The CSIR’s brand new research facility in Pretoria, launched last week, aims to reduce the country’s massive reliance on international supplies of active pharmaceutical ingredients, the importation of which costs South Africa R15bn every year, reports News24.
Around 98% of the active pharmaceutical ingredients (APIs) used to manufacture medicines locally are imported annually, but the Council for Scientific and Industrial Research’s (CSIR) new facility, FuturePharma, hopes to change that.
Based on the CSIR’s Scientia campus in Pretoria and funded by the Department of Science, Technology and Innovation, it plans to bridge the gap between promising lab research and the development and commercialisation of pharmaceutical technologies.
Dr Rachel Chikwamba, the CSIR’s group executive for advanced chemistry and life sciences, said the gap was not the result of inadequate scientific research.
South Africa had a significant body of internationally published and recognised scientific research, she said, but lacked the necessary infrastructure to translate that research into products and demonstrate their efficacy and safety.
Dr Jenny-Lee Panayides, a CSIR chief researcher, told News24 that FuturePharma was conceptualised four years ago after the CSIR identified several sectors in need of development.
“The pharmaceutical sector really stood out to us because it is very developed in terms of formulation, packaging and distribution. But there was a gap when it came to producing the APIs. FuturePharma spun out of the work we were doing as a facility to fill this gap,” she said.
Its development was also spurred on by the need for South Africa to strengthen its ability to produce medicines locally, with the Covid-19 pandemic having starkly highlighted the importance of health sovereignty exposing vulnerabilities in international supply chains.
Panayides noted that, at the time, South Africa was at the back of the queue for vaccines and small molecule drugs, like painkillers and anti-inflammatory medicines, because of factory closures in China.
“The Indian government also closed its borders to exports of certain active pharmaceutical ingredients and drug products. We could really see how unpredictable the international value chain was,” she added.
She said local companies depended on imported APIs, which could account for between 40% and 60% of the cost of a finished tablet. However, local manufacturing would reduce the cost of these APIs and make the country’s medicine suppliers more competitive with countries like India and China when bidding for Department of Health tenders.
The facility is open access, allowing people across the pharmaceutical value chain, as well as university students, to use its capabilities to research and test APIs. Before a project is taken on, its proof of concept, cost benefits and environmental benefits are assessed.
“Not everything makes it through, so we have quite a broad pipeline at the beginning and then it filters down,” she said.
Small, medium and micro enterprises that produce APIs for use in the pharmaceutical value chain can manufacture their products at the facility while gaining the skills and experience needed to operate independently.
“They can make what they need using our facility. They can learn the processes, train their staff and conduct their first production run so that they can access the market using our facility,” Panayides said.
Students and staff from the University of Pretoria, Stellenbosch University and the University of Limpopo were already working there, she added.
South African Health Products Regulatory Authority (SAHPRA) CEO Dr Boitumelo Semete-Makokotlela said the regulator had adopted a policy position that would enable local manufacturing, and that there were serious and critical shortages of basic drugs in this country.
“Having such capabilities locally will enable us to start manufacturing some of our own core medicines.
“SAHPRA will support the process by providing shorter evaluation timeframes and reduced assessment fees, while maintaining the same rigorous standards for quality, safety and therapeutic efficacy.”
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