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#Efficacy: European regulators suspend marketing of generics after ‘Data Manipulation’ by Indian tester

Pharmaceutical industry regulators in four European countries are to suspend the marketing approval of more than two dozen generic drugs due to concerns about the quality of clinical trial data compiled by an Indian tester of the drugs.

Regulators in France, Germany, Belgium and Luxembourg say the suspension is a precautionary measure given the poor quality of data emanating from clinical trials conducted by India’s GVK Biosciences.

French regulator ANSM said that no risk to human health has been established at this point and that patients can continue to use brand name equivalents of the drugs.

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.

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 drugmakers, 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on whether the marketing authorisations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU”.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 drugmakers. It did not name the drugs or companies affected.

BfArM said it was ordering drugmakers 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 drugmakers – 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 U.S. 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.



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