Kenya orders drug manufacturers to adopt digital tracking system by December 31

Pharmaceutical manufacturers operating in Kenya have until the end of December to put their products on a digital tracking system as the government moves to tighten surveillance of medicines and prevent counterfeit and poor-quality drugs from reaching the public.

The December 31, 2026 deadline requires manufacturers to adopt GS1 international standards, which will pave the way for a digital Track and Trace system capable of monitoring pharmaceutical products throughout the supply chain, from production to the final consumer.

Principal Secretary for Medical Services Ouma Oluga announced the deadline on Wednesday, November 4, during the Health Products and Technologies Stakeholder Meeting in Nairobi, which he attended on behalf of Health Cabinet Secretary Aden Duale.

Oluga said manufacturers were expected to bring their operations into line with the global standards as the government seeks to improve the safety, transparency and accountability of the pharmaceutical sector.

The planned digital platform will give regulators the ability to follow the journey of medicines from manufacturing facilities through distributors and suppliers to the people who eventually use them.

This will help establish the source of pharmaceutical products, their distribution routes and the points at which they are supplied, particularly when questions emerge about their quality or safety.

The Pharmacy and Poisons Board (PPB) has backed the initiative, saying better tracking of medicines is necessary to shield the public from falsified and substandard health products.

“Strengthening medicine traceability is essential to protecting Kenyans from falsified and substandard medicines and ensuring access to safe, effective and quality-assured health products,” the board said.

The board participated in the stakeholder meeting through its Director of Pharmacy Practice, Dr Wilfred Ochieng.

Through the proposed system, medicines will have improved digital identification, enabling authorities to establish their movement at every stage of the distribution process.

The arrangement is expected to deal with challenges faced by regulators when attempting to trace counterfeit, compromised or unsafe products after they have entered the market.

It will also improve the government's response to medicine safety alerts by giving authorities access to information that can help them identify affected batches and trace where the products were distributed.

This is expected to make it easier to withdraw unsafe medicines from circulation through timely recalls, reducing the risk of patients continuing to access products that do not meet the required standards.

The tracking system will further place greater responsibility on manufacturers, distributors, suppliers and other businesses handling pharmaceutical products, as their role in the movement of medicines will be easier to monitor.

By creating a clearer record of the supply chain, the government hopes to address weaknesses that have previously made it difficult to determine the origin of medicines and how they reach consumers.

The government is also looking beyond medicine safety, with the adoption of GS1 standards expected to improve the procurement of health products and encourage the growth of local pharmaceutical manufacturing.

The digital platform will provide institutions with improved details on the availability and distribution of medicines, helping them plan purchases based on more reliable information.

It is also expected to increase confidence in pharmaceutical products manufactured locally by making it easier to confirm their authenticity and follow their distribution from production facilities to the market.

The initiative is expected to improve the management of the pharmaceutical supply chain by giving regulators and other stakeholders better visibility of products at different stages of distribution.

With the December 31 deadline approaching, manufacturers are expected to align their operations with the international requirements ahead of the system's implementation.

The government views the transition as a key measure towards strengthening oversight of medicines, improving the handling of pharmaceutical products and ensuring patients have access to safe, effective and quality-assured health supplies.