FDA Eyes India Offices by 2009 to Ensure Import Safety
Signaling its intention to enhance monitoring the safety of products destined for America, the FDA says it will open two offices in India by next year.
The offices, to be located in Delhi and Mumbai, are part of the agency’s FDA Without Borders initiative, announced by FDA Commissioner Andrew von Eschenbach in March.
A growing number of drugs, medical devices and food products from India are being imported to the U.S., and 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 agency’s Office of International Programs, said.
The offices will help the FDA “make better, more risk-based decisions on where to use our inspection resources — both in the field and at our borders,” he said.
Besides 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.
As part of the FDA Without Borders initiative, the agency is finalizing an agreement with the Chinese government to open three offices there, Kelly said. Plans to open offices in the Middle East, Latin America and Europe also are under way.