The Ministry of Health and Family Welfare (MoH&FW), on December 30, 2025, notified regarding Nimesulide.
The following has been stated namely: -
• 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 safer alternatives to the said drug are available;
• And, whereas, the Central Government is satisfied that it is necessary and expedient in the public interest to prohibit the manufacture, sale and distribution of the said drug in the country for human use;
• Now, therefore, in exercise of the powers conferred by section 26A of the Drugs and Cosmetics Act, 1940 (23 of 1940), and after consultation with the Drugs Technical Advisory Board, the Central Government, hereby prohibits the manufacture, sale and distribution of the following drug, with immediate effect, namely:- “All oral formulations containing Nimesulide above 100 mg in immediate release dosage form.”
[Notification No. S.O. 6091(E)]
