Kenya is strengthening its pharmaceutical manufacturing base as 13 new companies advance plans to establish production facilities in the country.
The investments are expected to expand the domestic supply of medicines and other health products, create skilled employment and position Kenya to serve the wider regional market.
The manufacturers are Med Aditus, Kenya Biovax Institute, Biopharma Limited in Gatundu-Thika, Full Care Limited, Tanatis Global Limited, Crown Healthcare, Regal Pharmaceuticals through its new penicillin plant, Spora International, Recon Health, the KEMRI Production Facility, Zuventus Limited, Aviazure Limited and Galaxy Pharmaceuticals.
The companies are at various stages of plant construction, equipment installation, quality-system development and regulatory preparation.
Their establishment comes amid Government efforts to manufacture at least 50 per cent of essential health products locally.
Kenya currently imports an estimated 70 to 80 per cent of its health products and technologies, making the country susceptible to global supply disruptions and fluctuations in the cost of imported products and raw materials.
The Pharmacy and Poisons Board is working with the incoming manufacturers to ensure their facilities and products comply with national and internationally recognised standards.
PPB Chief Executive Officer Dr Ahmed Mohamed said an effective and predictable regulatory environment is necessary to attract investment while protecting patients.
“The entry of new manufacturers demonstrates growing confidence in Kenya’s pharmaceutical sector. Our responsibility is to provide a clear and predictable regulatory pathway that enables these investments to progress while ensuring that every locally manufactured product meets stringent standards of quality, safety and efficacy,” Dr Mohamed said.
The Board regulates the manufacture, importation, distribution and use of health products and technologies under the Pharmacy and Poisons Act, Cap. 244.
Its support to new and existing manufacturers includes regulatory clinics, technical advisory meetings, capacity-building programmes and Good Manufacturing Practice inspections. The inspections are conducted routinely and according to the level of risk associated with individual facilities and products.
Manufacturers have also been trained on pharmaceutical quality systems, dossier preparation, validation, qualification, data integrity and other regulatory requirements. PPB conducts follow-up inspections and monitors the implementation of corrective and preventive measures.
The interventions seek to address longstanding regulatory and technical constraints affecting local production. Kenya’s pharmaceutical sector remains largely focused on importing and distributing products, packaging and labelling, and manufacturing finished medicines.
Production of active pharmaceutical ingredients and excipients remains limited. These critical inputs are used in manufacturing medicines but are largely imported, increasing production costs and exposing local companies to external supply disruptions.
“Our ambition must extend beyond packaging and producing finished medicines. Kenya needs to progressively develop the capacity to manufacture pharmaceutical ingredients and other critical inputs locally, reducing dependence on imports and strengthening the resilience of our supply chains,” Dr Mohamed said.
The regulatory support programme aims to raise the utilisation of existing manufacturing capacity by 70 per cent and develop the technical capabilities required to produce selected high-volume pharmaceutical ingredients and excipients locally.
Manufacturers continue to face high utility and input costs, limited access to local bioequivalence testing and difficulties meeting the requirements for World Health Organization prequalification.
PPB is working with stakeholders to establish clearer frameworks for local bioequivalence study centres and clinical research organisations. It is also guiding manufacturers pursuing Good Manufacturing Practice certification and WHO prequalification.
“Kenyan manufacturers must be equipped to compete beyond the domestic market. Attaining internationally recognised standards will strengthen confidence in locally produced health products and open access to regional and global procurement opportunities,” Dr Mohamed said.
The Board is also pursuing World Health Organization Global Benchmarking Tool Maturity Level 3 status for medicines and vaccines. The designation would demonstrate that Kenya has a stable, integrated and well-functioning regulatory system.
Achieving the milestone is expected to increase confidence in health products regulated and manufactured in Kenya and strengthen the country’s prospects of accessing regional and international markets.
The growing pharmaceutical manufacturing base supports the Buy Kenya, Build Kenya initiative, Universal Health Coverage and the country’s health-security and industrialisation priorities. It is also expected to improve the availability of essential health products while reducing reliance on international supply chains.
