Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the Central Authorities are responsible for approval of New Drugs, Clinical Trials in the country, laying down the standards for Drugs, control over the quality of imported Drugs, coordination of the activities of State Drug Control Organisations and providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act. 

Drug Controller General of India is responsible for approval of licenses of specified categories of Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera. 
Central Drugs Standard Control Organization Head quarter is located at FDA Bhawan, Kotla Road, New Delhi 110002 and functions under the Directorate General of Health Services.

 

ZONAL OFFICES OF CENTRAL DRUGS STANDARD CONTROL ORGANISATION (CDSCO) 

The Central Government have established four zonal offices of the Central Drug Standard Control Organisation at Mumbai, Kolkata, Chennai, and Ghaziabad. The Zonal Offices work in close collabration with the State Drug Control Administration and assist them in securing uniform enforcement of the Drug Act and other connected legislations, on all India basis. The names of the office-in-charge of the Zonal Organisations, their address and names of the States are as follows: 

Central Drugs Laboratory (CDL)

The Central Drugs Laboratory, Kolkata is the national statutory laboratory of the Government of India for quality control of Drug and Cosmetics and is established under the Indian Drug & Cosmetics Act, 1940. It is the oldest quality control laboratory of the Drug Control Authorities in India. It functions under the administrative control of the Director-General of Health Services in the Ministry of Health and Family Welfare. 

The functions of the Laboratory include: 

I. Statutory Functions:

(a) Analytical quality control of majority of the imported Drug available in Indian market.

(b) Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations.

(c) Acting as an Appellate authority in matters of disputes relating to quality of Drug. 

II. Other Funtions:

(a) Collection, storage and distribution of International Standard International Reference Preparations of Drug and Pharmaceutical Substances.

(b) Preparation of National Reference Standards and maintenance of such Standards. Maintenance of microbial cultures useful in drug analysis Distribution of Standards and cultures to State Quality Control Laboratories and drug manufacturing establishments.

(c) Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.

(d) Training of World Health Organisation Fellows from abroad on modern methods of Drug Analysis.

(e) To advise the Central Drug Control Administration in respect of quality and toxicity of drug awaiting licence.

(f) To work out analytical specifications for preparation of Monographs for the Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India.

(g) To undertake analytical research on standardisation and methodology of Drug and cosmetics.

(h) Analysis of Cosmetics received as survey samples from Central Drug Standard Control Organisation.

(i) Quick analysis of life saving Drug on an All-India basis received under National Survey of Quality of Essential Drug Programme from Zonal Offices of Central Drug Standard Control Organisation.

In addition to the above functions the Central Drug Laboratory also actively collaborates with the World Health Organisation in the preparation of International Standards and Specifications for International Pharmacopoeia. It also undertakes collaborative study on behalf of the Indian Pharmacopoeia Committee. The senior Officers of the Laboratory have been appointed as Government Analysts on behalf of most of the States of the Union for analysis of drug samples.

 The Director of CDL is Dr.P.K.Guha, Director, Central Drugs Laboratory, 3, Kyd Street, Kolkata – 700 016. Phone : 033 -22299541, Gram : BIOSTANLAB. Fax: 033-22299380. 

Central Drugs Testing Laboratory (CDTL) Chennai , Tamil Nadu

Central Drug Testing Laboratory is one of the four National Laboratories in India engaged in the research and analysis of Drug and Cosmetics as per Drug and Cosmetics Act, 1940. 

The Director of the CDTL Chennai is, Dr. N. Murugesan, Director , Central Drug Testing Laboratory, Govt. of India, 37, Naval Hospital Road, Periamet, Campus G.M.S.D., Chennai – 600 003. Phone : 044-25610402/ 25610205, Gram : DRUGSLAB, Fax : 044 -25610906 E-mail : cdtl@dataone.in

Central Drugs Testing Laboratory (CDTL) Hyderabad, AP

Central Drug Testing Laboratory is one of the  Newly established Laboratories in the state of Andhra Pradesh,  India engaged in  testing ,  research and analysis of Drug and Cosmetics as per Drug and Cosmetics Act, 1940. 

The Director (incharge)/ Nodal Officer of the CDTL Hyderabad  is, Dr. N. Murugesan,  Central Drug Testing Laboratory, CDSCO, Zonal office Hyderabad , CDSCO BHAVAN, Beside T.B. & Demonstration Centre, S.R. Nagar, Hyderabad - 500038, A.P . Phone : 040-23811327/, Fax : 040- 23811328, E-mail : cdtlhyd@gmail.com

Central Drugs Testing Laboratory (CDTL) Mumbai

The Central Drugs Testing Laboratory – Mumbai is another national statutory laboratory of the Government of India, functioning under administrative control of the Drug Controller General (India), DGHS, Ministry of Health and Family Welfare. 

The major functions of the laboratory include: 

Testing of imported bulk drugs and formulations referred by ADCs, Mumbai, Nhava Sheva & Chennai, Survey and Watchers samples referred by Deputy Drugs Controller (India), West Zone. Lately, new drugs and formulations are also being referred by the Drugs Controller General (India). The laboratory is notified as Apellate Laboratory for Copper T Intra-Uterine Contraceptive Device and Tubal Rings under the Drugs and Cosmetics Rules, (Medical Stores) & Regional Directors of Department of Family Welfare and procurement and field samples of Oral Contraceptive Pills, Copper T and Tubal Rings referred by the Dept. of Family Welfare. 

The Director of the Laboratory is Dr. (Mrs) Gopa Ghosh, Director In-charge, Central Drugs Testing Laboratory-Mumbai, Government Medical Stores Depot Compound,Belasis Road, Opp. Sahil Hotel, Mumbai Central, Mumbai 400008 . Phones : Offi. : 022 - 23002309, (Resi.) : 23620293, Gram : DRUGSLAB, Telefax : 23099240. e-mail: cdtlmumbai@rediffmail.com

Regional Drugs Testing Laboratory (RDTL) Guwahati

The Regional Drugs Testing Laboratory Guwahati is the one of the five National Laboratory of the Govt of India for quality control of Drugs and Cosmetic and is established under the Indian Drugs & Cosmetics Act 1940 functioning under administrative control of the Drugs Controller General of India and sub ordinate office under Directorate General of Health Services, Ministry of Health & Family Welfare. The laboratory was set up in the year 2002 for entire North Eastern State including Sikkim and is housed in its own building at Guwahati.

1. Statutory Function:
a. Analytical quality control of drugs and cosmetic manufactured within the country on behalf of the Central and State Drugs Controller Administration.
b. To assists the Central Drugs Standard Control Organization in the testing of Drugs and cosmetic.

The laboratory is headed by
Dr. Parthajyoti Gogoi, Director-in-Charge Regional Drugs Testing Laboratory, Directorate General of Health Services, Guwahati-781 037 (Assam)
Phones -Off- 0361-2338555/2330555(Fax) ,Resi-0361-2337272/2330899
e-mail : parthajyoti@sancharnet.in , mailto: pjgogoi@gmail.com , pig.rdtl@assam.nic.in

Regional Drugs Testing Laboratory (RDTL) Chandigarh

Regional Drugs testing laboratory, Chandigarh has become operational since November, 2007. Presently the laboratory is testing the drugs at an average of 50 samples per month, primarily to cater the requirements of CDSCO (North Zone). The laboratory is in the process of up-gradation in infrastructure and manpower in order to increase the testing capacity.

Regional Drugs Testing Laboratory, Sector 39-C, Chandigarh 160036,  Director : Dr. R.A Singh, Phone : 0172 - 2688239; Fax 0172-2636316, e- mail :directorrdtlchd@yahoo.com

Central Drugs Laboratory, CRI Kasauli

Central Drugs Laboratory at Central Research Institute (CRI) Kasauli is a Central laboratory engaged in the testing of vaccines. It is a notified laboratory under the Drugs and Cosmetics Act, 1940 to function as Central Drugs Laboratory for testing of the following drugs or classes of drugs;

i)  Sera

ii) Solution of serum proteins intended for injection

iii) Vaccines

iv) Toxins

v) Antigens

vi) Anti-toxins

vii) Sterilized surgical ligature and sterilized surgical suture

viii) Bacteriophages, including Oral Polio vaccine. 

The Director of CDL Kasauli is Dr.Arun Bhardwaj, Phone: 01792-272046, Fax: 01792 -272049

Email:nclkasauli@gmail.com

Indian Pharmacopoeial Commission (IPC)

Indian Pharmacopoeial Commission is an Autonomous Institution under the Ministry of Health & Family Welfare, Govt. of India dedicated for setting of standards for drugs, pharmaceuticals and healthcare devices/ technologies etc besides providing Reference Substances and Training. Its functions are :

a) To develop comprehensive monographs for drugs to be included in the Indian Pharmacopoeia, including active pharmaceutical ingredients, excipients and dosage forms as well as medical devices, and to keep them updated by revision on a regular basis.

b) To accord priority to monographs of drugs included in the national Essential Drugs List and their dosage forms.

c) To prepare monographs for products that have normally been in the market for not less than 2 years except for certain special categories of new drugs like antiretrovirals, antituberculosis and anticancer drugs and their formulations introduced more recently, which may be accorded priority attention

d) To give special attention to the methods of manufacture used by the indigenous industry in selecting the pharmacopoeial tests for monitoring the toxic impurities of the concerned drug.

e) To take note of the different levels of sophistication in analytical testing/instrumentation available while framing the monographs.

f) To accelerate the process of preparation, certification and distribution of IP Reference Substances, including the related substances, impurities and degradation products required.

g) To collaborate with pharmacopoeias like the Ph Eur, BP, USP, JP and International Pharmacopoeia with a view to harmonizing with global standards.

h) To organize educational programs and research activities for spreading and establishing awareness on the need and scope of quality standards for drugs and related articles/ materials.

The Indian Pharmacopoeia Commission has been registered as a Society under the provisions of the Societies Registration Act, 1860(Act No. 21 of 1860) for the registration of Literary, Scientific and Charitable Societies, on 09 December 2004.

The Director of Indian Pharmacopoeial Commission is Dr. G.N. Singh, Raj Nagar, Sector -23, Ghaziabad 201002 (U.P) Phone: 95120- 2783401 (D) 2783337; Fax: 091 -24783311, E-mail : ipclab@vsnl.net