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Offices and Departments

Food and Drug Administration India Office

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Food and Drug Administration

FDA’s goals in India are to obtain better and more robust information to help FDA officials in the various FDA headquarter Offices and Centers and at the borders make better decisions about the products from India that are being developed for the U.S. market. This includes products that are being reviewed for marketing authorization in the USA, and that are presently already on the U.S. market. To this end, FDA activities in India include:

  • Engaging with our Indian counterpart regulatory authorities to ensure the timely exchange and communication of information regarding clinical trials that are conducted, and the manufacturing of and transport of products from India, that are destined for the USA;
  • Partnering with our Indian counterpart agencies on various bilateral and regional capacity-building initiatives;
  • Working with the regulated-product industries in India that wish to export their products to the USA to assure their understanding of our standards and expectations regarding FDA-regulated products;
  • Coordinating and collaborating on a daily basis on product quality and safety issues with other U.S. government agencies overseas that have complementary missions to our own (e.g., Department of Agriculture (USDA), Department of Homeland Security’s Customs and Border Protection (CBP), Department of Justice, Department of Commerce’s Foreign Commercial Service (FCS), the U.S. Trade Representative (USTR), and Department of State, as well as the Department of Health and Human Service (DHHS).  FDA is an agency in the DHHS Family of Agencies and closely coordinates with the Office of Global Health Affairs (OGHA) as also with other DHHS entities - Centers for Disease Control and Prevention (CDC), and the National Institutes of Health (NIH);
  • Assessing, in real time and in-country, conditions and events in those areas that might have an impact on the safety and quality of FDA-regulated products exported to the USA from India; and
  • Gathering better information about the clinical trial data conducted in India that support marketing applications in the USA and the manufacture of FDA-regulated products destined for the USA through increased capacity for more direct FDA inspections of relevant high-risk facilities and by working with private- and public-sector entities that wish to engage with FDA on third-party certification efforts regarding these products.