US FDA visit to India results in first Statement of Intent

A Statement of Intent has been jointly signed by officials at India’s Ministry of Health and Family Welfare and US Food and Drug Administration Commissioner Margaret Hamburg, she reported yesterday.

The first Statement of Intent between the two agencies, was signed in “the spirit of continued collaboration and a commitment to quality”, she said, during her visit to India this week. “While the Statement of Intent is an important milestone, I am proud to report that FDA’s Office in India has already been working closely with India’s drug regulators to reinforce the importance of producing quality products for patients. Drug and food regulators in India have participated in FDA-hosted workshops and observed FDA inspections of manufacturing facilities and clinical sites with operations in India,” said Commissioner Hamburg.

She added: “Ensuring that the products distributed in the United States meet our requirements for product safety and quality is among my top priorities as Commissioner. Unfortunately the many Indian companies that understand good manufacturing and quality processes have been overshadowed by recent lapses in quality at a handful of pharmaceutical firms.”