The Union Minister for Health and Family Welfare Dr Anbumani Ramadoss has officially kicked off the national pharmacovigilance programme here on November 23, 2004. Announcing the launch of the programme, the minister informed that the surveillance of a new drug would now begin from its developmental stage and would continue throughout the life of the drug in the market.
"India is beginning its pharmacovigilance programme in the backdrop of one billion population, presence of 25000 branded formulations and a virtually non-existing ADR tracking," he said.
The first assignment to be taken up by the National Pharmacovigilance Advisory Committee (NPAC) would be to scrutinize the safety aspects of COX 2 inhibitors. The attempt is to make sure that COX 2 inhibitors that are currently available in the market do not possess the serious adverse effects that were noticed in the case of rofecoxib, the drug withdrawn from the global markets by Merck, the patent holder company.
The NPAC scrutiny is expected to throw light on the possible risks attached to the long-term use of drugs like etoricoxib, parecoxib and valdecoxib. The Indian pharmaceutical companies aggressively market these drugs.
It should be noted that experts had long time back warned that all such 'coxibs' are likely to have similar adverse effect and hence should be treated with caution. They had pointed out that the very reason why there are no reported cases of myocardiac risk in these alternatives is the absence of any study in that direction.
The National Pharmacovigilance programme launch function witnessed the presence of clinicians from across the country. The Director General of Health Services, Drugs Controller General of India, representative from the WHO, Neelima Ksheersagar, Dean, KEM Hospital, Mumbai were among the dignitaries who attended the function.