Since 2007 the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has implemented its Falsified Medical Products Strategy in order to combat the threat of counterfeit drugs.
Talking with in-Pharmatechnologist.com, the Agency said any report it received concerning a falsified medicine – any medicinal product with a false representation of its identity, source or history, according to the European Parliament, though not strictly defined internationally – was taken very seriously and sent to the MHRA Laboratory for analysis.
“Spectroscopic techniques such as Near Infra-red and Raman spectroscopy are used to determine the authenticity of the products,” we were told.
Furthermore, “separation techniques such as Liquid Chromatography-Mass Spectroscopy and Gas Chromatography-Mass Spectroscopy are also deployed for this purpose.”
However, in the last few years the Agency’s response from suspect medicines at borders, warehouses and pharmacies has been expedited by the portability of instruments.
“It is now no longer necessary to take samples of medicinal products to the laboratory. Portable spectrometers can now be carried to wholesalers, pharmacies, and ports of entry to test suspect medicinal products in situ.”
Such technology has been used successfully in Nigeria. During a 2011 analysis of 251 drug samples selected randomly from pharmacies across Lagos, portable Raman spectrometers identified substantially more substandard products than other methods, including thin-layer chromatography and visual inspection.
Furthermore, the US Food and Drug Administration (FDA) commissioned a report last year to investigate the effectiveness of Thermo Scientific’s TruScan Raman spectroscopic device in detecting substandard and counterfeit drugs.
However, while Mustapha Hajjou, the lead author on the report and Manager for Promoting the Quality of Medicines Programme (PQM), told this publication at the time such technology – which works due to registering the shift of energy when laser lights interact with molecular vibrations, relaying the make-up of a substance to the user – was simple and effective, it is just one tool in stopping counterfeiters.
“While any one test may suffice to label a drug substandard or falsified, no single analytical technique provides enough information to confirm that a drug is genuine,” he said.
While substandard shipments and the technology used are of course an issue, the MHRA said the largest threat (to the UK at least) from fake drugs came from medicines purchased through Internet websites, particularly those based overseas.
“For this reason, we have developed specific operational arrangements for dealing with illegal activity taking place on the Internet,” we were told. Whilst many suppliers of such substances set up their operations from countries where there is little, or no, regulatory control, the MHRA works with the EU and other international regulatory authorities to clamp down on fake drugs.
This includes the collaboration of the MHRA and other regulators with Interpol as part of Operation Pangea, which has been an annual initiative since 2006. Last year, action was taken against 9,600 websites with over $41m (€31m) of counterfeit drugs seized.