FRANKFURT (Reuters) – German drugmakers including Stada, Torrent’s Heumann and Dr. Reddy’s betapharm have appealed a regulator’s decision to suspend approval of some drugs over concerns about clinical trials conducted by an Indian company.
Regulators in France, Germany, Belgium and Luxembourg this month suspended marketing approval for 25 drugs over the quality of trial data from India’s GVK Biosciences.
Companies that have filed an appeal will be allowed to resume sales of affected products until their appeals are either approved or struck down, Germany’s Federal Institute for Drugs and Medical Devices (BfArM) said on Monday.
“We are reviewing the appeals thoroughly and quickly,” a spokesman for BfArM said.
The regulator last week had published a list of 80 affected products that their manufacturers would not be allowed to sell until they had provided new clinical data.
(Reporting by Frank Siebelt; writing by Maria Sheahan; editing by Jason Neely)