Central Drugs Standard Control
Dte.GHS, Ministry of Health and Family Welfare, Government of India



Drugs Control Administration 
Central Drugs Standard Control Organization 
State Drugs Standard Control Organization 
Drugs Control Administration 
Functions undertaken by
Central Government
Functions undertaken by
State Governments
Statutory Functions
Statutory Functions
Laying down standards of drugs, cosmetics, diagnostics and devices.

Licensing of drug manufacturing and sales establishments.

Laying down regulatory measures, amendments to Acts and Rules.

Licensing of drug testing laboratories.

To regulate market authorization of new drugs.

Approval of drug formulations for manufacture.
To regulate clinical research in India.

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

To approve licenses to manufacture certain categories of drugs as Central Licence Approving Authority i.e. for Blood Banks, Large Volume Parenterals and Vaccines & Sera.

Investigation and prosecution in respect of contravention of legal provisions.

To regulate the standards of imported drugs. Administrative actions.

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

Pre- and post- licensing inspection.
Testing of drugs by Central Drugs Labs.
Recall of sub-standard drugs.
Publication of Indian Pharmacopoeia.
Other Functions    

Coordinating the activities of the State Drugs Control Organizations to achieve uniform administration of the Act; and policy guidance.


Guidance on technical matters.

Participation in the WHO GMP certification scheme.    
Monitoring adverse drug reactions (ADR).    
Conducting training programmes for regulatory officials & Govt. Analysts.    
Distribution of quotas of narcotic drugs for use in medicinal formulations.    
Screening of drug formulations available in Indian market.    

Evaluation/Screening of applications for granting No Objection Certificates for export of unapproved/banned drugs.


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