The Pharmacy and Poisons Board (PPB), under the Ministry of Health, has issued a public advisory on the proper storage, handling, and formulation of Health Products and Technologies (HPTs). The notice, dated March 12, 2025, addresses rising market complaints about product degradation, often linked to improper storage and handling practices.
According to the board, these issues pose significant risks to product quality, safety, and efficacy, ultimately affecting patient health outcomes. “The Board has received multiple market complaints regarding HPT degradation, often linked to improper storage and handling,” the statement reads. “These issues pose a significant risk to product quality, safety, and efficacy, ultimately affecting patient health outcomes.”
The PPB emphasized that all manufacturers, distributors, wholesalers, retailers, and healthcare facilities must adhere strictly to manufacturer-specified temperature and humidity conditions to maintain product integrity. It also stressed the importance of following Good Distribution Practices (GDP) across the supply chain.
To safeguard public health, the Board has outlined key compliance requirements:
- Conducting stability studies in accordance with ICH Zone IVb climatic conditions.
- Implementing robust packaging to protect products from environmental stressors.
- Clearly labeling storage conditions and special handling instructions.
- Providing adequate training to supply chain stakeholders on best practices for handling temperature-sensitive products.
The Board warned that non-compliance could lead to regulatory actions, including product recalls, license suspensions, or other enforcement measures. “The Board will conduct inspections and compliance audits to enforce these requirements,” the notice stated.
Dr. F.M. Siyoi, Chief Executive Officer of the PPB, urged all stakeholders to take immediate action to preserve the integrity of HPTs from manufacturing to end-user distribution. For further clarification, the Board has provided contact through their official email, pms@ppb.go.ke.
