By Dr. Ahmed I. Mohamed, Chief Executive Officer, Pharmacy and Poisons Board
Healthcare begins with trust. Every time a patient takes a prescribed medicine, receives a vaccine, uses a medical device or purchases treatment from a pharmacy, there is an expectation that the product is safe, effective and of assured quality. Few people stop to consider the systems that make that confidence possible. Yet behind every medicine on a pharmacy shelf is an extensive regulatory process designed to protect patients and safeguard public health.
As Kenya continues to advance Universal Health Coverage and improve access to healthcare, the availability of safe, quality and effective medical products has become more important than ever. Access alone is not enough. Medicines must be properly evaluated before they reach 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 improve health can instead place lives at risk.
This is the role of medicines regulation. Although it often operates behind the scenes, it is one of the most important pillars of a resilient health system. Effective regulation protects patients from substandard and falsified medicines, promotes confidence in healthcare services, supports innovation and ensures that quality health products remain available to those who need them.
In Kenya, this responsibility is entrusted to the Pharmacy and Poisons Board, 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 made by the Board is guided by one overriding objective: protecting the health and safety of the Kenyan people.
Many people associate regulation with the approval of medicines. In reality, authorisation is only one step in a much broader 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 are required to meet strict regulatory standards. Even after products are approved, the work continues through pharmacovigilance, post-market surveillance, laboratory testing and enforcement activities that monitor their safety, effectiveness and quality throughout their lifecycle.
This continuous oversight is essential because healthcare is constantly evolving. New therapies, biological products, digital health technologies and increasingly complex supply chains present tremendous opportunities for improving patient outcomes, but they also require strong regulatory systems capable of responding to emerging risks while supporting innovation.
Despite these safeguards, no regulator can protect the public alone. Medicines regulation is most effective when it is supported by healthcare professionals, manufacturers, distributors and, importantly, informed consumers. Every stakeholder has a role in ensuring medicines are used safely and responsibly.
Consumers should seek treatment from qualified healthcare professionals, purchase medicines only from licensed pharmacies and avoid products sold through unregulated channels. Before purchasing medicines, members of the public should verify that a pharmacy is licensed by the Pharmacy and Poisons Board. They should also ask questions about the medicines they are prescribed, understand how to use them correctly and promptly report suspected poor-quality products or adverse events. These simple actions strengthen the country’s surveillance systems and help prevent harm to others.
Healthcare professionals equally play a critical role by prescribing and dispensing medicines responsibly, reporting adverse events and maintaining the highest standards of professional practice. Manufacturers, importers and distributors must comply with regulatory requirements that ensure only safe, quality and effective products enter and remain within the Kenyan market. Together, these actions reinforce a regulatory system that places patient safety at its centre.
Kenya has made significant progress in strengthening its regulatory systems, aligning with international best practices and enhancing oversight across the pharmaceutical sector. These efforts not only protect public health but also build confidence in the country’s healthcare system, support local pharmaceutical manufacturing and facilitate access to quality medical products for all Kenyans.
Ultimately, medicines regulation is not solely the responsibility of the Pharmacy and Poisons Board. It is a shared national responsibility. A regulator can establish standards and enforce compliance, but lasting public safety depends on informed decisions by healthcare providers, stakeholders, industry 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 requires vigilance, collaboration and a shared commitment to patient safety. That is why medicines regulation is, and will always remain, everyone’s business.
How You Can Help Protect Your Community
- Verify that your pharmacy is licensed through the Pharmacy and Poisons Board’s Facilities Register (https://practice.pharmacyboardkenya.org/) before purchasing medicines
- 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: pv@ppb.go.ke | pms@ppb.go.ke
- Telephone: 0795 743049