India's spurious drug industry sells 35 percent of its produce worldwide. The problem of spurious and substandard drugs in the country is quite unbridled

Regulatory systems

Central level

  1. Laying down regulatory measures and amendments to the Drugs and Cosmetics Act (D&CA), 1940, and Rules. 
  2. Approval of new drugs introduced in the country. 
  3. Permission to conduct clinical trials – registration and control on the quality of imported drugs. 
  4. Laying down standards for drugs, cosmetics, diagnostics and devices and updating India Pharmacopoeia. 
  5. To approve licences as the Central Licence Approving Authority (CLAA) for the manufacture of large volume parenterals and vaccines and operation of blood banks and such other drugs as may be notified by the government from time to time. 
  6. Coordinating the activities of the States and advising them on matters relating to uniform administration of the Act and Rules.

State level

  1. Licensing of drug manufacturing establishments and sales premises. 
  2. Carrying out inspections of licensed premises for ensuring compliance to conditions of licences. 
  3. Drawing samples for test and monitoring the quality of drugs and cosmetics moving in the State. 
  4. Taking appropriate action like suspension cancellation of licences. 
  5. Instituting legal action wherever needed as provided under the D&CA and Rules.