02-05-2025
'Nimesulide Is Safe': Dr Reddy's Defends Painkiller As Ban Looms On Doses Above 100 Mg
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The company told News18 that the robust research and clinical trials have consistently established the safety and efficacy of Nimesulide when used as prescribed.
Hyderabad-based pharmaceutical giant Dr Reddy's Laboratories is defending the use of the painkiller Nimesulide, even as the drug comes under regulatory scrutiny over safety concerns, with a possible ban looming on doses above 100 mg.
In January this year, the company submitted a detailed presentation, seen by News18, to the apex drug regulatory body along with top officials from the Indian Council of Medical Research (ICMR) and the Directorate General of Health Services (DGHS), arguing against the idea of banning Nimesulide.
Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) which has been widely used in India for its analgesic and antipyretic properties. However, safety concerns emerged over its adverse effects, particularly side effects on the liver, leading to regulatory scrutiny and actions across the globe.
According to the report prepared by the country's top medical research body, the Indian Council of Medical Research (ICMR) – following a request from the Drugs Technical Advisory Board (DTAB) – all formulations of the popular painkiller Nimesulide above 100 milligrams should be banned, and a 'black box" warning should be made mandatory on all products containing the drug.
Highlighting the poor safety profile, an 11-page report by ICMR suggests that the drug should be reserved only as a second-line treatment and used only after all first-line options have been tried and found ineffective.
While agreeing with many of ICMR's findings, the apex panel of experts recommended that all oral formulations of Nimesulide above 100 mg in 'immediate release dosage form" should be prohibited. They also advised restricting its use among vulnerable groups such as children under 12, adults over 60, pregnant and lactating women, and people with kidney or liver diseases. However, the recommendations are yet to be approved by the Drug Controller General of India (DCGI).
Why does Dr Reddy's want to protect Nimesulide?
According to data from the research firm Pharmarack, Dr Reddy's is the largest seller of branded Nimesulide under the name 'Nise', with a moving annual turnover (MAT) of Rs 94 crore as of March 2025, followed by Mankind Pharma, Maneesh Pharmaceuticals, and IPCA Labs.
Responding to News18's query on the latest DTAB recommendations, Dr Reddy's said: 'We acknowledge and appreciate the Drugs Technical Advisory Board's (DTAB) directives to the Indian Council of Medical Research (ICMR) for conducting a systemic review of Nimesulide's use across various age groups." It further added that 'the DTAB's minutes also recognise Nimesulide as an effective medication, highlighting its significance and necessity."
The company also clarified: '…our company does not manufacture or distribute Nimesulide in doses exceeding 100 mg. The prescribing information specifies that Nimesulide is indicated for short-term treatment in approved indications and not exceeding more than 10 days."
Additionally, it said its prescribing information states that 'Nimesulide is not recommended for use in pregnant or lactating women and patients with renal or hepatic impairments."
How is Dr Reddy's trying to convince ICMR and experts that Nimesulide is non-fatal?
In January, Dr Reddy's Laboratories wrote a detailed letter to the Joint Drug Controller (FDA Bhawan), Rajiv Bahl (Director General, ICMR), and Dr Atul Goel (Directorate General of Health Services) — after ICMR was tasked with conducting a safety assessment of the drug.
The company cited several judicial proceedings in multiple high courts where no ban was imposed on Nimesulide, relying on earlier DTAB submissions affirming the drug's safety.
'We wish to highlight that the subject matter of the safety of Nimesulide came before various courts such as the High Court of Judicature at Delhi and Madras in 2004, and again in 2008, and most recently before the Delhi High Court in 2023."
The company noted that in these proceedings, the DTAB stated: 'After detailed deliberations, members opined that, having considered the issues raised by the petitioner and the overall data on this drug, there is no ground for banning Nimesulide for adult or pediatric use. The drug is considered to be as safe or unsafe as any other commonly used NSAID."
'It was on the basis of this report that the High Courts concluded that no ban on Nimesulide for human use is necessary," the company said.
The company also provided additional studies and findings from independent bodies supporting the drug's safety. It referred to a 2004 PIL in which DTAB had again found Nimesulide safe. 'DTAB, in its report, considered opinions from bodies including the Indian Academy of Pediatrics (IAP), the Indian Medical Association (IMA), AIIMS, and other experts," the letter said.
'…No causal relationship with serious liver toxicity or Reye's Syndrome, as alleged side effects of the drug, was reported by any of these experts…," it said.
It further added that '…the High Court concluded that the allegations are not worth further consideration." The company included a subhead titled 'Data indicating safety in the human adult population."
'As already indicated by DTAB and the Government of India before various High Courts, and also by leading medical associations, we submit that the product remains safe for adult use. We also present safety data from India and international agencies, including the WHO, that establish the safety of Nimesulide," the letter said.
The letter, written by Sandeep Khandelwal, Head – India Sub-Continent, Dr. Reddy's Laboratories, urged top experts to consider 'the above information in your deliberations on the safety of Nimesulide for use in the adult population."
Khandelwal further stated, 'We submit that the data enclosed clearly establish Nimesulide's safety as one of the highest in its category. This is why DTAB and other independent bodies have consistently found no significant adverse effects and reported high acceptance among physicians and patients."
Overall, Dr. Reddy's sought to reassure the latest DTAB panel by referencing past DTAB evaluations that found Nimesulide to be safe.
'We trust that our effort to provide a historical summary of DTAB's evaluations — supported by associations like the IMA and other experts — will serve as sufficient evidence of this drug's safety and efficacy," the letter concluded, adding, 'Should your findings require any collaboration or further material in support of these submissions, we remain at your disposal and will be glad to furnish the requisite information."
Globally, the European Medicines Agency (EMA) restricted the use of Nimesulide in 2002 to adults only, and since then, many countries, including the United Kingdom, the United States, Canada, Australia, Singapore, and Japan, have imposed bans or strict usage guidelines for both human and veterinary applications. It is only in India and Pakistan that the drug is available for consumption by the elderly and adults.
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tags :
Dr Reddy's Laboratories Painkillers
Location :
New Delhi, India, India
First Published:
May 02, 2025, 11:34 IST
News india 'Nimesulide Is Safe': Dr Reddy's Defends Painkiller As Ban Looms On Doses Above 100 Mg
