Although National Pharmacovigilance Advisory Committee recommended DCGI to ban the sale of Vadecoxib formulations in India, soon after the drug was withdrawn from the world markets by Pfizer Inc., most of the Indian companies are still selling their products all over the country.
The companies are all waiting for DCGI to issue a notification banning the drug. However, Ranbaxy Labs withdrew its brand voluntarily from the market shortly after Pfizer's decision. There are 20 other companies including Glenmark, Nicholas Piramal, Cipla and Unichem which are manufacturing and marketing valdecoxib formulations in the country. Some of the widely prescribed brands are Valus, Valcox and Vah.
"Our company will not withdraw the drug from the market until the government comes out with a notification," said Vijay Sathe, Nicholas Piramal.
Ashok Jain, Unichem laboratories, said that Unichem had stopped supplying fresh stocks of valdecoxib to the stockists after the reports of withdrawal by Pfizer. But, the company will not withdraw the drug from the market unless the government notifies the ban. Its valdecoxib formulations market is about Rs 4 crore. The total valdecoxib market in India is about Rs 80 crore.
Valdecoxib is the second Cox-2 inhibitor which had been withdrawn from the world markets for serious adverse drug reactions. Soon after Merck's withdrawal of Roficoxib, an anti-arthritis drug in the US, DCGI had issued a notification banning its sale in India. Two years ago, paediatric usage of nimesulide was disallowed by DCGI for serious side effects. In many of the European countries and in the US, the drug is totally banned.