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NEW DELHI: The central government has banned the manufacture, sale, and distribution of all oral formulations of painkiller Nimesulide containing more than 100 mg in immediate-release form, saying such doses posed risk to human health.In a notification issued on Monday, the ministry of health and family welfare said it was “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”. The government also noted that safer alternatives to the said drug were available.
The ban has been imposed with immediate effect under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board. On the same day, the ministry issued a separate notification proposing amendments to the Drugs Rules, 1945. The draft rules propose omitting the word “syrup” from a specific entry in Schedule K, which pertains to drugs exempt from certain regulatory provisions.The government said the draft amendments are being published for information of all persons likely to be affected and that objections or suggestions received within 30 days will be considered. In January, the Centre banned the manufacture, sale, and distribution of all formulations of Nimesulide, widely used as a painkiller for animals, after studies conducted by scientists at the Indian Veterinary Research Institute (IVRI) at Izatnagar, Bareilly, confirmed its toxicity to vultures.
