Govt bans Rs 90 crore arthritis drug

The central government has banned the block-buster arthritis drug, Valdecoxib. The generic versions of this drug, invented by Pfizer, is currently manufactured and marketed in India by Cipla, Ranbaxy, Dr Reddy's Lab, Nicholas Piramal, Glenmark and seven other pharmaceutical companies.

The total market for this drug is about Rs 90 crore.

The ban follows the National Pharmacovigilance Advisory Committee (NPAC) recommendation that the drug may be prohibited for manufacture and sale in India under the Drugs and Cosmetics Act, 1950.

The Union health ministry notification has, however, directed the companies to withdraw drug from the market with immediate effect.

Studies abroad have shown that the prolonged use of the drug may have the risk of heart attacks apart from serious skin reactions.

Glenmark Pharma had a major market share in this segment with sales of Rs 25 crore. This has subsequently dropped to around Rs 12 crore, according to analysts.

Glenn Saldanah, managing director of Glenmark Pharma, told Business Standard that the company would withdraw the product immediately. "We have, in fact, slowed down the production since the safety alert on the product was released sometime back by the US Food and Drug Administration," he said.

Ranbaxy had withdrawn the drug soon after the NPAC suggestion but all the other manufacturers remained in the market.

Following this alert, the US Food and Drug Administration early this year, had asked Pfizer-- the inventor to withdraw the drug. Pfizer never launched its brand Bextra in India.