New Delhi: In a move aimed at strengthening drug safety and promoting the rational use of medicines, the Union health ministry has banned the manufacture, sale and distribution of 16 fixed-dose combinations (FDCs) for human use across the country with immediate effect.
The decision was taken after a scientific review found that the drug combinations lacked therapeutic justification and posed potential risks to public health. The ministry issued notifications under Section 26A of the Drugs and Cosmetics Act, 1940, enforcing the prohibition nationwide.
The action follows directions from the Supreme Court, which had called for a comprehensive examination of fixed-dose combinations available in the Indian market. Acting on the court’s directive, the Drugs Technical Advisory Board (DTAB) constituted an expert committee to evaluate various FDCs and identify formulations that were irrational, medically unjustified or potentially harmful.
Based on the committee’s recommendations, the government concluded that the continued use of 16 FDCs was not beneficial when weighed against the associated health risks. The banned formulations include certain dermatological products, analgesic and antispasmodic medicines, as well as antibiotic-based combinations.
The health ministry said the move is part of the government’s ongoing efforts to ensure that only safe, effective and scientifically validated medicines remain available to patients. It noted that several irrational FDCs had been prohibited in the past following similar scientific assessments.
Officials have directed all state drug controllers, regulatory authorities and enforcement agencies to ensure strict implementation of the ban. Manufacturers, importers, distributors and other stakeholders have also been asked to take immediate corrective steps to comply with the new regulations.
The ministry said the measure reinforces its commitment to patient safety and evidence-based healthcare practices.
