Context:
The Union Health Ministry has imposed an immediate ban on oral immediate-release formulations of nimesulide above 100 mg, citing risks of liver toxicity. The decision has been taken under Section 26A of the Drugs and Cosmetics Act, 1940, after consultation with the Drugs Technical Advisory Board (DTAB).
Key Highlights:
Regulatory Action
• Ban applies to oral immediate-release nimesulide formulations above 100 mg.
• Enforced under Section 26A, Drugs and Cosmetics Act, 1940.
• Decision based on safety concerns and expert consultation with DTAB.
Scope & Exemptions
• Formulations below 100 mg remain permitted.
• Sustained/extended-release oral forms are exempt.
• Non-oral formulations (e.g., topical) are not covered under the ban.
Safety Concerns
• Higher doses linked to drug-induced liver toxicity (hepatotoxicity).
• Government cited availability of safer alternative NSAIDs as justification.
About Nimesulide
• A Non-Steroidal Anti-Inflammatory Drug (NSAID).
• Used for:
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Acute pain relief
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Painful osteoarthritis
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Primary dysmenorrhea
• Typically prescribed as a second-line treatment for short-term use.
Market Context
• Frequently used in fixed-dose combinations (FDCs) due to cost-effectiveness.
• Popular in India’s generic pharmaceutical market.