Nimesulide painkiller ban: Centre bars oral formulations over 100 mg, cites health risks
The central government has imposed an immediate ban on the manufacture, sale and distribution of all oral formulations of the painkiller nimesulide containing more than 100 mg in immediate-release form, citing risks to human health and the availability of safer alternatives. The decision, taken under the Drugs and Cosmetics Act after expert consultation, was notified by the health ministry. Separately, the ministry proposed changes to the Drugs Rules, inviting public feedback within 30 days.
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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.
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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.