In 2023, Kenya set an ambitious target of ensuring that 50 percent of essential medicines are sourced from local manufacturers by 2026, as part of a broader strategy to achieve universal health coverage while reducing reliance on costly imports and strengthening the local pharmaceutical industry.
According to the government, the initiative aims to reduce the country's annual import bill by Sh76 billion, increase export earnings, create more job opportunities, and promote long-term economic growth.
"We have not optimised aspects of technology transfer, transfer pricing, use of generic and branded medicines, bulk purchasing, and protection of local manufacturers. My government is aware of the challenges faced by local pharmaceutical manufacturers. Mark your calendars because this is important for you, the local manufacturers: by 2026, at least 50 percent of the drugs on the Essential Medicines List will be locally manufactured and available," said President William Ruto during the opening of the Mission for Essential Drugs and Supplies' microbiology laboratory in 2023.
However, as of March 2025, local production accounts for only 30 percent of the essential medicines list, leaving a 20 percent gap off the target which is to be filled in just nine months.
Essential medicines are defined as those that meet the priority health needs of the population.
Kenya has about 35 licensed pharmaceutical manufacturers, including Beta Healthcare Ltd, Cosmos Limited, Dawa Limited, Elys Chemical Industries Ltd, GSK (now known as Haleon Kenya Ltd) Laboratory and Allied Ltd, Regal Pharmaceuticals Ltd, and Universal Corporation Ltd.
These companies mainly produce generic drugs using imported raw materials, such as tablets, capsules, creams, ointments, and liquids.
They supply 30 percent of Kenya's local drug needs and export to neighbouring countries, including Tanzania, the Democratic Republic of Congo, Rwanda, Burundi, and Uganda.
According to an analysis by Newcastle University in the UK and Makerere University in Uganda, a significant barrier to achieving this goal is the lack of registration for many essential medicines in Kenya.
"Before a medicine can be made available in a country, manufacturers must apply to the country's medicines regulatory authority for a licence to sell it and demonstrate that the medicine is safe and effective - this is known as market registration. Without registration, local manufacturers cannot legally produce or sell these medicines, forcing the government and healthcare providers to continue to rely on imports," the analysis said.
The World Health Organization (WHO) recommends at least three different manufacturers for each essential drug to ensure a stable supply. In Kenya, however, 36 percent of registered essential medicines have fewer than three available products.
"Essential medicines should always be available, affordable, and of assured quality. Access to essential medicines is a basic human right, and governments must ensure that no one is left behind," said Dr Tedros Adhanom Ghebreyesus, WHO Director-General.
The Pharmacy and Poisons Board (PPB) oversees the registration of medicines, but the process is slow and cumbersome. Problems such as backlogs, limited staff, and high registration costs delay approvals, making it difficult for local manufacturers to enter the market.
Some essential medicines remain unregistered due to administrative delays, while others require imported active pharmaceutical ingredients (APIs), which also need to be registered before they can be used in production.
"We prioritise accessibility, especially for local manufacturers, and offer them reduced fees and accelerated assessments. The board is also committed to providing technical assistance to improve product quality," said Fred Siyoi, CEO of the PPB.
Currently, Kenya imports more than 70 percent of its essential medicines, mainly from India, China, and some European countries.
While these imports ensure a steady supply, they also expose the country to supply chain disruptions, price fluctuations, and foreign exchange challenges.
The Covid-19 pandemic highlighted the risks of over-reliance on imports, as global supply chains were disrupted and drug shortages occurred.
Strengthening local production could therefore improve the availability of medicines and increase Kenya's pharmaceutical self-sufficiency and economic resilience.
To this end, the government has introduced financial incentives for local manufacturers, including tax breaks and reduced import duties on pharmaceutical equipment.
Special Economic Zones (SEZs) have been designated to encourage pharmaceutical investment and attract both local and international players.
In addition, the ministry is working with private sector stakeholders to improve local manufacturing capacity and ensure compliance with Good Manufacturing Practice (GMP) standards.
"We are committed to strengthening our pharmaceutical industry by reducing registration bottlenecks, increasing investment, and ensuring that Kenyan-made medicines are of the highest quality," said Dr Patrick Amoth, Director General for Health.
Despite these efforts, Kenya faces serious consequences if it fails to meet its 50 percent local manufacturing target including continued reliance on imports could lead to higher healthcare costs and put essential medicines out of reach for many citizens.
Disruptions in the supply chain could lead to drug shortages, affecting the treatment of critical diseases such as malaria, diabetes, and hypertension.
Similarly, the local pharmaceutical industry would miss out on opportunities for economic growth, limiting job creation and innovation in the sector. Failure to meet the target would also hinder Kenya's goal of achieving universal health coverage, as the availability of medicines is a key pillar of the healthcare system.
"Kenya has the potential to become a pharmaceutical hub in Africa, but we need a more predictable regulatory environment, access to affordable financing, and a government that prioritises local manufacturers in procurement. If we don't act now, we will continue to rely on imports and miss out on a golden opportunity.To close the 20 percent gap and meet the 2026 target, Kenya must take decisive action. Fast-tracking the registration process through a simplified and accelerated system is essential. The Pharmacy and Poisons Board needs to increase its capacity, digitise applications and reduce registration backlogs," said Dr Maina Gitau, a pharmacist in Nairobi.
He added that stronger public-private partnerships are needed to align government procurement priorities with local manufacturing capacity.
In addition, financial incentives such as reduced registration fees and tax breaks can help ease the burden on local manufacturers.
Investing in local production of active pharmaceutical ingredients will also be crucial to reducing dependence on imports and ensuring a consistent supply of essential medicines.
