Pharmaceutical manufacturers have until 31 December 2026 to comply with internationally recognised #GS1 standards as the Government advances digital reforms aimed at strengthening medicine safety, authenticity, traceability and accountability across Kenya’s pharmaceutical supply chain.
The deadline was announced by the Principal Secretary for Medical Services, Dr. Ouma Oluga, during a high-level Health Products and Technologies (HPT) Stakeholder Breakfast Meeting at Villa Rosa Kempinski Hotel in Nairobi.
The meeting brought together pharmaceutical manufacturers, suppliers, regulators and government agencies to discuss implementation of the National Logistics Management Information System (NLMIS) and its integrated digital Track and Trace solution.
Speaking on behalf of the Cabinet Secretary for Health, Hon. Aden Duale, Dr. Oluga said the initiative will establish end-to-end visibility of health products, from manufacture to the patient, to help combat falsified and substandard medicines, strengthen regulatory oversight and build public confidence in the quality of medical products. Under the new requirements, manufacturers must comply with GS1 standards by the stipulated deadline, while products supplied through the Kenya Medical Supplies Agency (KEMSA) will be required to meet prescribed product identification and data standards.
The Principal Secretary emphasised that improved traceability will promote value for money through greater visibility of product information and pricing, informed procurement decisions and efficient utilisation of resources under the Social Health Authority (SHA). He further underscored the importance of coordinated procurement to aggregate demand, negotiate competitive prices and strengthen purchasing efficiency in support of Universal Health Coverage (UHC).
On local pharmaceutical manufacturing, Dr. Oluga reaffirmed the Government’s commitment to strengthening domestic production through appropriate incentives, access to financing, predictable supply arrangements and regulatory reforms. He noted that improved supply chain data will enhance market visibility, support investment planning and facilitate exports. He urged manufacturers and suppliers to designate technical and business representatives to work with the Ministry and its agencies in aligning product data, addressing interoperability requirements and preparing for theDecember 2026 compliance deadline.
The initiative is being spearheaded by the Digital Health Agency - Kenya (DHA), in collaboration with the Directorate of Health Products and Technologies (DHPT), KEMSA and the Pharmacy and Poisons Board (PPB).