Studies Betapharm recalls drugs

Poor drug trials: Betapharm recalls drugs

17/12/2014

The drug manufacturer Betapharm currently calls all delivered batches of the preparations
Levetiracetam and losartan potassium back. Cause for the recalls is a supposed scandal about poor drug trials from India: „The BfArM review was triggered by an inspection at the Indian company GVKBiosciences, which found significant deficiencies in the conduct of the study and data validity“, the BfArM in a press release.

Thus, at least for these two preparations for pharmacists is clear about how to deal with it. Remaining stocks should be returned to the manufacturer, as Betapharm asks in a statement.

For more specific reasons, a statement by Betapharm stated: „As part of an ongoing EU risk assessment process on potentially inaccurate bioequivalence studies, the BfArM has suspended temporary authorizations pending the submission of new studies“, even though, after a contradiction between the manufacturer and the Federal Institute for Drugs and Medical Devices (BfArM), there was initially a temporary approval for the products. „Because of the severity and the systematics of these deficiencies, the bioequivalence studies in the view of the BfArM in the sense of preventive patient protection can no longer be accepted as admission basis. In parallel with this national procedure of the BfArM in Germany, further approvals for possible deficiencies are being investigated at the level of the European Medicines Agency (EMA). The BfArM is also actively involved in this process“, the BfArM continues.

In the past week, the BfArM had temporarily deprived 80 preparations of their marketability. In addition to the drugs already mentioned by Betapharm, these included the preparations pramipexole and valsartan as well as a product of the parent company Dr. med. Reddy's.

Although Betapharm had filed an appeal against the notices according to the supervisory authority. As a result, the BfArM had then lifted the decision against the product of the parent company, while the other preparations have not yet been decided. Despite the suspensive effect of the contradictions Betapharm has decided that one „to recall the products that are in the market (Losartan and Levetiracetam)“ will. Betapharm had previously waived approval of the other two products.

A total of 80 products from 16 manufacturers are affected by the decisions of the BfArM, including the Indian manufacturers Dr. Ing. REeddy's and Betapharm also Stada and Mylan Dura. However, the list of affected drugs has become shorter with each update. A total of 55 preparations are affected, including nine of the manufacturer Betapharm which have now been recalled. The manufacturer objected to 18 notices, so that currently 46 drugs can not be distributed. Meanwhile, the generic drug maker Dexcel had criticized the rapid release of the list. (JP)