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Central Drugs Standard Control Organisation

Central Drugs Standard Control Organisation:

The CDSCO has become the sole authority for issuing manufacturing licences for new drugs meant for exports, withdrawing the power from state governments amid heightened global scrutiny of Indian made drugs.

  • Central Drugs Standard Control Organisation (CDSCO) is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs and Cosmetics Act.
  • It is responsible for overseeing the import, manufacture, sale, and distribution of medical device in the country.
  • The CDSCO ensures that medical devices comply with safety, quality, and efficacy standards.
  • It works under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.
  • The Drugs Controller General of India (DCGI) is the head of the CDSCO.
  • Headquarters: New Delhi.
  • Under the Drugs and Cosmetics Act, CDSCO is responsible for,
    • 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;
  • CDSCO, along with state regulators, is jointly responsible for the grant of licenses for certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine, and Sera.
  • The CDSCO conducts inspections and audits to ensure that medical device companies are complying with regulations related to safety, quality, and efficacy.