CSIR opens Tshwane pharma plant to close a 98% import gap

South Africa can do the early science. What it struggles to do is carry a promising molecule out of the laboratory and into a clinic, a factory and a patient’s hands.

The Council for Scientific and Industrial Research launched a facility in Tshwane on Wednesday intended to close that gap. FuturePHARMA is described by the CSIR as a bridge between scientific discovery and a stronger local pharmaceutical industry, and it opened with a promise from the medicines regulator to work closely with it.

Speaking at the launch, the CSIR’s Group Executive for Advanced Chemistry and Life Sciences, Dr Rachel Chikwamba, said about 98% of the active pharmaceutical ingredients used to make medicines locally are imported. That dependence, she said, leaves local manufacturing exposed to external shocks, rising input costs and foreign exchange swings.

South Africa’s research capability is strong at the early stage, she said, and weakens when an innovation has to be turned into a product that can be scaled safely and efficiently.

“The vision of Future Pharma is to close the gap. How can we ignite a thriving, inclusive local pharmaceutical manufacturing industry?” Chikwamba said.

The first phase of the facility, she said, focused on building the capability to take research through product development and into clinical testing, while laying the ground for more local manufacturing. A second phase will focus on scaling that capability and on preparedness for future pandemics.

Chikwamba said the facility brings together infrastructure, skills and expertise in process development, product development, analytics, quality systems and regulatory development, so that prototypes from the country’s innovation ecosystem can move towards clinical testing and eventually full-scale manufacturing.

It has two main capability areas. The first is small-molecule product and process development, aimed at medicines such as painkillers and anti-inflammatory drugs, using conventional batch chemistry, flow chemistry and biocatalysis with digital support. The second covers biopharmaceuticals, including protein-based medicines and vaccines, produced using plant systems, yeast expression systems and mammalian cell culture.

Guests at the launch were shown demonstrations of some of these capabilities, including small-molecule pilot products.

Chikwamba said the CSIR drew on more than two decades of investment in research and manufacturing infrastructure, including its biomanufacturing experience. Its Biomanufacturing Industry Development Centre has trained a skilled workforce while supporting product and service development, and the CSIR has since been recognised by the Africa Centres for Disease Control and Prevention as a regional manufacturing capability and capacity development hub. The World Health Organisation has designated it an African biomanufacturing training hub.

The facility is designed as an open-access national capability rather than something for the CSIR alone, Chikwamba said. Universities, other research councils and industry will be able to use it, and entrepreneurs and emerging businesses will get access to infrastructure, technical expertise, regulatory support, skilled personnel and manufacturing capability without having to fund their own facilities at the earliest stages.

They will be able to test ideas, establish whether a product is viable, develop technology packages and produce initial runs for market testing. They will also be connected to businesses, funders and other industry players. Chikwamba said the model can build a pipeline of new pharmaceutical businesses and develop the workforce the growing African pharmaceutical manufacturing sector needs.

For the South African Health Products Regulatory Authority, the facility is a chance to strengthen the ecosystem around local production. SAHPRA chief executive Dr Boitumelo Semete-Makokotlela said local manufacturing is not only an industrial objective but is tied directly to access to medicines and health security.

“The COVID-19 pandemic reminded us that countries and regions with limited manufacturing capacity can become vulnerable when global supply chains are disrupted,” she said.

SAHPRA has adopted a policy position aimed at enabling local manufacturing while holding the required standards for quality, safety and therapeutic efficacy. Under a policy published in 2025, the regulator supports locally manufactured health products through shorter evaluation timeframes and reduced assessment fees, while keeping rigorous regulatory standards.

Semete-Makokotlela said SAHPRA intends to work closely with the CSIR as FuturePHARMA develops the regulatory authorisation it needs to operate, and pointed to the support it gave the mRNA vaccine manufacturing platform.

“We are here today to communicate our intention to the CSIR that we will partner with you, we will support you, and there will be a moment where we will wear the hat of the police,” she said.

She said enabling local production cannot be done by the regulator alone and needs alignment between science, industry, financing, procurement, trade, health policy and regulation. That matters against the backdrop of medicine shortages in South Africa, where patients are sometimes unable to access medicines because global supply chains are disrupted.

SAHPRA is already working with the CSIR and other national regulatory authorities on the continent through the regional biomanufacturing hub hosted by the CSIR. Semete-Makokotlela said the partnership will extend to training regulators in small-molecule manufacturing, building on existing work on biological products.

The World Health Organisation’s representative to South Africa, Dr Shenaaz El-Halabi, said the facility can help address a longstanding difficulty in turning scientific discoveries into medicines that are available, safe, effective and affordable, and supports Africa’s ambition to take greater responsibility for its own health security.

“For a patient waiting for treatment, scientific progress means a medicine that is available when needed, safe and effective and affordable,” she said.

El-Halabi said dependence on external supplies leaves countries vulnerable when global production is disrupted or international demand rises sharply, as happened during the COVID-19 pandemic, and highlighted the need for partnerships between government, research institutions, industry, regulators, health services and international organisations.

The WHO framework for strengthening local production of medicines, vaccines and other health technologies in the African Region for 2025 to 2035 calls for a holistic approach covering research and development, innovation hubs, technology transfer and partnerships. Under it, governments align industrial development with public health priorities, research institutions contribute discoveries and skills, industry brings manufacturing expertise, and regulators ensure quality and safety.

El-Halabi also pointed to the CSIR’s growing role in developing Africa’s biomanufacturing workforce.

Looking ahead, Chikwamba described FuturePHARMA as a sandbox, a controlled environment in which the country can test not only whether it can develop and manufacture safe products but also the logistics, supply chains and technical systems needed in a health emergency. The facility will keep its capabilities active by producing products the innovation ecosystem needs and by continually training its workforce.

That, she said, means the country is not building infrastructure only during a crisis but holding a ready capability before the next emergency. It would allow a threat to be identified, a response activated and the platform mobilised faster.

“Our response rate will be faster. We will not be waiting in line to get products from other countries,” Chikwamba said.

Source: SAnews (South African Government News Agency), FuturePHARMA to bridge scientific discoveries gap