Routine quality control of medicines in developing countries: Analytical challenges, regulatory infrastructures and the prevalence of counterfeit medicines in Tanzania

Counterfeit and substandard medicines still constitute a worldwide problem and do not only affect healthcare systems in low and middle income countries but also in the industrialized world. Whereas in the developed world the quality of pharmaceutical preparations is assured by a dense network of quality control laboratories utilizing modern analytical techniques the situation is completely diverse in resource constraint countries. Implementing full monograph testing according to the American or the European Pharmacopoeia represents an extreme challenge. The respective quality control organs easily become overburdened and face central problems when supplying immaculate medicines. This review collected information on the prevalence of counterfeit and substandard pharmaceuticals in Tanzania and discusses suitable analytical approaches for their analysis, e.g. non-sophisticated HPLC, low-field NMR, capillary electrophoresis, or vibrational spectroscopy. Due to the limited validity and reproducibility of field assay kits like the Minilab® the impact of precise, simple, and robust analytical methods is highlighted.