The Drugs and Cosmetics Act, 1940 regulates the import, manufacture, sale and distribution of Drugs and Cosmetics in the country. Under this Act import, manufacture and sale of sub-standard, spurious, adulterated or misbranded Drugs and Cosmetics are prohibited. The Government is empowered to check the quality of imported drugs, lay dawn regulatory measures and standards of drugs and grant approval for the import or manufacture of new drugs. The control over the quality of drugs, which are manufactured, sold and distributed in the country, is exercised by State Governments through state licensing authorities. The Zonal Offices of the Central Drugs Standard Control Organisation (CDSCO) at Mumbai, Kolkata, Ghaziabad and Chennai and sub-zonal offices at Ahmedabad and Hyderabad maintain close liaison with state organisation for uniform enforcement of the provisions of this Act. CDSCO also arranges training programmes for personnel concerned with drugs standard control. The Central Drugs Laboratory (CDL), Kolkata functions as the testing laboratory for imported drugs and for analytical quality control of drugs manufactured within the country. It is assisted by Central Indian Pharmacopoeia Laboratory, Ghaziabad, and Central Drugs Testing Laboratories at Chennai and Mumbai and Regional Drugs Testing Laboratories at Guwahati and the State Drugs Testing Laboratories in the states. The CDL, Kolkata is the appellate laboratory, under the Drugs and Cosmetics Act to test samples of drugs sent to it by the Courts. Central Licensing Approval Authority (CLAA) at CDSCO, New Delhi approves the licenses for blood banks, blood products, large volume parenteral, sera and vaccines, r-DNA products notified medical devices licensing authorities. The Central and State Governments are advised on technical matters by the Drugs Technical Advisory Boards, a statutory body State Drug Control Authorities or independently drug manufacturing units, blood banks and approved drug testing laboratories.

The Ministry of Health and Family Welfare has constituted an independent IP Commission to ensure timely publication of updated versions of Indian Pharmacopoeia and to prepare reference standards of drugs for their use by drug testing laboratories, R & D Centre and academic institutions in the country.

A National Pharmacovigilance Programme has been launched for the first time in the country. It involves a large number of medical colleges as peripheral centres, 5 regional centers and tow zonal centre to capture data on adverse drug reactions and their causality and relations. A broad based National Pharmacovigilance Advisory Committee has been constituted to over look the activities of the programme.