FRANKFURT (Reuters) – Germany has named 16 generic drugmakers, including Stada and Dr. Reddy’s, that produce drugs affected by its suspension of marketing approval over concerns about clinical trials conducted by an Indian company.
Regulators in France, Germany, Belgium and Luxembourg last week suspended marketing approval for 25 drugs over the quality of trial data from India’s GVK Biosciences.
Germany’s Federal Institute for Drugs and Medical Devices (BfArM) on Tuesday published a list of 80 affected products, including multiple entries for different dosages of the same active ingredients, and the drugmakers that marketed them.
The companies affected also include U.S. drugmaker Mylan as well as German subsidiaries of India’s Torrent Pharmaceuticals and Lupin.
The drugs include generic versions of blood thinner Plavix, also called clopidogrel, or generic version of heartburn treatment Nexium, or esomeprazol.
BfArM said there is no shortage of freely available treatments that have the same active ingredients as the suspended drugs.
French and German regulators have said they were investigating the drug approvals based on clinical trials, which were meant to show that these generic drugs were equivalent to the original branded versions, conducted by GVK Bio between 2008 and 2014.
The regulators said that anomalies were found in the way electrocardiograms (ECG) were monitored by GVK Biosciences during the bioequivalence studies. GVK has disputed the findings.
Germany’s BfArM reiterated on Tuesday that there have been no signs that the health of patients was put at risk.
(Reporting by Ludwig Burger; Editing by David Goodman)