In a move aimed at enhancing drug safety standards, the Union Health Ministry has prohibited the production, sale, and distribution of oral pain-relief and fever medications containing Nimesulide in doses exceeding 100 mg in immediate-release form. The restriction has come into force with immediate effect.
The decision was taken under Section 26A of the Drugs and Cosmetics Act, 1940, following recommendations from the Drugs Technical Advisory Board (DTAB). According to an official notification, “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 are available.”
Nimesulide, a non-steroidal anti-inflammatory drug (NSAID), has long faced international scrutiny due to concerns related to liver toxicity and other adverse reactions. The latest step reflects the government’s continued effort to phase out medicines considered to carry a higher risk profile, while promoting safer therapeutic options.
The ban applies only to high-dose oral formulations meant for human use. Lower-strength Nimesulide products and alternative pain-management therapies will continue to be permitted in the market.
Drug manufacturers currently marketing affected formulations have been directed to immediately stop production and initiate recalls of impacted batches. Market analysts believe the financial implications for large pharmaceutical companies will remain minimal, as Nimesulide contributes only a small portion of overall NSAID revenues. However, smaller firms with heavier reliance on the drug may experience short-term revenue pressure.
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