EU regulators disapprove GVK Bio's clinical trials
06 December 2014
Health regulators in France, Germany, Belgium and Luxembourg have suspended marketing approval for 25 generic drugs of GVK Biosciences over what French watchdog ANSM says concern over the quality of data from clinical trials conducted by Indian drug firm.
Regulators in the European Union are investigating alleged irregularities committed by Hyderabad-based contract research and clinical trials firm GVK Bio in certifying results of human clinical trials conducted on behalf of several European generic drug manufacturers.
At stake are over 100 medicines, as regulators in several European countries are reportedly evaluating whether to suspend their use, because of the suspicion that GVK Bio provided allegedly fraudulent medical reports of human trials.
The suspected fraud that came to light following a probe by the French health regulator and the fraud is reported to have occurred over a five-year period between 2008 and 2013, at GVK Bio's clinical facility in India.
GVK Bio said the French health regulator ANSM has concluded that the bioequivalence studies conducted by it were not sufficient to support marketing authorisation for the approved medicines.
While the French authorities have questioned the authenticity of data on ECGs on the volunteers participating in the clinical trial, GVK Bio said it had provided all relevant evidence on activities pertaining to trials.
But the French regulator is not convinced as the employees who may have fudged the ECG data were also involved in other aspects of the clinical trial.
"We are disappointed that despite providing detailed clarifications, unfortunately CHMP (Committee for Medicinal Products for Human use) has concluded that though the 'check-out' ECGs may have no direct relevance to the quality of the testing of drugs, the fact that the same employees were involved in other critical activities, left an element of doubt on the bio-equivalence results," the company said in a statement.
Expecting that the marketing authorisation holders would need to repeat the studies in the next 12-15 months, GVK Bio said it believes that "the studies conducted are in accordance with the GCP guidelines….We honour the conclusion made by CHMP," the company said, adding that it was working with its "clinical development customers to provide new data that meets all regulatory requirements."