Duale Issues July 1 Ultimatum on Digital Tracking of Medicines

By Mbungu Harrison

Email, thecoastnewspaper@gmail.com

Health cabinet secretary Aden Duale has issued a July 1 ultimatum requiring all pharmaceutical players in the country to comply with a new digital regulatory framework aimed at improving medicine safety, eliminating counterfeit drugs and strengthening oversight of the country’s pharmaceutical supply chain.

Speaking during the Pharmaceutical Society of Kenya conference, the CS announced that the Ministry of Health in collaboration with the Pharmacy and Poisons Board (PPB) and the Digital Health Agency (DHA) will roll out three national digital platforms across the pharmaceutical sector beginning July 1, 2026.

The platforms include the National Track and Trace System (NTTS), Practice360 and Facility360.

According to him the systems are designed to strengthen pharmaceutical governance, improve patient safety, enhance supply chain visibility and ensure compliance with national health regulations.

“Effective 1st July 2026, all pharmacists, pharmaceutical technologists, pharmacies, chemists, manufacturers, importers, distributors, wholesalers and healthcare facilities handling pharmaceutical products shall be required to register, integrate and maintain active compliance with these platforms,” he said.

The NTTS will provide end-to-end monitoring and traceability of pharmaceutical products imported, manufactured, distributed, prescribed, dispensed and consumed within the country.

Practice360 will serve as the national licensing and professional management platform for pharmacists and pharmaceutical technologists while Facility360 will manage licensing, compliance and oversight of pharmaceutical establishments including pharmacies, manufacturers and distributors.

The CS said all pharmaceutical stakeholders would also be required to comply with GS1 global standards for product identification, serialization, authentication and traceability.

They will further be required to capture and report pharmaceutical products and transactions through the National Logistics Management Information System and the NTTS while ensuring interoperability with national digital health systems.

“The Pharmacy and Poisons Board shall only issue, renew or maintain licences for pharmaceutical establishments that demonstrate full compliance with the prescribed digital health, interoperability and pharmaceutical traceability requirements,” he warned.

The directive is anchored in the Digital Health Act, 2023, its accompanying regulations, the Health Act and relevant provisions of the Pharmacy and Poisons Act.

Duale cautioned that non-compliance would attract regulatory action under existing laws.

“All stakeholders are required to achieve full compliance by 1st July 2026. Non-compliance shall attract regulatory action in accordance with applicable laws and regulations,” he said.

Beyond regulation, the CS challenged universities and training institutions to modernise pharmacy education to align with emerging technological demands.

“Technology is only as effective as the professionals who deploy it,” he said.

“The pharmacist of the future must be clinically competent, digitally literate, entrepreneurial, research-oriented and capable of leading innovation rather than merely adapting to it,” he added.

The health boss also linked the pharmaceutical reforms to the government’s efforts to reduce maternal and newborn deaths through the Every Woman Every Newborn Everywhere (EWENE) Initiative and the Maternal and Newborn Health Rapid Results Initiative.

He noted that pharmacists play a critical role in ensuring uninterrupted availability of life-saving commodities, quality assurance and rational use of medicines.

“No woman should lose her life while giving life because an essential medicine was unavailable, substandard or poorly managed,” he said.

The CS highlighted the importance of ensuring consistent access to key maternal and newborn health commodities including heat-stable carbetocin, oxytocin, magnesium sulphate, antibiotics, blood products and newborn medicines.

He described pharmacists as the final safeguard between medicines and patients, urging practitioners to uphold the highest ethical standards.

“Whenever commercial interests conflict with public interest, the patient must always come first,” he said.

He assured the pharmaceutical sector of the government’s support in strengthening regulation, combating antimicrobial resistance, accelerating local manufacturing and harnessing digital innovation to expand access to quality healthcare.

He challenged conference delegates to generate practical recommendations that could inform policy and improve implementation across the health sector.

“I look forward to receiving a practical and actionable white paper that will help inform policy, strengthen implementation and accelerate our collective pursuit of the highest attainable standard of health.”