White paper outlines how novel techniques can expose fake medicines

One of Europe's leading global experts in material analysis and quality testing has published a white paper highlighting how surface analysis can expose counterfeit medicines.

In its paper, CERAM Surface and Materials Analysis, a consultancy specialist offering product development and quality assessment to pharmaceutical businesses, describes how technologies such as X-ray photoelectron spectroscopy (XPS) and Time-of-Flight Secondary Ion Mass Spectroscopy (ToFSIMS) are being used in novel ways to analyse the composition of various pharmaceuticals, and determine differences in the manufacturing processes involved.

"Counterfeit medicines are incredibly dangerous and represent a significant challenge to public health, so it is vital that drug manufacturers and authorities implement stringent QA processes," said Dr Justine Bentley, the author of the white paper. "Surface analysis enables the identification of previously undetectable chemical copies and the technology is now so sophisticated that we can determine the manufacturing process of, for example, a particular tablet to find out if it has been produced by the correct licensed process. If it hasn't, then that tablet is as much a potential health hazard as one that contains the wrong ingredient."

According to the World Health Organization (WHO), counterfeit medicines are part of the broader substandard pharmaceuticals sector - medicines manufactured below established quality standards and, therefore, dangerous to patients" health and ineffective for the treatment of diseases. They are deliberately and fraudulently mislabelled with respect to identity or source. The US-based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will be worth an estimated US$75bn (Euro 56bn) globally in 2010, a staggering increase of more than 90% from 2005.

The CERAM white paper is available as a free download by clicking on the top right corner of this page.