Germany Bans 80 Drugs For Insufficient Trials By gvk bioSciences Private Limited
Published: Dec 11, 2014
December 10, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Germany’s drug regulatory agency, the Federal Institute for Drugs and Medical Devices (BfArM), published on Tuesday a list of 80 products banned on the grounds that India’s pharmaceutical research company GVK Biosciences conducted insufficient clinical trials on the generic medications.
GVK Biosciences, a Hyderabad-based contract research company, conducted the trials concerned between 2008 and 2014 in order to demonstrate the generic drugs were bioequivalent to the original branded medications. Drug approvals and marketing authorizations were based on these trials.
The German regulatory agency informed manufacturers of the drugs on the list on Monday and the ban went into effect on Tuesday, according to The Financial Express.
BfArM indicated the ban would not cause a shortage because other treatments exist with the same active ingredients as the banned drugs. In addition, the agency stated that there were no reports that the health of patients was at risk, according to Reuters.
The drugs affected by the ban include the generic version of the blood thinner Plavix, also called clopidogrel, the generic version of the heartburn treatment Nexium, or esomeprazol, among others, according to Reuters. Additional medications on the list include those used for treating high blood pressure, depression, migraine, epilepsy and Parkinson’s disease, reported The Financial Express. Products of 16 pharmaceutical companies are involved, including those of U.S. drugmaker Mylan, German drugmaker Stada, Indian drugmaker Dr. Reddy’s and the German subsidiaries of both India’s Torrent Pharmaceuticals and India’s Lupin Pharmaceuticals.
GVK Biosciences Chief Executive Officer Manni Kantipudi held a press release this week in India during which he addressed the issue of the ban. He informed the press that drug studies had stopped at the Hyderabad facility, reported India’s Economic Times.
“Customers are asking one of the three things. They say please redo the studies in Ahmadabad,” Kantipudi was quoted as saying by The Economic Times. “Some of them have said please redo the studies somewhere else but you bear the cost and some are saying please refund my money...We are willing to do any of the three options,” he continued.
He also stated that the company has received no orders since August. “Even existing orders were put on hold,” he was quoted as saying. “The customers say no more orders till this issue is resolved,” he further stated. He didn’t give a definite date for when the issue would be resolved.