The role of the regulatory framework for the growth of domestic pharmaceutical manufacturing in Tanzania

Abstract The growth of pharmaceutical manufacturing in Tanzania has been stalled, despite the reforms made to the pharmaceutical regulatory framework over the years. This resulted in dependence on the importation of medical products from abroad. Nevertheless, there is limited literature regarding the influence of government regulatory structures on the development of pharmaceutical manufacturing. This study explored the influence of the pharmaceutical regulatory framework on the growth of domestic pharmaceutical industries in Tanzania. A qualitative study design using interview guides was employed to collect information. The purposefully selected key informants represented regulatory institutions and private domestic pharmaceutical industries. The selected five regulatory institutions were the Ministry of Health (MoH), the Tanzania Investment Centre (TIC), the Tanzania Revenue Authority (TRA), the Tanzania Medicines and Medical Device Authority (TMDA) and the Medical Store Department (MSD). The total number of key informants was determined by the saturation of information. Thematic analysis with NVivo 11 was used for data analysis. Eleven key informants were included in the study, with 8 (73%) from the government institutions. Three overarching themes and eight sub-themes emerged from this study. The themes were the existence of legal frameworks influencing the growth of pharmaceutical manufacturing, the provision of technical support and incentives to domestic manufacturers and the challenges facing the growth of domestic pharmaceutical manufacturing. The challenges were both government-related and partly manufacturer-related. The Tanzania pharmaceutical regulatory framework supports domestic pharmaceutical manufacturing through the enforcement of policies and regulations and the provision of incentives and technical support. However, there is a nuanced balance between the advantages provided by incentives and the challenges faced by manufacturers, limiting the expansion of domestic manufacturers. The ongoing efforts for attracting investment in domestic pharmaceutical manufacturing should also prioritize the attraction of investment in manufacturing active pharmaceutical ingredients (APIs).