Centre Bans High-Dose Nimesulide Oral Drugs Over Health Risk Concerns

The central government has taken a major decision regarding the drug nimesulide, a commonly used non-steroidal anti-inflammatory drug (NSAID) prescribed for pain, fever and inflammation. In a move aimed at safeguarding public health, the Centre has prohibited the manufacture, sale and distribution of oral formulations of nimesulide containing more than 100 mg, with immediate effect, across the country.

According to the government notification, oral formulations of nimesulide containing more than 100 mg have been banned with immediate effect as such high-dose preparations may be risky for human health. The order clearly states that safer alternatives to this drug are available in the market, and therefore, in the public interest, the continued availability of high-dose nimesulide is not justified.

The ban has been issued under Section 26A of the Drugs and Cosmetics Act, 1940, which empowers the Centre to restrict or prohibit drugs that pose a risk to patients. Before arriving at this decision, the government consulted the Drugs Technical Advisory Board (DTAB), the country's apex advisory body on technical matters related to drugs and cosmetics.

Nimesulide has long been under regulatory and medical scrutiny due to concerns over its safety profile, particularly its association with liver toxicity. The World Health Organization (WHO) has not included nimesulide in its Model List of Essential Medicines, reflecting global caution around its use. Regulatory authorities in several countries have either restricted or withdrawn the drug due to safety concerns related to hepatic injury (WHO pharmacovigilance reports).

In India, the Central Drugs Standard Control Organisation (CDSCO) has repeatedly reviewed the risk-benefit profile of nimesulide. Medical experts have also pointed out that widely used alternatives such as paracetamol and ibuprofen, when used at recommended doses, have a better-established safety record, supported by evidence from organisations such as the Indian Council of Medical Research (ICMR).

The latest order clarifies that the ban comes into effect immediately and will be applicable throughout the country, ensuring uniform implementation across states and Union Territories.

The prohibition of high-dose nimesulide oral formulations marks a significant step towards strengthening drug safety regulations in India. By acting on expert advice and prioritising public interest, the government aims to reduce avoidable health risks while encouraging the use of safer and well-studied alternatives for pain and fever management.

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