The Hindu Business Line : Domestic firms await USFDA decision on arthritis drugs — Green signal could lead to reintroduction of rofecoxib

Industry & Economy - Pharmaceuticals

Domestic firms await USFDA decision on arthritis drugs — Green signal could lead to reintroduction of rofecoxib

Nithya Subramanian

New Delhi , Feb. 21

IT IS not just Merck or Pfizer that are awaiting a final word from the US Food and Drug Administration (FDA) on the controversial arthritis drugs — Vioxx, Celebrex and Bextra.

Indian pharmaceutical companies too feel that a favourable decision from the US regulator could pave the way for re-introduction of rofecoxib (the generic version of Vioxx) in the domestic market.

An FDA advisory committee had last week ruled that the drugs could be sold despite the heart risks they pose.

According to sources in the Health Ministry, "The Government will closely watch the developments in the US before taking a decision on re-allowing rofecoxib. We have asked companies to change their labelling to include a cautionary note on all other cycloxygenase II (cox-II) inhibitors. The National Pharmaco-vigilance Advisory Committee (NPAC) has also suggested cautious use of these class of drugs."

The Health Ministry had last year decided to ban the drug and had asked all the companies to withdraw their brands after Merck voluntarily withdrew Vioxx due to adverse side-effects, including cardiac problems.

Local industry officials feel that once the FDA gives the drug the go ahead for the re-introduction in the US, the Drug Controller-General of India (DCGI) could be persuaded to lift the ban.

An official of Ranbaxy Laboratories said, "We will be able to re-launch our products only if the regulator here permits us to do so." The company's Managing Director and CEO, Dr Brian Tempest, had said that it had to make write-offs as a result of discontinuation of rofecoxib.

According to Mr J.P. Parswani, Vice-President, Marketing, Cadila Pharmaceuticals, "Any positive decision by the FDA will help in allaying fears about the Cox-II class of inhibitors, which we feel are a good set of drugs for pain management. While we do not expect a surge in demand immediately after the lifting of the ban, it will definitely be a soothing factor."

Several domestic companies such as Ranbaxy, Dr Reddy's, Zydus Cadila, Glenmark Pharmaceuticals, Torrent Pharmaceuticals and Sun Pharmaceuticals manufacture other Cox II inhibitory drugs such as celecoxib, valdecoxib and eterocoxib. The companies have been trying to push their products despite some question marks on the side-effects of this class of drugs. The market for Cox II inhibitors has been estimated at over Rs 200 crore with rofecoxib garnering a major share.

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