English Annual Report 2020-21-0

Annual Report
2020-21
Government of India
Ministry of Chemicals & Fertilizers
Department of Pharmaceuticals
Annual Report 2020-21
CONTENTS
1. An Overview
2. Functions and Organizational Set-Up
3. Programmatic Intervention
4. Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)
5. National Institutes of Pharmaceutical Education & Research

(NIPERs)
6. Public Sector Undertakings (PSUs)
7. National Pharmaceutical Pricing Authority (NPPA)
8. Implementation of Rajbhasha
9. Citizen Centric Governance
10. Information and Communication Technology
11. Annexures
BRIEF CONTENTS
1. AN OVERVIEW 1
1.1 Pharmaceutical Industry

1.2 Medical Devices
1.3 Indian Medical Device Market
1.4 India Pharma 2020 & India Medical Device 2020
1.5 Foreign Direct Investment (FDI)
1.6 Joint Working Group (JWG) / High Technology Cooperation Group (HTCG)
1.7 International Participations
1.8 National Pharmaceutical Pricing Policy 2012
1.9 COVID-19 Response
2. FUNCTIONS AND ORGANIZATIONAL SET-UP 19
2.1 Mandate of Department of Pharmaceuticals

2.2 Vision
2.3 Mission
2.4 Organizational set-up.
2.5 Attached Office
2.6 Registered Society
2.7 Autonomous Institutes
2.8 Public Sector Undertakings
3. PROGRAMMATIC INTERVENTIONS 27
3.1 Scheme for Development of Pharmaceutical Industry

3.2 Medical Device Schemes
3.3 Pharma Bureau
4. PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP) 35

4.1 Background of the Scheme
4.2 Progress made during the last five financial years
4.3 Achievements during last one year
4.4 Jan Aushadhi Diwas Celebration

5. NATIONAL INSTITUTES OF PHARMACEUTICAL EDUCATION & RESEARCH

(NIPERs) 43

5.1 Background
5.2 NIPER Mohali
5.3 NIPER Hyderabad
5.4 NIPER Ahmedabad
5.5 NIPER Guwahati
5.6 NIPER Raebareli
5.7 NIPER Kolkata
5.8 NIPER Hajipur
6. PUBLIC SECTOR UNDERTAKINGS (PSUs) 81
6.1 Central Public Sector Undertakings

6.2 Indian Drugs & Pharmaceuticals Ltd. (IDPL)
6.3 Hindustan Antibiotics Ltd. (HAL)
6.4 Karnataka Antibiotics & Pharmaceuticals Ltd. (KAPL)
6.5 Bengal Chemicals & Pharmaceuticals Ltd. (BCPL)
6.6 Rajasthan Drugs & Pharmaceuticals Ltd. (RDPL)
7. NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA) 107
7.1 National Pharmaceutical Pricing Authority (NPPA)

7.2 Pricing
7.3 Initiatives Taken to Address the Exigencies of Covid-19
7.4 Monitoring & Enforcement
7.5 E-Initiatives
7.6 Recovery of Overcharged Amount
7.7 Rajbhasha Implementation
7.8 Vigilance Awareness Week
7.9 Constitution Day
8. IMPLEMENTATION OF RAJBHASHA 121
8.1 Use of Hindi in Official Work

8.2 Official Language Implementation Committee
8.3 Hindi Prayog Protsahan Pakhwara, 2020

8.4 Review of the Status of Use of Hindi In the Offices Under the Department
8.5 Conduct of Hindi Workshop
9. CITIZEN CENTRIC GOVERNANCE 125
9.1 Our Vision

9.2 Our Mission
9.3 Our Clients
9.4 Our Commitment
9.5 Our Services
9.6 Our Activities
9.7 Right to Information Act 2005
9.8 CPGRAMS
10. INFORMATION AND COMMUNICATION TECHNOLOGY 129
10.1 Local Area Network (LAN)

10.2 Website and Social Media
10.3 Video Conferencing
10.4 Virtual Private Network (VPN) Facility
10.5 Workflow Automation
10.6 E-Governance
11. ANNEXURES 135
Annexure - I [A] List of PSUs and Other Organizations

Annexure - I [B] Address and Name of Various Organizations &
PSUs
Annexure - I [C] List of Responsibility Centers and Subordinate
Organizations
Annexure – II Organizational Chart of NPPA
Annexure – III C&AG’s Audit Observations
CHAPTER -1
An Overview
1.1 Pharmaceutical Industry
1.2 Medical Devices

1.3 Indian Medical Device Market
1.4 India Pharma 2020 & India Medical Device 2020
1.5 Foreign Direct Investment (FDI)
1.6 Joint Working Group (JWG) / High Technology Cooperation

Group (HTCG)
1
2
CHAPTER 1
AN OVERVIEW
1.1 Pharmaceutical Industry:
The Indian pharmaceutical industry is the world’s 3rd largest by volume and 14th largest in terms
of value. Total Annual Turnover of Pharmaceuticals was Rs. 2,89,998 crore for the year 2019-2020. Total
pharmaceutical exports and import were to the tune of Rs. 1,46,260 crore and Rs. 42,943 crore respectively
in the year 2019-20.

Major Segments of Pharmaceutical Industry are Generic drugs, OTC Medicines and API/Bulk
Drugs, Vaccines, Contract Research & Manufacturing, Biosimilars & Biologics.
India has the second-highest number of US FDA approved plants outside the US. India is a global
leader in the supply of DPT, BCG, and Measles vaccines. India accounts for 60 percent of global vaccine
production, contributing 40 to 70 percent of the WHO demand for Diphtheria, Tetanus and Pertussis
(DPT) and Bacillus Calmette–Guérin (BCG) vaccines, and 90 percent of the WHO demand for the measles
vaccine.
India is the largest provider of generic drugs globally. Access to affordable HIV treatment from
India is one of the greatest success stories in medicine. India is one of the biggest suppliers of low-cost vac-
cines in the world. Because of the low price and high quality, Indian medicines are preferred worldwide,
thereby rightly making the country the “Pharmacy of the World”. Pharma sector currently contributes to
around 1.72% of the country’s GDP.
India’s pharmaceutical sector forms a major component of the country’s foreign trade, with attractive
avenues and opportunities for investors. India supplies affordable and low-cost generic drugs to millions
of people across the globe and operates a significant number of United States Food and Drug Administra-
tion (USFDA) and World Health Organization (WHO) Good Manufacturing Practices (GMP)-compli-
ant plants. India has occupied a premier position among pharmaceutical manufacturing countries of the
world.
India is 3rd largest market for APIs globally, 8% share in Global API Industry, 500+ different APIs
are manufactured in India and it contributes 57% of APIs to prequalified list of the WHO.
3
Graph-1A
(Trade in Pharmaceuticals)
(Source: DGCIS Kolkata)

Graph-1B
(Region wise India’s Pharma exports FY 2019-20)

(Source: Pharmaceuticals Export Promotion Council of India)

4
1.2 Medical Devices
The Medical Device industry is highly capital intensive with a long gestation period and requires
development/induction of new technologies. The major manufacturing of medical devices in the country
is currently happening with respect to disposables such as catheter, perfusion sets, extension lines, can-
nula, feeding tubes, needles, syringes and implants such as cardiac stents, drug eluting stents, intra-ocular
lenses and orthopaedic implants. Medical devices ranges from simple, low-risk devices such as medical
thermometers, disposable gloves etc. to complex, high-risk devices like pacemakers, Implants, Ventilator,
CT Scan and MRI etc.
Basic Medical Devices
High-end Medical Devices
5
1.3 Indian
Indian MedicalDevice
Medical DeviceMarket
Market:
Medical
Medical device
device industry
industry in in Indiahas
India hasthe
thepotential
potentialtotoreach
reach$50
$50bnbnbyby2025.
2025.India
Indiaisisthe
the4th largest
4th largest
Asian medical devicesAsian
market medical devicesChina,
after Japan, market after
and Japan,
South China,
Korea and and
alsoSouth
ranks Korea
amongand thealso
top 20 global
ranksmarkets
medical device among the top world.
in the 20 global medicalIndia
Currently, deviceis markets
exportingin ventilators,
the world. Currently, India is kits, sani-
PPEs, diagnostic
tizers and exporting ventilators,
surgical gloves (2/3 ,ply)
PPEs, diagnostic
in the ongoing kits, sanitizers pandemic.
COVID-19 and surgicalExports
gloves (2/3
and ply) in theof Medical
Imports
ongoing
Devices over COVID-19
past two 19 pandemic.
financial years are asExports
under:and Imports of Medical Devices over past two
financial years are as under:

Table-1A (Values in USD million)
(India’s Medical Devices Trade) (Values in USD million)
Source: EEPC
Imports Exports
2018-19 2019-20 2018-19 2019-20
2019
5700.44 5845.41 2138.14 2292.87
Source: Engineering Export Promotion Council of India (EEPC)
India's Medical Graph-1C

Devices Trade
(India’s Medical Devices Trade)
5700.44 5845.41
2138.14 2292.6
-3562.3 -3552.81
3552.81
Table-1B
Classification of HS codes at 8-digitw.r.t. exports (E)
(Classification of HS codes at 8-digit w.r.t. exports)
Exports- Exports %Share
Range E (Mn No. of Codes
USD) 2018-19 2019-20 2018-19 2019-20
1 E > 50 10
Imports 1066.02 Trade
Exports 1106.61 49.9
Balance 48.3
2 25 < E ≤ 50 18 576.64 653.45 27.0 28.5
3 10 < E ≤ 25 19 303.14 342.09 14.2 14.9
4 5 < E ≤ 10 14 86.58 97.83 4.0 4.3
5 1<E≤5 34 82.93 75.64 3.9 3.3
6 E≤1 52 22.83 16.98 1.1 0.7
TOTAL 147 2138.1 2292.6 100.0 100.0
Exports Data for Medical Devices

6 Range 1 - Exports to World(E) E > 50 mn Exports Values in US $ million
USD WORLD
S
HS Code Commodity Description 2018-19 2019-20
No.
2 25 < E ≤ 50 18 576.64 653.45 27.0 28.5
3 10 < E ≤ 25 19 303.14 342.09 14.2 14.9
4 5 < E ≤ 10 14 86.58 97.83 4.0 4.3
5 1<E≤5 34 82.93 75.64 3.9 3.3
6 E≤1 52 22.83 16.98 1.1 0.7 Annual Report 2020-21
TOTAL 147 2138.1 2292.6 100.0 100.0
Table-1C
(Export
Exports DataFor
Data Medical
for Medical Devices)
Devices
Range 1 - Exports to World(E) E > 50 mn Exports Values in US $ million

USD WORLD
S
HS Code Commodity Description 2018-19 2019-20
No.
CONTRACEPTIVE BASED ON
1 30066010 138.16 144.19
HORMONES
OTHR MADE UP
2 63079090 200.45 145.7
ARTCLSOTHRTHNCOTTION
3 90181990 Other- Electro - DiagnostcApprts 108.91 95.33
4 90183930 Cannulae 82.75 95.5
5 90183990 Others 174.6 189.23
6 90189019 Other Diagonostics Instruments 31.1 66.92
Other Surgical Instruments and
7 90189099 78.2 102.01
Appliances ( INCLVTRNRY)
Orthopaedic or fracture
8 90211000 38.51 52.86
appliances
9 90223000 X-ray tubes ** 125.91 133.52
10 90229090 Other 87.43 81.35
Sub Total 1066.02 1106.61
TOTAL 2138.14 2292.6
% share in total exports 49.86 48.27
Classification of HS codes at 8-digitw.r.t. Table-1D

imports
(Classification of HS codes at 8-digit w.r.t. imports)
Imports- Imports % Share

Range No. of Codes
I (Mn USD) 2018-19 2019-20 2018-19 2019-20
1 I > 75 24 4114 4166 72.2 71.3
2 50 < I ≤ 75 8 438 501 7.7 8.6
3 25 < I ≤ 50 17 590 622 10.3 10.6
4 10 < I ≤ 25 21 305 330 5.4 5.6
5 5 < I ≤ 10 17 124 117 2.2 2.0
6 1<I≤5 34 118 101 2.1 1.7
7 I≤1 26 11 10 0.2 0.2
TOTAL 147 5700.4 5845.4 100.0 100.0
Source: EEPC
1.4 India India

1.3 Pharma 2020 and
Pharma 2020India Medical
and India Device
Medical 20202020
Device
The 5th Edition
The of India
5th Edition Pharma
of India 20202020
Pharma andand
India Medical
India Device
Medical Device2020
2020was
wasorganized
organizedin collabo-
in collaboration with FICCI. It witnessed over 1200 delegates and visitors from all over India,
meeting with buyers to provide an exclusive platform for various stakeholders to present their
offerings through exhibition, international conference; B-2-B meetings; MSME vendor
development program and the DPIIT investment lounge. DoP also announced the launch of 7
Pharma Bureau, a Body of Technical Experts, which would act as a single-point interface for
the pharmaceutical and medical device industry for issues relating to the Government of India
and various State Governments. DoP had also conferred “5th India Pharma and India Medical
ration with FICCI. It witnessed over 1200 delegates and visitors from all over India, meeting with buyers
to provide an exclusive platform for various stakeholders to present their offerings through exhibition, in-
ternational conference; B-2-B meetings; MSME vendor development program and the DPIIT investment
lounge. DoP also announced the launch of Pharma Bureau, a Body of Technical Experts, which would
act as a single-point interface for the pharmaceutical and medical device industry for issues relating to
the Government of India and various State Governments. DoP had also conferred “5th India Pharma and
India Medical Device Awards” for 6 categories. The three-day event including exhibition witnessed partic-
ipation of over 200 exhibitors showcasing their products to delegates and business visitors from across the
country.
The theme of this year’s pharma conference was “Meeting Challenges for Affordable and Quality
Healthcare”. As part of Conference, various Plenary Sessions were organized on Ease of Doing Business;
Ecosystem for R&D, Innovation & Start Ups in the Pharma Sector; State Drug Regulators Meet with Phar-
maceutical & Medical device industry; Affordability, Accessibility and Availability of Quality Drugs &
Medical Devices; Emerging trends in Healthcare. State drug regulators from 15 states participated in the
regulators meet. FICCI-EY Report “Reshaping India into a Life Sciences Innovation Hub” was also released
during the Event. The Pharma CEO Round Table was chaired by Hon’ble Union Minister. Over 50 CEOs
had detailed discussions on Pharma Sectoral Issues relating to API Industry Revival; Drug Pricing; Ease of
doing Business; Regulatory including Clinical Trials, recent Export Ban by DGFT due to COVID-19 and
other forward-looking suggestions by the industry.
Medical Devices Conference was organized with focused theme “Promoting Affordable Quality
Medical Devices for Universal Healthcare” witnessing deliberations on various key sessions such as Role of
Regulations in Med-tech, Innovate to Make in India for the world; Affordability, Accessibility and Avail-
ability of Quality Drugs & Medical Devices; Emerging trends in Healthcare. The key highlight of this
Event, CEOs Round Table was chaired by Hon’ble Minister and attended by over 40 CEOs and key issues
like Medical Devices Regulations, Standards, Role of Innovations were discussed during the Conference.
the world; Affordability, Accessibility and Availability of Quality Drugs & Medical Devices;
This year for thetrends
Emerging first time, a start-up Boot
in Healthcare. Camp
The key was organized
highlight to promote
of this Event, CEOsnew innovations
Round in the sector
Table was
and support
chaired their growth,Minister
by Hon’ble in whichand
12 innovators
attended bypresented their innovations
over 40 CEOs in the
and key issues likepresence
Medicalof industry
members and Regulations,
Devices investors. Standards, Role of Innovations were discussed during the Conference.
This year for the first time, a start-up Boot Camp was organized to promote new innovations
1.4.1 in5th
the India
sector Pharma
and support
andtheir growth,
Medical in which
Device 12 innovators presented their innovations in
Awards
the presence of industry members and investors.
5th India
th
Pharma and Medical Device Awards were conferred on 5th March 2020 by Shri D.V. Sad-
1.3.1 5 India
ananda Gowda, Hon’ble Pharma
Ministerand(Chemicals
Medical Device Awards to celebrate Innovation and Excellence in the
& Fertilizers)
Pharma and Med TechPharma
5th India Sectors.and
ListMedical
of Winners of 5th
Device Indiawere
Awards Pharma and India
conferred on 5Medical
th Device
March 2020 byAwards are
as under:-
ShriD.V. SadanandaGowda, Hon’ble Minister (Chemicals & Fertilizers) to celebrate
Innovation and Excellence in the Pharma andTable-1EMed Tech Sectors. List of Winners of 5th India
Pharma and India Medical Device Awards (Winner-awardees
are as under:-of 2020)
Category No. Category Name Name of Awardee

1 India Pharma Leader Award Lupin Limited
2 India Pharma Bulk Drug Company of the SMSLifesciences India Ltd.
Year Award
3 India Pharma Innovation of Year Award Laurus Labs Limited
4 India Pharma Corporate Social
Responsibility (CSR) Programme of the Sun Pharmaceutical Industries Ltd.
8
Year Award
5 India Medical Device Company of Year Innovation Imaging Technologies Pv
Award Ltd
Category No. Category Name Name of Awardee
1 India Pharma Leader Award Lupin Limited
2 India Pharma Bulk Drug Company of the Annual
SMSLifesciences India Ltd. Report 2020-21
Year Award
3 India Pharma Innovation of Year Award Laurus Labs Limited
4 India Pharma Corporate Social
Responsibility (CSR) Programme of the Sun Pharmaceutical Industries Ltd.
Year Award
5 India Medical Device Company of Year Innovation Imaging Technologies Pv
Award Ltd
6 India Pharma Swachhta Champion Award Karnataka Antibiotics and
Pharmaceuticals Limited
Hon’ble Minister (C&F), Hon’ble MOS (C&F), Secretary (Pharma) and other dignitaries at the
India Pharma 2020 & India Medical Device 2020 held on 5-7 March 2020 at Gandhinagar, Gujarat
Award distribution at the India Pharma 2020 & India Medical Device 2020
9
Lighting the lanp ceremony at the India Pharma 2020 & India Medical Device 2020
Press conference at the India Pharma 2020 & India Medical Device 2020
1.5 Foreign Direct Investment (FDI) in Pharmaceutical Sector
Pharmaceutical is one of the top ten attractive sectors for foreign investment In India. 100% foreign
investment is allowed under automatic route in Medical Devices. Foreign investments in pharmaceutical
greenfield projects are allowed upto 100% under the automatic route and for brownfield pharmaceutical
projects, foreign investment beyond 74% to upto 100% Government approval is required.
After abolition of Foreign Investment Promotion Board (FIPB) in May 2017, the Department of
Pharmaceuticals has been assigned the role to consider the foreign investment proposals under the Gov-
10
Pharmaceutical is one of the top ten attractive sectors for foreign investment In India.
100% foreign investment is allowed under automatic route in Medical Devices. Foreign
investments in pharmaceutical greenfield projects are allowed upto 100% under the automatic
route and for brownfield pharmaceutical projects, foreign investment beyond 74% to upto
100% Government approval is required.
After abolition of Foreign Investment Promotion Board (FIPB) in May 2017, the
Department of Pharmaceuticals has been assigned the role to consider the foreign investment
ernment proposals under
approval the Government
route. Apart from approval route.Department
this, the Apart from this, the Department
considers all FDIconsiders
proposals of pharmaceutical
all FDI proposals of pharmaceutical sector arising out of Press Note 3
sector arising out of Press Note 3 of 2020 dated 17.04.2020 wherein investors/ultimate of 2020 dated beneficiaries in the
17.04.2020 wherein investors/ultimate beneficiaries in the proposals are from the land
proposals are bordering
sharing from thecountries
land sharing
of India.bordering countries of India.
The Department of ofPharmaceuticals
The Department has
Pharmaceuticals has approved
approved 17proposals
17 FDI FDI proposals
worth Rs.worth
1,512 Rs. 1,512 crore under
the brownfield pharmaceutical projects in the year 2020-21 (upto
crore under the brownfield pharmaceutical projects in the year 2020December
2020-21 2020).
21 (upto December
2020).
Graph-1D
(FDI inflows in Pharmaceutical sector, which includes both pharmaceuticals and medical devices)
FDI inflows in Pharmaceutical Sector
(₹ in crore)
5,846
6,000
5,000
2,950 3,039
4,000
3,000
2,000
1,000
-
2018-19
2018 2019-20 2020-21
21 (upto September
2020)
Source:
FDI inflows data includes Compiled
for both from DPIIT’s
pharmaceuticals website
and medical devices
Source: Compiled from DPIIT’s website
1.6 Joint Working Group (JWG)/High Technology Cooperation Group (HTCG)
1.5 Joint Working Group (JWG)/High Technology Cooperation Group (HTCG)
Department of Pharmaceuticals has the following Joint Working Groups/High Technology Coop
Department of Pharmaceuticals has the following Joint Working Groups/High
eration Technology
Group:- Cooperation Group:--
1. EU-India Joint Working Group on Pharmaceuticals, Biotechnology and Medical Devices
2. India-Tunisia Joint Working Group on Drugs and Pharmaceuticals
3. India-Ukraine Joint Working Group on Pharmaceuticals and Healthcare
4. India-Belarus Joint Working Group on Pharmaceuticals
5. India-Philippines Technical Working Group (TWG) for considering “Pharmazone” and
“Registration and other Issues related to Pharmaceuticals”
6. India-Algeria Joint Working Group (JWG) on Pharmaceuticals
7. India-Egypt Joint Study Group (JSG) on Pharmaceuticals and Health
8. India-Uzbekistan Joint Working Group on Pharmaceuticals
9. India-Russia Joint Working Group on Pharmaceuticals to readdress the issues on India
Pharma Industries
10. India-China Joint Working Group on Pharmaceuticals
11
10th meeting of EU-India Joint Working Group on Pharmaceuticals, Biotechnology and Medical
Devices was held on 15th October 2020 at New Delhi through Video Conferencing under the Co-Chair-
manship of Shri Navdeep Rinwa, Joint Secretary, Department of Pharmaceuticals.
The Department of Pharmaceuticals notified the National Pharmaceutical Pricing Policy-2012

(NPPP-2012) on 07.12.2012 with the objective to put in place a regulatory framework for pricing of drugs
to ensure availability of required medicines - “essential medicines” - at reasonable prices, while providing
sufficient opportunity for innovation and competition to support the growth of industry, thereby meeting
the goals of employment and shared economic well-being for all. The Government is now contemplating
to introduce a new National Pharmaceutical Policy with the following objectives:
- Making essential drugs accessible at affordable prices to the common masses;
- Providing a longer-term stable policy environment for the pharmaceutical sector;
- Making India sufficiently self-reliant in end-to-end indigenous drug manufacturing;
- Ensuring world class quality of drugs for domestic consumption & exports;
- Creating an environment for R & D to produce innovator drugs;
- Ensuring growth and development of the Indian Pharma Industry.
The Department of Pharmaceuticals actively led the fight against the COVID-19 pandemic, not only
nationally but also internationally. Since the onset of the COVID-19 crisis and the resultant lockdown,
DoP worked on a mission mode basis to address the challenges arising out of the same. The challenges in-
cluded co-ordination with various Ministries/Departments and State Governments to resolve the issues as-
sociated with availability of Drugs for COVID-19 and other Essential Drugs including HCQ, Paracetamol,
Vaccines, TB, Insulin and cardiac drugs, issues relating to sub optimal production, logistics, shortages
and exports of pharmaceuticals and medical devices. There was continuous and round-the-clock activity
including work on weekends & Gazette holidays. DoP had to face issues with a range of activities and mul-
tifaceted challenges which the Department had never dealt earlier. The details are outlined below:
A. Assessing the Availability and Ensuring Adequate Stock of Essential Items.

• India, one of the largest manufacturers of drug formulations/medicines is heavily dependent on
China for import of critical bulk drugs. India imports around 70% of total imports of bulk drugs
from China. The outbreak of the deadly Novel Corona Virus (COVID-19) in China in December
2019 brought out the risk of disruption of supply chain which could jeopardize the Indian pharma
sector and could have adverse impact on the drug security in India. DoP regularly monitored the
availability of medicines to avoid any potential shortage in the country.
• Immediately after the first case of the COVID-19 pandemic in India was reported on 30 Janu-
ary 2020, DoP assessed the situation and fast-tracked actions as a measure of public healt pared-
ness.The Department held a series of meetings on 31st January; 2nd, 3rd and 6th February 2020
with all the stakeholders to assess the domestic availability of (i) Drug Lopinavir+Ritionavir fixed
12
drug combination which was included in the initial protocol of ICMR for treating the COVID-19
disease (ii) Active Pharmaceutical Ingredients (API), intermediates and Key Starting Materials
(KSM) for which India is critically dependent on China.
• DoP assisted Ministry of Health and Family Welfare and Ministry of External Affairs to procure
various medical supplies required in India and other countries.
• Regular meetings were held under the chairmanship of Secretary (Pharmaceuticals) to review the
status of availability of ventilators, thermometers, PCR machines, diagnostics kits and related lo-
gistics issues and to explore manufacturing of ventilators by automobile companies.
• DoP conducted series of meetings through Video conferencing with the officers/officials of Central
Government Ministries/Departments/Organisations, DCGI/State Drug Controers/ Pharma and
Medical Device Associations, Pharma/ Medical Device Manufacturers and Air Cargo Units for
ensuring availability/stock of medicines and medical devices (PPE kit, Gloves, Masks, Hand Sani-
tizers, Face Shield, other essential medicines and logistics issues.
• An inter-ministerial Committee was constituted by DoP on 06.02.2020 under the chairmanship
of Dr. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard Control Organization (CD-
SCO) to address the issue of drug security in the country. The committee submitted its report on
27.02.2020. The Committee reviewed the situation regarding impact on import of APIs and KSMs
due to outbreak of Corona virus and identified four core issues viz. (1) Disruption of manufactur-
ing activity in China due to holidays (2) Logistics issues (3) Restriction on movement of personnel
and (4) Availability of raw materials for manufacturing of APIs/KSMs. The committee observed
that there could be major impact on import of certain APIs and KSMs which are manufactured in
Hubei province in China. Based on the recommendations of the Committee:
• DoP issued necessary instructions to National Pharmaceutical Pricing Authority (NPPA),
Drugs Controller General of India (DCGI) and State Governments to ensure adequate supply of
APIs and formulations at affordable prices in the market and to prevent black-marketing, illegal
hoarding, creating artificial shortages in the country.
• DoP made recommendations to DGFT to restrict exports of 13 APIs and formulations
made using these APIs. (On 03.03.2020 DGFT notified restriction on exports of 13 APIs and their
corresponding formulations as a measure against the implications of COVID-19 outbreak in Chi-
na.). Subsequently, after a short period the export restrictions were removed when the domestic
availability became adequate.
B. Measures to ensure domestic manufacturing of critical bulk drugs.
The outbreak of the COVID-19 in China brought out the risk of disruption of supply chain of crit-
ical bulk drugs for the Indian pharmaceutical sector, highlighting the need for India to attain a sufficient
degree of self-reliance in bulk drugs. In this regard, a Technical Committee was constituted by DoP on
02.03.2020 under the chairmanship of Dr. Eswara Reddy, Joint Drugs Controller, Central Drugs Standard
Control Organization (CDSCO) to make recommendations for the revival of fermentation industry, new
technologies for manufacturing of APIs including its backward integration, costing of the projects and
identification of strategic business models. On the basis of the recommendations of the committee, the
Department prepared the following two schemes for promoting domestic manufacturing of critical KSMs/
Drug Intermediates and APIs by attracting investments in the sector to ensure their sustainable domestic
supply and thereby reduce India’s import dependence on other countries for critical KSMs/Drug Interme-
diates and APIs:
13
(a) Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of criti-
cal Key Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients
(APIs) In India: Under the scheme, financial incentive is proposed for manufacturing of 41 eligible prod-
ucts under the four Target Segments viz.:
i. Fermentation based KSMs/Drug Intermediates.
ii. Fermentation based niche KSMs/Drug Intermediates /APIs.
iii. Key Chemical Synthesis based KSMs/Drug Intermediates.
iv. Other Chemical Synthesis based KSMs/Drug Intermediates/APIs.
Incentives for incremental sales will be given to selected participants for a period of 6 years. The
total outlay of the scheme is Rs. 6,940 crore and the scheme is under implementation after receiving good
response from the participants.
(b) Scheme for Promotion of Bulk Drug Parks: To provide grant-in-aid to 3 Bulk Drug Parks for cre-
ation of Common Infrastructure Facilities (CIF) with a maximum limit of Rs.1000 crore per park or 70%
of the project cost of CIF, whichever is less. In case of North Eastern States and Hilly States (Himachal
Pradesh, Uttarakhand, Union Territory of Jammu & Kashmir and Union Territory of Ladakh) financial
assistance would be 90% of the project cost. The total size of the Scheme is Rs. 3000 crore and the tenure of
the Scheme will be five years (2020-21 to 2024-25).

The detailed guidelines of the above-mentioned schemes are available on the website (http://phar-
maceuticals.gov.in) of the Department of Pharmaceuticals.
C. Support to Industry during lockdown
The lockdown across the country in the wake of the COVID 19 pandemic had resulted in supply dis-
ruptions even though pharma and medical devices industry was exempted by the government from the
lockdown as they are essential services. The major challenge was with respect to transportation, especially
inter-state movement of medicines and medical products and movement of labourers. In addition, there
were other challenges in terms of non-availability of ancillary services such as availability of Packing Ma-
terials, courier services etc. The issues are given in detail below:
(a) Challenges in transportation.
Connectivity between company to warehouse and warehouse to stockists was disrupted. The vari-
ous problems faced included:
i. Non availability of trucks due to unwillingness/ reluctance of transporters.

ii. Shortage of willing truck drivers as they were facing issues of manhandling by police, unavailability
of food and diesel on the way.
iii. Principally, unorganized labour is employed for loading/unloading and operating trucks. Most of
this labour force had returned to their hometowns as they had assurance of being paid even when
not working.
iv. Trucks were frequently held up at borders of states/districts due to restrictions imposed by local ad-
ministration. Lock down strictness/understanding was not uniform across the country. Strictness
14
also varied according to the status of new Covid-19 cases found in a particular area.
v. Secondary transportation from CFA (drug forwarding agencies) to stockists (medical stores) was
also badly hampered.
vi. Air transport – severe reduction of cargo movement from key international hubs.
• Stopping of passenger flights also impacted movement of cargo that used to come in on these flights.
• Dedicated cargo freighters are quite few.
• Essential and life-saving drugs are getting piled-up at hub locations, but movement to India is slow.
(b) Reduced availability of workers.

i. Movement of labour to-from plants was restricted. Some of these workers travel across state bound-
aries and were being stopped at borders.
ii. Contractual workers deployed in packing, material movement, loading & unloading were mainly
from states like UP, Bihar & Odisha. Many of whom had left for their home states. Apart from fac-
tors like fear of contracting disease, pressure from the family not to go to work, the announcement
by Government of India that they would get their wages/salary irrespective of the fact that they
worked or not was also one of the reasons of their not reporting for work. The Pharma workers
needed to be exhorted/ motivated to continue coming to work. There was a need to make them
realize that similar to medical professionals their role is also very important and the country was
looking towards them in this challenging situation.
iii. Housing societies in which the employees of pharma units resided, pressurized them not to go to
work due to their fear that their daily movement could bring infection in their society.
(c) Dependence on mandatory items which were generally not considered essential by states/local
administration but were actually essential for manufacturing of medicines.
Ancillary suppliers of inputs including packaging material, excipients (required for tablets and cap-
sules manufacturing), utility consumables like briquettes/gases (required to run boilers) and spare
parts were not able to operate/supply as they were not recognized by Police/local administration to
be essential commodities and services.
(d) Restriction in Inter-state movement of workers in plants situated at border of two states.
Inter-state and inter-district daily movement of workers was not being allowed from Vapi (Gujarat)
to plants in Daman & Silvasa. Major Pharma companies such as Sun Pharma (3 plants), IPCA, Al-
chem, USV, Macleod etc. have plants there. Apart from these plants, there are more than 30 plants
of Small & Medium size Companies. Similarly, in Baddi & Paonta Sahib (Himachal Pradesh), a
large number of Pharma units were facing this problem as many of their workers lived in Punjab &
Haryana. Apart from the above-mentioned examples there were other such instances e.g. workforce
in Sarigam plant of Mylan company in Gujarat were not allowed from UT of Silvasa & Daman.
(e) Disruption in operations of Courier services.
Operation of courier services is a very important factor in the supply chain of medicines. Pharma
Industry has informed that the courier services were largely not operational. In some metro cities,
15
the courier services had started operating, however it remained non-operational for most Tier1
and Tier2 cities. The dispatches from Carrying & Forwarding agents to stockiest had become a big
challenge.
D. Actions initiated in the Department to address Logistics related issues
• Regular meetings were held with State Drug Controllers, Drug and medical devices manufactur-
er Associations and Chemists and Pharmacist Associations and the situations were assessed and
resolutions given on real time basis. Cases brought out by Industry Associations & general public
continuously were taken up with the States/UTs over phone calls and e-mails.
• Various WhatsApp groups which formed to tackle issues arising out of lockdown e.g group of as-
sociation of pharmaceutical and medical devices manufacturers, group of distributors of AIOCD,
group of Drug Controller General of India with the state drug controllers, group of automobile
companies interested in making ventilators, group of glove manufacturers, group of masks, overall
IMC group on exports of medicines, group of officers from railways and postal services etc. Many
issues brought to the knowledge of department through these WhatsApp groups were flagged to
concerned states/ departments.
• A Control Room (with Phone No. 011-23389840 and email: [email protected]) was set up
on 28.03.2020 in Department of Pharmaceuticals for handling transport and logistics services re-
lated issues of industry engaged in providing essential services following the lockdown across the
country. A total of 277 cases were handled from 29.03.2020 to 20.05.2020. The cases received re-
lated to the following issues viz. Transportation of goods/medicines/ medical equipments; Cargo/
custom related issues; Regulatory issues; Pharma companies HRD matters like shortage of workers,
issue of e-pass to employees/workers etc.; availability of Essential medicines; Inter-state transport
issues; Medical equipment manufacturing and Manufacturing restricted /barred in some states;
permission to function printing and packaging units required by drug manufacturers. The issues
raised were addressed and resolved; required information provided; some issues were forwarded to
concerned authorities for redressal, as the case may be.
• DoP requested Ministry of Home Affairs (MHA) to issue necessary instructions to State Author-
ities for effective resolution of issues faced in production, distribution and management of criti-
cal, lifesaving essential medicines and medical devices including non-operational courier services
and ancillary suppliers of inputs including packaging materials, excipients, utility consumables and
spare parts not recognized as essential services in the wake of lockdown for COVID-19. MHA
was further requested to take suitable effective measures to prevent any shortage of medicines and
medical devices in future and DoP made certain suggestions for tackling the situation including
ferrying back contractual labourers from their native places; treating commercial driving license
as a pass during the lock down; sensitizing local authorities of the need to restore production of
medicines and medical devices, restoration of courier services etc.
• DoP was in constant touch with Key Ministries/Depts. including Civil Aviation, Posts, Air Force,
Railways, Customs for effective resolution of transport and logistics services related issues in ensur-
ing availability of medicines across the country.
16
• DoP conducted various meeting through video conferencing with representatives of major pharma
and medical devices associations to discuss latest issues/ challenges faced by them following lock-
down for COVID-19, to obtain the status update from the industry regarding their working and to
take suggestions from them on tackling the situation.
• DoP requested all Chief Secretaries of States/UTs to ensure that all district authorities and field
agencies are informed that no separate passes are required for through traffic of trucks and goods
carriers including empty trucks etc., so that there is no ambiguity at the ground level and movement
of through traffic of trucks and goods carriers including empty trucks is allowed without hindrance.
• Further, DoP along with NPPA and CDSCO regularly monitored the working status of pharma-
ceutical and medical device manufacturing units and assess the situation, pre COVID and post
COVID.
E. Letters written to Ministries/Departments/States etc. by Secretary DoP
Secretary wrote to all the Chief Secretaries of States and UTs on 23.03.2020 to direct the authorities
concerned to make necessary arrangements for issuance of IDs/Entry Pass so as to facilitate movement of
the workers engaged in these essential activities.
On 02.04.2020 Secretary also wrote to Secretary, Ministry of Home Affairs to issue necessary in-
structions to State authorities in order to ensure availability of life saving essential medicines during this
critical time. Further, Secretary on 03.04.2020 wrote to Secretary, Ministry of Home Affairs requesting
him for issuing appropriate instructions for urgent intervention of the State authorities in the issues related
to the supplies of ancillary goods and operation of courier services.
On 09.04.2020, Secretary wrote to Secretary, Ministry of Home Affairs suggesting measures to
prevent shortage of medicines in the domestic market, which included allowing pharma and medical
device industry to ferry back their contractual labourers from their native places, allowing drivers in pos-
session with driving license of a commercial vehicle to move with or without their vehicle, addressing the
apprehensions of drivers regarding ill treatment by the police and to motivate/incentivize (Insurance etc.)
them, sensitizing State and District Authorities to the need of bringing back the production of pharma and
medical device industry to its pre-lockdown level and need to make courier services fully functional for
ensuring movement of medicines and medical devices.
On 24.04.2020, Secretary wrote to Secretary, Ministry of Home Affairs for issuing instructions to
State authorities to take effective measures for enabling pharma units to work in full capacity and raise the
production to reach the pre-lockdown level and avoid future shortages of medicines and medical devices
in the country. List of ancillary service relating to pharma and medical device industry was also provided
for circulation to State Authorities for their clarity.
The interventions by the Department resulted in timely issuance of instructions/advisories to State/
local authorities ensuring that the production process in the pharmaceutical industry is not hampered and
supply of essential medicines in the country is not adversely affected. As per the information provided by
CDSCO, of the 5891 manufacturing units operational in the country in the pre Covid-19 situation only
3222 manufacturing units (55.1%) were operational with 39.5% employees working and average daily pro-
duction of 34.4% during mid-April 2020. However, the situation improved after that and as on 01.07.2020,
4797 manufacturing units (81.4%) were operational with 53.49% employees working and having an aver-
age daily production of 50.00%.
17
18
CHAPTER -2
Functions and Organizational Set-Up
2.2 Vision

2.3 Mission

2.4 Organizational set-up

2.5 Attached Office



19
20
CHAPTER 2
FUNCTIONS AND ORGANISATIONAL SET-UP
The Department of Pharmaceuticals was created on the 1st July, 2008 under the Ministry of Chemi-
cals & Fertilizers with the objective to give greater focus and thrust on the development of pharmaceuticals
sector in the country and to regulate various complex issues related to pricing and availability of medicines
at affordable prices, research & development, protection of intellectual property rights and international
commitments related to pharmaceuticals sector which require coordination with other Ministries.
The following works have been allocated to the Department of Pharmaceuticals:
1. Drugs and Pharmaceuticals, excluding those specifically allotted to other Departments.

2. Medical Devices- Industry issues relating to promotion, production and manufacture; excluding
those specifically allotted to other Departments.
3. Promotion and co-ordination of basic, applied and other research in areas related to the pharma-
ceuticals sector.
4. Development of infrastructure, manpower and skills for the pharmaceuticals sector and manage-
ment of related information.
5. Education and training including high end research and grant of fellowships in India and abroad,
exchange of information and technical guidance on all matters relating to pharmaceutical sector.
6. Promotion of public- private-partnership in pharmaceutical related areas.
7. International Co-operation in pharmaceuticals research, including work related to international
conferences in related areas in India and abroad.
8. Inter-sectorial coordination including coordination between organizations and institutes under the
Central and State Governments in areas related to the subjects entrusted to the Department.
9. Technical support for dealing with national hazards in pharmaceutical sector.
10. All matters relating to National Pharmaceutical Pricing Authority including related functions of
price control/monitoring.
11. All matters relating to National Institutes of Pharmaceuticals Education and Research.
12. Planning, development and control of, and assistance to all, industries deal with by the Depart-
ment.
13. Bengal Chemicals and Pharmaceuticals Limited.
14. Hindustan Antibiotics Limited.
15. Indian Drugs and Pharmaceuticals Limited.
16. Karnataka Antibiotics and Pharmaceuticals Limited.
17. Rajasthan Drugs and Pharmaceuticals Limited.
The work of the Department has been mainly divided into Pricing, Policy, Scheme, NIPER, PSU &
Medical Device Divisions. National Pharmaceuticals Pricing Authority (NPPA) is an attached office of the
Department.
(Ms. S. Aparna is holding the charge of Secretary of the Department w.e.f. 01.10.2020)
21
2.2 Vision:
To promote Indian pharma as the global leader for quality medicines and to ensure availability,
accessibility and affordability of drugs and medical devices in the country.
2.3 Mission:
• Investment for Make in India in pharma sector,
• Make in India in critical APIs and medical devices,
• Industry expansion, skilling, R&D and innovation,
• Stable and effective price regulation and
• Generic medicines by expanding Janaushadhi scheme
2.4 Organizational Set-up:
The Department is headed by Secretary to the Government of India who is assisted by two Joint
Secretaries and one Economic Adviser.
The Department has as many as 13 Divisions to carry out the various mandated functions and re-
sponsibilities. The summary of the various Divisions is given below:
(a) Integrated Finance Division (IFD)- exercising expenditure control and management, ensuring
rationalization of expenditure and compliance of economy measures in accordance with the in-
structions of the Department of Expenditure including regular monitoring of expenditure through
monthly/ Quarterly reviews and submission of reports to the concerned. IFD also prepares the
budget of the Department in consultation with various Divisions and Department of Expenditure.
(b) Pricing Division- all matters relating to National Pharmaceutical Pricing Authority (NPPA) in-
cluding administrative/Establishment, budgetary matters, Fund release etc.; Review cases against
NPPA’s orders; Administration of DPEA funds; Administration of DPCO and all issues relating to
Pharmaceutical Pricing Policy & Pricing of drugs.
(c) Policy Division- all policy matters other than Pricing Policy; processing of Foreign Direct Invest-
ment (FDI) proposals; International Cooperation and any other matters related to WTO/ TRIPS /
Patents, etc. and trade agreements; Joint working groups of various countries, regional groups etc.;
Matters related to Ministry of Commerce; New PLI Scheme under Atmanirbhar Bharat and imple-
mentation of the scheme- “Promotion of Bulk Drug Parks”
(d) Public Sector Undertakings (PSUs)- all matters relating to five Central Public Sector Enterprises
(CPSEs) under the administrative control of the Department of Pharmaceuticals.
(e) NIPER Division - All matters related to National Institutes of Pharmaceutical Education & Re-
search (NIPERs) under the administrative control of the Department of Pharmaceuticals.
(f) Scheme Division- Internal coordination of the schemes, implementation of the scheme “Pradhan
Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)”; Implementation of “Pharmaceutical Promo-
tion and Development Scheme (PPDS)”; Implementation of PLI Scheme for Medical Devices,
Implementation of PLI Scheme for Bulk Drug, implementation of Pharmaceutical Technology
Upgradation Assistance Scheme(PTUAS), and implementation of the scheme assistance for phar-
maceuticals industry for common facilities.
(g) Medical Device Division- All matters related to Medical Devices & Medical Device Industry in-
cluding promotion, production & manufacture; all issues related to investment in the medical de-
vice sector and implementation of the scheme “Assistance to Medical Device Parks’’
22
(h) Rajbhasha- implementation of the various provisions of the Official Language Policy
of the Union of India including those of Official Languages Act, 1963 as well as Official
Languages (Use for Official Purposes of the Union) Rules, 1976 and orders issued there
under. Annual Report 2020-21
(i) Establishment & Administration Division- all matters related to Establishment,
Information Technology (IT), Cash and Administration, dealing with provision of day-
(h) Rajbhasha- implementation of the various provisions of the Official Language Policy of the Union
to-day articles needed for smooth running of office, housekeeping services, maintenance of
of India including those of Official Languages Act, 1963 as well as Official Languages (Use for Offi-
office equipments including air conditioners, photocopiers etc., printing of annual report,
cial Purposes of the Union) Rules, 1976 and orders issued there under.
(i) hospitality
Establishmentservices. Establishment
& Administration also deals
Division- with related
all matters all service-related matters
to Establishment, of
Information Tech-
officers/officials
nology (IT), Cash of Department of Pharmaceuticals.
and Administration, dealing with provision of day-to-day articles needed for
smooth
(j) runningDivision-
Parliament of office, all
housekeeping services,
matters related to themaintenance of office equipments
meetings of consultative committee,including air
conditioners,
Standing photocopiers
Committee, etc., printing
Parliamentary of annual
Assurances etc.report, hospitality
and also services.
centralized Establishment
handling of also
deals with all service-related matters of officers/officials of Department of Pharmaceuticals.
parliament questions like marking of questions, handling of questions once questions get
(j) Parliament
approved by Division- all matters
Joint Secretary/ related
Secretary, to the
taking meetings
approval of Consultative
of Minister Committee,
and submission of Standing
Committee, Parliamentary Assurances etc. and
necessary copies to Lok Sabha / Rajya Sabha/ PIB etc. also centralized handling of parliament questions
like marking of questions, handling of questions once questions get approved by Joint Secretary/
(h) Coordination
Secretary, Division-
taking approval all matters
of Minister andofsubmission
coordination related tocopies
of necessary intra to
andLokinter-
Sabha / Rajya
Department, RTI,
Sabha/ PIB etc. preparation of Annual report, submission of monthly summary report to
(h) cabinet etc.
Coordination Division- all matters of coordination related to intra and inter-Department, RTI,
preparation
(i) of Annual
Vigilance Division-report, submission
all matters relatedoftomonthly
vigilance,summary report
transparency andtoaccountability.
cabinet etc.
(i) Vigilance Division- all matters related to vigilance, transparency and accountability.
Employment of Scheduled Castes / Scheduled Tribes / Physically Handicapped:-
Employment of Scheduled
The status Castes / of
of employment Scheduled Tribes
Scheduled / Physically
Castes Handicapped:-
/ Scheduled Tribes / Other
The status of employment of Scheduled Castes/ Scheduled Tribes/ Other BackwardasClasses/
Backward Classes / Physically handicapped in the Department of Pharmaceuticals, on Phys-
ically handicapped in
31.12.2020 is as under:- the Department of Pharmaceuticals, as on 31.12.2020 is as under:-
Table-2A
Table-2A
(Employment position
(Employment position ofofSC/ST
SC/ST in
in the
the Department)
Department)
Group Total In position Scheduled Scheduled Other Back- Physically
No. of Castes Tribes ward Classes Handi-
Posts capped
A 27 21 5 2 1 -
B 48 23 3 3 7 -
C 18 16 5 - 5 -
Total 93 60 13 5 13 -
Officers in Group A include officers belonging to Central Secretariat Service besides

Officers in Group A include officers belonging to Central Secretariat Service besides officers on
officers on deputation from All India Services, Central Services and other Departments/
deputation from All India Services, Central Services and other Departments/ Undertakings. Appointment
Undertakings. Appointment to posts in Group B and C is mostly done based on nominations
to posts in Group B and C is mostly done based on nominations made by the Department of Personnel &
made by the Department of Personnel & Training.
Training.
(The organizational
(The chart
organizational of the
chart of Department is given
the Department at Annexure
is given 2A) 2A)
at Annexure
2.5 Attached Office

2.5 Attached Office
National Pharmaceutical
National PharmaceuticalPricing Authority
Pricing - an-attached
Authority an attachedoffice of the
office of Department and the func-
the Department
and the functions, inter-alia, include fixation and revision of prices of scheduled formulations
tions, inter-alia, include fixation and revision of prices of scheduled formulations under the Drugs (Prices
under
Control) the Drugs
Order (Prices
(DPCO), Control)
as well Order (DPCO),
as monitoring as well as monitoring
and enforcement of variousand enforcement
provisions of
of DPCO. NPPA
various provisions of DPCO. NPPA also provides inputs to Government on Pharmaceutical
also provides inputs to Government on Pharmaceutical policy and issues related to affordability, availabil-
ity andpolicy and issues related to affordability, availability and accessibility of medicines.
accessibility of medicines.

Bureau of Pharma PSUs of India (BPPI) - set up on 1st December, 2008 by the 23
Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, Government of India,
with the objective to have focused and empowered structure to implement the Jan Aushadhi
Scheme launched by Department of Pharmaceuticals
Bureau of Pharma PSUs of India (BPPI) - set up on 1st December, 2008 by the Department of Phar-
maceuticals, Ministry of Chemicals & Fertilizers, Government of India, with the objective to have focused
and empowered structure to implement the Jan Aushadhi Scheme launched by Department of Pharmaceu-
ticals
National Institute of Pharmaceutical Education & Research (NIPER)- NIPER at SAS Nagar (Moha-
li) was set up as a registered society under the Societies Registration Act 1860, Subsequently the Institute
was given statutory recognition by an act of Parliament, NIPER Act, 1998 and was declared as an Institute
of National Importance. Six more new NIPERs were started at Ahmedabad, Guwahati, Hajipur, Hyder-
abad, Kolkata and Raebareli with the help of Mentor Institutes during 2007-08.
Central Public Section undertakings- the Department has 5 Central Public Section undertakings
under its Administrative control, they are
(a) Indian Drugs & Pharmaceuticals Ltd. (IDPL), Dundahera Industrial Complex, Dundahera,
Gurgaon, Haryana,
(b) Hindustan Antibiotics Ltd, Pimpri, Pune, Maharashtra,
(c) Karnataka Antibiotics & Pharmaceuticals Limited, Bangalore-560010,
(d) Bengal Chemicals & Pharmaceuticals Ltd, Kolkata, West Bengal and
(e) Rajasthan Drugs and Pharmaceuticals Limited, Road NO.12, V.K.I. Area, Jaipur-302013.
24
Annexure-2A
ORGANIZATIONAL CHART – DEPARTMENT OF PHARMACEUTICALS
Shri D. V. Sadananda Gowda

Hon'ble Minister
Shri Mansukh L. Mandaviya

Hon'ble Minister of State
Ms. S Aparna,
Secretary
Ms. Alka
Tiwari, SS &
FA
Ms. Barnali
Khastgir, DS
(IFD)
Shri Rajneesh Tingal, JS Shri H. K. Hajong, EA

Shri Navdeep Rinwa, JS (Parliament, Coordinati
(Pricing.
(Policy, Medical on,Vigilance, Admin, Est
Scheme, NIPER, PMBJP ablishment, Cash, Rajbh
Device, Pharma Bureau)
) asha, FDI, PSU)
Shri Sumit
Garg, DS Ms. S. SHri A.V.
Shri Krishan Shri Pawan Shri Parveen Shri Parveen Shri Parveen
(Policy, Medic Kumar Pilli, Dir Rajalakshmi, D Lakra, Dir
Kumar, JD Kumar, DS Kumar, DS Kumar, DS
al (NIPER, PMBJP) S.
(Pricing) (Admin, Estt., IT (Parliament & (PSU)
Device, Pharm (Scheme) (Rajbhasha, FDI)
& Media, Cash) Coordination)
a Bureau)
Shri S. U.
Shri Satish Shri Navin Shri S. U. Ansari, US
Ms. (Vigilance)
Kumar, US Kishor Ansari, US
Aparna, US
Shri Arvind (NIPER) Joshi, US (Parliament &
Kumar, US (PMBJP) (Pricing) Coordination) Ms. Uma
Shri Sandeep Ms. Kiran Shri Venkat
Shri Navin Magesh, US
(Medical Device) Kumar, US Chauhan DD Hariharan Asha
Kishor (OL) (PSU)
Joshi, US (Admin, Estt & (FDI)
Shri Venkat (PMBJP) IT, Cash)
Hariharan
Asha
Ms. Anshu
(Policy)
Gupta, AD
(OL)
25
26
CHAPTER -3
Programmatic Interventions


3.3 Pharma Bureau
27
28
CHAPTER 3
Programmatic Intervention
3.1.1 Umbrella Scheme - Development of Pharmaceutical Industry

The Department has an Umbrella Scheme namely ‘Scheme for Development of Pharmaceutical
Industry’. Its objective is to increase efficiency and competitiveness of domestic pharmaceutical industry
so as to enable them to play a lead role in the global market and to ensure accessibility and availability of
quality pharmaceuticals for mass consumption. This Scheme is a Central Sector Scheme and comprises the
following seven sub-schemes:
a. Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of
critical Key Starting Materials (KSMs)/Drug Intermediates (DIs)/ Active Pharmaceutical
Ingredients (APIs) in India
b. Production Linked Incentive (PLI) Scheme for Promoting Domestic Manufacturing of
Medical Devices
c. Promotion of Bulk Drug Parks
d. Promotion of Medical Device Parks
e. Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)
f. Assistance to Pharmaceutical Industry for Common Facilities (API-CF)
g. Pharmaceutical Promotion and Development Scheme (PPDS)
The Guidelines for implementation of the Sub-Schemes are available on the Department’s website
at https://pharmaceuticals.gov.in/schemes.
New PLI Scheme for Pharmaceuticals
The Union Cabinet in its meeting on 11.11.2020 approved yet another Production Linked Incentive
scheme for Pharmaceuticals with the objective to enhance India’s manufacturing capabilities by increasing
investment and production in the sector and contributing to product diversification to high value goods in
the pharmaceutical sector. One of the objectives of the scheme is to create global champions out of India
who have the potential to grow in size and scale using cutting edge technology and thereby penetrate the
global value chains.
The outlay of the scheme is Rs 15,000 crore and three categories of pharmaceutical goods will be
incentivized under the scheme based on their incremental sales. The tenure of the scheme is proposed to
be from 2021-22 to 2028-29.
a) Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of crit-
ical Key Starting Materials (KSMs)/Drug Intermediates (DIs)/Active Pharmaceutical Ingredients
(APIs) in India
With a view to attain self-reliance and reduce import dependence in critical APIs, a scheme called
“Production Linked Incentive (PLI) Scheme for promotion of domestic manufacturing of critical Key
29
Starting Materials (KSMs)/ Drug Intermediates (DIs) and Active Pharmaceutical Ingredients (APIs) In
India” has been approved by the Government of India on 20th March, 2020. The Scheme intends to boost
domestic manufacturing of identified KSMs, Drug Intermediates and APIs by attracting large investments
in the sector and thereby reduce India’s import dependence in critical APIs. The guidelines for implemen-
tation of the scheme were initially issued on 27.07.2020. However, based on the feedback received from
the investors, the guidelines were revised on 29.10.2020. Financial incentives under the scheme shall be
provided on sales of 41 identified products for six (06) years at the rates given below:
(i) For Fermentation Based Products, Incentive for FY 2023-24 to FY 2026-27 would be 20%,
for 2027-28 - 15% and for 2028-29 - 5%.
(ii) For Chemical Synthesis Based Products, Incentive for FY 2022-23 to FY 2027-28 would be
10%.

The tenure of the Scheme is from FY 2020-21 to FY 2029-30. The total financial outlay of the
Scheme is Rs. 6,940 crore.
The scheme has received good response from the industry. A total of 215 applications have been
received under the Scheme.
b) Promotion of Bulk Drug Parks
The outbreak of the COVID-19 in China has brought out the risk of disruption of supply chain of
critical bulk drugs for the Indian pharmaceutical sector, highlighting the need for India to attain a suffi-
cient degree of self-reliance in bulk drugs. In this regard, a Technical Committee was constituted by DoP
on 02.03.2020 under the chairmanship of Dr. Eswara Reddy, Joint Drugs Controller, Central Drugs Stan-
dard Control Organization (CDSCO) to make recommendations for the revival of fermentation industry,
new technologies for manufacturing of APIs including its backward integration, costing of the projects and
identification of strategic business models. On the basis of the recommendations of the committee, De-
partment had prepared the scheme for promoting domestic manufacturing of critical KSMs/Drug Inter-
mediates and APIs by attracting large investments in the sector to ensure their sustainable domestic supply
and thereby reduce India’s import dependence on other countries for critical KSMs/Drug Intermediates
and APIs.
This sub-scheme aims to provide grant-in-aid to 3 Bulk Drug Parks for creation of Common Infra-
structure Facilities (CIF) with a maximum limit of Rs.1000 crore per park or 70% of the project cost of CIF,
whichever is less. In case of North Eastern States and Hilly States (Himachal Pradesh, Uttarakhand, Union
Territory of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90% of the
project cost. The total size of the Scheme is Rs. 3000 crore and the tenure of the Scheme will be five years
(2020-21 to 2024-25). The application window of the scheme got closed on 15.10.2020. A total number of
13 States have submitted their proposals under the scheme.
c) Pharmaceutical Technology Upgradation Assistance Scheme (PTUAS)

The objective of the sub-scheme is to facilitate Small and Medium Pharma Enterprises (SMEs) to
upgrade their plant and machinery to World Health Organization (WHO)/Good Manufacturing Practices
30
(GMP) standards so as to enable them to participate and compete in global markets. Assistance in the form
of interest subvention against sanctioned loan by any scheduled commercial bank/financial institution,
both in Public and Private sector will be provided to 900 Pharma SMEs of proven track record. The Scheme
will be implemented through a Public Sector Financial Institution (PSFI) to be identified by the Govern-
ment by inviting Expression of Interest. A total of Rs. 144 Crore has been earmarked for the scheme. The
upper limit of interest subvention on loans for technology/infrastructure upgradation shall be restricted to
6% per annum for a period of three years on reducing balance basis. The maximum loan eligible for this
purpose will be Rs. 4 Crore, availed by the concerned SME.
d) Assistance to Pharmaceutical Industry for Common Facilities (API-CF)

This sub-scheme is implemented in a Public Private Partnership (PPP) mode. Financial assistance
under this scheme is provided for creation of Common Facilities, such as Common Testing Centre, Train-
ing Centre, R&D Centre, Central Effluent Treatment Plan (CETP), Common Logistic Centre, etc. to a Spe-
cial Purpose Vehicles(SPVs) set up for the purpose. Maximum limit for the grant-in-aid under this scheme
is Rs 20.00 crore per cluster or 70% of the cost of project whichever is less. A total of Rs 12.00 crores has
been sanctioned for the year 2020-21.
At present one project of Chennai Pharma Industrial Infrastructure Upgradation Company (CPIIUC) to
set up Common Effluent Treatment Plan (CETP) at Alathur, Tamil Nadu is under process. The total cost
of the project is Rs 10,59,90,000/-. The project is expected to be completed by January, 2021. Four other
proposals have been given ‘in principle approval’.
e) Pharmaceutical Promotion & Development Scheme (PPDS)

The Scheme aims at promotion, development and export promotion in Pharmaceutical sector by
extending financial support for conducting seminars, conferences, exhibitions, mounting delegations to
and from India for promotion of exports as well as investments, conducting studies/ consultancies, for
facilitating growth, exports as well as critical issues affecting Pharma sector. Under PPDS, the Department
of Pharmaceuticals on its own or through financial support by way of Grant-in-aid to the Institutions, or-
ganizations, Voluntary organizations or Non-Government Organizations as mentioned in Rule 228 of GFR
2017:-
i. Conduct Training/knowledge improvement programs/activities on issues/subjects relevant to
growth of pharmaceutical industry. An indicative list of subject is as under: - a. Quality Manage-
ment System/Quality Improvement Program b. Handling USFDA notice c. Success Story Pre-
sentation-Pharmaceutical Entrepreneur d. Government regulations/guidelines for clinical trials in
India versus USA, EU etc. e. Waste Management.
ii. Organize Summits, Conventions, Exhibitions, Pharmacy weeks, meetings etc. in India and abroad
and produce promotional materials like films, displays etc.
iii. Conduct research studies, sector reports etc.
iv. Purchase books, quality standards, pharmacopoeias, magazines, directories, software for develop-
ing information data banks, developing e-learning modules etc.
v. Give awards to achievers in pharmaceutical industry.
vi. For creating awareness and publicity of important activities related to Pharmaceutical/ Medical
Device and related sector.
vii. For any other activity not covered under above categories which may be decided by the Depart-
ment of Pharmaceuticals from time to time.
31
a) Production Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical De-
vices
The domestic medical devices industry faces challenges related to considerable cost of manufac-
turing disability, among other things, on account of lack of adequate infrastructure, domestic supply chain
and logistics, high cost of finance, inadequate availability of quality power, limited design capabilities and
low investments on R&D and skill development. With a view to address these challenges in manufacturing
of medical devices in India vis-à-vis other major manufacturing economies, a Scheme called “Production
Linked Incentive Scheme for Promoting Domestic Manufacturing of Medical Devices” has been approved
by the Government of India on 20th March, 2020. The guidelines for implementation of the Scheme were
initially issued on 27.07.2020. However, based on the feedback received from the investors, the guidelines
were revised on 29.10.2020.
The Scheme is applicable only to the Greenfield projects and intends to boost domestic manufac-
turing and attract large investments in the Medical Devices Sector. Under the Scheme, financial incentive
will be given to selected companies at the rate of 5% on incremental sales of medical devices manufactured
in India and covered under the Target segments of the scheme, for a period of five (5) years. The tenure of
the scheme is from FY 2020-21 to FY 2027-28. The total financial outlay of the Scheme is Rs 3,420 crore.
The four Target Segments of medical devices are :-
• Cancer care/ Radiotherapy medical devices

• Radiology & Imaging medical devices (both ionizing & non-ionizing radiation products) and Nu
clear Imaging devices
• Anesthetics & Cardio-Respiratory medical devices including Catheters of Cardio Respiratory Cate
gory
• Renal Care medical devices and all Implants including implantable electronic devices.

The scheme has received good response from the industry. A total number of 28 applications have
been received under the scheme.
Guidelines for implementing the provisions of Public Procurement (Preference to Make in In-
dia) Order for Medical Devices Sector
The policy of the Government of India is to encourage ‘Make in India’ and promote manufactur-
ing and production of goods and services in India with a view to enhancing income and employment. In
this direction, DPIIT has issued revised Public Procurement (Preference to Make in India) Order, 2017
dated 16.09.2020 and accordingly, Department of Pharmaceuticals has issued the revised guidelines dated
09.11.2020 for implementing the provisions of the public procurement order relating to goods & services
related to Medical Device Sector.
b) Promotion of Medical Devices Parks
Recognizing the need for creation of medical technology parks and creation of testing and labo-
32
ratory facilities, a scheme called “Promotion of Medical Device Parks” has been approved by the Govern-
ment of India on 20th March 2020. Under this scheme, the central government will finance the creation of
common infrastructure facilities with a grant-in-aid of Rs. 100 crore each to 4 medical device parks which
will come up in 4 different States. Such financing of the common infrastructure facilities will reduce the
burden of capital expenditure on the manufacturers who will develop their units in these parks. Therefore,
by providing support to the capital expenditure of the manufacturers, the Government aims to attract
investment in the medical device sector. The total financial outlay of the scheme is Rs. 400 crore and the
tenure of the scheme is from FY 2020-2021 to FY 2024-2025.
Financial assistance to a selected Medical Device Park would be 70% of the project cost of common
infrastructure facilities. In case of North Eastern States and Hilly States (Himachal Pradesh, Uttarakhand,
Union Territory of Jammu & Kashmir and Union Territory of Ladakh) financial assistance would be 90%
of the project cost. Maximum assistance under the scheme for one Medical Device Park would be limited
to Rs 100 crore.
A Medical Device Park project selected under the Scheme will be implemented by a State Imple-
menting Agency (SIA). The proposals under the scheme will be approved by the Scheme Steering Com-
mittee (SSC) constituted by Department of Pharmaceuticals. A Technical Committee, constituted by the
DoP will assist the SSC in discharging its functions by providing advice on technical matters. A Project
Management Agency (PMA) will assist DoP for effective implementation of the Scheme.
The application window of the scheme got closed on 15.10.2020. A total number of 16 States have
submitted their proposals under the scheme.
3.3 Pharma Bureau
• Pharma Bureau provides facilitation to investors and resolution of their inter-departmental coordi-
nation issues in the Pharmaceuticals and Medical Devices sector.
• It consists of technical experts in the area of :-
1. Pharmaceuticals
2. Medical Devices
3. Project Management
4. Legal
5. FDI
• Pharma Bureau also provides policy support to DoP for framing incentive schemes for the indus-
try.
• Pharma Bureau is committed to its goal to increase engagement, productivity and satisfaction of
entrepreneurs of pharmaceutical and medical devices sector by addressing most critical roadblocks.
• It also works as Project Development Cell of the Department.

33
34
CHAPTER -4
PRADHAN MANTRI BHARTIYA JANAUSHADHI
PARIYOJANA (PMBJP)
4.1 Background of the Scheme

4.2 Progress made during the last five financial years


35
36
Chapter 4
Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)
4.1 Background
Despite the country being one of the leading exporters of generic medicines to the world, the ma-
jority of Indians lack sufficient access to affordable medicines. The branded (Generic) medicines are sold
at significantly higher prices than their un-branded generic equivalents, though are identical in the thera-
peutic value.
With an objective of making quality generic medicines available at affordable prices to all espe-
cially for the poor and the deprived ones, Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP) was
launched by the Department in the year 2008. Under this scheme, dedicated outlets known as Pradhan
Mantri Bhartiya Janaushadhi Kendras (PMBJK) are opened all over the country to provide generic medi-
cines to the masses.
Objectives
• To make available quality medicines consumables and surgical items at affordable prices for all and
reduce out of pocket expenditure of consumers/patients.
• To popularize generic medicines among the masses and dispel the prevalent notion that low priced
generic medicines are of inferior quality or are less effective.
• To ensure easy availability of the menstrual health services to all women across India.
• Generate employment by engaging individual entrepreneurs in the opening of PMBJP Kendras.
Implementing Agency
Bureau of Pharma Public Sector Undertakings of India (BPPI) was set up on 1st December, 2008
by the Department with a major objective to have focused and empowered structure to implement the Jan
Aushadhi Campaign.
The Governing Council of the Bureau in its 34th meeting held on 26.02.2020 decided to change
its name from ‘Bureau of Pharma PSUs of India (BPPI)’ to ‘Pharmaceuticals & Medical Devices Bureau of
India (PMBI)’ and also to constitute a Pharma Bureau within. It also decided to revise/ expand its Memo-
randum of Association. Subsequently, the SFC of the PMBJP Scheme has been approved with provision of
including establishment expanses of the Pharma Bureau.
Salient features of the Scheme

The Scheme has been approved for continuation with the financial outlay of Rs. 490 crore for the
period from 2020-2021 to 2024-2025. The target is to open 10,500 PMBJP Kendras in all over the country
by March 2025. It has also been decided to enhance the product basket of PMBJP up to 2,000 medicines
and 300 surgical by March 2025.
In order to popularize the Scheme amongst individual entrepreneurs, the incentive has been dou-
bled and in case of women, divyang, SC, ST entrepreneurs and entrepreneurs opening stores in aspirational
districts, Himalayan, Island territories and the North-Eastern States, new incentive plan has been launched
with following details:
Normal Incentive: The incentive to Kendras run by entrepreneurs that are linked with BPPI through soft-
37
ware has been enhanced up to Rs. 5 Lakh. The incentive is given @ 15% of monthly purchase made from
BPPI by these Kendra subject to a ceiling of Rs. 15,000/- per month. This also applies to existing Kendras
whose existing limit of incentives of Rs. 2.50 lakh has been fully disbursed.
Additional Incentive
In order to popularize the Scheme amongst women, divyang, SC&ST entrepreneurs and entrepre-
neurs opening stores in aspirational districts, Himalayan, Island territories and North-Eastern States, a
new incentive plan has been launched. Such Kendras now get an amount of Rs. 2 lakh in addition to nor-
mal incentives, as under:
i. Rs. 1.50 lakh reimbursement of furniture and fixtures

ii. Rs. 0.50 lakh as reimbursement for computer, internet, printer, scanner etc.
Procurement of medicines
Product basket of PMBJP comprises of around 1,450 drugs and 204 surgical instruments. The med-
icines are procured only from World Health Organization – Good Manufacturing Practices (WHO-GMP)
certified suppliers for ensuring the quality of the products. Apart from this, each batch of drug is test-
ed at laboratories accredited by ‘National Accreditation Board for Testing and Calibration Laboratories’
(NABL). Only after passing the quality tests, the medicines are dispatched to PMBJP Kendras
Implementation of IT Enabled Warehousing/Supply Chain System

To overcome the problem of making the range of products available, IT-enabled End-to-End Sup-
ply Chain system has been implemented and one central warehouse at Gurugram and three regional ware-
houses at Chennai, Bengaluru & Guwahati. Further, it has been planned to open two more warehouses in
Western and Central India. In addition, appointment of Distributors in States/UTs is also being envisioned
to strengthen the supply chain system.
Implementation of SAP and POS System

A single IT enabled system (SAP) introduced in 2017 ensure monitoring of every process from
placing the order of medicines to manufactures till the supply of drugs to Store’s doorstep.
Saving to a Common man

A medicine under PMBJP is priced on the principle of a maximum of 50% of the average price of
the top three branded medicines. Therefore, the price of Jan Aushadhi Medicines is cheaper at least by 50%
and in some cases, by 80% to 90% of the market price of branded medicines. In the financial year 2019-20,
PMBJP achieved sales of Rs. 433.61 crores (at MRP). This has led to savings of approximately Rs. 3,000
crores of the common citizens of the country. The number of Kendras increased to 6871 from 6306 in the
financial year 2019-20. The average monthly sales turnover per store also increased from Rs. 45,000/- to Rs.
51,000/-.
Suvidha Sanitary Napkins

To ensure easy availability of the menstrual health services to all women across the country, “Janau-
shadhi Suvidha Oxy-Biodegradable Sanitary Napkin” was launched by the Department in the year 2018,
which are now available for sale in all PMBJP Kendras across the country @ Rs. 1.00 per sanitary pad. The
Jan Aushadhi Suvidha napkins come with a special additive, which makes it bio-degradable when it comes
38
in contact with oxygen after being discarded. This step has ensured ‘Swachhta, Swasthya and Suvidha’ for
the women in the country.
Jan Aushadhi SUGAM

A mobile application “Janaushadhi Sugam” is an important facility for the general public by provid-
ing a digital platform at the tip of their fingers, by the virtue of which they can avail a host of user-friendly
options like - locate nearby PMBJK (direction guided through Google Maps), search janaushadhi medi-
cines, analyze product comparison of Generic vs Branded medicine in the form of MRP saving etc.
Awareness about the Scheme

The awareness about the salient features of the Scheme is spread through various types of advertise-
ments through Print Media, Radio, TV & Cinema Advertisements and Outdoor publicity like Hoardings,
Bus Queue Shelter branding, Bus branding, Auto wrapping. In addition, the public are educated about the
usages of Jan Aushadhi generic medicines through social media platforms like Facebook, twitter, Insta-
gram, YouTube, etc. It has also been planned to start a comprehensive media campaign in FM Radio & TV
in coming festival season.
like Facebook, twitter, Instagram, YouTube, etc. It has also been planned to start a
4.2 Progress made
comprehensive during
media the last
campaign fiveRadio
in FM financial
& TVyears:
in coming festival season.
4.2 Progress made during the last five financial years:

Table-4A
Number of PMBJPKendras functional
Sales at MRP Value
Financial Year
Yearly Addition Cumulative in Cr.
2014-15 14 86 7.29
2015-16 154 240 12.16

2016-17 720 960 32.66
2017-18 2233 3193 140.84
2018-19 1863 5056 315.70
2019-20 1250 6306 433.60

2020-21
712 7018 473.70
(As on 05.01.2021)

Coverage of the Scheme

Coverage of the Scheme
As onAs05.01.2021, 70187018
on 05.01.2021, PMBJP Kendras are
PMBJPKendras are functional across
functional across thethe country.
country. The Pariyojana has
The Pariyojana
markedhas
itsmarked
presence in every in
its presence district of India
every district ofby covering
India all theall734
by covering the districts of the
734 districts country.
of the country.
BasketBasket of medicines
of medicines & Stock
& Stock position
position
Product basket of BPPI comprises of around 1450 drugs and 204 surgical instruments.
Product basket of BPPI comprises of around 1450 drugs and 204 surgical instruments.
Introduction of New Incentive Plan
IntroductionToof make
New Incentive
the schemePlan
more attractive, the incentive provided to the Kendra owners has
To make the scheme moreRs.
been enhanced from existing attractive,
2.50 lakhthe incentive
to Rs. provided
5.00 lakh, to @
maximum theRs.
Kendra
15,000owners has been en-
per month.
Further, one time incentive of Rs. 2 lakh for computer and furniture has been approved for stores
opened by women, SC and ST & any entrepreneur in aspirational districts or North-Eastern
States.
39
Suvidha Sanitary Napkin
To ensure easy availability of the menstrual health services to all women across the
country, “JanaushadhiSuvidha Oxy-Biodegradable Sanitary Napkin” was launched by the
hanced from existing Rs. 2.50 lakh to Rs. 5.00 lakh, maximum @ Rs. 15,000 per month. Further, one time
incentive of Rs. 2 lakh for computer and furniture has been approved for stores opened by women, SC and
ST & any entrepreneur in aspirational districts or North-Eastern States.
Suvidha Sanitary Napkin

To ensure easy availability of the menstrual health services to all women across the country, “Janau-
shadhi Suvidha Oxy-Biodegradable Sanitary Napkin” was launched by the Department in the year 2018,
which are now available for sale in all PMBJP Kendras across the country @ Rs. 1.00 per sanitary pad. Till
now more than 9 cr. pads have been sold through PMBJKs.
In his address to the nation from the ramparts of the Red Fort on the Independence Day, 2020,
the Hon’ble Prime Minister referred about the issue of mensuration hygiene and subsidized sanitary pads
being provided by PMBJKs all across the country. Pursuant thereto, efforts are on for upscaling of scheme
of distribution of Suvidha Sanitary Napkins.
Inclusion of Ayush medicines in the product basket of PMBJP

Decision has been taken to include 75 AYUSH drugs especially Ayurvedic medicines in the prod-
uct basket to expand the utility of Kendras.
Role of PMBJP during Covid-19

In the wake of COVID 19 crisis, BPPI has sold about 15 lacs Face masks, 80 lacs tablets of Hydroxy-
chloroquine and 100 lacs Paracetamol Tablets, which saved around Rs. 1,260 crore of the citizens and also
maintaining adequate stock of the medicines which are currently under demand viz. Face Masks, Hand
Sanitizers, Hydroxychloroquine, Paracetamol and Azithromycin. Recently, BPPI has launched N95 masks
@ Rs 25 per piece.
BPPI is maintaining adequate stock of the medicines which are currently under demand viz. Face
Masks, Hand Sanitizers, Hydroxychloroquine, Paracetamol and Azithromycin. 60% growth in Sales has
been achieved in the 1st half of the Financial Year 2020-2021 as compared to same period of the previous
Financial Year. Envisioning current market demand, BPPI has also placed purchase orders for procure-
ment of these medicines to have enough stock for the next six months.

All PMBJP Kendra owners celebrated 7th March 2020 as “Janaushadhi Diwas” across the country.
In the celebration, a wide range of activities were carried out to propagate the achievements of the scheme
and create awareness about its benefits. All activities were organized in close co-ordination with Kendra
owners, beneficiaries, students, media, doctors, pharmacists, NGOs, social workers and people’s represen-
tative like Hon’ble MPs, MLAs & local body members. Hon’ble Prime Minister announced for instituting
awards in various categories for those who have contributed for successful implementation of the scheme.
On Jan Aushadhi Diwas 2020, Hon’ble Prime Minister of India, Shri Narendra Modi interacted with people
from various PMBJKs through video conferencing. The Prime Minister interacted with stores owners and
beneficiaries at selected stores across the country, including Guwahati, Dehradun, Coimbatore, Varanasi
and Pune.
40
Celebration of Jan Aushadhi Diwas on 7th March 2020

Celebration of Jana AushadhiDiwas on 7th March 2020
41
42
CHAPTER -5
NATIONAL INSTITUTES OF PHARMACEUTICAL EDUCATION &
RESEARCH (NIPERs)
5.1 Background
5.2 NIPER Mohali
5.3 NIPER Hyderabad
5.4 NIPER Ahmedabad
5.5 NIPER Guwahati
5.6 NIPER Raebareli
5.7 NIPER Kolkata
5.8 NIPER Hajipur
43
44
CHAPTER 5
National Institutes of Pharmaceutical Education & Research
5.1 Background

1. Indian Pharma Industry has been a global leader in Generic drugs. In order to acquire leadership
position in drug discovery and development and to continue to excel in the formulations, Government
recognized that human resources/talent pool is very critical. National Institute of Pharmaceutical Edu-
cation & Research (NIPER) at SAS Nagar (Mohali) was set up as a registered society under the Societies
Registration Act, 1860 and given statutory recognition by an act of Parliament, NIPER Act, 1998 and was
declared as an Institute of National Importance.
2. During 2007-08, six new NIPERs were started at Ahmedabad, Guwahati, Hajipur, Hyderabad, Kol-
kata and Raebareli with the help of Mentor Institutes. Subsequently, NIPER at Madurai was approved in
the year 2012. During 2015-16, Finance Minister in his Budget Speech announced 3 new NIPERs for the
states of Chhattisgarh, Maharashtra and Rajasthan. Another NIPER is proposed to be set up at Bengaluru,
Karnataka.
3. The present status of seven existing NIPERs is as under:
Table-5A
3. The present status of seven existing NIPERs is as under:
(Present status of NIPERs)
NIPER Academic session Status of land/construction
started in
Mohali 1998 NIPER, Mohali has its own campus in 129.25 acres of
land.
Ahmedabad 2007 60 acres land in Gandhinagar, Gujarat has been
allocated and Hindustan Steelworks Corporation
Limited (HSCL) has been selected as Project
Management Consultant (PMC). The tender for
construction of campus has been finalized. Construction
has begun.
Guwahati 2008 51.42 acres land at Village Sila, Changsari, Dist,
Kamrup has been allocated and Engineering Projects
India Limited (EPIL) has been selected as Project
Management Consultant (PMC). Construction was
started in June 2015. More than 85% construction work
of the campus has been completed.
Hajipur 2007 12.5 acres of land at EPIP Campus, Industrial Area,
Hajipur has been allocated by Govt. of Bihar.
Hyderabad 2007 Government of Telangana has allocated 50 acres of land

for construction of NIPER-Hyderabad campus. The
Department has proposed to allot 50 acres of IDPL land
to NIPER-Hyderabad for construction of its permanent
campus.
45
Kolkata 2007 10 acres of land at Mouza-Gopalpur, P.S. Kalyani, Dist
Nadia has been allocated by Govt. of West Bengal.
Department has proposed to allot 20 acres of surplus
Management Consultant (PMC). Construction was
started in June 2015. More than 85% construction work
of the campus has been completed.
Hajipur
Annual 2007
Report 2020-21 12.5 acres of land at EPIP Campus, Industrial Area,
Hajipur has been allocated by Govt. of Bihar.
Hyderabad 2007 Government of Telangana has allocated 50 acres of land

for construction of NIPER-Hyderabad campus. The
Department has proposed to allot 50 acres of IDPL land
to NIPER-Hyderabad for construction of its permanent
campus.
Kolkata 2007 10 acres of land at Mouza-Gopalpur, P.S. Kalyani, Dist
Nadia has been allocated by Govt. of West Bengal.
Department has proposed to allot 20 acres of surplus
land of BCPL to NIPER-Kolkata for construction of its
permanent campus.
Raebareli 2008 49 acres land at Village Vinayakpur, Pargana

Bachrawan, Tehsil Maharajganj, Raebareli has been
allocated.
4. The aims and objectives of NIPER are:

4. The aims and objectives of NIPER are:

i. to nurture and promote quality and excellence in pharmaceutical education and research
ii. to concentrate on courses leading to master’s degree, doctoral and post-doctoral courses and re-
search in pharmaceutical education
iii. to hold examinations and grant degrees
iv. to confer honorary awards or other distinctions
v. to cooperate with educational or other institutions having objectives wholly or partly similar to
those of the Institute by exchange of faculty members and scholars and generally in such manner as
may be conductive to their common objective
vi. to conduct courses for teachers, pharmaceutical technologies, community and hospital pharma-
cists and other professionals
vii. to collect and maintain world literature on pharmaceutical and related sciences and technology so
as to develop an information centre of its own kind for other institutions within the country and in
the developing world
viii. to create a central faculty of pharmaceutical instrumentation and analysis for use by the researches
within and outside the Institute
ix. to have a centre to experiment and innovate and to train teachers and other workers in the art or
science or pharmaceutical teaching
x. to develop a world level centre for creation of new knowledge and transmission of existing infor-
mation in pharmaceutical areas with focus on national, educational professional and industrial
commitments
xi. to develop a multi-disciplinary approach in carrying out research and training of pharmaceutical
manpower so that the larger interests of the profession academia and pharmaceutical industry are
better served and a pharmaceutical work culture is evolved which is in tune with the changing
world trends and patterns of pharmaceutical education and research
xii. to organise national or international symposia, seminars and conferences in selected areas of phar-
46
maceutical education, from time to time

xiii. to arrange courses catering to the special needs of the developing countries
xiv. to act as nucleus for interaction between academic and industry by encouraging exchange of scien-
tist and other technical staff between the Institute and the industry and by undertaking sponsored
and funded research as well as consultancy projects by the Institute and
xv. to pay due attention to studies on the distribution and usage of drugs by the rural masses, taking
into account the socio-economic spectrum in the country
5. Administrative structure of NIPERs

NIPER Act was notified in the year 1998 (amended in 2007), NIPER Statutes were notified in 2003
(amended in 2014), NIPER Ordinances were notified in 2005 (amended in 2014).
6. Board of Governors and other Committees:

Board of Governors (BoG) of the respective Institute is responsible for general superintendence,
direction and control of its affairs. Chairman, BoG is appointed by the Visitor. Director of the Institute is
appointed by the BoG with prior approval of Visitor. The last BoG of NIPER Mohali was constituted on
03.10.2016 for a term of three years, which has expired on 02.10.2019. It is yet to be re-constituted. The
First BoGs of other sixof
Visitor.Director NIPERs were constituted
the Institute for by
is appointed a period of three
the BoG with years
prior on 09.03.2019.
approval of Visitor. The last
BoG of NIPER Mohali was constituted on 03.10.2016 for a term of three years, which has expired
Table-5B
on 02.10.2019. It is yet to be re-constituted. The First BoGs of other six NIPERs were constituted
(Board of
for a period of three years on 09.03.2019. Governors of NIPERs)
NIPER Chairman: BoG NIPERs
NIPER-Ahmedabad Dr. Ketan R. Patel

Chairman-cum Managing Director, Troikaa Pharmaceuticals Ltd.
Gujarat
NIPER-Guwahati Dr. S. Chandra Shekhar
Director, CSIR-IICT, Hyderabad
NIPER-Hajipur Dr. Sanjay Singh
Vice Chancellor, Babasaheb Bhimrao Ambedkar University,
Lucknow
NIPER-Hyderabad Dr. Satish Reddy
Chairman, Dr. Reddy’s Laboratory Ltd., Hyderabad
NIPER-Kolkata Prof. (Dr.) Bhabatosh Biswas
Former Vice Chancellor, Bengal University of Health Sciences,
Kolkata
NIPER-Raebareli Prof. Rakesh Kapoor
Director, Sanjay Gandhi PGIMS, Lucknow
National Institutional Ranking Framework (NIRF):

As per National Institutional Ranking Framework of the Ministry of Education, under the
‘Pharmacy’ category, six NIPERs are amongst the top thirty pharmacy Institute in the country,47
as
under:
NIPERs 2017 2018 2019 2020

NIPER-Raebareli Prof. RakeshKapoor
Director, Sanjay Gandhi PGIMS, Lucknow

As per National Institutional Ranking Framework of the Ministry of Education, under the ‘Pharmacy’ cat-
As six
egory, perNIPERs
National
are Institutional Ranking
amongst the top FrameworkInstitute
thirty pharmacy of theinMinistry of as
the country, Education,
under: under the
‘Pharmacy’ category, six NIPERs are amongst the top thirty pharmacy Institute in the country, as
Table-5C
under: (NIPERs in NIRF Ranking)
NIPERs 2017 2018 2019 2020
Mohali 2nd 1st 3rd 3rd
Hyderabad 5th 6th 6th 5th
Ahmedabad - 14th 9th 8th
Guwahati - - - 11th
Raebareli - - - 18th
Kolkata - - - 27th
5.2 5.2
NIPER
NIPER Mohali
Mohali
NIPERS.A.S. Nagar has been declared as an “Institute of National Importance” through an
NIPER S.A.S. Nagar has been declared as an “Institute of National Importance” through an Act of
Act of Parliament.
Parliament. The InstituteThehasInstitute has been conceptualized,
been conceptualized, planned and planned
set upandto set up toleadership
provide provide leadership
in pharma-
in pharmaceutical sciences and related areas not only within the country, but also
ceutical sciences and related areas not only within the country, but also to the countries in South East Asia,to the countries
in South
South Asia andEast Asia,ItSouth
Africa. is onlyAsia
one and
of itsAfrica.
kind inItitsisdomain
only one andofisits kind valued
highly in its domain and is highly
for its outcomes, namely
wellvalued
trainedforand
its focused
outcomes, namely
human well trained
resources and focused human
(students/researchers); resources (students/researchers);
publications of high impact and novel
processes/outputs
publications of of industrial
high impact relevance
and novelinprocesses/outputs
its chosen areas ofofworking.
industrialNIPER S.A.S.
relevance inNagar has aareas
its chosen campus
thatofcaters for research facilities for ten different fields, three boy’s hostels with intake
working. NIPERS.A.S. Nagar has a campus that caters for research facilities for ten different capacity of 472 and a
girl’s hostelthree
fields, with boy’s
intakehostels
capacitywith
of 220, 18 married
intake capacityhostels,
of 472 133andquarters
a girl’s (Type–II
hostel with- 12,intake
Type-III - 36, Type-
capacity of
IV -220,
30, Type-V
18 married hostels, 133 quarters (Type–II - 12, Type-III - 36, Type-IV - 30, Type-V - 42,and
- 42, Type-VI - 12, Director Bungalow - 1) for the NIPER staff. NIPER offers Masters’
Ph.D. degrees in 15 streams and caters to the various needs of pharmaceutical industry.
Type-VI - 12, Director Bungalow - 1) for the NIPER staff. NIPER offers Masters' and Ph.D.

1. degrees in 15 streams
Achievements – and caters to the various needs of pharmaceutical industry.
Academic excellence : In 2020-21, the Institute has published 79 articles in journals of repute (till
25th November 2020). Institute has filed 192 patents applications and out of which 104 patents are granted/
Achievements –
issued till date. Since the inception of academic programme (till 20th November 2020), 3746 students have
passed Academic
out (Masters 2764, MBA 643 & Ph.D. 335).
excellence
2. In 2020-21,
Research – the Institute has published 79 articles in journals of repute (till 25thNovember
2020).
A. Institute has filed
Neglected 192 patents
diseases applications
- Research (families)
is carried out and out
in the areas of which 104
of tuberculosis, patents areand
leishmaniasis
th
granted/issued
malaria. New till molecules
date. Sincearethe inception
being of academic
synthesized and theirprogramme
mechanisms (till
of 20
actionNovember
are being2020),
worked
3746out.
students have passed out (Masters 2764, MBA 643 & Ph.D. 335).
B. Other diseases - Metabolic pathways in diseases like inflammation, infection, cancer, dia-
betes, obesity, Parkinson’s disease, neurodegeneration are being worked out
C. Drug development and formulation
i. Improvement of oral bioavailability, synergistic anticancer efficacy and reduced tox-
icity of drugs has been attempted.
ii. New formulations are being developed.
iii. Standardization of Herbal drugs and formulations
48
iv. Toxicological studies
D. Other areas
i. Biopharmaceuticals
ii. Epigenetics
iii. Chemo-enzymatic synthesis of drugs
iv. Monograph on herbals is being developed.
v. Study of the effect of RNA aptamers on stabilization of misfolded proteins
vi. Assessment of an appropriate and reliable method to diagnose neuropathic pain
vii. Artificial intelligence, Machine Learning, Big data Analytics.
viii. Utility of Physiology Based Pharmacokinetic (PBPK) Modeling in prediction of
PK of drugs in special populations and in study of food effects on drug PK
3. Students
Table-5D
Students
(Degrees/programmes/ subject offered year-wise with admission status)
(Degrees/ programmes/ subjects offered year-wise with admission status)
Level Degree Discipline No. of students admitted
Masters/ MS/MBA/MTech/ Ph.

Doctoral D
Years 2019-20 2020-21
Masters’ M.S.(Pharm.) 28 26
Medicinal Chemistry
Doctoral PhD 2
Pharmacoinformatics
Doctoral PhD 0 1
Natural Products
Doctoral PhD 4
Masters’ M.S.(Pharm.) Traditional Medicine 5 5
Pharmaceutical Analysis
Doctoral PhD 0
Pharmacology & Toxicology
Doctoral PhD 4 1
Masters’ M.S.(Pharm.) Regulatory Toxicology 9 9
Masters’ M.Tech.(Pharm.) 7 7
Pharmaceutical Technology
Doctoral PhD (Formulations)
0
5.3 NIPER- Hyderabad

49
NIPER-Hyderabad started functioning in September 2007 in the premises of IDPL, R&D
centre, Balanagar, Hyderabad. The Institute has been functioning with the mission of developing
human resource with excellence through conducting Postgraduate and PhD courses. NIPER-
Hyderabad has M.S. (Pharm), M. Tech. and MBA courses in different disciplines i.e., Medicinal
vii. Artificial intelligence, Machine Learning, Big data Analytics.
viii. Utility of Physiology Based Pharmacokinetic (PBPK) Modeling in prediction of PK of
drugs in special populations and in study of food effects on drug PK
4. Academic and Non

Academic and –Non
academic Staff Staff
– academic
Table-5E
(Academic andand
(Academic non-academic staffstaff
non-academic position)
position)
Man-Power Sanctioned In-Position Vacancy
Academic 62 26 36
Non-Academic 223 127 96
(Allocation of fund by the Government during last 4 years)(Rs. In cr.)

5. Total fund allocated by the Government during the last 4 years
Table-5F
3. Total fund allocated by the Government during the last 4 years
(Allocation of fund by the Government during last 4 years)(In Rs.)
Year M.S.(Pharm.)
Masters’ Allocation BERegulatory Toxicology
Allocation RE Total Release
9
(Crores) (Crores) 9 (Crores)
Masters’ M.Tech.(Pharm.)
27.74
2017-18 (Allocation 42.32 42.31 7 7
of fund by the Government during last 4 years)(Rs. In cr.)
Pharmaceutical
29.00Technology 29.00
2018-19 PhD 32.00
Doctoral
(Formulations)
2019-20 30.60 30.60 30.60 0
2020-21* 41.00 45.77 45.77
*Fund released till December 2020.
Students
NIPER-Hyderabad
(Degrees/ started functioning
programmes/ subjectsin offered
September 2007 inwith
year-wise the premises
admission of status)
IDPL, R&D centre,
Balanagar, NIPER-Hyderabad startedhas
Hyderabad. The Institute functioning in September
been functioning 2007
with the in theofpremises
mission developingof human
IDPL, R&D
resource
withLevel
excellence
centre, Degree
through
Balanagar, conductingThe
Hyderabad. Discipline
Postgraduate andbeen
Institute has PhDfunctioning No. of students
courses. NIPER-Hyderabad
with the missionhas admitted
M.S. (Pharm),
of developing
M. human
Tech., and MBA
resource courses in different
with excellence disciplines i.e. Medicinal Chemistry, Pharmaceutical Analysis,
Masters/ MS/MBA/MTech/ Ph. through conducting Postgraduate and PhD courses. NIPER-
Pharmacology
Hyderabad has& Toxicology, Pharmaceutics, Process Chemistry, Regulatory Toxicology and Pharmaceu-
Doctoral D M.S. (Pharm), M. Tech. and MBA courses in different disciplines i.e., Medicinal
tical Management.
Chemistry, Pharmaceutical Analysis, Pharmacology & Toxicology, Pharmaceutics, Process
1. Chemistry, Regulatory Toxicology
Achievements: Yearsand Pharmaceutical Management. 2019-20 2020-21
Table-5G
1. Achievements:
Masters’ M.S.(Pharm.) (Achievements of NIPER Hyderabad) 26
28
Medicinal Chemistry
Doctoral 1 PhD
Master Students Passed Out 2 1060
2 Master Students pursuing course 303
3 Students pursuing Ph.DPharmacoinformatics
course 97
Doctoral 4 Doctoral degree awarded
PhD 53 1
0
5 Patents (filed) 15
Masters’ 6 M.S.(Pharm.)
Research Publications 13 715 13
Natural Products
Doctoral 7 Sanctioned extramural research projects
PhD 34
4
Masters’
2. Details ofM.S.(Pharm.)
Faculty & Staff: Traditional Medicine 5 5
50
Pharmaceutical Analysis
Doctoral
i. PhDFaculty
Regular : 14 0
ii. Regular Staff : 06
Masters’
iii. M.S.(Pharm.)
Contractual Faculty : 02 18 18
2. Details of Faculty & Staff:
i. Regular Faculty : 14
ii. Regular Staff : 06
iii. Contractual Faculty : 02
iv. Contractual Administrative and Technical Staff : NIL
3. Total Allocation by the Government during the last 4 years
Table-5H
(Allocation of fund by the Government during last 4 years) (Rs. in crores)
Allocation
Year
2017-18 Allocation BE
20.00 30.00 Total
30.00Release
RE
2018-19
2017-18 24.00
20.00 24.00
30.00 24.00
30.00
2019-20
2018-19 25.00
24.00 27.00
24.00 27.00
24.00
2020-21
2019-20 30.50
25.00 30.50
27.00 30.50
27.00
*Fund
2020-21released till December
30.50 2020. 30.50 30.50
*Fund released till December
4. Teacher-Student ratio: 2020.
Presently 1:8
4. Teacher-Student ratio:
Presently 1:8
Presently 1:8
5. Employability/ Placements Status:-
A. A. Year wiseCompanies
Year wise Companies participated
participated in
in campus
campus selection
selection/placement
/ placement
Every
A. Yearyear
wisestudents were participated
Companies placed in reputed companies’
in campus like- Novartis, Syngene, Springers Nature
selection/placement
Every year students were placed in reputed companies’
Publishing, Eli Lilly, Cipla, Sai life Sciences, AMRI, ViVo Biotech, like- Novartis, Syngene,
Credo Life Springers
Sciences, Cognizant
Nature Publishing,
Every year
Healthcare, Eli
students
Johnson Lilly, Cipla,
were placed
& Johnson, Mylan, Sai life
inGentech, Sciences,
reputed Shasun, AMRI,
companies’
Lupin,like-ViVo Biotech, Credo
Novartis,Biological
Aurobindo, Life
Syngene,E,Springers
Aizant,
Sciences,
Cipla,
Nature Cognizant
Cognizant
Publishing, Healthcare,
Health care,
Eli Johnson
CoreCipla,
Lilly, Sai &life
Diagnostics, Johnson,
Sciences,Mylan,
Aurobindo, AMRI,Gentech,
Macleods Shasun,Credo
Pharmaceuticals,
ViVo Biotech, Lupin,Life
Roche etc.
Aurobindo, Biological E, Aizant, Cipla, Cognizant Health care, Core Diagnostics, Aurobindo,
B. LastSciences,
few years Cognizant
placements Healthcare, Johnson campus
status: in campus/off & Johnson, Mylan, Gentech, Shasun, Lupin,
Macleods Pharmaceuticals, Roche etc.
Aurobindo, Biological E, Aizant, Cipla, Cognizant Health care, Core Diagnostics, Aurobindo,
Table-5I
Macleods Pharmaceuticals,
Last few years placements
(Placement Roche
status: etc.
in
Status campus/off
: in Campus campus
/ off Campus)
Last few years placements status: in campus/off campus
Year 2012 2013 2014 2015 2016 2017 2018 2019 2020
In campus
Year 882012 852013 822014 822015 802016 832017 1002018 992019 902020
Placements (%)
In campus
88 85 82 82 80 83 100 99 90
Placements (%)
6. Teachers
6. Teachers
NIPER has some of the talented and dedicated faculty who came from the best institutions and
having6. good training abroad as post-doctoral fellows in their specializations. The performance of the fac-
Teachers
NIPER has some of
ulty is assessed periodically. Thetheassessment
talented and dedicated
is based faculty
on the whofeedback,
student came from the best
output frominstitutions
the research
and having good training
NIPER has some
activities and contributions abroad as post-doctoral
of the talented
to institutional growth fellows
andassessed
dedicated in their
byfaculty specializations.
subjectwho The performance
came from the best institutions
experts.
of the faculty is assessed periodically. The assessment is based on the
and having good training abroad as post-doctoral fellows in their specializations.student feedback, output
The performance
fromof the
theresearch activities
faculty is assessedand contributions
periodically. Theto assessment
institutionalisgrowth
based assessed by subject
on the student experts.output
feedback,
from the research activities and contributions to institutional growth assessed by subject experts.
7. Core Research areas: 51
7. Core Research areas:
 Integrated Drug Discovery & Product Development Programmes
 Integrated Drug Discovery & Product Development Programmes

Cancer, Inflammation and related proliferative diseases
7. Core Research areas:

• Integrated Drug Discovery & Product Development Programmes
Cancer, Inflammation and related proliferative diseases
Diabetes and other metabolic disorders
Neurodegenerative diseases
Infectious diseases
Psoriasis
• In vitro and in vivo screening
• Development of novel Process for NCEs, Bulk Drugs and Intermediates
• Development of Analytical Methods, Impurity Profiling and Stability studies
• Solid state characterization
• Targeted drug delivery systems
8. Innovation / knowledge transfer

a) Patents and commercialization- 15 patents filed in areas of Cancer Drug Discovery, Formu-
lation Development and Analytical Method Development
b) Revenue Generation: 1.20 Crores (FY 2020-21) till Nov-2020
9. Impact of NIPER:
Creation of human resources by imparting high quality education and training in pharmaceutical
sciences helped the pharmaceutical industry. Serve as a research institute and focusing on thrust areas of
national and international relevance. Institute helped in fostering academic and industrial collaborations
to address some of the key issues in the pharma sector and the needs of Pharmaceutical industry in the
country.
10. Collaborations / MoUs

NIPER-Hyderabad signed 43 MoUs with national and international bodies to enhanced research
areas and multidimensional research. The principal collaborators are:
• Karnataka Antibiotics & Pharmaceuticals Limited (KAPL), Bengaluru
• AMTZ, Vizag
• Momentous Molecules Private Ltd., Banjara Hills, Hyderabad
• PS3 Laboratories LLP, Kukatpally, Hyderabad
• Innatura Scientific Pvt. Ltd., Uppal, Hyderabad
• CSIR-IITR
• Sarvotham care limited
• Babasheb Bhimrao Ambedkar University, Lucknow
• NBI Bioscience Private Limited, New Delhi
• Phaeno Biotech, Inc, USA
• University of Bialystok, Poland,
• Lifeactivus, TenchiKSM and NIPER Hyderabad
• ESIC Medical College Sanathanagar, Hyderabad
• Lifeactivns Private Limited, Medchal, Hyderabad
• Apollo Hospitals Educational & Research Foundation (AHERF)
• National Institute for Micro, Small and Medium Enterprises (ni-msme)
• Vline Pharmachem Private Ltd
52
• Lorven Biologics Private Limited, Andra Pradesh

• Zystus Nutraceuticals Private Limited
• Almelo Private Limited, Hyderabad
• National Research Development Corporation, New Delhi
• IIT Hyderabad
• Dr Reddy’s Laboratories Ltd, Hyderabad
• Central Council for Research Institute of Unani Medicine (CCRUM)
• BOGAR Laboratories
• Novartis Healthcare Pvt. Ltd
• Extrovis Pvt. Ltd.
• Biological E. Ltd.
• United States Pharmacopeia (USP, India), Hyderabad
• National University of Singapore
• Department of Health Sciences of University “Magna Graecia” of Catanzaro
• Dr Reddy’s Laboratories Ltd, Hyderabad
• Bharat Biotech International Ltd
• NATCO Pharma Ltd, Hyderabad
• Natural & Essential Oils Pvt. Ltd.
• Natco Research Center
• Clearsynth Labs Ltd Research Center
• DAEWOONG Pharmaceutical Co. Ltd.
• Dr. Reddy’s Institute of Life Sciences
• Calyx Chemicals and Pharmaceuticals Ltd.
• College of Pharmacy, University of Minnesota
• Central Research Institute of Unani Medicine (CRIUM), Hyderabad
• Jubilant Biosys Ltd., Bangalore
11. Various events/ Workshops carried out by the institute

NIPER Hyderabad conducted various scientific events, workshops training for students. Following
are some photograph of the various events in NIPER-Hyderabad.
Some Photographs
53
th th
NIPER-Hyderabad
NIPER-Hyderabad conducted
conducted its
its 8
8th e-Convocation
e-Convocation on
on July
July 24
24th,, 2020
2020
NIPER-Hyderabad conducted its 8th e-Convocation on July 24th, 2020
th th
NIPER
NIPER Hyderabad
NIPERcelebrated
Hyderabad Hyderabad14
celebrated th Foundation
14celebrated 14thDay
Foundation on
on 10
10thNovember,
Foundation
Day 2020
Day on 10th
November, November, 2020
2020
5.4 NIPER- AHMEDABAD

NIPER-Ahmedabad was set up in 2007 and is currently functioning from a transient, temporary
building on a 60-acre landsite at Gandhinagar since August 2016. The institute is presently offering MS
and Ph.D. programs in 07 streams (Pharmaceutics, Pharmaceutical Analysis, Pharmacology & Toxicology,
Biotechnology, Natural Products, Medicinal Chemistry, and Medical Devices) and from academic year
2020 NIPER-A has started Masters program in MBA (Pharm.). The interdisciplinary courses and cultural
diversity at NIPER Ahmedabad sparks the spirit of innovative research and all-round development of its
students. The location of the Institute ensures a symbiotic association with Pharmaceutical Industries,
Medical centers, and technological universities. The Institute aspires to serve as a good launching platform
to revamp the pharmaceutical education and research and to initiate the new era of Pharmaceutical and
biomedical sciences.
1. Achievements:
National Institute Ranking Framework-2020 (NIRF)
The Institute has been Ranked # 2nd in Teaching and Learning Resources (TLR) and All India
54
Ranking of #8th among all Pharmacy Educational and Research Institutions in India as per NIRF 2020
released by Ministry for Human Resource Development, Government of India.
Atal Ranking of Institutions on Innovation Achievements-2020 (ARIIA)

The Institute has been placed in Band A (Rank Between11th– 25th) under the category of Publicly
Funded Institutions
Publications - The Institute has published 530 articles in peer reviewed journals of repute.
Students in MS Programme
i. 607 M.S Pharm. students have already graduated from NIPER-Ahmedabad and are well placed in
various Pharma industries in India and abroad.
ii. Presently, 252 students are pursuing their M.S. (Pharm) and MBA (Pharm) course in 8 disciplines.
Students in PhD Programme

i. 10 students have been awarded Ph.D. Degree till date.
ii. 65 students are continuing for their Ph.D. studies.
Patents - Institute has filed up till now 12 patents wherein faculty or students of NIPER-Ahmedabad are
inventors.
Placement of Students - 100% placement of willing students have been achieved
2. Details of Faculty & Staff

2. Details
2. Details of
of Faculty &
& Staff
In addition
Faculty to the post of Director, following posts are filled up:
Staff
Table-5J
In
In addition
addition to
to the
the post
post of
of Director,
Director, following posts are
are filled
filled up:
(Details of Faculty posts
following & Staff) up:
Faculty
Faculty Regular
Regular Contractual
Contractual
Associate Professor
Associate Professor 66 00
Assistant Professor
Assistant Professor 12
12 11
Admin Staff
Admin Staff 10
10 04
04
Technical Staff
Technical Staff 03
03 05
05
3. Total Allocation by the Government during the last 4 years (Rs. in crores)
Total Allocation
3. Total
3. Allocation by
by the GovernmentTable-5K
the Government during the
during the last
last 44 years
years (Rs.
(Rs. in
in crores)
crores)
(Total Allocation by the Government during the last 4 years)
Year
Year Allocation
Allocation BE
BE Allocation
Allocation RE
RE Total
Total Release
Release
2017-18
2017-18 22.96
22.96 27.96
27.96 27.96
27.96
2018-19
2018-19 12.00
12.00 12.00
12.00 12.00
12.00
2019-20
2019-20 15.00
15.00 18.50
18.50 18.50
18.50
2020-21*
2020-21* 36.50
36.50 36.50
36.50 36.50
36.50
** Fund
Fund released till December 2020
released till December 2020
* Fund released till December 2020
4. Students
4. Students
Degrees/programmes
Degrees/programmes offered
offered and
and Subjects
Subjects offered
offered (with
(with year)
year) with
with admission
admission status
status
No. 55
Masters/
Masters/ No. of
of students
students admitted
admitted
MS
MS /PhD
/PhD Discipline
Discipline
Doctoral
Doctoral
2018-19
2018-19 2019-20 2020-21
2020-21
2017-18 22.96 27.96 27.96
2018-19 12.00 12.00 12.00
2019-20 15.00 18.50 18.50
2020-21* 36.50 36.50 36.50
* Fund released till December 2020
4. Students
4. Students Table-5L
(Degrees/programmesoffered
Degrees/programmes offeredand
andSubjects
Subjects offered
offered year-wise with
(with year) admission
with status)
admission status
Masters/ No. of students admitted

MS /PhD Discipline
Doctoral
2018-19 2019-20 2020-21
Masters M.S.(Pharm.) 10 10 13
Biotechnology
Doctoral PhD 01 1 4
Medicinal Chemistry
Doctoral PhD 01 3 4 +2*
Medical Devices
Doctoral PhD 01 0 1
Natural Products
Doctoral PhD 01 1 1
Masters
Masters M.S.(Pharm.)
M.S.(Pharm.) 1818 2121 2222
Pharmaceutical
PharmaceuticalAnalysis
Analysis
Doctoral
Doctoral PhD
PhD 0101 22 33
Masters
M.S.(Pharm.) Pharmacology
Pharmacology && 1515 1717 2222
Toxicology
Toxicology
Doctoral
Doctoral PhD
PhD 0101 33 3 3++2*2*
Masters
M.S.(Pharm.) 1717 2121 2222
Pharmaceutics
Pharmaceutics
Doctoral
Doctoral PhD
PhD 0101 22 3 3++1*1*
MBA
MBA 2020
MBA (Pharm) - -
(Pharm) MBA (Pharm) - -
(Pharm)
103 119 169
103 119 169
*PhDProject Seats
*PhD Project Seats
*PhDProject Seats
Table-5M
Degree/MS/MBA/ No. of students admitted
Degree/MS/MBA/ Discipline No. of students admitted
M.Tech/Ph.D Discipline 2017-19 2018-20 2019-20 2020-21
M.Tech/Ph.D 2017-19 2018-2096 2019-20 2020-21
MS 7 Disciplines 72 107 125
MS
Ph.D 7 7Disciplines
Disciplines 7211 967 107
12 12519 +5*
Ph.D
MBA (Pharm) 7 Disciplines 11- 7- 12- 19 +5* 20
MBA
*PhD(Pharm)
Project Seats - - - 20
*PhDProject
*PhD ProjectSeats
Seats
56
Presently 1: 16.6 (19 Faculty: 317 students)
Course Ratio
Ph.D 7 Disciplines 11 7 12 19 +5*
MBA (Pharm) - - - 20
*PhD Project Seats
Table-5N
(Teacher-Student ratio)
Course Ratio
Ph.D. (S-65:F19) /3.4:1
Masters’ (Science) (S-252 :F19) /13.2 :1
* Guest faculty members are also taking classes

* Guest faculty members are also taking classes
6. 6. Employability/ PlacementsStatus:
Employability/ Placements Status:Last
Last3 3years
years placements
placements status:
status: in in Campus/off
Campus/off campus
campus Table-5O
(Employablity/Placements
Total no of Not placed Status)
Total no of student Going for higher
Batch
student
Total no of Not placed placed
Total no of student Goingstudies
for higher
Batch Total no of
student
Not placed Totalplaced
no of student Going for higher
studies
Batch
2016-18 student
69 6 placed
54 studies
9
2016-18 69 6 54 9
2017-19 72 1 46 25
2017-19 72 1 46 25
2018-20 96 13 65 18
2018-20 96 13 65 18
7. 77 Teachers: International
Teachers:
Teachers: International
InternationalResearch Collaboration
Research
Research Collaboration
Collaboration
NIPER-Ahmedabad
NIPER-Ahmedabad
NIPER-Ahmedabad hashas
established
has an an
established
established International
an International
International Research Collaboration
Research
Research Collaboration
Collaboration with faculties
with
with from
faculties
faculties
Harvard
from Medical School,
Harvard
from Harvard MedicalBoston,
Medical School,USA,
School, JohnsUSA,
Bostion,
Bostion, Hopkins
USA, Johns
Johns University
Hopkins School
Hopkins of Medicine,
University
University School
School of ofBaltimore,
Medicine,
Medicine, MD,
USA,Baltimore,
Baltimore, MD,
MD, USA,
Massachusetts Massachusetts
Institute
USA, of Technology,
Massachusetts Institute
USA; of
Institute of Technology,
University USA;
USA; University
of Washington,
Technology, Seattle, of
University of Washingtion,
USA; the University
Washingtion,
Seattle,
Seattle, USA;
of Newcastle, USA; the
SchooltheofUniversity
Biomedicalof
University Newcastle,
Sciences
of School
School of
and Pharmacy,
Newcastle, Biomedical
Australia;
of Sciences
University
Biomedical and
and Pharmacy,
of Mississippi
Sciences School of
Pharmacy,
Australia; University of Mississippi School of Pharmacy, USA; Wayne State University Use-
Pharmacy, USA;
Australia; Wayne State
University University Use-inspired
of Mississippi Biomaterials
School of Pharmacy, USA;& Integrated
Wayne StateNano Delivery Systems
University Use-
inspired Biomaterials & Integrated Nano Delivery Systems Laboratory, USA; and National
Laboratory,
inspired USA; and National
Biomaterials UniversityNano
& Integrated of Ireland,
DeliveryGalway, Ireland.
Systems Under thisUSA;
Laboratory, initiative,
University of Ireland, Galway, Ireland. Under this initiative, research faculties from these foreign
and research
Nationalfac-
ulties from these
University of foreign
Ireland,Universities/Institutes
Universities/Institutes Galway,
have agreedIreland.
to Under have agreed
this
establish toresearch
establish
initiative,
future future
research research
faculties from
collaborations collaborations
andthese foreignand
academic
academic partnerships with
Universities/Institutes the
have faculty
agreed members
to from
establish
partnerships with the faculty members from NIPR-Ahmedabad. NIPR-Ahmedabad.
future research collaborations and academic
partnerships with the faculty members from NIPR-Ahmedabad.
8. 8. MoUs signed during 2019-20
MoUs signed During 2019-20
Table-5P
8. MoUs signed During 2019-20
(MoUs
MoUssigned during 2019-20) Date
University of Prince Edward Island, MoUs

Canada Date
21-03-2019
University
Sai of Prince
Life Sciences Edward
Limited, Island, Canada
Hyderabad 21-03-2019
01-04-2019
Université Paris-EstCréteil
Sai Life Sciences Limited, (UPEC) CréteilCedex, France
Hyderabad 01-04-2019
01-04-2019
Ophthalmic Marketing & Services Pvt. Ltd., Ahmedabad 03-09-2019
Université Paris-EstCréteil (UPEC) CréteilCedex, France 01-04-2019
Novartis Healthcare Pvt. Lt., Switzerland 11-06-2020
NovugenPharma, Shah Alam, Selangor, Malaysia 31-08-2020
All India Institute of Medical Sciences, Jodhpur 04-09-2020
IITGandhinagar, Gujarat 12-10-2020
All India Institute of Medical Sciences, Jodhpur 04-09-2020 57
State Implementing Agency (SIA), Gujarat Industrial Development
22-10-2020
Corporation (GIDC), Gandhinagar
Intas Pharmaceuticals Ltd.Ahmedabad, Gujarat 09-11-2020
University of Prince Edward Island, Canada 21-03-2019
Sai Life Sciences Limited, Hyderabad 01-04-2019
Université Paris-EstCréteil (UPEC) CréteilCedex, France 01-04-2019

All India Institute of Medical Sciences, Jodhpur 04-09-2020
State Implementing Agency (SIA), Gujarat Industrial Development

22-10-2020
Corporation (GIDC), Gandhinagar
Intas Pharmaceuticals Ltd.Ahmedabad, Gujarat 09-11-2020
9. Research: Active Research Areas:
Department of Biotechnology
Genetic profile and biomarker identification of OSCC patients through transcriptome analysis
• Dissecting the molecular mechanisms by which healthy cells become cancerous and metastasize
• Epigenetic modulation in diabetic nephropathy through miRNA
• Modulating breast cancer stem cells using exogenous hyaluronic acid induction
• Combining experimental and computational approaches to design and validation of anticancer-
molecules
• Structural and Functional Evaluation of Indole Based Anti-cancer Compounds targeting Histione-
deacetylases (HDACs)
• Molecular characterization of hippocampal sAHP modulation in temporal lobe epilepsy
• Role of ER-PM connecting junctional proteins in the potentiation of sAHP in aging
• Differential regulation of L-type calcium channels in ischemic brain injury
• Development of targeted therapeutics for acute myeloid leukemias (AMLs)
• Establishment of Patient-derived organoids (PDO) from head and neck cancer patient’s samples
Department of Medicinal Chemistry

• Multi target-directed ligands for Alzheimer’s proteopathy
• Ultrashort-peptides and peptidomimetics as smart-bioinspired material
• Reversible anticancer covalent inhibitors
• Construction of drug candidate(s) through C–H bond activation
• Sustainable synthesis and functionalization of carbo/heterocycles employing water as reaction me-
dium
• Green chemical process toward the synthesis of pharmaceuticals (drugs)
Department of Medical Devices
• Biomaterial Platforms
• Bioengineered three-dimensional aligned scaffold for intervertebral disc repair
• Polymeric conduit for spinal cord regeneration
• Smart 3D smart scaffolds for musculoskeletal tissue regeneration and repair
• Development of osteoconductive and high strength bone cements for joint arthoplasties
58
• Advanced strategies for cancer theranostics

• Paper microfluidics for diagnostic applications
• Micro/nanodevices for life-sciences and biomedical applications
• Development of bioengineered 3D disease models with a focus on cancer
• Fabrication of in vitro biophysical micro environment to understand disease biology
• Non-invasive screening platforms for early detection of cancer
Department of Natural Product
• LC-MS based dereplication strategy for isolation of novel bioactive natural products from plant
sources
• Establishment of Q-Marker system for standardization of traditional Ayurvedic polyherbal formu-
lations
• Finger printing herbal extracts by LC-UV-MS for chemical marker identification and extraction
efficiency
• Bio-prospecting of endolichenic fungi to discover novel bioactive scaffolds
• Identification of a Natural Products possessing GLP-1R agonist activity from the plants recognized
to have anti-diabetic potential;
Department of Pharmaceutical Analysis
• Drug-excipient compatibility studies

• Forced degradation studies of APIs and NCEs using HPLC, LC-MS/MS and qNMR
• Drug-Device compatibility and drug release study
• Bioanalysis, drug metabolism and pharmacokinetics
• Analytical Approaches for Polymer Characterization
• Biosimilars characterization
Department of Pharmacology and Toxicology
• Mitochondrial protection in ischemic stroke using intra-arterial mesenchymal stem cell treatment
• Stem Cell Therapy to Counteract Endoplasmic Reticulum Stress in Ischemic stroke
• Therapeutic strategy based on targeting growth hormone releasing hormone (GRH) receptors for
mitochondrial protection in ischemic stroke
• Investigating the role of inosine on inflammasome signaling in animal model of ischemic stroke
• Exploring the effect of endoplasmic reticulum stress in exacerbation of stroke pathology in chronic
kidney disease
• Deciphering the role of statin in neurogenesis after focal cerebral ischemia
• Exacerbation of ischemic stroke pathology in CKD: Involvement of mitochondrial dysfunction
• Probable mechanism of exacerbation of Ischemic stroke pathology in CKD
• Investigating the role of inosine in cerebral ischemia via pi3k/akt pathway
• Neuroprotective role of apelin-13 in post stroke depression
• Exploring neuroprotective effect of Phyllanthusemblica in animal model of ischemic stroke
• Exploring DAP-kinase pathway in Ischemic stroke by Intra-Arterial Mesenchymal Stem Cells
(MSCs) intervention
59
• Targeting interplay of lectin–like ER chaperone with calcineurin by stem cells therapy in ischemic
stroke
• Intra Arterial delivery of mesenchymal stem cells to target “ER-UPR mediated neuronal cell death”
in ischemic stroke
• Inhibition of Caspase 1 via Stem Cell Therapy to prevent Mitophagy and neuronal cell death in
cerebral ischemia.
• Investigating the role of enteric neuronal inflammation in the pathogenesis of Parkinson’s disease
• Targeting alpha synuclein accumulation and transmission: Role of AMPK activator
• Exploring the role of miRNAs in the breast cancer metastasis by regulating PKM2 and CD98 ex-
pression
• Effect of Boronic acid derivative on chemically induced oral carcinoma in mice via activation of
Pyruvate kinase M2
Department of Pharmaceutics
• Development of novel polymeric nanomaterial for effective cytosolic delivery of anticancer bioac-
tive
• Formulation Development of Injectable RNA interfering nanoparticle for targeted therapy of dia-
betic nephropathy
• Tripartite approach for the treatment of triple-negative breast cancer (TNBC) using graphene oxide
wrapped polymeric nanoparticles
• NIR laser activatable Nanoplates for the treatment of resistant tumors
• NIR laser activatable Nanoseeds for the prevention of post-surgical relapse of the resectable tumor
• Electrospraying Vs Lyophilization: Impact of on Solid-state properties of drug Nanosuspension
• Formulating the poorly soluble drugs in conventional dosage forms for bioenhancement
• Exploiting the oral route for delivery of macromolecular therapeutics using penetration enhancer(s)
10. Impact of NIPER
NIPER-Ahmedabad is committed to building human resource for promoting research and devel-
opment in the country and contribute towards ‘‘Make in India’’ initiative as a part of its national responsi-
bility. The Institute has established itself as one of the top technological pharmacy research institutes in the
country with research collaboration as an integral part of the growth strategy. It has expanded its outreach
to the industry as well as collaborated with the best academic institution of USA, UK, Australia, Ireland
and Malaysia for collaborating research, faculty visit, syllabus up-gradation and regulatory reforms with
several industries and leading institutes. The Institute has conducted various conferences, symposiums,
discussions which were attended by masters’ students, PhD, Post Docs and researchers from academia and
industry. The discussions are scientifically stimulating and have led to healthy cross talks and collabora-
tions.
11. Awards
1. The faculty got various multilateral Research Grants, Start-up Research Grants, IBRO Regions
Connecting Grant and various awards.
60
2. The student got various fellowships including ICMR-Senior Research Fellowship, DST Travel Grant,
Khorana Program for Scholars 2020, Japan-Asia Youth exchange program in science, Copenhagen Travel
Grant Award and won various awards including Best Posters Award, PharmInnova Award, got selected in
MHRD Innovation Cell, Japan-Asia Youth exchange program in science, selected in IBRO-APRC, Nestle
powder challenge award, Paul Dudley White International Scholar Award, etc.
12. Patents
The Institute filed 12 patents during the year.
13. Events/ Workshops carried out by the institute

NIPER Ahmedabad conducted various events, conference workshops/seminar/webinar/ training
for students. Some of the photographs of the various events in NIPER-Ahmedabad are as under:
7th Convocation of NIPER-A (18-01-2020)
A workshop on Mammalian cell culture, cell-based staining, imaging & molecular expression tech-
niques (16-20 September- 2019)
61
Dr. A P J Abdul Kalam innovation week (7th Oct. to 11th Oct. 2019)
International Conference On Neurological Disorders & Therapeutics (ICNDT) 2019 (24th to 26th Oct-2019 )
National Unity Day (31-10-2019)
62
5.5 NIPER Guwahati
NIPER Guwahati started functioning from 2008 under the Mentor Institute, Guwahati Medical
College, Guwahati up to July 2017. Dr. USN Murty took over the charge of the Director of the Insti-
tute from 3rd November 2016. NIPER-Guwahati is now functioning from its own permanent campus at
Changsari, Kamrup (Rural), North Guwahati, Assam from January 2020.
This institute owns six National Centers identified by different agencies of Govt. of India namely,
i. National Centre for Pharmacoengineering funded by Technology Development Transfer Board, DST; ii
BioNEST Incubation Centre, BIRAC, DBT; iii. Centre of Excellence Tribal Health Care from Ministry of
Tribal Affairs ; iv. GMP accredited pilot scale-up extraction facility, DBT; v. Quality assessment & value
addition Centre for herbal industry in the North Eastern states of India Under TIES, Min. of Commerce &
vi. GLP accredited animal house facility from Min. of DoNER.
1. Achievements: -
i. Ph.D. - 44 (enrolled), Degrees awarded – 09 (since inception),
ii. Total M.S. (Pharm.) (since inception),
Students enrolled – 460
Graduated - 324 (135 students are currently pursuing their P.G. courses)
iii. 95% of students in each department got placed in various reputed Industries like Novartis,
SPARC, Sun Pharma, Lupin, etc. through on/off campus placement modes.
iv. Publications: In total, 268 articles have been published since inception in peer-reviewed
International journal out of which 51 articles have been published in 2019-20 in various
National and International Journals.
v. Institute has total 08 patents including 1 design patent and 2 copyrights.
2. Details of faculty & staff
Administrative Staff : 11
Academic Staff
Associate Professors : 04
Assistant Professors : 06
Research Associate : 04
Staff: Technical : 05
Multi-Task Staff : 12
3. Total Allocation by the Government during the last 4 years.
Table-5Q
(Allocation by the Government during the last 4 years.) (Rs. in crores)
Year Allocation BE Allocation RE Total Release
2017-18 31.50 52.00 52.00
2018-19 33.50 33.50 33.50
2019-20 36.90 43.90 43.90
2020-21 34.45* 34.45 34.45
*Fund released till December 2020
*Fund4.released till December 2020
Students:-
Degrees/programmes offered and Subjects offered (with year)
63
Level Degree Discipline Year
Masters/ MS/ MBA/ 2017-18 2018-19 2019-20

Doctoral M.Tech/ Ph.D
2017-18 31.50 52.00 52.00
2018-19 33.50 33.50 33.50
2019-20 36.90 43.90 43.90
2020-21 34.45* 34.45 34.45
*Fund released till December 2020
4. Students:-
4. Students:-
Degrees/programmes offered and subjects offered (with year)
Table-5R
Degrees/programmes offered and Subjects offered (with year)
(Degrees/programmes and subjects offered year-wise with admission status)
Level Degree Discipline Year
Masters/ MS/ MBA/ 2017-18 2018-19 2019-20

Doctoral M.Tech/ Ph.D
Masters MS (Pharm) Pharmacology and 20 15 15

Toxicology
Masters MS (Pharm) Biotechnology 9 10 10
Masters M. Pharm. Pharmacy Practice 10 10 9
Masters M. Pharm. Pharmaceutics Not started 15 18
Masters M. Pharm. Pharmaceutical Analysis Not started 15 18
Doctoral Ph.D. Pharmacology and 2 2 1+2*

Toxicology
Doctoral Ph.D. Biotechnology 1 1 0
Doctoral Ph.D. Pharmacy Practice 1 1 1
Doctoral Ph.D. Pharmaceutics Not started 2 1+2*
Doctoral Ph.D. Pharmaceutical Analysis Not started 1 1+1*
5. Teacher-Studentratio:
5. Teacher-Studentratio:
Biotechnology : 1:5
PharmacologyBiotechnology:
and Toxicology 1:5 : 1:5
Pharmacy Practice :
Pharmacology and Toxicology:1:5
1:5
Pharmaceutics : 1:6
Pharmaceutical Analysis : 1:8
6. Employability/ Placements Status :
In the acedemic session 2019-20, 6 students have been placed in Novartis, Hyderabad. Many other
companies are in pipeline for placements.
7. Research
Biotechnology:

Development of Biopharmaceuticals using Biomolecular Engineering/Synthetic Biology approach
es -
• Oncogenic mRNA cleaving Deoxyribozymes
64
• Development of new approaches of Immune rerouting for targeting cancer cells

• Riboswitch mediated gene regulation of oncogenes
• Generation of random Protein coding sequences & Aptamer based therapeutics and diag-
nostic tools
Pharmacology And Toxicology
• Molecular Pharmacology
• Development of Cancer targeted drug delivery systems
• Screening Indian biodiversity and Indian Systems of Medicine in search of newer compounds in
the area of inflammation, arthritis, diabetes, cancer and hepatoprotective activities
• Targeting RANKL for the treatment of inflammation and cancer induced bone disorders
• Screening of NCE’s & North-East plant products for anti-Parkinson’s and anti-depressant effects
• Studies on the mitigation of drug induced toxicities through natural products derived from North-
East India
Pharmacy Practice
• Study of drug utilization pattern for antiepileptic and antipsychotic drugs

• Impact of Lipodystrophy on Quality of Life, Social and Psychological Aspects in PLHIV on First
line and Second line Anti-Retroviral regimen
• Haemovigilance: An important tool for improving safe blood transfusion practices
Pharmaceutics
• Lipid nanoarchitectionics against dreadful diseases

• Pharmacoengineering & Molecular Pharmaceutics
• Ligand anchored targeted drug delivery systems
• Drugs in-adhesive (DIA) matrix patch design
• Pathogen mimetic delivery devices
• Nanomedicines & Nanobiotechnology
• Translationalcutting edge pharmaceutical & biomedical research
• Pre-formulation studies of active pharmaceutical ingredients
• Dosage form development and optimization for poorly water-soluble drug molecules
• Drug targeting using lipid-and polymer-based nanoparticulate systems
• Micro-and nano-theragnosis concepts for the early detection and treatment of malignant diseases
and other life-threatening diseases
• Eradication of biofilm-producing microorganisms from the surfaces of implanted or inserted med-
ical devices into human body
Pharmaceutical Analysis:
• Bioavailability, IVIVC and IVIVE analysis

• Analytical (ICH Guidelines) & Bio-analytical (FDA-Industry Guidance) method development &
validation using HPLC, UPLC, LC- MS/MS
65
• Short-term/accelerated, mid-term and long-term stability testing of formulations and degradation

studies
• Pharmacokinetic, Toxicokinetic, Metabolic and Impurity profiling
8. Students’ enrolment:
Current strength of Ph.D. students: 31

(Pharmacology & Toxicology-13; Biotechnology-06; Pharmacy Practice-04; Pharmaceutics-06 and
Pharmaceutical Analysis-03)
Current strength of Masters Students: 135
(Pharmacology & Toxicology-30; Biotechnology-20; Pharmacy Practice-19; Pharmaceutics-33 and
Pharmaceutical Analysis-33)
9. Patents and Commercialization:

Institute has total 08 patents and 2 copyright, of which 1 is design patent.
10. Collaboration:
NIPER-G entered into 26 active MoUs. During the financial year, NIPER-Guwahati has exchanged
MoUs with the many Institutes like IIT-Bombay, ILBS-New Delhi, CSIR-CCMB, etc.
11. Impact of NIPER:
The establishment of NIPER-Guwahati has given a strong boost to the promotion of Pharma-
ceutical Education & Research in the North East region of India. Research efforts of NIPER Guwahati
have revived the studies on medicinal value of local herbs of North East Region against various diseases.
NIPER-Guwahati has organized a National conference entitled “Ethno-medicine and Traditional Health
Practices in Northeast region of India” in collaboration with the Society for Ethnopharmacology (SFE),
India, on 25th August 2018. Around 76 traditional healers from Assam, Mizoram, Meghalaya, Sikkim and
Tripura attended this meet and showcased their plant-derived medicinal products in individual stalls.
The faculty members of NIPER-Guwahati have been awarded 06 Extramural projects in the year
2018 from different funding agencies like DBT, DST, DRDO, Ministry of Environment, Forest and Climate
Change, etc.
NIPER-Guwahati is the only NIPER to have a Synthetic Biology Laboratory, which has been award-
ed ‘Genome Editing Task Force’ project by DBT, Govt. of India. The Institute has entered into several MoUs
with leading Research institutes, Hospitals and Pharmaceutical Industries to give students and faculty the
best of the academic and research support to eventually come up with technologies and products for the
benefit of the society.
12. Number of students received M.S./M. Pharm. degree
Table-5S
(Number of students received M.S./M. Pharm. degree)
66
into several MoUs with leading Research institutes, Hospitals and Pharmaceutical Industries to
give students and faculty the best of the academic and research support to eventually come up
with technologies and products for the benefit of the society.
11. Number of students received M.S./M. Pharm. degree Annual Report 2020-21
Sl. No. Batch Number of student Number of students

enrolled received degree
1 2015-17 26 26
2 2016-18 35 35
3 2017-19 39 39
2018-20
Some4Photographs 65
Felicitation 100 Chairman, AICTE 100

Total of Chief Guest, Prof. Anil D. Sahasrabudhe,
Some Photographs
Some
Felicitation of Chief Guest, Prof. Anil D. Photographs
Sahasrabudhe, Chairman, AICTE
NIPER-Guwahati conducted One-day Workshop on “Good Pharmacy Practice (GPP)

Training for Community
Felicitation of Pharmacists” on 28Anil
Chief Guest, Prof. September 2019.
D. Sahasrabudhe, Chairman, AICTE
NIPER-Guwahati conducted One-day Workshop on “Good Pharmacy Practice (GPP)

Training for Community Pharmacists” on 28 September 2019.
NIPER-Guwahati conducted One-day Workshop on “Good Pharmacy Practice (GPP) Training for
Community Pharmacists” on 28 September 2019.
67
5.6 NIPER- Raebareli

National Institute of Pharmaceutical Education and Research (NIPER), Raebareli was established
in 2008. It offers doctoral and masters programs in Medicinal Chemistry, Pharmaceutics, Pharmacology &
Toxicology, Regulatory Toxicology and Biotechnology with 150 enrolled students. It is currently running
from its transit campus in Lucknow with a world class central instrumentation facility within its premises
and an animal house to perform pre-clinical studies.
1. Achievements
• The Division of Pharmaceutics at NIPER-Raebareli developed new technologies for nano-based

drug-delivery systems for better delivery of anti-psychotic and anti-tubercular drugs.
• The Institute has filed 12 patents and one copyright till 2019-20.
• The Institute received nearly one crore rupees as extramural research grant for research in the the-
matic areas of the Institute.
• More than 100 publications in last 3 years (52 publications in the current year) in the journals of
International repute.
• One book entitled “Handbook on the Preparedness on Chemical Warfare Agents” published by
Elsevier/ Academic Press (USA).
• Central Instrumentation Facility was created housing sophisticated instruments such as Nuclear
Magnetic Resonance (NMR), LC-MS (QTOF-HRMS), HPLC, FT-IR, Flow-cytometry etc.
2. Academic/Non-Academic staff
Academic 01 Director Regular

10 Associate Professor/ Assistant Professor (7 Regular, 3 Contract)
Non-Academic 19 Administrative/Technical Staff (7 Regular, 12 Contractual/Outsourced)

Total 19 posts of regular faculty and 25 posts of regular Non-faculty have been created in February, 2019.
Second Phase recruitment for regular staff is under process and the posts are likely to be filled shortly.
3. Total fund allocation by the Government during the last 4 years:-
(Allocation of fund by the GovernmentTable-5T

during the last 4 years)
(Total fund allocation by the Government during the last 4 years)
(Rs. in Crore)
(Rs. in Crore)
2017-18 8.50 9.50 9.45
2018-19 12.00 15.00 15.00
2019-20 16.00 17.01 17.01
2020-21* 22.00 22.00 22.00

4. Students
68 Degrees/programmes offered and subjects offered (with year) with admission status:

2019-20 16.00 17.01 17.01
2020-21* 22.00 22.00 22.00

4. Students
4. Students
Degrees/programmes offeredoffered
Degrees/programmes and subjects offeredoffered
and subjects (with year)
(withwith
year)admission status: status:
with admission
Table-5U
Subject Degree Sanctioned seats Admission Status
Medicinal Chemistry M.S. (Pharm) 22 20
Pharmaceutics M.S. (Pharm) 17 15
Pharmacology & Toxicology M.S. (Pharm) 16 15
Regulatory Toxicology M.S. (Pharm) 11 11

Medicinal Chemistry Ph.D 02 02
Pharmaceutics Ph.D 02 02
Pharmacology & Toxicology Ph.D 02 02
5. Teacher Student Ratio - 1:14

5. TeacherStudent Ratio - 1:14
6. Employability/ Placements StatusA graph showing the year-wise placement status of
6. Employability / Placements Status, A graph showing the year-wise placement status
NIPER-Raebareli.
of
NIPER-Raebareli.
(Year-wise placement status of NIPER-Raebareli)
Graph-5A
(Year-wise placement status of NIPER-Raebareli)
69
List of some of the companies participated in 2020
7. Awards/ Teachers:
Dr. S.J.S Flora was Ranked as No.1 Toxicologist in India

In a subject-wise analysis conducted by the team of scientists at Stanford University, ten scientists
from different NIPERs spread across the country have found place in the world ranking of top 2% scientists
in India. Dr. S.J.S Flora, Director was ranked No. 1 in the list of Indian toxicologists and globally he was
ranked 44th.
8. Research
a. Active Research Areas:
• Neurodegenerative diseases
• Heavy Metal Toxicity
• Japanese Encephalitis
• Tuberculosis
• Development and evaluation of drugs using Nano formulations.
• Development of green and eco-friendly synthetic methods
b. Projects: Ongoing : 03
c. Publications and Patents : 50
9. Impact of NIPER
NIPER-Raebareli has emerged as an Institution of significance both in academics and research
particularly in Central India with modern laboratories, highly sophisticated instrument. It has achieved
70
number of milestiones and Pharma industries have shown interest in collaborating with us besides training
our students for short term and long term basis.
The Institute initiated collaborative projects/ work with national and international academic and
research institutes in the area of immediate importance like such as Japanese Encephalitis, Tuberculosis
and Neurodegenerative diseases. An online portal has been created to facilitate seamless sample analysis
for drug discovery. NIPER Raebareli is also providing highly skilled human resources for the Indian Phar-
The Institute started the “Distinguished Lecture Series” to bring the subject experts
maceutical Industry.
in the field of Pharmaceutical Sciences on a regular basis with a purpose to bring eminent
10. researchers
Various events/workshops carried
to talk about their out byand
research the institute
also to acquaint young students with the
emerging trends in this field. To state in this series, various eminent academic & Industry
i. Distinguished
experts Lecture
were invited Series
who visited and interacted with faculty & students of NIPER-R for
possible research collaboration.
The Institute started the “Distinguished Lecture Series” to bring the subject experts in the field of
Pharmaceutical Sciences on a regular basis with a purpose to bring eminent researchers to talk about their
ii. and
research Rajbhasha Workshop
also to acquaint young students with the emerging trends in this field. To state in this series,
various eminent academic & Industry experts were invited who visited and interacted with faculty & stu-
Hindi workshop was organized on 14th June to promote progressive use of Hindi as an
dents of NIPER-R for possible research collaboration.
official language and in accordance with Official Language Act, rules and orders.
ii. Rajbhasha Workshop
iii. Workshop on “Scientific Writing and Research Ethics’’ (October 31, 2019)
Hindi workshop was organized on 14th June to promote progressive use of Hindi as an official lan-
guage andTheinInstitute conducted
accordance one dayLanguage
with Official workshopAct,
on rules
‘’Scientific Writing and Research Ethics’’ which
and orders.
focused on creativity in writings and scientific research in all its conceptual, methodological,
iii. disciplinary
Workshop on and“Scientific
professional aspects.
Writing and Research Ethics’’ (October 31, 2019)
The Institute conducted one day workshop on ‘‘Scientific Writing and Research Ethics’’ which fo-
iv. Constitution
cused on creativity Day Activities
in writings and scientific research in all its conceptual, methodological, disciplinary
and professional aspects.
The Institute organized various programs/ activities on the theme throughout the year.
iv. Constitution Day Activities th
DrP.D. Vaghela,organized
The Institute Secretary Department
various programs/ofactivities
Pharmaceuticals wasthroughout
on the theme the Chiefthe
Guest
year. of 5
Convocation of NIPER-Raebareli
Dr. P.D. Vaghela, Secretary Department of Pharmaceuticals was the Chief Guest of 5th Convocation
of NIPER-Raebareli
5.7 NIPERKolkata
71
The National Institute of Pharmaceutical Education & Research Kolkata (NIPER-
Kolkata) was established in the year 2007 and is presently functioning from its rented campus
atChunilalBhawan,Maniktala, Kolkata. It is striving to achieve academic excellence through
5.7 teaching, research and scholarship. At the moment teaching remains central function and
NIPER Kolkata
overridingresearch
teaching, goal. and scholarship. At the moment teaching remains central function and
overriding
The National goal.Institute of Pharmaceutical Education & Research, Kolkata (NIPER-Kolkata) was
1. Achievements
established in the year 2007 and is presently functioning from its rented campus at Chunilal Bhawan, Man-
1. Achievements
iktala, Kolkata. It is striving to achieve academic excellence through teaching, research and scholarship. At
In
the moment teaching 2020-21(till
remains November 2020)and
central function 24 overriding
research papers
goal. published, 4MoU signed. Since
In 2020-21(till November 2020) 24 research
inception, 479students have been graduated,Master- 477students papers published,
and PhD-4MoU signed. Since
2 students.
inception, 479students have been graduated,Master- 477students and PhD- 2 students.
1. Achievements
2. Academic and
In 2020-21(till Non-Academic
November staff: papers published, 4 MoU signed. Since inception, 479
2020) 24 research
students2.haveAcademic and Non-Academic
been graduated, staff: and PhD- 2 students.
Master- 477 students
Total19 posts of faculty and 25 posts of Non-faculty have been approved by
2. AcademicTotal19
Department and posts of faculty
Non-Academic
of Expenditure and2019.
staff:
in January 25 posts of Non-faculty have been approved by
Department
Total 19 posts of of
Expenditure
faculty andin25January
posts of2019.
Non-faculty have been approved by Department of Expen-
diture in3. January 2019.
Total allocation by the Government during the last 4 years
3. Total allocation by the Government during the last 4 years
3. Total allocation(Allocation
by the Government
of fund byduring the last 4 years
the Government during the last 4 years)
(Allocation of fund by the Government during the last 4 years)
Table-5V (Rupees in Crore)
(Allocation of fund by the Government during (Rupees the last 4in
years)
Crore)
Year BE RE Total(Rupees in Crore)
Year BE RE Total
Release
2017-18 9.00 11.50 Release
11.50
2017-18
2018-19 9.00
12.00 11.50
12.00 11.50
12.00
2018-19
2019-20 12.00
16.00 12.00
18.00 12.00
18.00
2019-20 16.00 18.00 18.00
2020-21* 23.00 23.00 23.00
2020-21* 23.00
*Fund released till December, 2020-21.23.00 23.00
*Fund released till*Fund released
December, till December, 2020-21.
2020.
4. Students
4. Students
4. Students
Degrees/programsoffered,
Degrees/programs offered,and
andSubjects
Subjectsoffered
offered(with
(withyear)
year)with
withadmission
admissionstatus:
status:
Degrees/programs offered, and Subjects offered (with year) with admission status:
(Degrees/programs and SubjectsTable-5W offered year-wise with admission status)
(Degrees/programsand
(Degrees/programs andSubjects
Subjects offered
offered year-wise
year-wisewith
withadmission
admissionstatus)
status)
Level Degree Discipline No. of students admitted
Level Degree Discipline 2015 201 No. 2017of students
2018 admitted
2019-2 2020-21
2015
- 201 2017
6-17 - 2018
-19 2019-2
0 2020-21
-
16 6-17 -
18 -19 0
16 18
Masters M.S. Medicinal Chemistry 17 14 16 08 08 14
Masters (Pharm.)
M.S. Medicinal
Natural Chemistry
Products 17
13 14
14 16
14 08
08 08
06 14
07
(Pharm.) Natural Products 13 14 14 08 06 07
Pharmacoinformatics 09 14 14 03 04 05
Pharmacoinformatics 09 14 14 03 04 05
Pharmacology - - - 08 13 14
Pharmacology - - - 08 13 14
72
& Toxicology
Rare disease - - - - - -
Pharmaceutics - - - - - 14
Doctoral Ph.D. Medicinal Chemistry - 04 04 - - 03
Natural Products - 04 04 01 - -
Pharmacoinformatics - 02 04 - -
Pharmacology - - - - 01
& Toxicology 03
Pharmaceutics - - - - -
02
Teacher-Student 1:6 1:6
ratio:
Classes are managed by NIPER faculty and visiting faculty /guest faculty.
Classes are managed by NIPER faculty and visiting faculty /guest faculty.
6. Employability/ Placements Status
Since inception, large number of Pharma Companies came to NIPER-Kolkata to recruit students.
Most of the students have been large
Since inception, absorbed in the
number ofindustries, colleges and
Pharma Companies research
came institutes. A number
to NIPER-Kolkata to of
students are pursuing higher studies within the country as well as abroad. Placement was achieved for
recruit students. Most of the students have been absorbed in the industries, colleges and
researchaccording
these students institutes.to
Atheir
number of students
options are pursuing
for employment higher studies
in companies as wellwithin the country
as in Institute as
for teaching
well as abroad.
and higher studies. Placement was achieved forthese students according to their options for
employment in companies as well as in Institute for teaching and higher studies.
Table-5X
(Employability/Placements
(Employability/Placements Status)
(Employability/Placements Status)
Status)
Masters
Masters :: M.S.
M.S. (Pharm.)
(Pharm.)
Year (Batch) Total No. of students No. of students placed
Year (Batch) Total No. of students (*as per No. of students
available placed
records with us)
2007-2009 29 (*as per available
24 records with us)
2008-2010 32 26
2007-2009 29 24
2009-2011 40 29
2008-2010
2010-2012 32 49 3326
2009-2011
2011-2013 40 47 29
30
2012-2014 37 29
2010-2012 49 33
2013-2015 49 20
2011-2013
2014-2016 47 42 30 29
2012-2014
2015-2017 37 39 29 32
2013-2015 49 20
2014-2016 42 29
2015-2017 39 32
2016-2018 42 36
2017-2019 44 32
2018-2020 27 19
Total 477 339
Doctorate: Ph.D.
2013-2017 02 02 Placed 73
2016-2020 10 09 Pursuing
2017-2021 12 10 Pursuing
2014-2016 42 29
2015-2017 39 32
2016-2018 42 36
2017-2019
Annual Report 2020-21 44 32
2018-2020 27 19
‘ Total 477 339
Doctorate: Ph.D.
2013-2017 02 02 Placed
2016-2020 10 09 Pursuing
2017-2021 12 10 Pursuing
2018-2022 01 01 Pursuing
2019-2023 01 01 Pursuing
2020-2024 08 08 Pursuing
Total 34 32 Pursuing and 2 placed
6. Recognition to Faculty:
7. Recognition to Faculty:
Faculty of NIPER-Kolkata includes DST awarded/funded faculty and other guest
faculty
Faculty of NIPER-Kolkata
are also involved from theincludes
MentorDST awarded/funded
Institute faculty of
and other Institutes and other guest
Kolkata, faculty are also
such as
involved from the Mentor Institute and other Institutes of Kolkata, such as Calcutta University, Jadavpur
Calcutta University, JadavpurUniversity, Indian Association for the Cultivation of Science
University, Indian Association for the Cultivation of Science Kolkata, Bose Institute Kolkata, Saha Institute
Kolkata, Science,
of Nuclear Bose Institute Kolkata, Saha
CSIR-CGCRI, NICED,Institute
AIIH&PHof Nuclear Science,
and SSKM CSIR-CGCRI,
Hospital, TCG Life NICED,
Sciences and they
areAIIH&PH and SSKM
well recognized Hospital,
in their TCG Life
own areas. For Sciences and they
rare diseases are well
16 guest recognized
faculty in their own
from AIIHPH, Kolkata Medical
areas. Kolkata
College, For rareApollo
diseasesHospital,
16 guestMedica
facultysuper
from specialty
AIIHPH, hospital,
Kolkata Medical College,
Tata Medical Kolkata
centre all from Kolkata,
Drugs controller Kolkata, CSIR-IICB etc. Five adjunct faculties (2 from Sanofi India Ltd.,
Apollo Hospital, Medica super specialty hospital, Tata Medical centre all from Kolkata, Drugs 1 from Biological
E and 2 from CSIR-CGCRI) are also part of the faculty.
8. Research

• Structural bioinformatics; New drug discovery/repurposing for Infectious Diseases and Metabolic
disorders.
• Structural bioinformatics; New drug discovery/repurposing for Infectious Diseases and Metabolic
disorders.
• Metabolic bio-engineering for production of small molecules
• Immunology, Leishmaniabiology, Vaccines.
• Diabetes mediated Non-alcoholic steatohepatitis and Hepatocellular carcinoma: Pharmacological
and biochemical characterization.
• Phytochemistry; Chemicals transformation; Herbal products analysis
• Network Pharmacology of herbal medicines in Respiratory diseases
• Biopharmaceuticals
9. Innovation/ Knowledge transfer/ MoUs signed
Memorandum of Understanding various Institutes/organizations executed to promote academic
74
and research co-operation for fostering research worksigned between the following:
1. M/s. Broadline Technologies Private Limited, Chennai and NIPER Kolkata;
2. Innvocept Global Solution Pvt. Ltd., Thane and NIPER Kolkata.
3. Sikkim University, Gangtok and NIPER Kolkata.
4. Vishwa-Syntharo PharmaChem Private Limited Pvt. Ltd., Chennai and NIPER Kolkata
10. Impact of NIPER:
a. A total of 477 highly skilled students have been graduated.

b. 2 scholars have been awarded with the Ph.D. degree.
c. 339 students are engaged to work in companies/institutions.
d. 113 Research papers have been published.
e. M.S. (Pharm.) students of NIPER-Kolkata stood 1st and 2nd position in the National Eligibility
Test for Ph.D. course admission conducted by NIPER-Hyderabad, Mohali and Ahmedabad continuously
three years 2016-17, 2017-18 and 2018-19 respectively.
11. Institution Leadership Impact of NIPER
Institutions are important for the development and success of a society. Institutions serve as a
place for the evolution of ideas. An institute must labor to meet the requirement of social circumstances.
NIPER-K has taken a major research drive towards developing newer strategies to tackle two important
infectious diseases like tuberculosis and Leishmaniasis.
NIPER Kolkata Webinar on COVID-19 on 30-April-2020
The 8th Convocation of NIPER Kolkata held on 30.09.2020 at NIPER Kolkata.
75
The 8th Convocation of NIPER Kolkata held on 30.09.2020 at NIPER Kolkata.

5.8 NIPER-Hajipur
5.8 NIPER-Hajipur
NIPER-Hajipur
NIPER-Hajipur started functioning
started functioning in 2007
in 2007 under under the mentorship
the mentorship of Rajendraof RajendraResearch
Memorial Memorial
Research
Institute of Medical Institute of Medical Patna.
Sciences (RMRIMS), Sciences (RMRIMS),
It imparts education Patna. It imparts
in three education
specializations, in (i)
namely three
specializations,
M.S. in Biotechnology, (ii)namely (i) M.S.
M. Pharm. in Biotechnology,
in Pharmacy (ii)(iii)
Practice, and M. M.Pharm. in Pharmacy Practice
S. in Pharmacology and (iii)
& Toxicology
M. S. of
with an intake in 19
Pharmacology & Toxicology with an intake of 19 in each course.
in each course.
1. Achievements
10. Achievements
Since inception, total 393 students have been passed out (M. pharm- 382 and Ph.D- 11), 83 re-
search papers have beeninception,
Since publishedtotal
and 393
5 MoUs have have
students been been
signed so far.out
passed NIPER-Hajipur has and
(M. pharm- 382 signed 4 MoUs
Ph.D- 11), 83
in this academic year. 1 Patent was filed in November 2020.
research papers have been published and 5 MoUs have been signed so far. NIPER-Hajipur has
2. signedof
Details 4 faculty
MoUs in&this
staffacademic year. 1below
are appended Patent was filed November 2020.
Academic : Director, 05 (regular) and 03 (on Contract)
2. Details of faculty
& staff are appended below
Non-Academic Academic
: : Director,
01 (regular) and 03 05
(on(regular)
contract)and 03 (on
Contract)
3. Fund allocationNon-Academic
by the Government
: during the last and
01 (regular) 4 years:
03 (on contract)
Table-5Y
3. Fund allocation by the Government
(Fund allocation during the
by the Government last 4the
during years:
last 4 years)
Year Budget Estimated Revised Estimated Total Release

(Rs. in Crores)
2017-18 6.00 5.00 5.00
2018-19 9.50 9.50 9.50
2019-20 10.50 10.50 5.00
2020-21* 15.00 15.00 15.00
76 4. Students
Students are admitted through a common Joint Entrance Examination (JEE) of all
NIPERs. The PG sanctioned seat intake in each of the 03 (three) existing departments is 19
(Rs. in Crores)
2017-18 6.00 5.00 5.00
2018-19 9.50 9.50 9.50
2019-20 10.50 10.50 5.00
2020-21* 15.00 15.00 15.00 Annual Report 2020-21
4. Students
4. Students
Students are admitted through a common Joint Entrance Examination (JEE) of all NIPERs. The PG
sanctioned seatStudents
intake in are
eachadmitted
of the 03 through
(three) existing
a commondepartments is 19 (nineteen)
Joint Entrance and 02(JEE)
Examination (two) for
of Ph.D.
all
in each Department.
NIPERs. The PG sanctioned seat intake in each of the 03 (three) existing departments is 19
Table-5Z
(nineteen) and 02 (two) for Ph.D. in each Department.
(Capacity intake for PG and Ph.D degrees)
Students Male Female General OBC SC ST EWS Total
+PH
PG-II (passed out) 23 13 17 10 07 02 0 36
(Batch 2018-20)
PG-II (current)
(Batch 2019-21) 27 15 08 20 10 04 0 42
(Batch 2019-21)
(Batch
PG-I 2019-21)
(current) 29 23 22 14 7 3 5+1 52
PG-I (current) 29 23 22 14 7 3 5+1 52
PG-I (current)
(Batch 2020-22) 29 23 22 14 7 3 5+1 52
(Batch 2020-22)
(Batch
Ph.D.2020-22)
(on roll) 14 06 13 04 03 0 0 20
Ph.D. (on roll) 14 06 13 04 03 0 0 20
Ph.D. (on roll) 14 06 13 04 03 0 0 20
5. 5. Teacher-Student
Teacher-Student ratio ratio 1:10 1:10
5. Teacher-Student ratio 1:10
Employability/ ratio
5. 6.Teacher-Student Placements Status
1:10
6. 6. Employability/
Employability/ Placements
Placements StatusStatus
Placement details of NIPER-Hajipur MS Students (For last 3 years)
Table-5AA
Placement details of NIPER-Hajipur MS Students (For last 3 years)
Placement (Placement
details of NIPER-Hajipur MS Students MS
details of NIPER-Hajipur (ForStudents
last 3 years)
for last 3 years)
Batch Year Total No of Placement % Placement
Batch Year Total
Students No of Placement
Industry Higher %
(Total) Placement
Students Industry Higher (Total)
Students Industry Higher
Studies (Total)
Studies
2016-18 28 16 Studies09 89%
2016-18 28 16 09 89%
2016-18
2017-19 2832 1621 0904 89%78%
2017-19 32 21 04 78%
2017-19
2018-20 32 36 21 05 04 07 78%33%
2018-20 36 05 07 33%
2018-20 36 05 07 33%
Placements details of NIPER-Hajipur PhDTable-5AB
Students (For last 3 years)
Placements details of NIPER-Hajipur PhD Students (For last 3 years)
Placements details
(Placements details of NIPER-Hajipur(For
of NIPER-Hajipur PhD Students PhD last 3 years)for last 3 years)
Students
Batch Year Total No of
Students Placement %
(Total) Placement
Students (Total)
Students Industry Higher (Total)
Industry Higher
Industry Higher
Studies
Studies
2012-17 3 1 Studies2 100%
2012-17 3 1 2 100%
2012-17
2013-18 32 10 22 100%
100%
2013-18 2 0 2 100%
2013-18
2014-19 21 00 21 100%
100%
2014-19 1 0 1 100%
2014-19 1 0 1 100%
7. Research
7. Research
7.1 7. Departmental
Research Research Activities: Deptt. of Biotechnology
7. 7.1.Research
Departmental Research Activities: Dept. of Biotechnology
7.1. Departmental Research Activities: Dept. of Biotechnology
7.1. Departmental Research Activities: Dept. of Biotechnology
 Chromosome organization and regulation of transcription in pathogenic organisms
 Chromosome organization and regulation of transcription in pathogenic organisms 77
mechanism organization
  Chromosome of drug resistance and development
and regulation of effective
of transcription drugs against
in pathogenic resistant
organisms
 mechanism of drug resistance and development of effective drugs against resistant
microbes of drug resistance and development of effective drugs against resistant
 mechanism
microbes
Structure guided discovery of small molecule/peptide-based inhibitors as drug candidates.
 microbes
 Structure guided discovery of small molecule/peptide-based inhibitors as drug candidates.
Application
  Structure of discovery
guided Nanotechnology asmolecule/peptide-based
of small a biosensor for detectioninhibitors
and diagnosis ofcandidates.
as drug diseases.
• Chromosome organization and regulation of transcription in pathogenic organisms

• mechanism of drug resistance and development of effective drugs against resistant microbes
• Structure guided discovery of small molecule/peptide-based inhibitors as drug candidates.
• Application of Nanotechnology as a biosensor for detection and diagnosis of diseases.
• Application of functionalized and conjugated gold Nanoparticles for improved antimicrobial effi-
cacy.
• Ubiquitin conjugating enzymes as drug targets in Leishmaniadonovani.
• Green synthesized gold nanoparticles as antifungal and antiparasitic agents.
7.2 Departmental Research Activities: Dept. of Pharmacy Practice
• Exploration of nutritional and immunological factors along with quality of life in patients of viscer-
al leishmaniasis.
• Exploration of cardiovascular risk along with quality of life and KAP study in patients with HIV/
VL co-infection in Bihar
• Evaluation of Efficacy and Toxicity of Concurrent Capacitabine with Radiation in Locally Ad-
vanced Rectal Cancer Patients of Bihar.
• Knowledge, Attitude and Practices study regarding awareness on cervical cancer screening and
HPV Vaccination in Bihar, India.
• Evaluation of Adverse Drug Reaction of Imatinib with reference to P110 & p190 fusion Transcripts
in Chronic Myloid Leukemia Patients and its exploration in Indian Populations.
• Assessment of Risk Factors and Management of Post Kala Azar Dermal Leishmaniasis, Project.
• HPV and its Associated Clinical Outcomes in Cervical Cancer.
7.3 Departmental Research Activities: Deptt. of Pharmacology & Toxicology
• Cognito-behavioural studies including Fluorosis-induced neuro-developmental disorders.

• Anticancer research with electrochemical therapy, immunotherapy and chemotherapy approaches
• Role of extracellular vesicles (Exosomes) in drug-tolerant persister cells and its contribution to
cancer-initiating cells in breast cancer.
• To study the molecular reprogramming landscape of pre and post neoadjuvant chemotherapy in
Gastric Cancer and its therapeutic implications in Humanized mice for the 3Dorganoid model.
• Establishing the cross-talk between RNA methylation and tumor-initiating cells with respect to
Autophagy /EMT /Metabolism Extracellular vesicles
• Evaluation of investigational drugs on different disease model (wound healing, Diabetes, Hyper-
tension, Cancer)
7.4 Funded Projects
• Modulation of fluoride-induced histopathological, cognitive-behavioural alteration in adult and

developing rodents by naringin (Rs ~ 96 Lakhs, Funding agency ICMR)
8. Special Lectures/Webinars conducted
The Institute organized special lectures on ‘Visceral Leishmaniasis and Kala-azar – current status
78
and future implications’, ‘Role of actin and cytoskeletion proteins in survival and infection of parasite
L. donovani’, special webinar on the topic “COVID-19 outbreak – the significance of virus and its ur-
gent awareness”. In collaboration with NIPER-Kolkata, NIPER-Hajipur organized Webinar on the theme
“COVID-19: from a challenge to an opportunity for Indian pharmaceutical companies to be self-reliant”
Foundation day was celebrated on 26th and 27th November through online mode with Dr. YK Gupta as
the chief guest.
9. Impact and achievements
The Institute has successfully produced 382 PG and 11 PhD students in three disciplines who are
either employed in different pharmaceutical industries or pursuing their higher education in different
institutes or universities across the globe. Many of NIPER Hajipur ex-students are engaged as faculty at
different institutions. Pharmacology and Toxicology laboratory established in October 2020. During the
year, animal house has received CPCSEA approval.
10. Future plan of NIPER-Hajipur

NIPER-Hajipur is in process of expanding its academic infrastructure by incorporating 2 new de-
partments –Pharmaceutics and Pharmaceutical Analysis from next session. A central instrumentation fa-
cility is under development. Recruitment in regular positions in the 1st phase for teaching/non-teaching
position has been completed. Infrastructure development of campus with hostels, boundary walls, and new
buildings for academic activities is under process.
Some photographs
Republic Day and Independence Day Celebrations
Republic Day and Independence Day Celebrations
79
80
CHAPTER

-6
PUBLIC SECTOR UNDERTAKINGS (PSUs)
6.1 Central Public Sector Undertakings
6.2 Indian Drugs & Pharmaceuticals Ltd. (IDPL)
6.3 Hindustan Antibiotics Ltd. (HAL)
6.4 Karnataka Antibiotics & Pharmaceuticals Ltd. (KAPL)
6.6 Rajasthan Drugs & Pharmaceuticals Ltd. (RDPL)
81
82
CHAPTER 6
CENTRAL PUBLIC SECTOR ENTERPRISES
Background
1. There are five Public Sector Undertakings (PSUs) under the aegis of the Department, namely, Kar-
nataka Antibiotics & Pharmaceuticals Limited (KAPL), Bengal Chemicals and Pharmaceuticals Limited
(BCPL), Hindustan Antibiotics Limited (HAL), Indian Drugs & Pharmaceuticals Limited (IDPL) and Ra-
jasthan Drugs & Pharmaceuticals Limited (RDPL).
2. The Cabinet in April 2016, while considering a proposal for sale of part of surplus and vacant land
of Hindustan Antibiotics Limited (HAL) for meeting its liabilities directed that the Minister of Finance,
Minister of Road Transport, Highways & Shipping and Minister of Chemicals & Fertilizers may compre-
hensively examine the status of all pharmaceutical companies in the public sector and suggest the future
course of action. After detailed deliberations, the Ministers recommended in December 2016 that:
i. Only that much of surplus land of Hindustan Antibiotics Limited (HAL), Indian Drugs & Pharma-
ceuticals Limited (IDPL), Rajasthan Drugs & Pharmaceuticals (RDPL) and Bengal Chemicals &
Pharmaceuticals Limited (BCPL) as would be required to meet the liabilities be sold through open
competitive bidding to Government agencies and the outstanding liabilities be cleared from the
sale proceeds. Voluntary Separation Scheme/Voluntary Retirement Scheme also be implemented
in these PSUs to pave way for their closure. Remaining part of the land should be managed in ac-
cordance with guidelines of Department of Investment and Public Asset Management (DIPAM)
and Department of Public Enterprises (DPE) in this regard and if need be, vested in a SPV created
for this purpose.
ii. After liabilities have been met, balance sheet cleansed and the Voluntary Separation Scheme/Vol-
untary Retirement Scheme effected, the IDPL & RDPL be closed and HAL & BCPL be put up for
strategic sale.
iii. While taking a decision to close the PSUs, the Department may also explore the possibility of hiv-
ing off the subsidiary companies of HAL and IDPL for private participation, wherever found viable.
The Cabinet considered the recommendations of the Ministers’ and approved the same in its meeting held
on 28.12.2016.
3. The Department/ PSUs had the tenders issued for sale of surplus land of the PSUs, but no bids
were received, the bidding being restricted to the government agencies as per the Cabinet’s decision. As
the land could not be sold, the liabilities of the PSUs could not be met and no progress made in respect of
their closure/ strategic sale. The matter was again placed before the Cabinet, which in its meeting held on
17.07.2019 decided to:
(i) Modifying the earlier decision dated 28.12.2016 of sale of land of PSUs to government agencies and
83
instead permitting the sale of land as per revised DPE’s guidelines dated 14.06.2018.
(ii) Providing budgetary support as loan to the tune of Rs 330.35 cr. for meeting the employees’ liabili-
ties (Unpaid salary – Rs. 158.35 cr. + VRS Rs.172.00 cr.) as per following break-up:
a. IDPL – Rs. 6.50 cr.

b. RDPL – Rs. 43.70 cr.
c. HAL – Rs. 280.15 cr.
(iii) Constitution of a Committee of Ministers for taking all decisions pertaining to closure/ strategic
sale of the four Public Sector Undertakings, including the sale of assets and clearance of outstand-
ing liabilities.
4. Separately, the Cabinet Committee on Economic Affairs (CCEA) in its meeting held on 1.11.2017
has ‘in principle’ approved strategic disinvestment of 100% Government of India equity in Karnataka An-
tibiotics & Pharmaceuticals Limited (KAPL), Bengaluru.
Table-6A
(Summary of CPSUs of the Department)
(As on December 2020)
(As on December 2020)
HAL IDPL RDPL BCPL KAPL
Established in 1954 05/04/1961 02-11- 1981 1981
1978
Classification Sick Schedule-B, Sick PSU CPSE- Sick (now Miniratna
UNDER Profit “C”
CLOSUR Making)
E
Net worth ( in cr.) -606.20 -7785.84 cr 21.32Cr. -53.68 216.53
Turnover ( in cr.) 63.97 0.15 cr NIL 55.50 366.67
Operating -19.47 -160 cr -12.60CR 22.30 27.50

profit/loss ( in cr.) (loss before
Interest,De
preciation)
Liabilities ( in cr.) 1053.08 7860.65 cr. 75.29Cr 208.92 95.37
Referred to BIFR 1997 Referred to BIFR on NO 1992 No
25.05.1992
BIFR declared IDPL Sick on
12.08.1992
Total land 263.57 Gurgaon: 89.79 acres 37856 72.89 acre 40 Acres & 8
acres (Freehold) SQ.MTR Guntas
Hyderabad: 891.95 acres
(Freehold)
Rishikesh: 833.878 acres
(Leasehold)
Total: 1815.618 acres
(Excluding Subsidiary Unit)

Leasehold NIL 833.878 acres NIL 1.10 acre -
Freehold 263.57 981.74 acres 37856 71.79 acre 40 Acres & 8
acres Sq.Mtr. Guntas
84
6.2 Indian Drugs and Pharmaceuticals Ltd. (IDPL)
Background:
Indian Drugs & Pharmaceuticals Limited (IDPL) was incorporated as a public limited company on
5th April 1961 under the Companies Act, 1956. The main objectives of the company were to create self-suf-
ficiency in respect of essential lifesaving medicines, to free the country from dependence on imports and
to provide medicines to the millions at affordable prices. IDPL was basically conceived and established as
a part of Healthcare Infrastructure and has played a pioneering infrastructural role in the growth of Indian
Drugs Industry base.
The Registered Office of the Company is located at IDPL Complex, Dundahera, Gurgaon. The
company has three main Plants at Rishikesh (Uttarakhand), Gurugram (Haryana), Hyderabad (Telangana)
and two 100% wholly owned subsidiaries, namely, IDPL (Tamil Nadu) Limited, Chennai (Tamil Nadu) and
Bihar Drugs & Organic Chemicals Limited (BDOCL) at Muzaffarpur (Bihar). In addition, IDPL has one
Joint Venture, promoted in collaboration with Industrial Promotion & Investment Corporation of Orissa
Limited (IPICOL), Government of Odisha, namely Odisha Drugs & Chemicals Ltd. (ODCL) Bhubaneswar
having share of 51% and 49% respectively.
IDPL played a major role in the strategic National Health Programmes like Family Welfare Pro-
gramme & Populations Control (Mala-D & Mala-N), anti-malarial (Chloroquine) and prevention of dehy-
dration (ORS) by providing quality medicines. IDPL has encourage indigenous production and supporting
Government in meeting emergent situations in Cyclone, Flood and Earthquake in Odisha, Uttrakhand and
J&K providing lifesaving medicines on time. IDPL has always supplied quality medicines and its presence
has played a price balancing role in the competitive and business environment.
The main objectives of setting up IDPL were not to earn profits but to encourage indigenous pro-
duction of pharmaceuticals and to support various health programmes of the Central Government. IDPL
earned Profit before Depreciation, Interest & Tax (PBDIT) from 1965 to 1968 and again from 1971 to
1974. It earned net profit from five years continuously from 1974 to 1979; the Company lost its profitability
primarily due to change in Government policy about import of bulk drugs from supply to pharmaceuti-
cals Industry. The imports, which were canalized through IDPL till 1979, were entrusted to State Trading
Corporation (STC). IDPL was thus divested of a profit-making segment. The erstwhile Board for Industrial
& Financial Reconstruction (BIFR) declared IDPL as a sick industrial Company in August. 1992. In Feb-
ruary 1994, BIFR approved the Rehabilitation Scheme under Section 17(2) of SICA. The package, however,
failed to turnaround the company. In January 1996, BIFR appointed Industrial Development Bank of India
(IDBI) as Operating Agency (OA) for Techno-Economic Analysis and preparation of Revival Package. The
issue of revival of the company remained pending in BIFR as well as with the Govt. while attempts were
made in 2001-02 to privatize the Company. OA (IDBI) however, did not find any proposal worthy of rec-
ommendations to BIFR.
Based on a Draft Rehabilitation Scheme (DRS) prepared by IDPL, a Note for Cabinet Committee
on Economic Affairs (CCEA) was prepared and submitted for approval on 11.5.2007. The Note was con-
sidered by CCEA in its meeting held on 17.5.2007 and it referred the matter to Group of Ministers (GoM).
The GoM in its meeting held on 11.10.2007 advised that IDPL’s revival plan should be based on public
85
interest goals and ensuring the viability of the Company. The Union Cabinet decided on 28.12.2016 for
closure of the company.
In view of Cabinet decision, the company is in the process of closure. The company has signed
an MoU with M/s NBCC to act as Land Management (LMA) in October’ 2019 for disposal of its land /
immovable properties and with M/s MSTC Limited to function as Auctioning Agency (AA) for sale of its
moveable and immovable properties by e-auctioning. The valuation of Land of IDPL Gurugram Plant and
Hyderabad Plant (including building) has been done by Land Management Agency (LMA) –NBCC and
approved by the Board.
A valuer has also been appointed to assess the moveable and immoveable properties of IDPL. The
valuation of Movable Assets and Immovable Assets (Building only) of Rishikesh (Main Plant) and Subsid-
iaries Units – BDOCL Muzaffarpur & IDPL (TN) Ltd., Chennai has been done by a Govt. approved valuer
and approved by the respective Board. The valuations of Movable Assets and Immovable Assets of IDPL
Gurugram (excluding land) and Hyderabad (excluding Land & building) are under process by the valuer.
All units are now closed in view of closure decision of the Union Cabinet taken on 28.12.2016. Pres-
ently, the company has no regular employees as all the regular employees of IDPL have been given VRS as
per DPE Guidelines dated 14.06.2018. There are only 76 contractual employees in the Company including
100% Subsidiaries.
100% IDPL Wholly Owned Subsidiaries:
IDPL (Tamil Nadu) Ltd, Chennai
IDPL (TN) Ltd. Chennai was incorporated in September 1965, initially it was a Surgical Instru-
ments Plant and later diverted for formulations. In terms of revival package approved by BIFR in 1994 this
Plant was converted into a wholly owned subsidiary in the name and style of IDPL (Tamil Nadu) Limit-
ed, Chennai with effect from 01.04.1994. IDPL (Tamil Nadu) is a Schedule-M compliant plant and was
engaged in manufacture of pharmaceuticals formulations up to September’2018. There is no production
activity in this unit since October’ 2018
Bihar Drugs & Organic Chemicals Ltd. (BDOCL), Muzaffarpur
Bihar Drugs & Organic Chemicals Ltd., (BDOCL) Muzaffarpur was incorporated in 1979, converted into
a wholly owned subsidiary with effect from 01.04.1994. IDPL holds the entire equity capital of this Unit.
Since November 1996 there is no production activity in BDOCL Plant.
Joint Venture
Orissa Drugs and Chemicals Ltd (ODCL), Bhubaneshwar
Orissa Drugs & Chemicals Limited (ODCL) was incorporated in 1979 and commissioned fully for
production from September 1983. ODCL is a Joint Venture promoted by Indian Drugs & Pharmaceuticals
Ltd. (IDPL) and Industrial Promotion & Investment Corporation of Orissa (IPICOL). IDPL holds 51% of
86
passed orders for winding up in April 2003 under the provisions of SICA Act, 1985. High Court
of Orissa had appointed a provisional Liquidator. This has since been stayed by a larger Bench of
the Odisha High Court.
Presently Company is engaged in manufacture of pharmaceuticals Annual Reportformulations

2020-21 in the
form of Tablets, Capsules, Powder, ORS and Injectables etc. ODCL Plant is Schedule-M
compliant.
the equity shares and 49% is with IPICOL. The erstwhile BIFR passed orders for winding up in April 2003
under the provisions
INJECTIBLE of SICA Act, 1985. High Court of Orissa had appointed a provisional Liquidator. This
SECTION-ODCL
has since been stayed by a larger Bench of the Odisha High Court.
Presently Company is engaged in manufacture of pharmaceuticals formulations in the form of

Tablets, Capsules, Powder, ORS and Injectables etc. ODCL Plant is Schedule-M compliant.
Tablet & Oitment Sections of Hyderabad Unit

Injectible Section-ODCL
Tablet & Oitment Sections of Hyderabad Unit
RMG FBD Blister Packg. Prod. Facility
Ointment Mfg.Tube filling Purified water HPLC

RMG FBD Blister GenerationPackg. Prod.
System Facility
Ointment Mfg.Tube filling Purified water HPLC Generation System
FINISHED PRODUCTS
87
Ointment Mfg.Tube filling Purified water HPLC
Generation System
FINISHED PRODUCTS
Finished Products
BLISTER PACKING MACHINE (GURGAON PLANT)
Blister Packing Machine (Gurgaon Plant)

PLANETARY MIXER (GURGAON PLANT)
88
PLANETARY MIXER (GURGAON PLANT)
Planetary Mixer (Gurgaon plant)

BLISTER PACKING MACHINE -RISHIKESH
BLISTER PACKING MACHINE -RISHIKESH
Blister Packing Machine -Rishikesh

TABLET SECTION- ODCL
TABLET SECTION- ODCL
Tablet Section- ODCL
89
6.3 Hindustan Antibiotics Limited (HAL)
Background
Hindustan Antibiotics Limited (HAL) is a wholly owned Government Company engaged in the
manufacturing & marketing of life saving drugs. It was established in 1954 with WHO/ UNICEF assistance
and the first to manufacture the Antibiotics like Bulk drugs, Streptomycin and Gentamycin. HAL has rare
distinction of inventing two new molecules viz. Hamycin and Auerofungin.
HAL, at present, is bouncing back to productive and efficient work culture and taking all the steps
to achieve the enhanced turnover and profitability for the company.
Performance Rating Under MoU
HAL has entered into MOU for the year 2019-20 with the Ministry of Chemicals & Fertilizers,
Department of Pharmaceuticals. Based on the audited results of the Company, HAL is likely to receive
“EXCELLENT” MOU rating for the year 2019-20. The company has also been rated “GOOD” in the MOU
2017-18 and 2016-17 by the Department of Public Enterprises (DPE).
Corporate Governance
HAL is committed to follow good Corporate Governance Practices in conducting its business in
legal, ethical & transparent manner. During the year 2019-20, HAL has got “EXCELLENT” rating in Self
Evaluation for compliance of Guidelines on Corporate Governance issued by DPE for CPSEs. During pre-
vious years also HAL has got “Excellent” rating in this category.
Joint Ventures and Subsidiaries
The company has two subsidiaries, namely, Maharashtra Antibiotics and Pharmaceuticals Limited
(MAPL) and Manipur State Drugs & Pharmaceuticals Limited (MSDPL)
Brief of Facilities available
The company’s manufacturing facilities include the following: -
a. Bulk Plant:
HAL is having fermentation-based manufacturing facilities including 19X92M3 fermentors along

with its downstream processing, solvent recovery and associated utilities like steam, chilled water,
cooling tower water, compressed air etc. These facilities were earlier used for manufacturing fer-
mentation-based bulks like Penicillin-G, Streptomycin Sulphate, Gentamycin etc. These facilities
are idle at present.
b. Formulation facility:

90
HAL is having fermentation-based manufacturing facilities including
19X92M3 fermentors along with its downstream processing, solvent recovery and
associated utilities like steam, chilled water, cooling tower water, compressed air etc.
These facilities were earlier used for manufacturing fermentation-based bulks like
Penicillin-G, Streptomycin Sulphate, Gentamycin etc. These Annualfacilities are idle at
Report 2020-21
present.
The company is focusing at present on manufacturing Pharma formulation and promising Agro-
b. Formulation facility:
formulation to The
cater company
to wide range of Pharma and Agro market. Its pharma products include vari-
is focusing at present on manufacturing Pharma formulation and
ous dosage forms
promising Agro- formulationproducts,
like Dry Powder Injectable Tablets,
to cater to wide Capsules, Intra-Venous
range of Pharma Fluidmarket.
and Agro (IVF) Its
products, Liquid Syrup products
pharma etc. include various dosage forms like Dry Powder Injectable products,
The manufacturing formulation
Tablets, Capsules,capacities including
Intra-Venous FluidPharma & Agro-Chem,
(IVF) products, Liquid are as follows:
Syrup etc. -
The manufacturing formulation capacities including Pharma&Agro-Chem, are as
follows: - Table-6B
(Manufacturing formulation capacities including Pharma & Agro-Chem )
Capacities (Existing) Lac Nos. /
Sr.No. Production facilities
annum
A. Pharma Plants:
1 Dry Powder Injectables:
a. Cephalosporin 450
b. Penicillin 450
2 Tablets:
a. Penicillin 1200
b. Non-Penicillin 2400
3 Penicillin Capsules: 2500
4 I.V.Fluids: 120
Liquid Syrup & External
5 24
preparation:
B Agro-Chem Plants:
1 Agro- Chem (Streptocycline) 180
2 Humaur formulation 210 KL*
3 Aureofungin Bulk 0.810 tionnes
4 Azotomeal 50 KL*
5 Phosphmeal 50 KL*
C Alcoholic Hand Disinfectant (AHD) 12
*Capacity of these products can be increased depending upon requirement since
HAL
*Capacity of these products canisbehaving idledepending
increased sizable fermentation facilitiessince HAL is having idle sizable
upon requirement
fermentation facilities
c. During the year 2019-20, HAL has consolidated manufacturing of following Agro
c. During theProducts:
year 2019-20, HAL has consolidated manufacturing of following Agro Products:
i.
i. Aureofungin Aureofungin
ii. Humaur Humaur
ii.
iii. Phosphomeal
iii. Phosphomeal
iv. Azetomeal
iv. Azetomeal
d. During the year 2019-20, the company has re-started manufacturing and marketing of its
IVF products, which was under upgradation. The company is proud to state that it is the
d. During theonly
yearunit
2019-20, the companytohas
in the pharmaPSUs re-started
have manufacturing
facility for manufacture and marketing
of IVF Fluids. of its IVF
e. which
products, Research
wasand Development:
under upgradation. The company is proud to state that it is the only unit in
the pharma PSUs to have facility for manufacture of IVF Fluids.
HAL’s R & D Department is engaged in manufacturing standard size Narcotic Drugs
Detection Kits, Precursor Chemicals Detection Kits and Ketamine Detection Kits as
e. Research and per
Development:
requirements of Narcotic Control Bureau, Department of Internal Security,
Ministry of Home Affairs, Govt. of India. HAL is the only exclusive manufacturer of
HAL’s R & D Department is engaged in manufacturing standard size Narcotic Drugs Detection
the product in the country.
Kits, Precursor Chemicals Detection Kits and Ketamine Detection Kits as per requirements of Narcotic
91
Control Bureau, Department of Internal Security, Ministry of Home Affairs, Govt. of India. HAL is the
only exclusive manufacturer of the product in the country.
Present Status of the Company
The Company has successfully steered to a steady growth and consolidated its position in the coun-
Present Status of the Company
try as a leading Public Sector Pharmaceutical Company. During the year 2019-20, all its Plants were oper-
ational, which The
helped in enhancing
Company the turnover
has successfully of theto
steered company.
a steady growth and consolidated its position in
the country as a leading Public Sector Pharmaceutical Company. During the year 2019-20, all its
The Cabinet
Plants in its meeting
were operational, which held on 17.7.2019
helped approved
in enhancing loan to of
the turnover thethe
tune of Rs. 280.15 crores for
company.
meeting the employee’s liabilities (unpaid salary and VRS). The company introduced and implemented
VRS during 2019-20 and a total
The Cabinet of meeting
in its 380 employees
held on were given VRS.
17.7.2019 The company
approved loan to isthe
having
tune 460 employees
of Rs. 280.15
as on 01.12.2020. The company appointed M/s NBCC as the Land Management
crores for meeting the employee’s liabilities (unpaid salary and VRS). The company introduced Agency (LMA) for its
main plant
and as well as subsidiaries.
implemented VRS during The process
2019-20of and hiving off ofof
a total MAPL
380 and MSDPLwere
employees is in process and is The
given VRS. ex-
pected company
to be completed early. After valuation of its surplus 87.70 acres of land by
is having 460 employees as on 01.12.2020. The company appointed M/s NBCC as theM/s NBCC, the company
is expected
LandtoManagement
dispose of itsAgency
land subject
(LMA) to for
approval
its mainof the
plantGovernment.
as well as subsidiaries. The process of hiving
off of MAPL and MSDPL is in process and is expected to be completed early. After valuation of
its
Thesurplus
company87.70 acres of
proposes to land by M/s APIs,
manufacture NBCC, forthe company
which is expected
a proposal to dispose
for in-principle of its land
approval has
subject to approval of the Government.
been submitted. The company is also exploring the possibility of exporting its quality products to African
countries. During the year 2019-20, HAL has contributed a sum of Rs.25.50 crores to the exchequer of
TheGovt.
Central and State company
by wayproposes
of Incometo manufacture
Tax, Customs, APIs,
GST,forService
whichTax
a proposal
etc. for inprinciple approval
has been submitted. The company is also exploring the possibility of exporting its quality products
DetailstoofAfrican
Production, SalesDuring
countries. Turnoverthe and
yearNet Profit /HAL
2019-20, Loss has contributed a sum of Rs.25.50crores to
the exchequer of Central and State Govt. by way of Income Tax, Customs, GST, Service Tax etc.
Table-6C
(In-house production
Details of Production, Sales Turnover and figures for the/ last
Net Profit Lossfive years)
(Rs in Crores) (Rs in Crores)
2015-16 2016-17 2017-18 2018-19 2019-20 2020-21
(till
15.12.20)
Production 14.45 11.36 37.44 54.51 43.05 42.28
Sales Turnover 15.12 10.73 35.21 63.17 58.56 59.97
Net Profit (74.68) 78.24 208.32* (71.10) (138.30)** (36.19)

(Loss)
* The*said
TheNet
saidProfit
Net is the result
Profit is theof an extraordinary
result item of item
of an extraordinary income viz. waiver
of income viz.by Govt.by
waiver of India
Govt.
of its Plan and Non-Plan loan of Rs.186.96 crores and the interest there on of
of India of its Plan and Non-Plan loan of Rs.186.96crores and the interest there onRs.89.94 crores. Total
of
Rs.276.90 crores.
Rs.89.94crores. Total Rs.276.90crores.
** The
** above loss isloss
The above theisresult of theofexceptional
the result expenses
the exceptional such as
expenses relieving
such of employees
as relieving of on VRS.
employees
The on
actual
VRS.operational
The actualloss is Rs. 66.10
operational crores
loss is Rs.as66.10
against Rs. 71.10
crores croresRs.
as against during
71.10the previous
crores duringyear.
the
previous year.
During 2019-20, HAL has achieved production of Rs.43.05 crores against Rs.54.51crores in 2018-
19 and achieved a sales turnover (total revenue) of Rs.58.56 crores in 2019-20 against Rs.63.17 crores in
2018-19. The operational loss in 2018-19 was Rs.71.10 crores, which was reduced to Rs. 66.10 crores for the
year 2019-20. During 2019-20, HAL has achieved production of Rs.43.05crores against Rs.54.51crores
in 2018-19 and achieved a sales turnover (total revenue) of Rs.58.56crores in 2019-20 against
Rs.63.17crores in 2018-19. The operational loss in 2018-19 was Rs.71.10, which was reduced to
92 Rs. 66.10 crores for the year 2019-20.
Graph-6A
(Sales Turnover of HAL since 2015-16)
Sales Turnover (Rs.Crores)

70 Sales Turnover (Rs.Crores)
63.17
58.56
70
60 63.17
58.56
60
50
50
40 35.21
40
30 35.21
30
20 15.12
10.73
20
10 15.12
10.73
10
0
2015-16 2016-17 2017-18 2018-19 2019-20
0
2015-16 2016-17 2017-18 2018-19 2019-20
Graph-6B
(Value of Production in HAL since 2015-16)
Value of Production (Rs.Crores)
60 Value of Production (Rs.Crores)
54.51
60
50 54.51 43.05
50
40 37.44
43.05
40 37.44
30
30
20 14.45
11.36
20
10 14.45
11.36
10
0
2015-16 2016-17 2017-18 2018-19 2019-20
0
2015-16 2016-17 2017-18 2018-19 2019-20
Projects implemented so far:

Projects implemented so far:
HAL has implemented
Projects completed setting-up of new Cephalosporin power injectable facilities. This facility was
so far:setting-up
HAL has completed of new Cephalosporin power injectable facilities. This
accredited with WHO-GMP certification. The upgradation of IVF, Betalactam & Quality Control Lab is
facility was accredited with WHO-GMP certification. The upgradation of IVF, Betalactam&
complete and ready for WHO-GMP inspection. Non-Parental facility is also beinginjectable
planned tofacilities.
be upgraded
Quality HAL has
Control completed
Lab setting-up
is complete of new
and ready Cephalosporin
for WHO-GMP power
inspection. Non-Parental facilityThis
is
facility
to WHO-GMP was accredited
compliance, duringwith WHO-GMP
2020-21. The certification.
setting-up of The
facility upgradation
for Alcoholic of IVF,
Handrub
also being planned to be upgraded to WHO-GMP compliance, during 2020-21. The setting-up of Betalactam&
Disinfectant,
Quality
the onlyfacility Control
centralfor
PSU Lab such
to have
Alcoholic is complete
facility,
Handrub and also
was ready
Disinfectant, for only
WHO-GMP
completed.
the central PSUinspection.
to haveNon-Parental
such facility,facility
was alsois
also being
completed. planned to be upgraded to WHO-GMP compliance, during 2020-21. The setting-up of
facility for Alcoholic Handrub Disinfectant, the only central PSU to have such facility, was also
completed. 93
Planned Projects:
HAL is planning upgradation of following facilities to generate more funds for the company:
• Facility for bulk drugs like Meropenem, Telmisartan and Gabapentin. The funding for the above
projects is proposed to be done through internal resources. The manufacturing of these bulk API’s
shall also compliment the Hon’ble Prime Minister’s ‘Make in India’ initiative for bulk drugs / APIs.
• HAL is in the process of setting-up facility for HAL Cloud Clinic- a Health Kiosk- which measures
23 health parameters in 5 minutes. This is a sort of Health ATM which identifies different health
parameters, from which one can identify their physical fitness & take corrective action according-
ly. This Health Kiosk stores data of the person on its cloud storage & can be very useful to Health
Institutions, Govt. Hospitals, CPSEs etc.
Strategy for Marketing:
HAL’s sales are at present largely dependent on institutional sale with PPP model. In order to re-
duce the dependence on PPP business, the company intends to adopt the following strategies:
• Enhancing the Trade Sale through well established distribution network of distributors, C & F
agents and branches to support product supply chain.
• Inducting new products having high value & high margin & phasing out products which are at the
end of their life cycle.
• Increasing the sales of existing high margin products.
• To be competitive in Institutional business with cost reduction.
• To expand Agro-vet business having high potential & better margin.
• To capture growing export markets since the manufacturing facilities would be WHO-GMP com-
pliant.
Human Resource and Industrial Relations:
The Company had 918 employees on 31st March 2019, which were reduced to 460 as on 1st De-
cember 2020. The employees are getting salaries in 1997 pay scales. Various social security schemes like
Provident Fund, Gratuity & Medical schemes are in place in the Company. During the year 2019-20, five
training programmes / seminars were arranged on topic like cGMP, Good Documentation Practices &
Data Integrity, Financial Empowerment of Women, International Yoga Day, Integrity – A way of life etc.
About 124 officers and 95 workers attended these in-house training programmes.
The training centre, in coordination with the Monitoring Committee of ‘Swachh Bharat Abhiyan’,
played major role in implementing ‘Swachh Bharat Abhiyan’ in the organization. Swachhata Pakawada was
observed during 16th to 31st August, 2019 as per the directives from DPE (Min. of HI & PE). Cleanliness
drives were carried out with enthusiasm and zeal by the employees, colony residents and also by H.A.
School students.
Activities like Hindi Day / Pakhawada, International Yoga day, International Women’s Day, Vigi-
94
lance Awareness Week and pledge taking on the occasions of Constitution Day & Anti-Terrorism Day were
organized at Training centre.
Cost cutting measures
• System of regular monitoring of ‘A’ category raw material and packaging material with respect to
the standard consumption norms is being introduced.
• Utilization of funds to reduce interest burden and controls on fund management.
• Cost cutting measures in all the areas of operation is strictly enforced.
• Optimum utilization of available manpower is enforced.
HAL- Building front view of Cephalosporin Plant
Celebration of Vigilance Awareness Week at H.A. Board Room
95
Participant receiving Award as a part of Hindi Pakhwada
Republic Day Celebrations at H.A. Company
Managing Director inspecting parade at H.A. School as a part of Independence Day Celebrations
96
6.4 KARNATAKA ANTIBIOTICS & PHARMACEUTICALS LIMITED, BENGALURU

(KAPL) Independence Day Celebrations at H.A. Company
6.4 BACKGROUND:
Karnataka Antibiotics & Pharmaceuticals Limited, Bengaluru (KAPL)
Background:
Karnataka
Karnataka Antibiotics
Antibiotics and Pharmaceuticals
and Pharmaceuticals LimitedLimited
(KAPL)(KAPL) is a Profit-making
is a Profit-making Joint SectorJoint
Com-
pany incorporated in the year 1981 [with 59% share by Government of India and 41% shareIndia
Sector Company incorporated in the year 1981 [with 59% share by Government of and 41%
by Government
share bythrough
of Karnataka Government of State
Karnataka Karnataka through
Industrial Karnataka State
and Infrastructure Industrial
Development and Infrastructure
Corporation (KSIIDC)].
Development Corporation (KSIIDC)]. The basic objective of the Company is to make available
The basic objective of the Company is to make available life-saving drugs of good quality to Government
life-saving drugs of good quality to Government Hospitals and other Institutions along with
Hospitals and other Institutions along with Private Medical Practitioners. The Company has WHO-GMP
Private Medical Practitioners. The Company has WHO-GMP Certified manufacturing facilities
Certified manufacturing facilities for Dry Powder Injectables, Liquid Injectables, Tablets, Capsules, Dry
for Dry Powder Injectables, Liquid Injectables, Tablets, Capsules, Dry Syrups and
Syrups and Suspensions.
Suspensions. The paid-up
The paid-up share share capital
capital of the
of the Company
Company as asonondate
date is
is Rs.
Rs.13.49
13.49crores.
crores.At Ban-
At
galore Plant, Pharmaceutical
Bangalore ProductsProducts
Plant, Pharmaceutical are beingare
manufactured and at plant
being manufactured andatatKotur, Dharwad,
plant at Karnataka,
Kotur, Dharwad,
Ayurvedic Products
Karnataka, are being
Ayurvedic manufactured.
Products are being manufactured.
Production And Sales Performance:
PRODUCTION AND SALES PERFORMANCE:
Table-6D
(Rs. in Crores)
(Production & Sales Perfromance of HAL) (Rs. in Crores)
YEARS PRODUCTION SALES
2017-2018 366.82 353.83
2018-2019 388.63 360.36
2019-2020 489.57 437.08
2020-21( UptoNov.2020) 319.90 328.67
PastPAST
Achievements:
ACHIEVEMENTS:
• Mini Ratna CPSE
• ISO 9001:2015 (QMS), ISO 14001:2015 (EMS) and ISO 45001:2018 (OSHAS)
•  Mini
PIC/S Ratna CPSE
Certification
 ISO 9001:2015 (QMS), ISO 14001:2015 (EMS) and ISO 45001:2018 (OSHAS)
 PIC/S Certification
97
POPULAR BRANDS:
PHARMA – TRADE
PAST ACHIEVEMENTS:
Mini2020-21
Annual Report Ratna CPSE
 ISO 9001:2015 (QMS), ISO 14001:2015 (EMS) and ISO 45001:2018 (OSHAS)
 PIC/S Certification
Popular Brands:
POPULAR
Pharma – TradeBRANDS:
PHARMA – TRADE Table-6E
(Pharma Trade)
No Products Therapy Segments NLEM Monopoly Market Value
1 Grenil Anti Migraine No No Rs. 13.00 Cr
3 Cyfolac Pre & Probiotics No No Rs. 5.00 Cr
4 Remcc Group Cough & Cold No No Rs. 3.00 Cr
5 Zinfe Group Haematinic Yes No Rs. 2.00 Cr
6 Verclav Group Antibiotic No No Rs. 2.00 Cr
7 PoP-e Platelet Booster No No Rs. 2.00 Cr
Pensbiotic MD/ DS, Gentabiotic, K-Flox
Pensbiotic MD/ DS, Gentabiotic, K-Flox
Agrovet: Table-6F
AGROVET: (Agrovet)
No Products Therapy Segments NLEM Monopoly Market
Value
1 K- Cyline Insecticide No No 3.5 Cr
3 Kalvimin Group Feed Supplement No No 3 Cr
4 K- Live Hepato-Protective No No 2.5Cr
5 K- Cythrin Mineral Mixture No No 3 Cr
6 Pensbiotic MD/DS Antibiotics No No 6.5 Cr
Gentabiotics, K-Flox
7 Fluvet Ecto-Parasiticide No No 1.5 Cr
Distribution Network:
DISTRIBUTION NETWORK:
Pharma:
PHARMA
The Company has been expanding its operations in Retail Trade Sector with a planned effort so
as to caterThe
to the needs of has
Company the been
Private Medical Practitioners.
expanding its operations In in this direction
Retail Trade the Company
Sector with ahas been pe-
planned
riodically
effort solaunching New to
as to cater Products in the
the needs ofvarious Therapeutic
the Private Medical Segments. The Domestic
Practitioners. In this operations spans
direction the
through the country manned by a highly dedicated professional field force
Company has been periodically launching New Products in the various Therapeutic and backed by a well-knit chan-
nelSegments.
of distribution
Theensuring
Domestic KAPL’s presence
operations at the
spans Metrothe
through as well as Micro
country Markets.
manned by a highly dedicated
professional field force and backed by a well-knit channel of distribution ensuring KAPL’s
presence
KAPL at has its Branches
the Metro as welllocated
as MicroinMarkets.
almost all the State Headquarters. The Company also has an
excellent Distribution Network at almost 20 branches at Major Cities catering to the respective State area
through Channel
KAPL has Marketing. The located
its Branches suppliesinare madeall
almost effective
the Statethrough approvedThe
Headquarters. Stockists
Companyto Retailers,
also
Nursing
has anHomes and Dispensing
excellent Distributiondoctors
Networkin the
at Trade
almostSegment and directly
20 branches to Institutions
at Major in RatetoContract
Cities catering the
(RC) & Non-Rate Contract (NRC) Sectors.
respective State area through Channel Marketing. The supplies are made effective through
approved Stockists to Retailers, Nursing Homes and Dispensing doctors in the Trade Segment and
Marketing:
directly to Institutions in Rate Contract (RC) & Non-Rate Contract (NRC) Sectors.
Pharma:
MARKETING:
The Company has been mainly focusing on Prescription Market as Medical Professional as Cus-
PHARMA:
The Company has been mainly focusing on Prescription Market as Medical Professional as
98
Customers, where many of the MNCs and Private Pharma Players have a major share. The
Company is also dependent on PPP Policy for Institutional Business, where the concentration is
on Govt. Hospitals, State Government Hospitals, Corporates, PSU Hospitals, Defence and
Insurance. It has potential to expand in Trade Segment and also to increase volumes by focusing
tomers, where many of the MNCs and Private Pharma Players have a major share. The Company is also
dependent on PPP Policy for Institutional Business, where the concentration is on Govt. Hospitals, State
Government Hospitals, Corporates, PSU Hospitals, Defence and Insurance. It has potential to expand in
Trade Segment and also to increase volumes by focusing on CPSE Hospitals and large Corporate Hospitals.
Agrovet:
The Company is focusing on Agro Dealers, Department of Agriculture/ Horticulture for Agro
Products. Products are being focused on Veterinary Practitioners, Farmers, Animal Husbandry Depart-
mentHusbandry
of all StatesDepartment of allforStates
and Milk Unions and Products
Veterinary Milk Unions forSupplements.
and Feed Veterinary Products and Feed
Supplements.
New Products (Pharma & Agrovet) For 2019-20
NEW PRODUCTS (PHARMA&AGROVET) FOR 2019-20
Table-6G
(New products-pharma & agrovat - for 2019-20)
Sl.No Products Therapeutic Category
PHARMA
a) Kapitra Antifungal
b) Kaplicon Antifungal
AGROVET
a) Vet CPM (Chlorpheniramine Maleate) Inj Anti Allergic
b) K-Live Gold Liver Tionic
EXPORTS
Exports
KAPL products
KAPL are currently
products exported
are currently to about
exported to 17 different
about countries
17 different including
countries Russia, Malaysia,
including Russia,
Philippines, SriPhilippines,
Malaysia, Lanka, SouthSriAfrica,
Lanka, Zimbabwe, Yemen,
South Africa, Uganda, South
Zimbabwe, Yemen, Africa etc. to
Uganda, nameAfrica
South a few. etc.
Its Pen-
to
icillinname a few. Its Penicillin
and Cephalosporin and Cephalosporin
Dry Powder Dry Powder
Parenteral facilities and alsoParenteral facilities
Liquid Injection and also Liquid
manufacturing facil-
ities Injection manufacturing
are compliant facilities
to International GMP arenorms
compliant to International
and approved by PICs GMP normsMCAZ
(Malaysia), and approved
(Zimbabwe),by
PICs (Malaysia),
NDA (Uganda). MCAZ (Zimbabwe), NDA (Uganda).
KAPL - Sole manufacturer of Oxytocin in the country

The High Court of Himachal Pradesh, Shimla has in its judgement dated 15.03.2016 in PIL No.
KAPL - SOLE MANUFACTURER OF OXYTOCIN IN THE COUNTRY
16 of 2014 noted that there is large scale clandestine manufacture and sale of drug Oxytocin leading to its
grave misuse, which
The Highis Court
harmful of to animals and
Himachal humans.
Pradesh, The has
Shimla Government entrusteddated
in its judgement to KAPL the respon-
15.03.2016 in
sibility
PIL No. 16 of 2014 noted that there is large scale clandestine manufacture and sale of drugby
of being sole domestic manufacturer and distributor in the country. Further, manufacturing
private manufacturers
Oxytocin leading was
to itsrestricted vide Gazette
grave misuse, which Notification
is harmful todated 27.04.2018
animals issuedThe
and humans. by the Ministry of
Government
Health & Family Welfare. Some private parties approached Hon’ble High Court of
entrusted to KAPL the responsibility of being sole domestic manufacturer and distributor in the Delhi challenging the
said notification and the
country. Further, High Court ofbyDelhi
manufacturing videmanufacturers
private its order datedwas 15.12.2018
restrictedquashed the said
vide Gazette notification.
Notification
Special Leave
dated Petition has
27.04.2018 beenby
issued filed
thebyMinistry
the Ministry of Health
of Health & Family
& Family welfare at
Welfare. the Hon’ble
Some private Supreme
parties
Court of India and the matter is presently sub judice.
approached Hon’ble High Court of Delhi challenging the said notification and the High Court of
Delhi vide its order dated 15.12.2018 quashed the said notification. Special Leave Petition has
The Oxytocin
been filedformulations
by the Ministry manufactured
of Health &byFamily
the KAPL are at
welfare supplied only to
the Hon’ble the registered
Supreme hospitals
Court of and
India and
theinmatter
clinics Publicis and
presently
PrivatesubSector
judice.directly, or to the Pradhan Mantri Bhartiya JanAushadhi Pariyojna
(PMBJP) and AMRIT outlets in the country, which in turn supply the drug for its therapeutic usage to the
The Oxytocin
registered hospitals formulations
and clinics in public manufactured by the KAPL are supplied only to the registered
and private sector.
hospitals and clinics in Public and Private Sector directly, or to the PradhanMantriBhartiya Jan
AushadhiPariyojna (PMBJP) and AMRIT outlets in the country, which in turn supply the drug for
its therapeutic usage to the registered hospitals and clinics in public and private sector.
99
100
Background
Bengal Chemicals and Pharmaceuticals Limited (BCPL) was founded in 1901 by Acharya Prafulla
Chandra Roy, a renowned Scientist and Academician. The Government of India took over its manage-
ment in 1977. The company was subsequently nationalized in 1980 and registered as Bengal Chemicals
& Pharmaceuticals Limited (BCPL) under the Companies Act in 1981. The company was declared sick
in 1992 and was sanctioned scheme for revival in 1995 by the erstwhile Board for Industrial & Financial
Reconstruction (BIFR).
Business Operations
BCPL is engaged in the business of Industrial Chemicals (Ferric Alum), Generic Medicines and
Home Products like Phenol, Naphthalene balls, Bleaching powder, Toilet cleaners, Floor cleaners and Hair
oil.
Manufacturing Locations
At present BCPL has four factories; at Maniktala (Kolkata) and Panihati in West Bengal, Mumbai
and Kanpur.
Maniktala Unit: This unit was set up in 1905 and primarily produces Pharmaceuticals Formula-
tions which include branded as well as unbranded generic medicines. Commercial production in Tablet,
Capsule, Ointment and Cosmetics Sections is going on full-fledged. It also produces Cantharidine Hair
Oil. In August 2020, the company launched its Hand Sanitizer “BENSANI+”, which is essential to prevent
the spread of Coronavirus Disease (COVID-19) in present pandemic scenario.
Panihati Unit: This unit set up in 1920 primarily produces Industrial Chemicals and Home Prod-
ucts which includes Pheneol, Naphthalene Balls as well as other Disinfectants and Chemicals. During the
present pandemic situation, BCPL touched an all-time record of manufacturing 60,680 bottles of Pheneol
450 ml. in a single day (26th September 2020) as against an average daily production of 30,000 bottles.
Mumbai Unit: Mumbai unit was set up in 1938. Presently, the commercial space developed has
been leased out to third parties for generation of additional sources of revenue for the company.
Kanpur Unit: Kanpur Unit set up in 1949 primarily produces tablets for acute disorders.
Past Achievements
The Company has retained its brand position in home products even during the crisis period and
well set to capitalize on these brands now.
Sickness and Revival
The Company was referred to erstwhile BIFR in 1992. The revival package for BCPL was approved
by the Government in December 2006. The package of Rs 440.60 Cr was approved which comprised of
101
restructuring of existing debts on the books of BCPL, capital investments, support for development of
marketing infrastructure and promotional measures, grant for wage revision and implementation of VRS
and funds for payment of non-Government dues. Even after restructuring the Company in 2006, it was
running in losses and its operational performance had come down drastically to Rs.17 Crore turnover in
2013-14, which was the lowest ever turnover since its inception as Government Company and reported
a Net Loss of Rs.36.55 Crore in 2013-14. However, from the financial year 2016-17 onwards, the com-
pany became a Turnaround Company and reported a Net Profit of Rs.4.51Crore and a Gross Margin of
Rs.24.05Crore. In the consecutive 2nd financial year also i.e., in 2017-18, BCPL reported a Net Profit of
Rs.10.06Crore. In the year 2018-19, BCPL again reported a Net Profit of Rs.25.26Crore and Rs.13.07Crore
in 2019-20. Further, BCPL has repaid the entire Bank Loan of Rs.28Crore to United Bank of India which
was taken in 1983 by mortgaging Registered Office building and now BCPL is a debt free company (except
Govt. of India Loans). BCPL has also paid Rs.23.73 Crore to Government of India till date, towards repay-
ment of loans taken in the year 2005 and 2006.
Product Profile
Division
Product profile- Iand range Division – II Division - III
The products
Industrial manufactured
Pharma Genericsunder each of these
Pharma business segmentsHair
Disinfectants are mentioned
Oil below:
Other
Chemicals BrandedTable-6H Products
Alum, Tablets, Capsules, Aqua(Product Pheneol,
Profile)
Product Profile Cantharidine Naphthal-ene
Bleaching
Division - I Injectables,
Division –Ptychotis,
II White Tiger, Hair Oil
Division - III Balls
Powder
Industrial Ointments,
Pharma Kalmegh,
Generics Pharma Klin Toilet,
Disinfectants Hair Oil Liquid Soap
Other
Chemicals Liquids, Branded
Eutheria, Lysol Products
Aguru
Alum, External-Liquids,
Tablets, Benflam Gel Pheneol,
Capsules, Aqua Essence
Cantharidine Naphthal-ene
Bleaching Injectables,
ASVS,BENSANI+Ptychotis, White Tiger, Hair Oil Balls
Powder Ointments, Kalmegh, Klin Toilet, Liquid Soap
Liquids, Eutheria, Lysol Aguru
External-Liquids, Benflam Gel Essence
ASVS,BENSANI+
Popular
Popular brands
brands
Popular brands
Lamp
Lamp brand
brand Pheneol,
Pheneol, White
White Tiger,
Tiger, Bleaching
Bleaching Powder,
Powder, Naphthalene
Naphthalene Balls,Cantharidine
Balls, CantharidineHair
Hair Oil,
Oil,
Bensani+
Lampetc.
Bensani+ etc.
brand Pheneol, White Tiger, Bleaching Powder, Naphthalene Balls, Cantharidine Hair Oil,
Bensani+ etc.
Manpower
Manpower
Table-6I
Manpower
Particulars Manpower (As on 30.11.2020)
(Manpower)
Executives 48
Supervisors 13
Particulars Manpower (As on 30.11.2020)
Workers 84
Executives
Grand Total
48
145
Supervisors 13
Workers
Distribution network 84
Grand
The Total has a strong distribution network pan India with 6 Depots
company 145and 6 C&F Agencies.
BCPL has also opened 4 Exclusive Retail Stores in Kolkata and 1 in Mumbai.
Distribution network
Distribution network
The The
company has has
company a strong distribution
a strong network
distribution pan pan
network IndiaIndia
with with
6 Depots and and
6 Depots 6 C&F Agencies.
6 C&F Agencies.
BCPL
BCPL has has
alsoalso opened
opened 4 Exclusive
4 Exclusive RetailRetail
StoresStores in Kolkata
in Kolkata and 1and 1 in Mumbai.
in Mumbai.
102
Performance
Performance
Performance
The details of Production, Turnover and Financial Performance of BCPL from 2017-18 onwards
arePerformance
as under:
The details of
of Production,
Production, Turnover
Turnover and
and Financial
Financial Performance
Performance ofof BCPL
BCPL from
from 2017-18
2017-18 onwards
onwards
The details
are as under:
are as under: Table-6J
The details of Production,(Financial
TurnoverPerformance
and Financialof BCPL for last three
Performance of BCPLyears) (Rs.(Rs.
from 2017-18
(Rs. in Crores)
inonwards
in Crores)
Crores)
are as under:
Particulars
Particulars 2019-20
2019-20 2018-19
2018-19 2017-18
2017-18
(Rs. in Crores)
Production
Production 84.19
84.19 123.45
123.45 98.18
98.18
Particulars 2019-20 2018-19 2017-18
Income
Income 85.64
85.64 119.67
119.67 94.80
94.80
Production
Gross
Gross Margin
Margin 84.19
20.26
20.26 123.45
32.83
32.83 98.18
24.23
24.23
Income
Interest
Interest Expenses
Expenses (Finance
(Finance cost)
cost) 85.64
0.68
0.68 119.67
2.45
2.45 94.80
9.05
9.05
Gross Margin 20.26 32.83 24.23
Depreciation
Depreciation 5.12
5.12 5.12
5.12 5.12
5.12
Interest Expenses (Finance cost) 0.68 2.45 9.05
Net Profit(Loss)
Net Profit(Loss) 13.07
13.07 25.26
25.26 10.06
10.06
Depreciation 5.12 5.12 5.12
DPENetrating
Profit(Loss) 13.07 25.26 10.06
DPE
DPE rating
rating Table-6K
(DPE rating)
DPE ratingYear MOU
MOU Assessment
Assessment Corporate
Corporate Governance
Governance
2017-18
2017-18 “Not
“Not applicable”
applicable” “Excellent”
“Excellent”
2018-19 Year
2018-19 MOU
“Not Assessment
applicable” Corporate
“Excellent”Governance
“Excellent”
2017-18
2019-20
2019-20 “Not
“Notapplicable”
applicable” “Excellent”
“Excellent”
“Excellent”
2018-19 “Not applicable” “Excellent”
Marketing:
2019-20
Marketing:Share of Institutions
Share “Notand retailretail
applicable”
of Institutions
Institutions and “Excellent”
Marketing: Share of and retail
Table-6L
Marketing:
Sl.
Sl. No.
No. DIV Share
DIV & of Institutions
& PRODUCTS
PRODUCTS and retail
(Marketing: ShareMARKET
MARKET PROFILE/Major
PROFILE/Major
of Institutions and retail) clients
clients
1.
Sl.
1. No. DIV
DIV II –
DIV & Products – FERRIC
FERRIC SAIL (DURGAPUR,
(DURGAPUR,clientsIISCO,
Market Profile/Major
SAIL IISCO, BOKARO,
BOKARO,
ALUM
ALUM REFRACTORY
REFRACTORY UNIT, UNIT, IISCOCHASNALA)
IISCOCHASNALA)
1. DIV I – Ferric Alum BCCL
SAIL (((Durgapur,
BCCL BOWRA& BLOCK
BOWRA& IISCO,
BLOCKBokaro,II)
II) Refractory Unit,
IPCL (FARAKKA,
(FARAKKA, DISERGARH)
IISCOCHASNALA)
IPCL DISERGARH)
PHE
BCCL (MALDA,
( Bowra SILIGURI)
&
PHE (MALDA, SILIGURI)Block II)
OTHER PRIVATE
IPCL (Farakka,
OTHER PARTIES
PARTIES &
Disergarh)
PRIVATE & MUNICIPAL
MUNICIPAL
CORPORATIONS
PHE (Malda,
CORPORATIONS Siliguri)
2.
2. DIV
DIV II
II –GENERIC Other Private
–GENERIC AFMSD,
AFMSD, Parties RAILWAY,
ESIC,
ESIC, & Municipal Corporations
RAILWAY, SAIL,
SAIL, DHS,
DHS,
TABLET,CAPSULE,
TABLET,CAPSULE, APMSIDC, TSMSIDC, JMHIDPCL, OTHER
2. DIV II –Generic Tablet, Capsule, APMSIDC,
AFMSD, ESIC, TSMSIDC, RAILWAY,JMHIDPCL, SAIL,OTHER
DHS,
OINTMENT,
OINTMENT, INJECTION,
INJECTION, STATE
STATE GOVERNMENTS.
GOVERNMENTS. SECL&
SECL& OTHER
OTHER PSUs
PSUs
Ointment, Injection, Liquid, Hand APMSIDC, TSMSIDC, JMHIDPCL, other state
LIQUID,
LIQUID, HAND
HAND SANITIZER
SANITIZER
Sanitizer Governments. SECL & other PSUS
DIV
DIV II
II –
– BRAND
BRAND SOLD
SOLD THROUGH
THROUGH RETAIL
RETAIL TRADE AS OTC
DIV II – brand Sold through retail trade as OTCTRADE
medicinesAS OTC
AQUAPTYCHOTIS,
AQUAPTYCHOTIS, MEDICINES
MEDICINES
Aquaptychotis, Eutheria,
EUTHERIA,
EUTHERIA, KALMEGH
KALMEGH
KALMEGH
3. DIV
DIVIIIIII
III– – COSMETIC &
& HOME
HOME MAINLY TRADE BUSINESS (70-75%) && BULK
3.3. DIV –Cosmetic
COSMETIC & Home MAINLY
Mainly tradeTRADE BUSINESS
business (70-75%)(70-75%) BULK
& bulk Government
PRODUCTS
PRODUCTS GOVERNMENT
GOVERNMENT INSTITUTIONS
INSTITUTIONS BUSINESS
BUSINESS (25-
(25-
Products institutions business (25-30%)
30%)
30%)
Future projects
103
Future projects:
ASVS Project: BCPL was planning to start ASVS Project as the product is not available in the coun-
try at the moment in required quantity. BCPL has stopped production of ASVS for the last 12 years. Due
to non-availability of fund and also due to project cost escalation the project could not be started. The total
project cost for ASVS block as on date is Rs 31.00 Cr. Further, BCPL is under strategic sale so the project
could not be taken up.
The Cabinet decision dated 28th December 2016 for strategic sale of the company after meeting all
its liabilities from sale of surplus land was challenged by the Bengal Chemicals Sramik Karmachari Union
filed a Writ Petition before the Hon’ble High Court of Calcutta, which vide its order dated 13.02.2018 set
aside the decision of the Union Cabinet regarding strategic sale of the company. An appeal has been filed
against the order and judgement for early listing and hearing.
Managing Director of BCPL administered the pledge to the Officers & Employees of BCPL, Corporate
Office, on 21st October, 2020, to join the Jan Andolan launched by Hon’ble Prime Minister to fight
against COVID-19
104
The Employees of Corporate Office of BCPL, Kolkata are taking integrity pledge on the occasion of
Vigilance Awareness Week (27.10.2020- 02.11.2020)
6.6 Rajasthan Drugs & Pharmaceuticals Limited (RDPL)
6.6 RAJASTHAN
Rajasthan DrugsDRUGS & PHARMACEUTICALS
& Pharmaceuticals Limited (RDPL) isLIMITED
a Central (RDPL)
Public Sector Unit in Joint Sec-
tor with a total paid-up equity capital of Rs. 4.98 crores where Government of India (GoI) and Rajasthan
Rajasthan Drugs & Pharmaceuticals Limited (RDPL) is a Central Public Sector Unit in
State Industrial Development & Investment Corporation Limited (RIICO, Govt. of Rajasthan) hold 51%
Joint Sector with a total paid-up equity capital of Rs. 4.98 crores where Government of India
and 49% shares respectively. It was incorporated in 1978 and commercial production started in 1981. The
(GoI) and Rajasthan State Industrial Development & Investment Corporation Limited (RIICO,
Company has its manufacturing facilities & registered office at Road no. 12, VKI Industrial Area, Jaipur
Govt. of Rajasthan) hold 51% and 49% shares respectively. It was incorporated in 1978 and
(Rajasthan). Theproduction
commercial productionstarted
activities in theThe
in 1981. Company
Companyhave stopped
has since October
its manufacturing 2016. & registered
facilities
office at Road no. 12, VKI Industrial Area, Jaipur (Rajasthan). The production activities in the
PastCompany
Performance:
have stopped since October 2016.
Table-6M
Past Performance: (Past Performance of RDPL)
(Rs.
(Rs. in in Crores)
Crores)
2016-17 2017-18 2018-19
Net Worth (-) 39.53 (-) 54.78 (-) 69.88
Turnover 7.66 0.40 0.14
Earnings (-) 14.88 (-) 15.25 (-) 15.10
(Before Tax)
Earnings (After (-) 14.88 (-) 15.25 (-) 15.10
Tax)
Net Profit/Loss (-) 14.88 (-) 15.25 (-) 15.10
Union Cabinet
Union has decided
Cabinet on 28.12.2016
has decided for closure
on 28.12.2016 of RDPL,
for closure ofafter
RDPL,selling its surplus
after landsurplus
selling its as would
be required to meet the liabilities. M/s MSTC Limited was appointed as auctioning agency
land as would be required to meet the liabilities. M/s MSTC Limited was appointed as auctioning for e-auction
agency for e-auction of RDPL on 19.04.2017. Central Government/State Government/leading
PSUs/Financial Institutions were invited to bid for the land, but no response was received. The
Union Cabinet has on 17.07.2019 modified its earlier decision and permitted sale of surplus land
to any entity. Further, it has sanctioned Rs.43.70crore for meeting employees’ liabilities. The 105
Company has given VRS to 99 employees. Subsequently, the company has appointed M/s NBCC
as Land Management Agency (LMA), which has done valuation of the land. The disposal of the
land will be done on approval of the Government.
of RDPL on 19.04.2017. Central Government/State Government/leading PSUs/Financial Institutions were

invited to bid for the land, but no response was received. The Union Cabinet has on 17.07.2019 modified its
earlier decision and permitted sale of surplus land to any entity. Further, it has sanctioned Rs.43.70crore for
meeting employees’ liabilities. The Company has given VRS to 99 employees. Subsequently, the company
has appointed M/s NBCC as Land Management Agency (LMA), which has done valuation of the land. The
disposal of the land will be done on approval of the Government.
106
CHAPTER -7
NATIONAL PHARMACEUTICAL PRICING AUTHORITY
(NPPA)
7.2 Pricing
7.3 Initiatives Taken to Address the Exigencies Of Covid-19
7.5 E-Initiatives
7.6 Recovery Of Overcharged Amount
7.7 Rajbhasha Implementation
7.8 Vigilance Awareness Week
7.9 Constitution Day
107
108
CHAPTER 7
7.1.1 The National Pharmaceutical Pricing Authority (NPPA), an independent body of experts in the
Ministry of Chemicals and Fertilizers, Department of Pharmaceuticals was constituted by the Govern-
ment of India vide resolution published in the Gazette of India No. 159 dated 29.08.97. The functions of
NPPA, inter-alia, includes fixation and revision of prices of scheduled formulations under the Drugs (Pric-
es Control) Order (DPCO), as well as monitoring and enforcement of prices. NPPA also provides inputs
to Government on pharmaceutical policy and issues related to affordability, availability and accessibility of
medicines.
7.1.2 The Government notified DPCO, 2013 on 15th May, 2013 in supersession of DPCO, 1995.
7.1.3 Salient features of DPCO, 2013 are as follows:
• The National List of Essential Medicines (NLEM) notified by the Ministry of Health & Family
Welfare is adopted as the primary basis for determining essentiality and is incorporated in the First
Schedule of DPCO, 2013 which constitutes the list of scheduled medicines for the purpose of price
control.
• Ceiling prices of scheduled formulations are fixed based on ‘market-based data’.

• Price control is applied to specific formulations with reference to the medicine (active pharmaceu-
tical ingredient), route of administration, dosage form / strength as specified in the First Schedule.
• The National List of Essential Medicines 2015 (NLEM 2015) was notified by the Ministry of Health
and Family Welfare in December 2015. It was, thereafter, notified as the First Schedule of DPCO
2013, in March 2016, by the Department of Pharmaceuticals.
7.1.4 The functions of the National Pharmaceutical Pricing Authority (NPPA) are:
• To implement and enforce the provisions of the DPCO, 1995 / 2013 in accordance with powers
delegated to it.
• To undertake and/or sponsor relevant studies in respect of pricing of drugs/formulations.
• To monitor the availability of medicines, identify shortages, if any, and to take remedial steps.
• To collect/maintain data on production, exports and imports, market share of individual compa-
nies, profitability of companies etc. for bulk drugs and formulations.
• To deal with all legal matters arising out of the decisions of the Authority.
• To render advice to the Central Government on changes/revisions in Pharmaceutical policy.
• To render assistance to the Central Government in parliamentary matters relating to Pharmaceuti-

cal pricing.
109
 To render advice to the Central Government on changes/revisions in Pharmaceutical
policy.
 To render assistance to the Central Government in parliamentary matters relating to
Pharmaceutical pricing.
7.2 PRICING
7.27.2.1Pricing
PRICE FIXATION
A. CEILING PRICE
7.2.1 Price Fixation
NPPA fixes the ceiling price of formulation listed in Schedule I of the DPCO,
A. 2013. Ceiling
UnderPrice
the market-based approach adopted in DPCO, 2013, the ceiling price of a scheduled
formulation
NPPA fixes the ceiling price
is determined of formulation
by first working outlistedthe in Schedule
simple I of the
average of DPCO,
price to2013. Under
retailer (PTR)the in
mar-
ket-based
respectapproach adopted in DPCO,
of all branded-generic 2013, the
and generic ceiling of
versions price
thatofparticular
a scheduled formulation
formulation is determined
having a market by
firstshare
working
of one percent and above, and then adding a notional retailer margin of 16 percent toand
out the simple average of price to retailer (PTR) in respect of all branded-generic it. generic
The
versions of that particular formulation having a market share of one percent and
maximum retail price (MRP) for that particular drug formulation must not exceed the notified above, and then adding
a notional retailer margin of 16 percent
ceiling price plus applicable taxes. to it. The maximum retail price (MRP) for that particular drug
formulation must not exceed the notified ceiling price plus applicable taxes.
NLEM 2015 contains 966 scheduled drug formulations (including formulations as per
explanation
NLEM 20151 to contains
Schedule966
– Ischeduled
of DPCOdrug
2013)formulations (including
spread across formulations
31 therapeutic as per
groups. explanation
NPPA also
1 tofixes
Schedule – I of DPCO
the ceiling prices2013) spread acrosslisted
of formulations 31 therapeutic groups. NPPA
under Explanation-I to also fixes the
Schedule – ceiling prices of
I of DPCO
formulations listed under Explanation-I to Schedule – I of DPCO 2013. NPPA has
2013. NPPA has fixed the ceiling prices of 881 formulations under DPCO, 2013 till 31stfixed the ceiling prices
of 881 formulations
December 2020. under DPCO, 2013 till 31st December 2020.
Statement
Statementshowing range
showing of reduction
range in ceiling
of reduction price
in ceiling of scheduled
price formulation
of scheduled withwith
formulation respect to the
respect
highest price on the basis of data furnished by Pharmatrac/pharmaceutical companies is as given be-
to the highest price on the basis of data furnished by Pharmatrac/pharmaceutical companies
low:
is as given below:
Table-7A
(Statement showing % range of reduction
Table –I in ceiling price)
% reduction with respect to Maximum Price No. of formulations

0<= 5%* 242
5<=10% 140
10<=15% 104
15<=20% 101
20<=25% 93
25<=30% 69
30<=35% 46
35<=40% 26
Above 40% 60
Total formulations in NLEM 2015 881
The prices are notified through Gazette Notifications which are also uploaded on NPPA’s website at
www.nppaindia.nic.in. The ceiling prices become operative and legally enforceable from the date on which
the price is notified in the Gazette.
NPPA also capped the maximum retail price of 106 formulations (anti-diabetic and cardiovascular)
under para 19 of DPCO 2013 in July 2014.
B. Retail Price
NPPA fixes the retail price of medicine based on the Form-I application received from the man-
110
ufacturing/ marketing companies. The notified retail prices are applicable only to the applicant manu-
facturing/ marketing companies. The retail prices of the medicine are also fixed on the same method as
applicable for fixation of ceiling price. NPPA notified retail prices of 1462 ‘new drugs’ [those qualifying as
‘new drugs’ as per para 2(u) of DPCO, 2013] till 31st December 2020 under DPCO, 2013.
NPPA has taken special efforts for fixing retail price fixation of new drug cases and all the pending
cases have been cleared. As on 31st December 2020 only current cases are pending for price fixation.
7.2.2 Review Order

Any company aggrieved by the orders of NPPA files review application to Department of Phar-
maceuticals under para 31 of DPCO, 2013. Department of Pharmaceuticals after hearing gives necessary
review directions. NPPA implements the review directions of the Department on merit.
NPPA has taken special efforts for implementation of review orders in time and implemented 47
review orders comprising 68 formulations during 2018-19, 10 review orders in 2019-20 and 2 review or-
ders in 2020-21 (Till 31st December, 2020). As on 31st December 2020, one review order is pending for
implementation.
7.2.3 Price Revision of Anti-Cancer Drugs Based on Trade Margin Rationalization

National Pharmaceutical Pricing Authority capped the Trade Margin of all the non-scheduled for-
mulations of select 42 Anti-Cancer drugs, recommended by Expert Committee of Ministry of Health &
Family Welfare, under the ‘Trade margin Rationalization Approach’ vide order SO 1041(E) dated 27th
February 2019. The Pilot has been taken up as Proof of Concept, invoking provision of para 19 of DPCO,
2013, under extra-ordinary circumstances in public interest.
As per data submitted by manufacturers, the MRP for 526 brands have shown reduction up to 91%.
Percentage wise reduction in prices of brands is as follows: -
Table – 7B
Table –inIIprices of brands)
(Percentage wise reduction
S.No. Slab-percentage reduction in prices No. of Brands

1. 75% and above 63
2. 50% to 75% 167
3. 25% to 50% 169
4. Up to 25% 127
TOTAL 526
This has resulted in notional annual savings of Rs. 984 crore per annum to cancer patients. NPPA
This has resulted
has issued necessary in notional
directions annualControllers
to State Drug savings ofand
Rs. Superintendents
984 crore per annum to cancer
of Hospitals patients.In-
/ Medical
NPPAto
stitutions has issuedcompliance
ensure necessary ofdirections
the ordertoissued
State Drug
so thatControllers and
the benefits Superintendents
under this measureofbeHospitals
available to
/ Medical
the patients. Institutions to ensure compliance of the order issued so that the benefits under this
measure be available to the patients.
7.2.4 Savings to the Consumers
7.2.4The fixation
SAVINGS TO THE
of ceiling CONSUMERS
prices of scheduled formulations listed in NLEM 2015 (revised Schedule-I)
The fixation of ceiling prices of scheduled formulations listed in NLEM 2015 (revised
Schedule-I) has enabled savings of Rs. 2643.00 crore to the consumers in addition to the saving of
Rs. 4,547 crores to consumers on account of price fixation of coronary stents. Fixation of ceiling
111
prices of scheduled formulations under Schedule-I of NLEM 2011 enabled savings of 2,422.24
crore to the consumers. The para 19 price notifications resulted in savings of approximately Rs.
350 crore to the consumers. NPPA has also fixed the ceiling price of the Non-
has enabled savings of Rs. 2,643 crore to the consumers in addition to the saving of Rs. 4,547 crores to con-
sumers on account of price fixation of coronary stents. Fixation of ceiling prices of scheduled formulations
under Schedule-I of NLEM 2011 enabled savings of Rs.2,422.24 crore to the consumers. The para 19 price
notifications resulted in savings of approximately Rs. 350 crore to the consumers. NPPA has also fixed the
ceiling price of the Non-Scheduled Orthopaedic Knee Implants has enabled savings of Rs. 1,500 crore to
the consumers. A savings of Rs. 984 crores to the consumers is estimated through the trade margin ratio-
nalization of anti-cancer drugs. Thus, regulation of prices of medicines under DPCO 2013 by NPPA has
resulted in net savings of approximately Rs. 12,447 crores per annum to the consumers.
7.2.5 Revision of Ceiling Retail Price under Para 19 of DPCO, 2013

Para 19 of DPCO, 2013 empowers the Government to revise the ceiling price of medicines under
extra ordinary circumstances as it deems fit. Presently, the powers under para 19 of DPCO, 2013 is entrust-
ed with NPPA. NPPA received applications for upward price revision under para 19 of DPCO, 2013 citing
various reasons like repeated price control, increase in API cost, increase in cost of production exchange
rates etc. resulting in unviability in sustainable production and marketing of the drugs.
Most of these drugs were used as first line of treatment and are crucial to the public health program
of the country. The mandate of NPPA is to ensure availability of drugs at affordable prices and it was noted
that while ensuring affordability, access cannot be jeopardized and the life-saving essential drugs must
remain available to the general public at all times.
Based on the recommendations of the Standing Committee on Affordable Medicines and Health
Based on the recommendations of the Standing Committee on Affordable Medicines and Health
Products (SCAMHP), ceiling price of shortlisted 21 scheduled formulations of 12 medicines were
Products (SCAMHP), ceiling price of shortlisted 21 scheduled formulations of 12 medicines were revised
revised by
by allowing allowing
one-time one-time
price increase price
of 50%increase
from theofpresent
50% ceiling
from the present
price ceiling
in public price
interest inexception-
as an public
interest as
al measure by an exceptional
invoking para 19measure by invoking
of DPCO, 2013. Thepara 19 of
details ofmedicines
DPCO, 2013.are asThe details of medicines
follows:
are as follows:
Table – 7C
Table
(Revision of Ceiling Retail Price - III Para 19 of DPCO, 2013)
under
Sl. No. Name of the Scheduled Dosage form & Strength Unit Ceiling Price
Formulation (Rs.)
(1) (2) (3) (4) (5)
1. BCG vaccine Each Dose 8.75
2. Benzathine Powder for Injection 12 lac Each Pack 17.84
benzylpenicillin units
3. Benzathine Powder for Injection 6 lac Each Pack 11.81
benzylpenicillin units
4. Benzyl penicillin Powder for Injection 10 Lac Each Pack 7.64
Units
5. Chloroquine Tablet 150mg 1 Tablet 1.16
6. Dapsone Tablet 100 mg 1 Tablet 0.35
7. Furosemide Tablet 40 mg 1 Tablet 0.74
8. Furosemide Injection 10mg/ml 1 ml 2.43
9. Metronidazole Oral Liquid 200 mg/5ml 1 ml 0.44
10. Metronidazole Tablet 200 mg 1 Tablet 0.68
12. Metronidazole Injection 500mg/100ml 1 ml 0.20
13. Ascorbic Acid (Vitamin Tablet 500 mg 1 Tablet 1.34
112 C)
14. Co-trimoxazole Tablet 400 mg(A)+80 mg(B) 1 Tablet 0.77
(Sulphamethoxazole
(A)+Trimethoprim (B)]
Units
5. Chloroquine Tablet 150mg 1 Tablet 1.16
6. Dapsone Tablet 100 mg 1 Tablet 0.35
7. Furosemide Tablet 40 mg 1 Tablet 0.74
8. Furosemide Injection 10mg/ml 1 ml Annual2.43
Report 2020-21
9. Metronidazole Oral Liquid 200 mg/5ml 1 ml 0.44
12. Metronidazole Injection 500mg/100ml 1 ml 0.20
13. Ascorbic Acid (Vitamin Tablet 500 mg 1 Tablet 1.34
C)
(Sulphamethoxazole
(Sulphamethoxazole
16. Co-trimoxazole Oral Liquid 1 ml 0.32
(Sulphamethoxazole 200mg(A)+40mg(B)/5ml
17. Pheniramine Injection 22.75 mg/ml(10ml 1 ml 1.67
pack)
18. Pheniramine Injection 22.75 mg/ml (2ml 1 ml 2.24
pack)
19. Prednisolone Drops 1% 1 ml 4.92
20. Clofazimine Capsule 50 mg 1 Capsule 2.13
21. Clofazimine Capsule 100 mg 1 Capsule 3.63
7.2.6 Price Fixation Of Medical Devices:
A. Coronary Stents:
The Government had notified Coronary Stents as scheduled Medical Devices under DPCO, 2013
in December 2016. Aftermath, Government had notified the ceiling prices for Coronary Stents vide noti-
fication dated 13th February 2017. The current Ceiling Prices (excluding GST) for Coronary Stents for the
year 2020-21 is as under:
i. Bare Metal Stents: Rs. 8,417/-
ii. Drug Eluting Stents (DES) including metallic DES and Bioresorbable Vascular Scaffold (BVS)/ Bio-
degradable Stents: Rs. 30,647/-
` The price reduction for Coronary Stents worked out up to 85% for Bare Metal Stents and 74% for
Drug Eluting Stents in the year 2017. The Ceiling Prices fixation of Coronary Stents resulted in
notional saving of Rs. 4,547 crores annually to the consumers/patients.
B. Orthopedic Knee Implants For Knee Replacement System:
NPPA has also fixed the ceiling price of the Non-scheduled Orthopaedic Knee Implants for the
first time on 16th August 2017 under Para 19 of the DPCO, 2013 in the extraordinary circumstances in the
larger public interest. The above ceiling price was to be maintained for one year i.e. up to 15th August 2018.
Subsequently, NPPA vide Order dated 13th August 2018, extended the applicability of above ceiling prices
for another one year (i.e. up to 15th August 2019).

113
B. ORTHOPEDIC KNEE IMPLANTS FOR KNEE REPLACEMENT SYSTEM:
NPPA has also fixed the ceiling price of the Non-scheduled Orthopaedic Knee Implants
for the first time on 16th August 2017 under Para 19 of the DPCO, 2013 in the extraordinary
circumstances
Annual in the larger public interest. The above ceiling price was to be maintained for one
Report 2020-21
year i.e. up to 15th August 2018. Subsequently, NPPA vide Order dated 13th August 2018,
extended the applicability of above ceiling prices for another one year (i.e. up to 15th August
In the year 2019, after revisiting the ceiling prices of the orthopaedic Knee Implants, the Authority allowed
2019).
an increase in Maximum Retail Prices (MRPs) of orthopaedic Knee Implants up to 10% of the previous
MRP vide 2019. Further,
Notification in the
dated 13thyear 2020,
August the Further,
2019. Authority did year
in the not 2020,
allow the
anyAuthority
increase did
in the
notceiling
allow any
increase
pricesinofthe ceiling
Knee pricesfor
Implants of the
Knee Implants
year 2020-21 forand
the extended
year 2020-21 and extended
the same the same
for the another onefor theup
year another
to
one15th
yearSeptember
up to 15th2021
September 2021 vide Notification dated 15th September 2020. A summary
vide Notification dated 15th September 2020. A summary of price revision of price
revision for orthopaedic
for orthopaedic Knee Knee Implants
Implants is as under:
is as under:
Table -7D
Table - IV Knee Implants)
(Price Revision of Orthopedic
Ceiling Ceiling
Type of Knee Implant Price fixed w.e.f. 16/08/2017 to Price fixed w.e.f. 16/08/2019 to
15/08/2019 (Rs.) 15/09/2021 (Rs.)
Primary Knee Implants
Cobalt Chromium (widely used) 54,720 60,192
Special Metal like Titanium &
76,600 84,260
Oxidized Zirconium
High Flex Implant 56,490 62,139
Revision Knee Implants
Revision Implants 1,13,950 1,25,345
The aforesaid price reduction for orthopaedic Knee Implants worked out up to be 69%. The ceiling price
fixation of orthopaedic Knee Implants resulted in notional saving of Rs. 1,500 crore annually to the con-
sumers/patients.
7.3 Initiatives taken to address the exigencies of COVID-19
During the COVID-19 pandemic in the country, NPPA played an active role in addressing the
exigencies arising out of COVID-19 pandemic and undertook necessary measures to ensure continued
availability of life saving essential medicines throughout the country.
7.3.1 Pricing of Drugs
Pricing is an instrument to ensure continued availability and affordability of essential life-saving

drugs with improved access to consumers. In times of the pandemic, the NPPA invoked extraordinary
powers in public interest to ensure that pricing issues do not impede the access to life saving drugs like
Heparin and Medical Oxygen.
Heparin
Heparin is used as blood thinner and Heparin Injection 5000IU/ ml has been considered as an
essential COVID plus medicine and widely used for COVID-19 treatment. The Active Pharmaceutical
Ingredient (API) of this drug is imported from China. For this drug, NPPA received representations from
several manufacturers about upward increase in prices of API of the drug. Heparin Injection 5000IU/ ml,
being under ceiling price, the increase in API prices posed a challenge for continued availability of this
important drug. NPPA got the issue examined through Export-Import Monitoring Committee constitut-
114
ed by NPPA to inform impact on API pricing. The Committee reported 200% increase in landing cost of
Heparin API and on its recommendation, NPPA revised the ceiling price of Heparin upward for a period
of six month to ensure its continued availability during the pandemic.
Medical Oxygen:
The situation of COVID-19 resulted in increased demand of Medical Oxygen (MO) in the coun-
try. Medical Oxygen is not only an essential life-saving drug but critical for COVID management. Due to
increase in price of LMO being supplied to filler, the margins for them was squeezed which was impacting
their operational viability. Due to excess demand, delivery through cylinders had increased from 11%
pre-COVID to 50% of current oxygen supply. It was therefore, imperative to cap price of LMO to ensure
uninterrupted availability of Medical Oxygen though cylinders to the hospitals and consumers.
After extensive deliberations, NPPA, in exercise of extraordinary powers conferred by para 19 of

the Drug (Prices Control) Order, 2013 and powers conferred under section 10(2)(l) of the Disaster Man-
agement Act, 2005, in public interest, capped the price of Liquid Medical Oxygen (LMO) and the Oxygen
Inhalation (Medicinal gas) for six months. Timely intervention by NPPA eased the situation of Medical
Oxygen availability throughout the country, especially in distant and far flung areas.
N95 Mask:

NPPA took cognizance of reports of differential pricing in government/institutional procurement
and non-government procurement. In order to ensure availability of N95 mask at affordable prices in the
country, NPPA directed Manufacturers/ Importers/Suppliers of N95 Mask to maintain parity in prices for
non-government procurements and to make available the same at reasonable prices. After issuing such an
Advisory, major manufacturers/importers of N-95 Masks reduced their prices significantly up to 67%.

NPPA fine tuned its interventions during the COVID pandemic to strike at profiteering tendencies
by manufacturers/marketers in public interest. However, the strategy also ensured enabling ecosystem for
the industry to increase production of quality benchmarked medical devices for domestic use and exports.
7.3.2 Medical Diplomacy:

During this period, Government had constituted an Inter-ministerial Empowered Committee to
make recommendation for the export of drugs/items requested by foreign governments especially drugs
like Hydroxychloroquine and Paracetamol. NPPA coordinated with drug manufacturers of these medi-
cines and created a reporting framework for production and supply of these medicines. This facilitated
the Empowered Committee to make recommendations for release of surplus drugs produced to foreign
countries after ensuring the sufficient domestic availability.
Based on recommendations of Empowered Committee, DoP/NPPA issued recommendation/or-

ders which enabled the MEA/DGFT to fulfill various export commitments towards 114 Countries, in-
cluding SAARC Nations, in respect of HCQ and 24 Countries in respect of Paracetamol. This exercise was
undertaken on humanitarian grounds as well as on Commercial terms.
7.3.3 Enhanced Production Capacity:
115
On the intervention of Empowered Committee, during March-May 2020 period the numbers of
manufacturing units of Hydroxychloroquine increased from 2 to 12 and the country’s production capac-
ity of Hydroxychloroquine has increased three times i.e. from 10 Crore (Approx) tablets per month to 30
Crore (Approx) tablets per month. Currently, India is having surplus of Hydroxychloroquine tablets over
and above its domestic requirements.
7.3.4 Availability Of Essential Drugs:
NPPA has taken a number of steps to ensure the availability of medicines throughout the coun-
try: NPPA had greater interaction with Industry, manufacturers, All India Organisation of Chemists and
Druggists (AIOCD), State Drug Controllers (SDCs), District Magistrates (DMs) etc. to ensure that supply
chains were not compromised during lockdown and Unlock phases. Such steps taken by NPPA are men-
tioned below:

Monitoring Export/ Import Trends to ensure domestic availability of key drugs and Medical
Devices: In order to monitor trends of export and import of APIs/Formulations and Medical Devices as
well as to ensure timely availability of drugs mentioned by MoHFW, NPPA constituted an inter-ministerial
Committee to develop a mechanism to assess bottlenecks and impediments in imports of APIs and to sug-
gest possible alternative sources & export trend analysis to ensure domestic availability of key drugs and
Medical Devices during the pandemic.
COVID-19 Treatment Protocol Drug Availability: NPPA undertook various steps to ensure
the availability of life saving essential drugs like Hydroxychloroquine, Paracetamol, Methylprednisolone,
Enoxaparin, Dexamethasone, Remdesivir etc. NPPA also ensured the availability of Vaccines, Anti-Tu-
berculosis drugs, Anti-diabetic drugs, Cardiac drugs, imported Anti- epileptic drugs and drugs like FDC
Lopinovir&Ritionavir, Favipiravir, Zinc Sulphate, etc.

COVID and COVID plus Drugs Database: NPPA, in coordination with CDSCO, developed a
comprehensive database for COVID & COVID plus (55+97) drugs as a measure of preventive prepared-
ness for fighting COVID-19. This has been immensely useful in current scenario as well as future needs
of the organization. A State wide mechanism was created to obtain timely alerts (ring the bell) in case of
shortages to take immediate remedial action.

7.4.1 Monitoring Availability Of Medicines
The Government is effectively monitoring the prices of scheduled as well as non-scheduled med-
icines under DPCO, 2013 and takes action against companies found overcharging the consumers based
on the references received from the State Drugs Controllers / individuals, samples purchased from the
open market and reports from market based data and complaints reported through the grievance redres-
sal websites, ‘Pharma Jan Samadhan’ and ‘Centralized Public Grievance Redress and Monitoring System
(CPGRAMS)’. The monitoring of increase in the price of formulations beyond the permissible limit is also
done on the basis of data submitted by AIOCD (Pharmatrac Data) and individual complaints received.
Whenever companies are found selling scheduled formulations at prices higher than the price no-
tified by NPPA, action is taken against such companies under the relevant provisions of DPCO 2013 and
116
the overcharged amount, along with interest is levied on the company. Similar action is taken whenever
companies are found selling non-scheduled formulation at a price which is 10% higher than the MRP of
the preceding twelve months and Wholesale Price Index (WPI) violation for scheduled formulations.
Non-compliance with the notified ceiling prices in case of scheduled drug formulations or, in other
words, the MRP breaching ceiling price plus applicable local taxes tantamount to overcharging the con-
sumer. Such overcharged amounts are recovered from the pharmaceutical company along with interest
thereon from the date of overcharging. Cases of companies not complying with the demand notices are re-
ferred to the District Collectors for recovery of overcharged amounts as arrears of land revenue and could
also attract prosecution under the provisions of the Essential Commodities Act (EC Act), 1955.
NPPA monitors the availability of drugs, identify shortages, if any, and take remedial steps to make
the drugs available to consumers. NPPA is carrying out this responsibility mainly through the State Drugs
Controllers, NGOs and individuals. As and when the reports for shortages of particular drug(s), in any
part of the country are received, the concerned company is asked to rush the stock to the affected areas and
to make the drugs available.
7.4.2 Monitoring Of Price Movement Of Medical Devices:
Para 20 of the DPCO, 2013 empowers the Government to monitor the Maximum Retail Price
(MRP) of all the drugs including the non-scheduled formulations & notified medical devices as drugs
and ensure that no manufacturer increases the maximum retail price of a drug more than ten percent of
maximum retail price during preceding twelve months and where the increase is beyond ten percent of
maximum retail price, it shall reduce the same to the level of ten percent of maximum retail price for next
twelve months. The manufacturer shall be liable to deposit the overcharged amount along with interest
thereon from the date of increase in price in addition to the penalty.
There are twenty-four (24) medical devices which have been notified/regulated as Drugs by Minis-
try of Health & Family Welfare, Government of India. Out of the above, four (4) medical devices namely (i)
Cardiac Stents (ii) Drug Eluting Stents (iii) Intra Uterine Devices (Cu-T) and (iv) Condoms are scheduled
medical devices which have been included in the Schedule-I of the DPCO, 2013. Hence, these four medical
devices are under price control.
NPPA by exercising the power under Para 20 of the DPCO, 2013, monitors the MRPs of all the
non-scheduled Medical Devices to ensure that no manufactures/importers can increase the MRP more
than 10% in preceding twelve months. Upon violation of the above provision, NPPA issues overcharging
notices to the defaulting companies.
As per Ministry of Health & Family Welfare’s Notification dated 11th February, 2020, all Medical
Devices have been notified as ‘Drugs’ w.e.f. 1st April 2020. By virtue of the above, all the medical Devices
have come under regulation of Drugs & Cosmetics Act, 1940, Medical Devices Rules, 2020 and Drugs
(prices Control) Order, 2013 under Essential Commodities Act, 1955. This would enable the Government
to regulate the Quality, Efficacy and Prices of Medical Devices in the country.
7.4.3 Price Monitoring and Resource Units (PMRUs)
117
1955. This would enable the Government to regulate the Quality, Efficacy and Prices of Medical
Devices
Annual in the
Report country.
2020-21
7.4.3 PRICE MONITORING AND RESOURCE UNITS (PMRUS)

NPPA is in the process of establishing Price Monitoring and Resource Units (PMRUs) at State level
NPPA isofin‘Consumer
under the scheme the processAwareness,
of establishing Priceand
Publicity Monitoring and Resource
Price Monitoring’ . PMRUsUnits
are (PMRUs) at
societies regis-
State
tered underlevel
theunder the scheme
Societies of ‘Consumer
Registration Act havingAwareness, Publicity andofPrice
its own Memorandum Monitoring’.
Association/Bye PMRUs
laws. PMRUs
are societies
constituted at theregistered under
State/Union the Societies
Territories Registration
function under the Act
directhaving its own
supervision of Memorandum
the concerned of State
DrugAssociation/Bye laws. PMRUs constituted at the State/Union Territories function under the direct of
Controllers for increasing outreach of NPPA. As on 31st December 2020, 17 PMRUs in the States
Kerala, Odisha, Gujarat,
supervision Rajasthan,State
of the concerned Punjab, Haryana,
Drug Nagaland,
Controllers Tripura, Andhra
for increasing Pradesh,
outreach Mizoram,
of NPPA. As on Jam-
mu31 & Kashmir,
st
DecemberKarnataka,
2020, 17Telangana,
PMRUs inMaharashtra,
the States of Goa, Madhya
Kerala, Pradesh
Odisha, and Uttar
Gujarat, PradeshPunjab,
Rajasthan, have been
set Haryana,
up. Nagaland, Tripura, Andhra Pradesh, Mizoram, Jammu &Kashmir, Karnataka,
Telangana, Maharashtra, Goa, Madhya Pradesh and Uttar Pradesh have been set up.
7.4.4 Enforcement Activities
7.4.4 ENFORCEMENT ACTIVITIES
To ensure that medicines are available to patients at the notified prices, NPPA works closely with
State DrugsToControllers for medicines
ensure that enforcementareactivities.
availableSamples of medicines
to patients are picked
at the notified up from
prices, open
NPPA market
works
regularly
closelyand analyzed
with to monitor
State Drugs the price
Controllers for at which the medicines
enforcement activities. are sold toofpatients.
Samples medicinesEnforcement
are pickedac-
tivities from 2010-11 to 2020-21(up to 30.11.2020) are given as under:
up from open market regularly and analyzed to monitor the price at which the medicines are sold
to patients. Enforcement activities from 2010-11 to 2020-21(up to 30.11.2020) are given as under:
Table - 7E
(Enforcement ActivitiesTable
From- 2010-11
V To 2020-21)
Year No. of Samples Collected Prima Facie

Violations detected
2010-2011 553 225
2011-2012 559 156
2012-2013 626 165
2013-2014 993 389
2014-2015 3898 # 1020
2015-2016 2534 # 613
2016-2017 1817 # 930
2017-2018 2418 # 1032
2018-2019 1391# 324
2019-2020 938# 350
2020-2021 1018# 522
(up to 30.11.2020)
# Cases of Overcharging referred from State Drug Controllers are included under the
# Cases of Overcharging referred from State Drug Controllers are included under the ‘Samples Collected’.
‘Samples Collected’.
7.5 7.5 E-Initiatives:
E-INITIATIVES:
NPPA has also
NPPA has undertaken following
also undertaken e-initiatives
following for betterfordisposal
e-initiatives better of grievances
disposal of general public:
of grievances of
general public:
7.5.1 Eco-System For Online Applications:
NPPA has implemented single window online Eco-system for timely disposal and monitoring of
various applications filed by the pharmaceuticals companies under DPCO, 2013 to promote the Ease of
Doing Business for ‘Atmanirbhar Bharat’. Under the Eco-system, various applications such as retail price
118
approval, discontinuation approval etc. from pharmaceutical companies are received through on-line
mode and duly acknowledged. Timelines for disposing off various applications has also been fixed and a
tracking system is also in force by way of uploading the present status of applications received.
Through this reform, simplification in applying for various approvals has been ensured and bur-
den to submit various documents with offline applications has been reduced for ease of doing business for
Pharmaceuticals industry.
7.5.2 Pharma Jan Samadhan (PJS)
The PJS was launched on 12th March, 2015. PJS is a web enabled system developed by the NPPA
with assistance of National Informatics Centre (NIC). PJS serves as a robust e-governance tool for protec-
tion of consumer interest through effective implementation of the Drugs (Prices Control) Order, 2013. The
primary objective of PJS is to put in place a speedy and effective complaint redressal system with respect to
availability of medicines, overpricing of medicines, sale of ‘new drugs’ without prior price approval (WPA)
and refusal to supply or sell medicines. Complaints can be registered under PJS link available at the NPPAs
website i.e. www.nppaindia.nic.in and also at the toll free number 1800111255 & Email – monitoring-np-
[email protected] .
Any individual or consumer organization or stockiest / distributor / dealer / retailer or State Drug
Controller can lodge complaints online to NPPA through PJS. Action on the complaint received through
PJS with complete information is initiated within 48 hours by the NPPA.
7.5.3 Pharma Data Bank (PDB) - Integrated Pharmaceutical Database Management System (IPDMS)
IPDMS was launched on 25th June 2015. IPDMS was developed by the NPPA in collaboration with
National Informatics Centre (NIC). This comprehensive online system provides a platform to the pharma-
ceutical manufacturer/ marketing/ importer/ distributor companies to file mandatory returns prescribed
in Form II, Form III and Form V of DPCO, 2013. Application for price approval of ‘new drug’ in Form-I
can also be filed through this portal.
IPDMS provides industry with a user-friendly mechanism to comply with the mandatory require-
ment of filing returns; it also helps NPPA to monitor price compliance. 966 Pharma companies have regis-
tered themselves under IPDMS and 81901 Product registered till 31st December, 2020.
7.5.4 Mobile Application ‘Pharma Sahi Daam’ And ‘Search Medicine Price’ Utility
NPPA launched its mobile app on 29.08.2016 named as “Pharma Sahi Daam” for the benefit of the
common people of India through which anybody can easily search the brand name, composition, ceiling
price and MRP of the formulation. This app can be downloaded from Google play store free of cost for
Android based mobile phones and from App store for IOS based mobile Phone (iPhone). Ceiling Price
of scheduled formulations may also be obtained by using the tool ‘Search Medicine Price’ available in the
website of NPPA. The app or search medicine facility tool facilitates consumers to verify whether medi-
cines are being sold within the approved price range and also to detect any case of overpricing by phar-
maceutical company/chemist. If there is any ceiling price violation, the buyer is able to lodge a complaint
against company/ chemist through Pharma Jan Samadhan (http://www.nppaindia .nic.in/redressal.html).
119
7.6 Recovery Of Overcharged Amount:
NPPA has initiated about 2116 cases of overcharging as on 31st December 2020. Amount of Rs.
978.82 Crore (Rs. 557.74 Crore under DPCO 1995 and Rs. 421.08 Crore under DPCO 2013) has been
recovered as on 31st December 2020, from pharmaceutical companies. Action for recovery of the over-
charged amount along with interest thereon is a continuous process. NPPA takes action as per the provi-
sions of DPCO’ 1995 / DPCO’ 2013 read with Essential Commodities Act, 1955.
7.7 Rajbhasha Implementation:
Official language Implementation Committee has been working under the Chairmanship of the
Chairman and others are the members of this Committee which includes Joint Secretary and others Ga-
zetted officers. The objective of this Committee is to periodically review in three months the progressive
use in the Official work. All the members discuss and suggest the suitable measures to increase the use of
Hindi in the Official work. Its meetings were held on regular intervals. Official language Implementation
Committee meetings were held on 25th September 2020 and 19th October 2020.
7.7.1 Rajbhasha Prayog Protsahan Pakhwara, 2020
Rajbhasha Prayog Protsahan Pakhwara, 2020 was organised in the NPPA from l6th to 30th Sep-
tember 2020 with the objective to encourage the Officers and employees so that progressively increase the
use of Hindi in their official work and also to help the Department to create an atmosphere conducive to
use of Hindi. Because of COVID-19 five competitions were held by video conferencing and making PDF
by scanning all the written paper. Officers and staff enjoyed competitions with video conferencing. Hindi
Pakhwara programme was successful in 2020. Winners were awarded with cash prizes.
7.7.2 Review Of The Status Of Use Of Rajbhasha Under The Department:
Inspection of NPPA scheduled on l4th October 2020 by Parliamentary Official Language Commit-
tee was deferred.
7.8 Vigilance Awareness Week:
Vigilance awareness week was observed in NPPA from 27th October 2020 to 2nd November 2020.
A pledge was administered by the Chairman to all the officers and staff of NPPA on 27th October 2020.
7.9 Constitution Day:
Constitution day was observed on 26th November 2020 in the office of NPPA. The Chairman NPPA
read out the Preamble of the Constitution in the gathering of Senior Officers and staff of NPPA by main-
taining the COVID-19 norms.
120
CHAPTER -8
IMPLEMENTATION OF RAJBHASHA
8.1 Use of Hindi in official work
8.4 Review of the status of use of Hindi in the offices under the
Department
121
122
CHAPTER 8
IMPLEMENTATION OF RAJBHASHA
8.1 Use of Hindi in official work
Every possible effort was made for implementation of the various provisions of the Official Lan-
guage Policy of the Union of India including those of Official Languages Act, 1963 as well as Official Lan-
guages (Use for Official Purposes of the Union) Rules, 1976 and orders issued thereunder. All the docu-
ments mentioned in Sub Section (3) of Section 3 of the Official Languages Act, 1963 were issued bilingually
i.e. in Hindi as well as in English. Letters received in Hindi and representations etc. signed in Hindi were
replied to in Hindi as per provisions of the Rule 5 and Rule 7(2) of the Official Languages (Use for Official
Purposes of the Union) Rules, 1976 (as amended in 1987).

Department is having Official Language Implementation Committee working under the Chair-
manship of the Joint Secretary to periodically review the progressive use of Hindi in the official work and
suggest the suitable measures to increase the use of Hindi in the official work. Its meetings were held on
regular intervals and implementation status of the various targets set in the Annual Programme for trans-
action of the official work of the Union in Hindi for the year 2020-21 issued by the Department of Official
Language, Ministry of Home Affairs was reviewed.

Hindi Prayog Protsahan Pakhwara was observed in the Department from 14th to 28th Septem-
ber 2020 with the objective to encourage the officers and employees of the Department to progressively
increase the use of Hindi in their official work and also to help the Department to create an atmosphere
conducive to use of Hindi.
In addition to the message issued by the Secretary (Pharma) requesting, inter-alia, all the officers/
employees to make a commitment to use of Hindi, various Hindi competitions were held during the Pa-
khwara in which officers/officials participated and made this programme successful. Winners were award-
ed with cash prizes.
8.4 Review of the status of use of Hindi in the offices under the Department
Periodical review of the use of Hindi in the offices under the Department was made through the
quarterly reports on progressive use of Hindi received from them in compliance with the targets set in the
Annual Programme for use of Hindi for the year 2020-21. During this year, to achieve the prescribed target
(inspection of at least 25% offices) in the Annual Official Language Programme 2020-21, the successful
inspection of subordinate offices of Department of Pharmaceuticals was not carried out due to pandemic.
To help the officers/employees of the Department of Pharmaceutical to work in official language

in official work and to encourage to use official language Hindi, a Hindi workshop on the subject ‘Official
Language Rules and Hindi Quarterly Progress Report’ was organised on 23.12.2020.
123
124
CHAPTER -9
CITIZEN CENTRIC GOVERNANCE
9.1 Our Vision
9.2 Our Mission
9.3 Our Clients
9.4 Our Commitment
9.5 Our Services
9.6 Our Activities
9.8 CPGRAMS
125
126
CHAPTER 9
CITIZEN CENTRIC GOVERNANCE
9.1 Our Vision:
To promote Indian pharma as the global leader for quality medicines and to ensure availability,
accessibility and affordability of drugs and medical devices in the country.
9.2 Our Mission:
• Investment for Make in India in pharma sector

• Make in India in critical APIs and medical devices
• Industry expansion, skilling, R&D and innovation
• Stable and effective price regulation and
• Generic medicines by expanding Janaushadhi scheme
9.3 Our Clients
• Citizens of India
• Pharmaceutical Industry including Micro, Small and Medium Enterprises
• Pharmaceutical companies seeking relief under DPCOs
• NPPA/CPSUs/NIPERs

9.4 Our Commitment
We are committed to provide impartial, sympathetic and prompt services to the public in matters
relating to the pharmaceutical industry.
Our commitment is to take prompt steps to provide quick redressal of the grievances of our per-
sonnel and public at large.
Our commitment is to formulate policies and initiate consultations with all Industry Associations/
stakeholders and to amend them whenever so required.
9.5 Our Services
We formulate and implement policies relating to drugs and pharmaceuticals, dye stuff and dye in-
termediates.
9.6 Our Activities
The key activities of the Department:
1. Ensure availability of drugs at reasonable prices as per provisions of the Drugs
127
(Prices Control) Order, 2013
2. Ensure proper functioning of the Central Pharma Undertakings in control of the Department.
3. Project Based Support and Revival Schemes for CPSUs
4. Ensure proper management of M Pharma and Ph.D. programs in NIPERs
5. Develop Human Resources, Infrastructure for Pharma R&D and Industry including Public-Pri-
vate-Partnerships (PPP)
6. Formulate Scheme/ Project for promoting Pharma Brand India
7. Formulate Scheme/Project for promoting environmentally sustainable development of Pharma-

ceutical Industry
8. Formulation of Annual Plan, Budget and Monitoring of Budget Expenditure. The Citizen Charter
of the Department has been placed on the website of the Department.
As per the provisions of the RTI Act, 2005, the RTI cell in Coordination Division has been estab-
lished which acts as Nodal Cell for RTI matters. RTI applications are transferred to the CPIOs concerned.
RTI cell also coordinates follow-up action on the appeals/orders received from Central Information Com-
mission and submits returns etc. The list of Central Public Information Officers (CPIOs) and Appellate
Authorities are updated regularly on the Department’s website. Proactive action is taken under Section 4 of
the RTI Act for suo-moto disclosures on the website in pursuance of transparency.
9.8 CPGRAMS (Centralized Public Grievances Redress and Monitoring System)
Public Grievances received offline and through CPGRAMS are monitored and disposed on regular
basis.
128
CHAPTER -10
INFORMATION AND COMMUNICATION TECHNOL-
OGY
10.1 Local Area Network (LAN)
10.2 Website and Social Media
10.3 Video Conferencing
10.4 Virtual Private Network (VPN) Facility
10.5 Workflow Automation
10.6 E-Governance
129
130
Chapter 10
Information and Communication Technology
Under Digital India program, Department of Pharmaceuticals has taken sincere initiatives towards
adoption of E-Governance to deliver information and services online. This has led to benefits in terms of
transparency, easy accessibility of services, improvement of internal processes and decision support sys-
tem.
An IT based Computer Centre set up by National Informatics Centre (NIC) is operational in the
Department and is equipped with latest Client machines for providing various IT related services to the
Department. NIC is delivering valuable key services like Technical consultancy, Networking, application
development and implementation, Internet & E-Mail, database management and Training. With NIC’s
presence and expertise, Department had been instrumental in steering following IT/E-governance initia-
tives. Also to enhance the delivery and security, web applications are migrated to cloud environment.
10.1 Local Area Network (LAN):
All workplaces in the department are connected on Local Area Network (LAN) which is already
IPv6 compliant and is managed by the National Informatics Centre (NIC) to provide round the clock fa-
cilities for E-mail, intranet / internet and database access operations. The IPv6 compliant ICT hardware is
available to all officers/ divisions/ sections for the use at their desktop.
10.2 Website and Social Media:
Bilingual Web Site of department http://pharmaceuticals.gov.in is hosted on NIC cloud to ensure

security and maximum reach of information to the citizens. The website is developed by NIC using content
management framework and is GIGW compliant. It provides details of organizational set up of the depart-
ment, its functions, subordinate offices, policies, publications, statistical data/information on functional
parameters. Standardization testing and Quality Certificate (STQC) certification is completed.
Social media has enormous potential to reach people. To improve the quality of Government deci-
sions, policy making and create awareness, Dept. has created Facebook and Twitter accounts. Information
regarding the conferences, Seminars, launches by Minister, MoS, Secretary and other officers of Dept. is
posted on it promptly. Various posts to create awareness regarding various activities and decisions taken by
the Department are posted on Facebook and twitter pages of the Department.
10.3 Video Conferencing:
During the Corona Pandemic, to avoid person to person meetings, Video Conferencing facility is
provided to all the officers of the Department so as to discuss all the important issues through VC. PSUs
and Educational Institutes (NIPERs) have also installed the Video Conferencing facility. VC facility enables
Department to interact with PSUs and NIPER frequently to monitor their performance and communicate
the decisions. Pragati meeting, monitoring tool of PM office, is conducted every month and Hon’ble PM
interacts with all Secretaries and State CS to address issues which are long pending through Video Confer-
encing. Video Conferencing facility is also utilized for interacting with foreign delegates.
131
10.4 Virtual Private Network (VPN) Facility:
During Corona Pandemic, when it was not possible for all the officials to attend the office, aVirtual
Private Network (VPN) Facility was provided to them so that they can work from home and dispose of the
official work smoothly.
10.5 Workflow Automation:
Another initiative taken by Department towards Digital India is to implement automation of work-
flow inside the Department. E-office is a standard product presently consists of e-File, e-Tour, Knowledge
Management System (KMS), Personnel Information Management System (PIMS), Collaboration & Mes-
saging Service (CAMS) and is aimed at increasing the usage of workflow and rule-based file routing, quick
search and retrieval of files and office orders, digital signatures for authentication, forms and reporting
components. E-Office has implemented to reduce duplicity of work, increases transparency and efficiency.
10.6 E-Governance:
Taking advantage of latest ICT enabled tools, Department of Pharmaceuticals with the support of
NIC has taken sincere initiatives towards adoption of best practices. Various applications have been de-
veloped and implemented by NIC to strengthen, monitoring and decision making and high availability of
right information at right time.
• SPARROW- Smart Performance Appraisal Report Recording Online Window (SPARROW) appli-
cation which allows online submission of APAR of IAS and CSS cadre officers is implemented successfully.
• Visitor Management System – e-Visitor System is a web-based solution for Visitor Management.
This facilitates citizens for online registration of requests for their visit and approval is given to authenti-
cated visitors and gate pass is issued.
• Legal Information Management & Briefing System (LIMBS)– LIMBS is a web-based portal de-
veloped by Department of Legal Affairs, Ministry of Law & Justice for monitoring and handling of various
court cases of Government. Cases pertaining to High Court and Tribunals are being uploaded by the con-
cerned departments. It facilitates officials to generate useful reports.
• Online RTI-MIS – To dispose of and monitor RTI applications efficiently, Deptt. has taken ini-
tiative to use Online RTI-MIS. Necessary training was imparted to concerned officials/staff to implement
RTI-MIS successfully.
• Centralized Public Grievance Redress Monitoring System (CPGRAMS)- CPGRAMS is imple-

mented in the Department and all the attached offices to address Public grievances received online with
minimum delay.
• E-publishing of Tenders – E-publishing of tenders is implemented by uploading tenders on Cen-

tral Public Procurement Portal. It has improved the accessibility of tenders.
• Electronic-Human Resource Management System(e-HRMS) is a web based Human Resource
132
Management System is a web portal https://ehrms.gov.in/implemented in the Department of Pharmaceu-

ticals. Employee Data of all the employees are uploaded. Module Service book Detail, Leave and LTC are
operational.
• https://supremo.nic.in/ is web portal being maintained by Department of Personnel and Training

(DOPT), Government of India. This is single user platform related to employees of Government of India.
Information of the personnel under Appointment Committee of the Cabinet (ACC) are being uploaded
onto the website.
To enhance e-Governance further following initiatives has been taken up.
• Development of software for grant – in - aid under Plan Scheme “Pharmaceuticals Promotion
and Development Scheme (PPDS)”. The objective of PPDS is promotion, development and promotion in
Pharmaceutical sector by extending financial support for conduct of seminars, conferences, exhibitions,
mounting delegations to and from India for promotion of exports as well as investments, conducting stud-
ies/ consultancies, for facilitating growth, exports as well as critical issues affecting Pharma Sector. The
software is under development phase.
• National Institutes of Pharmaceutical Education & Research (NIPERs) are situated at Ahmed-
abad, Guwahatii, Hajipur, Hyderabad, Kolkata, Raebareli, Mohali. NIPER MIS http://nipermis.pharma-
ceuticals.gov.in/ has been developed and hosted on NIC cloud to monitor different activities of the insti-
tutes. Next Version of the MIS is developed and is under the process of implementation.
• DBT MIS portal http://dbt.pharmaceuticals.gov.in is hosted on the NIC cloud for two schemes
of Department of Pharmaceuticals viz. Scholarship to NIPER students and Pardhan Mantri Bhartiya Jan
Aushadhi Pariyojana (PMBJP). This portal disseminates the information about beneficiaries and transac-
tions. This portal validates the beneficiary’s details from Aadhar and transaction details from DBT Bharat.
• Dashboard of the Department is developed and under implementation.
• Stationery MIS (http://10.21.81.76/store) is the MIS of the Stationery item for the Department of
Pharmaceuticals. Here employee can request for the stationery items. Dealing hand accepts the request and
after approval of the Admin employee can receive the item. Stock of the stationery items are being main-
tained and issue through this portal dynamically. Next Version of this software is proposed.
• E-registry of all Dak: The Department has functioning module of e-diarising of all dak/receipts in
the Department for the purpose of database and e-monitoring. All papers received in the Department in-
cluding all official e-mails are diarised electronically in the Central Registryof the Department. Periodical
reports of pending papers are generated and monitored.
• NIPER MIS: An information management portal for all the NIPERS which implement direct ben-
efit transfer to students/PhD scholars has been prepared. Live data is shared from NIPER MIS with DBT
UMANG Portal and the PRAYAS Portal.
• The Department is in the process of preparing MIS for monitoring and evaluation of the Foreign
Direct Investment (FDI) in pharma sector and the sector specific conditions.
133
134
CHAPTER -11
ANNEXURES
Annexure - I [A] List of PSUs and Other Organizations
Annexure - I [B] Address and Name of various Organizations &

PSUs
Annexure - I [C] List of Responsibility Centers and Subordinate

Organizations
Annexure – II Organizational Chart of NPPA
Annexure – III C&AG’s audit observations
135
136
CHAPTER 11
CHAPTER 11
ANNEXURES
ANNEXURES
ANNEXURE I [A]
ANNEXURE I [A]
List of Public Sector Undertakings
List of Public
1 Sector Undertakings
Indian Drugs & Pharmaceuticals Ltd, Dundahera Industrial Complex, Dundahera,
Gurgaon, Haryana.
1 Indian Drugs & Pharmaceuticals Ltd, Dundahera Industrial Complex, Dundahera, Gurgaon,
2
Haryana. Hindustan Antibiotics Ltd, Pimpri, Pune, Maharashtra.
2 3
HindustanKarnataka Antibiotics
Antibiotics & Pharmaceuticals
Ltd, Pimpri, Limited, Bangalore-560010.
Pune, Maharashtra.
3 4
KarnatakaBengal Chemicals
Antibiotics & Pharmaceuticals
& Pharmaceuticals Ltd,Bangalore-560010.
Limited, Kolkata, West Bengal.
4 5
Bengal Rajasthan&Drugs
Chemicals and Pharmaceuticals
Pharmaceuticals Limited.
Ltd, Kolkata, Road NO.12, V.K.I. Area, Jaipur-
West Bengal.
5 Rajasthan302013.
Drugs and Pharmaceuticals Limited. Road No.12, V.K.I. Area, Jaipur-302013.
OTHER
OTHERORGANISATIONS
ORGANISATIONS
1. 1.
Bengal Bengal Immunity
Immunity Limited, West
Limited, Kolkata, Kolkata, West Bengal.
Bengal.
2. 2. Stanistreet
Smith Smith Stanistreet Pharmaceuticals
Pharmaceuticals Ltd. West
Ltd. Kolkata, Kolkata, West Bengal.
Bengal.
ANNEXUREI [B]
ANNEXURE I [B]
Address
Address and and
Names of Names
Head ofof Head Organization
various of various Organization
& PSUs under&the
PSUs under theofDepartment
Department of -
Pharmaceuticals:
Pharmaceuticals: -
Table-11
Table-11AA
(Contact
(Contactaddress of of
address 5 PSUs)
5 PSUs)
Sl. No. Address and Organization Name Designation
1. Indian Drugs & Pharmaceuticals Shri Rajneesh Tingal Chairperson &
Limited, (IDPL), Gurgaon Managing Director
2. ited (IDPL),
Hindustan Gurgaon Limited
Antibiotics Ms. Nirja Saraf Managing Director
(HAL), Pune-411010
3. Pune-411010
Karnataka Antibiotics Mr. Sunil Kumar Kaimal Managing Director
&Pharmaceuticals Limited (KAPL),
Banglore-700013
4. re-700013
Bengal Chemicals & Ms. Nirja Saraf Managing Director
Pharmaceuticals (Additional Charge)
Limited (BCPL), Kolkata-700013
5. Rajasthan Drugs & Pharmaceuticals Ms. Nirja Saraf Managing Director
Limited (RDPL), Road No. 12 V.K.I (Additional Charge)
Area Jaipur-302013
137
ANNEXURE
ANNEXURE I [B] I [C]
138
List of Responsibility Centers and Subordinate Organizations
S. Directors of Landline Email Mobile Address

No. NIPER Number butcher
1 Dr. SJS Flora 0172-2214690 [email protected] 9425482305 SAS Nagar, NIPER Mohali,
NIPER-Mohali 0172-2214697 [email protected] Punjab - 160062

(Additional Charge)
2 Dr. Kiran Kalia, 079-66745555 [email protected]@niper 9714618573 Palaj Opp. Air Force Station Head
NIPER- ahm.ac.in Quarter, Gandhinagar- 382355,
Ahmedabad Gujarat.
Dr. Shashi Bala 040-23073741 [email protected] 9999297992 NIPER, Hyderabad IDPL
Singh [email protected] Township, Balangar, Hyderabad-
NIPER- 500007
Hyderabad
Dr.V. 0012-2631565 [email protected] 944396348 1 E.P.I.P. Campus, Industrial
Ravichandiran, [email protected]@niper Area, Hajipur-844102, Bihar
NIPER-Hajipur hajipur.ac.in
(Additional
Charge)
5 Dr.V. 033-24995803 [email protected] 944396348 1 Chunilal Bhawan, 168, Maniktala
Ravichandiran, 033-23200086 [email protected] main road, Kolkata-700054, West
NIPER-Kolkata Bangal
6 Dr. USN Murty 0361-2132751 [email protected] 9127060998 C/ o NITA-Mirza Santipur, Parlli
NIPER-Guwahati [email protected] Part, NH-37 Mirza, Kamrup, Assam
[email protected] – 781125
7 Dr. SJS Flora 0535-2700851 [email protected] 9425482305 Bijnor-Sisendi Road, Sarojini
NIPER-Raebareli [email protected] Nagar, Near CRPF Base Camp,
Lucknow (UP) 226002
ANNEXURE II
Organizational Chart of NPPA
139
Annexure-III
Report No. 3 of 2020 of Comptroller and Auditor General of India (CAG) on Union Government (Eco-
nomic & Service Ministries) - Compliance Audit Observations
Board of Governors (BoG) were not constituted in the six new NIPERs till March 2019 and the
Steering Committee was discharging the functions of the BoG. The BoG at NIPER, Mohali was reconstitut-
ed after a delay of two years. In the absence of a dedicated governing body, permanent academic staff and
adequate infrastructure facilities, the Institutes have been unable to achieve their objective to further phar-
maceutical education in the country in a significant way. This adversely impacted performance in terms of
research papers published and patents awarded and poor placement of students. The Institutes were largely
financed by grants from Ministry and only a very small portion of the expenditure was met through their
own revenue.
(Para 2.1)
140
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Annual Report

2. Functions and Organizational Set-Up

4. Pradhan Mantri Bhartiya Janaushadhi Pariyojana (PMBJP)

5. National Institutes of Pharmaceutical Education & Research

6. Public Sector Undertakings (PSUs)

7. National Pharmaceutical Pricing Authority (NPPA)

9. Citizen Centric Governance

10. Information and Communication Technology

1.1 Pharmaceutical Industry

2. FUNCTIONS AND ORGANIZATIONAL SET-UP 19

2.1 Mandate of Department of Pharmaceuticals

3.1 Scheme for Development of Pharmaceutical Industry

4. PRADHAN MANTRI BHARTIYA JANAUSHADHI PARIYOJANA (PMBJP) 35

5. NATIONAL INSTITUTES OF PHARMACEUTICAL EDUCATION & RESEARCH

6. PUBLIC SECTOR UNDERTAKINGS (PSUs) 81

6.1 Central Public Sector Undertakings

7. NATIONAL PHARMACEUTICAL PRICING AUTHORITY (NPPA) 107

7.1 National Pharmaceutical Pricing Authority (NPPA)

8. IMPLEMENTATION OF RAJBHASHA 121

8.1 Use of Hindi in Official Work

8.3 Hindi Prayog Protsahan Pakhwara, 2020

9. CITIZEN CENTRIC GOVERNANCE 125

9.1 Our Vision

10. INFORMATION AND COMMUNICATION TECHNOLOGY 129

10.1 Local Area Network (LAN)

11. ANNEXURES 135

Annexure - I [A] List of PSUs and Other Organizations

1.2 Medical Devices

1.4 India Pharma 2020 & India Medical Device 2020

1.5 Foreign Direct Investment (FDI)

1.6 Joint Working Group (JWG) / High Technology Cooperation

1.7 International Participations

1.8 National Pharmaceutical Pricing Policy 2012

1.9 COVID-19 Response

1.1 Pharmaceutical Industry:

(Source: DGCIS Kolkata)

1.2 Medical Devices

Basic Medical Devices

High-end Medical Devices

Source: Engineering Export Promotion Council of India (EEPC)

India's Medical Graph-1C

Exports Data for Medical Devices

Range 1 - Exports to World(E) E > 50 mn Exports Values in US $ million

Classification of HS codes at 8-digitw.r.t. Table-1D

Imports- Imports % Share

1.4 India India

Category No. Category Name Name of Awardee

1.5 Foreign Direct Investment (FDI) in Pharmaceutical Sector

1.7 International Participations

1.8 National Pharmaceutical Pricing Policy 2012

The Department of Pharmaceuticals notified the National Pharmaceutical Pricing Policy-2012

1.9 COVID-19 Response

A. Assessing the Availability and Ensuring Adequate Stock of Essential Items.

B. Measures to ensure domestic manufacturing of critical bulk drugs.

C. Support to Industry during lockdown

(a) Challenges in transportation.

i. Non availability of trucks due to unwillingness/ reluctance of transporters.

(b) Reduced availability of workers.

(e) Disruption in operations of Courier services.

D. Actions initiated in the Department to address Logistics related issues