Centre Bans Sale of High-Dose Nimesulide Oral Formulations

Centre Bans Sale of High-Dose Nimesulide Oral Formulations

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TNI Bureau: The Central government has prohibited the manufacture, sale and distribution of all oral formulations of the painkiller Nimesulide exceeding 100 mg, citing potential risks to human health.

An official notification issued on Monday said the decision was taken after recommendations from the Indian Council of Medical Research (ICMR) and in consultation with the Drugs Technical Advisory Board. The ban applies to immediate-release oral dosage forms of Nimesulide above 100 mg and comes into effect immediately.

The government stated that it was satisfied such high-dose formulations are likely to pose health risks and that safer alternative medicines are available. Invoking powers under Section 26A of the Drugs and Cosmetics Act, 1940, the Centre said the prohibition was necessary in the public interest.

Nimesulide has also been under scrutiny for its environmental impact. In recent years, several cow shelters in Rajasthan and Madhya Pradesh stopped using veterinary drugs harmful to vultures, including Nimesulide, following advisories from the Bombay Natural History Society. Other vulture-toxic drugs such as diclofenac, aceclofenac and ketoprofen have also been phased out, with safer alternatives like meloxicam and tolfenamic acid being adopted.

The latest move is aimed at strengthening drug safety and protecting public health.

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