Portable drug anti-counterfeiting device to hit market

By Anna Lewcock

- Last updated on GMT

Related tags Pharmaceutical industry Food and drug administration Authentication

The pharmaceutical industry's first fully portable drug
anti-counterfeiting device will be presented in Baltimore later
this month at IFPAC, the International Forum on Process Analytical
Chemistry.

The briefcase-sized instrument is manufactured by US-based Analytical Spectral Devices (ASD), and uses the company's Near Infrared (NIR) spectroscopic technology.

ASD claim that their system is superior to other technologies such as RFID and bar coding as these merely read package labelling and do not directly analyse the product itself.

ASD's NIR device, the RxSpec 700Z, works on the premise that nearly every product has a unique "spectral fingerprint" determined by its molecular composition. The firm's technology can then use this information to rapidly and non-destructively analyse products to verify authenticity.

The new portable device is a modified version of the company's patented technology that was introduced into mail order pharmacies two years ago, and means that suspect drugs can be tested on the spot in real time rather than taken to a lab for testing.

Analytical Spectral Devices already markets its NIR systems within the pharmaceutical industry, and has seven US patents addressing pharmaceutical verification. The system is currently being used in drug verification, whereby chemical compositions and dosages are ascertained by the RxSpec technology and compared to an FDA database of approved drugs to confirm they are in quality compliance with the FDA.

The technology also has applications in pharmaceutical packaging (providing qualitative and quantitative analysis of packaging materials to ensure correct composition, as well as optimising product performance and economical processing), and raw material analysis across several industries.

In 2003 the US Food and Drug Administration (FDA) established the Counterfeit Drug Task Force to try and tackle the growing counterfeit drug market, estimated to be worth a hefty $75bn (€57.3bn) globally by 2010.

"Drug counterfeiting is a growing problem, as evidenced by the FDA's actions to combat it,"​ said ASD CEO Dave Rzasa.

"The RxSpec 700Z is a tool that fits the FDA's call for applying new technologies to distinguish legitimate drugs from counterfeits."

Back in June 2006, the FDA task force announced further steps to strengthen protection against the problem of counterfeit drugs reaching consumers. Among other measures, the FDA recommended the implementation of electronic pedigrees or "e-pedigrees" for tracking the movement of drugs through the supply chain.

"We must remain vigilant in our efforts to ensure our nation's drug supply is protected against an increasingly sophisticated criminal element engaging in a dangerous type of commerce,"​ said FDA commissioner, Andrew von Eschenbach.

While the task force emphasises the widespread introduction of electronic track and trace technology with particular emphasis on RFID, ASD's NIR technology would also seem to have a place in helping protect the drug supply chain.

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