Functions undertaken by Central Government.

Statutory Functions

• 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.

Other Functions.

• 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

Statutory Functions

• 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.