NEW DELHI: The Centre has banned the manufacture, sale, and distribution of all oral formulations containing the painkiller nimesulide above 100 mg in immediate-release dosage form, citing risks to human health.
The Union Health Ministry took the decision after a recommendation of the Indian Council of Medical Research (ICMR) and consultation with the Drugs Technical Advisory Board (DTAB) in public interest. The prohibition has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect immediately.
“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.
“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,” it added. Nimesulide is a non-steroidal anti-inflammatory drug used for pain and fever, but has faced scrutiny for liver toxicity.
Officials said the ban tightens safety. In 2011, it was barred for children. In 2007, the European Medicines Agency found that the risks outweighed the benefits, while Canada, Japan, the US, Australia, and the UK had never approved it earlier.
Order In effect immediately
The decision follows ICMR recommendation and consultation with DTAB
The prohibition has been imposed under Section 26A of the Drugs and Cosmetics Act, 1940, and takes effect immediately
Officials say the ban tightens safety