The reason for the decrease in Nimesulide sales remains unclear.
The Drugs Technical Advisory Board (DTAB) has endorsed safety guidelines for Nimesulide, a non-steroidal anti-inflammatory drug with a long history in India as a short-term fever and pain relief medication. The endorsement comes after the DTAB reviewed an Indian Council of Medical Research (ICMR) report on Nimesulide's effects in adults.
The overall Nimesulide market has shown steady growth over the past five years, rising from ₹414 crore in August 2021 to ₹503 crore in August 2025, representing an 8% Year-on-Year (YoY) increase last year and a 5% five-year Compound Annual Growth Rate (CAGR). However, sales have plateaued over the last few years, growing from Rs 124 crore in August 2021 to Rs 153 crore in August 2025.
The growth of the Nimesulide market is shaped by clinical effectiveness, regulatory measures, and growing preference for combination therapies. The ENDEVER study, conducted in collaboration with Dr. Reddy's Laboratories, reports that Nimesulide quickly reduced fever and fever-related pain in adults aged 18-60. The combination of Nimesulide with Paracetamol has the largest market share, with a 13% YoY growth to ₹269 crore, and a 5-year CAGR of 6%.
Combination therapies such as Nimesulide with Loratadine, Ambroxol, or Phenylephrine have shown short-term spikes in demand. Drotaverine paired with Nimesulide expanded 11% YoY to ₹25 crore, showing an 8% CAGR over the same period.
Safety guidelines for Nimesulide include its use as a second-line therapy, avoidance in pregnant or lactating women, and prohibition of immediate-release oral formulations above 100 mg. The DTAB has also recommended that ICMR conduct a systematic review on the use of Nimesulide in children under 12, adolescents aged 12-18, and adults over 60.
The Central Government has mandated a "Box Warning" on Nimesulide labels, cartons, package inserts, and promotional materials. Several companies have manufactured and marketed the active ingredient Nimesulide in India, including major pharmaceutical firms like Dr. Reddy's Laboratories, Cipla, Emcure, Macleods, Ipca, Glenmark, Biobrick Pharma, Henin Lukinz, and Therawin. API producers of Nimesulide in India include Mangalam Drugs & Organics, Vital Laboratories, Manus Aktteva Biopharma, Thykn Products, Unimark Remedies, and Aarti Drugs.
The stagnation in Nimesulide sales is due to historical concerns over liver toxicity. Despite this, Nimesulide provided faster pain relief than the other groups in the ENDEVER study. The growth of the Nimesulide market is also influenced by the Central Government's regulatory measures, such as the mandated "Box Warning" on Nimesulide labels.
In conclusion, the Nimesulide market in India continues to grow, driven by clinical effectiveness, regulatory measures, and the growing preference for combination therapies. However, safety concerns persist, and further research is needed to ensure the safe and effective use of Nimesulide in various demographics.
