IOSR Journal of Pharmacy and Biological Sciences (IOSR-JPBS)

e-ISSN:2278-3008, p-ISSN:2319-7676. Volume 12, Issue 2 Ver. II (Mar. - Apr.2017), PP 08-13

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Drugs Regulation in Telangana State India: A Overview

Kempaiah Suresh1, Balamuralidhara V2, T.M. Pramod Kumar3,
1
Research Scholar Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS
University, Sri Shivarathreeshwara Nagara, Mysore – 570 015, Karnataka, India
2
Assistant Professor Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS
University, Sri Shivarathreeshwara Nagara, Mysore – 570 015, Karnataka, India
3
Professor Regulatory Affairs Group, Department of Pharmaceutics, JSS College of Pharmacy, JSS University,
Sri Shivarathreeshwara Nagara, Mysore – 570 015, Karnataka, India

Abstract: Pharmacy is the health profession that links the health science with chemical science and it is
charged with ensuring the safe and effective use of pharmaceutical drugs. Telangan has Drugs Control
Department independent of the Health Department and the Heads of these Departments are reporting to the
Government directly. The State of Telangana as some of the country's most dynamic entrepreneurs who are
original and fast-paced in their thinking and focused in their drive for growth and profitability. Telangana is
one of the most industrialised states in the country.. It has a strong base of educational institutions imparting
courses in Pharmacy and some of the institutions have international repute to its credit. Telangana is one of the
fastest growing states in the Country and nearly 400 pharma and biotech companies and 33000 Retail and
Wholesale are housed in the State. Telangana is a vibrant pharmaceutical manufacturing hub for Bulk Drugs
fortified with sound knowledge based institutions and skilled human resource available in the state, it provides
innovative, quality and affordable health care solution to masses. In this short review author provides some of
the glimpses of the pharmacy profession in Telangana.
Keywords: Pharmacy profession, Telangana, Education, Health, Drug.

TELANGANA

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 Drugs Regulation in Telangana State India: A Overview

I. Introduction
Telangana is one of the 29 states in India, located in southern India. Telangana has an area of 112,077
square kilometres (43,273 sq mt) and a population of 35,193,978 (2011 census). Making it the twelfth largest
state in India, and the twelfth most populated state in India. Telangana consists of following major cities which
include Hyderabad, Warangal, Nizamabad, Khammam, Karimnagar and Ramagundam. Telangana is bordered
by the states of Maharashtra to the north and North West, Chhattisgarh to the north, Karnataka to the west
and Andhra Pradesh to the east and south. Telangana acquired its identity as the Telugu-speaking region of
the princely state of Hyderabad, ruled by the Nizam of Hyderabad, joining the Union of India in 1948. In 1956,
the Hyderabad state was dissolved as part of the linguistic reorganisation of states and Telangana was merged
with former Andhra State to form Andhra Pradesh. Following a movement for separation, it was awarded
separate statehood on 2 June 2014. Hyderabad will continue to serve as the joint capital city for Andhra Pradesh
and Telangana for a period of not more than ten years. 1

II. Drugs Control Administration Telangana

 History
The Drugs Control Administration was extended to Telangana region after the formation of Andhra Pradesh
State in the year 1956 when four Drugs Inspectors were appointed and implementation of Drugs & Cosmetics
Act was extended to this area.
Subsequently, Drugs Control Administration was also entrusted with the enforcement of Prevention of Food
Adulteration Act and the Head of the Department was designated as Drugs Controller and Food Health
Authority. In the year 1981 the Department of Drugs Control Administration was accorded independent status
with a separate Directorate headed by a Director functioning under the Ministry of Medical and Health.

 Drugs Control Administration was extended to Telangana

The organizational set up of various functionaries in Drugs and Control Administration are broadly classified
into two wings.
1.EnforcementWing
2. Laboratory Wing.

Enforcement Wing performs the functions of enforcement of the above legislations in the State and Laboratory
Wing performs the Test/Analysis of various Drugs/Cosmetics samples sent for analysis and issues the
Certificate of Test/Analysis.
In 1976, FDA was carved out from the Directorate of Medical and Health, headed by an IPS Officer till 1981.
Drugs Control Administration, A.P was separated from the office of the Drugs Controller & State Food Health
Authority in the year 1981 and was made an independent Department headed by Director, DCA till 1996.
In Aug 1996, Govt. had posted an IPS officer of the rank of Inspector General of Police, Drugs and Copyright to
head the DCA. Subsequently this post was upgraded to ADGP/DGP level as the HOD.
After the bifurcation of erstwhile Andhra Pradesh state, the Drugs Control Administration department of
Telangana State was setup on 02.06.2014.

 Organisation chart

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 Drugs Regulation in Telangana State India: A Overview

Drugs Control Administration - Head Quarters Assitant Director -I, II, III
Two Assistant Director (TC) at Head Office
Sales establishment – All the district are headed by Assistant Director and under them Drugs Inspector and
supporting staff are working
Drugs Control Administration - Medak District
Drugs Control Administration - Mahabubnagar District
Drugs Control Administration - Nalgonda District
Drugs Control Administration - Nizamabad District
Drugs Control Administration - Khammam District
Drugs Control Administration - Warangal Distric
Drugs Control Administration - Karimnagar District
Drugs Control Administration - Adilabad District

 The main objective of Drugs Control Administration is to ensure that the drugs that are made available
to the public, who use them for prevention, mitigation or treatment of diseases are of the required standards of
quality, purity and strength and are packed in containers giving all necessary information about the drug and its
manufacturer. Drugs control Administration regulates the manufacture, sale and distribution of drugs in the state
of Telangana by implementing the following central legislations throughout the state.
Drugs control Administration regulates

Drugs and Cosmetics Act, 1940 and Rules 1945

following central legislations

Drugs and Magic Remedies (Objectionable Advertisement) Act, 1954 & Rules, 1955

A.P Narcotic Drugs and Psychotropic Substances Rules, 1986. (For limited purpose).
- Grant of licenses (NDPS-1 & NDPS-2) and transport permits for NDPS drugs

The Cigarettes and Other Tobacco Products Act 2003. -Prohibition of Advertisement and Regulation
of Trade and Commerce Production and Supply and Distribution relating to tobacco and tobacco
products)

Allopathic
Drugs

Drugs regulated
By Drugs
Control
Administration:

Medical Blood, Blood

Components
Devices

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 Drugs Regulation in Telangana State India: A Overview

 Objective of the Drugs Control Administration:

 To ensure safety, efficacy, purity and quality of Drugs.
 To prevent consumers from self-medication.
 To ensure availability of drugs at authorized prices.
 To create an awareness about the importance of proper storage of drugs.
 To eliminate irrational combinations /banned drugs.
 To study the problems and suggestions made by the stakeholder.
 To collect the information in general about the drug trade and take necessary steps.
 To prepare policy regarding drug matter.

 To prevent misuse of Narcotics drugs

There are about Sales Firms = 28000 Retailers 5000 Wholesalers, in Telangana

Sales lICENCES

Retailers
Wholesalers

Services offered by Department:

S.No Item of work targeted Maximum Response time
( In no. of working days)
1 Grant of manufacturing licenses 30
2 Renewal of Manufacturing licenses 30
3 Grant/Renewal of approval for Approved Laboratories 30
4 Approval of Additional products 10
5 Approval of Technical Staff 10
Recommending for Grant/Renewal of Licenses to Central Licensing
Authority, Delhi with respect to Vaccines and sera; Large Volume
6 parenterals:Blood 30
7 Effecting changes in existing licenses 10
8 Issue of free sale Certificate 5
9 Issue of Market Standing Certificate 5
10 Issue of GMP Certificate 10
11 Issue of Non-Conviction Certificate 5
12 Issue of Production capacity Certificate 5
13 Issue of WHO GMP Certificate 20
14 Issue of test licenses 15

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 Drugs Regulation in Telangana State India: A Overview

There are about 468 Manufacturing Licences

Ther are about 132 Blood Banks and 35 Blood Storage Units in Telangana (2, 3)

Manufacturing and Blood Banks and Storage Centres

0

132
35
Blood Banks
Blood Storage Centres
468
Manufacturing Units

III. Pharmaceutical Industry

 HYDERABAD – Vibrant and Progressive Hyderabad, joint capital of Telangana & Andhra Pradesh, is
the sixth largest urban agglomeration of India. Hyderabad has a dominant position in Pharma Sector, it ranks
first in manufacturing of bulk drugs and third in formulations in the country. It accounts for 40 per cent of the
total Indian bulk drug production and 50 per cent of the bulk drug exports and is considered as the ‘Bulk Drug
Capital of India’. In value terms, the industry is worth US$ 1.6 billion and exports accounting to over US$ 500
million. The Pharma industry and exports from here are expected to grow at 20 per cent annually. Telangana is a
home to few of the top pharma companies Viz. Dr. Reddy’s Laboratories, Aurobindo pharmaceuticals, Mylan,
Novartis, Nicholas Piramal, Divi Labs, NATCO Pharma, Gland Pharmaceuticals, etc. There are more than 200
‘Active Pharmaceutical Ingredients (API)’ units in the state, which are poised to grow at a rate of 10 to 15 per
cent annually in the coming days. Hyderabad is also referred to as the 'Vaccine Hub of India'. The city is home
to leading vaccine producers such as Bharat Biotech, Biological E, Shantha Biotech, Indian Immunologicals,
Globion Bio among others. The Clinical Trial sector in Hyderabad has also witnessed a steep rise, with leading
clinical trial companies such as GVK Biosciences, Sipra, Vimta Labs and Quintiles among others.
 Evolution & Growth of Pharma Industry in Hyderabad
Hyderabad has grown into a pharma hub for bulk drugs basically for two reasons, firstly due to establishment of
Indian Drugs and Pharmaceuticals Ltd. (IDPL) and secondly due to the enterprising nature of its people and
availability of adequate talent pool in the state. Indian Drugs and Pharmaceuticals Ltd. (IDPL) was set up in the
year 1961 at the behest of India’s first Prime Minister, Pandit Jawaharlal Nehru as India’s largest public sector
drug maker in the early days, to enable the country attain self-sufficiency in life-saving drugs. In 1977 the
government has established an industrial estate at Jeedimetla in Hyderabad, to develop ancillary units for IDPL.
This started off a growth phase of the pharma cluster here. The proactive steps and availability of infrastructure
has attracted lot of Technical talent into the industry. Large number of current MSME entrepreneurs here are
technocrats who have working experience with large or medium pharma firms and Organizations. The units
started in small way and rapidly graduated to the next level Dr. Reddy’s Lab, Aurobindo Pharma, Natco, Divi’s
Lab, Matrix, SuvenPharma, Vimta Lab, Neuland Laboratories, etc. are now internationally recognized names.

 Key Pharma companies in Hyderabad

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 Drugs Regulation in Telangana State India: A Overview

Dr Reddy's Laboratories Established in the year 1984, Aurobindo Pharma is a manufacturer of generic
pharmaceuticals and APIs. Matrix Laboratories Matrix Laboratories is a public limited company manufacturing
APIs and solid oral dosage forms based in Secunderabad. Divis Laboratories established in the year 1990, is a
Hyderabad-based pharma company, known for making APIs and intermediates, apart from contract
manufacturing. Suven Life Sciences is based in Hyderabad. Bharat Biotech International Bharat Biotech
International (BBI), Hyderabad, is a multidimensional biotechnology company specialising in product-oriented
research, development and manufacturing of vaccines and biotherapeutics. Shantha Biotechnic Ocimum
Biosolutions is an integrated global genomic services company with operations in Hyderabad and Gaithersburg,
Maryland, US. Transgene Biotek Transgene Biotek was probably the first true biotech company in India. It is
listed on the Indian Stock Exchanges and is involved in the development of several cutting edge technologies.

IV. Telangana Pharmacy Council

The Government of Andhra made ‘Andhra State Pharmacy Council Rules, 1955’by G.O.Ms.1021,
Director of Medical health Services, Sultanbazar, Hyderabad, Dated 9th July 1955 in accordance with powers u/s
46 of The Pharmacy Act, 1948. Subsequently I came into existence by .O.Ms. 2073. Health, dated 15 th July
1963 as Andhra Pradesh Pharmacy Council Rules, 1955.
The Government of Andhra vide G.O. Ms. No.891, Health dated 8th December 1955 vide powers u/s
33A (4) of The Pharmacy Act, 1948 directed the Registrar Madras Pharmacy Council to prepare First register.
It was published in the year 1956 with a list of 236 Pharmacists who were practicing pharmacy in the erstwhile
state of Andhra. Presently the registration of pharmacists is around 70000. Now that the Council is functioning
under In-charge, Director, Drugs Control Administration, Government of Telangana. After the formation of the
Telangana State, the Andhra Pradesh state pharmacy council has shifted its office to Guntur. However they are
now registering the pharmacist 3 days at Hyderabad and 3 days at Guntur. The State government has formed the
Telangana State Pharmacy Registration Tribunal, Nampally, Hyderabad, Telangana for the registration of
pharmacist. There are about more than 60 colleges in Telangana State. (5,6)

V. Conclusion
The pharmacy education in Telangana has witnessed tremendous expansion in last one decade. We
have Seventy thousands of pharmacists in the state. The entire spectrum of the pharmacy related activities in
Telangana are brought under one roof, i.e., drugs control administration, pharmacy education, pharmaceutical
Industry and trade business establishment for all around the development of pharmacy from the inception of it.

Acknowledgement
I would like to thank Sri Rajbhanu Assiatnat Director Drugs Control Adminsitration Telangana for providing
the learning’s that made this manuscript in the best mode form.

Conflicts Of Interest
 The Author declares that there are no conflicts of interest.

References
[1]. Profile of Telanaga [Internet], Telangana [cited 2017 Jan 5] - Available from:Wikipedia https://en.wikipedia.org/wiki/Telangana
[2]. Drugs Control Administration, Telangana [Internet] [cited 2017 Jan 8] Available from: PDF]GOVERNMENT OF ANDHRA
PRADESH DRUGS CONTROL ... - inogent inogent.com/images/GMP-Certificate-2011.pd
[3]. Drugs Control Administration, Government of Telangana [Internet] [cited 2017 Jan 8] Available from:www.dca.telangana.gov.in/
[4]. Telangana Pharameuctical Industry [Internet] [cited 2017 Jan 8] Available
from:PHARMAHITEXwww.hitex.co.in/downloads/Industry%20Reports%20on%20Pharmaceutical%20Industry.pdf
[5]. Information on Telangana pharmacy council [Internet] [cited 2017 Jan 15] Available from:Official Website of Pharmacy Council
appharmacycouncil.gov.in/site/bpharmreg
[6]. Central Council - Pharmacy Council of India [Internet] [cited 2017 Jan 8] Available
from:http://pci.nic.in/CouncilMembers/CentralCouncil.aspx

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