US FDA unveils its offices in India

New Delhi: The US Food and Drug Administration (FDA) on Thursday opened offices in New Delhi and Mumbai to share best practices with Indian manufacturers of generic drugs and food products.

India is the fourth-largest exporter, by volume, of drugs and biologics, especially generic pharmaceuticals, to the US. The Secretary of the US Department of Health and Human Services (HHS), Mr Mike Leavitt said, “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. Consumers in India and the US 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.”

The new offices in India are part of FDA’s ‘Beyond Our Borders Initiative’, which will place 35 personnel in 14 locations around the world, mostly connected to US Embassies, Consulates and Missions. This initiative will expand HHS/FDA consumer-protection efforts beyond the US to form collaborative partnerships with governments and industry on product safety.

HHS/FDA will post 10 experienced officials in India to work closely with industries that ship food and medical products to the US 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.

With the opening of these offices, HHS/FDA now has an in-country presence in China, Central America, India, and Europe.