The Hindu Business Line : Indian cos going slow on promoting Valdecoxib

This comes close on the heels of Pfizer, the original patent holder of Valdecoxib, being asked by the US regulatory authority to "voluntarily remove Bextra (Pfizer's brand of Valdecoxib) from the market".

The US food and Drug Administration (USFDA) felt that not only did it pose a heart-related risk, like other drugs in its family, but also increased the risk of a rare but serious skin reaction.

So while Bextra is off the shelf in the US and Europe, it continues to be sold in India, though not actively promoted, said a medical representative.

Valdecoxib is an estimated Rs 90 crore market in the country and players in the segment include Glenmark, Ranbaxy, Nicholas Piramal, Unichem, Cipla, Torrent and Ajanta Pharma, he said.

"The USFDA has suspended the drug. But we are waiting for clarity on whether the drug has been suspended forever or whether Valdecoxib will be back with black box warning. Nevertheless, we are slowing down our promotion of the drug," said Dr Swati Piramal, Director-Strategic Alliances, Nicholas Piramal.

Vah is the brand under which Valdecoxib is sold by Nicholas Piramal and the company is working on three other line extensions in the pain-killer segment, she said.

Ranbaxy move: Ranbaxy has voluntarily discontinued all its Valedicoxib formulations with immediate effect from Indian markets, a company statement said.

"All patients presently consuming Ranbaxy's Valdecoxib formulations should consult their physicians for alternate and appropriate medications/treatment options," the note added.

According to an analyst, Ranbaxy's Valdecoxib formulations clocked sales of about Rs 13 crore, while Nicholas Piramal's Vah was an estimated Rs 8 crore brand. Glenmark's brand Valus has an estimated sale of Rs 9 crore, the analyst said.

However, Glenmark officials were not available for comment on the status of their Valdecoxib drug.

Domestic drug companies are waiting for some indication from the Drug Controller's office on the issue. A senior official with the Indian regulator, however, said that the issue was under scrutiny and a decision would be taken as more information was available on the risk-profile of the drug.

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