There are four drug-testing laboratories under the direct control of CDSCO. A fifth one is coming up at Chandigarh. In addition to these central facilities, there are state level drug testing laboratories in almost every state of the country. The regulatory agency also takes the assistance of central institutions like Central Drug Laboratory, Kasauli, National Institute of Biologicals, Noida and Indian Veterinary Research Institute. A brief on the CDSCO labs and their statutory responsibilities are given below:
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. If 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:
v Analytical quality control of majority of the imported Drug available in Indian market.
v Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations.
v Acting as an Appellate authority in matters of disputes relating to quality of Drug.
II. Other Funtions:
v Collection, storage and distribution of International Standard International Reference Preparations of Drug and Pharmaceutical Substances.
v 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. v Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
v Training of World Health Organisation Fellows from abroad on modern methods of Drug Analysis.
v To advise the Central Drug Control Administration in respect of quality and toxicity of drug awaiting licence.
v To work out analytical specifications for preparation of Monographs for the Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India.
v To undertake analytical research on standardisation and methodology of Drug and cosmetics.
v Analysis of Cosmetics received as survey samples from Central Drug Standard Control Organisation.
v 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 B. Mandal, M.Sc., Director, Central Drugs Laboratory, 3, Kyd Street, Kolkata - 700 016. Phone : 2299541, Gram : BIOSTANLAB. Fax: 033-2299380.
Central Drugs Testing Laboratory (CDTL) Chennai
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,
A.R. Singh, Dy. Drug Controller (India), Director (Acting), Central Drug Testing Laboratory, Govt. of India, 37, Naval Hospital Road, Periamet, Campus G.M.S.D., Chennai - 600 073.
Phone : 5386402
Fax : 044-5386402.
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. K.V. Jogi. M.Pharm., Ph.D.,Central Drugs Testing Laboratory-Mumbai, 4 th Floor, ESIS Hospital Bldg., Road No. 33, Wagle Estate. Thane-400 604 (Maharashtra).
Phones : Offi. : 5823843, 5825057, (Resi.) : 5829774, Gram : DRUGSLAB,
Telefax : 5832575.
Central Drugs Testing Laboratory (CDTL) 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.
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 Mr.Parthajyoti Gogoi, M.Pharm (Tech), Government Analyst, Officer-in-Charge Regional Drugs Testing Laboratory, Guwahati-781 037 ( Assam) Phones-Off-0361-2338555/ 2330555 (Tele-Fax), Resi-0361-2337272/ 233899 e-mail :parthajyoti@sancharnet.in parthajg@sify.com pjg.rdtl@assam.nic.in Central Indian Pharmacopoeia Laboratory (CIPL) Central Indian Pharmacopoeia Laboratory is the national statutory laboratory of Government of India for quality control of Drugs and Cosmetics and is established under the Indian Drugs and Cosmetics Act, 1940. It functions under the administrative control of Director General of Health Services in the Ministry of Health and Family Welfare. Its functions are :
a) To draw up standards and analytical specifications for monographs to be incorporated in the Indian Pharmacopoeia.
b) To function as government Analyst for such states who do not have their own testing facilities.
c) To assist the central Drug Standard Control Organization in the testing of drugs and cosmetics.
d) To carry out the work pertaining to the National Formulary of India.
e) Quality control of mechanical contraceptives under Drugs and Cosmetics Act.
f) To act as appellate authority in matters of dispute relating to quality of condoms.
g) To carry out investigations for establishing simpler and reliable methods of analysing drugs and their preparations.
h) To carry out research work for standardising and characterising drugs incorporated in the Indian Pharmacopoiea.
i) Training of Drug Analysts of Drug Control Laboratories of different states.
j) Nodal centre for regular condom testing, research & training for other Condom Testing Laboratories.
In addition to above functions, the laboratory actively collaborates with World Health Organisation in preparation of standards and specifications for international Pharmacopoeia. It also undertakes collaborative studies on behalf of Indian Pharmacopoeia Committee. The laboratory is approved as research Centre by Meerut University. The laboratory is housed in its own building.
The laboratory is headed by Dr. G.N. Singh, Director, Central Indian Pharmacopoeia Laboratory, Raj Nagar, Sector-23, Ghaziabad, 201002 (U.P.). Phones : Off. 91-4783400, 91-4783392, 91-4783401 (Direct), Gram : CIPLAB, Fax : 091-4783311, e-mail : goicipl@nda.vsnl.net.in