The Hindu Business Line : Merck's drug withdrawal turns spotlight on generic makers

ALL eyes are on the regulatory office of the Drug Controller General of India (DCGI) with regard to the fate of Rofecoxib, a pain-killer and arthritis drug.

Rofecoxib, sold under the brandname Vioxx by Merck & Co, has been withdrawn globally with immediate effect due to side effects such as heart-attack and stroke.

But the spotlight in India would be on the 30-odd Indian companies, which make the generic, or chemically equivalent version of the same drug. These include Ranbaxy, Unichem and Torrent, who between the three corner about 65 per cent of the market.

Speaking to Business Line, the Drug Controller, Mr Ashwini Kumar, said that his office was examining the issue and calling for more details before taking any decision on whether these drugs need to be banned locally too.

Meanwhile, drug company representatives expressed worry on whether the adverse side-effects were restricted to just the drug in question, or the entire class of these drugs.

And even as the company globally prepares for more litigation on whether it misled consumers, questions remain unanswered on what happens to people who have already consumed the medicine.

"Vioxx was launched in the US in 1999 and has been marketed in more than 80 countries. Worldwide sales of Vioxx in 2003 was $2.5 billion," Merck said on its Web site.

In India, Merck's drug is sold under the Acrobat brandname. However, efforts to contact the company proved futile.

Dr P.A. Mody, Chairman and Managing Director, Unichem Laboratories Ltd, said : "Our regulatory people are already looking at the issue, even as we wait for some direction from the DCGI's office."

Launched about three years ago, Unichem's version of the drug sells under the brandname Roff and has clocked sales in excess of Rs 10 crore, he said.

Other companies that market the drug include Ind-Swift (drug name Askil), Panacea Biotec (Dolib), Dr Reddy's Labs (McRofy), Lyka Labs (R-oxib), Nicholas Piramal (Rexib), IPCA Labs (Rodiff), Ranbaxy (Rofibax), Alembic (Rofegesic), Wockhardt (Rofiz), Torrent (Toroxx) and Cadila Healthcare (Zyrof).

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