Pharmaceutical technologists have declared a regulatory crisis in the medicines sector, warning that illegal chemists now outnumber licensed pharmacies four to one, exposing millions to unsafe and unaccountable dispensing of prescription drugs.
Kenya Pharmaceutical Association (KPA), Secretary General Eric Gichane, accused authorities of presiding over an enforcement vacuum that has normalised the casual sale of antibiotics and other potent medicines without prescriptions.
“We have a regulatory crisis unfolding in real time. The real crisis is not a single transaction caught on camera. The real crisis is a system that allows unsafe dispensing practices to become routine,” he said.
Kenya, he said, has about 5,000 pharmacists and 14,000 enrolled pharmaceutical technologists — roughly 19,000 trained professionals serving more than 53 million people, yet unregistered outlets were proliferating across towns and estates, often run by unqualified attendants dispensing prescription-only medicines without proper assessment or documentation.
“We estimate that for every one licensed pharmacy, there are four illegal ones operating daily with zero accountability. This is not a grey area. It is dangerous,” he said.
His remarks come amid heightened scrutiny of pharmacy practice following Public Health and Professional Standards Principal Secretary (PS) Mary Muthoni’s admission that she was sold antibiotics without being asked for a prescription, as well as a viral video showing a dispensing error involving a child.
Addressing the media in Kisumu during the KPA Central Council meeting on Saturday, Gichane insisted that the focus must shift from isolated incidents to systemic failure.
“One licensed error is investigated and accounted for. Thousands of illegal outlets operate daily beyond scrutiny. That is the imbalance we must confront,” he said.
He accused the Pharmacy and Poisons Board of failing to enforce its own guidelines, particularly those meant to strengthen professional self-regulation, ethical compliance and discipline within the sector.
“This failure is not technical; it is structural. Key regulations designed to protect Kenyans have been allowed to become optional,” he said.
He further pointed to what he termed a glaring capacity gap at the regulator, which has only 40 drug inspectors nationally to oversee more than 15,000 premises and monitor medicines entering the country each year.
“A regulator without a sufficient workforce is not a regulator. It is a powerless observer,” he said.
Gichane called on the Ministry of Health to expand the inspection workforce, fully implement self-regulation frameworks, link licence renewal to compliance with professional bodies, impose tougher penalties on unqualified dispensing of prescription medicines and mount a nationwide crackdown on illegal chemists.
“Medicines are not ordinary commodities. Pharmacy practice is not a kiosk business to be left to chance. Patient safety is a right, not a privilege,” he said.
KPA President Chitechi Amboka echoed the enforcement-focused message, arguing that empowering professional associations to oversee members would resolve most of the sector’s challenges.
“We cannot have professionals practising in silos. If all pharmaceutical technologists operate under one umbrella, adhering to a clear Code of Ethics and safer pharmacy charter, we will significantly reduce errors and eliminate quack practice,” he said.
He added that existing continuing professional development (CPD) guidelines already require practitioners to earn part of their renewal credits through professional bodies — a mechanism he described as critical to strengthening accountability if properly enforced.
Amboka warned that medical errors can occur at multiple stages — prescribing, dispensing, documentation or follow-up but stressed that the bigger threat lies in unregulated outlets where incidents go unrecorded.
“The bigger question is how many errors are happening that we do not track. If one case surfaced because of a video, what about the many taking place in illegal chemists?” he asked.
He dismissed claims that only pharmacists are legally permitted to practise, clarifying that both pharmacists and pharmaceutical technologists are recognised under Kenyan law.
He framed the crisis as a test of political will, warning that unless enforcement is restored and illegal operators shut down, public confidence in the pharmaceutical sector will continue to erode and patient safety will remain exposed.