The Union Ministry of Health and Family Welfare has prohibited the manufacture, sale, and distribution of 16 Fixed Dose Combination (FDC) drugs across India, citing lack of therapeutic justification and potential risks to public health.
In a major move aimed at protecting public health and promoting the rational use of medicines, the Union Ministry of Health and Family Welfare has prohibited the manufacture, sale, and distribution of 16 Fixed Dose Combinations (FDCs) for human use across the country with immediate effect.
The action has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, following a comprehensive scientific review mandated by the Supreme Court. Acting on the Court's directions, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to evaluate various FDCs available in the Indian market and identify combinations that lacked therapeutic justification or posed potential health risks.
Based on the committee's recommendations, the government concluded that 16 FDCs did not offer sufficient therapeutic benefits to outweigh the risks associated with their continued use. The banned formulations span multiple therapeutic categories, including dermatological products, pain-relief medicines, antispasmodics, antibiotics, and anti-diabetic combinations.
Among the prohibited combinations are Acetyl Salicylic Acid + Ethoheptazine, Gliclazide + Chromium Picolinate, Paracetamol + Lignocaine, Amoxicillin + Serratiopeptidase, Cefadroxyl + Probenecid, and Cefuroxime + Serratiopeptidase. Several aloe vera-based dermatological combinations have also been included in the ban list.
The Ministry stated that the decision aligns with the government's ongoing efforts to ensure that only scientifically validated, safe, and effective medicines remain available to the public. It also noted that similar actions had been taken in the past against irrational drug combinations following detailed scientific assessments.
All State Drug Controllers and enforcement agencies have been instructed to strictly implement the notification. Manufacturers, importers, distributors, and retailers have been directed to immediately comply with the order and discontinue the sale and distribution of the identified products.
Health experts believe the move will strengthen patient safety and encourage evidence-based prescribing practices across the healthcare system.
