India Not Getting Advance Notice of Inspections, Officials Charge

Indian officials are accusing FDA investigators of inspecting drug manufacturers in the country without Indian inspectors present, violating an agreement between the two countries that calls for local regulators to tag along on FDA drug manufacturing inspections as observers.

The FDA denies the allegations, saying it is still working out how it plans to incorporate Indian investigators into the inspections.

FDA Commissioner Margaret Hamburg and India’s health minister signed a statement of intent in February 2014 that specifically calls for Indian officials to accompany U.S. investigators. The Indian and U.S. regulators must still resolve the details of how the FDA will notify Indian regulators of a planned inspection and the terms the two inspectors will operate under, agency spokesman Christopher Kelly said.

P.V. Appaji, director general of the Pharmaceutical Export Promotion Council in the Department of Commerce, said the FDA has ramped up its inspections of facilities that supply generics to the U.S., resulting in Form 483 observations and slowing down exports from the subcontinent.

While Appaji said he supports the increase in inspections, due to the growing number of manufacturing plants in India, he does not believe it should be taking this long for Indian inspectors to be participating in inspections.

Keep pace with the latest worldwide inspections news by subscribing to FDAnews Inspection Insider. Nowhere else will you find a more comprehensive collection of inspections intelligence. With Inspection Insider, you’ll have an unmatched source of critical information to ensure you’re prepared when investigators come knocking.