BackFrance, Germany suspend some drug approvals over Indian data
ANSM said it found 'anomalies' in the way ECGs were monitored during the bioequivalence studies at GVK Bio's site in Hyderabad
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Frankfurt/London/Paris/Mumbai: Regulators in France, Germany, Belgium and Luxembourg are suspending the marketing approval of 25 generic drugs due to concerns over the quality of data from clinical trials conducted by India’s GVK Biosciences, French watchdog ANSM said on Friday.
The quality of Indian pharmaceuticals has come under fire this year, with regulators in Europe and the US citing problems ranging from data manipulation to sanitation and banning the import of certain products from several firms.
“This decision is taken out of precaution. No element at this stage has led to establish a true risk for human health or a lack of efficacy of these drugs," ANSM said on its website.
All of the drugs being suspended, several of which are made by Mylan and Abbott, have brand name equivalents that can be used instead, so patients will not have to interrupt their treatment, it added.
ANSM and Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said they were investigating the drug approvals based on clinical trials meant to show that these generic drugs were equivalent to the original branded versions conducted by GVK Bio between 2008 and 2014.
ANSM said it had alerted European authorities after it inspected GVK Bio’s site in Hyderabad, India, and found “anomalies" in the way electrocardiograms (ECG) were monitored during the bioequivalence studies.
It said the inspection raised serious concerns over whether the company’s studies complied with good clinical practices.
GVK Bio’s CEO Manni Kantipudi disputed the French watchdog’s findings and said ECGs were not an important component of the drug efficacy.
ANSM concluded GVK Bio, which conducts clinical research for domestic and foreign drug makers, manipulated the ECGs without taking into account the company’s views, he said.
“We have agreed to redo the studies, I’m fine with that, but don’t say that there was gross manipulation of the ECGs," Kantipudi told Reuters. He said the company had received board approval to spend $5.7-$6.5 million for new studies.
The European Medicines Agency (EMA) separately released a statement saying it would “issue a recommendation on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU". That recommendation is expected in January 2015.
The German watchdog said it was investigating 176 approvals given to 28 drug makers. It did not name the drugs or companies affected.
BfArM said it was ordering drug makers whose approvals were found to have been based on data from GVK trials to stop distributing the concerned drugs until they could provide data from new studies.
ANSM said several drug makers—it did not identify them—had already offered to carry out new studies which, if positive, could allow the drugs on the market again.
GVK Bio’s Kantipudi said the company has started conducting new studies for five to six of its clients. About 35 of the company’s 400 clients have been affected by the Europoean regulator’s move, he said.
He said the US Food and Drug Administration inspected its Hyderabad plant in June, after the French regulator’s audit, and was satisfied with the ECG-related data. No other regulator had contacted the company since then, he added.Reuters
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