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outdated machinery, poor infrastructural support, lack of capital and lack of skilled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.
