India

The India Office engages proactively and consistently with Indian regulatory counterparts and industry representatives to better accomplish FDA’s domestic mission to assure the safety, efficacy, and quality of FDA-regulated products. This includes managing the sharing of information and addressing regulatory compliance issues, some of which have a global impact. FDA’s communication with its foreign regulatory counterparts allows it to share technical expertise that enhances the country’s ability to produce safe foods and quality medical products. These information sharing and capacity building activities strengthen the ability of India to provide exports that meet the FDA standard and allow FDA to fulfill its mandate of consumer protection for Americans. The India Office also will allow the agency to:

• Build or further strengthen a trusted regulator-to-regulator relationship with Government of India; 
• Learn more about the industries and challenges of how products are regulated in India; 
• More easily inspect manufacturing and processing facilities in India that are producing products destined for the USA or determine how FDA can further leverage inspections already performed by its counterparts in India; 
• Have increased interactions with Indian manufacturers to help ensure that products shipped to the United States meet FDA standards for safety and manufacturing quality; 
• Verify that imported products and the way they are manufactured meet U.S. health and safety requirements.

When fully staffed, FDA will have 12 Staff in India; seven in New Delhi and 5 in Mumbai. Those in New Delhi are based in the U.S. Embassy and include a Director and six senior technical experts covering medicines, foods and devices. The inspectors in Mumbai are based at the U.S. Consulate General and are Consumer Safety Officers with expertise in these same regulated-product areas.

More About the Office Activities »