The Hindu : Other States / Rajasthan News : Experts warn against use of banned drug

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Monday, Jan 03, 2005

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Other States - Rajasthan

Experts warn against use of banned drug

By Our Special Correspondent

JAIPUR, JAN. 2. Two medical experts here have expressed concern over a banned painkilling drug still allegedly being sold at retail outlets in Rajasthan and claimed that it would make the unsuspecting patients vulnerable to serious heart and brain disorders. Studies in the U.S. have found that the drug increases the chances of heart attack and brain stroke.

The drug, Rofecoxib, was till recently being sold with official approval across the country under as many as 91 brand names. The Central Government imposed the ban on Rofecoxib formulations for human use through a notification issued on December 13, 2004. The notification prohibited the drug's manufacture, sale and distribution with immediate effect.

S.G. Kabra and J.S. Bapna, visiting professors at the Indian Institute of Health Management Research (IIHMR) here alleged that the ban had not been fully implemented as yet and the patients, especially in rural areas, were still consuming the medicine following prescription by doctors at a great risk to their lives. "This is mainly because of negligence in the drug control mechanism and lack of monitoring by the Government machinery," Dr. Kabra said.

The Drug Controller of Rajasthan has since communicated the decision about ban on Rofecoxib to all the Assistant Drug Controllers and sent to them an annexure listing all the 91 brand names of the drug. However, Dr. Kabra claimed that the Central Government had not yet officially conveyed the notification to the State.

Though the pharmaceutical companies have stopped the production of Rofecoxib formulations, the stocks in the retail outlets are yet to be withdrawn. Dr. Kabra pointed out that physicians in remote areas might still be prescribing the drug due to lack of information and the chemists freely selling the residual stocks in violation of the ban orders.

Rofecoxib - a non-steroidal drug with Rs. 91-crore annual market value in the country - was generally prescribed all over world for acute pain during inflammation, dental pain, dysmenorrhoea, osteoarthritis and rheumatoid arthritis before its withdrawal by the U.S. manufacturer, Merck, on September 30, 2004.

"The side-effects of Rofecoxib can be more serious in India because our population is three times more susceptible to heart attacks and brain strokes," said Dr. Kabra, who has launched several campaigns against harmful drugs and destructive medical procedures.

He said the Central Government had taken two months to notify the ban on Rofecoxib after an emergency meeting of the National Pharmacovigilance Advisory Committee recommended the prohibition on October 11, 2004, following an outcry against the continued marketing of the drug.

"The Supreme Court had observed in one of its celebrated judgments that the marketing of an unsafe drug by a pharmaceutical company despite the knowledge of its lethal effects amounts to marketing murder," Dr. Kabra said, and added that the patients suffering any harm due to the consumption of Rofecoxib after the issue of notification could file suits for damages and lodge criminal complaints.

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