Govt bans manufacture & sale or Nimesulide

The Union Health Ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 milligrams (mg) for human use, citing serious health risks.“The Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use,” a government notification released late on December 29 stated. Adding that the “Central Government is satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form are likely to involve risk to human beings and that safer alternatives to the said drug is available”.The move follows, recommendation by India’s top research body- Indian Council of Medical Research (ICMR). In it’s earlier report to the drug regulatory body it had ecommended a total ban on all formulations of ninrsulide above 100 mg strength. The experts had found that there was significant risk when nimesulide was administered to patients below 18 years of age and elderly (60 and above). They found that the elderly have an increased frequency of adverse reactions with the use of nimesulide, especially gastrointestinal bleeding and perforation, which may be fatal. The drug has caused concerns over a long period of time. In 2011 too, the health ministry had banned the paediatric use of nimesulide in children below 12 years of age and in January 2025, the government prohibited the production, sale and distribution of all nimesulide formulations for veterinary use.The market for nimesulide formulations in India is Rs 497 crore, growing at 11% over the last 12 months, as per data from market research firm PharmaTrac.