The directives issued by the Cabinet Secretary of Health of Kenya, Hon. Aden Duale, to the Pharmacy and Poisons Board mark a decisive step in safeguarding public health and advancing Kenya’s pharmaceutical sector. By tackling substandard and counterfeit medicines, enforcing bioequivalence standards, and ending malpractice in licensing, the Ministry is reinforcing trust in our health system. We applaud the Cabinet Secretary and PPB for undertaking to have the 2019 Parallel Importation rules implemented.
Equally important is the recognition of PPB’s progress toward WHO Maturity Level 3 — a milestone that will not only enhance regulatory oversight but also unlock opportunities for local manufacturing, investor confidence, and expanded market access. The approval to recruit additional officers under the World Bank-supported Health Emergency Preparedness, Response and Resilience Project further demonstrates the commitment to building PPB’s regulatory capacity.
This will go a long way to accelerate the reforms at PPB towards attainment of ML 3 status – a welcome development to an industry that has had to contend with delays in regulatory processes due to staff shortages at PPB.
This is more than regulation – it is about protecting lives, ensuring access to the highest standard of healthcare for Kenyans through access to safe and quality health products and technologies, and positioning Kenya as a leader in medical products innovation and access. The call to enforce the law firmly, fairly, and without fear or favor is one we must all support.
We call upon all stakeholders – industry, healthcare professionals, patients, and government entities – to support the Ministry of Health and PPB as they embark on this raft of measures to strengthen Kenya’s regulatory environment for the benefit of patients. We, as an industry, offer our unreserved commitment to continuously adhere to the applicable rules and regulations
Dr James Mokoro,
On behalf of KAPI Leadership Team