India banned oral Nimesulide formulations above 100 mg
Why in news?
India recently banned oral Nimesulide formulations above 100 mg. The Union Health Ministry issued the order on December 29, 2025, prohibiting manufacture, sale, and distribution nationwide due to liver toxicity risks. Lower doses and non-oral forms remain permitted.​
Key Details of the Ban
- Drug involved: Nimesulide, a nonsteroidal anti-inflammatory drug (NSAID) used for pain relief and fever reduction.
- Scope of ban: All oral formulations above 100 mg in immediate-release dosage form.
- Legal basis: Implemented under Section 26A of the Drugs and Cosmetics Act, 1940.
- Reason: Higher doses are considered likely to pose risks to human health, especially liver toxicity.
- Alternatives: The government emphasized that safer substitutes are available.
- Previous restrictions: Already banned for use in children under 12 and for veterinary purposes.
Health Concerns
- Liver toxicity: Nimesulide has long been associated with liver damage in some patients.
- Risk-benefit balance: Authorities concluded that the risks outweigh the benefits at doses above 100 mg.
- ICMR recommendation: The ban followed advice from the Indian Council of Medical Research (ICMR), India’s apex health research body.
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