Centre bans oral formulations of nimesulide above 100mg
GS2Polity · Governance · IR· Health policy & public health· Prelims·
Why in news
The Union Health Ministry banned the manufacture, sale, and distribution of oral nimesulide formulations above 100mg in immediate release form due to liver toxicity concerns.
Background
The ban applies specifically to oral nimesulide formulations exceeding 100mg in immediate release form. The decision followed consultations with the Drugs Technical Advisory Board and notes that safer alternatives are available.
Facts for Prelims
- FactNimesulide was approved in India in 1995.
- FactThe ban applies to oral nimesulide formulations above 100mg in immediate release form.
- BodyThe Drugs Technical Advisory Board (DTAB) was consulted for the ban.
- PostThe Union Health Ministry issued the notification.
For Mains
Q. Discuss the regulatory framework for drug safety in India and the challenges in balancing the availability of affordable medicines with public health safety standards.
Dimensions to cover in your answer
- Regulatory oversight: Balancing rapid market entry of generic drugs with rigorous post-market surveillance for toxicity.
- Public health trade-offs: Managing the risk-benefit ratio of widely used analgesics versus the availability of safer alternatives.
Keywords: Pharmacovigilance · Drug Safety · Regulatory Framework · Public Health · Liver Toxicity
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