Centre bans arthritis drug Bextra, finally

Centre bans arthritis drug Bextra, finally

TIMES NEWS NETWORK[ FRIDAY, AUGUST 05, 2005 01:54:50 AM]

MUMBAI/NEW DELHI: The Indian government has issued a notification banning Bextra (Valdecoxib) one of Pfizer’s best selling drugs, months after the US Food & Drug Administration (USFDA) ordered its withdrawal.

The notification, which was issued last week, came after months of deliberation by the authorities. An expert committee under the health ministry recommended in May that the arthritis pill Valdecoxib be banned in India. The ban will affect over 50 brands, which account for a sizeable chunk of the over-Rs 200 crore cox-2 inhibitor market.

In April this year, the USFDA asked Pfizer to withdraw Bextra (Valdecoxib) due to concerns of serious, unpredictable and potentially life-threatening skin reactions, including death in patients using Valdecoxib.

According to reports, there were over 155 reports of adverse reactions to Bextra, which was commonly used to relieve pain and inflammation from arthritis, worldwide. Bextra had sales of $1.4bn last year.

Following the USFDA’s orders to Pfizer, the Drugs Controller General of India (DCGI), started its own process of reviewing the drug. The domestic industry, which had withdrawn their versions of Rofecoxib (a drug similar to Valdecoxib) when the innovator Merck recalled the product globally, were reluctant to do the same with Valdecoxib.

The reason could be that Valdecoxib was a newer drug, and it was doing much better than Rofecoxib.

The total Valdecoxib market was valued at close to Rs 100 crore with the top 10 brands accounting for almost 70% of the market. Glenmark’s Valus is the leading brand, followed by Nicholas Piramal’s.