Although the FDA hasn’t found any systemic issues that affect the effectiveness or safety of generic medicines clinically tested at Hyderabad, India-based CRO GVK BioSciences, it is supporting the European ban of hundreds of products.
Two weeks ago, the ban was placed on about 700 generics that received approval based, in part, on what regulators described as flawed clinical studies conducted at GVK. The FDA, however, will not take any action on products sold in Europe that included data from GVK studies in their applications, a decision apparently based on the fact that the U.S. agency’s own plant inspection did not raise similar concerns.
The agency has identified around 40 pharmaceutical product applications containing clinical study data compiled by GVK from 2007 to 2012. It has expressed confidence that there is no danger to patients from those products, citing its own inspection of the GVK facilities.