Centre Bans 16 Fixed-Dose Combination Drugs Over Safety and Effectiveness Concerns
The Central Government has banned the manufacture, sale, distribution, and supply of 16 fixed-dose combination (FDC) medicines across India with immediate effect. The decision was taken after an expert review found these drug combinations lacked therapeutic justification and posed potential health risks that outweighed their benefits.
According to the Union Health Ministry, the review was conducted following Supreme Court directions. An expert committee formed by the Drugs Technical Advisory Board (DTAB) examined various drug combinations and identified several formulations as irrational, therapeutically unjustified, or potentially harmful. The move is aimed at promoting the rational use of medicines and ensuring public access only to scientifically validated treatments.
The banned formulations include certain painkillers, muscle relaxants, antibiotic combinations, and dermatological products. Some of the prohibited combinations contain ingredients such as Amoxicillin, Serratiopeptidase, Paracetamol, Dicyclomine, and Aloe Vera-based formulations. State drug regulators and manufacturers have been directed to ensure strict compliance with the ban and take necessary corrective measures.
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