The European Medicine Evaluation Agency (EMEA) has banned the use of nimesulide in children below the age of 12 years in all member countries. The decision was announced early this month after a 16-month long review of the controversial drug by experts drawn from European Union member states. With the EMEA decision in effect now, India has become the only country in the world permitting nimesulide use in children.

The reference to EMEA for its adjudication was made by the National Agency on Medicines of Finland in April 2002. Earlier some countries like Finland, Spain and Portugal had suspended the use of nimesulide in the wake of reports of its serious adverse effects on liver. Nimesulide was discovered by an American company 3M Pharmaceuticals but never approved for use in United States, Britain, Australia, New Zealand and 140 other countries around the world.

While allowing its use in adults, the Agency has restricted its approved indications to acute pain associated with osteoarthritis and dysmennorhoea only. Its use for fever is not permitted. Also it cannot be used for dental diseases such as pain and inflammation. Its topical form is to be used only for relief of pain due to sprains and acute inflammation of tendons due to injury (traumatic tendonitis) only.

EMEA started operations in January 1995 to harmonise the regulations governing the approval and use of drugs in European Union member countries. While its negative recommendations are binding, member states are free not to accept its opinion on clearance of drugs. For example many EU member countries such as Britain have never approved the use of nimesulide and the current decree will not be applicable to them. However, Italy the only European country where nimesulide is approved for use in older children (over the age of 6 years) will have to ban its use in all paediatric patients. Italy is the biggest user of nimesulide in Europe.

India is the only country in the whole world where nimesulide is being marketed for use not only in children but infants below the age of 1 year. The office of the Drugs Controller General of India in his response to a Public Interest Litigation (PIL) filed by Social Jurist seeking ban on nimesulide informed the Delhi High Court that there was no reason to ban the drug for use in paediatric patients in India. There are over 70 brands of nimesulide paediatric suspensions in the Indian market including Nise of Dr. Reddy's Labs and Nimulid of Panacea Biotec. These two brands account for about 50 per cent of the market.

The European decision is likely to turn many faces red in India. On the basis of an "Opinion Poll" among just 50 doctors out of over 400,000 doctors, the Indian Medical Association (IMA) came to the conclusion that nimesulide was "safe and effective for all age groups starting with day 0 to over 60 years" for a variety of conditions including fever. The Indian Academy of Paediatricians has advocated the continued use of nimesulide in Indian children. Social Jurist has severely criticized both the organizations for being biased due to substantial financial support they receive from pharmaceutical manufacturers for their mega events.

Noted paediatrician Dr. Kunal Saha, currently with Children's Hospital in Ohio, United States says: "I have little doubt that a large fraction of paediatricians in India have been influenced by the mushrooming drug companies to support the continued use of nimesulide." Agrees Dr. Chandra M. Gulhati, Editor of Monthly Index of Medical Specialities (MIMS INDIA) "Unfortunately, drug promotion in India is dependent more on providing incentives and less on accurate information. Sending prescribers on foreign jaunts (with spouses) ostensibly to attend scientific conferences, giving expensive gifts including cars is not uncommon."

In the wake of media outcry, the sale of nimesulide preparations is steadily going down in India. It has already lost over 25% of its market in the past six months.