Gov't Clarifies Role of Diploma Holders Under New Pharmacy Practice Standards

The Ministry of Health has clarified the role of Diploma and Degree holders under the 2026 Good Pharmacy Practice Standards, following demonstrations by holders of Diploma in Pharmacy over concerns about the new regulations.

In a statement on Thursday, September 3, the ministry said it respects the right of pharmacy professionals to raise concerns and engage the government on matters affecting their practice, but maintained that the new Standards do not prevent diploma holders from practising within the health system.

"It is, however, necessary to clarify that the Standards do not bar any category of pharmacy professionals (whether diploma or degree holders) from practising or working at any level of the health system, provided they are duly enrolled or registered, licensed and operate within their lawful scope of practice," the statement read.

The ministry explained that the Standards distinguish between working as a pharmacy professional at a particular level of care and serving as the superintendent.

"Pharmacy professionals of different cadres will continue to work together across the health system. However, the minimum qualification of the superintendent must correspond to the nature, complexity and level of risk of the pharmaceutical services offered," the statement added.

The ministry said the requirement is based on competency and patient safety, with higher qualifications and competencies required where pharmaceutical services are more specialised and carry greater risks to patients.

"This is a competency-based patient-safety measure. As services become more specialised and the risks to patients increase, the qualifications and competencies of the person bearing overall responsibility (the superintendent) must increase accordingly," the ministry further said.

The ministry added that the approach is aligned with its Human Resources for Health Norms and Standards Guidelines for the Health Sector, which link staffing and professional responsibility to the services provided at each level of care.

"This approach is consistent with the Ministry’s Human Resources for Health Norms and Standards Guidelines for the Health Sector, which align staffing and professional responsibility with the services provided at each level of care," the statement explained.

The ministry further said the principal purpose of the Good Pharmacy Practice Standards is to protect patients and ensure the quality of pharmaceutical care. 

It said the Standards are also intended to strengthen the sector's ability to address illegal and unethical practices that put patients at risk.

"These include the ‘renting’ or ‘leasing’ of professional licences, operation of premises without proper professional oversight, inappropriate dispensing, misuse of antimicrobials and diversion or misuse of narcotic and psychotropic substances," the statement noted.

The ministry further rejected suggestions that the Standards were developed abruptly, saying the process took more than five years and involved multiple rounds of consultation and technical review.

According to the ministry, the consultations brought together government institutions, professional bodies, academia, healthcare providers, the pharmaceutical industry and development partners, among other stakeholders.

"The process involved the Ministry, county governments, professional associations (for both Diploma and Degree Holders), academia, public and private healthcare institutions, the pharmaceutical industry, development partners and other relevant stakeholders," the statement clarified.

The ministry said the views and recommendations received during the consultations were considered and incorporated where appropriate, based on legal requirements, professional competencies, patient safety and the wider public health interest.

"The inputs received were considered and incorporated, where appropriate, in accordance with the law, professional competencies, patient safety and the wider public health interest. The final Standards are therefore the outcome of an extensive, inclusive and consultative process," the statement concluded.

Elsewhere, this comes months after the Pharmacy and Poisons Board (PPB) responded to claims that 90 per cent of pharmacies in Nairobi were found selling illegal drugs.

In a statement on Saturday, July 4, the board's CEO, Ahmed Mohamed, clarified that the medicines examined in the study were legally imported under the parallel importation framework and were neither substandard nor unsafe for public use.

Addressing the report, Mohamed said the article's headline created a misleading impression about the status of the medicines that were assessed.

"The headline creates the impression that the medicinal products assessed were illegal, substandard, falsified or unsafe for patient use. This does not accurately reflect the findings of the study," the statement read.

Mohamed explained that the research was based on data collected between September 2023 and October 2024, meaning it did not reflect the current regulatory environment.

He also defended the parallel importation system, saying it is a legal mechanism established under the Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019 to improve access to medicines.

"Parallel importation is a lawful mechanism provided for under the Pharmacy and Poisons (Parallel Imported Medicinal Substances) Rules, 2019 to enhance the availability and affordability of medicines in Kenya," the statement noted.

Mohamed added that the medicines examined in the study had been approved under the existing legal framework and met internationally recognised manufacturing standards.

He concluded by urging the public, journalists and other stakeholders to seek accurate information from the regulator before publishing reports on pharmaceutical regulatory matters.

"The Board encourages the public, the media and all stakeholders to seek accurate regulatory information from the Pharmacy and Poisons Board and to verify regulatory matters before publication in order to promote responsible reporting," the statement concluded.