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In a major regulatory move, the Government of India has banned oral Nimesulide formulations above 100 mg in immediate-release form. The decision was officially announced through Gazette Notification S.O. 6091(E) dated 29 December 2025. (Click Here)
This ban is effective with immediate effect.
Why Was Nimesulide Restricted?
The government reviewed the safety data and concluded that:
- High-dose immediate-release Nimesulide may pose risks to patients
- Safer alternatives are already available in the market
- Allowing continued use is not in the public interest
What Exactly Is Banned?
The restriction applies to All Immediate release oral formulations containing Nimesulide strengths above 100 mg
Simply put:
👉 If an oral Nimesulide product releases the drug immediately and contains more than 100 mg, it can no longer be manufactured, sold, or distributed in India.
What Is Still Allowed?
- Nimesulide products up to 100 mg (as per existing approvals)
- The notification does not ban Nimesulide completely
What Should Pharma Companies Do Now?
This notification requires immediate action:
- Stop manufacturing affected products
- Remove banned stock from the supply chain
- Review product portfolios and approvals
- Ensure field teams and distributors are informed
There’s no adjustment period—compliance starts now.
For details of drugs banned in India, please refer here.
For More Details and support: Contact us at info@vaayath.com
