Indian Drug Manufacturers Association (IDMA), representing domestic drug manufacturers, in a letter addressed to DCGI on Monday has urged the Union Government to revoke the ban on rofecoxib, which it had notified in late 2004.
IDMA's appeal comes after last weekend's statement of the US FDA's panel allowing circulation of cox-2 inhibitors (including rofecoxib) in the US market with strong warnings of the risks on the pack of the drug.
The appeal comes as a support to Indian makers of COX-2 inhibitors (C2I), who had stopped production of rofecoxib after DCGI had banned the product in the country.
DCGI was under pressure to invoke a ban on rofecoxib sold in India, when its innovator Merck voluntarily withdrew its product (Vioxx) from the US market citing cardiac related side effects for patients consuming the drug. There were also questions raised regarding other C2Is like Celebra (celecoxib) and Bextra (valdecoxib).
After detailed discussions, a 34-member panel of medical experts was appointed by US FDA to study if C2Is should continue in the market. The panel, after prolonged discussion and study, recommended that although these group of drugs posed cardiac-related side effects, their benefits outweighed their drawbacks. The benefits being, the C2Is are the most effective painkillers and these group of drugs cause lesser number of stomach ulcers compared to the existing painkillers like NSAIDS.
With the latest announcement from the panel, US drug major Merck has strongly indicated to relaunch its product Vioxx in global markets.
"As US FDA has urged US drug makers to continue with their rofecoxib and other COX-2 brands, we urge the DCGI to revoke its ban on rofecoxib," said Dara Patel, secretary general, IDMA.
"It is too early to talk on this. However, IPA would like to take the matter to the DCGI if its member companies comes forward with their requests," said DG Shah, secretary general, IPA.
The association representing MNCs in India, OPPI, does not have plans to appeal with the DCGI for a ban revoke on rofecoxib. "It is not of concern to OPPI as its members have not launched rofecoxib brands in the country," said Dr. Ajit Dangi, director general, OPPI.
As Indian drug regulatory authority does not have infrastructure and resources to finance clinical studies, it always have to depend on the data available with the US or the European authorities to arrive at a conclusion to ban or revoke a ban on potentially risky molecules, said senior regulatory officials.
There were 70 odd manufacturers of Rofecoxib in India, which includes Unichem Labs, Ranbaxy, Dr. Reddy's, Zydus Cadila, Torrent Pharma, Blue Cross Labs, Micro Labs before the ban was imposed on the product.