Health Ministry Bans Nimesulide Doses Above 100 mg for Humans

The health ministry of the Union has prohibited all production, sale and distribution of oral formulations containing nimesulide more than 100 mg of the immediate release dosage form against human use without delay due to issues in the health of the people.

The move was made after the recommendations of the Drugs Technical Advisory Board (DTAB) were made after a thorough scrutiny by the Indian Council of Medical Research (ICMR).

In a notification issued, the Ministry said, "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 involve risk to human beings and that safer alternatives to the said drug are available". It further argued that the action is done in the national interest to ban production, sale and distribution of the drug in the nation.

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This was ordered pursuant to Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with DTAB. The Board reviewed the therapeutic application of the nonsteroidal anti-inflammatory drug (NSAID), nimesulide, in adults, and suggested the drug as a second-line therapy. DTAB agreed with ICMR that "Nimesulide should be used only as a second line drug, only after exhausting first line options".

The drug itself has already been banned as a veterinary drug because of its toxicity to vultures, with studies indicating that there is mortality within 24 hours of exposure. The new prohibition will enhance the control over drug safety and at the same time will support the attention of the government to the protection of the health of people.