Central Drugs Standard Control Organization (CDSCO) and Its Function


WHAT IS THE ROLE OF CDSCO :
The Central Drugs Standard Control Organization (CDSCO) is the national regulatory body for Indian pharmaceuticals and medical devices, and serves parallel function to the European Medicines agency of the European Union, the Japan, the Foods & Drugs Administration of the United states and the Medicines and Health care products Regulatory agency of the united Kingdom.
The Central Drugs Standard Control Organization (CDSCO) is the Central Drug Authority for Discharging functions assigned to the Central Government under the Drugs and Cosmetics Act. CDSCO has a good track record with the World Health Organization (WHO) . CDSCO Reports to Drug Controller General of India (DCGI)
Major Role of CDSCO:
  1. Under the Drug and Cosmetics Act, the regulation of manufacture, sale and distribution of Drugs is primarily the concern of the State authorities while the CDSCO Authorities are responsible for approval of New Drugs
  2. To Conduct of Clinical Trials of the drugs.
  3. To check the standards for Drugs.
  4. To control over the quality of imported Drugs in the country and 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.
  5. 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.
  6. To conduct Audit for World Health Organization (WHO) along with State Drug Control Organizations & to provide WHO Licence .
  7. CDSCO is constantly working 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. 
  8. Import Registration of drugs and medical devices and provide no objection certificates for export .
  9. Banning of drugs and cosmetics.

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