Govt Issues Advisory On Storage & Handling Of Medicines
PPB emphasized the urgent need for all manufacturers, distributors, wholesalers, retailers, and healthcare facilities to strictly adhere to manufacturer-specified temperature and humidity requirements.
Viral Tea Ke Writer 
The Pharmacy and Poisons Board (PPB) has raised concerns over the improper storage and handling of Health Products and Technologies (HPTs), warning that such practices are leading to product degradation and posing serious risks to patient safety.
In a statement on Wednesday, March 12, the Board CEO, Fred Siyoi, revealed that it has received multiple market complaints regarding the quality and efficacy of HPTs, often linked to failures in maintaining required storage conditions.
PPB emphasized the urgent need for all manufacturers, distributors, wholesalers, retailers, and healthcare facilities to strictly adhere to manufacturer-specified temperature and humidity requirements.
Pharmacy and Poisons Board offices. /FILE
"The Board has received multiple market complaints regarding HPT degradation, often linked to improper storage and handling. These issues pose a significant risk to product quality, safety, and efficacy, ultimately affecting patient health outcomes," the statement read in part.
To mitigate risks, PPB has directed marketing authorization holders to comply with the following key measures:
- Conduct stability studies under ICH Zone IVb climatic conditions to ensure product safety and effectiveness throughout its shelf life.
- Implement protective packaging to safeguard against heat, moisture, and environmental stress.
- Clearly label all products with storage conditions and handling instructions to ensure proper distribution and use.
- Provide training for supply chain stakeholders on best practices for handling temperature-sensitive products.
Siyoi warned that the board will carry out inspections and compliance audits to enforce these directives. Non-compliance could lead to severe regulatory action, including product recalls, license suspensions, or other enforcement measures.
"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," added the statement.
PPB is calling on all industry stakeholders to take immediate action to uphold the integrity of medical products. For further inquiries, stakeholders are urged to contact the Board at pms@ppb.go.ke.
On January 18, 2025, PPB announced new directives targeting pharmaceutical products entering the Kenyan market that reference the Indian Pharmacopoeia (IP) after the board raised the alarm regarding the increasing influx of unregistered pharmaceutical products in the Kenyan market, particularly those referencing the IP.
The Pharmacy and Poisons Board (the Board) is statutorily mandated to protect the health of the public by regulating the profession of pharmacy and ensuring access to quality, safe, efficacious and affordable health products and technologies.
