Preliminary Study on Counterfeiting of Artemether and Artesunate Marketed in Lubumbashi

Abstract

Pharmaceutical counterfeiting is a health scourge responsible for several cases of morbidity and mortality. Counterfeit medicines cause therapeutic failure, emergence of resistance in the treatment of infections. This study was conducted in order to identify counterfeit and authentic medicines in circulation in Lubumbashi. The study included artemether and artesunate for oral administration. A careful visual inspection of medicine, investigation of authenticity of pharmaceutical products from manufacturers and pharmaceutical regulatory authorities and determination of content were used as study parameters. 52 samples: 37 artemether and 15 of artésunate were collected. 7 samples (13%) have proven to be counterfeit. Artemether was the most counterfeit (71%) and 29% for artesunate. 6 (12%) samples were substandard according to the international pharmacopoeia in terms of content of active ingredient. Sixty-seven percent of non-compliance concerned counterfeit medicines. The proportion of non-compliance is highest among counterfeit medicines (71.43% vs 2.22%; p = 0.000004). It is obvious that strengthening the capacity of the drug regulatory authority of the DRC reduces the influx of counterfeit drug and substandard.