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Nithya Subramanian

Kolkata , Jan. 11

A POST-marketing study on nimesulide conducted by the Kolkata-based International Medical Research Organisation (IMRO) has indicated that the non-steroidal anti-inflammatory drug is safe and effective in the treatment of fever and a wide range of inflammatory conditions in children with few side-effects.

The study, commissioned by Panacea Biotec, was conducted on 1,000 children between 6 months and 12 years in 25 centres across the country to evaluate the efficacy and safety of Nimulid suspension (nimesulide) in the upper respiratory tract infection. The study was unveiled at a national paediatrics conference held here over the weekend.

According to Dr Arani Chatterjee, General Manager (Clinical Research), Panacea Biotec, "We will be sending this study to the Drug Controller General of India. We also want to try and get the results published in a reputed medical journal."

Nimesulide has not received any regulatory approval from the US FDA. "That is because the innovator company, Helsinn Healthcare of Switzerland, has not approached the regulator. However, the drug is available in several European countries," said Dr Chatterjee.

According to Dr A. Swain, Assistant Professor at the Sardar Vallabhbhai Patel Post-Graduate Institute of Paediatrics, Cuttack, and one of the investigators in the study, "There is no harm in giving nimesulide to children for treating fever and inflammatory problems provided people stick to the dosage as prescribed by paediatricians."

The controversy surrounding nimesulide started about two years ago when some adverse side-effects on children were reported. Subsequently, the then Health Minister, Ms Sushma Swaraj, had given the drug a clean chit after more than 20 expert paediatricians across the country and the Indian Academy of Paediatrics (IAP) were consulted.

Several companies such as Dr Reddy's Labs (DRL), Panacea Biotec, Alembic and Wander manufacture nimesulide in India.

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