The Tamil Nadu Health Development Forum (TNHDF), an NGO which had filed a PIL with the Chennai High Court demanding a completely ban of nimesulide in India, has plans to form an expert committee to conduct an independent in-depth study into the adverse drug reactions caused by nimelsulide and its combinations.
The Chennai High Court had accepted the TNHDF's PIL during the second week of September, last year, and had asked the Union Health Ministry and the Drug Controller of India (DCGI) to respond in the case. The final verdict in the case is expected within a few weeks.
Talking to Pharmabiz, Dr.C.S.Rex Saragunam, secretary of Tamil Nadu Health Development Forum said though the forum was expecting a favourable decision from the Chennai HC, the move to conduct a study on the efficacy of nimesulide was necessitated from the fact that there were lots of contradictory reports by the experts. The proposed committee would have at least five expert doctors from Tamil Nadu, especially a pediatrician, kidney and liver specialists, general practitioner etc.
"In our country many NGOs conduct various studies with committees appointed with experts. This proposed study is not intended as a move to mobilize opinion or to contradict the opinion of various experts and the Government. This study could create significant data on the dangerous side of nimesulide and its combinations," noted Dr.Rex.
He said the forum was planning to co-ordinate with similar NGOs fighting against the dangers of nimesulide. "We are waiting for the Chennai High Court judgment, and will decide our future course of action in consultation with the Delhi NGO," said Dr.Rex.
It is to be noted Pharmabiz recently had reported of a Delhi High Court decision to dismiss a civil writ petition filed by a Delhi based NGO Social Jurist, which sought to withdraw unapproved nimesulide formulations from the Indian market. The court also had asked the petitioners to follow criminal complaint against the pharmaceutical companies, following a positive nod from the DTAB which was asked by the HC to examine whether nimesulide, an anti-pyretic drug banned in many countries, is safe to consume.
In its petition, the Chennai NGO had said the Government's unwillingness to totally ban nimesulide drugs in the country amounts to infringement of Article 14 and 21 of the Indian constitution, which stands for equality before law, protection to life and liberty of the citizens. Nimesulide was a non-steroid anti-inflammatory drug (NSAID), not an anti-pyretic drug, widely prescribed by doctors for its ability to bring down the temperature faster than paracetamol, available in brands like Crocin, Metacin, Dolopar etc.
Studies show this drug is harmful to kidneys and liver on prolonged use. Even for minor fever related body pain, doctors prescribe it by going by the patient's psychology, without considering the long-term harmful impact of the drug. Nimesulide is among the most expensive drugs, offering the manufacturers profit margin of over 1300 percent, resulting in large scale manufacturing and marketing by pharma companies. The drug is not approved in many countries including the U.S., U.K., Canada and Australia. It has been banned in Finland, Spain, Turkey and Bangladesh, the Forum's PIL had contended.
It is estimated that 50 combinations of nimesulide and paracetamol out of 200 odd nimesulide formulations (70 nimesulide suspensions and 130 fixed dose combinations with other drugs) are currently available in the country.