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In a major step to strengthen patient safety and promote the rational use of medicines, the Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of 16 Fixed Dose Combination (FDC) drugs for human use across India.
The decision has been issued under Section 26A of the Drugs and Cosmetics Act, 1940 and comes into effect immediately.
The action follows directions from the Supreme Court, which asked for a comprehensive review of Fixed Dose Combination medicines available in the Indian market.
Acting on this, the Drugs Technical Advisory Board (Drugs Technical Advisory Board) formed an expert committee to evaluate the safety, efficacy and therapeutic justification of these combinations.
After a detailed scientific assessment, the expert panel concluded that 16 FDCs lacked sufficient therapeutic justification and could pose potential health risks.
The government further said the risks associated with these drugs outweighed their benefits, leading to a nationwide prohibition.
The banned combinations include products across multiple therapeutic categories such as dermatological formulations, pain-relief medicines, antispasmodic drugs and certain antibiotic combinations.
Authorities found these formulations to be irrational and not adequately supported by scientific evidence.
The Health Ministry said it aims to ensure only safe, effective and evidence-based medicines are available in India. It added that the government had taken similar action earlier after scientific reviews.
The order has now come into force, and India has banned the manufacture, sale, distribution and supply of 16 FDC drugs nationwide. Regulators must enforce the ban strictly.
State drug controllers, enforcement agencies, manufacturers, importers and distributors must comply and also remove the affected products immediately.
The government reaffirmed that the decision reflects its commitment to patient safety, scientific validation and the rational use of medicines in India’s healthcare system.
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