PPB Targets Absentee Pharmacists
Kenya’s pharmaceutical regulator is stepping up its crackdown on unethical practices in the medicines sector, targeting absentee pharmacists, illegal suppliers and businesses accused of misusing professional licences.
The Pharmacy and Poisons Board (PPB) is introducing a new digital system that will allow it to monitor pharmaceutical professionals, licensed facilities and the movement of medicines more closely.
The reforms come at a critical time for Kenya’s medicines regulatory system, with the country preparing for a World Health Organization (WHO) assessment in September.
Kenya is seeking to attain WHO Maturity Level 3, an internationally recognised benchmark for a stable and effective national medicines regulatory authority.
PPB Chairperson Dr John M. Munyu said the regulator had moved beyond planning reforms and was now putting new measures into practice.
“We are no longer talking about reform. We are implementing it,” Munyu said on Thursday at the 22nd Kenya Pharmaceutical Association Scientific Conference in Mombasa.
The first phase of the digital reforms will begin on August 3, when the PPB rolls out three electronic platforms designed to replace much of the paper-based oversight that has traditionally been used to monitor the pharmaceutical sector.
The platforms will cover pharmaceutical professionals, licensed facilities and the supply chain, giving the regulator greater visibility of activities across the industry.
PPB targets absentee pharmacists
One of the practices under scrutiny is the use of professional licences by pharmacists who are not physically present at the facilities where they are registered.
The PPB says some pharmacists register pharmacies but fail to supervise their operations, leaving medicines to be dispensed by people who may not have the required qualifications.
Munyu said inspectors had encountered cases where the licensed superintendent of a pharmacy lives hundreds of kilometres away while relatives, spouses or other unqualified individuals run the business.
“The days when a license is registered in Nairobi while its holder permanently resides elsewhere … shall at last come to an end,” he said.
The regulator is introducing Practice360 and Facility360 to strengthen the monitoring of pharmaceutical professionals and licensed premises.
The platforms are expected to make it easier for the PPB to establish where professionals are practising and whether licensed facilities are operating in compliance with regulatory requirements.
All licensed pharmaceutical professionals and facilities will be required to complete the onboarding process by October 31, 2026, to remain eligible for the 2027 licensing cycle.
Munyu warned that the deadline would be strictly enforced.
“There will be no extension and no negotiation,” Munyu said.
The digital transition marks a significant change in how the regulator intends to monitor the pharmaceutical sector.
Electronic records could also help the PPB identify irregularities more quickly and strengthen accountability among professionals and businesses operating within the industry.
The crackdown extends beyond pharmacies to companies involved in supplying medicines.
New system to track medicines
The PPB is strengthening oversight of the pharmaceutical supply chain through the National Authentication and Traceability System.
The system will enable medicines to be tracked from manufacturers through the supply chain until they reach patients.
Mandatory serialization of pharmaceutical products is scheduled to begin on January 1, 2027.
The move is expected to give regulators greater ability to trace medicines and identify weaknesses in the supply chain.
PPB enforcement teams have already stepped up operations against illegal pharmaceutical activities.
Munyu said intelligence-led operations had resulted in more than 95 arrests linked to illegal activities involving medicines.
The board has also initiated disciplinary proceedings against 22 wholesale distributors accused of supplying medicines to non-compliant retail outlets.
The enforcement campaign reflects growing concern over what happens to medicines after they leave manufacturers and authorised suppliers.
Poor storage, transportation and handling can affect the quality and safety of medicines even when the products were manufactured to the required standards.
“Medicines do not become poor quality only because they were poorly manufactured,” Munyu said. “They also become poor quality when they are poorly stored, poorly transported, or poorly handled.”
The PPB wants the new tracking system to strengthen accountability at each stage of the supply chain.
The reforms also form part of Kenya’s preparations for the upcoming WHO assessment.
The Global Benchmarking Tool assessment examines the capacity and performance of national medicines regulatory authorities against internationally recognised standards.
Kenya’s push to reach Maturity Level 3 reflects efforts to strengthen the country’s regulatory systems and improve confidence in the safety and quality of medicines available to the public.
The assessment comes at a time when the pharmaceutical industry is undergoing broader changes aimed at improving compliance with Good Storage and Distribution Practice standards.
Speaking at the conference, Principal Secretary for Public Health and Professional Standards Mary Muthoni urged pharmacists, pharmaceutical technologists and other industry players to maintain high standards of professionalism.
The conference provided an opportunity for regulators and pharmaceutical professionals to discuss the changes facing the sector and the role of stronger oversight in protecting patients.
Munyu said responsibility for medicine safety does not rest solely with the regulator.
Pharmacists, pharmaceutical technologists, manufacturers, distributors, wholesalers and pharmacy owners all have a role to play in ensuring medicines remain safe and effective from the point of manufacture to the patient.
The PPB’s latest measures could therefore reshape how pharmaceutical businesses operate, particularly those that have relied on paper-based records or arrangements that make it difficult to establish who is actually supervising a facility.
The regulator’s deadline also places pressure on licensed professionals and facilities to complete the new digital onboarding process ahead of the 2027 licensing cycle.
Failure to comply could affect their ability to obtain licences for the next cycle.
The introduction of mandatory product serialization from January 2027 will add another layer of accountability, allowing the regulator to follow medicines through the supply chain and potentially identify counterfeit, diverted or improperly handled products more efficiently.
Kenya’s pharmaceutical sector is consequently entering a new phase of regulatory oversight, driven by technology, stricter enforcement and greater accountability.
The PPB hopes the changes will strengthen the country’s medicines regulatory system ahead of the WHO assessment while ensuring that patients receive medicines that are safe, effective and properly handled.
The success of the reforms, however, will depend on how effectively the new systems are adopted by pharmaceutical professionals and businesses across the country.
The regulator has made clear that the era of weak oversight and loosely monitored pharmaceutical operations is coming under increasing pressure.
