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The FDA in India
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), Department of State, as well as
other Department of Health and Human Service 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. | 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. | |
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| FDA Offices in India
The India Office also will allow the agency to:
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. | Back to Top | |
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