The Ministry of Health has clarified the roles of diploma and degree holders under the 2026 Good Pharmacy Practice Standards following demonstrations by Diploma in Pharmacy holders who raised concerns about the new regulations.
In a statement issued on Thursday, September 3, the ministry said the new standards do not prevent diploma holders from practising within Kenya’s health system.
The ministry stressed that all pharmacy professionals, regardless of their academic qualification, can practise or work at different levels of the health system as long as they are properly enrolled or registered, licensed and operate within their legally defined scope of practice.
It explained that the standards distinguish between working as a pharmacy professional at a particular level of care and taking responsibility as a superintendent.
According to the ministry, pharmacy professionals from different cadres will continue working alongside one another across the health system. However, the minimum qualification required for a superintendent will depend on the nature, complexity and level of risk associated with the pharmaceutical services provided.
The ministry said the requirement is primarily intended to promote competency and protect patients. It noted that more specialised pharmaceutical services with greater risks require individuals with higher qualifications and appropriate competencies to take overall responsibility.
The approach, the ministry added, is consistent with its Human Resources for Health Norms and Standards Guidelines for the Health Sector, which link staffing requirements and professional responsibility to the level and type of services offered.
The ministry said the primary objective of the Good Pharmacy Practice Standards is to protect patients and improve the quality of pharmaceutical care.
The regulations are also intended to strengthen oversight of the sector and address practices that could endanger patients, including the leasing or renting of professional licences, operating pharmaceutical premises without adequate professional supervision, improper dispensing, misuse of antimicrobials and diversion or misuse of narcotic and psychotropic medicines.
The ministry also rejected claims that the standards were introduced without adequate consultation.
It said the development process lasted more than five years and involved several rounds of stakeholder consultations, technical reviews and discussions.
Participants included national and county government institutions, professional associations representing both diploma and degree holders, academic institutions, public and private healthcare providers, the pharmaceutical industry and development partners.
The ministry said feedback received during the process was reviewed and incorporated where appropriate, taking into account legal requirements, professional competencies, patient safety and the broader public health interest.
It maintained that the final standards were therefore the product of an extensive and consultative process.
The clarification comes months after the Pharmacy and Poisons Board (PPB) addressed reports alleging that 90 per cent of pharmacies in Nairobi were selling illegal medicines.
In July, PPB Chief Executive Officer Ahmed Mohamed disputed the impression created by the report, saying the medicines assessed in the study had been legally imported through the parallel importation framework and were not considered substandard or unsafe.
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Mohamed said the research relied on data collected between September 2023 and October 2024 and therefore did not necessarily represent the current regulatory environment.
He also defended parallel importation as a lawful mechanism established under the Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019, aimed at improving the availability and affordability of medicines.
The PPB CEO said the medicines examined in the study had been approved under the applicable legal framework and complied with internationally recognised manufacturing standards.
He urged the public, media and other stakeholders to verify pharmaceutical regulatory information with the regulator before publishing reports to avoid creating misleading impressions about the safety or legality of medicines.