Clinical Research

Roles and Responsibilities of CDSCO:

Many of us of in India, have heard about CDSCO and have got confused about its role and relation with DCGI. So what is CDSCO? CDSCO stands for Central Drugs Standard Control Organization. CDSCO is a licensing authority, a regulatory agency which approves any new chemical entity (drug) which is to be imported to India.

Authority: Who is Who?

CDSCO is controlled and governed by Directorate General of Health Services which comes under ministry of health and family welfare, Government of India. The headquarter  of the Central Drugs Standard Control Organization is located at New Delhi, while it has multiple zonal offices throughout India. CDSCO also works in close context with Central Drug Laboratories to perform quality control tests.

To regulate imported drugs as authority, the CDSCO works with the Drugs Technical Advisory Board and the Drugs Consultative Committee, while the Central Drugs Laboratory undertakes testing of such drugs.

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 Organizations and providing expert advice with a view of bringing about the uniformity in the enforcement of the Drugs and Cosmetics Act. The state authorities on the other hand are concerned with the regulation of manufacture, sale and distribution of Drugs licensing drug testing laboratories, approving drug formulations for manufacture, carrying out pre- and post-licensing inspections, and overseeing the manufacturing process, for drugs manufactured by respective state units and those marketed in the state. These authorities are formed under the Drug and Cosmetics Act 1940 and Rules 1945.

Functions undertaken by the central authority can be summarized as:

1. Laying down standards of drugs, cosmetics, diagnostics and devices.

2. Laying down regulatory measures, amendments to Acts and Rules.

3. To regulate market authorization of new drugs.

4. To regulate clinical research in India.

5. To approve licenses to manufacture certain categories of drugs as Central Licence approving Authority i.e. for Blood Banks, Large Volume Par-enterals and Vaccines & Sera.

6. To regulate the standards of imported drugs.

7. Work relating to the Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC).

8. Testing of drugs by Central Drugs Labs

9. Publication of Indian Pharmacopoeia.

Functions undertaken by the state authorities can be summarized as:

1. Licensing of drug manufacturing and sales establishments

2. Licensing of drug testing laboratories.

3. Approval of drug formulations for manufacture.

4. Monitoring of quality of Drugs & Cosmetics, manufactured by respective state units and those marketed in the state.

5. Investigation and prosecution in respect of contravention of legal provisions.

6. Administrative actions.

7. Pre- and post- licensing inspection

8. Recall of sub-standard drugs.


1. Central Drugs Standard Control Organization, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India, Feb 1st 2012,

Leave a Reply

Your email address will not be published. Required fields are marked *