US EditionGovt Bans Manufacture, Sale of Oral Formulations Containing Nimesulide Above 100 Mg-Here's Why
The Union Health Ministry banned oral immediate-release nimesulide above 100 mg due to liver and kidney toxicity risks, following Indian Council of Medical Research recommendations.
- The Union Health Ministry, citing safety concerns, prohibited manufacture, sale, and distribution of all oral nimesulide formulations above 100 mg in immediate‑release form on December 29, invoking Section 26A of the Drugs and Cosmetics Act.
- Following DTAB deliberations and ICMR review, the Union Health Ministry said oral formulations of Nimesulide above 100 mg pose risks, including hepatic concerns, prompting restrictions to second-line use.
- The notification is narrowly targeted and bans immediate‑release oral formulations above 100 mg while excluding non‑oral forms like topical gels, and the Rs 497 crore market includes brands like Nise and Nimrest.
- State regulators, such as the Telangana Drugs Control Administration, enforced the ban immediately via a gazette notice on December 29, citing violations under the Drugs and Cosmetics Act, 1940.
- Simultaneously, the Ministry proposed removing cough syrups from Schedule K and sought stakeholder input over thirty days after earlier reviews prompted by contaminated syrup incidents and past restrictions including the 2011 paediatric ban and January 2025 veterinary prohibition.
14 Articles
14 Articles
Govt bans common pain and fever medication nimesulide’s oral tablets over 100 mg; removes cough syrups from OTC sales
The Union Health Ministry has banned nimesulide for oral formulations above 100 mg due to safety concerns. Additionally, cough syrups are no longer over-the-counter, following tragic incidents in children. Stakeholders may submit feedback for the draft notification.
Telangana bans high-dose Nimesulide, a popular painkiller
HYDERABAD: The Telangana Drugs Control Administration (TDCA) has ordered an immediate ban on all oral formulations of the widely-used painkiller Nimesulide exceeding 100 mg, following a Union government directive citing serious health risks. The prohibition, issued through a gazette notification on Monday, December 29, by the Union Ministry of Health and Family Welfare, comes into effect immediately across the state, the TDCA said in a press rel…
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