The Indian Council of Medical Research (ICMR) has recommended that all formulations of the painkiller Nimesulide above 100 milligrams should be banned due to its poor safety profile. The recommendation comes after a report by ICMR, which was requested by the Drugs Technical Advisory Board (DTAB), highlighted the adverse effects of the drug, particularly on the liver. The report suggests that Nimesulide should be reserved only as a second-line treatment and used only after all first-line options have been tried and found ineffective.
The DTAB has also recommended that oral formulations of Nimesulide above 100 mg in “immediate release dosage form” should be prohibited, and its use should be restricted 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).
Dr. Reddy’s Laboratories, the largest seller of branded Nimesulide under the name ‘Nise’, has responded to the recommendations by stating that robust research and clinical trials have consistently established the safety and efficacy of Nimesulide when used as prescribed. The company clarified that it does not sell the drug in doses above 100 mg and that its prescribing information specifies that Nimesulide is indicated for short-term treatment and not exceeding more than 10 days.
Dr. Reddy’s has also written a detailed letter to the Joint Drug Controller, citing several judicial proceedings in multiple high courts where no ban was imposed on Nimesulide. The company referred to a 2004 PIL in which DTAB had found Nimesulide safe, and provided additional studies and findings from independent bodies supporting the drug’s safety.
The company is trying to convince ICMR and experts that Nimesulide is non-fatal by referencing past DTAB evaluations that found the drug to be safe. Dr. Reddy’s has also provided data indicating safety in the human adult population, including safety data from India and international agencies, such as the WHO.
Overall, the debate around Nimesulide’s safety continues, with Dr. Reddy’s attempting to reassure the latest DTAB panel by referencing past evaluations that found the drug to be safe. However, the ICMR’s recommendation to ban formulations above 100 mg highlights the ongoing concerns around the drug’s safety profile. The final decision on the matter is pending approval from the Drug Controller General of India (DCGI).