Kenya has removed more than 2,200 medicines from the market and moved to tighten controls on the pharmaceutical sector in a sweeping crackdown on fake, substandard and ineffective medical products that health officials say have exposed patients to serious risks for years.
Health Cabinet Secretary Aden Duale announced the nationwide action on Wednesday, saying the government would no longer allow unsafe medicines to remain in circulation. The move follows a review by the Pharmacy and Poisons Board (PPB) that found thousands of products failed to meet regulatory requirements.
Duale said protecting patients would remain the government's top priority and warned players in the pharmaceutical industry that strict compliance with the law was no longer optional.
“The action they are taking has the highest political backing in the interests of the Kenyan patient. So you either play by the law as provided by the regulator or you look for another country to go and do business,” Duale said.
The CS made the remarks during the launch of an Interministerial Steering Committee that will oversee the development of Kenya’s National Action Plan on Substandard and Falsified Medical Products.
He said the PPB recently carried out a mandatory review of medicines that had been allowed to remain on the market for many years without being subjected to updated regulatory assessment.
“As a result of that re-registration of legacy products, which had been postponed for too long, 2,258 products were removed from the register for non-compliance,” he said.
According to Duale, the exercise exposed the extent of a problem that has quietly placed many patients at risk of using medicines that are poorly manufactured, contain incorrect ingredients or fail to provide the expected treatment.
The crackdown comes at a time when concerns over fake medicines continue to grow across developing countries. The World Health Organization estimates that one in every 10 medical products used in developing nations is either substandard or falsified, with African countries bearing a large share of the burden.
As part of the reforms, Duale announced that the government would stop parallel importation of medicines, saying the arrangement had created opportunities for counterfeit and unsafe products to find their way into the country.
While the system allows genuine branded medicines to be imported from markets outside authorised local distribution channels, he said it had made regulation and market surveillance more difficult.
The Health CS also defended the rising number of product recalls and public safety alerts issued by the PPB, saying the figures reflected stronger oversight rather than a deterioration of the situation.
“Since January 2025, the Pharmacy and Poisons Board has coordinated 58 recalls of substandard medical products and issued 14 rapid public alerts on falsified medical products. Some may interpret these numbers as evidence of a worsening problem,” the CS said.
“I take a different view. This demonstrates a regulator that is more vigilant, more transparent and above all more effective in identifying risks, taking decisive action and informing the public.”
Duale described those behind fake medicines as criminals whose actions continue to endanger lives by causing treatment failure, promoting antimicrobial resistance, raising healthcare costs for families and weakening public confidence in health facilities.
A 2025 report by healthcare group CFAO estimates that fake medicines contribute to more than 100,000 deaths across Africa every year.
To strengthen monitoring of medicines across the supply chain, the government will begin piloting a national digital track-and-trace system this month before rolling it out fully on August 1.
“When that pilot goes live, every medicine dispensed in our country can be traced to the pharmacist, the distributor, the wholesaler and all the way to the manufacturer from a patient anywhere in Kenya,” Duale said.
He said the system would allow regulators to quickly identify unsafe medicines and remove them from circulation before they cause further harm to patients.
PPB Chairperson Dr John Munyu said Kenya had already strengthened regulation through a series of measures, including mandatory re-registration of older medicines, tighter inspections, improved surveillance at border points and expanded monitoring of products already available in the market.
The government says the latest measures are intended to close gaps in the pharmaceutical sector, improve accountability and ensure that patients only receive medicines that meet the required standards of safety, quality and effectiveness.