The influence of pharmaceutical regulatory framework in promotion of pharmaceutical industrialization in Tanzania”

Abstract

Background: Tanzania, has low pharmaceutical manufacturing capacity which causes high imports of pharmaceutical products to meet the local demands. Pharmaceutical regulatory framework is in place to guide local manufacturers. However, it’s not well known how pharmaceutical regulatory framework influence the growth of local pharmaceutical industrial in Tanzania. Objective: To explore the influence of pharmaceutical regulatory framework in promoting of pharmaceutical industrialization in Tanzania. Methodology: Exploratory qualitative study design that involved interviews with key informant responsible for policy making, manufacturers, drug GMP, registration, product, taxation and product quality. The key informants were from the Ministry of Health Community Development, Gender, Elderly and children (MoHCDGEC), Ministry of industry and Trade Tanzania, Medical Store Department (MSD), Tanzania Revenue Authority (TRA), (Tanzania Medical device and drugs Authority (TMDA) and Pharmaceutical industries. Data was collected using semi-structured interview guide. Prior to thematic analysis verbatim transcription was conducted for the audio recorded data which were enriched by notes taken during interviews. The sub-themes and themes were produced deductively from the codes generated. Results: The total of ten key informants were interviewed. We found that, lack of awareness on policy, poor government support as well as pharmaceutical regulatory bureaucracy deterred promotion of pharmaceutical industrialization in Tanzania. In addition, low production capacity of existing pharmaceutical industries is contributed by the use of outdated machinery, poor infrastructural support, lack of capital and lack of skilled personnel. These factors also affected the compliance to GMP standards and medicine registration. Conclusions and Recommendations: The selected components of pharmaceutical regulatory framework are not well implemented, which adversely affect the promotion of pharmaceutical industrialization in Tanzania. The key players of pharmaceutical industries are TMDA, MSD, MoHCDGEC, TRA, DRA, TIC and local industries should jointly resolve the challenges that hinder pharmaceutical industrialization in Tanzania.