Characterisation and risk evaluation of counterfeit antibiotics on the European market [counterfeit antibiotics]

Last updated on 27-2-2019 by Jill Alexandre
October 1, 2016
October 1, 2020

Financial Source

Service(s) working on this project

Sciensano's project investigator(s):

Sciensano's project investigator(s)

Eric Deconinck

Partners

Yaxin Tie
Erwin Adams

In short

Worldwide, antibiotics are the most counterfeited medicines. They account for more than 25% of all counterfeited drugs. The use of counterfeit antibiotics is emerging in Europe and could result in a higher level of bacterial resistance and even feed the emergence of superbugs. However, studies of counterfeit medicines in Europe mainly focus on lifestyle-drugs like slimming agents. As a result, there are currently no adequate analytical methods for counterfeit antibiotics on the European market. 

Project summary

This PhD project is a collaboration between Sciensano and KU Leuven and aims to develop analytical methods to detect and characterise counterfeit antibiotics from a chemical and pharmaco-technical point of view and to link this quality parameters to the risks for public health. 

Initially, a fast screening method for counterfeit antibiotics will be developed to check if the samples contain the indicated active pharmaceutical ingredient (API), followed by the development of a quantification method to check the dosages of the found APIs. Since counterfeit antibiotics are often produced in clandestine laboratories where adequate quality procedures cannot be expected, we will focus in the second part of the project on the detection of impurities. A market study of illegal samples, found on the European market, will be performed at the end of the project. Suspected samples will be screened and assays and tests will be set up to determine the presence of related substances and impurities.

Besides this, screening methods for on-site detection will be studied for the benefits of shorter analysis time and simple manipulations. 
This project considers applied research. Once the market study is completed, we will have a clear view on the active ingredients and their dosage in counterfeit antibiotics, the pharmaco-technical quality of the suspected antibiotics and the difference in quality between counterfeit and genuine antibiotics. The risk for public health, more precisely the risk for bacterial resistance and the emergence of superbugs, will be evaluated.
 

Associated Health Topics

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