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Whose main functions is to have regulatory control over the import of drugs, approval of new drugs and clinical trials?
Question

Whose main functions is to have regulatory control over the import of drugs, approval of new drugs and clinical trials?

A.

ICC

B.

ISSDA

C.

CDSCO

D.

FSSAI

Correct option is C

(c) CDSCO

Sol. The Central Drugs Standard Control Organization (CDSCO) is the regulatory authority in India responsible for overseeing the import of drugs, approving new drugs, and conducting clinical trials. It operates under the Ministry of Health and Family Welfare and ensures the safety, efficacy, and quality of drugs.

Information Booster:

  • CDSCO regulates the drug approval process and ensures compliance with standards.
  • The organization plays a crucial role in public health by monitoring adverse drug reactions.
  • It sets guidelines for clinical trials and oversees the licensing of drug manufacturers.
  • The CDSCO operates the Drug Technical Advisory Board (DTAB) for expert advice.
  • It also collaborates with international organizations for global health initiatives.
  • Its guidelines are essential for pharmaceutical companies to navigate the regulatory landscape.

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