India Bans High-Dose Nimesulide Oral Formulations: What Is The Drug And Why Is The Government Prohibiting It

The government has prohibited the production, distribution and sale of any oral formulations of fever and painkillers that include more than 100 milligrams of immediate-release Nimesulide. Given the drug’s possible hazards and the availability of safer substitutes, the decision was made with the goal of protecting public health.

According to reports, lower-dose formulations are still available, but high-dose medications will have to be removed from the domestic market.

Nimesulide is a nonsteroidal anti-inflammatory drug (NSAID) used to treat primary dysmenorrhea (period pain), painful osteoarthritis and short-term pain. Though the drug has been available since 1985, it has faced scrutiny for its potential liver toxicity.

Nimesulide is not authorised for use in the US. According to the European Medicines Agency, the drug is available on prescription in Europe, Austria, Bulgaria, the Czech Republic, Cyprus, France, Greece, Hungary, Italy, Latvia, Lithuania, Malta, Poland, Portugal, Romania, Slovakia, and Slovenia. It was also available in Belgium till December 2007.

Nimesulide has been linked to hepatic adverse reactions, ranging from mild increases in liver enzymes to severe liver failure that, in some cases, required transplantation, said the European Medicines Agency.

The prohibition, issued through a notification on Dec. 29, takes effect immediately. The Health Ministry said in the notification that using all oral formulations containing Nimesulide above 100 mg in immediate-release form is likely to involve risk to human beings, and safer alternatives are available.

The government reportedly said that the move is necessary in the public interest, following recommendations by the Indian Council of Medical Research (ICMR) due to concerns over severe liver damage, which could become life-threatening in some patients.

India has already banned Nimesulide use in children under 12, as per reports. The drug was also prohibited for veterinary use earlier this year in February.

The additional caution on Nimesulide comes following an ICMR report that flagged a concerning safety profile in adults, recommending the drug be used only as a second-line treatment after first-line therapies have proven ineffective.

While high-dose oral formulations are now prohibited, lower-dose Nimesulide and other NSAIDs reportedly remain available for patients requiring pain relief.