Detailed Explanation:

Question:
Which organization in India approves and gives regulatory clearance of biologicals?

• (1) Central Drugs Standard Control Organization (CDSCO)

• (2) National Institute of Biologicals (NIB)

• (3) Indian Pharmacopoeia Commission (IPC)

• (4) Department of Biotechnology (DBT)

Correct Answer:

(1) Central Drugs Standard Control Organization (CDSCO)

Explanation:

In India, the Central Drugs Standard Control Organization (CDSCO) is the primary authority responsible for approving and granting regulatory clearance for biological products. This includes vaccines, blood products, and other biologicals used in medical treatments. CDSCO functions under the Ministry of Health and Family Welfare and ensures that biological products meet the necessary standards of safety, efficacy, and quality before being introduced into the market.

Role of CDSCO:

• Approval Process: CDSCO reviews and approves all biological products before they can be marketed and used in India. This includes evaluating the clinical trials, product quality, and adherence to regulatory standards.

• Regulation of Biologicals: The organization also ensures that manufacturers comply with Good Manufacturing Practices (GMP) and other regulatory requirements to maintain the safety of biological products.

Other Organizations:

• National Institute of Biologicals (NIB) (Option 2): NIB plays a vital role in the standardization and quality control of biological products, particularly in the testing of vaccines and other biologics. However, it does not approve biologicals; rather, it provides support to the regulatory process.

• Indian Pharmacopoeia Commission (IPC) (Option 3): IPC is responsible for setting standards for drugs in India, including their quality and composition. However, it does not grant approval for biological products.

• Department of Biotechnology (DBT) (Option 4): DBT supports biotechnology research and innovation but does not directly approve biological products for market use. It provides funding and policy advice in the biotechnology sector.

Conclusion:

The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for approving biological products. This organization ensures that biologicals, including vaccines and therapeutics, meet stringent quality, safety, and efficacy standards before they can be used by the public.

If you need further information on the approval process for biologicals or other regulatory matters in India, feel free to ask!