India Office
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Established in November 2008, the Office of Global Policy and Strategy's (OGPS) India Office (INO) serves as the lead FDA on-site presence in New Delhi, India. The India Office addresses operational and policy matters concerning FDA-regulated products in collaboration with the Government of India counterparts. In line with the FDA's mission, the INO's primary focus is ensuring the safety, quality, and effectiveness of food and medical products exported to the United States.
The India Office advances the FDA's mission to protect and promote public health by:
- Conducting commodity-specific inspections to meet the requirements of FDA-specific legislative mandates;
- Building strong coalitions and partnerships with regulatory authorities, industry, academia, multilateral organizations, non-governmental organizations, and other relevant institutions to increase the FDA’s understanding of India’s regulatory framework and processes, and to share information about FDA science-based regulations and requirements;
- Enhancing FDA’s knowledge of India’s legal requirements and oversight capacity of India's regulatory agencies; Indian companies that manufacture or export products subject to the FDA’s jurisdiction; and emerging trends and issues of relevance to the FDA to ensure product safety and quality; and
- Expanding upon and building better quality data to inform the FDA’s regulatory decisions and actions.
Contact:
Sarah McMullen, Ph.D., Director
Deputy Director (Vacant)
U.S. Food and Drug Administration
Office of Global Policy and Strategy
India Office
U.S. Embassy New Delhi
New Delhi, India
Tel: +91-11-2419-8269
E-mail: US-FDA-INO@fda.hhs.gov
Focus on India
India is one of the largest exporters of drugs and biologics to the United States, as measured by FDA import lines. The country is also a global leader in the export of shrimp and spices.
- India’s Unique Opportunity and Important Responsibility as the Pharmacy to the World, FDA Voices, October 2023
- FDA visits Andhra University, attends BioAsia 2023 in Hyderabad, U.S. Consulate General Hyderabad (India), Press Release, February 2023
- Doing the Needful During India's "Second Wave," From a Global Perspective, August 2021
- FDA Collaborates to Promote Safety, Quality in Clinical Trials Done in India, FDA Voices, July 2017
- Practical Applications of FDA Regulations for the Indian Food Industry, FDA Voices, July 2016
- In a Country Full of Differences, Common Ground, FDA Voices, March 2016
- A FSMA Update for our Stakeholders in India, FDA Voices, March 2016
Partnerships and Collaboration
- India’s Unique Opportunity and Important Responsibility as the Pharmacy to the World, October 2023
- FDA in India – Championing a Culture of Quality, March 2017
- Confidentiality Commitment – Food
- FDA to Export Inspection Council of India, June 2016
- Export Inspection Council of India to FDA, June 2016
- Memorandum of Understanding - Medical Products Safety, (Indefinite)
- Memorandum of Understanding – Food Safety, March 2015
- Statement of Intent – Cooperation on Medical Products, February 2014
- FDA’s International Partnership Focus Areas
Resources For You
- Contact Information: OGPS Offices
- Countries and Regions Covered by OGPS Offices
- FDA Globalization
- Imports and Exports
- International Arrangements
- International Programs
- News, Speeches, and Publications
- Partnerships and Collaboration
- President's Emergency Plan for AIDS Relief (PEPFAR)