Centre bans 16 fixed dose combination drugs over safety and efficacy concerns

New Delhi, June 20 (IANS) In a major move aimed at strengthening patient safety and ensuring the rational use of medicines, the Ministry of Health and Family Welfare on Saturday said that it has prohibited the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs for human use across the country.

The ban has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, and has come into effect immediately.

The decision follows directions issued by the Supreme Court, which had called for a comprehensive review of Fixed Dose Combinations available in the Indian market.

Acting on these directions, the Drugs Technical Advisory Board (DTAB) constituted an Expert Committee to examine various FDCs and assess their safety, efficacy and therapeutic value.

After conducting a detailed scientific evaluation, the Expert Committee concluded that 16 FDCs lacked adequate therapeutic justification and that their continued use could pose potential health risks. Based on these findings, the government decided to prohibit these combinations, stating that the risks associated with their use outweighed any potential benefits.

The banned medicines belong to different therapeutic categories, including certain dermatological products, pain-relief and antispasmodic drugs, as well as some antibiotic-based formulations. The Ministry said that these combinations were found to be irrational and not supported by sufficient scientific evidence.

The Health Ministry emphasised that the action is part of the government’s ongoing efforts to ensure that only safe, effective and scientifically validated medicines are available to the public. It noted that similar actions have been taken in the past against irrational drug combinations following extensive scientific reviews.

With the latest notifications now in force, the manufacture for sale, sale, distribution and supply of the identified 16 FDCs for human use stand prohibited nationwide with immediate effect.

The Ministry has directed all State Drug Controllers, regulatory authorities and enforcement agencies to strictly implement the ban and ensure compliance. Manufacturers, importers, distributors and other stakeholders have also been advised to take necessary steps to align with the provisions of the law and discontinue the affected products.

The government said the move reinforces its commitment to evidence-based healthcare and patient safety while promoting the rational use of medicines in the country.

–IANS

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