New Delhi : The Union Health Ministry has announced a ban on the manufacture, sale, and distribution of all oral formulations containing nimesulide above 100 mg, citing serious health risks.
The move follows a recommendation from the Indian Council of Medical Research (ICMR), the country’s top health research body. The government has confirmed that these higher-dose formulations could pose a risk to human health and that safer alternatives are available.
In an official notification released on Monday, the government stated that it was acting in the public interest to prohibit the use of nimesulide oral doses exceeding 100 mg.
The notification specifies that these immediate-release dosage forms, when taken at higher doses, have been linked to potential harm, especially to the liver.
The notification further confirmed that the ban would take effect immediately, in line with powers granted under the Drugs and Cosmetics Act of 1940. The ban was imposed after consultations with the Drugs Technical Advisory Board, which reviewed the available evidence on the safety risks of higher doses of nimesulide.
Nimesulide, a widely used painkiller and anti-inflammatory drug, has been associated with liver toxicity in some cases, prompting health experts to recommend more stringent regulation of its use.
