Abstract

Researchers procured a range of antimalarial, antibiotic and antimycobacterial drugs from cities in six countries: Ghana, India, Kenya, Nigeria, Tanzania, and Uganda. Semi-quantitative thin-layer chromatography (TLC) and disintegration tests, Raman spectrometry, and near-infrared (NIR) spectrometry were used to measure the concentration of active ingredients and excipients (spectrometry only) to determine whether the tested samples were of good quality.  Overall, 15% of tested samples failed TLC, 13% of tested samples failed disintegration tests, 41% of tested samples failed NIR spectrometry, and 47% of tested samples failed Raman spectrometry.  The drug testing technologies were qualitatively compared in terms of time, cost, and reliability for identifying substandard drugs in the field.  NIR and Raman spectrometry compared favorably to TLC in most respects except cost.  If the indirect costs of TLC—including requirements for a climate controlled location and trained laboratory staff—are considered, the cost advantage of TLC may disappear in developing countries. 

 Key words: Raman and near-infrared spectrometry, thin-layer chromatography, counterfeit and substandard drug production, regulation of drug quality.