Established in 2008, the India Office serves as the lead for the U.S. Food and Drug Administration’s (FDA) on-site presence in India. The India Office addresses operational and policy matters concerning FDA-regulated products in collaboration with Government of India counterparts. In line with FDA’s mission, the India Office's primary focus is ensuring the safety, quality, and effectiveness of food and medical products shipped from India to the United States.
India is one of the largest exporters of drugs and biologics to the United States, as measured by FDA import lines. In addition to being a global manufacturer of generic drug products, India supplies approximately 40% of generics sold in the United States. India is also a global leader in the export of shrimp and spices.
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 as well as to share information about FDA science-based regulations and requirements;
- Understanding Indian legal requirements as well as the oversight capacity of India's regulatory agencies; Indian companies that manufacture or export products subject to the FDA’s jurisdiction; and the 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.
Focus on India
- FDA Collaborates to Promote Safety, Quality in Clinical Trials Done in India (FDA Voice, July 2017)
- FDA in India: Championing a Culture of Quality (FDA Voice, March 2017)
- Practical Applications of FDA Regulations for the Indian Food Industry (FDA Voice, July 2016)
- In a Country Full of Differences, Common Ground (FDA Voice, March 2016)
- A FSMA Update for our Stakeholders in India (FDA Voice, March 2016)
- Strengthening our Regulatory Relationships in India (FDA Voice, February 2016)
Partnerships and Collaboration
- FDA in India – Championing a Culture of Quality (March 2017)
- Confidentiality Commitment – Food
- Memorandum of Understanding – Food Safety (March 2015)
- Statement of Intent – Cooperation on Medical Products (February 2014)
- FDA’s International Partnership Focus Areas