Daiichi, Ranbaxy to cooperate with U.S. drug regulator as Indian firm faces charge

Friday, 27 February 2009, 11:35 Hrs
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Washington: Ranbaxy Laboratories' Japanese parent, Daiichi Sankyo, Thursday said it took the U.S. Food and Drug Administration (USFDA)'s allegation that its Indian subsidiary had falsified data and test results in drug applications "very seriously" and will try to resolve the issue.

"Daiichi Sankyo takes the issue very seriously, and both Daiichi Sankyo and Ranbaxy have already formed a team to solve this issue," a company statement said.

The Ranbaxy scrip, however, took a beating at the Bombay Stock Exchange, losing a whopping 18 percent in Thursday's trade as investors started dumping the company's shares as soon as news of the FDA charge broke.

The scrip did no better at the National Stock Exchange, falling 18.05 percent to close at 169.85.

The affected applications are for drugs that fall into three categories: Approved drugs made at the Paonta Sahib plant in Himachal Pradesh for the US market; drugs pending approval at the FDA that are not yet marketed; and certain drugs manufactured in the US that relied on data from the Paonta Sahib facility.

"Companies must provide truthful and accurate information in their marketing applications. The American public expects and deserves no less," said Janet Woodcock, director of the USFDA's Center for Drug Evaluation and Research (CDER).

However, the USFDA said that to date it had no evidence that these drugs did not meet their quality specifications and has not identified any health risks associated with currently marketed Ranbaxy products.

It also recommended that patients not disrupt their drug therapy because this could jeopardise their health. Individuals who are concerned about their medications should talk with their health care professionals, it said.

On Sep 16, 2008, the FDA issued two warning letters and instituted an Import Alert barring the entry of all finished drug products and active pharmaceutical ingredients from Ranbaxy's Dewas, Paonta Sahib and Batamandi facilities due to violations of current US Good Manufacturing Practices requirements.

That action barred the commercial importation of 30 different generic drugs into the US and remains in effect.

In an earlier press statement, Ranbaxy Laboratories said it will analyse the letter from the FDA informing it about action against the Paonta Sahib facility, placing it under a policy entitled Application Integrity Policy (AIP), and "respond appropriately in a timely manner".

The FDA has said that no products from Ranbaxy's other manufacturing facilities are included in the AIP, it noted.

Ranbaxy will continue to cooperate with the FDA, it said. Further, no effort or action will be spared to timely protect key drug applications from Paonta Sahib, which include some First to File applications.
Source: IANS
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