Centre bans oral formulations containing nimesulide above 100 mg citing health risks

LINKED TO LIVER TOXICITY

- OUR CORRESPONDENT

NEW DELHI: The Union Health Ministry has prohibited the manufacture, sale and distribution of all oral immediate-release formulations of the painkiller nimesulide containing more than 100 mg, citing concerns over risks to human health and the availability of safer alternatives.

The ban, which takes effect immediately across the country, follows a review and recommendation by the Indian Council of Medical Research (ICMR) and consultations with the Drugs Technical Advisory Board.

In a gazette notification issued on Monday, the Centre said it was "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." It added that it was necessary and expedient, in the public interest, to prohibit the manufacture, sale and distribution of such formulations for human use. The order has been issued under Section 26A of the Drugs and Cosmetics Act, 1940.