Centre Amends Drugs Rules, 1945 to Ensure Uniform Regulation of Advanced Cell and Gene Therapies
Amendments to Drug Rules Enhance Regulation of Advanced Therapies

The Central Government amended the Drugs Rules, 1945, expanding regulatory oversight to include advanced therapies. Cell or stem cell-derived products, gene therapeutic products, and xenografts now fall under the Central Licensing Authority (CLAA) framework.
This amendment directly impacts the innovation landscape in healthcare, specifically regarding regulatory practices for emerging medical technologies, relevant for GS Paper II and III.
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