HHS Opens U.S. Food and Drug Administration Offices in India

HHS Secretary Mike Leavitt and Commissioner of the HHS Food and Drug Administration (FDA) Andrew C. von Eschenbach, M.D., today marked the opening of the HHS/FDA offices in New Delhi, and Mumbai, 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," Secretary Leavitt said. "Consumers in India and the United States will benefit from the enhanced safety of food, drugs and medical devices. If called upon, we are also prepared to work with the Indian government as it strengthens its own regulatory institutions."

HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the United States, to improve safety and quality, which will facilitate the smooth flow of trade. 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 United States, 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 United States and India.

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, mostly connected to U.S. Embassies, Consulates and Missions. This initiative will expand HHS/FDA consumer-protection efforts beyond the United States to form collaborative partnerships with governments and industry on product safety.

In January 2008, Secretary Leavitt and Commissioner 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. The goal of these discussions was to establish a pathway to improve regulatory cooperation for the benefit of American and Indian consumers. While in India, they toured food- and pharmaceutical-manufacturing facilities.

India is the fourth-largest exporter by volume of drugs and biologics, especially generic pharmaceuticals, to the United States. India is also a significant exporter of food products.

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 -- México, South America, Europe and the Middle East.