The union ministry of health is expected to issue the notification banning the manufacture and sale of valdecoxib formulations in the country in a few days from now, it is learnt.
The office of Drug Controller General of India has already forwarded the recommendation made by the National Pharmacovigilance Advisory Committee (NPAC) seeking a ban on the drug and its formulations to Director General of Health Services early this month.
The order banning the drug has to be signed by the joint secretary, ministry of health once DGHS forwards the recommendation.
The NPAC in its meeting held in Delhi on May 2 discussed the safety profile of the drug in India in the wake of the US FDA observations on its serious adverse drug reactions and wanted the drug to be withdrawn from the domestic market.
On April 7, the US FDA asked Pfizer Inc to withdraw its valdecoxib brand, Bextra, from the market after reports of serious and potentially life-threatening reactions including deaths in patients using the drug.
This is the second Cox-2 inhibitor being withdrawn from the Indian market in a period of a few months. The first was rofecoxib and its formulations withdrawn last year after Merck voluntarily withdrew its brand Vioxx from the world markets for increased risk of cardio vascular events.
Soon after the reports of serious ADR of valdecoxib, Ranbaxy is the only company in India, which had withdrawn its brand from the domestic market. Some of the other prominent players like Cipla, Nicholas Piramal, Unichem, Alembic and Glenmark are yet to withdraw their brands.
The companies like Novartis, Alembic, Brown and Bork and Unichem have, however, stopped supplying the fresh stocks of valdecoxib to the stockists after NPAC’s recommendation to ban the sale of valdecoxib formulations is known.
“We are expecting the notification shortly. But, till then we will not withdraw the drug from the market, though we have stopped the fresh supply of valdecoxib stocks,” said, Ashok Jain, Unichem Laboritories.
Meanwhile, a good number of medical practitioners in India have stopped prescribing valdecoxib formulations following reports of its adverse drug reactions and started prescribing pain killers such as Diclofenac, Ibuprofen and Naproxen. These painkillers have the advantage of being both less risky and affordable as compared to the Cox-2 inhibitors.