ReferIndia News Nimesulide ban: A necessary check on unsafe medicines

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Nimesulide ban: A necessary check on unsafe medicines

Published on: Jan. 3, 2026, 2:03 a.m. | Source: The Tribune

The Centre’s decision to ban the manufacture, sale and distribution of oral formulations of nimesulide above 100 mg is a long-overdue corrective in India’s drug regulation regime. Widely prescribed and easily available across the country, nimesulide has long occupied a grey zone between clinical utility and well-documented health risks, particularly liver toxicity. The ban, issued under the Drugs and Cosmetics Act after expert review, reflects a growing willingness of regulators to prioritise patient safety over market convenience. Scientific evidence has consistently shown that higher doses of nimesulide significantly increase the risk of hepatotoxicity, sometimes with fatal consequences. That there are safer alternatives for pain and inflammation management only strengthens the case for withdrawing high-dose formulations.

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