Centre prohibits oral nimesulide doses above 100 mg, cites safety risks

The Union Health Ministry has banned the manufacture, sale and distribution of all oral formulations containing the popular painkiller nimesulide above 100 mg, citing serious risks to health, an official notification said.

The decision was taken following a recommendation by ICMR, the apex health research body of India, it said.

"The Central government is satisfied that the use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings and that safer alternatives to the said drug are available," the notification issued on Monday said.

It stated that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the drug in the country for human use.

 

"Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 and after consultation with the Drugs Technical Advisory Board, the Centre, hereby prohibits the manufacture, sale and distribution of the drug, with immediate effect," the notification said.