Indian Health Ministry Imposes Immediate Ban on 16 Drugs

New Delhi, June 20: The Ministry of Health and Family Welfare has made a significant decision to impose an immediate ban on the manufacture, sale, and distribution of 16 Fixed Dose Combination (FDC) drugs. This notification was issued under Section 26A of the Drugs and Cosmetics Act, 1940, and is effective immediately.

This decision follows directives from the Supreme Court, which ordered a review of the FDC drugs available in the country. In compliance with these directives, the Drugs Technical Advisory Board (DTAB) formed an expert committee. The committee’s goal was to evaluate various FDC drugs and identify those that may be scientifically unsound, clinically inappropriate, or pose risks to human health.

In a statement, the ministry noted that based on scientific evaluations and the recommendations of the expert committee, the government has taken action against these 16 FDC drugs. These drugs were found to lack therapeutic justification, and their continued use was deemed potentially harmful.

The banned FDCs belong to various therapeutic categories, including some dermatological medications, analgesics, anticonvulsants, and antibiotic-based drugs.

The ministry emphasized that this action aligns with the government’s ongoing efforts to ensure that the public has access only to safe, effective, and scientifically validated medications. Previously, several FDCs were banned following extensive scientific reviews, reinforcing the government’s commitment to patient safety and evidence-based healthcare.

The statement further indicated, “Accordingly, the manufacture (for sale), sale, distribution, and supply of these 16 FDCs will be halted nationwide with immediate effect. All state drug controllers, regulatory authorities, and enforcement agencies have been directed to ensure strict compliance and implementation of this notification.”

The ministry has also advised drug manufacturers, importers, distributors, and other stakeholders to take necessary corrective measures to comply with the legal provisions.

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