Determination of the Prevalence of Different Brands of Fixed Dose Artemether/Lumefantrine Tablets Sold in Pharmacies in Uganda

Buyinza Nicholas, Jonans Tusiimiire and Silvano Twinomujuni

Department of Pharmaceutics and Pharmaceutical Technology, Kampala International University, Uganda


Substandard, counterfeit and falsified antimalarial agents are a big challenge to effective malaria elimination interventions mainly in developing countries.  In low-and middle-income countries (LMICs), the quality of antimalarial agents inclusive of AL is affected by several factors including insufficient regulation porous borders and limited funds. This study therefore focused evaluation of quality of different brands of fixed dose artemether/ lumefantrine tablets sold in Ugandan Pharmacies. This was an experimental study conducted using AL tablets obtained from different pharmacies in the different cities of Uganda purchased using mystery shopper method. The samples were screened for quality using visual inspection, assessed different physical quality parameters like weight variation, friability, disintegration and dissolution and content assay tests were also done both for the brands from the pharmacies and their correspondent LTR. The assay test was done using HPLC technique USP method. The samples were considered substandard if the API content was outside 90-110% range of the label claim. Data was analysed using descriptive statistics and presented as means with standard deviations and frequencies. 400 AL samples were collected from the different Pharmacies in the different cities and the corresponding LTRs in the strengths of 20/120, 60/360 and 80/480 with commonest brands Lumartem, Lumaren and Artefan.  The presence of A/L brands that are unregistered and the total assay failure of the brands of 18% for the AL tablets purchased causes alarm.

Keywords: Artemether lumefantrine, quality, tablets, prevalence


Artemether Lumefantrine (AL) is the most commonly used Artemesinin Combination Therapy (ACT) in the management of uncomplicated P. falciparum malaria [1]. Both artemether and lumefantrine are blood schizontocides [2]. However, artemisinin also has some gametocytocidal activity resulting in a decrease in malarial parasite transmission [2]. Food enhances the absorption of both Artemether and Lumefantrine however, this effect is more pronounced for lumefantrine [3]. Therefore, there is a necessity for a standard African diet is adequate to ensure optimal efficacy for Artemether lumefantrine [3].

Artemether is a herbal remedy anciently used in Chinese for relapsing fever from Artemisia annua, alternatively called sweet wormwood [4]. Lumefantrine on the other hand is not from nature rather formed by chemical synthesis following research carried out in 1967 by the academy of Military Medical Sciences in Beijing China [5] The initial approval of AL as an ACT to the market dates back to 1999 and has been used ever since then in the management of un complicated malaria worldwide [5]. The presence of unregistered antimalarial agents on the market has been reported in different parts of the world and the quality of these agents remains in question causing a great risk to the general population taking these agents [5]. 

Substandard and falsified antimalarials are very prevalent in countries considered as low and middle income (LMICS) at a rate of 19.1% [6] and have significant negative health and economic effect, with a high deaths burden, disability and wastage of money on cost-ineffective antimalarials leading to health inequities in Uganda [7]. Developing countries including Uganda have over 25% of their medicines reported as counterfeit and substandard, these medicines lead to around 0.25 million deaths per year. However, treatment with good quality medicines can help reduce all these deaths [8].

Treating malaria with good quality antimalarials (artemether-lumefantrine) instead of counterfeits and substandard drugs can help to prevent the high death rates, morbidity due to consumption of poor-quality drugs [9]. The recommended first-line treatment for management of uncomplicated falciparum malaria a species that causes the most severe forms of malaria and subsequent deaths is fixed dose artemether lumefantrine [10]. AL is used in management of uncomplicated plasmodium falciparum malaria in Uganda however due to the presence of porous borders and unregulated private sector drug procurement, there may be poor quality artemether-lumefantrine on the market. Therefore, this study will focus on evaluating the quality of different brands of fixed-dose artemether-lumefantrine tablets on the Ugandan market.


The different brands of AL obtained and used in this study were sourced from India, Uganda and Switzerland (Table 3) to reach the Ugandan Market. Though, findings from the study express that most of the imported brands were not having Ugandan registration numbers imprinted on the pack but were having registration numbers from other countries (Table 4). This brings out numerous concerns to National Drug Authority since the safety, effectiveness and quality of these medicines is not assured. The Ugandan registration status was written on the insert for some of the samples in this study but not on the packaging material where it was expected to be imprinted. This may be indicative of product falsification and also a manufacturer’s gap to renew their registration status. The presence of unregistered AL brands on the market could be attributed to the porous borders presence that may have facilitated not just free entry but also un-monitored distribution of these products [12-15]. The registration process in the country can alternatively be weakened by inefficiency and ineffectiveness in the implementation of some policies set by National Drug Authority (NDA) especially due to insufficient funding [16-18]. Therefore, there is need for regulatory authorities to strengthen pre and post market surveillance for surety that all AL Brands in the market are licensed and registered.


The presence of A/L brands that are unregistered (without Ugandan registration number on insert and pack) causes alarm and this calls for NDA to intensify on its operations of Pharmacy supervisions to find out the conformity of the pharmacies to selling only registered medicines.


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CITE AS: Buyinza Nicholas, Jonans Tusiimiire and Silvano Twinomujuni (2024). Determination of the Prevalence of Different Brands of Fixed Dose Artemether/Lumefantrine Tablets Sold in Pharmacies in Uganda. IAA Journal of Applied Sciences 11(1):87-93.