Amended Drugs Rules, 1945 to ensure uniform regulation of advanced cell and gene therapies | Current Affairs | Vision IAS

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In Summary

  • New amendment includes Cell/Stem Cell products, Gene therapies, and Xenografts under CLAA framework.
  • CLAA is a division of the Central Drugs Standard Control Organisation (CDSCO).

In Summary

The new amendment will bring Cell or Stem Cell derived products, Gene therapeutic products and Xenografts under the ambit of the Centrally License Approving Authority (CLAA) framework.

  • CLAA is a division of the Central Drugs Standard Control Organisation (CDSCO).
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Central Drugs Standard Control Organisation (CDSCO)

The National regulatory body for pharmaceuticals and medical devices in India. It is responsible for the approval of drugs, medical devices, and clinical trials, ensuring their safety and efficacy.

Centrally License Approving Authority (CLAA)

CLAA is a division within the Central Drugs Standard Control Organisation (CDSCO) responsible for granting approval for the manufacture, sale, and import of various categories of drugs and medical devices in India. Its expanded scope ensures centralized regulation of advanced therapies.

Xenografts

Xenografts are organs or tissues transplanted from one species to another, for example, from a pig to a human. They are a potential solution to the organ shortage crisis, though they face significant immunological challenges.

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