India bans manufacture and sale of oral nimesulide above 100 mg
Pharma companies must stop production and sale of high-dose nimesulide
Change
India prohibited manufacture, sale, and distribution of oral nimesulide formulations above 100 mg.
Why it matters
The ban applies to all oral formulations exceeding 100 mg and replaces prior partial restrictions. It is based on safety findings and is enforceable across the pharmaceutical supply chain.
Implications
- — Pharmaceutical manufacturers must halt production of affected formulations immediately — non-compliance risks regulatory enforcement
- — Distributors and retailers must withdraw banned products from supply chains — failure risks penalties and product seizure
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