NAIROBI, Kenya — Health Cabinet Secretary Aden Duale has defended the 2026 Good Pharmacy Practice Standards amid protests by holders of Diplomas in Pharmacy, insisting that the new regulations do not prevent qualified pharmacy professionals from practising.
In a statement issued on Wednesday, September 3, Duale said the standards distinguish between practising as a pharmacy professional and serving as a superintendent, who carries overall professional and regulatory responsibility for a pharmaceutical facility.
The Ministry maintained that both diploma and degree holders can continue working across Kenya’s health system as long as they are duly registered, enrolled and licensed and operate within their legally defined scope of practice.
“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 Ministry stated.
Duale explains superintendent requirements
While defending the standards, Duale acknowledged that different qualification requirements apply to professionals appointed as superintendents.
According to the Ministry, the minimum qualification for a superintendent will depend on the nature, complexity and level of risk associated with the pharmaceutical services provided by a particular facility.
The government says the distinction is intended to ensure that professionals carrying overall responsibility for a facility possess the level of competence required for the services being offered.
More specialised or higher-risk pharmaceutical services would therefore require higher levels of qualifications and competency from the professional responsible for their overall management.
“The principal purpose of the Good Pharmacy Practice Standards is to protect the patient and assure the quality of pharmaceutical care,” Duale stated.
Ministry cites patient safety and professional standards
The Ministry said the new standards are intended to strengthen professional practice and protect patients from unsafe or unethical practices within the pharmaceutical sector.
Among the practices the government says it seeks to address are the alleged renting or leasing of professional licences, operation of pharmaceutical premises without adequate professional oversight and inappropriate dispensing of medicines.
The Ministry also cited concerns over the misuse of antimicrobials, as well as the diversion or misuse of narcotic and psychotropic substances.
According to the government, stronger professional standards are necessary to ensure that medicines are handled, dispensed and managed by appropriately qualified personnel.
Government defends legal basis of regulations
Duale also defended the legal and constitutional basis for the Good Pharmacy Practice Standards.
The Ministry cited Article 43 of the Constitution, which guarantees the right to the highest attainable standard of health, and Article 46, which protects consumer rights to quality goods and services, adequate information and protection of health and safety.
The government also referred to Section 3B(3)(a) of the Pharmacy and Poisons Act, which gives the Pharmacy and Poisons Board a mandate to promote pharmacy practice that complies with universally accepted norms and values.
The Ministry argues that the standards are therefore part of its broader responsibility to safeguard patients and improve the quality of pharmaceutical services.
Ministry says standards took five years to develop
Responding to concerns that pharmacy standards were introduced without adequate consultation, the Ministry said their development took more than five years.
According to Duale’s statement, the process went through 11 iterations, alongside stakeholder consultations and technical reviews.
The Ministry said the process involved a wide range of participants, including:
- The Ministry of Health
- County governments
- Professional associations representing diploma and degree holders
- Academic institutions
- Public and private healthcare facilities
- The pharmaceutical industry
- Development partners
- Other stakeholders
The government said submissions received during the process were reviewed and incorporated where appropriate, taking into account the law, professional competency, patient safety and wider public health considerations.
“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 Ministry stated.
Diploma holders protest new standards
The government’s clarification comes amid demonstrations by pharmacy professionals holding diplomas who have raised concerns about the implications of the new standards.
The protests have centred on the interpretation of qualification requirements, particularly the distinction between practising as a pharmacy professional and taking responsibility as a superintendent.
The Ministry insists that the standards should not be interpreted as barring diploma holders from employment or practice.
Instead, it says the qualification requirements for leadership and supervisory roles are linked to the complexity and risk profile of individual pharmaceutical facilities.
The distinction is likely to remain a key issue as pharmacy professionals assess how the standards will affect their employment opportunities and career progression.
Implementation begins in January 2027
The Pharmacy and Poisons Board is expected to provide further clarification and implementation support as the sector prepares for the new standards.
The 2026 Good Pharmacy Practice Standards are scheduled to take effect on January 1, 2027.
Duale said the Ministry remained open to engaging pharmacy professionals as concerns over the implementation of the regulations continue.
