Kenya attracts 13 new pharmaceutical manufacturers

Dr Ahmed Mohammed, during an interview in his office. [Bernard Orwongo, Standard]

Kenya has attracted 13 new pharmaceutical manufacturers that are at various stages of establishment and operationalisation, strengthening the country’s efforts to expand local production of medicines and other health products.

The new manufacturers are Med Aditus, Kenya Biovax Institute, Biopharma Limited in Gatundu-Thika, Full Care Limited, Tanatis Global Limited, Crown Healthcare, Regal Pharmaceuticals with its new penicillin plant, Spora International, Recon Health, the KEMRI Production Facility, Zuventus Limited, Aviazure Limited and Galaxy Pharmaceuticals.

The companies are progressing through different stages of plant construction, equipment installation, quality-system development and regulatory readiness.

Their entry signals growing investor interest in Kenya’s pharmaceutical sector and its potential to serve both domestic and regional markets.

The Pharmacy and Poisons Board (PPB) is providing regulatory guidance and technical support to facilitate the establishment of the facilities while ensuring that locally manufactured health products meet the required standards of quality, safety and efficacy.

Amid onboarding of the manufacturers, PPB Chief Executive Officer Dr Ahmed Mohamed told The Standard that effective regulation is essential to building a competitive and trusted pharmaceutical manufacturing industry.

“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,” said Dr Mohamed.

Dr Ahmed Mohammed, during an interview in his office. [Bernard Orwongo, Standard]

Kenya imports an estimated 70 to 80 per cent of its health products and technologies, leaving the country vulnerable to disruptions in international supply chains.

The Government has therefore prioritised domestic production, with a target of manufacturing at least 50 per cent of essential health products locally.

Under the Pharmacy and Poisons Act, PPB regulates the manufacture, importation, distribution and use of health products and technologies.

The Board is supporting both new and existing manufacturers through regulatory clinics, technical advisory meetings, capacity-building programmes and routine and risk-based Good Manufacturing Practice inspections.

Manufacturers have received training on Good Manufacturing Practice requirements, pharmaceutical quality systems, dossier preparation, validation, qualification, data integrity and other regulatory expectations.

PPB also conducts follow-up inspections and monitors corrective and preventive actions to promote continuous compliance and improvement.

These interventions are intended to address regulatory and operational constraints that have limited the growth of local manufacturing.

Kenya’s pharmaceutical industry remains concentrated in importation and distribution, packaging and labelling, and the manufacture of finished dosage forms.

Production of active pharmaceutical ingredients and excipients, as well as investment in research and development, remains limited.

Manufacturers also face difficulties in attaining World Health Organisation (WHO) prequalification, accessing local bioequivalence testing services and meeting the high cost of production associated with utilities and imported inputs. 

PPB is working with stakeholders to develop clearer frameworks for establishing local bioequivalence study centres and clinical research organisations.

The Board is also supporting manufacturers seeking Good Manufacturing Practice certification and World Health Organisation prequalification, which are critical for accessing regional and international markets.

“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,” added Mohamed.  

The regulatory support programme further aims to increase the utilisation of installed local manufacturing capacity by 70 per cent and build the technical capabilities required to produce selected high-volume active pharmaceutical ingredients and excipients locally. 

“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,” he said. 

Additionally, PPB is working towards attaining and sustaining World Health Organisation Global Benchmarking Tool Maturity Level 3 status for medicines and vaccines.

Achieving this milestone will demonstrate that Kenya has a stable, well-functioning and integrated regulatory system and enhance confidence in Kenyan-made products. 

“A strong pharmaceutical industry must be supported by an equally strong regulatory system. Maturity Level 3 will provide further assurance that medicines and vaccines regulated in Kenya meet consistent and internationally recognised standards,” Dr Mohamed said.

The expansion of local manufacturing is expected to improve the availability of essential health products, create skilled employment, attract investment and reduce Kenya’s exposure to global supply-chain disruptions.

It will also support the Buy Kenya, Build Kenya initiative, Universal Health Coverage and the country’s broader health security and industrialisation goals.