E-DRUG: Nimesulide put under focused pharmacovigilance programme in India
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Dear e-druggers,
Nimesulide put under focused pharmacovigilance programme in India
Nimesulide, a non-steroidal anti-inflammatory drug, which has been banned in many countries but being marketed in India aggressively, has been put under focused surveillance in the National Pharmacovigilance Programme by the authorities.
However, the drug regulatory authorities claimed that no adverse drug reaction report had been received on the use of Nimesulide in the country so far to necessitate a review. After the United States, countries like Ireland and Singapore also banned this drug recently following information suggesting an increased risk of liver toxicity compared to other drugs in the same class. The European Medicines Agency has also taken up an independent assessment of the liver toxicity risk following safety concern by the Irish authority. However, the authorities in India said the oral suspension of nimesulide was still permitted to be marketed in many countries including India.
The expert opinion of Drugs Technical Advisory Board (DTAB), a statutory body under the Drugs and Cosmetics Act, was sought by the Delhi High Court in December, 2002 during the hearing of a Public Interest Litigation. The recommendations of DTAB were filed before the Court wherein DTAB had opined that there was no ground for banning of nimesulide for adult or pediatric use, sources said.
Meanwhile, in a survey by a leading channel in the country recently, about 80 per cent of the respondents favored a ban of nimesulide in the country while rest of the participants treated it safe. It may be noted that the same drug is not approved for use in Britain, Canada, Sweden, Denmark, Australia, New Zealand, Japan and other 168 countries. However, the product is widely available in India under the brand names Nise (Dr Reddy's) and Nimulid (Panacea Biotech). The same is used in a number of fixed dose combination drugs too and experts have felt that many of them were irrational as the efficacy was not assessed fully.
Congrats and thanks to all involved in Pharmacovigilance in India!!
Regards,
Bindu Raol.
Ahmedabad-India.