The Hindu : European agency bans drug

Online edition of India's National Newspaper
Sunday, Aug 17, 2003

National

National

European agency bans drug

By Bindu Shajan Perappadan

NEW DELHI AUG. 16. In a move that has isolated India as the only country allowing nimesulide to be legally administered to its neonates, infants and children, the European Medicine Evaluation Agency (EMEA) has disallowed the use of nimesulide by children below the age of 12 years in all its member-countries.

Experts drawn from European Union member-states announced the decision earlier this month after a 16-month-long review of the controversial drug. Following the decision, India is the only country where nimesulide is being marketed for use not only by children, but also by infants below the age of one year.

The Drugs Controller-General of India, earlier in his response to a Public Interest Litigation (PIL) filed by Social Jurist seeking a ban on nimesulide, informed the Delhi High Court that there was no reason to ban the drug 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.

The two account for about 50 per cent of the market. According to the ``new rules'', the EMEA has restricted its use to acute pain associated with osteoarthritis and dysmennorhoea in adults 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.

The European decision, according to experts, is likely to turn many faces red in India. On the basis of an ``opinion poll'' among just 50 doctors of the 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 one to over 60 years'' for a variety of conditions, including fever in the wake of media reports on the drug this year.

The Indian Academy of Paediatricians also advocated continued use of nimesulide by Indian children. Social Jurist has criticised both organisations for being biased due to the substantial financial support they receive from pharmaceutical manufacturers for their mega-events, claim sources.

Paediatrician, Kunal Saha, currently with Children's Hospital in Ohio, United States, says: ``I have little doubt that a large section of paediatricians in India have been influenced by the mushrooming drug companies to support the continued use of nimesulide.''

Agrees the Editor of the Monthly Index of Medical Specialities (MIMS India), Chandra M. Gulhati: ``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.''

According to experts, despite the intensive pressure from the drug manufacturers in the wake of media outcry earlier this year, the sale of nimesulide preparations is steadily going down in India.

It has already lost over 25 per cent of its market in the past six months.

Meanwhile, several countries including Finland, Spain and Portugal suspended the use of nimesulide in the wake of reports of its serious adverse effects on liver.

The drug, discovered by an American company, 3M Pharmaceuticals, never got approval for use in the U.S., Britain, Australia, New Zealand and 140 other countries around the world.

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