The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority (NRA) for Pharmaceuticals and Medical devices. It is under the Directorate General of Health Services, Ministry of Health & Family Welfare, Govt. of India. The headquarter is located at FDA Bhavan, Kotla Road, New Delhi, 110002. CDSCO is spread across the country with 6 zonal offices, 4 sub zonal offices, 13 Port offices, and 7 laboratories.

The Drugs & Cosmetics Act, 1940 have entrusted various responsibilities to central & state regulators for regulation of drugs & cosmetics. It contemplates uniform implementation of the provisions of the Act & Rules made there under for ensuring the safety, rights, and well being of the patients by regulating the drugs and cosmetics. CDSCO is constantly thriving upon to bring out transparency, accountability, and uniformity in its services in order to ensure safety, efficacy and quality of the medical product manufactured, imported and distributed in the country.

  • Approval of New Drugs
  • Conduct of Clinical Trials
  • Laying down the standards for Drugs
  • Control over the quality of imported Drugs in the country
  • Coordination of the activities of State Drug Control Organizations by providing expert advice with a view of bring about the uniformity in the enforcement of the Drugs and Cosmetics Act.

Further CDSCO along with state regulators, is jointly responsible for grant of licenses of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.


  • Approval of new drugs and clinical trials
  • Import registratration and Licensing
  • License approving of Blood Banks, LVPs, Vaccines, r-DNA products & some Medical Devices (CLAA Scheme)
  • Amendment to D & C Act & Rules
  • Banning of drugs and cosmetics
  • Grant of Test License, Personal License, NOCs for Export
  • Testing of new drugs
  • Oversight and market survillance through Inspectorate of Centre over and above the State Authority