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Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) commonly prescribed for pain relief, inflammation and fever in adults, and is widely sold across India under popular brand names such as Nise, Nimulid, Nicip and several fixed dose combinations used for pain and fever.
The decision, announced in a government notification issued on December 29, is aimed at protecting public health and safety. According to a notification issued by the Ministry of Health and Family Welfare, the government is satisfied that the use of high-dose nimesulide formulations poses a risk to humans and that safer alternatives are available.
“Whereas 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 pose a risk to humans and that safer alternatives to the said drug are available; and, Whereas, the Central Government is satisfied that it is necessary and expedient in the public interest to ban the manufacture, sale and distribution of the said drug in the country for human use.”
The ban is effective immediately and applies to all oral formulations containing nimesulide above 100 mg in immediate-release dosage form.
The move is based on the recommendations of the Drugs Technical Advisory Board (DTAB) and is being exercised under the powers conferred under Section 26A of the Drugs and Cosmetics Act, 1940.
“Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government hereby prohibits the manufacture, sale and distribution of the following drug with immediate effect, namely: ‘All oral formulations containing nimesulide above 100 mg in immediate release dosage form’,” it said.
The ministry had already banned nimesulide formulation for use in children below 12 years of age on the recommendations of an expert committee constituted by the DTAB citing safety concerns.
“The drug is known to be hepatotoxic and children are considered to be more susceptible to hepatotoxicity,” the notification said.
In February this year, the ministry had also banned the manufacture, sale, distribution and use of nimesulide and its formulations for animal use.
Nimesulide is manufactured and marketed by several Indian drug manufacturers, either as standalone tablets or in fixed dose combinations. Companies at risk include Dr Reddy’s Laboratories, Cipla, Sun Pharma, Abbott India, Alkem Laboratories, Torrent Pharmaceuticals, Lupine and Intas Pharmaceuticals as well as several mid-sized players.
The restriction applies only to oral, immediate-release nimesulide formulations above 100 mg and is not equivalent to a complete ban. Patients are advised not to stop the medication suddenly and to consult doctors for alternatives if necessary.