30 Oct 2024        11:12:25 am

Political

Central Drugs Standard Control Organisation (CDSCO)

Tags : Central Drugs Standard Control Organisation (CDSCO)

Topic: Regulatory Bodies

Why in the news?

• The Central Drugs Standard Control Organisation (CDSCO), in its drug alert for August, has listed that samples of more than 50 drugs, including commonly used paracetamol, Pan D, calcium, vitamin D3 supplements, and anti-diabetes pills, are “not of standard quality”. The drugs are allegedly manufactured by companies including Alkem Laboratories, Hindustan Antibiotics Limited, Hetero Labs Limited, Karnataka Antibiotics and Pharmaceuticals Ltd, Nestor Pharmaceuticals Ltd, and Priya Pharmaceuticals.

Source: The Hindu 

About Central Drugs Standard Control Organisation (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.
• Its headquarters are located in 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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