FDA to open offices in India, beginning international expansion

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The FDA plans to open two offices in India by next year, to be located in Delhi and Mumbai.

The new offices will be a part of the FDA Without Borders initiative, announced by FDA Commissioner Andrew von Eschenbach in March.

A growing number of medical devices and drugs are being exported from India to the U.S., according to the agency.

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, told FDA News.

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 its public health standards, according to Kelly.

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