Warning about deficient drug substances
Medicines supervision: Warning of deficient drugs
05/04/2014
The Federal Institute for Drugs and Medical Devices (BfArM) is concerned that pharmaceutical companies are increasingly sourcing their active ingredients from emerging markets. This could „Sooner or later, even greater damage will occur“, as the president of the institute thinks.
Defects and deliberate distortions can not be ruled out
The Federal Institute for Drugs and Medical Devices (BfArM), an independent higher federal authority, is causing concern as pharmaceutical companies increasingly source their active ingredients from emerging markets. Institute President Walter Schwerdtfeger told the newspaper „The world“: „In most of these countries, the testing density of manufacturing plants is lower than in Europe or the USA.“ It has been several times before deficiencies before further processing or deliberate falsifications have not been recognized. This can not be completely ruled out in the future. „According to the laws of statistics, it can therefore be expected that sooner or later such damage can lead to greater damage“, so Schwerdtfeger.
Politics should create incentives
He further explained: „In Germany and almost all European countries, the competent authorities have long since reached the limits of efficiency after the euro crisis and the austerity cycles of recent years.“ The drug monitoring would need for a sufficiently tight control probably twice as much staff as currently available. The BfArM president said: „In my view, it would be desirable for producers to relocate at least part of their production back to Europe, especially of particularly important raw materials. So far, almost all companies reject for cost reasons.“ He called on politicians to create incentives to better reward the safety of drug production.
Millions of plagiarisms seized worldwide
In addition to difficult-to-control drug production, the trade in counterfeit drugs is a big problem. And not only in Germany, but worldwide. In June of last year, in a worldwide raid led by Interpol, 9.8 million plagiarisms were confiscated in about 100 countries, as Wolfgang Schmitz from the Customs Criminal Police Office had reported at that time. An expert of the authority meant that thereby only „scratched on the iceberg“ had been. It remains unknown how many plagiarisms are actually produced. (Ad)
Picture credits: Andrea Damm