By N, KNA
Health Cabinet Secretary (CS) Aden Duale has ordered the Pharmacy and Poisons Board (PPB) to step up enforcement against counterfeit, falsified and substandard medicines.
He warned that the government will not tolerate activities that endanger public health or compromise the integrity of the country’s pharmaceutical supply chain.
Duale, said the regulator must adopt a more coordinated and technology-driven approach to monitoring pharmaceutical products entering the Kenyan market.
He emphasised that criminals exploiting weak enforcement, unlicensed wholesalers and illegal online sales of medicines must be held accountable.
“You must immediately rid the Kenyan market of all substandard, falsified, poor-quality and unregistered medicines. This is not optional,” Duale said.
“Any pharmacy selling counterfeit drugs must be closed, and action taken against those in charge, including their directors,” he added.
Speaking on Wednesday during a visit to the institution, Duale directed the PPB to work closely with law enforcement agencies, county governments, and the Kenya Revenue Authority (KRA) to strengthen inspections at points of entry and across retail outlets, and to ensure timely prosecution of violators.
He stressed that enforcement must be consistent and uncompromised to protect the credibility of Kenya’s pharmaceutical regulatory system.
He underscored the importance of modern technology and digitisation in regulatory oversight, instructing the Board to integrate all its systems into the national Digital Health Superhighway managed by the Digital Health Agency.
Duale said this would ensure medicines are traceable from manufacturers to consumers, improve reporting, and enhance efficiency and transparency across all operations.
State Department for Public Health and Professional Standards Principal Secretary (PS) Mary Muthoni said that safe regulation of medicines and chemicals is a core public health priority, warning that substandard and falsified products, misuse of antibiotics, and weak reporting mechanisms continue to threaten lives.
“Safe regulation of medicines is essential to prevent avoidable diseases, disability and even death,” she said.
“We must close regulatory gaps, strengthen inspection and licensing, raise awareness, build capacity, and ensure strict adherence to legal requirements. Absenteeism will no longer be tolerated in the Ministry of Health, and staff must fully commit to their responsibilities.” she added
The PS added that the ministry is committed to supporting the Board in implementing time-bound reforms, including digitisation of all regulatory functions, training of personnel, and tighter collaboration with counties and law enforcement agencies.
PPB Board Chair Dr. John Munyu welcomed the CS’s directives, noting the historic nature of the visit, and said no minister had ever visited the Board since its inception nearly seven decades ago.
He said the CS’s support reinforces ongoing reforms within the regulator.
“I can confirm you are the first minister ever to visit this regulatory authority since 1957,” Dr. Munyu said. “Your passion for reforms and strengthening the regulator is clear, and the men and women in front of you are fully committed to delivering quality and efficient services to Kenyans.”
Dr. Munyu reported that the Board is already implementing internal reforms, including enhanced market surveillance, enforcement against illegal operators, and the use of digital tools for product traceability and adverse drug reaction reporting.
He said these measures are vital in protecting the public and supporting local pharmaceutical industry growth.
PPB CEO Dr. Ahmed Mohamed briefed the CS on the Board’s structure and operations, noting that it has 10 regional offices and 11 gazetted ports of entry.
He said the Board’s mandate is to regulate the practice of pharmaceutical personnel and control trade in medicines. Dr. Mohamed welcomed the CS’s engagement, saying it would reinforce ongoing reform efforts.
Duale reiterated that Kenya must achieve the World Health Organization (WHO) Maturity Level Three (ML3) regulatory status by March–April next year.
He said this milestone, issued under a directive from President William Ruto, will strengthen oversight, open markets, boost investor confidence, and support the country’s local manufacturing ambitions.
The CS also announced plans to address staffing gaps at the Board, including expediting the hiring of 45 officers under the World Bank-funded Emergency Preparedness, Response and Resilience Project.
He urged the Board to intensify enforcement against illegal parallel imports, ensure timely renewal of product registrations, and implement bioequivalence standards without compromise.
Duale further emphasised the need for fair treatment of all PPB staff.
“There should be no animal farm in this institution, those who work hard must be recognised and promoted on merit. Every Kenyan here has the right to work with dignity and receive necessary support,” he said.
He urged the Board to fully implement digitisation, enforcement, and public awareness campaigns, underscoring that these actions are central to strengthening the quality, safety and trust of Kenya’s healthcare system and supporting the government’s vision of universal health coverage.
