The ability to manufacture pharmaceutical products locally, specifically generic drugs, could catalyze affordable healthcare in Africa. In Kenya, local manufacturers have made great strides in producing these drugs. However, several challenges need to be addressed if such establishments are to achieve their goal.
This was part of the presentation made by Universal Corporation Limited Kenya (UCL) held on June 25, 2021 during the 21st Innovation Incubation webinar organized by the Innovation Centre for Molecular Biology and Biochemistry (iCMoB) of Jomo Kenyatta University of Agriculture and Technology (JKUAT).
The aim of the forum was to familiarize the participants with the process of Pharmaceutical Product Development at the local level, in line with one of the thematic areas addressed by iCMoB, namely; Drug development and disease control through innovations in vaccines and new drugs.
According to Meer Danani, the Business Development Manager, UCL is one of two World Health Organization (WHO) Pre-Qualified facilities in Sub-Saharan Africa with the capacity to produce generic medication that meets global standards at an affordable price. The Kenyan company, with 23 years’ experience, has a focus on anti-malaria and antiretroviral.
Mr. Ezekiel Kilimo, a Manufacturing and Science Technology Executive at the same company explained that the process of developing a drug was rigorous, and required that quality and human safety is ensured. This, he noted, is partly enabled by a computerized process which eliminates users who do not comply with the set standards
“Before a drug hits the market, it goes through an intensive formulation and development process that analyzes its stability to ensure that the quality does not degrade over time thereby affecting its active pharmaceutical ingredients. Further, all generic drugs must be certified as bioequivalent (similar) to the original drug before release,” affirmed Mr. Kilimo.
He said the industry is faced with myriad of challenges that included; difficulty in accessing data on market size, demand and competition, and lack of support from other industries such as the importation of starch in a country that produces maize and sugarcane. Other challenges include; high costs during the two-year stringent process in drug development in areas of compliance, experiments, among other things.
There was also a growing middleclass that correlated with a sharp rise in lifestyle diseases which are affecting productivity, and subsequently the economy. This, the meeting was informed, could be addressed by a robust pharmaceutical economy which could help achieve one of the objectives entrenched within the healthcare pillar in Kenya’s Big 4 Agenda.
Palu Dhanani, Founder and Managing Director UCL reiterated the need to strengthen local pharmaceuticals citing the impact of Covid-19 which affected importation of life saving medication, some up to nine months.
“There is need to support local pharma, because in addition to producing drugs, local pharmaceutical companies also cater for the needy in society as well as provide employment to thousands. This model of economic development can only be sustained by facilitating a robust manufacturing environment,” said Mr. Dhanani
He called for the revision of the education curriculum which, he said, only focused on clinical aspects of drugs thereby ignoring the manufacturing aspect of pharmaceuticals as observed by most students on attachment from Kenyan Universities. He said the linkage between industry and academia was necessary as it enabled students learn how to develop drugs and create new opportunities for medical products developed in universities.
Dr Amos Mbugua, the facilitator of the session, urged other stakeholders to further this discussion and explore research collaborations.