The Pharmacy and Poisons Board (PPB) has issued strict directives to manufacturers, distributors, wholesalers, retailers, and healthcare facilities to address concerns over the degradation of Health Products and Technologies (HPTs).
PPB Chief Executive Officer Siyou stated on Wednesday that the board had received multiple complaints about HPT degradation, often linked to improper storage and handling. He warned that such deterioration compromises product quality, safety, and efficacy, ultimately posing risks to patient health.
“All manufacturers, distributors, wholesalers, retailers, and healthcare facilities must store and handle HPTs according to manufacturer-specified temperature and humidity conditions,” said Siyou.
He emphasized that strict adherence to Good Distribution Practices is crucial to prevent product degradation and maintain integrity throughout the supply chain.
The board directed manufacturers to ensure that all HPT formulations distributed in Kenya are designed, developed, and tested to withstand high-temperature and high-humidity conditions.
Market authorization holders were also urged to conduct stability studies in line with ICH Zone IVb climate conditions to ensure the medicines maintain their quality, safety, and efficacy throughout their shelf life.
Additionally, manufacturers must implement robust packaging solutions to protect products from moisture, heat, and other environmental stressors.
Labels must clearly indicate storage conditions and special handling instructions to prevent improper storage at any point in the supply chain.
“The board will conduct inspections and compliance audits to enforce these requirements. Non-compliance may result in regulatory action, including product recalls, license suspension, or other enforcement measures,” Siyou warned.
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