Centre amends Drugs Rules, 1945 to ensure uniform regulation of advance cell and gene therapies

📌 Summary:

• The Centre amended the Drugs Rules, 1945 to bring stem cell-derived products, gene therapeutic products, and xenografts under the Central Licence Approving Authority (CLAA) framework
• Purpose: uniform, strengthened regulatory oversight of advanced and emerging medical technologies across the country
• Under the Drugs and Cosmetics Act, certain critical drugs and biological products already fall under joint Central-State regulatory supervision — including vaccines, large-volume parenterals (IV solutions over 100 ml) and r-DNA based medicines
• The amendment (notified via a Ministry release on July 2, 2026) expands this joint-supervision set to cover the new emerging technologies
• Significance: closes a regulatory gap for cutting-edge cell and gene therapies, ensuring central oversight rather than uneven state-level regulation

🎯 UPSC Relevance: GS3 Science & Tech / GS2 Governance — regulation of biotechnology and emerging medical therapies, drug safety architecture, Centre-State regulatory coordination.

📝 Prelims Facts:

• Amendment made to the Drugs Rules, 1945 (under the Drugs and Cosmetics Act)
• New categories added to CLAA framework: stem cell-derived products, gene therapeutic products, xenografts
• Existing joint-supervision items: vaccines, large-volume parenterals (>100 ml), r-DNA based medicines
• Xenograft = tissue/organ graft from one species to another

🔑 Key Term: Central Licence Approving Authority (CLAA) — mechanism of joint Central-State regulatory supervision for specified critical drugs and biological products.