Overview
- An extraordinary gazette notification issued on Dec 29 prohibits with immediate effect all oral immediate-release nimesulide formulations above 100 mg after consultation with the Drugs Technical Advisory Board.
- The restriction applies only to high-dose oral products, with lower-strength formulations continuing to be available as patients are advised to consult doctors before changing therapy.
- The action followed recommendations from the Indian Council of Medical Research and regulatory expert panels highlighting hepatotoxicity concerns in adults.
- Drugmakers have been told to stop producing affected strengths and recall impacted batches, with analysts expecting limited impact on large firms but pressure on smaller manufacturers reliant on these products.
- In a separate draft rule, the ministry proposed deleting the word “syrup” from Schedule K to tighten OTC oversight, inviting 30 days of public comment following safety alerts and reported child deaths linked to contaminated cough syrups.