CDSCO: The Regulatory Authority

In this blog will discuss about CDSCO: The Regulatory Authority.

The Central Drugs Standard Control Organization (CDSCO) is the National Regulatory Authority under Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India.

 

All India spread:

· HQ- FDA Bhawan, Kotla Road, New Delhi 110002

· Zonal offices-6

· sub-zonal offices-4

· Port offices-13

· Laboratories-7

CDSCO

SCOPE:

CDSCO is responsible for bringing the uniformity in the enforcement of the Drugs and Cosmetics Act. The broader areas of enforcement are:

· Approval of Drugs

· Conduct of Clinical Trials

· Laying down the standards for Drugs

· Control over the quality of imported Drugs

· Coordination of the activities of State Drug Control Organizations

· Grant of licenses of certain specialized categories of critical Drugs (joint responsibility with state regulators)

DCGI or Drug Controller General of India is drug license approving authority for various categories like vaccines, blood products, and IV fluids.

August 12, 2020
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