Date:13/10/2004 URL: http://www.thehindubusinessline.com/2004/10/13/stories/2004101302480200.htm

Back Govt bans rofecoxib sale

Our Bureau

New Delhi , Oct. 12

COMPANIES such as Ranbaxy, Torrent, Unichem and others that manufacture generic versions of Merck's arthritis drug, Vioxx, may have to withdraw their offerings from the market.

The Health Ministry has decided to impose a total ban on sale of rofecoxib - the generic version of Vioxx with immediate effect.

This decision comes close on the heels of the US-based Merck recalling its arthritis drug Vioxx, from the market after it discovered that prolonged usage of the drug caused serious side effects such as heart attacks and strokes.

The Government's decision to ban the sale of rofecoxib comes after the National Pharmacovigilance Advisory Committee (NPAC) under the chairmanship of the Director General of Health Services advised the Health Ministry against the continued use of the drug. The withdrawal of the drug voluntarily by Merck led to the Government asking the NPAC to give its views on the future of its generic versions available in the domestic market. The NPAC then sought Adverse Drug Reaction (ADR) reports from both within the country and outside before taking a decision.

The NPAC has also recommended for cautious use of other similar inhibitor drugs used to treat symptoms of osteoarthritis and rheumatoid arthritis.

In India, there are about 30 companies manufacturing generic or chemically equivalent version of the drug with Ranbaxy, Torrent and Unichem being the main players. Others such as Ind Swift, Panacea Biotec, Dr Reddy's Labs, Lyka Labs and Nicholas Piramal also have different branded versions of the drug. The total market size of this drug is estimated to be at about Rs 90 crore. Internationally, Vioxx was launched in the US in 1999 and has been available in over 80 countries with sales of $2.5 billion in 2003. In India, Merck sells the drug under the brand name, Acrobat.

Meanwhile, according to a Ranbaxy official, "Ranbaxy believes in co-operating with Government and will follow the guidelines issued by the Government." The company markets the drug under the brand name Rofibax.