Centre Bans Oral Nimesulide Formulations Above 100 mg Over Health Risks
New Delhi, Dec 31: The Union Health Ministry has banned the manufacture, sale and distribution of all oral formulations containing the painkiller nimesulide in doses above 100 mg, citing serious risks to human health, according to an official notification.
The decision was taken following a recommendation by the Indian Council of Medical Research (ICMR), India’s apex health research body.
“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 added that the move was necessary and expedient in public interest to prohibit the manufacture, sale and distribution of such formulations for human use in the country.
“Therefore, in exercise of the powers conferred under Section 26A of the Drugs and Cosmetics Act, 1940, and after consultation with the Drugs Technical Advisory Board, the Central Government hereby prohibits the manufacture, sale and distribution of the said drug with immediate effect,” the notification stated.
