The Central Government, after consultation with the Drugs Technical Advisory Board, has issued this notification prohibiting a specific category of Nimesulide formulations in public interest, citing risks to human health and availability of safer alternatives.

1. The manufacture, sale, and distribution for human use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form has been prohibited.
2. The prohibition is based on the Government’s satisfaction that such formulations are likely to involve risk to human beings.
3. The decision also considers that safer alternative drugs to the said formulation are available.
4. The prohibition has been imposed by invoking powers under Section 26A of the Drugs and Cosmetics Act, 1940.
5. The restriction applies with immediate effect from the date of publication of the notification.

Manufacturers, distributors, and sellers dealing in pharmaceutical products must immediately cease production, sale, and distribution of the prohibited formulations to avoid regulatory action.