB Include ELCB and safety mats
Warehouse Electrical burns. Safety mats testing in PMP.
Tested gloves Periodical review of electrical
safety tools and PPE
Provide protection for Arcing in
testing procedures.
7. Packing materials. Fire Proper segregation X Provide smoke detectors.

Ware house
8. Solvent tanks. Fire Double earthing X Sprinklers for tanker.
Tank Farm Explosion. Flame arrester. Static discharge interlock system
Loading unloading SOP Non-sparking tools.
FLP fixtures.
Fire extinguishers
Fire Hydrant
9. Liquid bromine. Exposure to vapours. Long sleeved gloves. X Supplied air mask.
Acids storage Shed Liquid contact. Chemical suit. Chemical clothing should be
Face shield based on permeability.
Canister mask.
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Reference tool for the Risk Assessment:
Likelihood/ Consequence Matrix

Consequence
Likelihood Consequence 1 2 3 4 5
A 1 A
M H H VH VH
Almost certain Insignificant
B 2 B
M M H H VH
Likelihood
Likely Minor
C 3 C
L M H H H
Possible Moderate
D 4 D
L L M M H
Unlikely Major
E 5 E
L L M M H
Rare Extreme
Very high – VH
High – H
Medium – M
Low – L
Risk assessment matrix

Likelihood/ Consequence Matrix Consequence
A 1 A
B 2 B H
Likelihood
Likely Minor
C 3 C H
Possible Moderate H
D 4 D
Unlikely Major
E 5 E
Rare Extreme
Identified Hazards (from above) Risk assessment Risk
score
Likelihood (L) Consequence L * C
(C)
Explosion C 4 C4 H
Thermal burns B 3 B3 H
Electrocution C 4 C4 H
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7.2.10 Major risk assessment
1. HAZARD (SUBJECT) BEING ASSESSED AND LOCATION (S).
1. Fire
2. Electrocution
3. Burn injuries
2. WHO MIGHT BE HARMED AND HOW?
Workmen-Performing the actual work

Maintenance staff-Performing repairs and PM
Contract personnel-Performing repairs and AM
3. RISK CONTROLS CURRENTLY IN PLACE (IF ANY).
1. Two SRVs
2. Insulation
3. Trip system
4. Earthing
5. PG
4. ASSESSED LEVEL OF RISK= HIGH
Fire Explosion-High
Electrocution-High
Burn injuries-High
5. IDENTIFICATION OF FURTHER ACTION REQUIRED:
1. Earth fault circuit breaker.

2. Interlocked pressure-Heating.
3. Effective insulation.
4. Relocation of boiler.
5. Relocation of control panel.
6. Therm-bar gloves.
7. Burn treatment kit.
8. PPE covering feet and ankle length.
6. ACTION PLAN: (TIME SCALES, PERSON RESPONSIBLE, etc.)
TIME SCALE-15 DAYS

RESPONSIBLE PERSON-Mr. PANDURANGA RAO KULAKARNI
6(a) DATE ASSESSMENT UNDERTAKEN:

03/04/2018
6(b) REVIEW DATE: 02/07/2018
6(c) ASSESSED BY: A.M.KULKARNI
DATE: 03/04/2018 TITLE: CONSULTANT
EIA
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Reference tool for the Risk Assessment:
Likelihood/ Consequence Matrix

Consequence
A 1 A
M H H VH VH
B 2 B
M M H H VH
Likelihood
Likely Minor
C 3 C
L M H H H
Possible Moderate
D 4 D
L L M M H
Unlikely Major
E 5 E
L L M M H
Rare Extreme
Very high – VH
High – H
Medium – M
Low – L
Risk Assessment matrix

Likelihood/ Consequence Matrix Consequence
A 1 A
B 2 B
Likelihood
Likely Minor
C 3 C H H H
Possible Moderate
D 4 D M M
Unlikely Major
E 5 E
Rare Extreme
Identified Hazards (from above) Risk assessment Risk score
Likelihood (L) Consequence (C) L*C
Fire/explosion risk C 4 C4 H
Electrocution C 5 C5 H
Entanglement D 3 D3 M
Thermal C 3 C3 H
Crushing D 4 D4 M
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7.2.11 Worst case analysis-control measures
Sl. Solvent Risk Worst Affected range threat Safety measures

no. case zone
1. METHANOL FIRE TANKER 37.5Kw-Less than 10M QRC coupled hose connections.
FAILURE 5.0kW-21M FLP electrical fixtures.
1.6kW-29M Electrostatic control measures.
Spark arrester to the vehicle.
Loading and unloading permit system.
Permit system for prevention of other ignition sources.
TOXIC ERPG3-5000ppm-33M
LEAK ERPG2-1000ppm-96M Hydrant system; foam monitor; sprinkler system for
ERPG1-200ppm-382M tanker; foam tank.
On site emergency plan.
OHC; Respiratory masks; SCBA; Antidotes.
2. ACETIC ACID FIRE TANKER Fire not considered for QRC coupled hose connections.
ACETIC FAILURE FP of the compound FLP electrical fixtures.
ANHYDRIDE being more than Electrostatic control measures.
ambient temp. Spark arrester to the vehicle.
TOXIC ERPG3-8M(250ppm) Permit system for prevention of other ignition sources.
LEAK ERPG2-400M(35ppm) Hydrant system; Foam monitor; Sprinkler system for
ERPG1-1300M(5ppm) tanker; Foam tank.
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Sl. Solvent Risk Worst case Affected range threat Safety measures
no. zone
3. HEXANE FIRE TANK 37.5kW-13M QRC coupled hose connections.
FAILURE 5kW-30M FLP electrical fixtures.
1.6KW-45M Electrostatic control measures.
Hydrant system; Foam monitor; Sprinkler system for
tanker; Foam tank.
4. TOLUENE FIRE TANK 37.5kW-13M QRC coupled hose connections.
FAILURE 5kW-30M FLP electrical fixtures.
1.6KW-45M Electrostatic control measures.
TOXIC ERPG3(1000ppm)-44M Spark arrester to the vehicle.
LEAK ERPG2(300ppm)-111M Loading and unloading permit system.
ERPG1(50ppm)-475M Permit system for prevention of other ignition sources.
tanker; Foam tank.
5. ETHYL FIRE TANK 37.5kW-Less than 10M QRC coupled hose connections.
ACETATE FAILURE 5.0kW-24M FLP electrical fixtures.
tanker; Foam tank.
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Sl. Solvent Risk Worst case Affected range threat Safety measures
no. zone
6. ACETONE FIRE. TANK FAILURE 37.5kW-11M QRC coupled hose connections.
5.0kW-25M FLP electrical fixtures.
Permit system for prevention of other ignition
sources.
Hydrant system; Foam monitor; Sprinkler system
for tanker; Foam tank.
7. BUTANOL FIRE TANK FAILURE 37.5kW-12M QRC coupled hose connections.
5.0kW-26M FLP electrical fixtures.
Permit system for prevention of other ignition
sources.
Hydrant system; Foam monitor; Sprinkler system
for tanker; Foam tank.
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7.2.12 Hazard and severity mapping for hazardous raw materials
1) LIQUID BROMINE
Prepared By:
KULKARNI ANAND M
INDUUSTRIAL SAFETY CONSULTANT
Punekar Compound, 6th Cross
Malmaddi, Dhrawad-50007
91-80-23582346, 9845202089
EMAIL: [email protected]
Prepared For:
Shilpa Medicare Ltd Unit-1
Plot No-1A, 1B, 2, 2A, 3A to3E & 4A to 4C, 5A, 5B
Deosugur Industrial area,
Raichur- Taluk & District
SITE DATA:
Location: RAICHURU, INDIA
Building Air Exchanges per Hour: 60 (user specified)
Time: April 6th, 2018
CHEMICAL DATA:
Chemical Name: BROMINE Molecular Weight: 159.81 g/mol
ERPG-1: 0.1 ppm ERPG-2: 0.5 ppm ERPG-3: 5 ppm
IDLH: 3 ppm
Ambient Boiling Point: 58.3° C
Vapor Pressure at Ambient Temperature: 0.42 atm
Ambient Saturation Concentration: 429,451 ppm or 42.9%
ATMOSPHERIC DATA: (MANUAL INPUT OF DATA)
Wind: 5 meters/second from SE at 3 meters
Ground Roughness: open country Cloud Cover: 0 tenths
Air Temperature: 35° C Stability Class: D
No Inversion Height Relative Humidity: 25%
SOURCE STRENGTH:
Evaporating Puddle
Puddle Area: 1 square meters Puddle Volume: 20 liters
Ground Type: Concrete Ground Temperature: 35°C
Initial Puddle Temperature: Ground temperature
Release Duration: ALOHA limited the duration to 1 hour
Max Average Sustained Release Rate: 1.77 kilograms/min
(Averaged over a minute or more)
Total Amount Released: 50.0 kilograms
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THREAT ZONE:
Model Run: Gaussian
Red : 116 meters --- (5 ppm = ERPG-3)
Orange: 399 meters --- (0.5 ppm = ERPG-2)
Yellow: 957 meters --- (0.1 ppm = ERPG-1)
2) HYDROCHLORIC ACID
SITE DATA:
Building Air Exchanges per Hour: 1.11 (unsheltered single storied)
CHEMICAL DATA: Hydrochloric acid

Warning: HYDROGEN CHLORIDE can react w ith water and/or water vapor. This
can affect the evaporation rate and downwind dispersion. ALOHA cannot
accurately predict the air hazard if this substance comes in contact with water.
Chemical Name: HYDROGEN CHLORIDE Molecular Weight: 36.46 g/mol

AEGL-1(60 min): 1.8 ppm AEGL-2(60 min): 22 ppm AEGL-3(60 min):
100 ppm
IDLH: 50 ppm
Ambient Boiling Point: -85.4° C
Vapor Pressure at Ambient Temperature: greater than 1 at Ambient Saturation
Concentration: 1,000,000 ppm or 100.0%

SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Non-flammable chemical is escaping from tank
Tank Diameter: 1 meters Tank Length: 1.27 meters
Tank Volume: 1000 liters
Tank contains liquid Internal Temperature: 35° C
Chemical Mass in Tank: 0.81 tons Tank is 100% full
Circular Opening Diameter: 2 inches
Opening is 0.5 feet from tank bottom
Release Duration: 1 minute
Max Average Sustained Release Rate: 12.2 kilograms/sec
Total Amount Released: 730 kilograms
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Note: The chemical escaped as a mixture of gas and aerosol (two phase flow).
THREAT ZONE:
Model Run: Heavy Gas
Red : 1.7 kilometers --- (100 ppm = AEGL-3(60 min))
Orange: 3.0 kilometers --- (22 ppm = AEGL-2(60 min))
Yellow: 7.5 kilometers --- (1.8 ppm = AEGL-1(60 min))
3) ACETIC ANHYDRIDE
SITE DATA:
Building Air Exchanges per Hour: 60 (user specified)
CHEMICAL DATA:
Warning: ACETIC ANHYDRIDE can react with water and/or water vapor. This
can affect the evaporation rate and downwind dispersion. ALOHA cannot
accurately predict the air hazard if this substance comes in contact with water.
Chemical Name: ACETIC ANHYDRIDE Molecular Weight: 102.09 g/mol

ERPG-1: 0.5 ppm ERPG-2: 15 ppm ERPG-3: 100 ppm
IDLH: 200 ppm LEL: 29000 ppm UEL: 103000 ppm

SOURCE STRENGTH:
Leak from hole in horizontal cylindrical tank
Flammable chemical is burning as it escapes from tank
Tank Diameter: 1.6 meters Tank Length: 5.0 meters
Tank Volume: 10.1 cubic meters
Chemical Mass in Tank: 1000 kilograms
Tank is 9% full
Max Puddle Diameter: Unknown
Max Flame Length: 6 meters Burn Duration: 17 minutes
Max Burn Rate: 62.8 kilograms/min
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Total Amount Burned: 487 kilograms

Note: The chemical escaped as a liquid and formed a burning puddle.
The puddle spread to a diameter of 6.9 meters.
THREAT ZONE:
Threat Modeled: Thermal radiation from pool fire
Red : less than 10 meters (10.9 yards) --- (37.5 kW/ (sq. m))
Orange: 12 meters --- (5.0 kW/ (sq. m) = 2nd degree burns within 60 sec)
Yellow: 16 meters --- (1.6 kW/ (sq. m))
THREAT AT POINT:
Thermal Radiation Estimates at the point:
Downwind: 18.3 meters Off Centerline: 0.48 meters
Max Thermal Radiation: 1.07 kW / (sq. m)
4) TOLUENE
SITE DATA:
CHEMICAL DATA:
Chemical Name: TOLUENE Molecular Weight: 92.14 g/mol
ERPG-1: 50 ppm ERPG-2: 300 ppm ERPG-3: 1000 ppm

SOURCE STRENGTH:
Tank Diameter: 1.55 meters Tank Length: 5.3 meters
Tank is 94% full
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Max Flame Length: 11 meters

Burn Duration: ALOHA limited the duration to 1 hour
Max Burn Rate: 97.6 kilograms/min
Total Amount Burned: 5,790 kilograms
THREAT ZONE:
Red : less than 10 meters (10.9 yards) --- (37.5 kW/ (sq. m))
Orange: 20 meters --- (5.0 kW/ (sq. m) = 2nd degree burns within 60 sec)
Yellow: 30 meters --- (1.6 kW/ (sq. m))
5) CHLOROSULPHONIC ACID
SITE DATA:
CHEMICAL DATA:
Warning: CHLOROSULFONIC ACID can react with water and/or water vapor to
produce hydrochloric acid, sulfuric acid and heat. ALOHA cannot accurately
predict the air hazard if a reaction occurs.
Chemical Name: CHLOROSULFONIC ACID Molecular Weight: 116.52 g/mol

ERPG-1: 2 mg/ (cu m) ERPG-2: 10 mg/ (cu m) ERPG-3: 30 mg/(cu m)

SOURCE STRENGTH:
Leak from hole in vertical cylindrical tank
Non-flammable chemical is escaping from tank
Tank Diameter: 1.5 feet Tank Length: 4 feet
Tank Volume: 52.9 gallons
Tank is 60% full
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Circular Opening Diameter: 1.5 inches

Opening is 0.1 inches from tank bottom
Ground Type: Concrete
Ground Temperature: equal to ambient
Max Puddle Diameter: Unknown
Release Duration: ALOHA limited the duration to 1 hour
Max Average Sustained Release Rate: 657 grams/min
Total Amount Released: 35.2 kilograms
Note: The chemical escaped as a liquid and formed an evaporating puddle.
THREAT ZONE:
Model Run: Gaussian
Red : 69 meters --- (30 mg/(cu m) = ERPG-3)
Orange: 125 meters --- (10 mg/(cu m) = ERPG-2)
Yellow: 298 meters --- (2 mg/(cu m) = ERPG-1)
6) N-HEXANE
SITE DATA:
Location RAICHURU, INDIA
Time: April 6th 2018
CHEMICAL DATA:
Chemical Name: N-HEXANE Molecular Weight: 86.18 g/mol
TEEL-1: 400 ppm TEEL-2: 3300 ppm TEEL-3: 8600 ppm

Wind: 5 meters/second from NW at 3 meters
SOURCE STRENGTH:
Tank Diameter: 2 meters Tank Length: 4. meters
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Chemical Mass in Tank: 7,369 kilograms

Tank is 90% full
Circular Opening Diameter: 2.5 inches
Opening is 0 meters from tank bottom
Max Flame Length: 13 meters Burn Duration: 56 minutes
Max Burn Rate: 133 kilograms/min
Total Amount Burned: 7,369 kilograms
THREAT ZONE:
Red : less than 10 meters (10.9 yards) --- (37.5 kW/(sq. m))
Orange: 25 meters --- (5.0 kW/(sq. m) = 2nd degree burns within 60 sec)
Yellow: 37 meters --- (1.6 kW/(sq. m)
THREAT AT POINT:
Thermal Radiation Estimates at the point:
Downwind: -58.4 meters Off Centerline: 27.6 meters
Max Thermal Radiation: 0.236 kW/(sq. m)
Drawing showing maximum credible accident scenario is appended as Annexure

A11.
7.2.13 Mitigation measures for storage of hazardous raw materials
Measures for ensuring safety during storage and handling of hazardous raw
materials are listed below
Storage quantities is kept at the bare minimum and planned carefully
depending on production plan. Overstocking or stocking for long time is
avoided. Hence, the risk and effect of any accident like leakage or fire will
be less.
All hazardous raw materials are stored in carboys, drums etc. in a ware
house. The list of non-compatible chemicals is made and displayed in the
ware house.
Safety instructions and MSDS are displayed prominently at the storage area,
both in English as well as local language.
Safety eye showers are available at different locations.
Safe clear distances between the tanks is maintained as per the petroleum
storage rules applicable to the solvents base.
All pump motors, switches, lighting are flameproof.
Loading and unloading procedure for solvents is prominently displayed near
the tanks.
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Firefighting hydrant system, hydrant layout, dedicated water storage tank

for firefighting, firefighting pumps will be designed and installed as per IS
code 13039 and IS 9668 and other applicable codes.
As per the code, adequate portable fire extinguishers are installed around
tank area, plant, and offices.
7.2.14 Safety precautions during solvents storage, handling, transportation

and recovery
Solvent storage tank farm with protective dyke wall is available.

Safety precautions during storage, handling, transportation and recovery of all
solvents are in place and strictly followed in the industry. Details of methylene
dichloride (MDC) are elaborated in the following sections.
7.2.14.1 MDC HANDLING AND PRECATIONS AGAINST ANTICIPATED HAZARDS
Anticipated hazards Precautions

a. Inhalation of vapours. 1. All containers have hazard communicating
b. Contact with skin. labels, signs.
c. Accidental 2. Employees trained in identifying hazards and
consumption. degree of risk.
3. Availability of MSDS at hand.
4. Use of specific glove material having adequate
resistance to MDC.
5. Use of specific clothing material having
adequate resistance to MDC.
6. Respirator with full face mask to avoid
inhalation and splashing of MDC.
7. Availability of SCBA set at hand for respiratory
protection in emergency situation.
8. SOP is in Place for handling & MSDS is made
available.
7.2.14.2 MDC TRANSPORTATION
All drivers and employees are

Trained to identify hazard communication information on containers.
Trained to interpret information on TREM card.
Advised to prevent leak or spill entering sewage, sumps, nalahs, rivers,
wells and other water bodies by using spill control materials.
Advised to prevent public approaching container for help and other users of
the road, warn them about the hazards.
Trained to protect self with SCBA and help injured.
Trained to use emergency telephone no.s and contact specific authorities.
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7.2.15 General safety measures / precautions
Employees trained in the safe handling practices of hazardous chemicals

such as solvents, acids, caustics, ammonia etc.
Standard operating procedures are established and are being followed when
cleaning up chemical spills, handling of toxic/hazardous chemicals.
Local exhaust ventilation systems are provided to control dusts, vapors,
gases, fumes, smoke, solvents or mists which may be generated in
workplace.
To know the material nature, potential hazards (health, fire, reactivity and
environmental) and how to work safely with the materials MSDS are
provided at the work place.
Materials which give off toxic, asphyxiant, or anesthetic vapors or fumes are
stored in remote or isolated locations when not in use, e.g. bulk ammonia
storage.
While handling of toxic gas cylinders to identify leakages, gas detector
system is provided at ammonia gas handling area.
In case of leakage the toxic / hazardous materials automatic water sprinkler
systems are switched on to control the toxic vapors at work place.
3M cartridges, noise masks, air breathing suites are provided for protection
of respiratory system.
PVC/Nitrile/Neoprene hand gloves are there for handling of hazardous
materials.
Goggles/face shields are provided for eye/face protection.
In case of spillage/leakage while handling of hazardous materials spill
control kit is provided at work place.
All personnel protective equip are provided at work place for
handling of hazardous chemicals.
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7.2.16 Safety measures taken in hydrogenation process
Considering the hazardous nature of the process the unit is separated from
the main manufacturing block.
Prior to the start of the process, the integrity of the reactor i s checked and
certified.
Before starting the hydrogenation process inertisation is ensured by
alternating cycles of vacuum and nitrogen.
The system is provided with safety relief valve & rupture disk, both these
connected to a dump tank with water seal, the dump tank is provided with
the flame arrester.
High pressure & high temperature alarms are provided on the equipment.
Sensitive hydrogen leak detectors are provided near the reactor and
manifold.
Flash back arrestor in the manifold to the reactor.
Close system sampling is done & the system is flushed with the water.
Evacuation of hydrogen is done through the dump tank gradually in over one
hour.
Filtration is done in the closed pressure nutch filter & is done with the
nitrogen pressure.
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7.2.17 Occupational health & safety
INTRODUCTION
The OHS hazards anticipated in the proposed plant is mostly due to

chemical exposure hazard and physical hazard due to electrical &
mechanical operations & maintenance works.
A major anticipated occupational health & safety hazard is due to
chemical exposure.
Accidental skin & eye irritation & burns, respiratory & pulmonary
diseases on exposure to chemicals & solvent vapours & inhalation of
chemical vapours, respirable powders.
Liver kidney, CNS, CVS functions on chronic exposure.
Chemical burns due to vapours exposure in case of fire.
ANTICIPATED OCCUPATIONAL & SAFETY HAZARDS DUE TO PHYSICAL BURNS

& SHOCKS DUE TO ELECTRICITY
Accidents resulting from unsafe conditions due to poor housekeeping &
Accidents due to unsafe practice of operation and maintenance like gas

cutting and wielding may lead to injuries to various parts of the body.
Musculo skeletal disorders like muscular pains, spinal & joint pains due
to ergonomic problems, lifting with wrong postures.
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HEALTH HAZARDS & CONTROLS PROPOSED
Sl. Reason for anticipated Health Work place Control to prevent the Precautionary engineering
No. hazards hazard hazard controls provided
1 Toxicity, due to Methylene Production Supplied air mask while The condensers are
exposure, spillage, Chloride- area, solvents handling ammonia. provided with chilled water
leakage, emissions or Carcinogen- handling area Avoidance of employees & chilled brine circulation
reactor pressurisation 2(B), with premedical conditions to avoid the emissions.
of ammonia & Ammonia- for handling Ammonia/ Spill control training.
methylene chloride Irritation Methylene chloride. Hazard communication
Respirators approved by training conducted, PPE
NIOSH. EN or equivalent usage training & educating
IS. on the usage of PPE's.
Spill control materials like All the operations are
sorbent pads and booms. carried out in closed
conditions, with scrubbing
systems for emissions.
2 Exposure hazards. Skin & eye Production Respirators approved by Training as above is
Dermatitis with irritation, area, acids & NIOSH. EN or equivalent conducted.
prolonged contact with eyes & skin alkali IS. All the operations are
solvents. burns & dispensing Full face protection. carried out in closed
Severe chemical burns respiratory area Emergency shower and eye conditions, with scrubbing
due to splashing of problems, wash. systems for emissions.
solvents & acids & liver, kidney, Spill control materials like
alkalis. CNS, sorbent pads and booms.
Severe respiratory peripheral
problems due inhalation nervous
of corrosive fumes. system
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Sl. Reason for Health hazard Work place Control to prevent the hazard Precautionary engineering
No. anticipated controls provided
hazards
3 Exposure to Ursodeoxy cholic Production area All the solid chemicals & finished Hazard communication
finished acid, Nifedipine, products handling is done without training will be conducted,
products Phenylephrine HCl, manual intervention, directly PPE usage training &
Sildenafil Citrate - handled in closed conditions by educating the usage of
skin & eye vacuum conveying respirators PPE's.
irritation, approved by NIOSH. EN or All the operations are
excessive chronic equivalent IS. Full face carried out in closed
ingestion may be protection. conditions, with powder
toxic to blood, Emergency shower and eye wash. scrubbing systems for
CVS, CNS Spill control materials like finished products with
sorbent pads and booms. detoxification liquids.
4 Physical Contact with Production Good housekeeping Effective interlocks
injuries rotating parts area, Circuit breakers
-Slip, trip and falls mechanical Effective work permit system
-electric shocks workshop,
electrical panel
boards
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PARAMETERS FOR OCCUPATIONAL HEALTH MONITORING
Sl. Solvent/ Chemical Target organs Parameters for occupational Health Frequency
No. exposure monitoring
1 Hexane Skin sensitisation, CNS, Pre placement medical condition, Pre-placement,

peripheral nervous system, skin condition, urine samples Annual
decreased muscle strength. complete analysis, lung function
test
2 Acetic acid, Skin, respiratory system, eyes. Pre-placement medical check-up. Pre-placement,
acetic anhydride Function and integrity of eyes, skin Annual
and lungs.
3 Acetone Reduced memory, liver, Pre-placement medical check-up. Pre-placement,
kidney. Function and integrity of eyes, skin Annual
and lungs.
Blood and urine samples for index
of exposure.
4 Ammonia Respiratory system LFT and lung damage test. Pre-placement,
Annual
5 Bromine Lungs, Bronchitis Pre-placement medical check-up. Pre-placement,
Function and integrity of skin and Annual
lungs.
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Sl. Solvent/ Target organs Parameters for occupational Health Frequency

No Chemical monitoring
exposure
6 Ethyl acetate Skin, Liver, Kidneys. Pre-placement medical check-up. Function Pre-placement, Annual
and integrity of skin and lungs.
Blood and urine samples complete screening.
7 Methanol Skin-dermatitis, Liver, Integrity of skin, Profile of liver. Pre-placement, Annual
Optic atrophy, Integrity of eyes for pre-existence of eye
Blindness disease.
8 Toluene Liver, Kidneys, CNS, Pre-placement medical check-up. Pre-placement, Annual
Skin-Dermatitis. Liver function test.
Urine analysis for presence of Hippuric acid.
Function and integrity of skin.
9 Hydrochloric Kidney, Liver, Lungs- Pre-placement medical check-up. Pre-placement, Annual
acid Bronchitis Liver function test.
Urine analysis for presence of acid.
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OCCUPATIONAL HEALTH AND SAFETY PRECAUTIONS TAKEN
The importance of this point for the future of the industry is well taken, as the
wellbeing and safety of the employees has a direct bearing on the performance of
the industry. Therefore, all the measures as envisaged in the Risk analysis & Hazop
studies will be implemented with due care.
o All the employees are provided with personal protective equipments like safety
helmets, goggles, face shields, heat resistance shoes, dust masks/respirators,
self-contained breathing apparatus, breathing air masks etc. as per
requirement. Details are in fig 4.1, Chapter 4 of this report.
o Mock drills as per on site emergency plan as approved by Chief Inspector of
factories are conducted for fire hydrant systems, firefighting equipment. All
the emergency systems shall be placed in good working condition & shall be
made available in all emergency conditions by adopting effective preventive
maintenance, emergency preparedness of teams as per the onsite emergency
plan. This shall be ensured by conducting training by mock drills including
evacuation plans.
o All the emergency team members are trained for firefighting & first aid, all
the employees are trained for using the firefighting equipments,
evacuation path, head count etc. by mock drills.
o The Company has made an agreement with the multispecialty hospital
for medical checkups and emergency services.
o All the work places are provided with the MSDS of chemicals & materials being
handled. All equipment operating & production operating, chemicals handling,
procedures are laid down. The concerned employees are trained and all the
employees are made aware of the hazards in handling the chemicals.
o Inspection and preventive & breakdown maintenance of all the equipment
including pollution control equipment is undertaken by proper work permit
systems.
FREQUENCY & PARAMETERS OF HEALTH CHECK-UP
Pre-employment health check-up followed by periodical health checkup is

undertaken every year with special attention to occupational health hazards
for all the employees.
This activity is outsourced to the local hospitals and diagnostic centers.
The following parameters are part of pre-employment & annual periodical
medical checkup
Sl. Test Details

No.
1 Physical Fitness Certificate
2 Pulse
3 Blood Pressure
4 Complete Blood Examination Hemoglobin % (Hb%),WBC,RBC ,
Etc.
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5 Vision
6 Central Nervous System (CNS)
7 Respiratory System-Lung Function (RS)
8 Cardio Vascular System (CVS)
9 Electro Cardio Gram (ECG)
10 Chest X-ray
11 Total Leucocyte Count (TC)
12 Differential Leucocyte Count (DLC)
13 Absolute Eosinophil Count (AEC)
14 Complete Urine Examination [Physical / Chemical /Albumin,
Sugar & Bile Salt etc.
15 Random blood Sugar (RBS)
16 Sputum for Acid fast Bacillus (AFB for Tuberculosis)
OCCUPATIONAL HEALTH MONITORING
A number of hazardous materials and solvents are used in the manufacturing

process. In order to prevent any adverse impacts on the health of the employees a
number of precautionary measures are taken. Few of them are detailed in the
table below.
Sl. Solvent Target organs Parameters for Frequency

No. occupational
Health monitoring
1 Hexane Skin Pre placement medical Pre-
sensitization, condition. placement;
Central Nervous Skin condition. Annual
System (CNS), Urine samples for testing
Peripheral presence of
Nervous system, hexanedione.
Decreased muscle Exhaled air sampling.
strength.
2 Acetic acid Skin, Pre-placement medical Pre-
Acetic Respiratory check-up placement;
anhydride system, Function and integrity of Annual
Eyes. eyes, skin and lungs.
3 Acetone Reduced Pre-placement medical Pre-
memory, check-up placement;
Liver, Function and integrity of Annual
Kidney. skin and lungs.
Blood and urine samples
for index of exposure.
4 Ammonia Respiratory LFT and lung damage Pre-
system. test. placement;
Annual
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5 Bromine Lungs, Pre-placement medical Pre-

Bronchitis. check-up placement;
Function and integrity of Annual
skin and lungs.
6 Ethyl Skin, Pre-placement medical Pre-
acetate Liver, check-up placement;
Kidneys. Function and integrity of Annual
skin and lungs.
Blood and urine samples
for index of exposure
7 Methanol Skin-dermatitis, Integrity of skin Pre-
Liver, Profile of liver placement;
Optic atrophy, Integrity of eyes for Annual
Blindness. preexistence of eye
disease.
8 Toluene Liver, Pre-placement medical Pre-
Kidneys, check-up placement;
CNS, Liver function test. Annual
Skin-Dermatitis. Urine analysis for
presence of Hippuric
acid.
Function and integrity of
skin
9 Hydrochloric Kidney, Pre-placement medical Pre-
acid Liver, check-up; placement;
Lungs-Bronchitis. Liver function test. Annual
Urine analysis for
presence of Acid.
7.3 AIR POLLUTION DISPERSION MODELING STUDIES
7.3.1 Introduction
Atmospheric dispersion modeling is the mathematical simulation of how air

pollutants disperse in the ambient atmosphere. It is performed with computer
programs that solve the mathematical equations and algorithms and simulate
pollutant dispersion. Dispersion models are used to estimate or predict the
downwind concentration of air pollutants emitted from sources such as industrial
plants and vehicular traffic. Such models are important to governmental agencies
tasked with protecting and managing the ambient air quality. The models are
typically employed to determine whether existing or proposed new industrial
facilities are or will be in compliance with the National Ambient Air Quality
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Standards (NAAQS). The models also serve to assist in the design of effective
control strategies to reduce emissions of harmful air pollutants.
Prediction of impacts on the air environment has been carried out employing Lakes
Environmental Software, Version 9.6 and designed for multiple sources for
predicting the maximum ground level concentration (GLC).
In the present study, the baseline analysis reports and the routine monthly
monitoring reports clearly indicate that the parameters are well within NAAQS.
However, modeling studies are carried out to ascertain compliance to the
standards during peak loads. Moreover, when compared to the mega Raichur
thermal power plant at the next compound, the impact of M/s. Shilpa Medicare
Ltd. Unit I is negligible.
7.3.2 Air modeling study
The major air emissions at the site of M/s. Shilpa Medicare Ltd. Unit I, are SPM,
SO2 and NOx from boilers (4 THP). They are provided with stacks of adequate
height and multicyclone. DG sets are another source of pollution which is provided
with stack per KSPCB stipulations. Manufacturing process involves reactions in
completely closed reactors. Therefore, no emissions are anticipated. The site-
specific details considered as input data for the software (AERMOD by Lakes
Environmental) to predict the impacts on the air environment are given in table
7.2.
Table 7.2: Data considered for calculation of GLC

Particulars Details
DG set - 325 kVA Boiler I & II
- 2 no.s - 4 TPH
(each)
Stack height, m 5 m ARL for each 30 m AGL
Stack diameter, m 0.5 0.36
Cross sectional area, m2 0.196 0.102
Flue gas temperature, 0C 95 - 100 90 - 105
Exit gas velocity, m/s 6.5 - 7 6.0 - 7
Emission rate, g/s
PM10 0.0960 0.22
SO2 0.0895 0.3625
NOx 1.3577 0.225
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7.7.2 METEOROLOGICAL DATA

Meteorological data recorded at the site for one-year period (2017) and obtained
from Lakes Environment has been used for computations. The hourly
meteorological data is pre-processed using U.S. EPA AERMET program software.
7.7.3 PRESENTATION OF RESULTS

The simulations were made to evaluate incremental short-term concentrations due
to the industry within a study area of 10 km radius.
Table 7.3 shows the predicted incremental short-term concentrations due to the
industry. The isotherms for Suspended Particulate Matter (PM10), Sulfur di-oxide
(SO2) and Oxides of nitrogen (NO x ) are in fig 7.2, 7.3 & 7.4.
Table 7.3: Predicted incremental short-term concentrations

Time Maximum predicted Direction and distance of occurrence
concentrations, µg/m3
24 hour Annual 24 hour Annual
st st
1 98 1 highest 98 percentile
highest percentile values
values
Suspended 1.03 0.65 0.14 750088 E 750088 E; 750884.78 E;
Particulate 1808514.32 N 1808514.32 N 1808676.41 N
Matter Project site & Project site & Project site &
(PM10) adjacent site adjacent site adjacent site
South West South West South East
Sulfur di- 1.09 0.82 0.19 750884.78 E; 750884.78 E; 750884.78 E;
oxide (SO2) 1808676.41 N 1808676.41 N 1808676.41 N
Project site Project site Project site
south east south east south east
Oxides of 1.77 1.34 0.2899 750884.78 E; 750884.78 E; 750884.78 E;
nitrogen 1808676.41 N 1808676.41 N 1808676.41 N
(NOx ) Project site Project site Project site
south east south east south east
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Fig 7.2: Suspended Particulate Matter (PM10) isotherms

i) 24 hours 1st highest value
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ii) 24 hours 98 percentile
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iii) Annual
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Fig 7.3: Sulfur di-oxide (SO2) isotherms

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iii) Annual
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Fig 7.4: Oxides of nitrogen (NO x ) isotherms

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iii) Annual
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COMMENTS
The maximum short-term incremental ground-level concentrations are super

imposed on the baseline data to get the likely resultant levels during peak loads.
It has to be noted that the incremental concentrations during routine

operations will be included in the baseline analysis reports. However, the
below tabulated values are the maximum concentrations that can be attained
during peak loads.
Table 7.4: Resultant Maximum 24 hourly concentrations

Pollutant Incremental Max. baseline Resultant Limits as per
concentrations concentrations concentrations MoEF g/m3 for
g/m3 g/m3 g/m3 industrial area
(24 Hrs)
Project site (M1)
PM10 0.65 78.2 79.35 100
SO2 0.82 15.5 16.27 80
NOx 1.34 18.4 19.14 80
Hegsanhalli (M2)
PM10 0.01 71 71.16 100
SO2 0.002 14.4 14.47 80
NOx 0.002 17.4 17.45 80
Deosugur (M3)
PM10 0.01 74.6 74.61 100
SO2 0.002 14.5 14.51 80
NOx 0.005 15.3 15.31 80
Chicksugur (M4)
PM10 0.006 76.9 76.91 100
SO2 0.001 14.1 14.11 80
NOx 0.001 16.3 16.31 80
Kadlur (M5)
PM10 0.01 66.2 66.21 100
SO2 0.002 13.9 13.91 80
NOx 0.002 15.7 15.71 80
Krishna Village (Telangana) (M6)
PM10 0.006 73.9 73.906 100
SO2 0.001 21.1 21.101 80
NOx 0.002 15.2 15.202 80
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Muraharidoddi (Telangana) (M7)

PM10 0.01 73.8 73.81 100
SO2 0.001 19.3 19.301 80
NOx 0.002 19.9 19.902 80
According to MoEF air quality standards (as per the notification dated 16 th
November 2009 for industrial, residential & rural areas) 24 hourly or 8 hourly or 1
hourly monitored values, as applicable, shall be complied with 98% of the time in a
year; 2% of the time, they may exceed the limits but not on two consecutive days
of monitoring.
Therefore the 98% values are considered for estimation of the incremental
concentration.
The above table indicates that the cumulative resultant ambient air quality at
peak loads of industrial operation will be within the ambient air quality limits
specified by MoEF as per the notification dated 16 th November 2009 for industrial,
residential & rural areas.
7.4 SOCIAL IMPACT ASSESSMENT, R&R ACTION PLANS
No re-settlement and re-habilitation is envisaged as it is an existing industry

established in Deosugur industrial area.
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CHAPTER 8
PROJECT BENEFITS
8.1 IMPROVEMENTS IN THE PHYSICAL INFRASTRUCTURE, SOCIAL

INFRASTRUCTURE
Various activities are taken up by the Company to improve infrastructure of

schools, police station in the surrounding areas. Details are in Section 8.4 of this
Chapter.
8.2 TANGIBLE BENEFITS
The project has generated direct and indirect employment opportunities for the
local people.
The total no. of employees in the industry are 150. Out of these, about 105 local
people are employed.
Additionally, certain works like security is outsourced on contract. Local agency

with staff from surrounding areas has been employed for general cleaning
activities within the premises.
8.3 INTANGIBLE BENEFITS
Products manufactured will be at affordable prices when compared to

international manufacturers. This plant will employ skilled and semi-skilled
people from the surrounding areas.
The industry is providing business for ancillary units like equipment
manufacturers, machining works, motor rewinding for regular maintenance,
shut down, annual and mechanical consumable vendors, periodical painting
works etc. thereby giving work opportunities for local people like equipment
suppliers and various consumable vendors.
Briquettes (fuel for boiler) are obtained from saw mills in surrounding areas
generating business opportunities for them.
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8.4 OTHER BENEFITS
CORPORATE ENVIRONMENTAL RESPONSIBILITY (CER)
M/s. Shilpa Medicare Ltd. Unit I will be allocating an amount of about 98 Lakhs
for CER. The activities proposed to be taken up will include infrastructure for
drinking water supply, sanitation, health, skill development, solar power, solid
waste management facilities, rainwater harvesting, avenue plantation, plantation
in community areas etc.
The Company has been conscious of its Corporate Social
Responsibility (CSR) and Corporate Environmental Responsibility (CER) & has been
undertaking, implementing activities by establishing a trust called Shilpa
Foundation to provide financial assistance to the poor and needy and to give
donations to promote various social, cultural and philanthropic activities.
The various projects envisaged by the Company as part of CSR/CER is listed below.
(a) Setting up of old age homes/ orphanages;
(b) Motivating students of rural area by providing scholarships;
(c) Providing purified drinking water to people living in the villages and
surrounding areas;
(d) Development of infrastructural facilities like roads, water supply etc. in the
surrounding villages;
(e) Supplying plants and development of agroforestry in consultation with local
in the surrounding areas.
The Company has allocated Rs.244.93 Lakhs to Shilpa Foundation, a trust formed
by the Company for CER activities as on 31st March 2017.
The Company, has invested about Rs. 38 crore on renewable energy i.e wind mills at
various locations. Details are tabulated below.
Table 8.1: CSR activity - windmills

Sl. Location No. of Location
No. machines capacity
1 Vani Vilas Sagar, Chitradurga, Karnataka 2 1.2 MW
2 EP2 Road 4, Chitradurga, Karnataka 1 0.6 MW
3 Kalsapur, Gadag Taluk, Karnataka 4 3.2 MW
4 Madakaripura, Chitradurga, Karnataka 2 0.46 MW
5 Tadipatri, Ankireddipalli, Kurnool District, 2 1.6 MW
Andhra Pradesh
TOTAL 11 7.06 MW
Apart from this, few major CER activities carried out during years is detailed in table
8.2
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Table 8.2: Other CER activities

Sl.
Amount Date Particulars Remarks
No.
6 5,000 17.04.2015 Raichur DSS Union Ambedkar Jayanti
Traffic Police Station, Karnataka State Police
7 5,000 19.05.2015
Raichur Officers Welfare Fund
Market Yard Police Karnataka State Police
8 5,000 23.05.2015
Station, Raichur Officers Welfare Fund
Market Yard Police Karnataka State Police
9 2,000 27.06.2015
Rural Police Station,
10 5,000 06.08.2015 National Education Trust
Raichur
Raichur DSS Celebration of Ambedkar
11 5,000 11.04.2016
Association Jayathi
Sadar bazar Police Karnataka State Police
12 4,000 2.6.2016
13 51,000 28.10.2016 Raichur Towards Badminton Club
Nagappa Goalthne
14 5,000 9.11.2016 Karnataka Day
Raichur
15 19,000 6.3.2017 Viraj Foundation Social activities
Civil & Fabrication Work
16 1,24,620 13.08.2015 Jadcherla for Cool Water plant at
Polepally Jadcherla
The Prime Minister
17 1,00,000 5.7.2013 Raichur DC
National Relief Fund
Sponsorship for college
18 25,000 21.3.2014 Raichur SLN College
fest
Shri Manik Phabhu
Shri Manik Prabhu
19 11,000 15.04.2016 School for Blind,
Academy Blind Trust
Raichur
Sri Kanakadasa Seva
20 23,000 5.11.2016 Shikshana Samsthe, Orphanage children fees
Raichur
Hanuman temple
21 1,74,140 1.4.2016 Shanti Nagar Raichur
flooring, wall
Granite flooring
22 1,43,268 1.4.2016 Shanti Nagar Raichur
hanuman temple
Towards payment of
23 1,24,140 05.04.2016 Shanti Nagar Raichur granite laying work at
hanuman temple
Towards payment of
24 93,268 05.04.2016 Shanti Nagar Raichur granite tile steps, granite
slab.
Jadcherla Maheboob Supply sticker for vehicle
25 40,000 12.08.2016
Nagar sign boards
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Maheshwari Vidya
26 21,000 16.08.2016 Mumbai
Pracharak Mandal
Payment orphanage
27 23,000 18.11.2016 Raichur
children fees and books
Jawahar Nagar Payment for
28 2,50,000 30.06.2017 Raichur (Green reforestation and
Raichur) regaining of green cover.
Payment for
29 92,030 15.07.2017 Green Raichur (NGO) reforestation and
regaining of green cover.
Payment for
30 42,400 01.08.2017 Green Raichur (NGO) reforestation and
regaining of green cover.
Vijaya Bharat Seva Charity payment to
31 30,000 28.08.2017
Trust Vijaya Bharati Seva.
2nd Cross Shaktinagar
Payment for maintaining
32 25,000 28.08.2017 Sugureshwara
cleanliness
Temple Raichur
Payment for Basic
Yermaurs Raichur
33 90,500 20.09.2017 needs is SM Vidyalam
(Shashal)
School
Shri Manik Phabhu
Payment welfare trust
34 2,00,000 07.11.2017 School for Blind
towards development
Raichur
Health Camp at
35 5,00,000 Oct 2017 Mantralyam for the --
public with medicines
Hegsanahalli Benches for school
36 1,20,000 13.1.2018
Government School children
Rangapur Government Benches for school
37 66,080 30.3.2018
School children
Kannada Sahitya
38 50,00,000 Dec 2016 Funding from
Sammelana, Raichur
Seventy Four Lakhs Twenty Four Thousand
74,24,446 TOTAL
Four Hundred And Forty Six Only
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Fig 8.1: Photographs of CER activities
1) Windmills
2) Afforestation initiative in collaboration with Green Raichur (NGO)
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2) Medical camp at Mantralayam
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3) Benches provided at Hegsanahalli Government School
PROPOSED FUTURE INVESTMENTS
M/s. Shilpa Medicare Ltd. Unit I will be allocating an amount of about

Rs. 98 Lakhs for CER. The activities proposed to be taken up will include
infrastructure for drinking water supply, sanitation, health, skill development,
solar power, solid waste management facilities, rainwater harvesting, avenue
plantation, plantation in community areas etc.
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CHAPTER 9
ENVIRONMENTAL COST BENEFIT ANALYSIS
Cost Benefit Analysis (CBA) for M/s. Shilpa Medicare Ltd. Unit I is detailed below
9.1 NATURAL RESOURCES
The major natural resources consumed/utilized by M/s. Shilpa Medicare Ltd. Unit
I are
1. Raw materials for manufacture of APIs and intermediates

2. Water for domestic and industrial use
CBA for each is detailed below
A. Raw materials consumption
M/s. Shilpa Medicare Ltd. Unit I had obtained Consent to Operate (CTO) from
Karnataka State Pollution Control Board vide order no. PCB/HPI/053/2015-16/1245
dated 8th Oct 2015 (appended as Annexure A2) for manufacture of 30 APIs and
intermediates with total production capacity of 317.304 MT/annum. Details are in
Chapter 2, Section 2.6.1, Table 2.5 of this report. However, actual production is
very less. Comparative statement of consented and actual production for last
three years is tabulated below.
Correspondingly the raw materials consumed is also less.
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Table 9.1: Production consented vs actual (from 2012-13)

Consented production
Actual production, MT/annum
capacity
Sl.
APIs & intermediates CTO
no.
approved MT/annum 2012-13 2013-14 2014-15 2015-16 2016-17 2017-18
MT/month
1 Acebrophylline 3 36 0 0 0 1.2 1.115 0
2 Ambroxol HCl 6 72 24.32 26 38 70 70 71.5
3 Buflomedil HCl 1 12 0 0 0 0 0 0
4 Nifedipine 1 12 0.2 1 0 0 3.6 2.5
5 Phenyl ephrine HCl 1.5 18 0 0 0 0 0 0
6 Sildenafil citrate 1 12 0 0 0 0 0 0
7 Ticlopidine HCl 2 24 0 0 0 0 0 0
8 Ursodeoxycholic acid 9 108 41.2 48 53 108 108 108
9 Anastrozole 0.005 0.06 0 0 0 0 0 0
10 Bendamustine HCl 0.005 0.06 0 0 0.005 0 0 0
11 Bicalutamide 0.2 2.4 0 0 0.054 0 0 0
12 Bortezomib 0.001 0.012 0 0 0 0 0 0
13 Capecitabine 1 12 0 0 0 0 0 0
14 Carboplatin 0.05 0.6 0 0 0 0 0 0
15 Cisplatin 0.05 0.6 0 0 0 0 0 0
16 Docetaxel trihydrate 0.05 0.6 0 0 0 0 0 0
17 Epirubicin HCl 0.02 0.24 0 0 0 0 0 0
18 Gefitinib 0.01 0.12 0 0 0 0 0 0
19 Gemcitabine HCl 0.25 3 0.9 1.001 1.097 0.4 0.47 0.6
20 Imatinib mesylate 0.1 1.2 0 0 0 0 0 0
Irinotecan HCl
21 0.01 0.12 0.03 0.04 0.091 0.1 0.06 0.11
trihydrate
22 Lenalidomide 0.001 0.012 0 0 0 0 0 0
23 Letrozole 0.005 0.06 0 0 0 0 0 0
24 Oxaliplatin 0.005 0.06 0.005 0.026 0.01 0.003 0.0029 0.013
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25 Paclitaxel 0.01 0.12 0 0 0 0 0 0

26 Pemetrexed 0.01 0.12 0 0 0 0 0 0
27 Temozolomide 0.1 1.2 0.01 0.12 0.213 0.39 0.5 0.6
28 Thalidomide 0.05 0.6 0 0 0.085 0.1 0.12 0.06
29 Topotecan HCl 0.005 0.06 0 0 0 0 0 0
30 Zoledronic acid 0.005 0.06 0 0 0 0 0 0
TOTAL PRODUCTION,
26.442 317.304 66.665 76.187 92.555 180.193 183.868 183.383
MT/ ANNUM
NUMBER OF PRODUCTS
- - 7 7 9 8 9 8
MANUFACTURED
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B. Water consumption
Water is supplied by KIADB from Krishna river. Also, groundwater recharging

pits are provided at strategic locations to increase the level of groundwater.
The consented quantity of water consumption as per CTO is 7 KLD for domestic
purpose and 49 KLD for industrial purpose.
However, actual consumption is less; details are in table 9.3 below.
This is due to the corresponding decrease in the water requirement with
production.
Table 9.3: Water consumption - comparison between consented versus actual

water consumption (for last 3 consecutive years)
Sl. Particulars Water consumption, KLD
No. Total Domestic Industrial
1 Consented* 56 7 49
2 Actual for 2015-16 25 7 18
3 Actual for 2016-17 24 7 17
4 Actual for 2017-18 28.5 7 21.5
Source: Form V submitted to KSPCB
*Note: Consented quantity is as per the Consent to Operate (CTO) no.

PCB/HPI/053/2015-16/1245 dated 8th October 2015.
9.2 AIR ENVIRONMENT
All the air pollution sources detailed in Chapter 2 of this EIA report have been
provided with pollution control equipments and measures as stipulated in the
CTO.
To ensure compliance, monthly monitoring is done to check ambient air
quality. Also emissions from stacks, DG, boilers and process section are
analyzed monthly.
To substantiate, sample monitoring reports are appended as Annexure A3. The
emissions from all the sources are within the stipulated limits. Also ambient air
quality is within the standards stipulated by MoEF under Nation Ambient Air
Quality Standards dated 16th November 2009.
9.3 WATER ENVIRONMENT
Domestic sewage is treated in septic tank and soak pit and industrial effluent is
sent to M/s. Shilpa Medicare Ltd. Unit II located close by (4 km aerial distance
from Unit I) as stipulated in CTO by KSPCB.
The quantity of process wastewater generated is proportionate to actual
production and hence is lesser than the consented quantity.
Sample wastewater transfer slips are appended as Annexure A5.
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9.4 SOIL ENVIRONMENT
Measures taken to prevent impact on soil environment are listed below

Raw materials and products are stored in closed warehouse.
Solvents are stored in tanks in a designated area tank farm. Protective dyke
wall is provided to contain leakages, if any.
The solvents collected in dyke wall area if any will be treated in solvent
recovery system and reused in the process.
Hazardous waste is stored in designated area which is concreted and covered.
Also, the total quantity of hazardous waste disposed per annum is lesser than
the maximum quantity authorized by KSPCB.
Table 9.4: Hazardous waste generation - comparison between authorized versus

actual water consumption (for last 3 consecutive years)
Sl. Hazardous Waste Unit Quantity
No. waste category KSPCB Actual disposed
authorized* 2015-16 2016-17 2017-18
1 Used oil 5.1 KL/annum 0.2 0.091 0.03 0.03
2 Spent solvent 20.2 KL/annum 39.6 24.9 26.98 3.3
3 Distillation 20.3 MT/annum 2 1.8 1.59 1.3
residue
4 Process 28.1 MT/annum 2 1.6 1.01 1.41
residue and
waste
5 Discarded 33.3 No.s/annum 200 92 30 23
containers
6 Spent carbon 28.2 MT/annum 1 0.4 0.21 0.678
Source: Form IV submitted to KSPCB
Note: KSPCB authorized quantity is as per authorization by KSPCB no.

PCB/WMC/SEO/69748/2014-15 dated 23rd June 2014. The authorization is valid
from 1.7.2014 to 30.6.2019.
9.5 SOCIO-ECONOMIC ENVIRONMENT
The industry has generated direct employment opportunities for 150 people out
of which 70% (105) are local people. Also, security, housekeeping manpower
are locally employed.
Indirect employment opportunities to the truck drivers transporting raw
materials and products are generated.
Company manufactures lifesaving anti-cancer drugs which are made available
at an affordable price. Also, some of it is being exported to various other
countries and hitherto it has earned valuable foreign exchange.
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Table 9.5: Summary of CBA

Environment Cost/s Benefit/s
parameter
Natural Raw materials & Consumption is less compared to
resources water consumption. the quantity consented by KSPCB.
Air -- Proper management of all emission
sources by providing air pollution
control units and ensuring ambient
air quality within the NAAQ
standards, 2009.
Water -- Proper treatment and management
of wastewater generated.
Soil -- Preventive measures taken to
prevent soil contamination by
solvents, raw materials, solvents,
products and hazardous waste.
Socio- Nil Employment opportunities to the
economic local people and income generation
(both direct and indirect).
9.6 ASSESSMENT OF ECOLOGICAL DAMAGE TO THE ENVIRONMENT
Assessment of ecological damage with respect to air, water, land and other
environmental attributes has been done. Sampling and analysis has been carried
out by MSV Analytical Laboratories and Eco Green Solution Systems Pvt. Ltd. They
are NABL accredited/MoEFCC approved laboratory. Report is enclosed as Chapter
13.
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CHAPTER 10
ENVIRONMENTAL MANAGEMENT PLAN (EMP)

10.1 INTRODUCTION
The Environment Management Plan (EMP) is required to ensure sustainable

development. Hence it needs to be an all encompassive plan for which the
industries, Government, Regulating agencies like Pollution Control Board working
in the region and more importantly the population of the area need to extend
their co-operation and contribution.
It has been evaluated that the project area will not be affected significantly with
proposed project. Mitigation measures at the source level and an overall
Management Plan at the site level are elicited so as to not cause any major impact
on the surrounding environment.
The emphasis on the EMP is on the following:

Mitigation measures for each of the activities causing the environmental impact;
Monitoring plans for checking activities and environmental parameters;
Roles, responsibilities and resource allocation for monitoring.
Following sections describes in brief the environment management plan for

operation phase.
10.2 MITIGATION MEASURES
All activities of the industry which can cause impact on the environment are
identified and mitigation measures are implemented. The same is explained in
detail in Chapter 4 of this EIA report.
10.3 MONITORING PLANS
Monitoring plans are explained in detail in Chapter 6 of this EIA report.
10.4 ROLES, RESPONSIBILITIES AND RESOURCE ALLOCATION FOR MONITORING
Responsibility of timely monitoring is with the Environment Cell. Organization

chart of environment cell is shown in fig 10.1 below
To ensure this, yearly contract is given to NABL / MoEFCC accredited laboratory.
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Sample monitoring and analysis reports are enclosed as Annexure A3.
Details of resource allocation for monitoring are in Chapter 6, Section 6.1.4 of this
EIA report.
Fig 10.1: Organization chart of Environment Cell
MD
General Manager
Manager - EHS
Shift In charge- 3 posts EHS Safety Officer Approved

environmental
consultants,
Sr. Executive -2 Posts EHS laboratories for
Lab Chemist 1posts EHS
periodical
monitoring
Executive - 1 posts EHS
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CHAPTER 11
SUMMARY & CONCLUSION

Environmental Impact Assessment studies have been carried out M/s. Shilpa Medicare
Ltd. Unit I. The study conducted has covered various facets of the industry starting
with the purpose of this study, basic requirements of the industry like raw materials,
water requirement, availability of land, manufacturing process etc.
The metrological data and environmental attributes have been studied, analysed and
evaluated to understand the environmental setting of the project site. Also , the
ecological features of the location including flora & fauna, socio-economic
environment, the demographic structure have been studied and evaluated.
Assessment of ecological damage with respect to air, water, land and other
environmental attributes has been done. Sample analysis has been carried out by MSV
Analytical Laboratory, Bellary. It is a NABL accredited and MoEFCC approved
laboratory.
Groundwater quality at various locations in the immediate vicinity of the industry is

analysed.
Based on the these studies, an Environmental Impact Statement has been prepared to
ascertain the impacts of each activity of the industry on the environmental
parameters like air, water, land and socio-economic environment vis-à-vis mitigation
measures. An impact matrix has been prepared based on these observations.
An Environmental Management Plan has been prepared covering the environmental

aspects and the management plan adopted by the management during operation
phase. An environmental monitoring plan with details of frequency, location, data
analysis, reporting schedules that are being followed by the industry is shown.
Detailed risk assessment study is carried out to evaluate the risks involved due to
storage of various solvents & precautionary measures to be taken for
prevention/management of such risks. Fire and explosion index has been calculated
for the hydrogenation process.
Conclusions drawn from the above study relates to the fact that the APIs and
intermediates manufacturing industry M/s. Shilpa Medicare Ltd. Unit I has certain
level or marginal impacts on the local environmental setting, which will not affect the
natural environmental setting of the study zone either drastically or otherwise. This is
because due care is taken by establishing and implementing pollution control
equipments and measures. Also, certain beneficial impacts in terms of the
employment opportunities have been created for the local population. Also, there is
economic growth at the regional level.
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The Environment Cell in the organization monitors and implements programs to

improve its environmental status from time to time and will adopt technological
advances based on feasibility to reduce impacts due to its operation on the
environment.
Shilpa Medicare is an ISO 14001: 2015, ISO 18001:2007 certified organization and
committed to implement, maintain and improve the environmental management
system. Also, risk assessment studies are carried out and safety measures
implemented.
To put it in a nut shell the management of M/s. Shilpa Medicare Ltd. Unit I, strongly
believes in the concept of sustainable development and understands the impacts of
the industry on the environment from the Environmental Impact Assessment studies
conducted. It is committed to continue operations without giving room for any
adverse impacts on the environment and also lays emphasis on the implementation of
the recommendations of the Environmental Management Plan in true spirits.
EXPLANATION OF HOW ADVERSE EFFECTS HAVE BEEN MITIGATED

The measures adopted to mitigate the impacts due to the industry are tabulated
below
Table 11.1: Measures adopted to mitigate the impacts
Sl. Parameter Mitigation measures
no.
1 Water pollution sources
Domestic Domestic sewage is treated in septic tank and soak pit.
sewage
Industrial Effluent generated from the industry is sent to Shilpa
wastewater Medicare Unit II for final treatment and disposal.
Two 20 KL wastewater storage tanks provided at Unit I.
2 Air pollution sources
D.G. sets Stacks of adequate heights.
Steam boilers Stacks of adequate heights and multicyclone.
Process Packed column scrubbers
section
3 Noise Acoustics.
pollution
sources DG
sets
4 Solid/Hazardous waste
Domestic Segregated at source, collected in bins and disposed and
garbage disposed to waste collection system of the Municipality.
Hazardous Disposed through authorized channels.
solid waste
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CHAPTER 12
DISCLOSURE OF CONSULTANTS ENGAGED

A. DETAILS OF THE EIA CONSULTANT
CONSULTANT ORGANIZATION: SAMRAKSHAN

Address: F- 4, I Floor, Swastik Manandi Arcade,
S C Road, Sheshadripuram,
Bangalore - 560 020
Ph.: 080-23460102
E mail id [email protected], [email protected]
INTRODUCTORY PROFILE
SAMRAKSHAN is a Bangalore, Karnataka based Environmental Engineering Consultancy
Company. SAMRAKSHAN is an off shoot of AQUATECH ENVIRO ENGINEERS, Bangalore.
We are leading solutions providers of B2B solutions in the field of Environment since
two decades. SAMRAKSHAN is a specialized solution provider; we serve varied
industries like Distillery, Sugar, Fertilizers, Pharmaceuticals, Power generation,
Service industries, Common waste disposal facilities etc.
PROFESSIONAL SERVICES OFFERED

We undertake works related to Pollution Control,
Environmental Impact Assessment studies,
Preparation of Environmental Management plan,
design and execution of Effluent / wastewater and water treatment plants,
air pollution control and management,
solid and hazardous waste management,
Due-diligence studies.
Assists clients for implementation of conditions stipulated in the Environmental
Clearances, Consent to Establish and consent to operate issued by the
Regulatory agencies.
Assist clients in Environment related Project Management Consultancy.
Imparting training to the industries for Environment regulatory compliances.
Compliance report preparation.
We also undertake assisting clients in techno-legal issues before the
Honourable High Court, NGT and Supreme Court etc.
STAY ORDER DETAILS

Appended at the end of this report.
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508
Powered by TCPDF (www.tcpdf.org)

M/s. Shilpa Medicare Ltd. – Unit I
STAY ORDER
564
EIA
565
512
566
513
567
514
568
515
ANNEXURES
Annexures
- 569 -
LIST OF ANNEXURES
Annexure Details Pg no.
no. new
A1 ToR letter no. F. No. J-11011/191/2017-IAII(I) dated 14th June 2018 issued by MoEF&CC 571-574
Authorizations from Karnataka State Pollution Control Board (KSPCB) 575-607
A2 Consent For Consent no. Validity 576-583
Operation (CFO) From To
dated
1. 8th Oct 2015 No:PCB/HPI/053/2015-16/1245 1st July 2015 30th June 2016
st
2. Hazardous waste No. PCB/WMC/SEO/69748/2014- 1 July 2014 30th June 2019 584-585
authorization 15/309
dated 23rd June
2014
3. Consent For NO. KSPCB/HPI/053/Shilpa- - - 586-594
Establishment I/CFEx/2010-11/86
(CFE) dated 7th
May 2011
4. Consent for Combined consent order no. AWH- 1st July 2016 30th June 2021 595-607
Operation for 301739
Unit II dated 27th
Dec 2016
A3 1. Compliance report to the latest CFO dated 8 th Oct 2015 valid from 1st July 2015 to 608-633
30th June 2016
2. Routine monthly monitoring and analysis reports (for March 2018)
Ambient air
Process section – scrubbers & boiler, DG stacks
Ambient noise
Effluent
VOC (3 months once)
Soil (annual)
A4 Actual production record 634-635
A5 Wastewater transfer slips (from Unit I to Unit II) 636-640
A6 Summarized safety data including incidents/accidents, emergency response teams, 641-642
trainings etc.
A7 Sample log book records for scrubber 643-644
A8 License for storage of solvents from PESO 645-648
A9 HAZOP analysis 649-785
A10 Land records and gazette notification 786-853
Hazardous waste contracts
A11 Maps and drawings 854-858
1. Topo map – 10 km radius
2. Site plan
3. Layout of industrial area
4. Maximum credible accident scenario
Annexures
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ANNEXURE A1
ToR letter no. F. No. J-

11011/191/2017-IAII(I) dated
14th June 2018 issued by MoEF&CC
571
572
573
574
ANNEXURE A2
Authorizations from Karnataka State

Pollution Control Board (KSPCB)
575
· / Fax: . 25581383,25589112
25588151,25588270
{1€r..:DeE'Y / E-maIl: [email protected]
(j8)6c\ nW,-,j6/ Website: http://kspcb.gov.in 25588142,25586520
Ref: 1. Application filed by the industry at R.O. Raichur on 08.04.2015.

2. Inspection of the unit by R.O. Raichur on 24.04.2015 & report dated 06.05.2015
3. Report ofR.O. Raichur dated 30.06.2015.
4. Affidavit filed by the industry dated 23.07.2015.
5. Proceedings of the Consent Committee meeting held on 29.07.2015.
---0---
Consent is hereby granted under section 25 of the Water (Prevention and Control of
Pollution) Act 1974 and under Section 21 of the Air (Prevention and Control of Pollution)
Act 1981 (herein after referred as the-Water Act and the Air Act respectively) and the Rules
and Orders made there under.
Consent is granted to "The Managing Director, MIs. Shilpa Medicare Ltd., Unit-I, Plot
No.4, Deosugur Industrial Area, Raichur Taluk & District" authorizing him to operate
the industrial plant at the above said premises and to make discharge of effluents and
emissions and subject to the terms and conditions as detailed in the schedule annexed to this
order.
Discharge of effluents under the Water Act:
SI. Description Permitted Quantity of Place of discharge

No discharae
1 Trade effluent 26KLD Low TDS effluent shall be treated in the ETP
followed by R.O. R.O permeate shall be used
for cooling tower make up. R.O. rejects and
I High TDS effluent shall be transported and
treated in combined treatment facility i.e. in
MEE and ATFD. Provided at Unit-II,
Raichur Growth Centre, Raichur.
2 Domestic 6KLD l
Shall be discharged to Septic tank & Soak
effluent pit.
Discharge of air emissions under the Air Act from the following stacks etc.
Sl. Description of chimney/outlet Limits specified refer
No. schedule
As per annexure II
SENIOR ENVIRONMENTA'J;;;FICER
1'VOID USE OF PLASTICS- BE 'ECO' FRIENDLY

576
The consent is issued considering the activity/manufacture of:
51. No Products Capacity
1. Ambroxol HCI 6.0 MT/month <
2. Phenyl Ephrine HeI 1.5 MT/month ---
3. Buflomedil HCI 1.0 MT/month
4. Ticlopidine HCI 2.0 MT/month
5. Ursodeoxvchoflc acid 9.0 MT/month
6. Sildenafil Citrate MT/month I.
7. Nifedipine 1.0 MT/month
8. Acebrophvllme 3.0 MT/month
ONCOLOGY Products
9 Irinotecan HCI 10 Kq/month
10. Gemcitabine HCI 250 Kg/month
11. Oxaliplatin 5 Kg/month
12. Temozolomide 100 Kg/month
13. Imatinib Mesylate ---
100 Kg/month
14. Gefitinib 10 Kg/month
15. Anastrizole 5 Kg/month
16. Cisolatin 50 Kq/month
17. Carboplatln 50 Kg/month
18. Capecitabine 1000 Kg/month
19. Docetaxel 50 Kg/month
20. Thalidomide 50 Kg/month
21. Topotecan HCI 5 Kg/month
22. Bicalutamide 200 Kg/month
23. Letrozole 5 Kg/month
24. Lenalidomide 1 Kg/month
25. Bortezomib 1 Kg/month
26. Zoledronic acid 5 Kg/month
27. Bendamustine 5 Kg/month
28. Epirubicine 20 Kg/month
29. Paclitaxel 10 Kg/month
30. Premetrexed 10 Kg/month
Total 26.44 MT/m (317.28 MT/a)
The Consent is granted for the period from 01.07.2015 to 30.06.2016.
For and on behalf of the
Karnataka State Pollution Control Board
SENIOR ENVIRONMENTAL OFFICER
The Managing Director,

M/s. Shilpa Medicare Ltd.,
Unit-I, Plot No.4,
Deosugur Industrial Area,
Raichur Taluk. & District. ...
I 1. Size: L/M/S Large

2. Category: RlO/G Red
3. Consent Fee paid Rs. 3,00,0001- under both Water & Air Acts (3years)
4. Ca ital Investment Rs.3 8.09 Crores
Mis. Shtlpa Medicare, Unit-I, CFO, 20 15-16 2 577

SCHEDULE
TERMS AND CONDITIONS
(to accompany consent No: PCBI HPI/053/2015-16 Date: )
A. TREATMENT AND DISPOSAL OF EFFLUENTS UNDER THE WATER ACT.
1. Quantity of the water use:
1. The source of water is from River Krishna through CMC Raichur water supply. The
water consumption shall not exceed 7KLD for Domestic Purpose and 49 KLD for
industrial purpose.
II. Treatment and disposal of trade and sewage effluent:
1. The details of waste water discharge shall be as follows.
SI. Description. lPermitted Quantity Place of discharge
No of discharge
1 Trade effluent 26KLD Low TDS effluent shall be treated in the ETP
followed by R.O. R.O permeate shall be used
for cooling tower make up. R.O. rejects and
High TDS effluent shall be transported and
treated in combined treatment . facility i.e. in
MEE and ATFD. Provided at Un.it-II, Raichur
Growth Centre, Raichur.
2 Domesticeffluent 6KLD Shall be discharged to Septictank & Soak pit.
2. The sewage effluent shall be treated in septic tank and soak pit confirmingto IS 2470
Part-I and II and no overflow from soak pit is allowed
3. The applicant shall maintain records of quantity of effluent handed over and monthly
returns shall be submitted to Regional Office, Raichur.
4. The applicant shall furnish the daily quantity of effluent generated from the process
effluent including the scrubbed effluent generation and disposal.
5. The Applicant shall not change or alter either the quality or the quantity or the rate of
discharge or temperature or the route of discharge without the previous written
permission of the Board.
6. The applicant shall not allow the discharge from the other premises to mix with the
discharge from his premises. Storm water shall not be allowed to mix with the effluents
on the upstream of the terminal manhole where the flow measuring devices are installed.
7. No effluent shall be discharged outside the premises.
ill. Storm 'Vater Management:
The applicant shall not allow the discharge from the other premises to mix with the discharge
from his premises Storm water shalll not be allowed to mix with the trade andlor sewage effluent
on the upstream of the terminal manholes where the flow measuring devices will be installed.
The applicant shall establish Rain Water Harvesting
, system.
B. WATER CESS:
1. The industry shall comply with the provisions of Water (Prevention & Control of Pollution) Cess
Act, 1977, by installing water meters, filing water cess returns in Form-I and other provisions as
contained in the said Water (Prevention & Control of Pollution) Cess Act, 1977 and 2003.
.
Mis. Shilpa Medicare, Unit-I, CFO, 2015-16 3 578

C. DISCHARGE OF EMISSIONS UNDER THE AIR ACT,1981:
a) The discharge of emissions from the premises of the applicant shall pass through the air
pollution control equipment and discharged through stacks/chimneys mentioned in
Annexure - I where from the Board shall be free to collect the samples at any time in
accordance with the provisions of the Act and Rules made there under.
2. The type of emissions, rate of emissions, tolerance limits, stack heights and the Air
pollution equipments shall be as specified in Annexure-I.
3. The industry shall ensure that the ambient air quality in its premises shall conform to the new
National Ambient Air Quality Standards specified in Environment (Protection) Rules.
4. The industry shall upgrade/modifylreplace/change the control equipments/chirnney
heights if they are found inadequate to meet the standards stipulated. Prior permission of
the Board shall be obtained for the same. .
5. The industry shall prevent solvent loss by installing double condenser systems and
connecting the vents to a carbon tower to minimize the fugitive emissions.
6. Centrifuge vents shall be connected to scrubber.
7. In plant control measures for checking fugitive emissions from all the vulnerable sources
shall be provided. Fugitive emissions shall be controlled by providing closed storage.
Closed handling & conveyance of chemicals/materials, multi cyclone separator and water
sprinkling system. Dust suppression system including water sprinkling system shall be
provided at loading and unloading areas to control dust emissions. Fugitive emissions in
the work zone environment, product, raw materials storage area etc. shall be regularly
monitored & the emissions shall conform to the limits. The industry shall monitor VOC's
within its premises for which a monitoring plan indicating the parameters relevant to the
industry, location and the frequency shall be submitted within 30 days.
For further control of fugitive emissions, following steps shall be followed:
i. Closed handling system shall be provided for chemicals.
ii. Reflux condenser shall he provided over reactor.
iii. System of leak: detection and repair of pump/pipeline based on preventive
maintenance.
iv. The acid shall be taken from storage tanks to reactors through closed pipeline. Storage
tanks shall be vented through trap receiver and condenser operated on chilled water.
v. Cathodic protection shall be provided to the underground solvent storage tanks.
D. Solvent Management
Solvent management shall be carried out as follows:
i. Reactor shall be connected to chilled brine condenser systerm
ii. Reactor and solvent handling pump shall have mechanical seals to prevent leakages.
iii. The condensers shall be provided with sufficient HTA and residence time so as to
achieve more than 95% recovery.
iv. Solvents shall be stored in a separate space specified with all safety measures.
v. Proper earthing shall be provided in all the electrical equipment wherever solvent
handling is done.
E. MONITORING AND REPORTING:

1. Continue self monitoring system of emissions and effluents. Industry shall abide by the directions
issued by the CPCB/SPCB in implementing the continuous online monitoring system.
u.. r(,
Mis. Shilpa Medicare, Unit-I, CFO, 20 /5-/6 4 579

2. The applicant shall carryout self monitoring of effluents and emissions at the frequency
indicated and fumishe the reports of analysis to the area Regional officer.
3. The applicant shall monitor the ground water as per the MOEF Notification No.
S.0.2l51, dated 17.6.2005.
4. The applicant shall maintain log books to reflect the working condition of pollution
control systems and also self monitoring results and keep it open for inspection.
5. The applicant shall carry out VOC monitoring once in 3 months.
6. The applicant shall carryout the ambient air quality monitoring and submits the report to
the Regional Office of the Board. The AAQM stations shall be carried out in all the
established stations as per the requirement under the National Ambient Air Quality
Monitoring Standards stipulated in Enyironmental (Protection) Rules, 1986. Monitoring
shall include the parameters PM 2.5, PM 10, sulphur dioxide, Nitrogen Oxide, and H2S.
The industry shall furnish statistical analysis for annual average of pollutants at all the
locations as per Ambient Air Quality standards Notification once in a year.
7. The applicant shall monitor the hazardous air pollutants such as Benzene, Carbon tetra
chloride, 1-4 di-oxane, methanol, toluene, methyl chloride etc. and odorous compounds
mercapatan and hydrogen sulphide from the process area general exhaust and from the
process emission and report the results to the Board immediately.
F. ENVIRONMENTAL STATEMENT:_
The applicant shall submit the Environmental Statement every year for the period ending
31 st March inForm V of Rule as per Rule 14 of Environment (Protection) Rule 1986 on
or before 30th September. .'
G. NOISE POLLUTION CONTROL:
1. The industry. shall ensure that the ambient noise levels within its premises shall not
exceed the limits i.e. 75 dB (A) Leg during day time and 70 dB (A) Leg during night time
as specified in the Environment (Protection) Rules.
2.. The applicant shall provide acoustic measures to the D.G. Sets as per Sl.No.94 in
Schedule-I of Environment (Protection) Rules.
H. SOLID WASTE (OTHER THAN HAZARDOUS WASTE) DISPOSAL:
1. The industry shall collect; treat and dispose off all solid waste generated from the process
other than wastes covered under the Hazardous Waste (Management & Handling) Rules,
in such manner so as not to cause environmental pollution.
2. The solid waste in the form of packing material shall be sold to scrap dealers and boiler
ash (Coal ash) of quantity 3.0 MT/day shall be disposed to local brick manufacturers.
I. HAZARDOUS WASTES (MANAGEMENT, HANDLING & TRANSBOUNDARY
MOVEMENT) RULES 2008:
1. The industry shall comply with Hazardous Wastes (Management, Handling &
Transboundry Movement) Rules 2008 and shall apply for authorization for the same.
J. GENERAL
1. The Board reserves the right to review, impose additional conditions, revoke, change or
alter terms and conditions of this consent.
Mis. Shilpa Medicare, Unit-1, CFO, 2015-16 5 580

2. This consent for discharging sewage and/or Trade effluents from the factory shall not be
taken or construed as the Board's permission to continue to discharge the sewage and/or
Trade effluents from the factory into the place (as mentioned in this consent Order) which
pollutes the water there-in endangering the life and property of the persons using the said
water before, during or after the periods indicated in the Terms and Conditions of this
Consent Order.
3. The applicant shall display flow diagram of the pollution control system at the site.
4. The applicant shall not change or alter quality or quantity or the rate of discharge or
temperature or the route of discharge without the previous consent of the Board.
5. The applicant shall promptly comply with all orders and instructions issued from time to
time by the Board or any other officers of the Board duly authorized in this behalf.
6. The industry shall not change or alter (a) raw materials or manufacturing process, (b)
change the products or product mix (c) the quality, quantity or rate of discharge/
emissions and (d) installireplace/alter the water or air pollution control equipments
without the prior approval of the Board.
7. The applicant shall display the consent granted in a prominent place for perusal of the
inspecting officers of the Board.
8. The applicant shall provide alternate power supply sufficient to operate all Pollution
control equipments utilized by the applicant to maintain compliance with the terms and
conditions of this consent.
,
9. The Applicant shall forthwith keep the Board informed of any accidental discharge of
emissions/effluents into the atmosphere in excess of the standards laid down by the
Board. The applicant shall also take corrective steps to mitigate the impact.
10. The applicant shall not store any raw materials on naked ground. The applicant shall
construct impervious dyke walls/tank form for storage tanks constructed above ground
level.
11. The applicant shall provide port holes for sampling the emissions, access platforms for
carrying out stack sampling, electrical points and all other necessary arrangements
including ladder.
12. The industry shall take all necessary measures to avoid odour nuisance from the process
area, scrubber, effluent treatment plant, etc.
13. The applicant shall have an Environmental Cell with Qualified Environmental Engineer
or Environmental Scientist for which a criterion should be worked out.
14. The applicant shall comply with the guidelines under Corporate Responsibilities for
Environment protection 2003 issued by Ministry of Environmental Forests and CPCB
15. There shall not be public complaint against the'industry regarding any kind of pollution.
16. The applicant, his heirs, legal representatives or assigns shall have no claims what so ever
to the continuation or renewal of this consent after expiry of the period of consent.
17. The applicant shall provide alternative power supply sufficient to operate all Pollution
control equipments utilized by the applicant to maintain compliance with the terms and
SENIOR ENVIRONMEJTAZ OFFICER
Mis. Shilpa Medicare, Unit-I, CFO, 20 15-16 6

581
18. The entire premises shall be always kept clean. The effluent holding area, inspection
chambers, outlets, flow measuring points should made easily approachable.
19. The applicant shall maintain the Environmental Management System in conformity with
ISO 14001:2004 standards.
20. The Industry shall display the CFE, CFO, EC, compliance to consent and EC conditions,
monitoring results on their web site. The environmental statement shall also be posted on
their web site.
21. The applicant shall make an application for consent at least 120 days before expiry of this
consent.
22. Industry shall comply with all the consent conditions and furnish report within 30 days to
the Regional Office.
Mis. Shilpa Medicare, Unit-I, CFO, 2015-16 7 582

ANNEXURE - II
Chim. Chimney attached to Minimum Chimney Rate of Constituents to Tolerance Air Pollution Control Date of which air pollution I
No. height to be provided emission be controlled in limits equipment to be Control equipment shall be
3fHr
above ground level Nm the emission mg/Nnr' installed, in addition to provide to achieve the
chimney height as per stipulated tolerance limits
Col.(3). and chimney heights
conforming to stipulated
heights.
1 2 3 4 5 6 7 8
l. Boiler of 4 TPH 30mAGL - Particulate 150 Chimney Ht, as per At an times
matter column No.3 with
802 - multicyclone and bag filter I
2. of 4 TPH 30mAGL - Particulate 150 Chimney Ht, as per At all times I

matter column No.3 with I
802 - multicyclone and bag filter
3. 325 KVA DG Set 5m ARL (individual - 802 - Individual chimney as per At all times
chimney) Col. No.3 with acoustic
enclosures
4. 325 KVA DG Set 5mARL - 802 - Individual chimney as per At all times I
Col. No.3 with acoustic
enclosures
5. Process Emission from 3mARL - Acid Mist 35 Individual chimney of 3.0 At all times
production area ('
ill ARL with scrubber and
Reactors-37(88-20 & mist eliminator
I
GLR-17)
6. Process Emission from 3m ARL chimney - Acid Mist 35 Individual chimney of3.0 At all times
Production area mARL with scrubber and
Reactors-19 mist eliminator
(88-15 & GLR-4)
..
Mis. Shilpa Medicare, Unit-I, CFO, 20 15-16 8
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589
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(This document contains 6 pages including annexure & excluding additional conditions)
Combined Consent Order No. AWH-301739 PCB ID: 28295 Date: 27/12/2016
Combined consent for discharge of effluents under the Water (Prevention and Control of Pollution)
Act , 1974 and emission under the Air (Prevention and Control of Pollution)Act , 1981
Ref: 1. Application filed by the applicant/organization on 20/05/2016

2.Inspection of the on on 20/05/2016
Industry/organization/by RO,
3.Proceedings of the CCM dated 22/11/2016 ,held on 14/11/2016
Consent is hereby granted to the Occupier under Section 25(4) of the Water (Prevention & Control of Pollution) Act, 1974 (
herein referred to as the Water Act) & Section 21 of Air (Prevention & Control of Pollution) Act, 1981, ( herein referred to as
the Air Act) and the Rules and Orders made there under and authorized the Occupier to operate /carryout industry/activity &
to make discharge of the effluents & emissions confirming to the stipulated standards from the premises mentioned below and
subject to the terms and conditions as detailed in the Schedule Annexed to this order.
Location:
Name of the Industry: Shilpa Medicare Ltd 100% Eou
Address: Plot no 33,33A,40 TO 47, Raichur Growth Centre
Industrial Area: Raichur Growth Centre I.A, Chiksugur,
Taluk: Raichur, District: Raichur
Conditions:
a) Discharge of effluents under the Water Act:

Sr Water Code WC(KLD) WWG(KLD) Remark
1 Boiler Feed 20.000 2.000 For make up
2 Cooling Water 10.000 2.000
3 Domestic Purpose 5.000 4.000
4 Manufacturing Processes 15.100 15.100
5 Others ..... 1.500 1.500 Scrubbers & RnD Purpose
b) Discharge of Air emissions under the Air Act from the following stacks etc.
Sl. No. Description of chimney/outlet Limits specified refer schedule
The details of Sources, control equipments and its specification, type of fuel,constituents
to be controlled in emissions etc. are detailed in Annexure-II.
The consent for operation is granted considering the

following activities/Products;
Sr Product Name Applied Qty/Month Unit
1 3 alfa 7beta dihydroxy chloric acid 60.0000 M.T
2 Abroxol HCl 47.0000 M.T
3 Anastrozole 0.1000 M.T
4 Bicalutamide 0.5000 M.T
5 carboplatin 0.1000 M.T
6 Cisplatin 0.1000 M.T
7 coenzymeQ10 18.0000 M.T
8 Docetaxel trihydrate 0.1000 M.T
9 Gemcitabine HCL 0.3000 M.T
10 Irinotecan HCL trihydrate 0.1000 M.T
11 Oxaliplatine 0.1000 M.T
12 paclitaxel 0.1000 M.T
13 solenasol 60.0000 M.T
14 Temozolomide 0.1000 M.T
This consent is valid for the period from 01/07/2016 to 30/06/2021

S NANDA KUMAR
To,
Shilpa Medicare Ltd 100% Eou
COPY TO:
The Environmental Officer, KSPCB, Regional Office Raichur for information and necessary action.
2. Master Register.
3. Case file.
1. Consent Fee paid : Rs. 150000
SCHEDULE
TERMS AND CONDITIONS
A. TREATMENT AND DISPOSAL OF EFFLUENTS UNDER THE WATER ACT.

1. The discharge from the premises of the occupier shall pass through the terminal manhole/manholes where from
the Board shall be free to collect samples in accordance with the provisions of the Act/Rules made there under.
2(a). The sewage/domestic effluent shall be treated in septic tank and with soak pit. No overflow from the soak pit
is allowed. The septic tank and soak pit shall be as per IS 2470 Part-I & Part-II.
2(b). The treated sewage effluent discharged shall conform to the standards specified in Annexure-I.
3(a). The trade effluent generated in the industry shall be treated in the ETP and treated effluent shall confirm to the
standards stipulated by the Board in Annexure-1
3(b). The trade effluent shall be handed over to CETP and maintain logbook of effluent generated & sent every day.
4. The applicant shall install flow measuring/recording devices to record the discharge quantity and maintain the
record.
5. The applicant shall not change or alter either the quality or the quantity or the place of discharge or temperature
or the point of discharge without the previous consent/ permission of the Board.
6. The applicant shall not allow the discharge from the other premises to mix with the discharge from his premises.
Storm water shall not be allowed to mix with the effluents on the upstream of the terminal manhole where the flow
measuring devices are installed.
7. The daily quantity of domestic effluent and trade effluent from the industry shall not exceed the limits as
indicated in this consent order:
8. The applicant shall discharge the effluents only to the place mentioned in the Consent order and discharge of
treated/untreated outside the premises is not permitted.
B. EMISSIONS:
1. The discharge of emissions from the premises of the applicant shall pass through the air pollution control
equipment and discharged through stacks/chimneys mentioned in Annexure-II where from the Board shall be free
to collect the samples at any time in accordance with the provisions of the Act and Rules made there under.The
tolerance limits of the constituents forming the emissions in each of the stacks shall not exceed the limits laid down
in Annexure-II.
2. The applicant shall provide port holes for sampling of emission, access platforms for carrying out stack sampling,
electrical points and all other necessary arrangements including ladder as indicated in Annexure-II.
C. WATER CESS:
1. The applicant shall provide water meter at all the intake points as specified under Section (5) of the Water Cess
Act, 1977 and shall file the Water Cess returns regularly before fifth of every month and also pay the Cess assessed
with the time stipulated.
D.MONITORING & REPORTING:
1. The applicant shall get the samples of effluents & emissions collected and get them analyzed once a
month/either by in house monitoring laboratory or through EP approved laboratories for the parameters as Indicated in
Annexure I & II.
2. The applicant shall maintain log books to reflect the working condition of pollution control systems and also self monitoring
results and keep it open for inspection.
E. SOLID WASTE (OTHER THAN HAZARDOUS WASTE) DISPOSAL:
1.The applicant shall segregate solid waste from Hazardous Waste, Municipal Solid Waste and store it properly till
treatment/disposal without causing pollution to the surrounding Environment.
2.The solid waste generated shall be handled & disposed by scientific method without causing eye sore to the
general public and to the surrounding environment.
F. NOISE POLLUTION CONTROL:
1. The industry shall ensure that the ambient noise levels within its premises shall not exceed the limits i.e 75 dB(A) Leq
during day time and 70 dB(A) Leq during night time as specified in under the Air (Prevention and Control of Pollution)
Act, 1981.
G. HAZARDOUS WASTES (MANAGEMENT, HANDLING & TRANSBOUDARY MOVEMENT) 2008:
The applicant shall comply with the provisions of the Hazardous Wastes (Management, Handling & Transboundry
Movement) Rules 2008.
H. GENERAL CONDITIONS:
1. The applicant shall not allow the discharge from the other premises to mix with the discharge from his
premises.
2. The applicant shall promptly comply with all orders and instructions issued by the Board from time to time or
any other officers of the Board duly authorized in this behalf.
3. The applicant shall set-up Environmental Cell comprising of qualified and competent personnel for complying
with the conditions specified.
4. The Board reserves the right to review, impose additional conditions, revoke, change or alter terms and
5. The applicant shall forthwith keep the Board informed of any accidental discharge of emissions/effluents into
the atmosphere in excess of the standards laid down by the Board. The applicant shall also take corrective steps to
mitigate the impact.
6. The applicant shall provide alternative power supply sufficient to operate all Pollution control equipments.
7. The entire premises shall always be kept clean. The effluent holding area, inspection chambers, outlets, flow
measuring points should made easily approachable.
8. The applicant shall display the consent granted in a prominent place for perusal of the inspecting officers of the
Board.
9. The applicant his heirs, legal representatives or assignee shall have no claims what so ever to the continuation or
renewal of this consent after expiry of the validity of consent.
10. The applicant shall make an application for consent for subsequent period at least 45 days before expiry of this consent.
11. The applicant shall develop and maintain adequate green belt all around the periphery.
12. The applicant shall provide rain water harvesting system and shall provide proper storm water management
system.
13.This consent is issued without prejudice to any Court Cases pending in any Hon’ble Court
14. The applicant shall furnish the Environmental statement for every financial year ending with 31st March in
Form-V as per Environment (Protection) Rules, 1986. The statement shall be furnished before the end of
September.
15.The applicant shall display flow diagram of the pollution control system near the pollution contol system/s.
NOTE:
The following Conditions A[2(b),3(b)] & G mentioned in the schedule are not applicable.
Additional Conditions:
Please see additional condition to the consent order. The Annexure-I & II is applicable for discharge of effluent and
emission regulation.

S NANDA KUMAR
Note: All efforts should be made to remove colour and unpleasant odour as far as practicable.
Chi Chimne Capacity/ Minimum Constituents to be Tolerance Fuel Air pollution Date of which air
m.N y KVA chimney controlled in the limits Control pollution control
o. attached Rating height to be emission mg/NM3 equipment to equipments shall
to provided be be provided to
above installed,in achieve the
ground addition to stipulated
level chimney tolerance limits
(in Mts) height as per and chimney
col.(3) heights
conforming to
stipulated
heights.
1 Boiler 10 TPH 30 PM(mg/NM3),SO2 150,100,50 HUS DUS,MUL Before

(PPM),NOx(PPM) commissioning.
2 Boiler 6 TPH 30 PM(mg/NM3),SO2 150,100,50 HUS DUS,MUL Before
(PPM),NOx(PPM) commissioning.
3 D.G. 625 KVA 6 PM(mg/NM3),SO2 150,100,50 DIE N.A Before
Sets (PPM),NOx(PPM) commissioning.
6 Acid 500 lit 3 PM(mg/NM3),SO2 Acid mist, SCR Before
Mists (PPM),NOx(PPM) VOC commissioning.
16 Acid 500 li 3 PM(mg/NM3),SO2 Acid mist, SCR Before
Note:
DUS,MU : Dust Collector
L
N.A : Not Applicable
SCR : Scrubber
Note:
1. The Noise levels within the premises shall not exceed 75 dB (A) leq during day time and 70 dB(A) leq during night
time respectively.
2. The DG set shall be provided with acoustic measures as per SI.No.94 in Schedule-I of Environment
(Protection)Rules.
3. There shall be no smell or odour nuisance from the industry.

LOCATION OF SAMPLING PORTHOLES, PLATFORMS, ELECTRICAL OUTLET.
1. Location of Portholes and approach platform:
Portholes shall be provided for all chimneys, stacks and other sources of emission. These shall serve as
the sampling points. The sampling point should be located at a distance equal to atleast eight times the
stack or duct diameters downstream and two diameters upstream from source of low disturbance such as
a Bend, Expansion, Construction Valve, Fitting or Visible Flame for rectangular stacks, the equivalent
diameter can be calculated from the following equation.
2 (Length x Width)
Equivalent Diameter = -----------------------
(Length + Width)
2. The diameter of the sampling port should not be less than 100 mm dia”. Arrangements should be made so
that the porthole is closed firmly during the non sampling period
3. An easily accessible platform to accommodate 3 to 4 persons to conveniently monitor the stack emission
from the portholes shall be provided. Arrangements for an Electric Outlet Point of 230 V 15 A with suitable
switch control and 3 Pin Point shall be provided at the Porthole location.
4. The ladder shall be provided with adequate safety features so as to approach the monitoring location with ease.
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602
603
604
605
606
607
ANNEXURE A3
1. Compliance report to the latest

CFO dated 8th Oct 2015 valid
from 1st July 2015 to 30th June 2016
2. Routine monthly monitoring and

analysis reports (for March 2018)
• Ambient air
• Process section – scrubbers &
boiler, DG stacks
• Ambient noise
• Effluent
• VOC (3 months once)
• Soil (annual)
608
CFO Compliance status
January-17 to February-18
Consent Order No: PCB/HPI/053/2015-16/1245 dated 8/10/2015

S Compliance
Terms and conditions Compliance
No Status
Manufactured within consent
Total Production Capacity Qty. (MT/annum) products total capacity Qty.
(MT/annum) during 2017-18
1 317.28 183.383 MT/annum
A Treatment and disposal of effluents under the water act.
Quantity of the water use: The source of water is from River
Water consumption
Krishna through CMC Raichur water supply line. The water Complied.
I was within 56
consumption shall not exceed 7KLD for Domestic purpose and 49
KLD.
KLD for industrial purpose.
II Treatment and disposal of trade and sewage effluent:
1. The details of water consumption and waste water discharge shall be as follows.
Permitted quantity of Mode of Mode of
S.No Purpose
discharge KLD Disposal Treatment
Shall be
Domestic waste Raw water
discharged to
1. Domestic 6.0 discharged to septic consumption
Septic tank &
tank & Soak pit. and effluent
Soak pit.
Shall be transported water
and treated in After pretreatment generation
combined ETP i.e. Effluent per day 6kl details are in
2. Industrial 26 in MEE & ATFD to 7.5kl is sent to Annexure
provided at Unit II, Unit-II further A21 & A22.
Raichur Growth treatment.
Center, Raichur.
The sewage effluent shall be treated in septic tank and soak pit Domestic waste
2. confirming to IS2470 part and II and no over flow from soak pit is treated at septic Complied
allowed tank & Soak pit.
Maintained records Acknowledge
and monthly returns ment copies
The applicant shall maintain records of quantity of effluent handed
3. submitted to are appended
over and monthly return shall be submitted to regional office, Raichur
regional office as Annexure
Raichur. A5.
Sample log
Maintained the book records
The applicant shall furnish the daily quantity of effluent generated
daily recorded log are in
4. from the process effluent including the scrubbed effluent generation
book for the Annexure
and disposal.
effluent generated A22.
CFO compliance
609
Treating the
The Applicant shall not change or alter either the quality or the Effluent as per the
Being
5. quantity or the rate of discharge or temperature or the route of limits given in the
followed
discharge without the previous written permission of the Board. consent.
Agreed.
Flow meter
Online Flow meter
The applicant shall provide flow measuring devices at both inlet and and camera
(separate energy
outlet of ETP along with separate energy meter for the ETP and photos are in
6. meter) installed and
maintain log book for hourly recording for verification of inspecting EIA report,
Log books
officers. Chapter 6,
maintained.
Fig 6.1.
Effluent not Strom drain
discharged outside photos are in
premises. Effluent EIA report,
7. No effluent shall be discharged outside the premises.
sent to Unit-II as Chapter,
per CFO for further Chapter 2,
treatment. Fig 2.15.
III. Strom water management
Rain water
Rain water
harvesting system
The applicant shall not allow the discharge from the other premises to harvesting
in place.
mix with the discharge from his premises. Storm water shall not be system photos
The storm water
1. allowed to mix with the trade and/ or sewage effluent on the upstream are in EIA
drains are separate
of the terminal manholes where the flow measuring devices will be report,
and effluent does
installed. The applicant shall establish rain water harvesting system. Chapter 2,
not mix in the
Fig 2.15.
storm water drains.
B. WATER CESS
The industrial shall comply with the provisions of Water (Prevention Filing water cess Acknowledge
1. & Control of Pollution) Cess Act 1977, by installing water meters, monthly till July- ment copies
filling water cess returns in Form-1 and other provision as contained 2017. There after are appended
in the said water (prevention &control of pollution) Cess Act,1977 monthly data is as Annexure
and 2003. being submitted. A5.
C. DISCARGE OF EMISSIONS UNDER THE AIR ACT,1981
I. Emissions
Stack emissions are
checked every
The discharge of emissions from the premises of the Applicant shall
month by the Emissions test
pass through the air pollution control equipment and discharged
authorized Reports are
1. through stacks/chimneys mentioned in Annexure-I where from the
laboratories. The appended as
Board shall be free to collect the samples at any time in accordance
discharge of Annexure A9.
with the provisions of the Act and Rules made there under.
emissions is within
the limits.
Complied Emissions test
The type of emissions, rate of emissions, and the tolerance limits,
Stack emissions are Reports are
2. stack heights and the air pollution equipment shall be as specified
checked every appended as
Annexure-I.
month by Annexure A9.
CFO compliance
610
authorized
laboratories.
We are routinely Ambient air
The industry shall ensure that the ambient air quality in premises shall
checking ambient Reports are
3. conform to the new national ambient Air quality standards specified in
air quality in our appended as
Environment (Protection) Rules.
premises. Annexure A9.
The industry shall upgrade/modify/replace/change the control Air pollution
4. equipment’s/chimney heights if they are found inadequate to meet the control
-
standards stipulated. Prior permission of the Board shall be obtained equipment’s are
for the same. found adequate
Double
Double condenser condenser
The industry shall prevent solvent loss by installing double condenser
system is provided photos are in
5. systems and connecting the vent to carbon tower to minimize the
for all the process EIA report,
fugitive emissions
equipment’s . Chapter 2, Fig
2.13.
Centrifuge to
scrubber
All Centrifuge
connection
vents are connected
photos are
6. Centrifuge vents shall be connected to scrubbers to the scrubber for
attached as
controlling of
EIA report,
fugitive emissions.
Chapter 2, Fig
2.14.
In plant control measures for checking emission from all the Dust collector is
vulnerable sources shall be provided. Fugitive emissions shall be provided to boiler
controlled by providing closed storage. Closed handling & for controlling of
conveyance of chemical/materials, multi cyclone separator and water dust emissions at
sprinkling system. Dust suppression system including water sprinkling Boiler.
system shall be provided at loading and unloading areas to control
dust emissions, fugitive emissions in the work zone environment, i. All the Raw Raw material
product, raw materials storage area etc. Shall be regularly monitored materials and storage area
& the emissions shall conform to the limits. The industry shall chemicals are photos in EIA
monitor VOC’s within its premises for which a monitoring plan stored in closed report,
indicating the parameters relevant to the industry, location and the drums, vessels, Chapter 2, Fig
7.
frequency shall be submitted within 30 days. carboys & 2.5.
For further control of fugitive emissions, following steps shall be containers.
followed: Solvents are
transferred in
i. Closed handling system shall be provided for chemicals. closed condition. VOC
monitoring
ii. Reflux details are
condenser is appended as
provided to Annexure A9.
ii. Reflux condenser shall be provided over reactor. reactors. Every 3
months VOC
CFO compliance
611
emissions are
checked by
authorized
iii. The acid shall be vented through trap receiver and laboratories.
condenser operated on chilled water.
iii. Double
condenser system
is provided for all
the process
equipment’s.
iv. Cathodic protection shall be provided to the underground Primary
solvent storage tanks. condenser
connected to CT
water and
secondary
condenser Complied
connected to
Chilled water line
to prevent the
acid fumes.
iv. We are
providing cathodic
protection to
underground
storage tanks for
controlling
corrosiveness.
D. Solvent management
Double
Double condenser condenser
system is provided photos are in
1. Reactors shall be connected to chilled brine condenser system
for all the process EIA report,
equipment’s. Chapter 2,
Fig 2.13.
Rectors and solvent
handling pumps
Reactor and solvent handling pump shall have mechanical seals to
2. have mechanical Complied
prevent leakages.
seals for preventing
leakages.
Details are in
All the adequate
the EIA
heat exchanger is
The condensers shall be provided with sufficient HTA and residence report,
3. given to get the
time so as to achieve more than 95% recovery. Chapter 2,
recovery of solvent
Section
more than 95%.
2.8.5.1.
CFO compliance
612
Solvents are stored

Solvent
at Solvent storage
Explosive
yard with all safety
Solvents shall be stored in a separate space specified with all safety license is
4. measures installed.
measures. appended as
Valid Solvent
Annexure
explosive license is
A23.
available.
We provided
earthing and earth
Proper earthing shall be provided to all the electrical equipment rod for all solvent
5. Complied
wherever solvent handling is done. handling
equipment’s and
unloading area.
E. Monitoring and reporting
Continuous online Photographs
Continue self-monitoring system of emissions and effluents. Industry flow meter and are in EIA
1. shall abide by the directions issued by the CPCB/CPCB in camera installed at report,
implementing the continuous online monitoring system. wastewater storage Chapter 6,
area. Fig 6.1.
Monthly
Every month
reports
The applicant shall carryout self-monitoring of emissions at the monitoring reports
acknowledgem
2. frequency indicated and furnishes the reports of analysis to the area submitted to the
ent copies are
regional officer. local regional
appended as
officer of KSPCB.
Annexure A5.
Bore well water
Latest ground
testing done by the
water analysis
The applicant shall monitor the ground water as per the MOEF NABL, MOEF
3. report is
notification No S.O.2151.dated 17.6.2005 authorized
appended as
laboratory every six
Annexure A1
months.
Scrubber
Log book monitoring
The applicant shall maintain log books to reflect the working
maintained for reports
4. condition of pollution control systems and also self-monitoring results
scrubber appended as
and keep it open for inspection.
monitoring. Annexure
A21.
Every three months
VOC reports
VOC is monitoring
are appended
5. The applicant shall carry out VOC monitoring once in 3 months. done by the
as Annexure
authorized
A9.
laboratory.
The applicant shall carryout the ambient air quality monitoring and Ambient air Ambient air
submit the reports to the Regional Office of the Board. The AAQM monitoring is being Reports are
6.
stations shall be carried out in all the established stations as per the regularly done on appended as
requirement under the national ambient Air Quality Monitoring monthly basis, the Annexure A9.
CFO compliance
613
standards stipulated in Environmental (Protection) Rules, 1986. results are

Monitoring shall include the parameters PM 2.5, PM 10, Sulphur complying the
dioxide, Nitrogen oxide, and H2S. The industry shall furnish statistical national ambient
analysis for annual average of pollutants at all the locations as per Air quality
ambient Air Quality standards notification Once in a year. standards stipulated
in Environment
(Protection) Rules.
Parameters are
within the limits.
Benzene, Carbon
tetra chloride, 1-4
di-oxane,
mercaptan
The applicant shall monitor the hazardous air pollutants such as
materials are not
Benzene, Carbon tetra chloride,1-4 di-oxane, Methanol, toluene,
used. Complied.
7. Methyl chloride etc. and odorous compounds mercepatan and
and Methanol,
hydrogen sulfide from the process area general exhaust and from the
hydrogen sulphide.
process emission and report the results to the Board immediately.
toluene, methyl
chloride is used.
and VOC testing is
done.
F. Environmental statement :
Form-V
We are submitting
The applicant shall submit the Environmental statement every year for acknowledgent
the Environmental
1. the period ending 31st march in form V of rule as per Rule 14 of copies are
statement every
environment (protection) Rule 1986 on or before 30th September. appended as
year.
Annexure A7.
G. Noise Pollution Control :
We are checking
the noise levels
every month by the
authorized
laboratories and the
The industry shall ensure that the ambient noise level within its Noise reports
noise levels are
premises shall not exceed the limits i.e. 75 DB (A) leq. During day are appended
1. within the
time and 70 db (A) leq. during night time as specified in the as Annexure-
parameters as per
Environment Protection Rules. A9.
(Prevention and
Control of
Pollution)
Act, 1981.
Photos are in
EIA report,
The Applicant shall provide acoustic measures to the D.G. sets as per Acoustics are
2. Chapter 2,
sl.No.94 in schedule-1 of environment (Protection) rules. provided
Fig 2.16.
CFO compliance
614
H. Solid waste (other than hazardous waste) disposal :

The industry shall collect; treat and dispose of all solid waste
Domestic garbage
generated from the process other than wastes covered under the
1. is disposed through Complied.
Hazardous waste (managements & Handling) Rules, in such manner
local Municipality.
so as not to cause environmental pollution.
Contract copy
The solid waste in the form of packing material shall be sold to scrap Boiler ash is with brick
dealers and boiler ash (coal ash of quantity 3.0 mt/day shall be handed over to manufacturer
2.
disposed to local brick manufacturers. brick is appended as
manufacturers. Annexure
A13.
I. HAZARDOUS WASTE (MANAGEMENT, HANDLING & TRANSBOUNDARY MOVEMENT)
RULES 2008.
We have hazardous
waste authorization
as per Hazardous Hazardous
waste waste
The industry shall comply with Hazardous waste (management,
(management, Authorization
1. Handling & transboundry movement) rules 2008 and shall apply for
Handling & copy is
authorization for the same
transboundry appended as
movement) Rules Annexure A3.
2008 valid till 30th
June 2019.
J. GENERAL
The Board reserves the right to review, impose additional conditions,
1. Accepted -
revoke, change or alter terms and conditions of this consent
Sewage is treated in
This consent for discharging sewage and/or trade effluents from the septic tank and soak
factory shall not be taken or construed as the Board's permission to pit. Trade effluent is
continue to discharge the sewage and/or Trade effluents from the factory
sent to Shilpa
2. into the place (as mentioned in this consent Order) which pollutes the Complied
Medicare Unit II for
water there-in endangering the life and property of the persons using the
said water before, during or after the periods indicated in the Terms and
treatment as
Conditions of this Consent Order. stipulated.
Flow diagrams of
The applicant shall display flow diagram of the pollution control pollution control
3. Complied.
system at the site. system are
displayed.
The applicant shall not change or alter quality or the rate of discharge
4. or temperature or the route of discharge without the previous consent Accepted -
of the Board.
The applicant shall promptly comply with all orders and instructions
5. issued from time to time by the Board or any other officers of the Accepted -
Board duly authorized in this behalf.
The industry shall not change or alter (a) raw materials or
6. Accepted -
manufacturing process. (b) Change the products or product mix (c)
CFO compliance
615
the quality, quantity or rate of discharge/emissions and (d)

install/replace/alter the water or air pollution control equipment’s
without the prior approval of the Board.
The applicant shall display the consent granted in a prominent place
7. Displayed Complied
for personal of the inspecting officers of the Board.
We have a 2 DG
The applicant shall provide alternate power supply sufficient to sets of 325 kVA
8. operate all pollution control equipment’s utilized by the applicant to capacity each as Complied
maintain compliance with the terms and conditions of this consent. stand by incase of .
power shutdown
We will inform any
accidental discharge
The applicant shall forthwith keep the Board informed of any of
accidental discharge of emissions/effluents into atmosphere in excess emissions/effluents Condition
9.
of the standards laid down by the Board. The applicant shall also take into atmosphere in accepted
corrective steps to mitigate the impact. excess of the
standards laid down
by the Board.
Raw material
The applicant shall not store any raw materials / chemicals / Solid / All materials
storage area
Hazardous Waste on naked ground. The applicant shall construct mentioned are
photos are in
10. impervious dyke walls/tank form for storage tanks constructed above stored in designated
EIA report,
ground level. impervious storage
Chapter 2,
area.
Fig 2.5.
Stack
We have provided sampling
The applicant shall provide port holes for sampling the emissions,
platform, staircase location
access platforms for carrying out stack sampling, electrical points and
11. for sampling of photos are in
all other necessary arrangements including ladder.
emissions from EIA report,
stacks. Chapter 2,
Fig 2.16.
We have dedicated
scrubber for Scrubber
reactors and monitoring
The industry shall take all necessary measures to avoid odor nuisance centrifuge. We reports
12.
from the process area, scrubber, effluent treatment plant etc. routinely check the appended as
scrubber water pH Annexure
and change the A21.
water.
We have appointed
Environmental
qualified
cell
The applicant shall have environmental cell with qualified environment
organogram is
13. Environmental Engineer or Environmental scientist for which a engineer for
in EIA report,
criterion should be worked out. environment
Chapter 10,
management in the
Fig 10.1.
factory.
CFO compliance
616
The applicant shall comply with the guidelines under corporate responsibilities for environment protection
2003 issued by ministry of Environmental forest and CPCB.
1. Segregation of waste streams: Waste streams should be segregated
into high COD waste toxic waste, low COD waste, inorganic waste Effluent
Wastewater is sent transfer slips
etc, for the purpose of providing appropriate treatment. to the Unit-II for are appended
Implementation by December, 31, 2003 and action plan to be further treatment. as Annexure
submitted to SPCB by June 30, 2003. A14.
2. Detoxification and treatment of high COD waste streams: High ETP flow
chart is in EIA
COD streams should be detoxified and treated in XTP or thermally High COD waste
report,
destroyed in incinerator – Implementation by March 2004 and action stream is treated in Chapter 2,
plan to be submitted to SPCB by June 2003. ETP of Unit II.
Section
2.8.2.1.
We are providing
adequate PPE’s
(Hand gloves,
3. Management of solid waste: Proper facilities should be provided Respirator masks
for handling and storage of hazardous waste. For final disposal of etc.) for handling of
Hazardous
hazardous waste, recycling and reuse should be given priority, either hazardous waste.
waste annual
within the premises or outside with proper manifest system. In case of Impervious storage
returns in
incinerable waste, property designed incinerator should be installed facilities are
Form IV are
14. provided.
within the premises or outside as a common facility. The non- appended as
Spent solvent, used
incinerable hazardous waste should be disposed off in properly Annexure A6.
oil and discarded
designed secure landfill either within the industry’s premises or in a containers are sent
common facility implementation by march 2004 and action plan to be to recyclers/
submitted to SPCB by June 2003. reprocessors. The
rest are disposed
through authorized
channels.
4. Minimum scale of production to afford cost of pollution control For
new industries which are not connected with CETP & TSDF and NA as effluent is
which do not have the economics to install treatment facilities may treated in ETP at
not be considered for granting consent to establishment. Industry Unit II and
--
hazardous waste is
association shall submit proposal to SPCB/CPCB – implementation disposed through
by December 31, 2003 and action plan to be submitted to SPCB by authorized agencies.
June 30, 2003.
5. Long term strategies for reduction in waste: Consent for
establishment and consent for operation under the Water Act will be Water balance
based on pollution load and concentration of pollutants. Each industry chart is in EIA
Water balance chart
report,
will submit pollution load, concentration of final discharge along with is available
Capter2, Fig
water balance to SPCB/CPCB for formulation of strategy – action 2.10.
plan to be submitted to SPCB by June 30, 2003.
CFO compliance
617
Benzene, Carbon
tetra chloride, 1-4
6. Control of air pollution: Industry will take up in priority the control di-oxane, mercaptan
VOC
of hazardous air pollutants (such as benzene carbon tetrachloride 1-4 materials are not
monitoring
used.
diocane, methanol, toluene, methyl chloride etc). and odorous reports are
Methanol, hydrogen
compounds (mecapatan & hydrogen sulphide) – Implementation by sulphide. toluene,
appended as
Dec. 2004 and action plan to be submitted to SPCB by June 2003. Annexure A9.
methyl chloride is
used. VOC testing
done.
7. Self – regulation by Industry through regular monitoring and
environmental auditing: Industries on their will carry out monitoring Monitoring
environmental parameters, audit it at regular interval and submit the We are routinely reports are
monitoring ambient appended as
same to SPCB- Implementation by June 2003. Comment of BDMA-
air, VOC, noise etc. Annexure A9.
There shall be a policy for accreditating the auditors and the policy
guidelines may be issued by MoEF.
8. Organistional restructuring and accreditation of Environmental
Manager of Industry (a) Environment management cell will be We have appointed
created for each industry reporting to CEO directly- Implementation qualified Organogram is
by June 2003. (b) There should be a certification system for the environmental in EIA report,
environmental managers at individual level and common facility manager and Chapter 10,
level. BDMA may 2003 the programme along with SPCB/ CPCB Environmental Fig 10.1.
Implementation by March 31, 2000 and action plan to be submitted to engineers.
SPCB by July 2003.
9. Optimizing the inventory of hazardous chemicals: The Information
Hazardous chemical
shall be submitted to SPCB regularly along with rational- action plan inventory --
to be submitted to SPCB by May 31, 2003. maintained
We have full-
fledged pollution
There shall not be public complaint against the industry regarding any control facilities for
15. Complied.
kind of pollution. controlling any kind
of pollution.
The applicant, his heirs, legal representatives or assigns shall have no

16. claims what so ever to the continuation or renewal of this consent Accepted --
after expiry of the period of consent.
We have 2 DG sets
of 325 kVA
The applicant shall provide alternative power supply sufficient to capacity each as
17. operate all pollution control equipment’s utilized by the applicant to alternative power Complied.
maintain compliance with the terms and conditions of this consent. supply to operate
pollution control
equipment’s.
CFO compliance
618
Daily general
The entire premises shall be always kept clean. The effluent holding
cleaning is done in
18. area, inspection chambers, outlet, and flow measuring point should Complied.
the entire industry
made easily approachable
premises.
ISO
We are an ISO 14001:2015
The applicant shall maintain the environmental management system 14001:2015 certificate is in
19.
in conformity with ISO 14001:2004 standards. accredited EIA report,
Company. Chapter 4,
Fig 4.6.
The industry shall display the CFE, CFO, EC, compliance to consent Displayed the CFE
20. and EC conditions, monitoring results on their website. The in the website of the --
environmental statement shall also be posted on their web site. industry.
We have submitted
The applicant shall make an application for consent at least 120 days consent application Complied
21.
before expiry of this consent. within 120 days to
the regional office.
We have submitted
Industry shall comply with all the consent conditions and furnish -
22. compliance to the
report within 30 days to the Regional Office.
regional office.
CFO compliance
619
620
621
622
623
624
625
626
627
628
629
630
631
632
633
ANNEXURE A4
Actual production record
634
635
ANNEXURE A5
Wastewater transfer slips

(from Unit I to Unit II)
636
637
638
639
640
ANNEXURE A6
Summarized safety data including

incidents/accidents, emergency
response teams, trainings etc.
641
Shilpa Medicare Limited Unit-1
Yearly Data
S.No Discription
2012 2013 2014 2015 2016 2017
1 No.of minor incident/accidents from 9 10 8 11 4 5
2 No.of major incident/accidents from 0 0 0 0 0 0
3 No.of occupational health diseases reported 0 0 0 0 0 0
4 No.of hot work permits 120 85 75
5 No.of height work permits 13 11 12
6 No.of vessel/confined space entry work permits 65 88 95
7 No.of training programs conducted on OH&S 65 55 45 70 89 95
8 No.of persons under gone training 104 190 185 201 250 259
No.of competitions conducted for creating awareness on
5 5 5 5 5 5
9 safety among employees
10 Emergency response team 10 10 10 10 15 15
11 First aid trainings conducted 0 0 0 0 1 1
12 Emergency control system 1 1 1
642
ANNEXURE A7
Sample log book records for scrubber
643
644
ANNEXURE A8
License for storage of solvents from

PESO
645
646
647
648
ANNEXURE A9
HAZOP analysis
649
HAZOP ANALYSIS
1) HAZOP- Acebrophylline
Hazop Study - Process – for Acebrophylline Stage-1

Possible Hazards /
Stages Process Operation Remedial Action
failures
Operational control - checkpoint shall be included in
Bottom valve opened,
the batch sheet to indicate whether the bottom valve
or Leakage of Bottom
has been closed prior to charging methanol & is not
Valve
Charging of Leaking.
Reaction of 2-Amino-
Methanol, Methanol addition pipe is kept to the Bottom of the
3,5-Dibromo
Fire hazard due to reactor
Benzaldehyde with
static electricity Pipe lines are all SS and equipment motors are
Trans-4-amino-
flame proof.
Cyclohexanol,in
Charging of 2- Instruction is Laid in the SOP , To Avoid spillage
methanol with Sodium Spillage out side the
Amino-3,5-Dibromo outside the Equipment,Lay down the Poly Bags to
Stage-1 borohydride , reactor,
Benzaldehyde Collect the spilled Material,& Transfer to the reactor
Methanol after 24
Charging of Trans- Instruction is Laid in the SOP , To Avoid spillage
hours reflex Sodium Spillage out side the
4-amino- outside the Equipment,Lay down the Poly Bags to
botohydrade and distill reactor,
Cyclohexanol Collect the spilled Material,& Transfer to the reactor
out the methanol and
add the water to Fire hazard due to SS scoops to avoid static electricity. The reactor is
static electricity earthed by conducting wires
reaction mass then
Irritation to skin & Using hand gloves & goggles.
centrifuge the material.
eyes
The temperature is raised by slow heating till reflux;
Refluxing the the methanol Vapour Loss is due to Excessive heat,
Loss of Methanol
reaction mass Instruction is Given in SOP, To Open the steam
valve to Optimum so as to maintain the reflux
650
The centrifuge is earthed by conducting wires.

The filtration is carried out through a centrifuge.
Centrifuges are high speed machines and sources of
hazard in a chemical plant. Ample precautions are
taken to carry out the centrifuging as hazard free as
possible. We are using a 48 inch dia SS316
centrifuge, bottom driven and top discharge. this is a
four point suspension machines which are put on
Fire hazard due to
special vibra mount for smooth vibration free
static electricity,
To separate the Ist noiseless operation. The speed is controlled by a
operator hazard if any
Centrifuging Stage From the variable frequency drive and the feeding of the
loading / unloading
liquid centrifuge is done by pneumatically controlled
activity carried out in
valves at lower RPM under nitrogen purging. Even
a running centrifuge
the bearing housing of the centrifuge is provided
with a nitrogen purging facility. An interlocking
system is provided for ensuring that the lids cannot
be opened while the centrifuge is running and
thereby preventing any operational hazard by human
error . All the limits switches and the safety
interlocking switches are flame proof including the
VFD controls.
Instruction is Laid in the SOP , To Avoid spillage
Charging of sodium Spillage out side the
outside the Equipment, Lay down the Poly Bags to
borohydrade reactor,
Collect the spilled Material,& Transfer to the reactor
651

Charging of Bottom valve opened,
Theophylline-7- or Leakage of Bottom
has been closed prior to charging Theophylline-7-
acetic acid, Valve
acetic acid & is not Leaking.
Charging of Spillage out side the
outside the Equipment,Lay down the Poly Bags to
Ambroxol reactor,
Preparation of Operational control - checkpoint shall be included in
Acebrophylline by Charging of Bottom valve opened,
Ambroxol, Dimethyl Dimethyl or Leakage of Bottom
has been closed prior to charging Dimethyl formamide
formamide , Theophylline- formamide Valve
& is not Leaking.
7-acetic acid and Ethyl The Filtration Operation is Carried out in Closed SS
acetate Line, Filter cloth cleaned for Every Batch & this
Stage-2 Spillage, Filter Cloth Cleaning of the Filter along with Cloth is Incorporated
Filtration
Block In the BPR
Acetone Charging SS pipe is Fixed to the Bottom of

Fire hazard due to the reactor
static electricity Pipe lines are all SS and equipment motors are flame
proof.

Charging of Ethyl the batch sheet to indicate whether the bottom valve
acetate has been closed prior to charging Ethyl acetate & is
Valve
not Leaking.
652

possible. We are using a 48 inch dia SS316 centrifuge,
bottom driven and top discharge. this is a four point
Fire hazard due to suspension machines which are put on special vibra
static electricity, mount for smooth vibration free noiseless operation.
To separate the
operator hazard if any The speed is controlled by a variable frequency drive
Centrifuging Stage-II From the
loading / unloading and the feeding of the centrifuge is done by
liquid
activity carried out in a pneumatically controlled valves at lower RPM under
running centrifuge nitrogen purging. Even the bearing housing of the
centrifuge is provided with a nitrogen purging facility.
An interlocking system is provided for ensuring that
the lids cannot be opened while the centrifuge is
running and thereby preventing any operational hazard
by human error . All the limits switches and the safety
VFD controls
Charging of MLR All charging is done by vacuum sucking to avoid

Hazardous waste spillages and through the closed SS pipe lines.
Solvent recovery No specific hazard
after distillation
Drying of the RCVD is fitted with flame proof motors. Unloading

Drying Separation of solvents from product in into the bins by actuated valve, Hence No- Less
No specific hazard
operation the product Rotocone vacuum Exposure
Dryer Hand gloves & goggles should be used.
653
2) HAZOP- Ambroxol HCl
Hazop Study - Process – for Ambroxol Stage-1

Possible Hazards /
failures
Operational control - checkpoint shall be
Bottom valve
included in the batch sheet to indicate
opened, or Leakage
whether the bottom valve has been closed
of Bottom Valve
prior to charging methanol & is not Leaking.
Charging of Methanol,
Methanol addition pipe is kept to the Bottom
Fire hazard due to of the reactor
static electricity Pipe lines are all SS and equipment motors
Reaction of 2-Amino-3,5- are flame proof.
Dibromo Benzaldehyde Charging of 2-amino 3,5 Instruction is Laid in the SOP , To Avoid
Stage-1 with Trans-4-amino- Dibromobenzaldehyde& Spillage out side the spillage outside the Equipment,Lay down the
Cyclohexanol,in methanol Trans-4-amino reactor, Poly Bags to Collect the spilled Material,&
with Sodium borohydride cycloHexanol Transfer to the reactor
Fire hazard due to SS scoops to avoid static electricity. The
static electricity reactor is earthed by conducting wires
eyes
The temperature is raised by slow heating till
reflux; the methanol Vapour Loss is due to
Refluxing the reaction
Loss of Methanol Excessive heat, Instruction is Given in SOP,
mass
To Open the steam valve to Optimum so as to
maintain the reflux
654

To separate the
Centrifuging Ist Stage From
the liquid
VFD controls.
655

Charging of the batch sheet to indicate whether the bottom valve
acetone, has been closed prior to charging methanol & is not
Valve
Leaking.
Charging of Spillage out side the Collect the spilled Material,& Transfer to the reactor
Ambroxol Crude reactor,
The Filtration Operation is Carried out in Closed SS

Line, Filter cloth cleaned for Every Batch & this
Purification of Ambroxol Spillage,Filter Cloth Cleaning of the Filter along with Cloth is Incorporated
Crude By Carbon Treatment Filtration Block
Stage-2 In the BPR
& Crystallization by Hcl,
centrifuging
the reactor
Fire hazard due to Pipe lines are all SS and equipment motors are flame
static electricity proof.
The Addition of Hydrochloric acid is charged through

the Closed lines, without any Spillage,personnel
Hydrochoric acid Protective Equipments are Used to avoid the Exposure
Hcl Addition
Spillage & Irritation & tackle the irritation
656

VFD controls

after distillation

No specific hazard
657
3) HAZOP- BUFLOMEDIL HCl
Hazop Study - Process – for BUFLOMEDIL HCl -1

Possible Hazards /
failures
Bottom valve
opened, or Leakage
has been closed prior to charging Methylene
Charging of of Bottom Valve
Dichloride & is not Leaking.
Methylene
Methylene
dichloride
dichloride addition pipe is kept to the Bottom of the
Fire hazard due to
reactor
Reaction of 1,3,5- static electricity
Pipe lines are all SS and equipment motors are flame
Trimethoxy Benzene
Stage- proof.
with 4-Chlorobutyryl
1 Instruction is Laid in the SOP , To Avoid spillage
chloride, in Methylene Spillage out side
Charging of 1,3,5- outside the Equipment,Lay down the Poly Bags to
dichloride with AlCl3. the reactor,
Trimethoxy Collect the spilled Material,& Transfer to the reactor
Benzene,4- Fire hazard due to SS scoops to avoid static electricity. The reactor is
Chlorobutyryl static electricity earthed by conducting wires
chloride& AlCl3 Irritation to skin & Using hand gloves & goggles.
eyes
The temperature is raised by slow heating till reflux;
Refluxing the Loss of Methylene the methanol Vapour Loss is due to Excessive heat,
reaction mass dichloride Instruction is Given in SOP, To Open the steam valve
to Optimum so as to maintain the reflux
Adding of Pyrrolidine Operational control - checkpoint shall be included in
Bottom valve
Stage- & Ethyl acetate Charging of the batch sheet to indicate whether the bottom valve
opened, or Leakage
2 Of reaction mass. Pyrrolidine has been closed prior to charging Pyrrolidine & is not
of Bottom Valve
Leaking.
658
Pyrrolidine addition pipe is kept to the Bottom of the

proof.
Bottom valve
Charging of Ethyl the batch sheet to indicate whether the bottom valve
opened, or Leakage
acetate has been closed prior to charging Ethyl acetate & is
of Bottom Valve
not Leaking.
Ethyl acetate addition pipe is kept to the Bottom of
proof.
Bottom valve
opened, or Leakage
has been closed prior to charging IPA & is not
of Bottom Valve
Charging of IPA Leaking.
IPA addition pipe is kept to the Bottom of the reactor
Fire hazard due to
static electricity
Charging of IPA & proof.
HCL into the reaction The Addition of Hydrochloric acid is charged through
Hydrochoric acid
mass the Closed lines, without any Spillage,personnel
Spillage &
Protective Equipments are Used to avoid the
Irritation
Exposure & tackle the irritation
Fire hazard due to
Hcl Addition static electricity,
operator hazard if
any loading /
unloading activity
carried out in a
centrifuge, bottom driven and top discharge. this is a
running centrifuge
659

noiseless operation. The speed is controlled by a
variable frequency drive and the feeding of the
centrifuge is done by pneumatically controlled valves
at lower RPM under nitrogen purging. Even the
bearing housing of the centrifuge is provided with a
nitrogen purging facility. An interlocking system is
provided for ensuring that the lids cannot be opened
while the centrifuge is running and thereby preventing
any operational hazard by human error . All the limits
switches and the safety interlocking switches are
flame proof including the VFD controls
660

Centrifuges are high speed machines and sources
of hazard in a chemical plant. Ample precautions
are taken to carry out the centrifuging as hazard
free as possible. We are using a 48 inch dia SS316
centrifuge, bottom driven and top discharge. This
is a four point suspension machines which are put
Fire hazard due to
on special vibra mount for smooth vibration free
static electricity,
To separate the noiseless operation. The speed is controlled by a
nd operator hazard if any
Centrifuging 2 Stage From variable frequency drive and the feeding of the
loading / unloading
the liquid centrifuge is done by pneumatically controlled
thereby preventing any operational hazard by
human error. All the limits switches and the safety
VFD controls.
Charging of
MLR All charging is done by vacuum sucking to avoid
after distillation
Charging of Use properly personnel protective equipment.
Corrosive nature
caustic soda lye.
Add purified water and
Operational control - checkpoint shall be included
Stage-3 caustic soda lye to stage-3 Bottom valve
Charging of in the batch sheet to indicate whether the bottom
reaction. opened, or Leakage of
toluene valve has been closed prior to charging toluene &
Bottom Valve
is not Leaking.
661
toluene addition pipe is kept to the Bottom of the

flame proof.
Spillage out side the outside the Equipment,Lay down the Poly Bags to
reactor, Collect the spilled Material,& Transfer to the
Charging of
reactor
carbon to
Fire hazard due to SS scoops to avoid static electricity. The reactor is
organic layer
eyes
The Filtration Operation is Carried out in Closed
Spillage, Filter Cloth SS Line, Filter cloth cleaned for Every Batch &
Filtration
Block this Cleaning of the Filter along with Cloth is
Incorporated In the BPR
Acetone Charging SS
pipe is Fixed to the Operational control - checkpoint shall be included
Bottom of the reactor in the batch sheet to indicate whether the bottom
Pipe lines are all SS valve has been closed prior to charging IPA & is
Fire hazard due
and equipment motors not Leaking.
to static
are flame proof.
electricity
IPA addition pipe is kept to the Bottom of the
flame proof.
The Addition of Hydrochloric acid is charged
Hydrochoric acid through the Closed lines, without any Spillage,
HCl Addition
Spillage & Irritation personnel Protective Equipments are Used to avoid
the Exposure & tackle the irritation
662

Fire hazard due to
static electricity,
loading / unloading
centrifuge is done by pneumatically controlled
human error. All the limits switches and the safety
VFD controls
Charging of
MLR All charging is done by vacuum sucking to avoid
Solvent recovery Hazardous waste No specific hazard spillages and through the closed SS pipe lines.
after distillation
Drying of the RCVD is fitted with flame proof motors.

Drying
Separation of solvents product in Unloading into the bins by actuated valve, Hence
operati No specific hazard
from the product Rotocone No- Less Exposure
on
vacuum Dryer Hand gloves & goggles should be used.
663
4) HAZOP- Nifedipine
Hazop Study - Process – for Nifedipine Stage-1

Possible Hazards /
failures
Bottom valve
opened, or Leakage
of Bottom Valve
Charging of Methanol,
are flame proof.
Instruction is Laid in the SOP , To Avoid
Charging of Methyl Spillage out side the spillage outside the Equipment,Lay down the
Reaction of Methyl aceto aceto acetate reactor, Poly Bags to Collect the spilled Material,&
acetate, liquid ammonia Transfer to the reactor
Stage-1 and Methanol Fire hazard due to SS scoops to avoid static electricity. The
eyes
Spillage out side the spillage outside the Equipment, Charging is
Charging of Liq
reactor, Health done By Closed SS Pipe Line& Transfer to
Ammonia
Hazard on exposure the reactor, Personnel Protective Equipment
is
eyes
664

To separate the
the liquid
VFD controls.
No specific hazard
665
Hazop Study - Process – for Nifedipine Stage-II

Possible Hazards /
failures
Charging of Bottom valve opened,
Methyl aceoto or Leakage of Bottom
has been closed prior to charging Methyl aceoto
acetate Valve
acetate & is not Leaking.
Stage-I reactor,

Reaction of Stage-I, Methyl Bottom valve opened,
aceto acetate, IPA, Acetic Charging of IPA or Leakage of Bottom
Stage-II has been closed prior to charging IPA & is not
acid , Piperidine and ortho Valve
Leaking.
Nitro benzaldehyde
Charging of ortho outside the Equipment, Lay down the Poly Bags to
Spillage out side the
Nitro Collect the spilled Material,& Transfer to the reactor
reactor,
benzaldehyde
proof.
666

To separate the
liquid
VFD controls

after distillation

No specific hazard
667
Hazop Study - Process – for Nifedipine Stage-III

Possible Hazards /
failures
Methanol has been closed prior to charging methanol & is not
Valve
Leaking.
Reaction of Stage-I, Stage- Charging of Spillage out side the
II, Methanol then centrifuge Stage-I reactor,
Stage-III the reaction mass collect the
ML’s. after centrifuge dry Charging of Spillage out side the
the material. Stage-II reactor,
proof.
668

To separate the
liquid
VFD controls
Charging of MLR
Hazardous waste All charging is done by vacuum sucking to avoid
after distillation spillages and through the closed SS pipe lines.

No specific hazard
669
5) HAZOP- Phenylephrine Hcl
Hazop Study - Process – for Phenylephrine Hcl Stage-1

Possible Hazards /
failures
included in the batch sheet to indicate whether
the bottom valve has been closed prior to
Valve
Charging of charging methanol & is not Leaking.
Toluene Toluene addition pipe is kept to the Bottom of
flame proof.
Reaction of Liquid Bromine, Instruction is Laid in the SOP , To Avoid spillage
Stage -1 metahydroxy Actone in outside the Equipment, Charging is done By
reactor,Health Hazard
Tolune Closed SS Pipe Line& Transfer to the reactor,
on exposure
Charging of Liq Personnel Protective Equipment is
Ammonia Fire hazard due to SS scoops to avoid static electricity. The reactor
static electricity is earthed by conducting wires
eyes
reflux; the methanol Vapour Loss is due to
Refluxing the
Loss of Methanol Excessive heat, Instruction is Given in SOP, To
reaction mass
Open the steam valve to Optimum so as to
maintain the reflux
670

To separate the
the liquid
VFD controls.
671

acetone has been closed prior to charging methanol & is not
Valve
Leaking.
Charging of Spillage out side the Collect the spilled Material,& Transfer to the reactor
Ambroxol Crude reactor,

Purification of ambroxol Line, Filter cloth cleaned for Every Batch & this
Spillage,Filter Cloth Cleaning of the Filter along with Cloth is Incorporated
Crude By Carbon Treatment Block
Stage-2 In the BPR
& Crystallization by Hcl,
centrifuging
Filtration
the reactor
Fire hazard due to Pipe lines are all SS and equipment motors are flame
static electricity proof.

the Closed lines, without any Spillage,personnel
Hydrochoric acid Protective Equipments are Used to avoid the Exposure
HCl Addition
Spillage & Irritation & tackle the irritation
672

by human error. All the limits switches and the safety
VFD controls

after distillation

No specific hazard
673
6) HAZOP- Sildenafil Citrate
Hazop Study - Process – for Sildenafil Citrate Stage-1

Possible Hazards /
failures
Spillage out side the spillage outside the Equipment, Lay down the
Charging of 4-amino-1- reactor, Poly Bags to Collect the spilled Material,&
methyl-3-n-propyl pyrazolo Transfer to the reactor
-5-carboxamide Fire hazard due to SS scoops to avoid static electricity. The
Irritation to skin & eyes Using hand gloves & goggles.
Reaction of 4-amino-1- Operational control - checkpoint shall be
methyl-3-n-propyl pyrazolo -
Bottom valve opened, included in the batch sheet to indicate
5-carboxamide , Methylene
chloride, Triethyl amine, 2- or Leakage of Bottom whether the bottom valve has been closed
ethoxy benzoyl chloride and Valve prior to charging Methylene Chloride & is not
Stage-1 Dimethyl-2-amino pyridine
Charging of Methylene Leaking.
then separate the organic Chloride
Methylene Chloride addition pipe is kept to the
layer and centrifuge
Fire hazard due to Bottom of the reactor
are flame proof.
or Leakage of Bottom whether the bottom valve has been closed
Valve prior to charging Triethyl amine & is not
Charging of Triethyl Leaking.
amine
Triethyl amine addition pipe is kept to the
are flame proof.
674

Valve prior to charging 2-ethoxy benzoyl chloride & is
Charging of 2-ethoxy
not Leaking.
benzoyl chloride
2-ethoxy benzoyl chloride addition pipe is kept to
Fire hazard due to the Bottom of the reactor
are flame proof.
Valve prior to charging 2-ethoxy benzoyl chloride & is
Charging of Dimethyl-2- not Leaking.
amino pyridine
2-ethoxy benzoyl chloride addition pipe is kept to
are flame proof.
The centrifuge is earthed by conducting
wires.
The filtration is carried out through a
centrifuge. Centrifuges are high speed
Fire hazard due to
machines and sources of hazard in a chemical
static electricity,
plant. Ample precautions are taken to carry
To separate the Ist operator hazard if any
Centrifuging out the centrifuging as hazard free as possible.
Stage From the liquid loading / unloading
We are using a 48 inch dia SS316 centrifuge,
activity carried out in a
bottom driven and top discharge. this is a four
running centrifuge
point suspension machines which are put on
noiseless operation. The speed is controlled
by a variable frequency drive and the feeding
675
of the centrifuge is done by pneumatically

controlled valves at lower RPM under
nitrogen purging. Even the bearing housing of
the centrifuge is provided with a nitrogen
purging facility. An interlocking system is
provided for ensuring that the lids cannot be
opened while the centrifuge is running and
human error. All the limits switches and the
safety interlocking switches are flame proof
including the VFD controls.
Charging of MLR
Hazardous waste after All charging is done by vacuum sucking to
distillation avoid spillages and through the closed SS
pipe lines.
RCVD is fitted with flame proof motors.
Drying of the product
Drying Separation of solvents Unloading into the bins by actuated valve,
in Rotocone vacuum No specific hazard
operation from the product Hence No- Less Exposure
Dryer
Hand gloves & goggles should be used.
676
Hazop Study - Process – for Sildenafil Citrate Stage-II

Stage-I reactor
Charge Stage-I, Operational control - checkpoint shall be included in
Chlorosulphonic acid and water Charging of Bottom valve opened,
then separate the organic layer Chlorosulphonic or Leakage of Bottom
has been closed prior to charging Chlorosulphonic
and distillate the MDC then add acid Valve
N-methyl piperazine to reaction acid & is not Leaking.
mass then centrifuge the material.
Chlorosulphonic acid Charging SS pipe is Fixed to
proof.
Stage-II Charging of MLR
Solvent recovery MDC No specific hazard

Charging of N- or Leakage of Bottom the batch sheet to indicate whether the bottom valve
methyl piperazine has been closed prior to charging N-methyl piperazine &
Valve
is not Leaking.
N-methyl piperazine Charging SS pipe is Fixed to the

proof.
677

VFD controls

after distillation
Fire hazard due to The centrifuge is earthed by conducting wires.

To separate the static electricity, The filtration is carried out through a centrifuge.
Centrifuging IIst Stage From operator hazard if any Centrifuges are high speed machines and sources of
the liquid loading / unloading hazard in a chemical plant. Ample precautions are
activity carried out in a taken to carry out the centrifuging as hazard free as
678
running centrifuge possible. We are using a 48 inch dia SS316 centrifuge,

suspension machines which are put on special vibra
mount for smooth vibration free noiseless operation.
The speed is controlled by a variable frequency drive
and the feeding of the centrifuge is done by
pneumatically controlled valves at lower RPM under
nitrogen purging. Even the bearing housing of the
VFD controls.
679
Hazop Study - Process – for Sildenafil Citrate Stage-III

Stage-II reactor
Activated carbon reactor

Reaction of Stag-II, Acetone Acetone has been closed prior to charging Acetone & is not
and Activated carbon then Valve
Leaking.
Filter the spent carbon, send
filtrate in centrifuge and dry the Acetone Charging SS pipe is Fixed to the Bottom of
material. Collect the ML’s from Fire hazard due to the reactor
Stage-III centrifuge distillate and collect
recovered Acetone.
proof.
Citric acid has been closed prior to charging Citric acid & is not
Valve
Leaking.
Citric acid Charging SS pipe is Fixed to the Bottom
proof.
Spillage, Filter Cloth Line, Filter cloth cleaned for Every Batch & this
Filtration
Block Cleaning of the Filter along with Cloth is Incorporated
In the BPR
680

VFD controls
Fire hazard due to
static electricity,
To separate the taken to carry out the centrifuging as hazard free as
Centrifuging IIst Stage From possible. We are using a 48 inch dia SS316 centrifuge,
loading / unloading
the liquid bottom driven and top discharge. this is a four point
running centrifuge
mount for smooth vibration free noiseless operation.
The speed is controlled by a variable frequency drive
681

VFD controls.
Charging of MLR

No specific hazard
682
7) HAZOP- TICLOPIDINE HCl
Hazop Study - Process – for TICLOPIDINE HCl

Possible Hazards /
failures
Bottom valve opened, Operational control - checkpoint shall be included in the
Reaction of or Leakage of Bottom batch sheet to indicate whether the bottom valve has been
Charging of
Thiophene-2- Valve closed prior to charging toluene & is not Leaking.
Toluene
ethanol with Fire hazard due to Toluene addition pipe is kept to the Bottom of the reactor
Triethylamine, static electricity Pipe lines are all SS and equipment motors are flame proof.
Benzene sulfonyl Instruction is Laid in the SOP , To Avoid spillage outside
chloride Charging of the Equipment,Lay down the Poly Bags to Collect the
reactor,
in Toluene. Benzene spilled Material,& Transfer to the reactor
sulfonyl Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed
chloride static electricity by conducting wires
Stage- Irritation to skin & eyes Using hand gloves & goggles.
1 Operational control - checkpoint shall be included in the
batch sheet to indicate whether the bottom valve has been
Charging of closed prior to charging Thiophene-2-ethanol & is not
Valve
Thiophene-2- Leaking.
ethanol Thiophene-2-ethanol addition pipe is kept to the Bottom of
Fire hazard due to
the reactor
static electricity
Pipe lines are all SS and equipment motors are flame proof.
or Leakage of Bottom batch sheet to indicate whether the bottom valve has been
Charging of Valve closed prior to charging Triethylamine & is not Leaking.
Triethylamine Triethylamine addition pipe is kept to the Bottom of the
Fire hazard due to
reactor. Pipe lines are all SS and equipment motors are
static electricity
flame proof.
683

Fire hazard due to is a four point suspension machines which are put
static electricity, on special vibra mount for smooth vibration free
To separate the 1st operator hazard if noiseless operation. The speed is controlled by a
Centrifuging Stage From the any loading / variable frequency drive and the feeding of the
liquid unloading activity centrifuge is done by pneumatically controlled
carried out in a valves at lower RPM under nitrogen purging.
running centrifuge Even the bearing housing of the centrifuge is
provided with a nitrogen purging facility. An
interlocking system is provided for ensuring that
running and thereby preventing any operational
hazard by human error. All the limits switches
and the safety interlocking switches are flame
proof including the VFD controls.
after distillation
684

Bottom valve in the batch sheet to indicate whether the bottom
opened, or Leakage valve has been closed prior to charging Ortho
Charging of Ortho
of Bottom Valve chlorobenzylamine
chlorobenzylamine
& is not Leaking.
Ortho chlorobenzylamine addition pipe is kept to
Add Ortho Fire hazard due to
the Bottom of the reactor. Pipe lines are all SS
chlorobenzylamine and static electricity
Stage-2 and equipment motors are flame proof.
MDC in Ticlopidine HCl
Stage-1. Bottom valve
in the batch sheet to indicate whether the bottom
opened, or Leakage
valve has been closed prior to charging MDC
Charging of MDC of Bottom Valve
& is not Leaking.
MDC addition pipe is kept to the Bottom of the
Fire hazard due to
reactor. Pipe lines are all SS and equipment
static electricity
motors are flame proof.
Fire hazard due to
static electricity,
To separate the 1st operator hazard if
Centrifuging Stage From the any loading /
liquid unloading activity
carried out in a
running centrifuge
centrifuge is done by pneumatically controlled
valves at lower RPM under nitrogen purging.
Even the bearing housing of the centrifuge is
provided with a nitrogen purging facility. An
interlocking system is provided for ensuring that
685

running and thereby preventing any operational
hazard by human error. All the limits switches
and the safety interlocking switches are flame
Charging of MLR
Drying of the RCVD is fitted with flame proof motors.

Drying Separation of solvents product in Unloading into the bins by actuated valve, Hence
No specific hazard
operation from the product Rotocone vacuum No- Less Exposure
686
8) HAZOP- URSODEOXYCHOLIC ACID / 3 , 7 DIOXY CHOLANIC ACID
Hazop Study - Process – for 3 , 7 DIOXY CHOLANIC ACID

Possible Hazards /
failures
Bottom valve opened, Operational control - checkpoint shall be included in the batch sheet to indicate
Charging or Leakage of Bottom whether the bottom valve has been closed prior to charging Methanol & is not
of Valve leaking.
Reaction of Methanol Fire hazard due to static Methanol addition pipe is kept to the Bottom of the reactor
Cholic acid electricity Pipe lines are all SS and equipment motors are flame proof.
Into Instruction is Laid in the SOP , To avoid spillage outside the Equipment,Lay
methanol down the Poly Bags to Collect the spilled Material,& Transfer to the reactor
Charging reactor,
of Cholic Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by conducting wires
acid electricity Using hand gloves & goggles.
Stage- Irritation to skin & eyes
I The centrifuge is earthed by conducting wires.
The filtration is carried out through a centrifuge. Centrifuges are high speed
machines and sources of hazard in a chemical plant. Ample precautions are taken
to carry out the centrifuging as hazard free as possible. We are using a 48 inch dia
Fire hazard due to static
SS316 centrifuge, bottom driven and top discharge. This is a four point
To separate electricity, operator
suspension machines which are put on special vibra mount for smooth vibration
the 1st hazard if any loading /
Centrifuging free noiseless operation. The speed is controlled by a variable frequency drive and
Stage From unloading activity
the feeding of the centrifuge is done by pneumatically controlled valves at lower
the liquid carried out in a running
RPM under nitrogen purging. Even the bearing housing of the centrifuge is
centrifuge
provided with a nitrogen purging facility. An interlocking system is provided for
ensuring that the lids cannot be opened while the centrifuge is running and
thereby preventing any operational hazard by human error. All the limits switches
and the safety interlocking switches are flame proof including the VFD controls.
687
Charging of All charging is done by vacuum sucking to avoid spillages

MLR and through the closed SS pipe lines.
Solvent
Hazardous No specific hazard
recovery
waste after
distillation
Drying of the RCVD is fitted with flame proof motors. Unloading into
Drying Separation of
product in the bins by actuated valve, Hence No- Less Exposure
operati solvents from No specific hazard
Rotocone Hand gloves & goggles should be used.
on the product
vacuum Dryer
Instruction is Laid in the SOP , To avoid spillage outside
Charging of the Equipment, Lay down the Poly Bags to Collect the
reactor
Dimethyl amino spilled Material,& Transfer to the reactor
pyridine Fire hazard due to static SS scoops to avoid static electricity. The reactor is
electricity earthed by conducting wires
Add Dimethyl Spillage out side the
Charging of the Equipment, Lay down the Poly Bags to Collect the
amino reactor
Sodium spilled Material,& Transfer to the reactor
pyridine,
carbonate Fire hazard due to static SS scoops to avoid static electricity. The reactor is
Stage- Sodium
II carbonate,
Acetic
anhydride, and Spillage out side the
the Equipment, Lay down the Poly Bags to Collect the
in Stage-I Charging of reactor
spilled Material,& Transfer to the reactor
Acetic
Fire hazard due to static SS scoops to avoid static electricity. The reactor is
anhydride
Operational control - checkpoint shall be included in the
Charging of Bottom valve opened, or
batch sheet to indicate whether the bottom valve has been
Ethyl acetate Leakage of Bottom Valve
closed prior to charging Ethyl acetate & is not leaking.
688
Ethyl acetate addition pipe is kept to the Bottom of the

Fire hazard due to static reactor
electricity Pipe lines are all SS and equipment motors are flame
proof.

centrifuge, bottom driven and top discharge. This is a
Fire hazard due to
static electricity,
To separate the 2nd operator hazard if
carried out in a
running centrifuge
while the centrifuge is running and thereby
preventing any operational hazard by human error.
All the limits switches and the safety interlocking
switches are flame proof including the VFD controls.
Charging of ML’s
All charging is done by vacuum sucking to avoid
Hazardous waste
Solvent recovery No specific hazard spillages and through the closed SS pipe lines.
after distillation
689

Bottom valve
opened, or Leakage
has been closed prior to charging Sodium
hypochlorite & is not leaking.
Add Sodium Sodium
Sodium hypochlorite addition pipe is kept to the
hypochlorite, hypochlorite
Fire hazard due to Bottom of the reactor.
Sodium
Stage- metabisulphite,
proof.
III Acetic Acid, Water
Instruction is Laid in the SOP , To avoid spillage
and Spillage out side
Ethyl Acetate in the reactor,
Charging of Collect the spilled Material,& Transfer to the reactor
Stage-II
Sodium Fire hazard due to SS scoops to avoid static electricity. The reactor is
metabisulphite static electricity earthed by conducting wires
eyes
690

Bottom valve
opened, or Leakage
has been closed prior to charging Acetic Acid & is
of Bottom Valve
Charging of Acetic not leaking.
Acid Acetic Acid addition pipe is kept to the Bottom of the
Fire hazard due to reactor.
proof.
Bottom valve
opened, or Leakage
has been closed prior to charging Ethyl Acetate & is
of Bottom Valve
Charging of Ethyl not leaking.
Acetate Ethyl Acetate addition pipe is kept to the Bottom of
Fire hazard due to the reactor.
proof.
Solvent recovery Hazardous waste No specific hazard spillages and through the closed SS pipe lines.
after distillation
Fire hazard due to
static electricity,
To separate the 3rd operator hazard if
carried out in a
running centrifuge
691

Drying
Separation of solvents product in into the bins by actuated valve, Hence No- Less
from the product Rotocone vacuum Exposure
on
Bottom valve
opened, or Leakage
has been closed prior to charging Hydrazine hydrate
of Bottom Valve
Charging of & is not leaking.
Hydrazine hydrate Hydrazine hydrate addition pipe is kept to the Bottom
Fire hazard due to of the reactor.
Add Hydrazine static electricity Pipe lines are all SS and equipment motors are flame
hydrate, proof.
Stage- 2-methoxy ethanol, Operational control - checkpoint shall be included in
Bottom valve
IV And Potassium the batch sheet to indicate whether the bottom valve
opened, or Leakage
hydroxide has been closed prior to charging 2-methoxy ethanol
of Bottom Valve
into Stage-II. Charging of 2- & is not leaking.
methoxy ethanol 2-methoxy ethanol addition pipe is kept to the
Fire hazard due to Bottom of the reactor.
proof.
Spillage out side Use proper personnel protective equipment.
Charging of KOH
the reactor
692
Distillation of 2- All charging is done by vacuum sucking to avoid

methoxy ethanol spillages and through the closed SS pipe lines.
Hydrazine hydrate
into reaction mass
Bottom valve
opened, or Leakage
has been closed prior to charging Methylene chloride
of Bottom Valve
Charging of & is not leaking.
Methylene chloride Methylene chloride addition pipe is kept to the
Charge Methylene Fire hazard due to Bottom of the reactor.
chloride static electricity Pipe lines are all SS and equipment motors are flame
Stage-
And Sodium bromate proof.
V
Into Stage-IV organic Instruction is Laid in the SOP , To avoid spillage
Spillage out side
layer. outside the Equipment, Lay down the Poly Bags to
the reactor
Charging of
Sodium bromate
eyes
Fire hazard due to
static electricity,
To separate the 5th operator hazard if
carried out in a
running centrifuge
693

Charging of ML’s
Charging of sodium Fire hazard due to Use fully Personnel protective equipment and kept in
metal open with air kerosene use nitrogen blanket.
Bottom valve
Charge Sodium metal opened, or Leakage
has been closed prior to charging Butanol & is not
and Butanol into of Bottom Valve
Charging of leaking.
Stage- Stage-V.
Butanol Butanol addition pipe is kept to the Bottom of the
VI
Fire hazard due to reactor.
proof.
Distillation of All charging is done by vacuum sucking to avoid
Solvent recovery Butanol 2 into No specific hazard spillages and through the closed SS pipe lines.
reaction mass
694

Fire hazard due to
static electricity,
th special vibra mount for smooth vibration free
To separate the 6 operator hazard if
carried out in a
running centrifuge
Drying
Separation of solvents product in into the bins by actuated valve, Hence No- Less
from the product Rotocone vacuum Exposure
on
695
9) HAZOP- Anastrozole
Hazop Study - Process – for Anastrozole
Possible Hazards /
failures
Spillage out side the spillage outside the Equipment,Lay down the
Charging of , , , ,-
reactor, Poly Bags to Collect the spilled Material,&
tetramethyl-5-( methyl)-
Transfer to the reactor
1,3- benzene
diacetonitrile
Reaction of , , , ,- Irritation to skin & Using hand gloves & goggles.
tetramethyl-5-( methyl)- eyes
1,3- benzene diacetonitrile
with Acetonitrile, n-bromo
Bottom valve included in the batch sheet to indicate
succinamide, Ethyl acetate
opened, or Leakage whether the bottom valve has been closed
and Water then separate the
Stage-1 of Bottom Valve prior to charging Acetonitrile & is not
organic layer and
Acetonitrile Leaking.
distillation organic layer
Acetonitrile addition pipe is kept to the
and added cyclohexane
are flame proof.
n-bromo succinamide
eyes
696

of Bottom Valve prior to charging Ethyl acetate & is not
Ethyl acetate Leaking.
Ethyl acetate addition pipe is kept to the
are flame proof.
Distillation; the Acetonitrile
Distillation of the
Loss of Acetonitrile Vapour Loss is due to Excessive heat,
organic layer
Instruction is Given in SOP, To Open the
steam valve to Optimum so as to maintain
the Distillation.
of Bottom Valve prior to charging Cyclohexane & is not
Cyclohexane Leaking.
Cyclohexane addition pipe is kept to the
are flame proof.
Fire hazard due to The centrifuge is earthed by conducting
static electricity, wires.
operator hazard if The filtration is carried out through a
Centrifuging To separate the liquid any loading / centrifuge. Centrifuges are high speed
unloading activity machines and sources of hazard in a
carried out in a chemical plant. Ample precautions are taken
running centrifuge to carry out the centrifuging as hazard free as
697

centrifuge, bottom driven and top discharge.
this is a four point suspension machines
which are put on special vibra mount for
smooth vibration free noiseless operation.
The speed is controlled by a variable
frequency drive and the feeding of the
centrifuge is done by pneumatically
nitrogen purging. Even the bearing housing
of the centrifuge is provided with a nitrogen
human error . All the limits switches and the
Charging of MLR All charging is done by vacuum sucking to
Solvent recovery Hazardous waste after No specific hazard avoid spillages and through the closed SS
distillation pipe lines.
VTD is fitted with flame proof motors.
Drying Separation of solvents from Drying of the product in Unloading into the bins by actuated valve,
No specific hazard
operation the product VTD Hence No- Less Exposure
Reaction of Stage – I Operational control - checkpoint shall be
material, with Acetone, Bottom valve included in the batch sheet to indicate
Stage-2 Potassium carbonate and Charging Acetone opened, or Leakage whether the bottom valve has been closed
1,2,4-Triazole then filtrated of Bottom Valve prior to charging Acetone & is not
and added Ethyl acetate Leaking.
698
and Hydrochloric acid Acetone addition pipe is kept to the Bottom

are flame proof.
Potassium carbonate
eyes
1,2,4-Triazole
eyes
The Filtration Operation is Carried out in
Spillage,Filter Cloth Closed SS Line, Filter cloth cleaned for
Block Every Batch & this Cleaning of the Filter
along with Cloth is Incorporated In the BPR
Filtration
Acetone Charging SS pipe is Fixed to the
are flame proof.
Bottom valve
Ethyl acetate included in the batch sheet to indicate
opened, or Leakage
699
of Bottom Valve whether the bottom valve has been closed

prior to charging Ethyl acetate & is not
Leaking.
are flame proof.
of Bottom Valve prior to charging Hydrochloric acid & is
Hydrochloric acid not Leaking.
Hydrochloric acid addition pipe is kept to the
are flame proof.
Distillation; the Acetone and ethyl acetate
Distillation of the
Loss of Acetone Vapour Loss is due to Excessive heat,
organic layer
and ethyl acetate Instruction is Given in SOP, To Open the
steam valve to Optimum so as to maintain
the Distillation.
Fire hazard due to wires.
static electricity, The filtration is carried out through a
operator hazard if centrifuge. Centrifuges are high speed
Centrifuging To separate the liquid any loading / machines and sources of hazard in a
unloading activity chemical plant. Ample precautions are taken
carried out in a to carry out the centrifuging as hazard free as
running centrifuge possible. We are using a 48 inch dia SS316
700

No specific hazard
Reaction of stage –II
material, Sodium carbonate
and Ethyl acetate with Sodium carbonate
water then separated the
Stage-3 static electricity reactor is earthed by conducting wires
layer and added Ethyl
acetate and cyclohexane
eyes
tnen centrifuge the reaction
Bottom valve Operational control - checkpoint shall be
mass
Ethyl acetate opened, or Leakage included in the batch sheet to indicate
of Bottom Valve whether the bottom valve has been closed
701
prior to charging Hydrochloric acid & is

not Leaking.
Hydrochloric acid addition pipe is kept to the

are flame proof.
Distillation of the Distillation; the Ethyl acetate Vapour Loss is
Loss of Ethyl
organic layer due to Excessive heat, Instruction is Given in
acetate
SOP, To Open the steam valve to Optimum
so as to maintain the Distillation.
of Bottom Valve prior to charging Cyclohexane & is not
Cyclohexane Leaking.
Cyclohexane addition pipe is kept to the
are flame proof.
wires.
Fire hazard due to
static electricity,
operator hazard if
machines and sources of hazard in a
Centrifuging To separate the liquid any loading /
chemical plant. Ample precautions are taken
unloading activity
to carry out the centrifuging as hazard free as
carried out in a
running centrifuge
702

No specific hazard
703
10) Hazop-Bendamustin
Hazop Study - Process – for Bendamustin

Possible Hazards /
failures
Stage I Reaction of Ethyl-4-(5- Addition of Ethyl-4-(5- Instruction is Laid in the SOP , To Avoid
(bis(2-hydroxy ethyl) (bis(2-hydroxy ethyl) Spillage out side the spillage outside the Equipment,Lay down
amino)-1-methyl-1H- amino)-1-methyl-1H- reactor, the Poly Bags to Collect the spilled
benzoid) imidazol-2- benzoid) imidazol-2- Material,& Transfer to the reactor
yl)butanoate in presence of yl)butanoate Fire hazard due to SS scoops to avoid static electricity. The
thionyl chloride. static electricity reactor is earthed by conducting wires
eyes
Charging of Thionyl Operational control - checkpoint shall be
chloride Bottom valve opened, included in the batch sheet to indicate
Valve prior to charging thionyl chloride & is not
Leaking.
Thionyl chloride addition pipe is kept to
static electricity Pipe lines are all SS and equipment
wires.
Fire hazard due to
static electricity,
To separate the Ist operator hazard if any
Centrifuging machines and sources of hazard in a
Stage From the liquid loading / unloading
chemical plant. Ample precautions are
taken to carry out the centrifuging as
running centrifuge
hazard free as possible. We are using a 48
inch dia SS316 centrifuge, bottom driven
704
and top discharge. this is a four point

suspension machines which are put on
special vibra mount for smooth vibration
free noiseless operation. The speed is
controlled by a variable frequency drive
and the feeding of the centrifuge is done
by pneumatically controlled valves at
lower RPM under nitrogen purging. Even
the bearing housing of the centrifuge is
provided with a nitrogen purging facility.
An interlocking system is provided for
ensuring that the lids cannot be opened
while the centrifuge is running and
thereby preventing any operational hazard
by human error. All the limits switches
and the safety interlocking switches are
flame proof including the VFD controls.
Charging of MLR
Hazardous waste after All charging is done by vacuum sucking
Distillation distillation to avoid spillages and through the closed
SS pipe lines.
705
11) HAZOP- BICALUTAMIDE
Hazop Study - Process – for BICALUTAMIDE

Possible Hazards /
failures
Charging of 10 Instruction is Laid in the SOP , To Avoid spillage outside the
Spillage out side
N-[4-cyano-3- Equipment, Lay down the Poly Bags to Collect the spilled
the reactor,
trifluoromethyl Material,& Transfer to the reactor
phenyl]-3-[4- SS scoops to avoid static electricity. The reactor is earthed by
fluorophenyl Fire hazard due to conducting wires
Reaction of 10 N-[4- thio]-2- static electricity Using hand gloves & goggles.
cyano-3-trifluoromethyl hydroxy-2- Irritation to skin &
phenyl]-3-[4-fluorophenyl methyl eyes
thio]-2-hydroxy-2-methyl propanamide
propanamide and Bottom valve Operational control - checkpoint shall be included in the batch
Potassium permanganate opened, or Leakage sheet to indicate whether the bottom valve has been closed prior to
Stage -1 Charging of
in Acetonitrile. of Bottom Valve charging Potassium permanganate & is not Leaking.
Potassium
Potassium permanganate addition pipe is kept to the Bottom of
permanganate Fire hazard due to
the reactor. Pipe lines are all SS and equipment motors are flame
static electricity
proof.
Bottom valve Operational control - checkpoint shall be included in the batch
opened, or Leakage sheet to indicate whether the bottom valve has been closed prior to
Charging of of Bottom Valve charging Acetonitrile & is not Leaking.
Acetonitrile Acetonitrile addition pipe is kept to the Bottom of the reactor. Pipe
Fire hazard due to
lines are all SS and equipment motors are flame proof.
static electricity
The Filtration Operation is Carried out in Closed SS Line, Filter
Spillage, Filter
Filtration cloth cleaned for Every Batch & this Cleaning of the Filter along
Cloth Block
with Cloth is Incorporated In the BPR
706
Acetone Charging SS pipe is Fixed to the Bottom of the reactor

Fire hazard due to
static electricity
The filtration is carried out through a centrifuge. Centrifuges are
high speed machines and sources of hazard in a chemical plant.
Ample precautions are taken to carry out the centrifuging as hazard
free as possible. We are using a 48 inch dia SS316 centrifuge,
Fire hazard due to
bottom driven and top discharge. This is a four point suspension
static electricity,
machines which are put on special vibra mount for smooth
To separate the operator hazard if
vibration free noiseless operation. The speed is controlled by a
Centrifuging bicalutamide any loading /
variable frequency drive and the feeding of the centrifuge is done
from the liquid unloading activity
by pneumatically controlled valves at lower RPM under nitrogen
carried out in a
purging. Even the bearing housing of the centrifuge is provided
running centrifuge
with a nitrogen purging facility. An interlocking system is provided
for ensuring that the lids cannot be opened while the centrifuge is
running and thereby preventing any operational hazard by human
error. All the limits switches and the safety interlocking switches
are flame proof including the VFD controls.
Distillation of
Acetonitrile and All charging is done by vacuum sucking to avoid spillages and
hexane into through the closed SS pipe lines.
reaction mass
Drying of the VTD is fitted with flame proof motors. Unloading into the bins by
Drying Separation of solvents product in actuated valve, Hence No- Less Exposure
No specific hazard
operation from the product Vacuum tray Hand gloves & goggles should be used.
Dryer
707
12) Hazop- Bortizomib

Hazop Study - Process – for Bortizomib
Possible Hazards /
failures
Stage I Reaction of 3- Addition of Instruction is Laid in the SOP , To Avoid spillage
phenyl -2- Reaction of 3- outside the Equipment, Lay down the Poly Bags to
reactor,
[(pyrazine-2- phenyl -2- Collect the spilled Material,& Transfer to the reactor
carbonyl)-amino] [(pyrazine-2- Fire hazard due to static SS scoops to avoid static electricity. The reactor is
propionic acid with carbonyl)-amino] electricity earthed by conducting wires
R-Borolex-(+)- propionic acid Irritation to skin & eyes Using hand gloves & goggles.
pinanediol trifluoro Charging of MDC Bottom valve opened, or Operational control - checkpoint shall be included in
acetic acid Leakage of Bottom the batch sheet to indicate whether the bottom valve has
Valve been closed prior to charging MDC & is not Leaking.
MDC addition pipe is kept to the Bottom of the reactor
electricity
proof.
Hydroxy Instruction is Laid in the SOP , To Avoid spillage
succinamide outside the Equipment, Lay down the Poly Bags to
reactor,
Spillage Filter Cloth Line, Filter cloth cleaned for Every Batch & this
Filtration
In the BPR
Charging of MLR
708

Spillage, Filter Cloth Line, Filter cloth cleaned for Every Batch & this
Filtration
In the BPR
Stage II Addition of stage I Instruction is Laid in the SOP , To Avoid spillage
product outside the Equipment, Lay down the Poly Bags to
reactor,
Hydrochoric acid the Closed lines, without any Spillage, personnel
HCl Addition
Spillage & Irritation Protective Equipments are Used to avoid the Exposure
& tackle the irritation
Charging of N- Operational control - checkpoint shall be included in
Bottom valve opened, or
Heptane the batch sheet to indicate whether the bottom valve has
Leakage of Bottom
been closed prior to charging n-heptane & is not
Valve
Leaking.
n-heptane addition pipe is kept to the Bottom of the
proof.
709
Saturated sodium Instruction is Laid in the SOP , To Avoid

bicarbonate Spillage out side the spillage outside the Equipment, Lay down
reactor, the Poly Bags to Collect the spilled
Material,& Transfer to the reactor
Fire hazard due to static SS scoops to avoid static electricity. The
electricity reactor is earthed by conducting wires
Charging of MLR
pipe lines.
Charging Ethyl acetate Operational control - checkpoint shall be
Leakage of Bottom Valve
prior to charging ethyl acetate & is not
Leaking.
Fire hazard due to static Bottom of the reactor
electricity Pipe lines are all SS and equipment motors
are flame proof.
Charging methanol Operational control - checkpoint shall be
Bottom valve opened, or included in the batch sheet to indicate
Leakage of Bottom Valve whether the bottom valve has been closed
Fire hazard due to static of the reactor
are flame proof.
710

Closed SS Line, Filter cloth cleaned for
Spillage, Filter Cloth
Filtration Every Batch & this Cleaning of the Filter
Block
Charging of MLR
pipe lines.
Stage III Operational control - checkpoint shall be
Bottom valve opened, or included in the batch sheet to indicate
Leakage of Bottom Valve whether the bottom valve has been closed
Charging of methanol
methanol addition pipe is kept to the Bottom
are flame proof.
Spillage out side the spillage outside the Equipment, Lay down
reactor, the Poly Bags to Collect the spilled
Addition of stage II
product
Closed SS Line, Filter cloth cleaned for
Filtration Every Batch & this Cleaning of the Filter
Block
711
Charging of MLR
pipe lines.
Drying Separation of solvents Drying of the product in Unloading into the bins by actuated valve,
No specific hazard
operation from the product Rotocone vacuum Dryer Hence No- Less Exposure
712
13) HAZOP- CAPECITABINE

Hazop Study - Process – for CAPECITABINE
Possible Hazards /
failures
Instruction is Laid in the SOP , To Avoid spillage outside the
Charging 5- Spillage out side the
Equipment, Lay down the Poly Bags to Collect the spilled
methyl reactor,
Reaction of 5-methyl tetrahydrofuran- Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
tetrahydrofuran- 2,3,4-
electricity conducting wires
2,3,4-triyltriacetate, triyltriacetate
5-Fluorocytosine,
Stannic chloride, Spillage out side the
TMSC, HMDS and reactor,
Charging of 5- Material,& Transfer to the reactor
Sodium bicarbonate
Fluorocytosine Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
into MDC and
Stage -1 toluene.
Irritation to skin & eyes. Using hand gloves & goggles.
reactor,
Charging of Material,& Transfer to the reactor
TMSC Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
reactor,
HMDS Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
713

Charging of
of Bottom Valve charging Stannic chloride & is not Leaking.
Stannic chloride
Fire hazard due to Stannic chloride addition pipe is kept to the Bottom of the reactor.
static electricity Pipe lines are all SS and equipment motors are flame proof.
Charging of
of Bottom Valve charging MDC & is not Leaking.
MDC
Fire hazard due to MDC addition pipe is kept to the Bottom of the reactor. Pipe lines
static electricity are all SS and equipment motors are flame proof.
Charging of
of Bottom Valve charging toluene & is not Leaking.
toluene
Fire hazard due to toluene addition pipe is kept to the Bottom of the reactor. Pipe lines
Spillage, Filter
cloth cleaned for Every Batch & this Cleaning of the Filter along
Cloth Block
Filtration
Tri methylamine and Sodium bicarbonate Charging SS pipe is
Fire hazard due to
Fixed to the Bottom of the reactor. Pipe lines are all SS and
static electricity
equipment motors are flame proof.
Distillation of Loss of ethyl The temperature is raised by slow heating till reflux; the methanol
Solvent recovery MDC and acetate and Vapour Loss is due to Excessive heat, Instruction is Given in SOP,
Toluene acetonitrile To Open the steam valve to Optimum so as to maintain the reflux
Charge IPA into reaction
Charging of of Bottom Valve charging IPA & is not Leaking.
mass.
IPA IPA addition pipe is kept to the Bottom of the reactor. Pipe lines
Fire hazard due to
are all SS and equipment motors are flame proof.
static electricity
714

Fire hazard due to
To separate the static electricity,
Docetaxel operator hazard if
Centrifuging Trihydrate any loading /
stage-II from unloading activity
the liquid carried out in a
running centrifuge
Charging of
ML’s All charging is done by vacuum sucking to avoid spillages and
Solvent recovery Hazardous No specific hazard through the closed SS pipe lines.
waste after
centrifuging
No specific hazard
operation from the product vacuum tray Hand gloves & goggles should be used.
dryer
715

Charging of of Bottom Valve charging Pyriddine & is not Leaking.
Pyriddine Pyriddine addition pipe is kept to the Bottom of the reactor. Pipe
Fire hazard due to
Charge capecitabine lines are all SS and equipment motors are flame proof.
static electricity
stage-I, Pyriddine and n-
Stage-II
pentyl chloroformate into Bottom valve Operational control - checkpoint shall be included in the batch
MDC. opened, or Leakage sheet to indicate whether the bottom valve has been closed prior to
Charging of n- charging n-pentyl chloroformate & is not Leaking.
of Bottom Valve
pentyl
n-pentyl chloroformate addition pipe is kept to the Bottom of the
chloroformate Fire hazard due to
reactor. Pipe lines are all SS and equipment motors are flame
static electricity
proof.

Charging of of Bottom Valve charging MDC & is not Leaking.
MDC MDC addition pipe is kept to the Bottom of the reactor. Pipe lines
Fire hazard due to
are all SS and equipment motors are flame proof.
static electricity
Spillage, Filter
Cloth Block
Filtration with Cloth is Incorporated In the BPR
Fire hazard due to Pyridine Charging SS pipe is Fixed to the Bottom of the reactor.
Charge Heptane into Charging of charging Heptane & is not Leaking.
of Bottom Valve
organic layer Heptane
Fire hazard due to Heptane addition pipe is kept to the Bottom of the reactor. Pipe
static electricity. lines are all SS and equipment motors are flame proof.
716
The temperature is raised by slow heating till reflux; the methanol

Distillation of
Solvent recovery Loss of MDC Vapour Loss is due to Excessive heat, Instruction is Given in SOP,
MDC
To Open the steam valve to Optimum so as to maintain the reflux
Fire hazard due to
static electricity,
To separate the machines which are put on special vibra mount for smooth
operator hazard if
Capecitabine vibration free noiseless operation. The speed is controlled by a
Centrifuging any loading /
stage-II from variable frequency drive and the feeding of the centrifuge is done
unloading activity
the liquid by pneumatically controlled valves at lower RPM under nitrogen
carried out in a
running centrifuge
Charging of
waste after
centrifuging
No specific hazard
dryer
Charge capecitabine Bottom valve Operational control - checkpoint shall be included in the batch
Charging of
Stage-III stage-II, MDC, sodium opened, or Leakage sheet to indicate whether the bottom valve has been closed prior to
MDC
hydroxide and of Bottom Valve charging MDC & is not Leaking.
717
hydrochloric acid into Fire hazard due to MDC addition pipe is kept to the Bottom of the reactor. Pipe lines
methanol. static electricity are all SS and equipment motors are flame proof.
Charging of of Bottom Valve charging methanol & is not Leaking.
methanol Fire hazard due to methanol addition pipe is kept to the Bottom of the reactor. Pipe
static electricity lines are all SS and equipment motors are flame proof.
Hydrochoric acid The Addition of Hydrochloric acid is charged through the Closed
HCl Addition Spillage & lines, without any Spillage, personnel Protective Equipments are
Irritation Used to avoid the Exposure & tackle the irritation
Charging of
sodium Corrosive nature Use properly personnel protective equipment.
hydroxide
Distillation of The temperature is raised by slow heating till reflux; the methanol
Loss of MDC and
Solvent recovery MDC and Vapour Loss is due to Excessive heat, Instruction is Given in SOP,
methanol.
methanol. To Open the steam valve to Optimum so as to maintain the reflux
Charging of
toluene
Charge toluene into of Bottom Valve charging toluene & is not Leaking.
reaction mass Fire hazard due to Toluene addition pipe is kept to the Bottom of the reactor. Pipe

static electricity, The filtration is carried out through a centrifuge. Centrifuges are
To separate the
operator hazard if high speed machines and sources of hazard in a chemical plant.
Capecitabine
Centrifuging any loading / Ample precautions are taken to carry out the centrifuging as hazard
stage-III from
unloading activity free as possible. We are using a 48 inch dia SS316 centrifuge,
the liquid
carried out in a bottom driven and top discharge. This is a four point suspension
running centrifuge machines which are put on special vibra mount for smooth
718

Charging of
waste after
centrifuging
No specific hazard
dryer
719
14) HAZOP- Carboplatin

Hazop Study - Process – for Carboplatin
Possible Hazards /
failures
Charging of Potassium Transfer to the reactor
tetrachloroplatinate Fire hazard due to SS scoops to avoid static electricity. The
eyes
Charging of Potassium
tetrachloroplatinate,
Potassium iodide and 25%
Stage-1 of Ammonium hydroxide
into the reactor and then Potassium iodide
filtration and centrifuged
eyes
Bottom valve
opened, or Leakage
of Bottom Valve
25% Ammonium prior to charging methanol & is not Leaking.
hydroxide 25% Ammonium hydroxide addition pipe is
Fire hazard due to kept to the Bottom of the reactor
are flame proof.
720

Filtration
are flame proof.
wires.
Fire hazard due to centrifuge, bottom driven and top discharge.
static electricity, this is a four point suspension machines
operator hazard if which are put on special vibra mount for
To separate the Ist
Centrifuging any loading / smooth vibration free noiseless operation.
Stage From the liquid
unloading activity The speed is controlled by a variable
carried out in a frequency drive and the feeding of the
running centrifuge centrifuge is done by pneumatically
721

Charging of MLR
pipe lines.
No specific hazard
operation the product Rotocone vacuum Dryer Hence No- Less Exposure
Charging the 1,1-
cyclobutane
dicarboxylic acid
Charging of Stage-1 Irritation to skin & Using hand gloves & goggles.
material and eyes
1,1-cyclobutane Instruction is Laid in the SOP , To Avoid
dicarboxylic acid, Silver Spillage out side the spillage outside the Equipment,Lay down the
Stage-2
Oxide, and added carbon reactor, Poly Bags to Collect the spilled Material,&
then filtration and Transfer to the reactor
Silver Oxide
centrifuged Fire hazard due to SS scoops to avoid static electricity. The
eyes
Irrigate with water immediately, repeat as
needed to flush particle from eye. If irritation
Contact with eye
Carbon persists, consult medical personnel.
and skin
Wash with soap and water to avoid skin
drying or chapping
722

Filtration
are flame proof.
wires.
Fire hazard due to centrifuge, bottom driven and top discharge.
static electricity, this is a four point suspension machines
operator hazard if which are put on special vibra mount for
To separate the Ist
Centrifuging any loading / smooth vibration free noiseless operation.
unloading activity The speed is controlled by a variable
carried out in a frequency drive and the feeding of the
running centrifuge centrifuge is done by pneumatically
723

Charging of MLR
pipe lines.
No specific hazard
operation the product Rotocone vacuum Dryer Hence No- Less Exposure
724
15) HAZOP- Cisplatin

Hazop Study - Process – for Cisplatin
Possible Hazards /
failures
Charging of reactor, Poly Bags to Collect the spilled Material,&
Potassium Transfer to the reactor
tetrachloroplatinate Fire hazard due to SS scoops to avoid static electricity. The
Charging of Potassium Spillage out side the spillage outside the Equipment,Lay down the
tetrachloroplatinate, reactor, Poly Bags to Collect the spilled Material,&
Potassium iodide Transfer to the reactor
Stage-1 And Ammonium hydroxide Potassium iodide SS scoops to avoid static electricity. The
25% in to the reactor Fire hazard due to reactor is earthed by conducting wires
static electricity Using hand gloves & goggles.
Irritation to skin & eyes
Valve prior to charging 25% Ammonium hydroxide
25% Ammonium
& is not Leaking.
hydroxide
25% Ammonium hydroxide addition pipe is
Fire hazard due to kept to the Bottom of the reactor
are flame proof.
725

Filtration
are flame proof.
Drying Separation of solvents from Unloading into the bins by actuated valve,
operation the product Hence No- Less Exposure
Dryer
Charging the Silver
nitrate
Charging the stage – I
material, Silver nitrate and
Stage-2 water into the reactor then
filter the reaction mass and
added Potassium chloride
and centrifuged
Filtration
are flame proof.
726

Potassium chloride Transfer to the reactor
Filtration
are flame proof.
wires.
Fire hazard due to chemical plant. Ample precautions are taken
static electricity, to carry out the centrifuging as hazard free as
To separate the Ist operator hazard if any possible. We are using a 48 inch dia SS316
Centrifuging
Stage From the liquid loading / unloading centrifuge, bottom driven and top discharge.
activity carried out in a this is a four point suspension machines
running centrifuge which are put on special vibra mount for
727

Dryer
728
16) HAZOP- DOCETAXEL TRIHYDRATE

Hazop Study - Process – for DOCETAXEL TRIHYDRATE
Possible Hazards /
failures
Spillage out side
the reactor,
Charging of
Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by
CN1
static electricity conducting wires
Reaction CN1, Sodium eyes
chloride, 6N HCl
Acetonitrile and Sat. Spillage out side
Sodium bicarbonate in the reactor,
water into Ethyl acetate.
Sodium Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by
chloride static electricity conducting wires
Stage -1
eyes.
Spillage out side
the reactor,
bicarbonate static electricity conducting wires
eyes.
Charging of
of Bottom Valve charging Acetonitrile & is not Leaking.
Acetonitrile
Fire hazard due to Acetonitrile addition pipe is kept to the Bottom of the reactor. Pipe
729

Charging of
of Bottom Valve charging Ethyl acetate & is not Leaking.
Ethyl acetate
Fire hazard due to Ethyl acetate addition pipe is kept to the Bottom of the reactor.
Hcl Addition Spillage & lines, without any Spillage,personnel Protective Equipments are
Spillage, Filter
Cloth Block
Fire hazard due to Carbon Charging SS pipe is Fixed to the Bottom of the reactor
Spillage out side
the reactor,
sulphate static electricity conducting wires
Charge Sodium sulphate
eyes.
Into organic layer
Spillage, Filter
Cloth Block
Filtration
Carbon Charging SS pipe is Fixed to the Bottom of the reactor
Fire hazard due to
static electricity
Distillation of Loss of ethyl The temperature is raised by slow heating till reflux; the methanol
Solvent recovery Ethyl acetate acetate and Vapour Loss is due to Excessive heat, Instruction is Given in SOP,
and acetonitrile acetonitrile To Open the steam valve to Optimum so as to maintain the reflux
730

Charging of of Bottom Valve charging MDC & is not Leaking.
MDC MDC addition pipe is kept to the Bottom of the reactor. Pipe lines
Fire hazard due to
Charge MDC, Acetone are all SS and equipment motors are flame proof.
static electricity
and Petroleum ether into
reaction mass. Bottom valve Operational control - checkpoint shall be included in the batch
Charging of of Bottom Valve charging Acetone & is not Leaking.
Acetone Acetone addition pipe is kept to the Bottom of the reactor. Pipe
Fire hazard due to
static electricity
Charging of of Bottom Valve charging Petroleum ether & is not Leaking.
Stage-II Petroleum ether Petroleum ether addition pipe is kept to the Bottom of the reactor.
Fire hazard due to
static electricity
Fire hazard due to Ample precautions are taken to carry out the centrifuging as hazard
To separate the static electricity, free as possible. We are using a 48 inch dia SS316 centrifuge,
Docetaxel operator hazard if bottom driven and top discharge. This is a four point suspension
Centrifuging Trihydrate any loading / machines which are put on special vibra mount for smooth
stage-II from unloading activity vibration free noiseless operation. The speed is controlled by a
the liquid carried out in a variable frequency drive and the feeding of the centrifuge is done
running centrifuge by pneumatically controlled valves at lower RPM under nitrogen
731

Charging of
waste after
centrifuging
Drying of the RCVD is fitted with flame proof motors. Unloading into the bins
product in by actuated valve, Hence No- Less Exposure
Drying Separation of solvents
rotocone No specific hazard Hand gloves & goggles should be used.
operation from the product
vacuum tray
dryer
Charge methanol into charging methanol & is not Leaking.
Stage-III Docetaxel Trihydrate
methanol Methanol addition pipe is kept to the Bottom of the reactor. Pipe
crude. Fire hazard due to
static electricity

Spillage, Filter
Cloth Block
Filtration
Carbon Charging SS pipe is Fixed to the Bottom of the reactor
Fire hazard due to
static electricity
732

Fire hazard due to
To separate the static electricity,
Docetaxel operator hazard if
Centrifuging Trihydrate any loading /
stage-III from unloading activity
the liquid carried out in a
running centrifuge
Charging of
waste after
centrifuging
product in by actuated valve, Hence No- Less Exposure
Drying Separation of solvents
rotocone No specific hazard Hand gloves & goggles should be used.
operation from the product
vacuum tray
dryer
733
17) Hazop- Epribucin

Hazop Study - Process – for epribucin
Possible Hazards /
failures
Stage I Charging of Bottom valve opened, Operational control - checkpoint shall be included in the
ethanol or Leakage of Bottom batch sheet to indicate whether the bottom valve has been
Valve closed prior to charging methanol & is not Leaking.
Fire hazard due to Ethanol addition pipe is kept to the Bottom of the reactor
Addition of EPI- Instruction is Laid in the SOP , To Avoid spillage outside
1 the Equipment, Lay down the Poly Bags to Collect the
reactor,
Addition of Instruction is Laid in the SOP , To Avoid spillage outside
sodium boro the Equipment, Lay down the Poly Bags to Collect the
reactor,
hydrate spilled Material,& Transfer to the reactor
5% NaOH NaOH is charged through the Closed lines, without any
Spillage & Irritation Spillage, personnel Protective Equipments are Used to avoid
Hydrochloric acid is charged through the Closed lines,
Hydrochoric acid
HCl Addition without any Spillage, personnel Protective Equipments are
Spillage & Irritation
Used to avoid the Exposure & tackle the irritation
Charging of Bottom valve opened, Operational control - checkpoint shall be included in the
MDC or Leakage of Bottom batch sheet to indicate whether the bottom valve has been
Valve closed prior to charging MDC & is not Leaking.
MDC Charging SS pipe is Fixed to the Bottom of the
Fire hazard due to
reactor
static electricity
Charging of All charging is done by vacuum sucking to avoid spillages
Solvent recovery MLR No specific hazard and through the closed SS pipe lines.
Hazardous waste
734
after distillation
The filtration is carried out through a centrifuge. Centrifuges
are high speed machines and sources of hazard in a chemical
plant. Ample precautions are taken to carry out the
centrifuging as hazard free as possible. We are using a 48
inch dia SS316 centrifuge, bottom driven and top discharge.
Fire hazard due to this is a four point suspension machines which are put on
static electricity, special vibra mount for smooth vibration free noiseless
To separate the
operator hazard if any operation. The speed is controlled by a variable frequency
loading / unloading drive and the feeding of the centrifuge is done by
the liquid
running centrifuge nitrogen purging. Even the bearing housing of the centrifuge
is provided with a nitrogen purging facility. An interlocking
system is provided for ensuring that the lids cannot be
opened while the centrifuge is running and thereby
preventing any operational hazard by human error . All the
limits switches and the safety interlocking switches are
Stage II Instruction is Laid in the SOP , To Avoid spillage outside
Addition of stage Spillage out side the
the Equipment,Lay down the Poly Bags to Collect the
I product reactor,
NaOH is charged through the Closed lines, without any
Addition of
Spillage & Irritation Spillage,personnel Protective Equipments are Used to avoid
NaOH
Charging of Valve closed prior to charging MDC & is not Leaking.
MDC MDC Charging SS pipe is Fixed to the Bottom of the
Fire hazard due to
reactor
static electricity
735
Charging of
MLR All charging is done by vacuum sucking to avoid spillages
Solvent recovery Hazardous waste No specific hazard and through the closed SS pipe lines.
after distillation

The filtration is carried out through a centrifuge. Centrifuges
are high speed machines and sources of hazard in a chemical
plant. Ample precautions are taken to carry out the
centrifuging as hazard free as possible. We are using a 48
inch dia SS316 centrifuge, bottom driven and top discharge.
Fire hazard due to this is a four point suspension machines which are put on
static electricity, special vibra mount for smooth vibration free noiseless
To separate the
operator hazard if any operation. The speed is controlled by a variable frequency
Centrifuging IInd Stage From
loading / unloading drive and the feeding of the centrifuge is done by
the liquid
running centrifuge nitrogen purging. Even the bearing housing of the centrifuge
Drying of the RCVD is fitted with flame proof motors. Unloading into the
Separation of
Drying product in bins by actuated valve, Hence No- Less Exposure
solvents from the No specific hazard
operation Rotocone Hand gloves & goggles should be used.
product
vacuum Dryer
Instruction is Laid in the SOP , To Avoid spillage outside
Addition of stage Spillage out side the the Equipment, Lay down the Poly Bags to Collect the
Stage III
II Product reactor, spilled Material,& Transfer to the reactor
736

Charging of Valve closed prior to charging methanol & is not Leaking.
MDC Acetone Charging SS pipe is Fixed to the Bottom of the
Fire hazard due to
reactor
static electricity
Charging of
acetone
Valve closed prior to charging acetone & is not Leaking.
Acetone Charging SS pipe is Fixed to the Bottom of the
Fire hazard due to
reactor
static electricity
Addition of Instruction is Laid in the SOP , To Avoid spillage outside
sodium the Equipment,Lay down the Poly Bags to Collect the
reactor,
bicorbonate spilled Material,& Transfer to the reactor
Valve closed prior to charging methanol & is not Leaking.
methanol
methanol Charging SS pipe is Fixed to the Bottom of the
Fire hazard due to
reactor
static electricity
Charging of
MLR All charging is done by vacuum sucking to avoid spillages
Solvent recovery Hazardous waste No specific hazard and through the closed SS pipe lines.
after distillation

To separate the
static electricity, The filtration is carried out through a centrifuge. Centrifuges
Centrifuging IIIrd Stage From
operator hazard if any are high speed machines and sources of hazard in a chemical
the liquid
loading / unloading plant. Ample precautions are taken to carry out the
737
activity carried out in a centrifuging as hazard free as possible. We are using a 48

running centrifuge inch dia SS316 centrifuge, bottom driven and top discharge.
this is a four point suspension machines which are put on
special vibra mount for smooth vibration free noiseless
operation. The speed is controlled by a variable frequency
drive and the feeding of the centrifuge is done by
nitrogen purging. Even the bearing housing of the centrifuge
Drying of the RCVD is fitted with flame proof motors. Unloading into the
Separation of
Drying product in bins by actuated valve, Hence No- Less Exposure
operation Rotocone Hand gloves & goggles should be used.
product
vacuum Dryer
738
18) HAZOP- Gefitinib

Hazop Study - Process – for Gefitinib
Possible Hazards /
failures
Bottom valve
opened, or Leakage
of Bottom Valve
Charging of Thionyl prior to charging methanol & is not Leaking.
chloride , Thionyl chloride addition pipe is kept to the
Reaction of 7-methoxy-6-
(3-morphalino propyl)
Stage-1 quinazolin-4 (3H)-one and
are flame proof.
Thionyl chloride
7-methoxy-6-(3-
morphalino propyl)
eyes
739

To separate the
the liquid
VFD controls.
Charging of MLR
740

Charging reactor,
3-chloro-4-fluoro
aniline,
Bottom valve opened, the batch sheet to indicate whether the bottom valve
or Leakage of Bottom has been closed prior to charging methanol & is not
Valve Leaking.
Ethyl acetate
Reaction of stage –I Ethyl acetate addition pipe is kept to the Bottom of the
material, 3-chloro-4-fluoro Fire hazard due to reactor
Stage-2 aniline, Ethyl acetate static electricity Pipe lines are all SS and equipment motors are flame
And potassium carbonate proof.
then filtrated centrifuge. Instruction is Laid in the SOP , To Avoid spillage
Spillage out side the outside the Equipment,Lay down the Poly Bags to
reactor, Collect the spilled Material,& Transfer to the reactor
Potassium
carbonate Fire hazard due to SS scoops to avoid static electricity. The reactor is
Spillage,Filter Cloth Line, Filter cloth cleaned for Every Batch & this
Filtration Cleaning of the Filter along with Cloth is Incorporated
Block
In the BPR
741
Ethyl acetate Charging SS pipe is Fixed to the

proof.
centrifuge and the feeding of the centrifuge is done by
loading / unloading
VFD controls
Charging of MLR
All charging is done by vacuum sucking to avoid
Hazardous waste
Solvent recovery No specific hazard spillages and through the closed SS pipe lines.
after distillation
742
19) HAZOP- GEMCITABINE HCl

Hazop Study - Process – for GEMCITABINE HCl
Possible Hazards
/ failures
Spillage out side Instruction is Laid in the SOP , To Avoid spillage outside the
Charging of
Reaction of G- the reactor, Health Equipment, Charging is done By Closed SS Pipe Line& Transfer to the
Liq
Intermediate Hazard on reactor, Personnel Protective Equipment is
Ammonia
And ammonia into exposure
methanol. Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by
eyes
Stage -1
Bottom valve Operational control - checkpoint shall be included in the batch sheet to
opened, or indicate whether the bottom valve has been closed prior to charging
Charging of Leakage of Bottom methanol & is not Leaking.
methanol Valve
Fire hazard due to methanol addition pipe is kept to the Bottom of the reactor. Pipe lines
Distillation Loss of Methanol, The temperature is raised by slow heating till reflux; the methanol
of reaction Ammonium Vapour Loss is due to Excessive heat, Instruction is Given in SOP, To
mass benzoate Open the steam valve to Optimum so as to maintain the reflux
Bottom valve Operational control - checkpoint shall be included in the batch sheet to
opened, or indicate whether the bottom valve has been closed prior to charging
Charge methanol and Charging of Leakage of Bottom methanol & is not Leaking.
Stage-II Valve
carbon into stage-I methanol
Fire hazard due to methanol addition pipe is kept to the Bottom of the reactor. Pipe lines
743

Spillage out side
Equipment, Lay down the Poly Bags to Collect the spilled Material,&
the reactor,
Charging of
carbon
eyes
The Filtration Operation is Carried out in Closed SS Line, Filter cloth
Spillage, Filter
Filtration cleaned for Every Batch & this Cleaning of the Filter along with Cloth
Cloth Block
is Incorporated In the BPR
Hydrochoric acid The Addition of Hydrochloric acid is charged through the Closed lines,
Charge HCl into filtered
Hcl Addition Spillage & without any Spillage,personnel Protective Equipments are Used to
reaction mass
Irritation avoid the Exposure & tackle the irritation
The filtration is carried out through a centrifuge. Centrifuges are high
speed machines and sources of hazard in a chemical plant. Ample
precautions are taken to carry out the centrifuging as hazard free as
Fire hazard due to possible. We are using a 48 inch dia SS316 centrifuge, bottom driven
To separate
static electricity, and top discharge. This is a four point suspension machines which are
the
operator hazard if put on special vibra mount for smooth vibration free noiseless
Gemcitabine
Centrifuging any loading / operation. The speed is controlled by a variable frequency drive and the
stage-II
unloading activity feeding of the centrifuge is done by pneumatically controlled valves at
from the
carried out in a lower RPM under nitrogen purging. Even the bearing housing of the
liquid
running centrifuge centrifuge is provided with a nitrogen purging facility. An interlocking
system is provided for ensuring that the lids cannot be opened while the
centrifuge is running and thereby preventing any operational hazard by
human error. All the limits switches and the safety interlocking
744
Charging of
ML’s All charging is done by vacuum sucking to avoid spillages and through
Solvent recovery Hazardous No specific hazard the closed SS pipe lines.
waste after
centrifuging
Drying of VTD is fitted with flame proof motors. Unloading into the bins by
Drying Separation of solvents the product actuated valve, Hence No- Less Exposure
No specific hazard
operation from the product in Vacuum Hand gloves & goggles should be used.
tray Dryer
The Filtration Operation is Carried out in Closed SS Line, Filter cloth
Spillage, Filter
cleaned for Every Batch & this Cleaning of the Filter along with Cloth
Cloth Block
Charge Gemcitabiene Fitration is Incorporated In the BPR
Stage-II into purified Fire hazard due to Carbon Charging SS pipe is Fixed to the Bottom of the reactor
Stage-III water and filter the mass static electricity Pipe lines are all SS and equipment motors are flame proof.
then acetic acid and HCl Bottom valve Operational control - checkpoint shall be included in the batch sheet to
add into reaction mass Charging of opened, or indicate whether the bottom valve has been closed prior to charging
Acitic acid Leakage of Bottom Acitic acid & is not Leaking.
Valve
745
Acitic acid addition pipe is kept to the Bottom of the reactor. Pipe
Fire hazard due to
static electricity
Hcl Addition Spillage & lines, without any Spillage, personnel Protective Equipments are
opened, or sheet to indicate whether the bottom valve has been closed prior to
Charge acetone into Charging of Leakage of Bottom charging Acetone & is not Leaking.
filtered reaction mass Acetone Valve
Fire hazard due to Acetone addition pipe is kept to the Bottom of the reactor. Pipe
Charging of
ML’s Hazardous All charging is done by vacuum sucking to avoid spillages and
waste after after through the closed SS pipe lines.
ANFD
Drying of the ANFD is fitted with flame proof motors. Unloading into the bins
Drying Separation of solvents product in by actuated valve, Hence No- Less Exposure
No specific hazard
operation from the product Agitated nutsche Hand gloves & goggles should be used.
filter dryer
746
20) HAZOP- Imatinib Mesylate
Hazop Study - Process – for Imatinib Mesylate

Possible Hazards /
failures
Charging of 4- Instruction is Laid in the SOP , To Avoid spillage
methyl-N3-(5- outside the Equipment,Lay down the Poly Bags to
reactor,
pyridin-3yl Collect the spilled Material,& Transfer to the reactor
Reaction of 4-methyl-N3- pyrimidine-2-yl) SS scoops to avoid static electricity. The reactor is
(5-pyridin-3yl pyrimidine- Fire hazard due to
benzene-1,3- earthed by conducting wires
2-yl) benzene-1,3-diamine, static electricity
diamine Using hand gloves & goggles.
4-(4-methyl-piperazin-1- Irritation to skin & eyes
yl-ethyl)benzoic
acid dihydrochloride, 4-(4-methyl- Spillage out side the
Methylene dichloride, piperazin-1-yl- reactor,
Triethylamine, Hydroxy ethyl)benzoic
benzotriazole and then acid
Stage-1 static electricity earthed by conducting wires
filter the reaction mass and dihydrochloride
added Methane sulphonic
acid ,Methanol and Bottom valve opened,
batch sheet to indicate whether the bottom valve has
Carbon, and then filtered or Leakage of Bottom
been closed prior to charging Methylene dichloride & is
Methylene Valve
not Leaking.
dichloride
Methylene dichloride addition pipe is kept to the Bottom
proof.
Triethylamine batch sheet to indicate whether the bottom valve has
been closed prior to charging Triethylamine & is not
Valve
Leaking.
747
Triethylamine addition pipe is kept to the Bottom of the

proof.
Hydroxy reactor,
benzotriazole
static electricity earthed by conducting wires Using hand gloves &
Irritation to skin & eyes goggles.
Block Cleaning of the Filter along with Cloth is Incorporated In
the BPR
Filtration
proof.
batch sheet to indicate whether the bottom valve has
been closed prior to charging Methane sulphonic acid &
Methane Valve
is not Leaking.
sulphonic acid
Methane sulphonic acid addition pipe is kept to the
proof.
Methanol or Leakage of Bottom batch sheet to indicate whether the bottom valve has
Valve been closed prior to charging methanol & is not Leaking.
748
Methanol addition pipe is kept to the Bottom of the

proof.
Irrigate with water immediately, repeat as needed to
flush particle from eye. If irritation persists, consult
Contact with eye and
Carbon medical personnel.
skin
Wash with soap and water to avoid skin drying or
chapping
Block Cleaning of the Filter along with Cloth is Incorporated In
the BPR
Filtration
proof.
hazard in a chemical plant. Ample precautions are taken
Fire hazard due to to carry out the centrifuging as hazard free as possible.
static electricity, We are using a 48 inch dia SS316 centrifuge, bottom
To separate the
operator hazard if any driven and top discharge. this is a four point suspension
loading / unloading machines which are put on special vibra mount for
the liquid
activity carried out in a smooth vibration free noiseless operation. The speed is
running centrifuge controlled by a variable frequency drive and the feeding
of the centrifuge is done by pneumatically controlled
valves at lower RPM under nitrogen purging. Even the
749

switches and the safety interlocking switches are flame
RCVD is fitted with flame proof motors. Unloading into
Drying Separation of solvents Drying of the
No specific hazard the bins by actuated valve, Hence No- Less Exposure
operation from the product product in VTD
750
21) HAZOP- Irinotecan HCl Trihydrate
Hazop Study - Process – for Irinotecan HCl Trihydrate Stage-I

Possible Hazards /
failures
Bottom valve Operational control - checkpoint shall be included in the
opened, or Leakage batch sheet to indicate whether the bottom valve has been
Reaction of 7-ethyl-10- of Bottom Valve closed prior to charging Pyridine & is not Leaking.
Charging of Pyridine
hydroxy camptothecin, Pyridine addition pipe is kept to the Bottom of the reactor
Fire hazard due to
1-Chlorocarbonyl-4- Pipe lines are all SS and equipment motors are flame
static electricity
piperidino piperdine proof.
hydrochloride and Pyridine Charging of 7-ethyl-10- Spillage out side the Instruction is Laid in the SOP , To Avoid spillage outside
then distill out the pyridine hydroxy camptothecin the Equipment, Lay down the Poly Bags to Collect the
reactor
add the chloroform then spilled Material,& Transfer to the reactor
Stage-I distill out the chloroform Charging of 1- Instruction is Laid in the SOP , To Avoid spillage outside
add hexane to reaction mass Chlorocarbonyl-4- Spillage out side the the Equipment,Lay down the Poly Bags to Collect the
then centrifuge the material. piperidino piperdine reactor, spilled Material,& Transfer to the reactor
hydrochloride
Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed
static electricity by conducting wires
eyes
Charging of MLR
Hazardous waste after All charging is done by vacuum sucking to avoid spillages
distillation and through the closed SS pipe lines.

Charging of
opened, or Leakage batch sheet to indicate whether the bottom valve has been
Chloroform
of Bottom Valve closed prior to charging Chloroform & is not Leaking.
751
Chloroform addition pipe is kept to the Bottom of the

proof.
Charging of Hexane opened, or Leakage batch sheet to indicate whether the bottom valve has been
of Bottom Valve closed prior to charging Hexane & is not Leaking.
Hexane addition pipe is kept to the Bottom of the reactor
Fire hazard due to
static electricity
proof.
Centrifuges are high speed machines and sources of hazard
in a chemical plant. Ample precautions are taken to carry
out the centrifuging as hazard free as possible. We are
using a 48 inch dia SS316 centrifuge, bottom driven and
Fire hazard due to
top discharge. this is a four point suspension machines
static electricity,
which are put on special vibra mount for smooth vibration
operator hazard if
To separate the Ist free noiseless operation. The speed is controlled by a
Stage From the liquid variable frequency drive and the feeding of the centrifuge
unloading activity
is done by pneumatically controlled valves at lower RPM
carried out in a
under nitrogen purging. Even the bearing housing of the
running centrifuge
centrifuge is provided with a nitrogen purging facility. An
interlocking system is provided for ensuring that the lids
cannot be opened while the centrifuge is running and
thereby preventing any operational hazard by human error
. All the limits switches and the safety interlocking
Charging of MLR
Solvent recovery Hazardous waste after No specific hazard All charging is done by vacuum sucking to avoid spillages
distillation and through the closed SS pipe lines.
752

Bottom valve
Charging of Ethanol opened, or Leakage
has been closed prior to charging Ethanol & is not
of Bottom Valve
Leaking.
Preparation of Irinotecan HCl
Trihydrate Stage-II by Stage- Spillage out side the
Charging of Stage-I outside the Equipment, Lay down the Poly Bags to
I, Ethanol, DMF reactor,
Bottom valve
Charging of DMF opened, or Leakage
has been closed prior to charging DMF & is not
of Bottom Valve
Leaking.
Stage-II hazard in a chemical plant. Ample precautions are
Fire hazard due to
static electricity,
operator hazard if
To separate the Stage- mount for smooth vibration free noiseless operation.
II From the liquid The speed is controlled by a variable frequency drive
unloading activity
carried out in a
running centrifuge
753

VFD controls

Hazardous waste after spillages and through the closed SS pipe lines.
distillation
RCVD is fitted with flame proof motors. Unloading

Drying Separation of solvents Drying of the product in into the bins by actuated valve, Hence No- Less
No specific hazard
operation from the product Rotocone vacuum Dryer Exposure
754
Hazop Study - Process – for Irinotecan HCl Trihydrate Stage-III

Possible Hazards /
failures

Spillage out side the spillage outside the Equipment, Lay down
Charging of Stage-II
reactor the Poly Bags to Collect the spilled
Purification of Stage-III Spillage out side the spillage outside the Equipment,Lay down the
with carbon Charging of Carbon
Stage-III
eyes
Spillage, Filter Closed SS Line, Filter cloth cleaned for
Filtration
Cloth Block Every Batch & this Cleaning of the Filter
Fire hazard due to
wires.
static electricity,
operator hazard if
To separate the Stage- centrifuge. Centrifuges are high speed
II From the liquid machines and sources of hazard in a
unloading activity
carried out in a
running centrifuge
755

including the VFD controls
ANFD is fitted with flame proof motors.
Drying of the product in
Agitated Nutsche Filter No specific hazard
vacuum Dryer
756
22) HAZOP- LENALIDOMIDE

Hazop Study - Process – for LENALIDOMIDE
Stages Process Operation Possible Hazards / failures Remedial Action
Operational control - checkpoint shall be included in the batch
sheet to indicate whether the bottom valve has been closed prior to
Charging of Leakage of Bottom Valve
charging Raney Nickel & is not Leaking.
Charge 4- Raney Nickel
Fire hazard due to static Raney Nickel addition pipe is kept to the Bottom of the reactor.
nitrophthalide electricity Pipe lines are all SS and equipment motors are flame proof.
and Raney Instruction is Laid in the SOP , To Avoid spillage outside the
Nickel into Spillage out side the reactor, Equipment, Lay down the Poly Bags to Collect the spilled
methanol. Charging of 4- Material,& Transfer to the reactor
nitrophthalide Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
Stage -1 Irritation to skin & eyes Using hand gloves & goggles.
Charging of charging methanol & is not Leaking.
methanol Methanol addition pipe is kept to the Bottom of the reactor. Pipe
electricity
Spillage, Filter Cloth Block
Filtration
electricity
Distillation of The temperature is raised by slow heating till reflux; the methanol
Solvent
methanol into Loss of Methanol Vapour Loss is due to Excessive heat, Instruction is Given in SOP,
recovery
reaction mass To Open the steam valve to Optimum so as to maintain the reflux
757

To separate the electricity, operator hazard
Centrifuging Lenalidomide if any loading / unloading
from the liquid activity carried out in a
running centrifuge
Distillation of
Solvent All charging is done by vacuum sucking to avoid spillages and
methanol after No specific hazard
recovery through the closed SS pipe lines.
centrifuge ML’S.
Charge Stage- Instruction is Laid in the SOP , To Avoid spillage outside the
I, L-glutamine, Spillage out side the reactor, Equipment, Lay down the Poly Bags to Collect the spilled
N,N,Carbomyl Material,& Transfer to the reactor
Stage -II Diimidazole, Charging of L- SS scoops to avoid static electricity. The reactor is earthed by
Carbon into glutamine Fire hazard due to static conducting wires
Dimethyl electricity Using hand gloves & goggles.
sulphoxide. Irritation to skin & eyes
Charging of Instruction is Laid in the SOP , To Avoid spillage outside the

N,N,Carbomyl Spillage out side the reactor, Equipment, Lay down the Poly Bags to Collect the spilled
Diimidazole Material,& Transfer to the reactor
758
Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
Bottom valve opened, or sheet to indicate whether the bottom valve has been closed prior to
Charging of Leakage of Bottom Valve charging Dimethyl sulphoxide & is not Leaking.
Dimethyl
sulphoxide Dimethyl sulphoxide addition pipe is kept to the Bottom of the
reactor. Pipe lines are all SS and equipment motors are flame
electricity
proof.
Spillage out side the reactor, Equipment,Lay down the Poly Bags to Collect the spilled
carbon Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
Spillage, Filter Cloth Block cloth cleaned for Every Batch & this Cleaning of the Filter along
Fire hazard due to static Carbon Charging SS pipe is Fixed to the Bottom of the reactor
electricity Pipe lines are all SS and equipment motors are flame proof.
Distillation of
Solvent DMF, Ethyl All charging is done by vacuum sucking to avoid spillages and
No specific hazard
recovery acetate into through the closed SS pipe lines.
reaction mass
Charge
Charging Spillage out side the reactor Equipment, Lay down the Poly Bags to Collect the spilled
Potassium
Potassium Material,& Transfer to the reactor
bromide
bromide Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
into reaction
mass.
759

Spillage,Filter Cloth Block cloth cleaned for Every Batch & this Cleaning of the Filter along
Fire hazard due to static Acetone Charging SS pipe is Fixed to the Bottom of the reactor
To separate the electricity, operator hazard
Centrifuging Letrozole from if any loading / unloading
the liquid activity carried out in a
running centrifuge
Distillation of
Solvent All charging is done by vacuum sucking to avoid spillages and
DMS after No specific hazard
recovery through the closed SS pipe lines.
centrifuge ML’S.
Separation of actuated valve, Hence No- Less Exposure
Drying product in
solvents from No specific hazard Hand gloves & goggles should be used.
operation Vacuum tray
the product
Dryer
760
23) HAZOP- LETROZOLE

Hazop Study - Process – for LETROZOLE
Possible Hazards /
failures
Charging of p-
of Bottom Valve charging p-tolunitrile & is not Leaking.
tolunitrile
Fire hazard due to p-tolunitrile addition pipe is kept to the Bottom of the reactor. Pipe
Reaction of p-tolunitrile, static electricity lines are all SS and equipment motors are flame proof.
N-bromosuccinamide and Instruction is Laid in the SOP , To Avoid spillage outside the
Spillage out side
Hexane in Acetonitrile Equipment, Lay down the Poly Bags to Collect the spilled
the reactor,
N-bromo
succinamide
Stage -1
eyes
Charging of of Bottom Valve charging Acetonitrile & is not Leaking.
Acetonitrile Acetonitrile addition pipe is kept to the Bottom of the reactor. Pipe
Fire hazard due to
static electricity
Spillage,Filter
Cloth Block
Filtration
Fire hazard due to
static electricity
761
Distillation of
Acetonitrile All charging is done by vacuum sucking to avoid spillages and
into reaction through the closed SS pipe lines.
mass
Fire hazard due to
static electricity,
Centrifuging bicalutamide any loading /
from the liquid unloading activity
carried out in a
running centrifuge
No specific hazard
Dryer
Charge Stage-I,DMF, sheet to indicate whether the bottom valve has been closed prior to
opened, or Leakage
Potassium carbonate, charging DMF & is not Leaking.
Stage-II 1,2,4-Triazole,
DMF DMF addition pipe is kept to the Bottom of the reactor. Pipe lines
and Ethyl acetate Fire hazard due to
into Water. are all SS and equipment motors are flame proof.
static electricity
762

Charging of of Bottom Valve charging Ethyl acetate & is not Leaking.
Ethyl acetate
Fire hazard due to Ethyl acetate addition pipe is kept to the Bottom of the reactor.
Spillage out side
the reactor,
Potassium Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by
carbonate static electricity conducting wires
eyes
Spillage out side
the reactor,
Charging 1,2,4-
Triazole
eyes
Distillation of
DMF, Ethyl All charging is done by vacuum sucking to avoid spillages and
acetate into through the closed SS pipe lines.
reaction mass
Spillage out side
Charging the reactor,
Charge Potassium Material,& Transfer to the reactor
Potassium
bromide Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by
bromide
into reaction mass. static electricity conducting wires
eyes
763

Spillage,Filter
Cloth Block
Filtration
Fire hazard due to
static electricity
Fire hazard due to
static electricity,
Centrifuging Letrozole from any loading /
the liquid unloading activity
carried out in a
running centrifuge
Distillation of
DMF after All charging is done by vacuum sucking to avoid spillages and
centrifuge through the closed SS pipe lines.
ML’S.
No specific hazard
Dryer
764
24) HAZOP- OXALIPLATIN

Hazop Study - Process – for OXALIPLATIN
Stag Possible Hazards /
Process Operation Remedial Action
es failures
Spillage out side the Instruction is Laid in the SOP , To Avoid spillage outside the Equipment, Lay
Reaction of Charging
reactor, down the Poly Bags to Collect the spilled Material,& Transfer to the reactor
Potassium Potassium
Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by conducting
tetrachlorop tetrachloroplatinat
static electricity wires
latinate e
Trans-1,2-
Charging of Bottom valve opened, Operational control - checkpoint shall be included in the batch sheet to indicate
diamino
1,2-diamino or Leakage of Bottom whether the bottom valve has been closed prior to charging DMSO & is not
cyclohexane
cyclohexane Valve Leaking.
into purified
Fire hazard due to DMSO addition pipe is kept to the Bottom of the reactor. Pipe lines are all SS
water.
static electricity and equipment motors are flame proof.
Stag The centrifuge is earthed by conducting wires.
e -1 The filtration is carried out through a centrifuge. Centrifuges are high speed
machines and sources of hazard in a chemical plant. Ample precautions are
taken to carry out the centrifuging as hazard free as possible. We are using a 48
Fire hazard due to inch dia SS316 centrifuge, bottom driven and top discharge. This is a four point
static electricity, suspension machines which are put on special vibra mount for smooth
To separate the
Centrifugin operator hazard if any vibration free noiseless operation. The speed is controlled by a variable
Oxaliplatin stage-
g loading / unloading frequency drive and the feeding of the centrifuge is done by pneumatically
I from the liquid
activity carried out in a controlled valves at lower RPM under nitrogen purging. Even the bearing
running centrifuge housing of the centrifuge is provided with a nitrogen purging facility. An
interlocking system is provided for ensuring that the lids cannot be opened
while the centrifuge is running and thereby preventing any operational hazard
by human error. All the limits switches and the safety interlocking switches are
765
Charging of ML’s
Solvent
Hazardous waste No specific hazard All charging is done by vacuum sucking to avoid spillages and through the
recovery
after centrifuging closed SS pipe lines.
Dryi Separation Drying of the VTD is fitted with flame proof motors. Unloading into the bins by actuated
ng of solvents product in valve, Hence No- Less Exposure
No specific hazard
oper from the Vacuum tray Hand gloves & goggles should be used.
ation product Dryer
Instruction is Laid in the SOP , To Avoid spillage outside the Equipment, Lay
down the Poly Bags to Collect the spilled Material,& Transfer to the reactor
reactor,
Charge Charging of
Stage-I, Oxalic acid Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by conducting
Oxalic acid static electricity wires
and Silver Irritation to skin & eyes Using hand gloves & goggles.
oxide into Spillage out side the Instruction is Laid in the SOP , To Avoid spillage outside the Equipment, Lay
purified reactor, down the Poly Bags to Collect the spilled Material,& Transfer to the reactor
water. Charging of
Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by conducting
Silver oxide
static electricity wires
Stag Irritation to skin & eyes Using hand gloves & goggles.
e-II Instruction is Laid in the SOP , To Avoid spillage outside the Equipment, Lay
Charge down the Poly Bags to Collect the spilled Material,& Transfer to the reactor
reactor,
carbon into Charging of
reaction carbon Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by conducting
mass static electricity wires
The Filtration Operation is Carried out in Closed SS Line, Filter cloth cleaned
for Every Batch & this Cleaning of the Filter along with Cloth is Incorporated
Block
Filtration In the BPR
766

Ample precautions are taken to carry out the centrifuging as
hazard free as possible. We are using a 48 inch dia SS316
Fire hazard due to
centrifuge, bottom driven and top discharge. This is a four point
static electricity,
To separate the suspension machines which are put on special vibra mount for
operator hazard if
Oxaliplatin stage- smooth vibration free noiseless operation. The speed is controlled
II from the by a variable frequency drive and the feeding of the centrifuge is
unloading activity
liquid done by pneumatically controlled valves at lower RPM under
carried out in a
nitrogen purging. Even the bearing housing of the centrifuge is
running centrifuge
provided with a nitrogen purging facility. An interlocking system
is provided for ensuring that the lids cannot be opened while the
centrifuge is running and thereby preventing any operational
hazard by human error. All the limits switches and the safety
interlocking switches are flame proof including the VFD controls.
Charging of
ML’s Hazardous All charging is done by vacuum sucking to avoid spillages and
waste after through the closed SS pipe lines.
centrifuging
No specific hazard
operation from the product Rotocone vacuum Hand gloves & goggles should be used.
tray dryer
767
25) Hazop- PACLITAXEL

Hazop Study - Process – for PACLITAXEL
whether the bottom valve has been
closed prior to charging methanol & is
Charging of Methanol not Leaking.
Methanol addition pipe is kept to the
electricity Pipe lines are all SS and equipment
STAGE-
Reaction of TxL motors are flame proof.
1
RM Operational control - checkpoint shall be
closed prior to charging acetic acid & is
Charging of acetic acid not Leaking.
Acetic acid addition pipe is kept to the
spillage outside the Equipment,Lay
Addition of TxL RM Spillage out side the reactor,
down the Poly Bags to Collect the spilled
Charging of MLR All charging is done by vacuum sucking
Solvent recovery Hazardous waste after No specific hazard to avoid spillages and through the closed
distillation SS pipe lines.
STAGE Addition of stage I Instruction is Laid in the SOP , To Avoid
Spillage out side the reactor,
II Product spillage outside the Equipment,Lay
768
down the Poly Bags to Collect the spilled

Charging of methanol not Leaking.
Charging of MLR
Hazardous waste after All charging is done by vacuum sucking
distillation to avoid spillages and through the closed
SS pipe lines.
Separation of solvents Drying of the product in
Drying operation No specific hazard
from the product Rotocone vacuum Dryer
Addition of stage II spillage outside the Equipment,Lay
Product down the Poly Bags to Collect the spilled
STAGE Bottom valve opened, or
Charging of methanol whether the bottom valve has been
III Leakage of Bottom Valve
not Leaking.
Fire hazard due to static Bottom of the reactor.Pipe lines are all
electricity SS and equipment motors are flame
proof.
769
Charging of MLR
All charging is done by vacuum sucking
Hazardous waste after
Solvent recovery No specific hazard to avoid spillages and through the closed
distillation
SS pipe lines.
Addition of stage III spillage outside the Equipment,Lay
product down the Poly Bags to Collect the spilled
Charging of MDC whether the bottom valve has been
closed prior to charging MDC & is not
STAGE Leaking.
IV MDC addition pipe is kept to the Bottom
Charging of Acetone whether the bottom valve has been
closed prior to charging acetone & is not
Leaking.
770
Acetone addition pipe is

kept to the Bottom of the
electricity Pipe lines are all SS and
equipment motors are flame
proof.
Charging of MLR
All charging is done by
Solvent recovery No specific hazard vacuum sucking to avoid
distillation
spillages and through the
closed SS pipe lines.
771
26) Hazop- PEMETREXED
Hazop Study - Process – for PEMETREXED

Stage-1 Reaction of 4-(2- Operational control - checkpoint shall be
(2-amino -4-oxo- Bottom valve opened, or included in the batch sheet to indicate whether
4,7-dihydro-3H- Leakage of Bottom Valve the bottom valve has been closed prior to
pyrrolo[2,3-d] charging methanol & is not Leaking.
Charging of MDC,
pyrimidine-5- MDC addition pipe is kept to the Bottom of the
yl)ethyl benzoic Fire hazard due to static reactor
acid with l- electricity Pipe lines are all SS and equipment motors are
glutanoic acid flame proof.
Charging of 4-(2-(2- Instruction is Laid in the SOP , To Avoid
amino -4-oxo-4,7- spillage outside the Equipment,Lay down the
dihydro-3H- Spillage out side the Poly Bags to Collect the spilled Material,&
pyrrolo[2,3-d] reactor, Transfer to the reactor
pyrimidine-5-yl)ethyl
benzoic.
Charging of MLR
distillation
Stage II Reaction of 4-(2- The Addition of Hydrochloric acid is charged

(2-amino -4-oxo- Hydrochoric acid Spillage through the Closed lines, without any Spillage,
Hcl Addition
4,7-dihydro-3H- & Irritation personnel Protective Equipments are Used to
pyrrolo[2,3-d] avoid the Exposure & tackle the irritation
pyrimidine-5- The Addition of NaOH is done through the
yl)ethyl Closed lines, without any Spillage, personnel
benzamido NaOH Addition NaOH Spillage & Irritation Protective Equipments are Used to avoid the
pentanediate with Exposure & tackle the irritation.
NaOH
772
CENTRIFUGE The centrifuge is earthed by conducting wires.

free as possible. We are using a 48 inch dia
SS316 centrifuge, bottom driven and top
discharge. this is a four point suspension
machines which are put on special vibra mount
for smooth vibration free noiseless operation.
electricity, operator hazard
To separate the IInd The speed is controlled by a variable frequency
if any loading / unloading
Stage From the liquid drive and the feeding of the centrifuge is done by
pneumatically controlled valves at lower RPM
running centrifuge
under nitrogen purging. Even the bearing
housing of the centrifuge is provided with a
nitrogen purging facility. An interlocking system
is provided for ensuring that the lids cannot be
Addition of Spillage out side the spillage outside the Equipment,Lay down the
Reaction of
pemetrexed diacid reactor, Poly Bags to Collect the spilled Material,&
pemetrexed
Stage Transfer to the reactor
diacid with NaOH
III Operational control - checkpoint shall be
with acetone as
Bottom valve opened, or included in the batch sheet to indicate whether
solvent Charging of acetone
Leakage of Bottom Valve the bottom valve has been closed prior to
charging methanol & is not Leaking.
773
Acetone addition pipe is

kept to the Bottom of the
Fire hazard due to static electricity
static electricity Pipe lines are all SS and
equipment motors are
flame proof.
Charging of MLR
Solvent recovery Hazardous waste after No specific hazard
distillation
free as possible. We are using a 48 inch dia
SS316 centrifuge, bottom driven and top
discharge. this is a four point suspension
machines which are put on special vibra mount
for smooth vibration free noiseless operation.
electricity, operator hazard
To separate the IIInd The speed is controlled by a variable frequency
Centrifuging if any loading / unloading
Stage From the liquid drive and the feeding of the centrifuge is done by
pneumatically controlled valves at lower RPM
running centrifuge
under nitrogen purging. Even the bearing
housing of the centrifuge is provided with a
nitrogen purging facility. An interlocking system
is provided for ensuring that the lids cannot be
human error. All the limits switches and the
774
27) HAZOP- Temozolomide

Hazop Study - Process – for Temozolomide Stage-1
Possible Hazards /
failures
5-amino-1-(n-methyl
carbamoyl) imidazole-
4-carboxamide
Reaction of 5-amino-1-(n- Irritation to skin & eyes Using hand gloves & goggles.
methyl carbamoyl) Instruction is Laid in the SOP , To Avoid
imidazole-4-carboxamide Spillage out side the spillage outside the Equipment,Lay down the
with Sodium nitrite, reactor, Poly Bags to Collect the spilled Material,&
Sodium nitrite
Tartaric acid Transfer to the reactor
with Water Fire hazard due to static SS scoops to avoid static electricity. The
Stage-1
Tartaric acid
Fire hazard due to static The centrifuge is earthed by conducting
electricity, operator wires.
To separate the Ist
Centrifuging hazard if any loading / The filtration is carried out through a
unloading activity centrifuge. Centrifuges are high speed
carried out in a running machines and sources of hazard in a
775
centrifuge chemical plant. Ample precautions are taken

Rotocone vacuum No specific hazard
Dryer
Charging the stage-I Bottom valve opened,
Stage-2 material, Acetone, carbon Charging of Acetone , or Leakage of Bottom
and water into the reactor Valve
prior to charging Acetone & is not Leaking.
776
Acetone addition pipe is kept to the Bottom

are flame proof.
Irrigate with water immediately, repeat as
needed to flush particle from eye. If irritation
Contact with eye and
Carbon persists, consult medical personnel.
skin
Wash with soap and water to avoid skin
drying or chapping
Filtration
are flame proof.
wires.
Fire hazard due to static machines and sources of hazard in a
electricity, operator chemical plant. Ample precautions are taken
To separate the Ist hazard if any loading / to carry out the centrifuging as hazard free as
Centrifuging
Stage From the liquid unloading activity possible. We are using a 48 inch dia SS316
carried out in a running centrifuge, bottom driven and top discharge.
centrifuge this is a four point suspension machines
777

Rotocone vacuum No specific hazard
Dryer
778
28) HAZOP- THALIDOMIDE

Hazop Study - Process – for THALIDOMIDE
Spillage out side the reactor, Equipment, Lay down the Poly Bags to Collect the spilled
Charging of
N,N-carbomyl-
Reaction of p L- di-imidazole
glutamine,
Phthalic
anhydride,
N,N-carbomyl-
di-imidazole and
L-glutamine Fire hazard due to static SS scoops to avoid static electricity. The reactor is earthed by
Carbon
Into DMSO. electricity conducting wires
Stage -1
Charging of Leakage of Bottom Valve
charging DMSO & is not Leaking.
DMSO
Fire hazard due to static DMSO addition pipe is kept to the Bottom of the reactor. Pipe lines
electricity are all SS and equipment motors are flame proof.
Charging of
Phthalic
anhydride
Filtration Spillage, Filter Cloth Block cloth cleaned for Every Batch & this Cleaning of the Filter along
779
Fire hazard due to static Carbon Charging SS pipe is Fixed to the Bottom of the reactor
Distillation of The temperature is raised by slow heating till reflux; the DMSO
Solvent recovery DMSO into Loss of DMSO Vapour Loss is due to Excessive heat, Instruction is Given in SOP,
reaction mass To Open the steam valve to Optimum so as to maintain the reflux
To separate the electricity, operator hazard if
Centrifuging Thalidomide any loading / unloading
from the liquid activity carried out in a
running centrifuge
Charging of
waste after
centrifuging
Separation of
Drying product in actuated valve, Hence No- Less Exposure
operation Vacuum tray Hand gloves & goggles should be used.
product
Dryer
780
29) HAZOP- TOPOTECAN HCl

Hazop Study - Process – for TOPOTECAN HCl
Possible Hazards /
failures
Spillage out side
Equipment,Lay down the Poly Bags to Collect the spilled
the reactor,
Charging of 10- Material,& Transfer to the reactor
hydroxy Fire hazard due to SS scoops to avoid static electricity. The reactor is earthed by
camptothecin static electricity conducting wires
Reaction of 10-hydroxy Irritation to skin & Using hand gloves & goggles.
camptothecin, eyes
Dimethylamine and Bottom valve Operational control - checkpoint shall be included in the batch
Formaldehyde in water. opened, or Leakage sheet to indicate whether the bottom valve has been closed prior to
Charging of
of Bottom Valve charging Dimethylamine & is not Leaking.
Dimethylamine
Fire hazard due to Dimethylamine addition pipe is kept to the Bottom of the reactor
Stage -1
Charging of of Bottom Valve charging Formaldehyde & is not Leaking.
Formaldehyde Formaldehyde addition pipe is kept to the Bottom of the reactor
Fire hazard due to
static electricity
Spillage,Filter
Cloth Block
Filtration
Fire hazard due to
static electricity
781
Distillation of
Dimethylamine
All charging is done by vacuum sucking to avoid spillages and
Solvent recovery Formaldehyde No specific hazard
through the closed SS pipe lines.
into reaction
mass
Charging of of Bottom Valve charging acetic acid & is not leaking.
acetic acid Acetic acid addition pipe is kept to the Bottom of the reactor
Fire hazard due to
Charge wet material and static electricity Pipe lines are all SS and equipment motors are flame proof.
acetic acid into reactor The Filtration Operation is Carried out in Closed SS Line, Filter
Spillage, Filter
cloth cleaned for Every Batch & this cleaning of the Filter along
Cloth Block
Filtration with Cloth is Incorporated in the BPR.
Fire hazard due to Water charging SS pipe is Fixed to the Bottom of the reactor
Distillation
acetic acid of All charging is done by vacuum sucking to avoid spillages and
No specific hazard
into reaction through the closed SS pipe lines.
mass
No specific hazard
operation from the product Rotocone Hand gloves & goggles should be used.
vacuum Dryer
Hcl Addition Spillage & lines, without any Spillage,personnel Protective Equipments are
Add Stage-I, HCl and Irritation Used to avoid the Exposure & tackle the irritation
Stage-II
carbon into purified water. Charging of Instruction is Laid in the SOP , To Avoid spillage outside the
Spillage out side
carbon to Equipment,Lay down the Poly Bags to Collect the spilled
the reactor,
organic layer Material,& Transfer to the reactor
782
eyes
Spillage, Filter
Filtration cloth cleaned for Every Batch & this Cleaning of the Filter along
Cloth Block
Fire hazard due to
static electricity,
Centrifuging 2nd Stage From any loading /
the liquid unloading activity
carried out in a
running centrifuge
No specific hazard
operation from the product Rotocone Hand gloves & goggles should be used.
vacuum Dryer
783
30) Hazop- ZOLEDRONIC ACID

Hazop Study - Process – for ZOLEDRONIC ACID
Possible Hazards /
failures
Stage I Reaction of Charging of Toluene Bottom valve opened, or Operational control - checkpoint shall be included in
imidazole with Leakage of Bottom the batch sheet to indicate whether the bottom valve has
potassium Valve been closed prior to charging toluene & is not Leaking.
carbonate toluene addition pipe is kept to the Bottom of the
proof.
Addition of imidazole Instruction is Laid in the SOP , To Avoid spillage
reactor,
Addition of Potassium Instruction is Laid in the SOP , To Avoid spillage
carbonate outside the Equipment,Lay down the Poly Bags to
reactor,
Charging of iso-propyl Operational control - checkpoint shall be included in
alcohol Bottom valve opened, or the batch sheet to indicate whether the bottom valve has
Leakage of Bottom been closed prior to charging iso-propyl alcohol & is
Valve not Leaking.
Fire hazard due to static Iso-propyl alcohol addition pipe is kept to the Bottom
electricity of the reactor
784

proof.
hazard in a chemical plant. Ample precautions are taken
to carry out the centrifuging as hazard free as possible.
We are using a 48 inch dia SS316 centrifuge, bottom
driven and top discharge. this is a four point suspension
machines which are put on special vibra mount for
electricity, operator
smooth vibration free noiseless operation. The speed is
To separate the Ist hazard if any loading /
Centrifuging controlled by a variable frequency drive and the feeding
Stage From the liquid unloading activity carried
of the centrifuge is done by pneumatically controlled
out in a running
valves at lower RPM under nitrogen purging. Even the
centrifuge
switches and the safety interlocking switches are flame
Solvent recovery Hazardous waste after No specific hazard spillages and through the closed SS pipe lines.
distillation
RCVD is fitted with flame proof motors. Unloading
Separation of Drying of the product
Drying into the bins by actuated valve, Hence No- Less
solvents from the in Rotocone vacuum No specific hazard.
operation Exposure
product Dryer
785
ANNEXURE A10
• Land records and gazette

notification
• Hazardous waste contracts
786
787
788
789
790
791
792
793
794
795
796
797
798
799
800
801
802
803
804
805
806
807
808
809
810
811
812
813
814
815
816
817
818
819
820
821
822
823
824
825
826
827
828
829
830
831
832
833
834
835
836
837
838
839
840
841
842
843
844
845
846
847
848
849
850
851
852
853
ANNEXURE A11
Maps and drawings

1. Topo map – 10 km radius
2. Site plan
3. Layout of industrial area
4. Maximum credible accident
scenario
854
TOPO MAP - M/s. SHILPA MEDICARE LIMITED, UNIT I
Source: Survey of India 855 Topo map no. 56 H/7

856
EA
48
PEN AR
N
GODOW
RITY GATE
74 SECU
ROOM
ERT
CULV
ERT
CULV
T
VER OAD
CUL TING R
EX I S
.80
44030
T
VER
CUL

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ENVIRONMENT IMPACT ASSESSMENT (EIA)

M/s. Shilpa Medicare Limited (SML), 312-6-214/A1, Hyderabad Road,

Application was made to MoEFCC with project report for obtaining

3. EXTENT OF STUDY AND AREA COVERED

The broad scope of this EIA study includes detailed characterization of

Name of the industry M/s. Shilpa Medicare Limited (SML)

17 Epirubicin HCl 0.24

Transportation and communication

Health, medical and educational facility

The soil in the study area is moderately to strongly alkaline. Potassium,

FLORA and FAUNA

Konad/ Konnan halla

6. ENVIRONMENTAL MANAGEMENT PLAN (EMP) OPERATION PHASE

Impact on air quality

Wastewater treatment and disposal details

Sewage/wastewater treatment and discharge

Impact on water environment

Impact on noise level

Non-hazardous solid waste

Solid waste generation and management

Hazardous solid waste

7. ENVIRONMENTAL IMPACTS AND MANAGEMENT PLAN (EMP) - OPERATION PHASE

8. POST-PROJECT MONITORING PLAN

Company manufactures lifesaving anti-cancer drugs which are made available

The hazardous waste generated is being stored in the premises in a secured

In the mean-time the Ministry of Environment, Forest and Climate change

MoEFCC seeking environmental clearance under the violation category in April

In the Minutes of 3rd meeting of Expert Appraisal Committee for projects

1.2 IDENTIFICATION OF PROJECT AND PROJECT PROPONENT

successfully set up a 100% EOU project in at Raichur Growth Center in 2008

Being proactive in approach, Shilpa Medicare continuously seeks out avenues

ave received key regulatory approvals for its

At Shilpa Medicare, every effort is made to create an environment of openness

This unit has expertise in:

1.3.1 NATURE, SIZE AND LOCATION OF THE PROJECT

M/s. Shilpa Medicare Limited Unit I is an Active Pharmaceutical Ingredients

1.3.2 IMPORTANCE OF THE PROJECT TO THE COUNTRY, REGION

Presently over 80 percent of the antiretroviral drugs used globally to combat

Indian pharmaceutical sector is estimated to account for 3.1 3.6 percent of

$16.8 billion in 2016-17 and are

Indian companies received 304 Abbreviated New Drug Application (ANDA)

Some of the initiatives taken by the government to promote the

The Government of India is planning to set up an electronic platform to

The Indian pharmaceutical market size is expected to grow to US $100 billion

expected to grow by 9 percent year-on-year through fiscal 2020.

Reference source: Indian Brand Equity Foundation

Karnataka is one of the fastest growing states in terms of the pharmaceutical

1.4 SCOPE OF STUDY DETAILS OF REGULATORY SCOPING CARRIED OUT (AS

The purpose of EIA/EMP is to critically analyse the environmental impacts due

1.4.1 SCOPE OF STUDY

1.4.2 DETAILS OF THE STUDY

The scope of study broadly includes:

To identify critical environmental attributes required to be monitored

1.4.3 METHODOLOGY OF THE STUDY

Reconnaissance was conducted by the monitoring team and concerned officials

1.4.4 STUDY AREA DETAILS

1.4.5 TERMS OF REFERENCE (TOR)

have been considered for preparation of Environment Impact Assessment

All these are tabulated below

Table 1.1: Terms of Reference (TOR)