DCGI RELAXES NORMS FOR CLEARING VACCINES

  • June 2, 2021
  • Posted by: OptimizeIAS Team
  • Category: DPN Topics
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DCGI RELAXES NORMS FOR CLEARING VACCINES

Subject: Governance

Context: India’s apex drug regulator Tuesday waived the requirement for foreign companies to conduct post-launch bridging trials and test the quality and stability of their Covid-19 vaccines here if they have approvals from specific countries or health bodies

Concept:

Drugs Controller General of India (DCGI)

  • DCGI under gamut of Central Drugs Standard Control Organization (CDSCO) is responsible for approval of licenses of specified categories of drugs such as blood and blood products, vaccines, IV fluids and sera in India.
  • DCGI lays down standards and quality of manufacturing, selling, import and distribution of drugs in India.
  • It acts as appellate authority in case of any dispute regarding quality of drugs.
  • It prepares and maintains national reference standard.
  • It brings about uniformity in enforcement of Drugs and Cosmetics Act.
  • It trains Drug Analysts deputed by State Drug Control Laboratories and other Institutions.
DCGI RELAXES NORMS FOR CLEARING VACCINES Governance