Pharmaceuticals / Quality / Regulatory Affairs / Inspections and Audits

FDA Beefs Up U.S. Inspection Force in India

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The FDA is currently recruiting and training seven investigators for its India office, growing the agency’s in-country American staff acting from 12 to 19. The new hires were agreed to by Indian officials in March 2013.

The hires dovetail with the Feb. 10 signing of a five-year agreement by FDA Commissioner Margaret Hamburg and Indian health minister Keshav Desiraju to share data relating to drug manufacturing, clinical trial and laboratory practice inspections. The agreement also allows the two regulators to observe the other’s inspections.

“In my talks with regulators and companies here in India, I have placed a great deal of emphasis on why quality matters,” Hamburg said in a Feb. 14 posting to the FDA Voice blog from India, where she was winding up a trip to the South Asian nation. She emphasized that Indian drugmakers have a responsibility to ensure their products are safe and effective.

The trip — which included meetings with national and state regulators in Delhi, Mumbai and Cochin, as well as drug company executives — is part of the FDA’s transformation from a domestically focused agency to a proactive, global public health agency, said CDER spokesman Stephen King. That shift is helping the FDA more readily identify noncompliant players in the global generic drug industry, King said,  adding that the agency will be able to conduct biennial inspections at home and abroad within in five years.

Not only is India the second-largest provider of generic drugs to the U.S., but Indian manufacturers have been the focus of ongoing quality concerns. In May and November, the FDA issued import bans on Wockhardt’s Waluj and Chikalthana plants, requesting audits of management practices by a quality data probe. Earlier this month, the FDA barred active pharmaceutical ingredients produced at Ranbaxy’s Toansa plant from being shipped to the U.S.

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