High-Dose Nimesulide Banned in India Amid Health and Liver Toxicity Concerns

The Government of India has ordered an immediate ban on oral nimesulide products containing more than 100 mg. This move targets a popular non-steroidal anti-inflammatory drug used for pain, fever and inflammation. Officials say the step is meant to protect public health by limiting exposure to higher-risk doses.

The order covers manufacture, sale and distribution of all oral nimesulide formulations above 100 mg across India. It applies at once to every state and Union Territory, so implementation remains uniform. Lower-dose products are not covered by this specific ban, but remain under regulatory watch.

Government decision on nimesulide ban and legal basis

The Health Ministry issued the ban using powers under Section 26A of the Drugs and Cosmetics Act, 1940. This section allows the Centre to stop drugs that may harm patients. Before releasing the notification, the government consulted the Drugs Technical Advisory Board, the key technical body on medicines and cosmetics.

Authorities explained that high-dose nimesulide preparations may pose particular health risks. The notification notes that safer medicines are widely available for the same symptoms. Because these options exist, the government says keeping high-dose nimesulide on shelves is not justified in the public interest.

Medical concerns driving the nimesulide ban

Nimesulide has faced medical and regulatory concern for many years, especially over liver safety. Reports have linked the drug to hepatic injury, leading to repeated evaluations. The World Health Organization has not placed nimesulide on its Model List of Essential Medicines, reflecting caution over its risk profile.

Several foreign regulators have either restricted or fully withdrawn nimesulide. Their decisions draw on WHO pharmacovigilance reports and national safety reviews. These agencies focused mainly on possible liver toxicity. India’s latest move aligns with this broader international pattern of tighter oversight around the drug.

In India, the Central Drugs Standard Control Organisation has reviewed the risk-benefit profile of nimesulide multiple times. Medical specialists often highlight paracetamol and ibuprofen as first-line choices when used correctly. Evidence cited from the Indian Council of Medical Research supports the better-established safety record of these common pain and fever medicines.

The latest decision is presented as part of wider efforts to tighten drug safety regulation in India. By following expert advice and international evidence, the government aims to cut preventable medicine-related harm. People are encouraged to rely on better-studied options for routine pain and fever treatment, under medical guidance.

This report offers general information and should not replace personal medical advice from a qualified doctor. Individuals should speak to a healthcare professional before changing or stopping any medicine. NDTV is not responsible for this information, and readers must use their own judgement when acting on it.