A host of drugmakers will not have to pull from the market, at least for now, generic drugs that German regulators say are suspect. The companies have bought some time with appeals of a decision by regulators to nix sales of dozens of medications because of flaws in clinical trials handled by an Indian contractor.
Among those that have appealed the decision by the Federal Institute for Drugs and Medical Devices (BfArM) are German drugmaker Stada, as well as betapharm Arzneimittel and Heumann, the German divisions of India's Dr. Reddy's Laboratories and Torrent Pharmaceuticals, according to Reuters. The German regulator initially said that none of the drugs will be allowed back on the market until the companies can show through other studies that they meet standards. Now it says those that appealed can continue to sell the meds until their positions are assessed, Reuters reports.
"We are reviewing the appeals thoroughly and quickly," a spokesman for BfArM told the news service.
The German regulator this month suspended 80 drugs, many of them different doses of the same generic, sold by 16 drug companies. Another 96 drugs were cleared. It tied its decision to questions it said were raised by French authorities during an inspection of GVK Biosciences, the Indian company that had handled clinical trials for the medications. Authorities in France, Belgium and Luxembourg also ordered some drugs off their markets, saying their bioequivalence was suspect.
The European Medicines Agency in a statement said inspectors found that a number of electrocardiograms were falsified by employees at GVK Bio as part of 9 approval studies between 2008 and 2014. GVK has disputed the claims but also said it has set aside up to $6.5 million for new studies.
There have been no reports of adverse effects from any of the suspect products and no shortages are anticipated as a result of its actions, according to BfArM.
- read the Reuters story
Special Report: Top 20 generic molecules worldwide