Fake Generic Studies? Numerous copycat drugs in Germany taken off the market

Many copycat drugs may no longer be sold immediately
From now on, various cheaper counterfeit medicines may no longer be sold in Germany. A list of affected drugs has been published on the internet. Patients are advised not to stop medications but to consult a doctor or pharmacist.

No evidence of health hazards
From now on, various cheaper counterfeit medicines may no longer be sold in Germany. The Federal Institute for Drugs and Medical Devices (BfArM) published the list of affected drugs on Friday. By the end of July, the EU had already shelved around 700 approvals for poor drug trials by an Indian company. Among other things, including drugs for hypertension. However, the BfArM stated that "there are no indications of health risks". The list of affected drugs is updated daily. It can be viewed online at "www.bfarm.de".

Several generics were withdrawn because of insufficient study basis from the market. (Image: Kzenon / fotolia.com)

Studies may be manipulated
Patients are advised by the authorities not to dispose of the drugs concerned on their own initiative, but to consult the attending physician or pharmacist. Since sufficient comparable funds were available, the institute did not expect supply bottlenecks when switching to other preparations. The BfArM had already stopped the approval of 80 medicines in December last year. The preparations came from 16 pharmaceutical companies such as "Entacapone STADA" or "Levetiracetam beta". The office had claims to draw conclusions on abnormalities in studies of the Indian company "GVK Biosciences", which is a service provider for generic manufacturers. Thus, identical ECGs of patients would have suggested that these studies might be falsified.

The BfArM has also classified three medicines with the active substance tacrolimus as medicines, which are crucial for the care of patients.
Medicines containing the active substance tacrolimus are listed on the substitution exclusion list of the Joint Federal Committee. This means "that they must not be exchanged for an active substance-like preparation". The manufacturers now have twelve months to prove the bioequivalence of their products.

Drug manufacturers must submit reliable studies
According to BfArM information, it depends on the manufacturers of generic drugs, when the affected products will be available again. The producers would have to submit new reliable studies, which show how fast and strong the active ingredients in the body acted. The decision taken by the European Commission in July concerns a total of about 700 approvals but far fewer medicines. An authorization applies in each case to an active substance in a specific dosage and dosage form, for example as a drop or tablet. However, a drug can give it in different forms. In addition, it is currently only about national approvals in Germany. (Ad)