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Drug controller recommends ban on Nimesulide

Feb 22, 2011 10:25 AM IST India India
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New Delhi: After much ado the drug controller has finally recommended a ban on the pediatric formulation of Nimesulide, a popular drug for common fever and pain. Nimesulide has been known for its adverse effects on the liver for the last ten years.

The Drug Technical Advisory Board has recommended a ban on a total of five controversial drugs already banned in the west.

Cisapride, used to treat heartburn has been banned for the last ten years for causing heart problems. PPA, a popular decongestant has been banned for eight years, for causing stroke

Globally banned Obesity drug Sibutramine is known to increase heart ailments by 16 per cent.

Placentrex, a drug sold only in India was promoted for reducing radiation side effects and female infertility.

Pediatric formulation Nimesulide is known for its damaging effects on the liver, kidney, platelet destruction and even fatal bleeding.

But experts say this move is simply inadequate, till it is banned for use in adults as well.

Monthly Index of Medical Specialities (MIMS) Editor CM Gulati says, "You are banning only 10 per cent of the sale and not the 90 per cent. Also you are not paying attention to the fact that Nimesulide's combination with Paracetamol, which is not permitted in the world for any age group is being openly sold here."

The very entry of this drug in Indian markets in 1995, was in violation of the drugs and cosmetics act.

Gulati says, "There is a rule called section 30B of the drugs and cosmetics act which says that no drug that is prohibited in the country of its origin cannot be imported to India and Nimesulide is a product from USA and it was prohibited there, so how was it allowed?"

With a known market share of more than Rs 270 crore for adult Nimesulide, this ban, will just remain an eyewash.