Centre bans 16 Fixed-Dose Combination drugs over safety concerns

📌 Summary:

• The Centre has imposed an immediate ban on 16 Fixed Dose Combination (FDC) drugs, halting their manufacture, sale and distribution across India
• The Ministry of Health and Family Welfare issued the orders under Section 26A of the Drugs and Cosmetics Act after a scientific review found the formulations lacked therapeutic justification and could pose public-health risks
• The action stems from a Supreme Court-mandated review of the Indian drug market; the Drugs Technical Advisory Board (DTAB) formed an expert committee that examined clinical data
• The committee concluded these 16 combinations offered no real therapeutic value, leading to immediate prohibition

🎯 UPSC Relevance: GS2 (Governance / Health) — drug regulation, public-health safety, the regulatory role of DTAB/CDSCO, and judicial oversight of executive regulation.

📝 Prelims Facts:

• Section 26A, Drugs and Cosmetics Act: empowers the Centre to prohibit drugs in public interest
• FDC: a single dosage form combining two or more active ingredients in fixed ratios
• DTAB: highest statutory technical advisory body on drugs under the Act

🔑 Key Term: Fixed-Dose Combination (FDC) — a medicine combining two or more drugs in one pill; "irrational" FDCs lack therapeutic rationale and can harm patients.