Central Drugs Standard Control Organization

Major functions of CDSCO:

Approval of new drugs and clinical trials
Import registration and Licensing
License approving of blood banks, LVPs, Vaccines, r-DNA products and some medical devices
Amendments to Drugs and Cosmetics Act and rules
Banning of drugs and cosmetics
Grant of test license, personal license, NOCs for export
Testing of New drugs
Oversight and market surveillance through inspectorate of Centre over and above the state authority

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 preand post-licensing inspections, and overseeing the manufacturing process, for drugs manufactured by respective state units and those marketed in the state