Why protecting patients from substandard medicines is everyone’s business
The Pharmacy and Poisons Board officers inspect drugs and medicines nabbed in routine inspections and crackdown at their offices in Kisumu.
What you need to know:
- As Kenya advances Universal Health Coverage and expands access to healthcare, the availability of safe, quality, and effective medical products has never been more critical.
Healthcare is built on trust. Every time a patient takes a prescribed medicine, receives a vaccine, uses a medical device, or purchases treatment from a pharmacy, they trust that the product is safe, effective, and of assured quality. Few people pause to consider the systems that make that confidence possible, yet behind every medicine on a pharmacy shelf lies an extensive regulatory process designed to protect patients and safeguard public health.
As Kenya advances Universal Health Coverage and expands access to healthcare, the availability of safe, quality, and effective medical products has never been more critical.
But access alone is insufficient. Medicines must be rigorously evaluated before reaching patients, manufactured to internationally accepted standards, distributed through secure supply chains, and continuously monitored after they enter the market. Without these safeguards, the very products intended to heal can instead place lives at risk.
This is the role of medicines regulation. Though it often operates behind the scenes, it is one of the most essential pillars of a resilient health system. Effective regulation protects patients from substandard and falsified medicines, fosters confidence in healthcare services, supports innovation, and ensures that quality health products remain available to those who need them.
In Kenya, this responsibility rests with the Pharmacy and Poisons Board (PPB), the national medicines regulatory authority established under the Pharmacy and Poisons Act (Cap. 244). The Board regulates medicines, medical devices, in-vitro diagnostics, and other health products and technologies, while also overseeing the practice of pharmacy.
Every decision the Board makes is guided by one overriding objective: protecting the health and safety of the Kenyan people.
Many people associate regulation solely with the approval of new medicines. In reality, authorisation is just one step in a much broader, life-cycle process. Before a medicine reaches the market, scientific experts evaluate evidence on its safety, quality, and efficacy. Manufacturing facilities are inspected to ensure compliance with Good
Manufacturing Practices, while importers, distributors, and pharmacies must meet strict regulatory standards. Even after products are approved, the work continues through pharmacovigilance, post-market surveillance, laboratory testing, and enforcement activities such as monitoring safety, effectiveness, and quality throughout the product's entire lifecycle.
This continuous oversight is vital as healthcare never stands still. New therapies, biological products, digital health technologies, and increasingly complex supply chains offer tremendous opportunities to improve patient outcomes, but they also demand regulatory systems robust enough to manage emerging risks while fostering innovation.
Yet no regulator can safeguard public health alone. Medicines regulation works best when it is reinforced by healthcare professionals, manufacturers, distributors, and, crucially an informed public. Every stakeholder has a part to play in ensuring medicines are used safely and responsibly.
Consumers, for their part, should seek treatment from qualified professionals and purchase medicines only from licensed pharmacies, avoiding unregulated channels. Before buying, they can verify a pharmacy's registration with the Pharmacy and Poisons Board. They should also ask questions about prescribed medicines, understand proper usage, and promptly report any suspected poor-quality products or adverse effects. These simple actions strengthen national surveillance systems and help protect others from harm.
Healthcare professionals equally play a critical role by prescribing and dispensing responsibly, reporting adverse events, and upholding the highest professional standards. Manufacturers, importers, and distributors must remain fully compliant with regulatory requirements, ensuring that only safe, quality, and effective products enter and stay within the Kenyan market. Together, these collective efforts reinforce a regulatory system centred on patient safety.
Kenya has made notable strides in strengthening its regulatory framework, aligning with international best practices and enhancing oversight across the pharmaceutical sector.
These efforts do more than protect public health; they build confidence in the healthcare system, support local pharmaceutical manufacturing, and improve access to quality medical products for all Kenyans.
Ultimately, medicines regulation is not the sole responsibility of the Pharmacy and Poisons Board. It is a shared national duty. A regulator can set standards and enforce compliance, but lasting public safety depends on informed decisions by healthcare providers, industry players, and every citizen who uses health products.
Every Kenyan deserves the assurance that the medicines they take are safe, effective, and of assured quality. Protecting that assurance demands vigilance, collaboration, and an unwavering commitment to patient safety. That is why medicines regulation is and will always remain everyone's business.
How You Can Help Protect Your Community
i. Verify that your pharmacy is licensed through the Pharmacy and Poisons Board’s Facilities Register (https://practice.pharmacyboardkenya.org/) before purchasing
medicines
ii. Any suspected substandard or falsified medicine should be reported through the following official channels:
● Online Portal: https://pv.pharmacyboardkenya.org/users/mpublic
● Mobile App: mPvERS (Android and iOS)
● Email: [email protected] | [email protected]
● Telephone: 0795 743049
Dr Mohamed is the CEO at Pharmacy and Poisons Board
