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Translation Award to combat counterfeit drugs

27 July 2010

The Wellcome Trust has awarded £473 000 to a team of international researchers to create a system that can identify counterfeit and substandard drugs.

The team, from King's College London, will work in collaboration with scientists from Lund University, Sweden, with the aim of producing an inexpensive and robust instrument for low-income countries, where the problem of drug counterfeiting is particularly acute.

Dr Kaspar Althoefer from the Division of Engineering at King's, who will lead the programme, comments: "There is a growing awareness that counterfeit and substandard drugs constitute a fast-growing threat to public health the whole world over. To take just one example: the use of substandard drugs - drugs that contain an incorrect amount of active ingredient due to poor manufacturing controls or losses due to ageing - can lead to fatalities and also the emergence of drug-resistant forms of infectious agents, which has disastrous consequences for medical treatment programmes."

According to current estimates, around 1 per cent of drugs in high-income countries, and anywhere from 10 to 30 per cent of drugs in low-income countries, are counterfeit. And the proportion of substandard drugs is thought to be even higher still. There is a pressing need for reliable methods of authenticating pharmaceutical products before they reach the patient.

Dr Althoefer explains how the system will work: "Our approach is based on quadrupole resonance spectroscopy, QR, a technique that uses harmless radio waves to study the chemical structure of solid materials. QR can detect signals through multiple layers of, for example, cardboard, glass, plastic and/or wood, eliminating the need to remove drugs from their packaging prior to the analysis."

As the method is non-invasive and non-destructive, once the drug is given the all-clear, it can be returned to the shelf or passed safely to the patient. Any drug that fails the test can be retained for further testing or for use as evidence in future criminal proceedings.

QR can be used to analyse a broad range of solid materials and, in particular, it is ideally suited for the analysis of nitrogen, chlorine or bromine, sodium and potassium compounds, a group that includes over 80 per cent of all drugs.

The key to the project is that QR signals vary in known ways according to the type of chemical bond between atoms in the material being analysed, the presence of impurities and other factors specific to that material and how it was made. This means that counterfeit or substandard versions of the same drug can readily be distinguished and classified. This approach could not only be used to detect fake medicines, but also improve quality control for genuine drugs.

Ted Bianco, Director of Technology Transfer at the Wellcome Trust, comments: "There is nothing more invidious than putting lives at risk through the counterfeiting of medicines. The victims are often the poor and the most vulnerable in society. We need the tools to detect the fakes, trace the perpetrators and galvanise the industry to show zero tolerance to this evil practice."

The King's team is in the process of creating its first-generation product: a battery-powered, briefcase-sized device for use by regulatory authorities, pharmaceutical wholesalers and law enforcement agencies. They expect that this will be ready to take to market within two years.

Image: Bottle of pills. Credit: Wellcome Images

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