SRINAGAR: The Union Health Ministry has banned the manufacture, sale, and distribution of all oral formulations of the popular painkiller nimesulide exceeding 100 mg in immediate-release form, effective immediately, due to serious health risks, including potentially fatal liver damage.
Business Standard reported that the decision followed a recommendation from the Indian Council of Medical Research (ICMR), with the government deeming safer alternatives available under Section 26A of the Drugs and Cosmetics Act, 1940. India Today noted the move addresses longstanding concerns over hepatotoxicity, building on prior restrictions for children under 12 years of age and veterinary use.
An official notification declared high-dose nimesulide “likely to involve risk to human beings,” prohibiting its human use nationwide after consultation with the Drugs Technical Advisory Board (DTAB). The Hindu quoted the ministry stating the ban targets immediate-release tablets and suspensions, sparing lower doses deemed effective for short-term fever and pain relief.
Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has faced global scrutiny for liver toxicity, with severe cases turning fatal, prompting bans in countries like the US, UK, and Finland. Times of India detailed that DTAB’s 92nd meeting in April 2025 endorsed the curb, noting higher doses’ disproportionate risks despite efficacy. Medical Dialogues highlighted the immediate-release formulations’ vulnerability, following a January 2025 veterinary ban linked to vulture population declines from cattle medication residues.
India restricted nimesulide for paediatric use in 2011 after global hepatotoxicity alerts, and extended the veterinary prohibition earlier this year per CDSCO advice. Devdiscourse reported the ban safeguards consumers while allowing 100 mg doses, urging pharmacists to halt high-dose stocks. Times of India warned of enforcement challenges in a market dominated by generic versions, with industry bodies pledging compliance. Health experts anticipate minimal supply disruptions given alternatives like paracetamol and ibuprofen.
