President Yoweri Museveni has assented to the National Drug and Health Products Authority Act, 2025, ushering in sweeping reforms aimed at strengthening Uganda’s fight against counterfeit medicines and unsafe health products.
The new law repeals the 1993 regulatory framework and establishes the National Drug and Health Products Authority as a central regulator with expanded oversight over the entire lifecycle of medicines and related health products.
The legislation significantly broadens the scope of regulation beyond conventional pharmaceuticals to include vaccines, diagnostics, biologicals, medical devices, cosmetics, nutritional supplements, and other public health products.
At the core of the reforms is a strengthened enforcement regime designed to dismantle the illegal drug market. Individuals found manufacturing or distributing medicines without a licence now face up to 10 years in prison or fines of up to Shs200 million. Illegal importation attracts equally severe penalties.
The law further introduces stringent measures on drug advertising, with companies risking fines of up to Shs3 billion for promoting medicines without approval or outside authorised use. Individuals involved in such violations face up to 15 years in prison or fines of up to Shs400 million.
A notable provision under Clause 21 allows the Authority to grant controlled access to unregistered medicines for clinical trials, research, personal use, and emergency or compassionate cases. Officials say the provision is intended to facilitate access to potentially lifesaving treatments in critical situations, although Parliament’s Health Committee has cautioned that it must be implemented with strict safeguards to protect public health.
The Act also tightens regulation of pharmaceutical services by requiring all pharmacies to be licensed and operated by qualified pharmacists. Operating without compliance may attract imprisonment, while unlicensed drug shop operators risk up to five years in jail.
To further combat counterfeit medicines, the law introduces tracking and verification systems, including mandatory lot certification for vaccines and biological products, as well as a listing mechanism for medicines pending full registration.
In a bid to improve equitable access to medicines, regulators are also empowered to enforce minimum distance requirements between pharmacies.
For the first time, cosmetic products are brought under formal regulatory control, with heavy penalties prescribed for unlicensed manufacturing and distribution. The Minister of Health is additionally empowered to ban harmful imports through statutory instruments.
Government officials say the law represents a major step toward modernising Uganda’s pharmaceutical governance system, sealing regulatory loopholes, and restoring public confidence in the safety of health products.
President Museveni also assented to several other laws covering copyright, energy efficiency, employment, forensic science, and judicial administration reforms, signalling a broader push toward institutional strengthening and regulatory enforcement.
With the new framework in place, authorities say Uganda is positioning itself for a more robust and safety-driven health system aimed at decisively curbing the threat of counterfeit and substandard medicines.