Functions undertaken by Central Government.
- Laying down standards of drugs, cosmetics, diagnostics and devices.
- Laying down regulatory measures, amendments to Acts & Rules.
- To regulate market authorization of New Drugs.
- To regulate clinical research in India.
- To approve licences to manufacture certain categories of drugs as Central Licensee Approving Authority i.e. for Blood Bank, Large Vulume Parenterals, Vaccines and sera, some devices and Recombinant DNA (r-DNA) derived drugs.
- To regulate the standards of imported drugs.
- Work relating to Drugs Technical Advisory Board (DTAB) and Drugs Consultative Committee (DCC).
- Testing of Drugs by Central Drugs Labs.
- Publication of Indian Pharmacopoeia.
- Prohibition the manufacture and sale of Drugs and Cosmetics under section 26-A of D&C Act in India.
- Coordinating the activities of other State Drugs Contrul Organization to achieve uniform administration of the Act and pulicy guidance.
- Guidance on technical matters.
- Participation in the WHO GMP Certification Scheme.
- Monitoring Adverse Drug Reaction (ADR).
- Conducting training Programme for regulatory officials and Govt. Analysts.
- Distribution of quotas of Narcotic Drugs for use in medicinal formulations.
- Screening of drug formulations available in India market.
- Evaluation/Screening of applications for granting ‘No objection Certificate’ for export of unapproved/Banned Drugs.
Functions undertaken by State Government
- Licensing of drug manufacturing and sales establishments.
- Licensing of Drug Testing Laboratories.
- Approval of Drug Formulations for Manufacture.
- Monitoring of quality of Drugs & Cosmetics, manufactured by State Units and those marketed in the State.
- Investigation and prosecution in respect of contravention of legal provisions.
- Administrative Actions.
- Pre and Post-Licensing Inspections.
- Recall of Sub-Standard Drugs.