Overview
- The Health Ministry prohibited all oral immediate‑release nimesulide formulations above 100 mg under Section 26A after DTAB consultation, effective immediately.
- Regulators instructed companies to halt production and recall affected batches, citing the availability of safer alternatives.
- The restriction is limited to high‑dose oral immediate‑release products, with lower strengths, modified‑release forms, and non‑oral formulations remaining available.
- ICMR’s review flagged liver toxicity and advised nimesulide be used only as a second‑line option with specific contraindications.
- A draft rule proposes deleting the word “syrup” from Schedule K to curb OTC cough syrup sales, with a 30‑day comment window following child deaths and a WHO alert.