Characterization and risk identification of falsified medicines and adulterated dietary supplements

Characterization and risk identification of falsified medicines and adulterated

dietary supplements

Both the increasing occurrence of illegal and substandard medicines and adulterated dietary supplements or traditional medicines represent a treat to global public health.

A recent research project, financed by a scholarship of the Chinese Research Council (2016-2020), focused on the identification of the risks associated with the use of Illegal antibiotics. In this project, more than fifty seized samples were evaluated for their chemical, galenic and microbial quality, showing failures for impurity content, dissolution and microbial purity (presence of neurotoxin producing fungi). This project showed clearly that chemical quality of illegal medicines is not enough to evaluate their risk and that a broader characterization of the products is necessary for a correct risk evaluation. In another part of the project an onsite infrared based approach was developed for a first quality check of illegal antibiotics at e.g. customs.

The chemical adulteration of dietary supplements is a well-known and well documented problem in literature, but an underestimated problem is the Herbal adulteration of Plant Food Supplements (PFS) and herbal or traditional medicines. Our service works on the innovative application of chromatographic fingerprints, combined with chemometrics to detect prohibited or regulated plants in herbal mixtures. In a new project the service is turning towards multi-dimensional fingerprints and mass spectrometry fingerprints in order to augment selectivity and specificity for the detection of targeted plants in mixtures.

It stands to reason that collaborations on these topics would be beneficial for both the European and the Chinese policy makers to tackle this common threat, but also to protect the reputation of the pharmaceutical industry and the Traditional medicines in both regions. These collaborations can go from collaborative PhD projects (financed by one of the respective national bodies) over joint applications for research grants (Belspo, European commission, …) to joint labs and infrastructures, between the respective competent authorities for the development of analytical strategies, risk evaluation, standardisation of analytical methodologies (e.g. common monographs between the respective Pharmacopoeia)., etc.