Generic meds under TGA scrutiny

Bioequivalence studies of more than 1000 generic medications were thrown into doubt after a French regulatory agency inspected the GVK BIO clinical trial site in Hyderabad,India, uncovering manipulation of ECG data going back at least five years.

Among these drugs, 300 had enough supporting data from other sources to warrant continued use, according to the European Medicines Agency (EMA), however it recommended suspending the other 700.

The falsifications occurred in each of nine trials investigated and were performed by at least 10 individuals, “highlight[ing] critical deficiencies in the quality system

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