Table 2 Subthemes on participants’ opinions regarding the status of R&D in Ethiopian pharmaceutical plants
Subtheme | Focus area | Quotes from participants |
|---|---|---|
Status in pharmaceutical plants | Overall opinion about status | “From the currently active local manufacturers, may be two or three have a separate department for [R&D] formulation optimization, stability studies and similar activities” [Participant 06, from pharmaceutical manufacturer] “I would say that it is 0%… because there is no such research and development going on in Ethiopia… may be there is some formulation development done… that is within…the factory… but formulation development… whatever it is going on within the company… mostly the troubleshooting activity is going on rather than…. formulation development….” [Participant 11 from pharmaceutical manufacturer] “If you see each factory, they face product defect complaints during post marketing surveillance. But, they are not engaged in activities to study the reason for such defects. For example, if they want to change packaging… they do not have the capacity to search and find suitable material from local market, update their dossier application, get approval and continue production using the new material.” [Participant 01 from government agency] |
Types of pharmaceutical plants with respect to R&D capacity | “For us, R&D is the wing that greatly help us in cost minimization. As I told you in the beginning, we introduce new products through R&D only” [Participant 06 from pharmaceutical manufacturer] “We develop formulation in-house, by purchasing raw materials, developing the formula, doing the study, preparing the dossier, processing the registration. What we buy from foreign companies is the formulation for injectables… we currently have full dossier contract. But, such formula requires customization… because their machines and ours are different… so the formula needs to be customized for our facility and setup…” [Participant 12 from pharmaceutical manufacturer] “For all our products, the formulation, developmental study, all the data is taken from our parent company. So, we currently do not have R&D department.” [Participant 02 from pharmaceutical manufacturer] | |
Concerns on external sourcing of formulation development | “Some companies are multinational… the main R&D activity is done by the mother company. Here… they only mix and the challenge is that there will be no technology transfer. Especially, there will be huge problem when a problem arises in the production process as the experts and technicians cannot solve the problem. In my experience, companies that have R&D units have low recall rate when compared to those that do not have in-house R&D” [Participant 05 from pharmaceutical manufacturer] “Most of the local medicine manufacturers do not take R&D seriously. Moreover, companies with joint ventures have their R&D units in the parent company. This has made their R&D activities dependent on the parent company. Generally, local medicine manufacturing companies have very weak R&D work” [Participant 03 from government agency] | |
University–industry linkage | University–industry linkage | “The goal of research institutions is publication. Until recently, what we used to count as an output is the number of publications that we have. I have supervised masters and PhD students but their research did not go any further after publication. We never had the habit of translating research findings to something useful…” [Participant 08 from research/educational institution] “I don't know how useful the research output of universities is for industries that largely engage in formulation activities. That is why I say the research is not practical. They [universities] also do research on novel drug delivery… targeted delivery… liposomes and the like… which is not applicable…” [Participant 06 from pharmaceutical manufacturer] “Industries do not understand the value of R&D… they consider doing their routine production activities as a major success. As a result… they think pursuing collaborations with universities would lead to financial or time loss… they think it does not have any value” [Participant 04 from government agency] |