France, Germany suspend some drug approvals over Indian data
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 United States 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 manufactured by Mylan Inc 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 between 2008 and 2014.
ANSM said it had alerted European authorities after it inspected GVK's site in Hyderabad,India, and found "anomalies" in the way electrocardiograms were monitored during the bioequivalence studies. It said the inspection raised serious concerns over whether the company's studies complied with good clinical practices.
The London-based European Medicines Agency (EMA) separately released a statement saying it would "issue a recommendation on whether the marketing authorizations of the concerned medicines should be maintained, varied, suspended or withdrawn across the EU".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 and did not estimate how many approvals it would end up suspending.
BfArM said it was ordering drugmakers whose approvals were found to have been based on data from GVK trials to stop distributing the drugs concerned 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 was not immediately available for comment.
In a statement posted on its website, it said the EMA's Committee for Medicinal Products for Human Use (CHMP) had found that studies it conducted in Hyderabad were insufficient to support drug approvals.
"We at GVK BIO believe that the studies conducted are in accordance with the GCP (good clinical practice) guidelines while we honor the conclusion made by CHMP," it said in the statement, which was not dated.
It said it expected affected drugmakers would need to repeat the concerned studies in the next 12 to 15 months.