FDA to Establish Offices in India by 2009

As part of its effort to improve monitoring of imported products, the FDA plans to open two offices in India by next year.

The offices, to be located in Delhi and Mumbai, are part of the FDA Without Borders initiative announced by FDA Commissioner Andrew von Eschenbach in March.

A growing number of medical devices, drugs and food products are being exported from India to the U.S. The FDA “believes we can better help assure the safety and manufacturing quality of these products by having FDA personnel full time in India to work with our counterpart agencies there,” Christopher Kelly, a spokesman for the FDA’s Office of International Programs, said.

Kelly said the offices will help the agency “make better, more risk-based decisions on where to use our inspection resources — both in the field and at our borders.”

In addition to inspecting India-based companies, the FDA will work with private and public entities interested in certifying that products headed for the U.S. market meet U.S. public health standards, Kelly said.

The FDA also is in the process of finalizing an agreement with the Chinese government to open three offices there and hopes to have agency officials in Beijing, Shanghai and Guangzhou by the end of September, Kelly said.