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Counterfeits

Counterfeit drugs are a substantial and growing problem, both in the developed and in the developing world.

The legal definition of counterfeit drug varies by country, but one useful definition of that is that of the World Health Organization, which “defines a counterfeit pharmaceutical product as a product that is deliberately and fraudulently mislabeled with respect to identity and/or source.”

Counterfeit drugs represent a two-fold danger to the public. On one hand, counterfeits that do not contain the proper active ingredient in the proper quantity result in the patient’s condition going untreated. On the other hand, counterfeits may contain toxic materials. In both cases, the confidence in the public health-care system is undermined.

Determining whether a suspect product is genuine or counterfeit is often done with wet-chemical procedures. Accurate and reliable performance of these techniques requires skilled personnel and the appropriate laboratory facilities. Furthermore, these methods often cannot be performed as rapidly as desired.

Verification of the identity of a pharmaceutical products can be achieved using a Bruker's FT-NIR technology. The speed and precision of this analytical method can aid health authorities in their fight to protect the public from the increasing trade in counterfeit pharmaceuticals.

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MATRIX-F spectrometer in a mobile lab analysing couinterfeits in China.

Bruker help Chinese SFDA on counterfeit drug screening

In Asia, more than 50 per cent of counterfeit malaria medicines contain no active ingredient and even trusted and verified pharmacies unknowingly sell these counterfeit drugs. Many customers and authorities are examining whether a global testing of drugs is possible. FT-NIR spectroscopy is the most promising technology and already well-established for pharmaceutical quality testing. The big benefit is that FT-NIR spectrometers like Bruker's MATRIX-F system can be taken into the field. By using mobile units, networks can be built up for a nationwide fight against counterfeit drugs.

In 2001, the Chinese "State Food and Drug Administration" (SFDA) initiated a research project to evaluate the NIR technology for this task. In the meantime, more than 450 FT-NIR systems were built in small vans scrutinizing drugs all over China. This way it can be ensured that local hospitals and pharmacies have no counterfeits in their portfolio. With the help of modern analytical technologies, at least the legal distribution channels can be made substantially safer – for the well-being and the security of the people.