India bans 16 more fixed-dose combination drugs, including painkillers

India's Ministry of Health and Family Welfare has banned 16 additional fixed-dose combination (FDC) drugs, citing limited therapeutic value and potential risks. The prohibited medications include certain skin treatments, painkillers, and muscle relaxants.

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The health ministry has issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, prohibiting the manufacture for sale, sale and distribution for human use of 16 FDCs. The notifications have come into force with immediate effect.

The ministry issued notifications under the Drugs and Cosmetics Act, immediately prohibiting the manufacture, sale, and distribution of these 16 FDCs for human use. This action stems from Supreme Court directives mandating a comprehensive review of FDCs available in the country. An expert committee, formed by the Drugs Technical Advisory Board, evaluated various FDCs to identify those lacking therapeutic justification or posing health risks.

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Based on the scientific assessment and recommendations of the expert committee, the government has taken action against 16 FDCs that were found to lack therapeutic justification and whose continued use was not considered beneficial in relation to the potential risks involved.

"Based on the scientific assessment and recommendations of the expert committee, the government has taken action against 16 FDCs that were found to lack therapeutic justification and whose continued use was not considered beneficial in relation to the potential risks involved," the ministry stated. The banned combinations span various categories, including dermatological, analgesic, antispasmodic, and antibiotic formulations.

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The ministry noted that this action is in line with the government’s continuing efforts to ensure that only safe, effective and scientifically validated medicines are available to the public.

This move aligns with the government's commitment to patient safety and evidence-based healthcare. The ministry emphasized that this action follows previous bans on irrational FDCs, reinforcing its dedication to ensuring the public has access only to safe and effective medicines. State drug controllers and regulatory agencies have been directed to enforce the ban strictly.

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Accordingly, the manufacture, sale, distribution and supply of the identified 16 FDCs for human use shall stand prohibited with immediate effect across the country.