The Ministry of Health and Family Welfare, through notification S.O. 6091(E) dated 29 December 2025, has prohibited the manufacture, sale, and distribution of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form. The Central Government, citing risks to human health and availability of safer alternatives, exercised powers under Section 26A of the Drugs and Cosmetics Act, 1940, following consultation with the Drugs Technical Advisory Board.
The Central Government, after careful consideration and consultation with the Drugs Technical Advisory Board, determined that oral formulations containing Nimesulide above 100 mg in immediate release dosage form pose significant risks to human health.
It was further noted that safer alternatives to this drug are available in the market, making its continued use unnecessary and potentially harmful. Exercising powers conferred under Section 26A of the Drugs and Cosmetics Act, 1940, the Government declared it necessary and expedient in the public interest to prohibit the manufacture, sale, and distribution of such formulations across the country.
This prohibition applies with immediate effect and is intended to safeguard public health by eliminating unsafe drug formulations. The notification underscores the Government’s commitment to ensuring drug safety and protecting citizens from avoidable health risks.