Centre bans 16 fixed dose combination drugs over safety concerns
text_fields
New Delhi: In a major step aimed at strengthening patient safety and promoting the rational use of medicines, the Ministry of Health and Family Welfare on Saturday announced the prohibition of 16 Fixed Dose Combination (FDC) drugs meant 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 immediate effect.
The decision follows directions from the Supreme Court, which had called for a comprehensive review of Fixed Dose Combinations available in the Indian market.
Following the court's directions, the Drugs Technical Advisory Board (DTAB) constituted an Expert Committee to examine various FDCs and evaluate their safety, efficacy, and therapeutic value.
After a detailed scientific assessment, the Expert Committee found 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 the combinations, stating that the risks associated with their use outweighed any possible benefits.
The banned medicines fall under different therapeutic categories, including certain dermatological products, pain-relief and antispasmodic medicines, and some antibiotic-based formulations. The Ministry said these combinations were found to be irrational and were not backed 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 made available to the public.
It also noted that similar steps have been taken in the past against irrational drug combinations after extensive scientific evaluations.
With the latest notifications now in force, the manufacture for sale, sale, distribution, and supply of the identified 16 FDCs for human use have been prohibited nationwide with immediate effect.
The Ministry has directed all State Drug Controllers, regulatory authorities, and enforcement agencies to strictly enforce the ban and ensure compliance.
Manufacturers, importers, distributors, and other stakeholders have also been advised to take necessary steps to comply with the legal provisions and discontinue the affected products.
The government said the move reinforces its commitment to evidence-based healthcare, patient safety, and the promotion of rational medicine use in the country.
With IANS inputs