Health Cabinet Secretary Aden Duale has issued a series of stringent directives to the Pharmacy and Poisons Board (PPB), ordering an immediate nationwide crackdown on counterfeit, substandard, and unregistered medicines.
Speaking on Wednesday, during his maiden official visit to the regulatory agency, Duale said the government would not tolerate weak enforcement or regulatory lapses that endanger the lives of Kenyans.
“I am directing the Pharmacy and Poisons Board to immediately remove substandard, falsified, poor-quality, counterfeit, and unregistered medicines from the market,” he said.
“Anyone—whether individuals, directors, or entities—behind the distribution or sale of these dangerous products must be prosecuted.”
The CS underscored the need for strict adherence to the Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules of 2019, warning that any negligence by regulators would attract severe consequences.
“There will be no compromise,” Duale cautioned.
“Any inspector found to have neglected their work will face administrative, disciplinary, or even legal action.”
He further directed the Board to end the illegal practice of leasing professional licences, a malpractice he said undermines public safety and erodes trust in the sector.
Additionally, he ordered full enforcement of bioequivalence standards to ensure that generic medicines on the Kenyan market match the performance and safety of innovator drugs.
During the visit, Duale praised the PPB for its ongoing efforts to reach the World Health Organization’s Maturity Level 3, an advanced regulatory benchmark.
He described the achievement as ‘critical for strengthening regulatory oversight, boosting investor confidence, opening markets, and supporting Kenya’s local pharmaceutical manufacturing ambitions.’
To plug staffing gaps that have hampered regulatory operations, the CS announced that the government had approved the recruitment of 45 new officers under the World Bank-funded Health Emergency Preparedness, Response and Resilience Project.
Discussions with the National Treasury on additional staffing are ongoing.
Duale reaffirmed that the PPB remains central to ensuring the safety and efficacy of medicines used across Kenya and to supporting the country’s fast-growing pharmaceutical manufacturing sector.
“The Board has a duty to safeguard public health and ensure the well-being of all Kenyans,” he said.
“Enforce the law firmly, fairly, and without fear or favour.”
Principal Secretary for Public Health and Professional Standards Mary Muthoni, PPB Chair Dr. John Munyu, CEO Dr. Ahmed Mohamed, members of the Board, and senior staff attended the meeting, which marked Duale’s first engagement with the agency since taking office.
