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.