Rofecoxib makers to fall back on alternatives

Gireesh Chandra Prasad G I & Megha Lodha - Mumbai

Generics makers of banned pain-relief drug rofecoxib are ready with variants in the Cox 2 inhibitor class with better safety profile so as to mute the blow the drug's withdrawal would deal on their bottomlines.

Chandigarh-based Ind Swift Laboratories is planning to introduce Etoricoxib, an extension of another drug in the same Cox-2 inhibitor class, valdecoxib, by this year end.

Nicholas Piramal had discontinued its rofecoxib brand Rexib and brought in Valdecoxib a few months ago.

A senior Ranbaxy official told Express Pharma Pulse from New Delhi that it has three other drugs in the Cox-2 inhibitor class Celecoxib, Valdecoxib and Etoricoxib and that the impact of Rofecoxib withdrawal from its world markets would be very marginal.

Ind Swift's vice president, Sanjay Dheer told Express Pharma Pulse the company expects a better revenue from this product compared with the four per cent rofecoxib market share it had. Ind Swift would be the third company launching this generic version of a Pfizer drug in the Indian market. He said etoricoxib is a purified form of valdecoxib. The government's notification banning the drug is awaited.

Sanjay Dheer said when the company receives the notification, it would withdraw the product without delay. He said the company is marketing a whole range of products including combinations of the drug and therefore, the withdrawal would not amount to a major loss.

Many companies EPP spoke to were earlier planning to retain the drug with label changes but changed course after the DCGI decision to ban the product completely.

Hyderabad based Dr Reddy's Laboratories said its withdrawal of McRrofy - from all markets is in line with DRL's policy of evidence-based marketing. For DRL, McRofy was not a significant brand. Sun Pharma, another player in the painkiller market, chose not to comment.

Local pharmaceutical industries have been marketing Rofecoxib formulations for about four years in the country. The leading brands in this segment were Ranbaxy's Rofibax, Unichem's Roff, Torrent Pharma's Toroxx, Lupin Labs' Rofaday, Sun Pharma's Rofact and Micro Labs' Rofica.

Experts said that after Merck's voluntary withdrawal, not one Indian company followed suit prior to the DCGI decision.