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FDA Orders Companies to Redo Studies from Two Indian CROs

October 1, 2021

In a rare move, the FDA has informed multiple drug sponsors that used two Indian contract research organizations (CROs) with concerning data integrity practices that the bioequivalence or bioavailability studies those firms conducted will need to be repeated elsewhere.

Midway through September, the FDA issued a public warning to sponsors of new drugs and generics that it will not accept bioequivalence or bioavailability studies conducted by Synchron Research Services or Panexcell Clinical Lab, two Indian CROs that the agency identified as having troubling data integrity problems. The two companies have been operating since 1998.

“Data from Synchron or Panexcell are not acceptable to support a determination of safety or effectiveness for brand-name drugs, or to show affected generic products are bioequivalent to brand-name products,” the agency said.

This sort of action against CROs is something rarely seen from the FDA; the last occurrence was in April 2016 and involved another Indian CRO, Semler Research.

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