Centre orders thorough safety review of painkiller Nimesulide for adults

Nimesulide is classified as a Schedule H drug under the Drugs and Cosmetics Rules, 1945. Drugs listed under Schedule H are prescription drugs, which means they can only be sold by retail on the prescription of a registered medical practitioner.

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India's top medical research body will review this drug after it was withdrawn or had its use curtailed in several countries due to safety concerns. Recently, India completely banned this formulation for veterinary use due to safety concerns.

“There is a concern that Nimesulide drug may be causing side-effects to adults as well. To review the same, it has been referred to the ICMR. Right now, there is only one medicine—Paracetamol—to reduce fever, which reduces temperatures by 2 degrees. So, there’s no alternative. Now, the government is evaluating the effects of Nimesulide in adult population. The drug is already banned for paediatric use for children below 12 years," an official aware of the matter said.

Queries sent to a Union health ministry spokesperson remained unanswered till press time.

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Nimesulide belongs to a class of painkillers called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), widely used for its anti-inflammatory properties. The drug is easily available over the counter. Introduced in the early 1980s, it quickly became popular for its fast-acting and effective relief of various pain and inflammatory conditions.

Experts say that prolonged use of Nimesulide can adversely affect liver and kidney, and can also interfere with fertility.

In India, the use of Nimesulide is prohibited in children below 12 years of age, following reports of liver damage.

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Recent concerns have been raised regarding its continued use among adults, especially in high-risk groups, prompting the Central Drugs Standard Control Organization (CDSCO), headed by the Drugs Controller General of India (DCGI), to review the safety of the drug.

The issue was discussed at a Drugs Technical Advisory Board (DTAB) meeting held in the Union ministry of health and family welfare last week. “ICMR has been asked to conduct a systematic review of the use of the drug in adult population for further deliberation to take a final call," the official cited earlier said on the condition of anonymity.

Nimesulide is available in India under different brand names manufactured by several companies. 

To be sure, in 2023, a representative from Dr. Reddy’s Laboratories submitted a representation to DCGI highlighting the safety of Nimesulide in adult population.

A Dr. Reddy’s Laboratories' spokesperson said: "Robust research and clinical trials have consistently established the safety and efficacy of Nimesulide, when used as prescribed. We respect the ICMR's recommendations regarding Nimesulide. We wish to clarify that our company does not manufacture or distribute Nimesulide in doses exceeding 100 mg. Our Prescribing Information (PI) for Nimesulide serves as a comprehensive guide for healthcare providers, ensuring responsible prescription and use of the medication. The PI specifies that Nimesulide is indicated for short-term treatment in approved indications, and not exceeding more than 10 days. Additionally, the PI highlights that Nimesulide is not recommended for use in pregnant or lactating women and patients with renal or hepatic impairments." 

According to PharmaTrac data, the drug's Moving Annual Total (MAT) for sales, which represents the total sales value over the past 12 months, has grown by almost 15% since 2020 and currently stands at ₹424 crore.

During last week's DTAB meeting, ICMR said that that Nimesulide should be used only as a second-line drug, after exhausting first-line options, the official said.

At the meeting, ICMR said that Nimesulide should not be used in pregnant, lactating and women planning for pregnancy.

“Nimesulide should not be used in patients with renal and hepatic impairment and also should not be co-administered with other hepatotoxic and renal toxic drugs." All oral formulations of Nimesulide above 100mg in immediate release dosage form should be prohibited, it said.

Medical experts said that Nimesulide needs to be used cautiously, and dose should not exceed 100mg.

Dr. Arvind Aggarwal, senior consultant, internal medicine, Sri Balaji Action Medical Institute, Delhi, said: “Nimesulide is a Schedule H drug in India and requires a prescription, but it is widely available over the counter (OTC). Self-medication is the main concern which is increasing the risk of adverse effects. Prolonged use of Nimesulide can adversely affect liver and kidney, can also cause fertility issues. Hepatotoxicity or liver toxicity is the most widely observed side-effect of Nimesulide. The drug is banned for children under 12 due to severe liver damage risks."

He added that some European countries have restricted its use to short-term only, and consider as a second-line therapy if other drugs fail. However, in India, doctors are using it as a first-line treatment. “Hence, a regulatory concern is justified given the risk factors. The safety review of Nimesulide would lead us towards effective patient safety in terms of medicine use and surely reassess its role in adults, particularly in high-risk groups."