Central Drugs Standard Control Organization (CDSCO)

About Central Drugs Standard Control Organization (CDSCO):

• It is the National Regulatory Authority (NRA) of India for the medical devices industry under the provisions of the Drugs & Cosmetics Rules.
• It works under the Ministry of Health & Family Welfare.
• 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 of certain specialized categories of critical Drugs such as blood and blood products, I. V. Fluids, Vaccine and Sera.

 

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Q1) What is the Drugs Controller General of India (DCGI)?

Drugs Controller General of India (DCGI): DCGI is the head of the department of the CDSCO of the Government of India responsible for approval of licences of specified categories of drugs such as blood and blood products, IV fluids, vaccines and sera in India. DCGI also sets standards for the manufacturing, sales, import, and distribution of drugs in India.

Source: 48 commonly-used drugs fail latest quality test; CDSCO issues alert