The Union Ministry of Health and Family Welfare has banned the manufacture, sale and distribution of all oral formulations of nimesulide containing more than 100 mg in immediate-release dosage form for human use. The order has come into force with immediate effect.

The decision was taken following recommendations from expert bodies, including the Drugs Technical Advisory Board and the Indian Council of Medical Research, which raised concerns over the safety profile of higher-dose nimesulide formulations. Experts highlighted the increased risk of adverse effects, particularly hepatotoxicity, and noted the availability of safer therapeutic alternatives.

As per the notification, pharmaceutical manufacturers must discontinue production and withdraw from the market all affected oral dosage forms such as tablets and similar preparations exceeding the 100 mg strength. Formulations containing nimesulide at or below 100 mg will continue to be permitted, subject to existing regulatory conditions.

Nimesulide has been used in India for pain and inflammation management for several decades but has faced regulatory scrutiny due to safety concerns. Its use in children has already been restricted, and veterinary formulations have been prohibited in earlier regulatory actions.

The latest move reinforces the government’s focus on strengthening drug safety and ensuring that marketed pharmaceutical products meet acceptable risk–benefit standards. Manufacturers and marketers of nimesulide products will need to realign their manufacturing portfolios and ensure compliance with the revised regulatory framework.