Central Drug Testing Laboratories & Responsibilities

Introduction Central Drug Testing Laboratories & Responsibilities
Role of Central Drugs Testing Laboratory
No of laboratories in India, No of laboratories in each State
Presented by
J. Vinay Krishna
Department of Industrial Pharmacy

1. Central Drug Testing Laboratories & Responsibilities   A Seminar as a part of curricular requirement for Master of Pharmacy, I Year - I semester Presented by J. Vinay Krishna (20L81S0806) Dept of. Industrial Pharmacy Under the guidance/Mentorship of Mr. E. Bhargav M. Pharm., (PhD) Assistant Professor Department of Industrial Pharmacy,

2. Contents: 2 Introduction Role of Central Drugs Testing Laboratory No of laboratories in India No of laboratories in each State

3. Introduction CDL”- The Central Drugs Laboratory Established in Kolkata, CDL is the national statutory laboratory of the Government of India. It is under the control of a Director appointed by the Central Government. It is the oldest quality control laboratory of the Drug Control Authorities in India. 3

4. What is Drug Testing Laboratory ? Laboratory refers to a private or government facility that is capable of testing a specimen to determine the presence of dangerous drugs therein. NRL refers to the National Reference Laboratory for Environmental and Occupational Health, Toxicology and Micronutrient Assay designated by the Secretary of Health. 4

5. 5 Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations. Acting as an Appellate authority in matters of disputes relating to quality of Drug. Role of Central Drug Testing Laboratories CDTL

6. Central Drug Laboratory Kolkata I. Statutory Functions: Analytical quality control of majority of the imported Drug available in Indian market. Analytical quality control of drug and cosmetics manufactured within the country on behalf of the Central and State Drug Controller Administrations. Acting as an Appellate authority in matters of disputes relating to quality of Drug. 6

7. II. Other Functions Collection, storage and distribution of International Standard International Reference Preparations of Drug and Pharmaceutical Substances. 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. Training of Drug Analysts deputed by State Drug Control Laboratories and other Institutions. 7

8. Training of World Health Organization Fellows from abroad on modern methods of Drug Analysis. To advise the Central Drug Control Administration in respect of quality and toxicity of drug awaiting license. To work out analytical specifications for preparation of Monographs for the Indian Pharmacopoeia and the Homoeopathic Pharmacopoeia of India. 8

9. To undertake analytical research on standardisation and methodology of Drug and cosmetics. Analysis of Cosmetics received as survey samples from Central Drug Standard Control Organization. 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 Organization. 9

10. 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. 10

11. Central Drugs Testing Laboratory Hyderabad The CDTL, Hyderabad is one of the National Statutory Laboratories of the Government of India, functioning under administrative control of the Drug Controller General (India), Central Drugs Standard Control Organization (CDSCO), Directorate General of Health Services, Ministry of Health and Family Welfare, New Delhi. 11

12. The functions of the Laboratory include Analysis of Drugs and Pharmaceuticals, Cosmetics and Medical Devices manufactured in the country. Analysis of Import drugs & Cosmetics samples entering through the port offices of CDSCO. Analysis of Drugs & Pharmaceutical formulations received as Survey Samples from Central Drugs Standard Control Organization and its Zonal Offices. 12

13. Analysis of Drugs & Pharmaceuticals formulations received as national Survey samples from CDSCO or other offices under Ministry of Health & Family Welfare Imparting Training to Drugs Analysts deputed by the Government laboratories from time to time. 13

14. No of laboratories in India Sl.No Name and area of the Drug testing Laboratories 1 Central Drugs Testing Laboratory, Mumbai, Maharashtra 2 Central Drugs Laboratory, Kolkata, West Bengal 3 Central Drugs Testing Laboratory, Chennai, Tamil Nadu 4 Central Drugs Testing Laboratory, Hyderabad, Andhra Pradesh 5 Central Drugs Laboratory, Central Research Institute, Kasauli , Himachal Pradesh 6 Regional Drugs Testing Laboratory, Guwahati , Assam 7 Regional Drugs Testing Laboratory, Chandigarh 8 National Institute of Biologicals , Noida (U.P.) 14

15. No of laboratories in each State 15 Sl. No State No of Centres 01 Andhra Pradesh 2 02 Bihar 1 03 Chhattisgarh 1 04 Delhi 1 05 Goa 1 06 Gujarat 1 07 Haryana 1 08 Himachal Pradesh 1 09 Jammu & Kashmir 2

16. 16 Sl.no State No of Centres 10 Jharkhand 1 11 Karnataka 3 12 Kerala 1 13 Madhya Pradesh 1 14 Maharashtra 2 15 Meghalaya 1 16 Orissa 1 17 Pondicherry 1 18 Punjab 1 19 Rajasthan 1 20 Tamil Nadu 2

17. 17 Sl.no State No of Centres 21 Tripura 1 22 Uttar Pradesh 1 23 West Bengal 1 Total 29

18. 18