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Amendment to Drug Rules, 1945
July 7 , 2026
7 hrs 0 min
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- The Government amended the Drugs Rules, 1945, to bring advanced cell, stem cell, gene therapy products, and xenografts under a uniform central regulatory system.
- The amendment places these products under the Centrally Licensed Approving Authority (CLAA) for licensing and regulation.
- CLAA is a division of the Central Drugs Standard Control Organisation (CDSCO), India's national drug regulatory authority.
- Gene therapy products use genes to treat or prevent diseases, while stem cell-derived products are made using stem cells for medical treatment.
- Xenografts are organs or tissues transplanted from one species (such as pigs) to another species (such as humans).
- The amendment aims to ensure uniform regulation, safety, quality, and oversight of advanced therapies across India.
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