Officials will work with industry and government to ensure safety and quality.
HHS secretary, Mike Leavitt, and FDA commissioner, Andrew C. von Eschenbach, M.D., reported the opening of HHS/FDA offices in New Delhi and Mumbai. The aim is to improve safety and quality, which will facilitate the smooth flow of trade.
HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the U.S. Along with the office director, HHS/FDA will have four inspectors and five senior technical experts who will cover food, medical devices, and medicines.
These HHS/FDA personnel will provide technical advice, conduct inspections of facilities that export to the U.S., and work with Indian government agencies and the private sector to develop certification programs to allow the efficient flow of safe HHS/FDA-regulated goods between the U.S. and India.
“Through these offices, we can work more closely with manufacturers to share best practices and ensure producers build quality and safety into food and medical products,” remarks Leavitt.
In January 2008, Leavitt and von Eschenbach visited India to start discussions with Indian industry about the issue of product safety and with the Indian government on the potential of posting HHS/FDA personnel to the U.S. embassy in New Delhi and the U.S. consulate in Mumbai.
India is the fourth-largest exporter by volume of drugs and biologics, especially generic pharmaceuticals, to the U.S. India is also a significant exporter of food products.
These offices are part of HHS/FDA’s Beyond Our Borders Initiative, which will place 35 HHS/FDA personnel in 14 locations around the world. The goal is to expand HHS/FDA consumer-protection efforts beyond the U.S. and form collaborative partnerships with governments and industry on product safety.
With the opening of these offices, HHS/FDA now has an in-country presence in China, Central America, India, and Europe. HHS/FDA also plans to post FDA personnel to several more locations in 2009, such as Mexico, South America, Europe, and The Middle East.