One in every ten medical products in Africa is substandard or falsified, according to the World Health Organisation (WHO), posing a serious threat to public health.
Fake and poor-quality medicines contribute to more than 267,000 deaths annually from ineffective antimalarial drugs and another 169,271 deaths linked to substandard antibiotics used to treat severe pneumonia in children.
The illicit trade is driven by porous borders, informal markets, cross-border smuggling, weak enforcement, and organised criminal networks
Since 2021, the Pharmacy and Poisons Board (PPB) has recorded 1,413 product quality complaints, coordinated 99 product recalls, received 32,833 adverse drug reaction reports, and issued 18 public alerts on suspected falsified medical products.
Since January 2025 alone, the regulator has conducted 58 product recalls and issued 14 rapid alerts, with the closure of 200 non-compliant pharmaceutical outlets, alongside the arrest and prosecution of offenders.
To tackle the rise, the government has stepped up the fight against substandard and falsified medicines after Health Cabinet Secretary Aden Duale inaugurated an Interministerial Steering Committee (ISC) to oversee the implementation of Kenya's National Action Plan on Substandard and Falsified (SF) Medical Products.
The move is expected to strengthen coordination among government agencies responsible for regulating medicines, law enforcement, border security, and public health to protect Kenyans from unsafe and ineffective medical products.
The Steering Committee will provide strategic leadership and policy direction while coordinating efforts to prevent, detect, investigate, and respond to substandard and falsified medicines.
It will also address regulatory, legal, operational, and resource challenges that have allowed fake medical products to infiltrate the market.
Speaking during the inauguration, Duale described substandard and falsified medicines as one of the country's most pressing public health threats.
"Substandard and falsified medical products remain a major threat to patient safety, health security, and economic development. They contribute to treatment failure, antimicrobial resistance, and preventable deaths while eroding public confidence in our healthcare system and threatening the success of Taifa Care and Universal Health Coverage," said Duale.
He emphasised that the problem cannot be solved by one institution alone. "Addressing this challenge requires a coordinated whole-of-government and whole-of-society approach involving regulatory agencies, law enforcement, border control authorities, county governments, healthcare professionals, manufacturers, distributors, development partners, and the public," he added.
The launch comes as the PPB reports a significant increase in surveillance and enforcement activities aimed at safeguarding the country's pharmaceutical.
According to PPB, the rise in product recalls and adverse event reporting is largely attributed to improved surveillance systems, stronger reporting mechanisms, and expanded post-market monitoring rather than an increase in unsafe medicines alone.
The Board has strengthened inspections at Kenya's gazetted ports of entry through 100 per cent physical inspections, risk-based profiling, intelligence-led operations, rapid screening technologies, and deployment of additional inspectors.
It has also expanded its surveillance network by establishing 15 Post-Marketing Surveillance Sentinel Sites and 30 Pharmacovigilance Sentinel Sites across the country to improve early detection of poor-quality medicines and adverse drug reactions.
PPB Chairperson John M. Munyu said Kenya has made significant progress in strengthening the regulation of medicines, but warned that sustained collaboration is needed to eliminate substandard and falsified medical products.
He said key reforms already implemented include the mandatory re-registration of legacy medical products, strengthened surveillance at ports of entry, enhanced risk-based inspections across the pharmaceutical supply chain, and expanded post-market surveillance and pharmacovigilance systems to improve early detection of unsafe medicines.
"While these reforms have strengthened our regulatory system, they are not enough. Substandard and falsified medical products exploit weaknesses across supply chains, border control, law enforcement, and criminal networks. No regulator, regardless of its capacity, can address this challenge alone," said Dr Munyu.
He said the National Action Plan offers an opportunity to unite all relevant institutions in protecting public health and restoring confidence in Kenya's healthcare system.
"The National Action Plan presents an opportunity to establish a coordinated whole-of-government approach. Together, we can develop a practical and nationally owned plan that will protect the people of Kenya for years to come," he added.
Among the falsified products previously identified within Kenya's regulated market are counterfeit Truvada, Viagra, HIV rapid test kits, and heparin injections.
Health experts warn that falsified HIV medicines can lead to treatment failure and drug resistance; fake HIV test kits may produce incorrect results that delay diagnosis and treatment, while counterfeit heparin injections can cause severe bleeding, organ damage, and even death.
Kenya's National Action Plan seeks to address these challenges through five strategic pillars: Prevent, Detect, Respond, Communicate, and Sustain.
The strategy aims to strengthen border controls, improve intelligence sharing, enhance coordinated investigations and prosecutions, introduce digital traceability systems for medicines, increase public awareness, and build a safer pharmaceutical supply chain.
The newly established Interministerial Steering Committee will coordinate the implementation of the action plan through technical working groups responsible for each strategic pillar. Its immediate priorities include developing the National Action Plan, mobilising resources, coordinating implementation, and establishing monitoring and evaluation mechanisms to measure progress.
Health officials say the initiative marks a major milestone in Kenya's efforts to eliminate substandard and falsified medical products and ensure that patients have access to safe, effective, and quality-assured medicines.
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