Overview
- The prohibition takes immediate effect for oral, immediate‑release products above 100 mg, while lower strengths, non‑oral forms, and other release types remain permitted.
- The order was notified on Dec. 29 after consultation with the Drugs Technical Advisory Board under the Drugs and Cosmetics Act, 1940.
- Drugmakers have been directed to halt production of affected products and recall high‑dose batches, according to industry notices and media reports.
- ICMR‑backed guidance advises avoiding nimesulide in pregnancy, during lactation, in those planning pregnancy, and in patients with liver or kidney impairment, with the pediatric ban under 12 unchanged.
- Separately, a draft rule proposes removing cough syrups from over‑the‑counter exemption in Schedule K, with a 30‑day window for public comments following contamination‑linked child deaths.