Which are the fake companies in Hyderabad
A number of German pharmaceutical companies are threatened with the withdrawal of drug approvals due to allegedly falsified medical studies. The Federal Institute for Drugs and Medical Devices (BfArM) confirmed relevant research by NDR, WDR and Süddeutscher Zeitung.
The number of drugs affected cannot yet be precisely quantified, according to the BfArM. Apparently more than a hundred drug approvals are being tested. Among the affected manufacturers are the companies Betapharm from Augsburg and Hexal from Holzkirchen. Betapharm is about two drugs. The company states that it was unaware of any flawed studies. At Hexal, the antiallergic fexofenadine is affected. However, Hexal only acquired the rights to the drug after approval, said a spokesman.
All of the studies in question do not come from the pharmaceutical companies themselves, but from the Indian company GVK Bio in Hyderabad. In the spring of 2014, the French medicines monitoring authority ANSM found in a random sample that GVK Bio had apparently falsified some of the results in all nine studies examined. The results of heart examinations are said to have been manipulated.
GVK Bio tests drugs on people
GVK Bio is one of the largest research companies in Asia that carries out tests on humans on behalf of global pharmaceutical companies. Documents from the European Medicines Agency (EMA) and the EU Commission show that the EMA is assuming systematic manipulation in Hyderabad. According to this, at least ten GVK-Bio employees were involved in the manipulations. These also took place over a long period of time - at least between 2008 and 2013. GVK Bio did not comment on request.
The tests in question have so far only been bioequivalence studies. These are necessary for the approval of generics - copycat products that come onto the market after the patent protection of an original product has expired. The manufacturers have to prove that their generic is comparable to the original. But GVK Bio also offers studies for completely new drugs. So the suspicion could spread.
There is currently no evidence of any dangers to consumers
In July, the EMA wrote to all generics manufacturers who most recently worked with GVK Bio. She will shortly decide whether additional studies are necessary for some drugs or whether funds should be withdrawn from the market. The EU Commission then makes a legally binding decision.
The BfArM is responsible for approvals that only concern the German market. There the manufacturers were asked to comment in a hearing in November and now want to decide at short notice "whether the suspension of the approvals concerned will be ordered," as a spokeswoman explains. Not all comments have been received yet. One strives for a joint procedure with the other EU countries that is also coordinated in terms of time. Indications of health hazards for consumers are "currently not known".
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