NAIROBI, Kenya — The Ministry of Health has announced the rollout of a mandatory online system for the declaration of batch numbers for all imported, exported, and locally manufactured health products, in a major step aimed at tightening regulation of prescription-only medicines and strengthening oversight of the pharmaceutical supply chain.
Health Cabinet Secretary Aden Duale said the new system will become operational on January 1, 2026, and will require all manufacturers, importers, and exporters of health products to declare batch details through an online platform.
The move, he said, is part of a broader crackdown on the unlawful sale and distribution of prescription-only medicines.
“Batch declaration will be mandatory and enforceable. This measure is intended to enhance our ability to monitor the movement and sale of prescription medicines and protect the public from illegal and unsafe products,” Duale said in a statement released on Tuesday, December 23.
The CS said the online system will allow regulators to track medicines throughout the supply chain, making it easier to identify illegal diversions, counterfeit products, and non-compliant traders. The initiative is expected to improve accountability among manufacturers, wholesalers, and retailers, while strengthening consumer protection.
As part of the reforms, Duale revealed that the Ministry has finalised the Track and Authentication Standard for Health Products and Technologies, a framework designed to improve traceability, transparency, and visibility across the pharmaceutical sector.
“The Track and Authentication Standard will enhance traceability, accountability, and visibility across the entire pharmaceutical supply chain,” Duale said, adding that the technology will play a central role in ensuring that only authorised and quality-assured medicines reach patients.
The announcement comes amid intensified regulatory enforcement in the run-up to the 2026 licensing cycle. Duale said the Ministry is currently conducting 100pc inspections of all licensed pharmaceutical wholesalers within the Nairobi region, a process aimed at identifying and addressing non-compliance before licences are renewed.
Practitioners found to be in breach of regulatory requirements are being referred to the Board’s Ethics and Disciplinary Committee (EDC) for action. Sanctions imposed by the committee include suspension or revocation of practising licences, depending on the severity of the violations.
“Over 10 practitioners have already been presented before the Ethics and Disciplinary Committee for disciplinary proceedings,” Duale said.
The CS noted that new EDC board members were appointed on November 7, and the committee is expected to be fully operational from January 2026. Once operational, the board will handle pending disciplinary cases and oversee the referral of additional non-compliant practitioners for appropriate regulatory action.
Beyond enforcement, the Ministry is also working to improve regulatory clarity for both practitioners and the public. Duale said the government is in advanced stages of completing the scheduling of medicines, a process that will classify drugs based on their level of control and the conditions under which they can be dispensed.
“The scheduling of medicines will be made publicly available to Kenyans to enhance transparency, support compliance by practitioners and strengthen enforcement,” he said.
To bolster regulatory capacity, the Ministry has authorised the recruitment of additional regulatory staff, a move expected to significantly improve inspection coverage and enforcement at the retail pharmacy level, where illegal sale of prescription medicines has been a persistent challenge.
In parallel, the Ministry is rolling out public education and awareness campaigns to inform Kenyans about the dangers of using prescription-only medicines without proper medical authorization.
Health officials have repeatedly warned that misuse of such drugs can lead to serious health complications, drug resistance, and avoidable deaths.
The latest measures reflect growing concern within the government about gaps in pharmaceutical regulation and the proliferation of unregulated medicines in the market.
By combining technology-driven tracking systems, stricter inspections, and enhanced disciplinary processes, the Ministry says it aims to restore confidence in Kenya’s pharmaceutical sector and safeguard public health.
Duale said the reforms signal a firm commitment to enforcement, warning that practitioners and traders who fail to comply with the new requirements will face decisive regulatory action once the systems come into force in 2026.
