Health Ministry Prohibits Manufacture, Sale and Distribution of 16 Fixed Dose Combinations (FDCs)

📌 Summary:

• The Ministry of Health and Family Welfare issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture, sale and distribution of 16 Fixed Dose Combinations (FDCs) for human use, with immediate effect
• The action follows directions of the Supreme Court, which mandated a comprehensive review of FDCs in the country
• The Drugs Technical Advisory Board (DTAB) constituted an Expert Committee that identified FDCs that are irrational, lack therapeutic justification, or pose health risks
• The 16 prohibited FDCs span dermatological preparations, analgesic/antispasmodic medicines and antibiotic-based formulations (e.g., Amoxicillin + Serratiopeptidase; Paracetamol + Lignocaine; various Aloe-vera based combinations)
• All State Drug Controllers, regulatory authorities and enforcement agencies have been directed to ensure strict compliance; manufacturers and distributors advised to take corrective measures
• The move continues the Government's pattern of banning irrational FDCs to ensure only safe, effective and scientifically validated medicines reach the public

🎯 UPSC Relevance: GS2 — Health governance, drug regulation, rational use of medicines and patient safety; role of the judiciary and expert bodies in policy.

📝 Prelims Facts:

• FDCs were prohibited under Section 26A of the Drugs and Cosmetics Act, 1940
• The Drugs Technical Advisory Board (DTAB) is the highest statutory body advising on technical drug matters
• The action followed Supreme Court directions for a comprehensive FDC review

🔑 Key Term: Fixed Dose Combination (FDC) — a formulation combining two or more active drug ingredients in a fixed ratio in a single dosage form; "irrational" FDCs lack therapeutic justification.