DR Congo study shows 'strong' signal for fake malaria drugs

A sampling study in Democratic Republic of Congo (DRC) has revealed that a high proportion of antimalarial drugs fail quality testing that could indicate they are falsified.

The study was carried out in Bukavu, one of the larger cities in DRC over a five months period in 2019, and involved samples of quinine sulfate (QS) and artemether/lumefantrine(AL) products obtained from community pharmacies and street vendors.

The samples were subjected to a battery of simple lab tests, including visual inspection, UV spectrometry, thin layer chromatography, and conventional quality control procedures.

While most (93 per cent) of AL samples met quality standards, a third of the QS tablets contained no active ingredient at all suggesting they were falsified rather than simply substandard. Another 8 per cent had a different active ingredient, which also points to falsification.

All told, 17 per cent of the QS samples did not meet standards for tablet robustness and uniformity, and only a third performed as expected during disintegration testing.

The results "strongly alert" to the presence of fake antimalarial medicines, particularly QS, in the DRC marketplace, according to the researchers from the University of Bukavu. They have published their findings in the Future Journal of Pharmaceutical Sciences.

A recent report from the EUIPO/OECD estimated that the global market for falsified medicine is upwards of $4.4bn, with African economies most targeted by producers.

The report estimates that between 72,000 and 169,000 children die from pneumonia every year after receiving counterfeit drugs, while fake antimalarials kill another 116,000.

Substandard and falsified medicines undermine Africa's ability to achieve the Sustainable Development Goals (SDGs) and are also thought to contribute to the global threat of drug-resistant illnesses, according to the EU-funded ENACT Africa project.

"African countries face multiple kinds of counterfeiting favoured by poverty, lack of proxy control tools, and inefficacy of regulatory authority," write the authors of the DRC study.

"That raises the importance of surveying the quality of all pharmaceutical products imported," they add, noting that pharmacists should at the heart of efforts to crack down on the illicit trade and that "simple tests may be of significant help."