In a significant move to enhance public safety, the Union Health Ministry has imposed a nationwide ban on the manufacturing, sale, and distribution of specific high-dose pain and fever medications. The action targets oral formulations containing the drug Nimesulide in doses exceeding 100 milligrams in immediate-release form.
Why the Ban Was Implemented
The prohibition was enacted under Section 26A of the Drugs and Cosmetics Act, 1940, following thorough consultations with the Drugs Technical Advisory Board (DTAB). The ministry's official notification, cited in multiple reports, clearly states the rationale: "The use of all oral formulations containing Nimesulide above 100 mg in immediate release dosage form is likely to involve risk to human beings, and safer alternatives are available."
This decision is rooted in longstanding global concerns regarding Nimesulide, a non-steroidal anti-inflammatory drug (NSAID). The primary worry revolves around its potential to cause severe liver toxicity (hepatotoxicity), a risk that can manifest suddenly even with short-term use.
A History of Safety Concerns and Global Scrutiny
This is not India's first regulatory action on Nimesulide. In 2011, the health ministry banned its use for paediatric patients below 12 years of age. The government had noted then that the drug is hepatotoxic and children are more susceptible to such damage.
The global stance on Nimesulide has been cautious for years. Several European nations, including Finland, Spain, Ireland, and Belgium, withdrew the drug from their markets after reports linked it to serious liver damage, including acute liver failure requiring transplants. Following a review in 2007, the European Medicines Agency (EMA) concluded that its risks outweighed its benefits for routine pain relief, leading to its suspension or severe restriction across the EU.
Furthermore, major countries like Canada, Japan, the United States, Australia, and the United Kingdom never approved Nimesulide for human use, citing unresolved safety concerns from initial evaluations.
Implications and the Path Forward
The latest ban signifies the Indian government's ongoing effort to tighten drug safety standards and align with international best practices. It directs the pharmaceutical industry and healthcare providers to immediately cease production and dispensing of the specified high-dose formulations. Patients currently using such medications are advised to consult their doctors for safer alternative pain and fever management options.
This proactive step underscores a commitment to prioritising patient safety, especially when equally effective and less risky therapeutic alternatives exist in the market. The move is expected to prevent potential cases of drug-induced liver injury and foster greater public confidence in the national pharmacovigilance framework.
