FRANKFURT/LONDON/PARIS, (Reuters) – 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 yesterday.
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.
