Hamburg Says India Trip Furthered Quality Focus

FDA Commissioner Margaret Hamburg says her trip to India succeeded in syncing U.S.-India views on drug quality.

On the trip, Hamburg said she stressed the message that weak quality standards equate directly with harm to patients. “I’m happy to report my counterparts in India supported this view,” she said on a conference call with reporters to summarize the highlights of her visit.

During her visit, Hamburg signed a five-year accord with Indian Secretary of Health Keshav Desiraju creating a framework for the two sides to share information from quality inspections of drugmakers’ manufacturing facilities. The agreement also allows for more FDA inspectors to be stationed in the country, upping the total from 12 to 19 inspectors.

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