A drug banned in most parts of the world due to its side effects is still available in India, despite reports of serious adverse events observed among several children who had been taking it in the Sub-continent.
The drug Nimesulide, a non-steroidal anti-inflammatory drug, which has been reported as causing liver toxicity is still widely used in India commonly for pain relief and fever although it was approved for use in India in 1994 for painful inflammatory musculoskeletal disorders. Besides being available as a single ingredient, nimesulide is also available in more than 30 other drugs and as drops for children aged under1 year. All are unapproved by the drugs controller and therefore illegal.The drugs controller general of India, Ashwini Kumar, has said that the government was appointing a committee to look into the issue of adverse reactions to the drug. However in a statement made by the deputy drugs controller, Ram Teke, has been cited as saying that there was no move to reconsider its use or approval.
At present there is no system of monitoring adverse drug reactions in India hence drugs that are banned globally or whose use is severely restricted or not approved owing to serious side effects are freely available in India. Some of the names of the drugs banned in other parts of the world but available in India include anagen, cerivastatin, droperidol, furazolidone, lynestrenol, nitrofurazone, phenformin, phenolphthalein, phenylbutazone, piperazine, quiniodochlor.
Leading doctors in India say that if a particular drug is bad and harms people’s health, it has to be banned immediately and they also stress on the fact that at present such decisions are taken only to help manufacturers and to suit the commercial interests of the pharmaceutical companies thereby affecting the drug regulatory mechanism in India and until such issues are not sorted out the existing situation would prevail.
