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USFDA, Indian regulator to work together in facility inspection

Our Bureau New Delhi | Updated on March 12, 2018

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The US Food and Drug Administration and the Indian drug regulator will now work together while inspecting manufacturing facilities in each others’ countries.

Minister of Health and Family Welfare Ghulam Nabi Azad and Commissioner of US FDA Margaret Hamburg signed a Statement of Intent on Cooperation in the Field of Medical Products on Monday. Under this, the regulators will inform each other before undertaking inspections, allowing host-country inspectors to join inspections as observers.

Further, the regulators will also share information regarding any lacuna found in terms of lack of compliance with current good manufacturing practices, clinical practices, or laboratory practices by manufactures and sponsors of medical products and cosmetics.

Till now the countries did not have any data sharing agreement and inspections were conducted by the regulators separately.

Published on February 10, 2014

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