The Pharmacy and Poisons Board (PPB) has directed all manufacturers, distributors, wholesalers, retailers, and healthcare facilities to store and handle Health Products and Technologies (HPTs) according to manufacturer-specified temperature and humidity conditions.
In a statement on Wednesday, March 12, PPB CEO Fred Siyoi said the board has received multiple market complaints regarding HPT degradation which is often linked to improper storage and handling.
Siyoi noted that the issues pose a significant risk to product quality, safety, and efficacy, ultimately affecting patient health outcomes.
“All manufacturers, distributors, wholesalers, retailers, and healthcare facilities must store and handle HPTs according to manufacturer-specified temperature and humidity conditions.
“Strict adherence to Good Distribution Practices (GDP) is essential to prevent product degradation and maintain product integrity across the supply chain,” the statement by PPB read in part.
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Siyoi also said that manufacturers must ensure that any HPT formulation intended for distribution in Kenya is designed, developed, and tested to withstand high-temperature and high-humidity environmental conditions.
Further, the PPB CEO mentioned that marketing authorization holders are required to conduct stability studies in accordance with ICH Zone IVb climatic conditions to ensure the formulation maintains quality, safety, and efficacy throughout its shelf life.
They are also required to implement robust packaging to protect products from moisture, heat, and environmental stressors, clearly label storage conditions and special handling instructions on all product packaging, and provide adequate training and guidance to all supply chain stakeholders on how to handle temperature-sensitive products.
Additionally, Siyoi said the board will conduct inspections and compliance audits to enforce the requirements.
“Non-compliance may result in regulatory action, including product recalls, license suspension, or other enforcement measures.
"We urge all stakeholders to take immediate action to comply with these directives and ensure the integrity of HPTs from manufacturing to end-user distribution,” Siyoi added.
