Overview
- The Health Ministry has prohibited with immediate effect the manufacture, sale and distribution of all oral immediate‑release nimesulide formulations above 100 mg under Section 26A after consultation with the DTAB.
- The order does not cover lower strengths, non‑oral preparations or non‑immediate‑release forms, according to officials.
- Drugmakers marketing nimesulide brands have been told to halt production and recall affected batches, with analysts expecting limited impact on large firms and greater pressure on smaller players.
- In a draft rule, regulators have proposed deleting “syrups … for cough” from Schedule K’s OTC exemptions, inviting public comments for 30 days to shift oversight toward a product’s composition rather than its liquid form.
- Authorities link the broader tightening to safety concerns including hepatotoxicity findings and recent child deaths tied to contaminated cough syrups, building on earlier bans for pediatric use and veterinary formulations associated with vulture deaths.