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Centre Amends Drug Rules for Advanced Therapies

CENTRE AMENDS DRUG RULES TO STRENGTHEN REGULATION OF ADVANCED THERAPIES Why in the News? Drug Rules Amended: The Central Government has amended the Drugs Rules, 1945 to bring stem cell-derived products, gene therapeutic products, and xenografts under the Centrally Licensed Approving Authority (CLAA) framework. Regulatory Objective: The amendment aims to strengthen regulatory oversight of advanced …

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