The Hindu : Nimesulide remains a bitter pill

Online edition of India's National Newspaper
Monday, May 26, 2003

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Nimesulide remains a bitter pill

By Bindu Shajan Perappadan

NEW DELHI MAY 25. The Nimesulide controversy refuses to die. With directions from the Drugs Controller General of India (DCGI), Ashwini Kumar, asking pharmaceutical manufacturers to withdraw Nimesulide pediatric "drops'' while deciding to continue with tablets and paediatric suspension, several vital issues have been raised once again.

Says the Editor of Monthly Index of Medical Specialities (MIMS) Chandra M. Gulhati: "As per Section 26-A of the Drugs and Cosmetic Act, the DCGI can ban a drug or a specific formulation only by issuing a gazette notification. But nothing of this sort has been done. And so, the DCGI's advice has no legal basis as of date. Manufacturers are free to disregard his advice.''

Also what the DCGI seems to overlook is the fact that there are no Nimesulide formulations called "drops'' in the market. Two types of suspensions -- 5mg per ml and 25mg per ml -- are being sold. The high potency formulation of 25mg per ml suspension is supplied with a dropper by some manufacturers. This has apparently led the DCGI to call it `drops'.

``However the more important issue is the usage of the so-called drops. It is possible to use paediatric suspension (5mg per ml) wherever drops (25mg per ml) are being used even for very young infants. Hence, Nimesulide needs to be banned for certain paediatric age groups,'' asserts Dr. Gulhati.

In India, Nimesulide is being promoted for use in newborn babies. Except for Italy, no European country allows the use of Nimesulide for children below 12 years. In Italy it is not permitted to be used for children below 6 years. In Asian countries such as Thailand, Malaysia, Singapore etc. Nimesulide is not allowed for use in children at all. Nimesulide is not approved for use in United States, Britain, Canada, Australia and a large number of other developed countries even for adults. The drug was banned in Finland, Spain, Turkey and Bangladesh late last year. The Indian government, however, seems to have turned blind eye to all this.

Meanwhile, in a Public Interest Litigation (PIL) filed by Social Jurist, a group of lawyers in Delhi High Court, the petitioners have claimed that Nimesulide drops were being marketed without DCGI's mandatory prior approval.

In its affidavit, the Government did not respond to this claim but merely stated that it had approved tablets and 5mg per ml suspension. If so producers of Nimesulide drops have violated drug laws and should be made to face criminal charges.

``After the media outcry and PIL, the DCGI announced in a TV programme that an Expert Committee to review Nimesulide was being formed. Soon after, the Deputy Drugs Controller, Ramtake, told the British Medical Journal that there was no move to reconsider the use of Nimesulide,'' says Dr. Gulati adding that experts had long feared that the Government was dragging its feet under pressure from drug manufacturers ignoring public health.

In the aftermath of the controversy over its safety, the sale of Nimesulide is steadily going down. As per March figures of ORG-MARG, prescription of the drug has come down by over 20 per cent. Of late, many manufacturers have stopped marketing the drug, particularly the formulations for use in children.

Withdrawal of drops currently clocking just over Rs. 1 crore in sales will not affect the major Nimesulide producers. Nimesulide is the most expensive non-steroidal anti-inflammatory drug (NSAID) with a profit margin of over 1300 per cent and is not under the price control regime

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