U.S., Indian health regulators will inform each other before conducting inspections

U.S., Indian health regulators will inform each other before conducting inspecti

U. S. Food & Drug Administration (USFDA) Commissioner Margaret A Hamburg on Monday signed an agreement with India's Union Health Minister Ghulam Nabi Azad under which regulators from the two countries will inform the regulatory authorities of each other before conducting inspections.

Under the terms of the agreement, health inspectors of the host-country may join inspections as observers. The two countries also agreed to exchange information relevant to any lack of compliance with accepted good manufacturing practices (GMP) etc.

A government official confirmed that the two countries would exchange "information relevant to lack of compliance with accepted good manufacturing practices, good clinical practices, or good laboratory practices, as appropriate, by manufacturers and sponsors of medical products".

Margaret Hamburg is on her first, week-long visit to India. Her visit comes at a time when the USFDA has banned imports from a number of Indian pharma companies, citing serious shortcomings in their quality and production practices.

Last month, the USFDA banned the import of products manufactured by Ranbaxy at its Toansa plant. It was the Indian pharma giant's fourth plant to face regulatory action from the U. S. regulator, after its Mohali, Paonta Sahib and Dewas plants. Other Indian drug companies that have faced adverse regulatory actions by the FDA in the past few months include Wockhardt and Strides Acrolab.

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