Pharmacy board warns firms against mishandling health products

The Pharmacy and Poisons Board has issued stringent regulations on the handling, storage, and formulation of health products across the country.

In a statement on Wednesday, the board’s national regulatory authority announced that it would soon conduct surveillance inspections to identify and take action against those violating the conditions.

The regulations outline several measures that companies manufacturing Health Products and Technologies (HPTs) must implement to ensure patient safety.

They include ensuring that marketing authorisation holders 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.

Also required is the clear labelling of storage conditions and special handling instructions on all product packaging to ensure effective communication with distributors and healthcare providers.

The regulations also require firms to comply with providing adequate training and guidance to all supply chain stakeholders on best practices for handling temperature-sensitive products.

The board warned that all manufacturers, distributors, wholesalers, retailers, and healthcare facilities must store and handle HPTs according to manufacturer-specified temperature and humidity conditions.

“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,” said CEO Fred Siyoi.

According to the board, strict adherence to Good Distribution Practices (GDP) is essential to prevent product degradation and maintain product integrity throughout the supply chain.

“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,” the board stated.

The board said it will soon launch impromptu checks to ensure compliance as a way of ensuring the safety of Kenyans using health products and technologies.

"Non-compliance may result in regulatory action, including product recalls, license suspension or other enforcement measures,'' the board said.