In a major decision, the Ministry of Health and Family Welfare has banned the manufacture, sale, and distribution of 16 Fixed-Dose Combination (FDC) drugs with immediate effect. Issuing a notification under Section 26A of the Drugs and Cosmetics Act, 1940, the Ministry stated that the order is effective immediately.
Action taken following the Supreme Court directive
This decision follows a Supreme Court directive calling for a review of FDC drugs available in the country. The Drugs Technical Advisory Board (DTAB) constituted an expert committee for this purpose. The committee’s objective was to examine various FDC drugs and identify those that were scientifically unjustified or posed a risk to human health.
Decision based on scientific assessment
In a statement, the Ministry said that action against the 16 FDC drugs was taken based on scientific assessment and the expert committee’s recommendations. The examination found no justification for these drugs, concluding that the benefits of their use did not outweigh the risks.
Includes various categories of drugs
The banned FDCs cover a range of categories, including drugs used for skin conditions, painkillers, anti-spasmodic medicines, and antibiotic-based formulations.
Emphasis on safe and scientifically sound medicines
The Ministry stated that this move is part of the government’s ongoing efforts to ensure that only safe, effective, and scientifically approved medicines are available to the public. Several FDC drugs have previously been banned following detailed scientific reviews. This reflects the government’s commitment to patient safety and quality healthcare services.
Directives issued to states
The statement confirmed that the ban on the manufacture (for sale), sale, distribution, and supply of these 16 FDC drugs applies nationwide with immediate effect. Instructions have been issued to all State Drug Controllers, authorized authorities, and advertisers to comply with the notification and ensure adherence by the relevant authorities.
Advice to pharmaceutical manufacturers to take corrective measures
The Ministry has also advised pharmaceutical entrepreneurs, traders, distributors, and other stakeholders to comply with the law and take necessary corrective measures.
