The Union Ministry of Health and Family Welfare has finally decided to ban the paediatric use of the analgesic,Nimesulide suspension. A notification to this effect is expected soon,following which the drug will be off the shelves.
While the drug is banned and,in fact,not marketed in most countries,the sub-committee of the governments chief advisory body,the Drug Technical Advisory Board (DTAB),recommended banning the drug only last month to the Health Ministry. The Ministry asked the committee to hear the drug manufacturers out.
On January 27,the manufacturers briefed the sub-committee which reiterated its stand to the government. The drug is manufactured by Panacea Biotech which has its paediatric brand of Nimulid; Dr Reddys Labs brand is called Nise.
Given to children below 12,the drug has been under the scanner for a while now. Reports of it causing toxicity in the liver red-flagged the issue in Parliament. Worldwide,paediatric Nimesulide is approved in only a few countries including India,Russia,Colombia and Mexico. In fact,in the US and other developed nations,no one has ever applied for marketing permission of this drug. In Switzerland,where the medicine was discovered,it was never used. Bangladesh,too,recently banned its use in children and banned imports.
Pediatricians say the ban is welcome. We feel that Nimesulide in all age groups should not be allowed either in singular use or in any combination. It can precipitate acute liver and kidney damage. It can precipitate platelet destruction and fatal bleeding. Last year,we saw cases of death where Nimesulide was prescribed by local family physicians, said Dr Sanjeev Bagai,Senior pediatrician and Chief Executive Officer (CEO),Batra Hospital and Medical Research Centre.
Along with Nimesulide,the ministry is also likely to ban human placenta extract which is used for wounds and arthritis. Other drugs recommended for a ban by the DTAB sub committee include Cisapride,a drug which increases motility in the upper gastrointestinal tract; Phenylepropsalamine used in cough syrups; Sibutramine and R-Sibutramine used for losing weight.