Nimesulide painkiller restricted in India: Why oral doses above 100 mg are banned

The Indian government has banned the manufacture and sale of oral nimesulide formulations above 100 mg. Know why the popular painkiller was restricted, the health risks involved, and what it means for patients.


New Delhi: In response to safety concerns regarding the risk of Nimesulide, the Union Health Ministry of India has banned the manufacturing, selling, and distributing of Nimesulide oral formulations that contain higher than 100 milligrams (mg) of Nimesulide per dose for human consumption as a precaution. This ban is now effective and was initiated as a means to safeguard public health.


Why the Government Took Action

Nimesulide is a type of non-steroidal anti-inflammatory drug (NSAID) commonly used for pain relief and fever reduction. While it has been widely prescribed in India, experts and regulators have long worried about its potential to cause serious side effects, especially with higher doses. 

According to the Health Ministry’s notification, high-dose oral forms (above 100 mg) are likely to pose risks to human health. The decision follows recommendations from the Drugs Technical Advisory Board (DTAB) and a key report by the Indian Council of Medical Research (ICMR), which highlighted safety concerns associated with the drug. 

Health Concerns at the Heart of the Ban

Experts have repeatedly warned that nimesulide, particularly in high doses, can be harmful to the liver and kidneys. Reports from health authorities globally have tied the medicine to liver toxicity, including cases of liver damage and other complications. These concerns are especially significant for vulnerable groups such as older adults and people with existing health conditions. 

In fact, India’s health authorities had already banned nimesulide for children under 12 years of age many years ago because of similar safety concerns. 

What This Means for Patients and the Market

The ban affects only immediate-release oral doses above 100 mg; lower doses and other approved painkillers will still be available for patients. Pharmaceutical companies must stop producing the higher-strength products and recall existing stocks from pharmacies. 

Although nimesulide has been a familiar product in India, its overall share in the painkiller market is relatively small. Analysts suggest the impact on major drugmakers may be limited, but smaller manufacturers that rely on sales of high-dose versions could be more affected. 

A Safety-First Approach

This regulatory step is part of a broader global trend: many countries have never approved nimesulide due to safety concerns, and several have restricted its use to protect public health. 

For patients, doctors advise discussing alternative pain relief options with healthcare providers, especially if you regularly use or have been prescribed nimesulide.

News is originally taken from: https://bit.ly/4jg5dko


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