India may ban Valdecoxib

Kailash Rajwadkar - Mumbai

The estimated Rs 90-crore Valdecoxib, indicated for arthritis and acute pain, may finally be on its way out in India. The National Pharmaco Vigilance Advisory Committee has recommended that the drug may be prohibited for manufacture and sale in India under the Drugs and Cosmetics Act.

Indian companies, including Cipla, Nicholas Piramal and Glenmark, among 15-20 other brands, are manufacturing this drug. Ranbaxy is believed to have withdrawn the drug from the market last month. Other companies are tight lipped about the future outlook of the drug in India. It may be recalled that the US FDA had asked Pfizer Inc to withdraw the drug early this year. Pfizer India, however, did not market the drug in India. Studies abroad have shown that the drug may more than double the risk of heart attacks and strokes. Serious skin reactions have also been found.

In fact, Pfizer Inc, marketing the drug under the brand name Bextra, has withdrawn the drug, as the drug was found to be associated with increased risk of serious skin reactions. In India, Glenmark Pharma had a major marketshare in this product with sales of around Rs 25 crore. This has subsequently dropped to around Rs 12 crore, according to analysts.

A Glenmark official, reacting on the issue, stated that the company was adopting a ‘wait and watch’ approach and was going slow on production.

Commenting on the withdrawal of the drug, the official said the US FDA, prior to banning the valdecoxib drug, had constituted a committee seeking advise on the issue. The committee had suggested against withdrawal of the drug but the US FDA decided against it and withdrew the drug.

Indian Drug Manufac-turers Association president Suresh Kare said, ‘‘India normally follow the US model in the case of withdrawing drugs.’’ Citing a case on drug withdrawal, Kare said that the US FDA had banned an anti-diarrhea drug more than two decades back. The Indian government had then decided against the ban considering that the diarrhea was prevalent in India unlike in the US and it was an affordable option for Indians, Kare added.

— Financial Express