Characterization and hazard identification of substandard and falsified antimicrobial drugs

According to the World Health Organization (WHO), a counterfeit medicine is defined as follows: “A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredients or with fake packaging”. Counterfeit medicines are a growing problem in both developing and industrialised countries. In developing countries, it is estimated that about 30% of the drug market is covered by counterfeited medicines. Since it often concerns essentially lifesaving medicines like anti-malarial products, HIV inhibitors and antibiotics, it results not only in higher mortalities, but also in resistance of certain bacteria and viruses. It is evident that these counterfeit and substandard products are a serious risk for public health. The project aims to develop analytical methods to detect and characterise counterfeit antibiotics, both from a chemical and pharmaco-technical point of view. As the initial part of this project, a fast screening method of counterfeit antibiotics will be developed to check if the samples contain indeed the indicated active pharmaceutical ingredient (API). Based on the screening method, the method for the quantification of API will be studied. Since most antibiotics are still produced by bacterial strains, antibiotics contain more and higher amounts of impurities compared to synthetic drugs. As the third part of the project, methods for the determination of impurities will be developed for the most counterfeited antibiotics. In the end, a market study of illegal samples will be performed.