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INTERVIEW-US FDA seeks India post for food, drug checks
19 Jun 2008 22:03:57 GMT
Source: Reuters
*US FDA aiming for presence in India this year

*India a focus given volume of food, drug exports to US

*Jordan a possibility for FDA's Middle East site

By Lisa Richwine and Susan Heavey

WASHINGTON, June 19 (Reuters) - The U.S. Food and Drug Administration hopes to establish operations in India by year's end to better police the growing volume of food, medicines, medical devices and animal feed exported to the United States, a top official told Reuters on Thursday.

FDA Deputy Commissioner Murray Lumpkin said India was the next priority for the agency after it sets up offices in China to boost inspections and improve oversight.

"Our hope is we would be able at least to begin having a presence in India toward the end of this calendar year, or at the very beginning ... of 2009," Lumpkin said in an interview.

Concern about the quality of foreign-made food and medicines grew after a series of recalls last year of tainted pet food, toothpaste, seafood and other products from China.

Earlier this year, the deaths of dozens of patients given the blood-thinning drug heparin led to an FDA investigation. Agency officials said they found a contaminant in batches made with ingredients from China.

The agency has a limited budget for inspections and checks few foreign manufacturing plants now. After criticism for lax oversight, officials this year requested an infusion of money from Congress and announced plans to build a presence around the globe with inspectors and other staff.

An initial priority is setting up three offices in China this year, followed by stationing staff in New Delhi and Mumbai, India, Lumpkin said.

India warrants attention because it exports a large volume of products to the United States and is an increasingly popular site for drug company clinical trials, which the FDA also has the responsibility to monitor, Lumpkin said.

"They have become an area that the industries that we are responsible for overseeing in the United States are interested in going," said Lumpkin, the FDA's deputy commissioner for international and special programs.

"A lot of this is driven by where the industry decides to go to do its business to bring products into the United States," he added.

The FDA also would like to place staff in Amman, Jordan, to serve as a Middle East base, Lumpkin said, as well as in Central or South America and Europe. The administration of U.S. President George W. Bush asked for funds for its China office in its fiscal 2009 budget request. Lumpkin said the agency was preparing to launch the other new offices as soon as funds were made available.

"We see these offices as much a part of the way the FDA has to do its business as having an office in San Francisco or having an office in Philadelphia," he said. (Editing by Carol Bishopric)


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Last updated:Thu Jun 19 22:06:44 2008