•Wairimu said recognizing their critical function, condoms have been incorporated into the regulatory landscape as medical devices
•As a result, the PPB has established a robust post-market surveillance system, periodically assessing product conformity
The Pharmacy and Poisons Board has committed to ensuring stringent condom regulation.
The PPB Medical Devices Lead Paulyne Wairimu has said that classifying condoms as medical devices is due to the need to ensure their safety and effectiveness in maintaining public health.
Within the current regulatory context, condoms are classified as medical devices, with their categorization based on risk.
They fall into Class C, signifying a high level of regulatory control as any failure to perform according to their intended use could have significant consequences for users.
“Condoms have long played a pivotal role in safeguarding public health by preventing unintended pregnancies and curtailing the transmission of sexually transmitted diseases,” Wairimu said.
Wairimu said recognizing their critical function, condoms have been incorporated into the regulatory landscape as medical devices.
As a result, the PPB has established a robust post-market surveillance system, periodically assessing product conformity, and aiding in the detection and removal of counterfeit condoms from the market.
"The PPB ensures post-market surveillance to maintain adherence to standards and swiftly detect falsified devices, with a primary focus on prioritising public health," she said.
According to the medic, PPB established a regulatory framework for medical devices in 2011, aligning it with international standards and facilitating digital market authorization submissions.
The framework expedites approvals and timelines, including the UNFPA prequalification process for condom manufacturers.
This comes amid calls by civil society for the government to remove taxes on condoms as a measure to ensure availability.
The AIDS Healthcare Foundation said condom procurement is currently categorised as medical devices and products hence slapped with high taxes including 16 per cent VAT.
“We are urging the policymakers and regulators to categorize condoms as a medical supply so that they can be tax-free so that organizations that are willing to step in and help the country restock can freely do so,” AHF Country Director Samuel Kinyanjui.
According to Kinyanjui, the cost of providing and distributing condoms is much lower than the cost of treating people with HIV and other STIs.
He noted that statistically with enough condoms, the country will be saved from treating more than 800,000 newly infected persons in the next 10 years and avert up to 5.3 million unplanned pregnancies, 60 per cent of which are teenage.