PPB plans nationwide inspections to strengthen compliance in medicine supply

Pharmacy and Poisons Board inspectors conduct post-market surveillance to ensure health products meet required standards. [Benard Orwongo, Standard]

The Pharmacy and Poisons Board (PPB) is strengthening oversight of the storage, transportation and distribution of medicines and other health products as it plans nationwide compliance inspections.

The inspections are set to be conducted in public and private hospital pharmacies, retail pharmacies, pharmaceutical wholesalers and transporters.

The exercise forms part of the Board’s ongoing efforts to strengthen compliance with Good Storage and Distribution Practices and ensure that health products retain their quality, safety and effectiveness throughout the supply chain.

During the financial year 2025/2026, PPB conducted 3,453 compliance inspections, with 2,845 premises found to be compliant, representing an overall compliance rate of 82.4 per cent.

Regulatory actions, including closures and arrests, were taken against non-compliant premises.

PPB Chief Executive Officer Ahmed Mohamed said protecting medicine quality requires sustained oversight beyond the manufacturing stage, as poor handling or unsuitable storage and transportation conditions can compromise products before they reach patients.

“Medicines must be stored, transported and handled under the conditions approved for them. We are strengthening oversight across the supply chain to ensure that patients receive products whose quality, safety and effectiveness have been preserved,” said Mohamed.

Particular attention will be given to temperature-sensitive products, including vaccines, insulin and biological medicines, which require controlled storage and transportation conditions.

The inspections will assess whether facilities and transporters have appropriate monitoring systems, maintain temperature records and respond effectively to deviations.

Regulated entities will also be expected to demonstrate that they have suitable premises and equipment, qualified personnel, documented operating procedures and contingency arrangements for power interruptions, equipment failure and other incidents that could affect product quality.

The PPB boss emphasised that reliable records and effective traceability are essential to identifying the source and movement of products and supporting timely action when quality concerns arise.

“Every regulated health product should be traceable throughout the distribution chain. Accurate records enable us to identify affected products and coordinate timely action when substandard or suspected falsified products are detected,” he said.

The planned exercise will also examine sourcing and supply practices, including whether products are obtained from authorised suppliers and supplied to appropriately authorised recipients.

Inspectors will assess arrangements for identifying, segregating and handling expired, damaged, returned, recalled or suspected falsified products to prevent their unintended use or redistribution.

For pharmaceutical transporters, the focus will include whether vehicles, containers and handling procedures protect products against unsuitable temperatures, moisture, contamination, physical damage and theft.

Transporters handling temperature-sensitive products will be expected to demonstrate that the required conditions are maintained throughout transit.

Where compliance gaps are identified, entities will be required to implement corrective and preventive measures within stipulated timelines. Appropriate regulatory action will be taken where non-compliance poses a risk to public health.

Additionally, Mohamed called on public and private hospitals, retail pharmacies, wholesalers and pharmaceutical transporters to review their operations and address gaps as part of their routine responsibility to protect medicine quality.

“Good Distribution Practices are an essential public health safeguard. Every organisation handling medicines has a responsibility to ensure that the products reach patients in the condition intended,” he said.

Members of the public are encouraged to obtain medicines from licensed pharmacies and authorised health facilities, observe the recommended storage instructions and report products with damaged packaging, signs of alteration or other suspicious features.

Through continued inspections and the planned nationwide exercise, PPB aims to strengthen compliance across the pharmaceutical supply chain, reduce risks arising from poor storage and distribution, and safeguard the quality of medicines supplied to patients.