Health CS Aden Duale Issues Tough Directives in Crackdown on Fake and Substandard Medicine

Nairobi, 26 November 2025 – In a speech during his first official visit to the Pharmacy and Poisons Board (PPB) headquarters, Cabinet Secretary for Health Aden Duale, declared war on counterfeit, falsified, and substandard medicines, directing the regulator to “rid the Kenyan market” of illegal products without fear or favour.

“Kenya must not be a safe haven for falsified or substandard health products,” the CS told PPB leadership and staff, issuing a series of immediate directives that include arrests, prosecutions, premises closures, and seizures.

Key directives issued by CS Duale:

• Immediate removal from the market of all substandard, falsified, counterfeit, and unregistered medicines.
• Arrest and prosecution of individuals, directors, and entities involved in distributing or selling illegal medicines.
•  Full enforcement of the 2019 Parallel Importation Rules and removal of any non-compliant products or players.
• An end to the illegal leasing of professional licences to unqualified persons, with intensified surveillance ordered.
• Strict adherence to product registration renewal timelines, with no indefinite market stay allowed.
• Full implementation of the Bioequivalence Roadmap for generic medicines  “It is not negotiable,” the CS emphasised.

The Cabinet Secretary warned PPB inspectors that any compromise or neglect of duty would attract individual administrative, disciplinary, or legal action.

Duale also revealed that the Ministry has approved the recruitment of 45 additional officers through a World Bank-funded project to bolster regulatory capacity, while engaging Treasury for further hiring.

Pushing for global standards, the CS reiterated Kenya’s determination to attain World Health Organization Maturity Level 3 (WHO ML3) status for its medicines regulator, saying the milestone is critical for stronger oversight, market access, investor confidence, and the growth of local pharmaceutical manufacturing.

“I look forward to returning next year to celebrate this milestone with you,” he told the Board.

Framing the reforms within the government’s Bottom-Up Economic Transformation Agenda (BETA), Duale described the PPB as “the guardian of quality, safety, and trust” in Kenya’s healthcare system and a central player in achieving Universal Health Coverage and scaling up local production of medicines.

He addressed on the signals of an intensified regulatory crackdown as Kenya moves to clean up its pharmaceutical sector and align with international best practices.