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FDA Fully Confident in Indian Pharmaceutical Inspectors

The agency is working with the Indian government to ensure medical products manufactured there meet FDA requirements.

The FDA is working to strengthen the United States' regulatory relationship with India, as more and more drug products are being produced there.

"We are working with our counterparts in the Indian government to ensure the medical products manufactured there, especially those for export to the U.S., meet FDA’s safety and quality requirements," Mathew T. Thomas, Director, and Dean Rugnetta, Deputy Director, in FDA’s India Office in New Delhi, wrote in an FDA Voices blog post. "FDA established an office in India in 2008, in part to promote government-to-government interactions like these and to keep pace with rapid developments and innovations in the pharmaceutical sector."

Last November U.S. and Indian government health representatives met to "share inspectional techniques and guidance for conducting current good manufacturing practices of pharmaceutical facilities," according to the blog post.

The result? Learning more about each other's policies and standards.

"It was clear from the interactions that the Indian inspectors had extensive knowledge of FDA and of the international techniques for conducting inspections," according to the blog post.

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