Overview
- A Dec. 29 government notification bars the manufacture, sale and distribution of high‑dose immediate‑release nimesulide under Section 26A following DTAB consultation.
- The order applies only to oral immediate‑release products above 100 mg, while lower‑dose nimesulide and other NSAIDs remain available.
- Authorities cited hepatotoxicity as the key concern, with ICMR highlighting risks of severe liver injury and advising use only as a second‑line option.
- Manufacturers including Dr Reddy’s, Cipla, Sun Pharma, Abbott India, Alkem, Torrent, Lupin and Intas face withdrawal of affected products.
- Patients are advised not to stop medication abruptly and to consult physicians for alternatives, following earlier curbs for children under 12 and a separate veterinary ban.