Background: Presence of substandard and falsified anti-malarial medicines is a major concern in countries with high prevalence of malaria. Systematic assessment and monitoring of anti-malarial medicines circulating on the market is critical to National Medicines Regulatory Authorities (NMRAs) in ensuring quality of these products in the fight against the burden of malaria disease.

Background Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure and development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. To ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market. Methods This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All sampled ARVs were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and 10 % (10 %) of all that complied with the screening test requirements were selected for full quality control testing. Quality control testing was conducted at the Tanzania Medicines and Medical Devices Authority (TMDA) laboratory a World Health Organisation prequalified. Samples collected from the medicine distribution outlets were also, subjected to product information review. Results A total of 2,630 samples were collected, of which 83.7 % (2200/2630) were from port of entry (POEs). All sampled ARVs were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27 % (7/2630) and lamivudine/zidovudine/nevirapine 0.27 % (7/2630) that failed the disintegration test. Out of the 100 samples selected for full quality control testing, 3 % of them failed to comply with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2 % (2/100) and 1 % (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6 %) versus specification limits (90 -110 %). Out of the 430 samples which were subjected to product information review, 25.6 % (110/430) failed to comply with the TMDA packaging and labelling requirements. Conclusions The quality of majority of ARVs circulating on the Tanzania Mainland market was good, even so, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania Mainland market.

Background: Antiretroviral drugs (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Poor quality ARVs may result in harmful consequences such as adverse drug reactions, treatment failure, and prolonged illness, development of drug resistant strains and sometimes death, which in turn may undermine the healthcare delivery system. Thus, to ensure optimal treatment outcomes, medicines quality control must be undertaken regularly. This study was aimed at evaluating the quality of ARVs circulating on the Tanzania Mainland market.Methods: This was a survey study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All collected samples were subjected to screening testing using the Global Pharma Health Fund® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were selected for full quality control testing in the World Health Organisation prequalified laboratory at Tanzania Medicines and Medical Devices Authority (TMDA). Samples collected from the medicine distribution outlets were also subjected to product information review. Results: A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Of the 2200 samples screened, all conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. Also, of the 100 samples selected for full quality control testing, 3% of them failed to compile with the specifications, of which FDC stavudine/lamivudine/nevirapine failed disintegration and assay tests 2% (2/100) and 1% (1/100), respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. Conclusion: The quality of majority of ARVs circulating on the Tanzania Mainland market was good but, significant deficiencies on labelling and packaging were observed. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.

Background Human Immunodeficiency Virus and Acquired Immune Deficiency Syndrome (HIV/AIDS) is still health problem worldwide, particularly in sub-Saharan African countries, such as Tanzania. Anti-retroviral medicines (ARVs) have significantly reduced morbidity, mortality and improved the quality of life of people living with HIV infection. Thus, good quality ARVs is amongst the key factors which guarantee successful therapeutic outcomes and prevention of development of drug resistant strains. This study was aimed at monitoring the quality of ARVs circulating on the Tanzania Mainland market.Methodology This was a prospective cross sectional study. ARVs samples were collected in 20 regions of Tanzania Mainland, between 2012 and 2018. All samples were subjected to screening testing using the Global Pharma Health Fund ® Mini-Lab kits. Sampled ARV’s that failed screening test or yielded doubtful results and ten percent (10%) of all that complied with the screening test requirements were subjected to confirmatory testing using full pharmacopoeia monographs at the Tanzania Medicines and Medical Devices Authority (TMDA), quality control laboratory prequalified by the World Health Organisation. Samples collected from the medicine distribution outlets were also subjected to product information review.Results A total of 2,630 samples were collected, of which 83.7% (2200/2630) were from port of entry (POEs). Out of the 430 samples which were subjected to product information review, 25.6% (110/430) failed to comply with the packaging and labelling requirements. All sampled ARV’s that were screened and conformed to the specifications, except of the fixed dose combination (FDC) lopinavir/ritonavir 0.27% (7/2630) and lamivudine/zidovudine/nevirapine 0.27% (7/2630) that failed the disintegration test. In confirmatory testing using full pharmacopoeia monographs, all samples conformed to the requirements, except of FDC stavudine/lamivudine/nevirapine which failed disintegration 2% (2/100) and assay tests 1% (1/100) respectively. Samples failing the assay test had low content of stavudine (86.6%) versus specification limits (90% -110%).Conclusion The quality of majority of ARVs circulating on the Tanzania Mainland market was good. The existence of number of ARVs circulating on Tanzania Mainland market which do not comply with product information requirements was significant. These results call for continuous monitoring of quality of medicines circulating on the Tanzania market.