Museveni Signs Tough New Drug Law As Uganda Cracks Down On Counterfeits & Unsafe Medicines

President Yoweri Museveni has signed into law the National Drug and Health Products Authority Act, 2025, marking a major shift in Uganda’s fight against counterfeit medicines and unsafe health products.

The new legislation replaces an outdated 1993 framework and establishes a powerful central regulator, the National Drug and Health Products Authority, with sweeping powers to oversee the entire lifecycle of medicines and health-related products in the country.

In what officials describe as one of the most comprehensive health reforms in recent years, the law significantly expands regulation beyond conventional drugs to include vaccines, diagnostics, biologicals, medical devices, cosmetics, nutritional supplements and other public health products.

At the heart of the reform is a strong enforcement regime aimed at dismantling 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 similarly severe penalties.

Even stricter sanctions apply to violations involving drug advertising. Companies promoting medicines without approval or beyond their authorised use risk fines of up to Shs3 billion, while individuals face up to 15 years behind bars or fines of up to Shs400 million.

A notable provision in the law introduces controlled access to unregistered medicines under special circumstances. Clause 21 allows the Authority to approve such products for clinical trials, research, personal use and emergency or compassionate use.

Health Minister Jane Ruth Aceng said the measure is designed to ensure timely access to critical treatments during outbreaks and life-threatening situations.

“This will cater for emergencies and allow patients access to potentially lifesaving treatments that might otherwise be delayed,” she said.

However, Parliament’s Health Committee, chaired by Joseph Ruyonga, cautioned that such exemptions must be applied carefully to safeguard public health.

The law tightens control over pharmaceutical services by requiring all pharmacies to be licensed and operated under qualified pharmacists. Non-compliance could lead to imprisonment, while unlicensed drug shop operators face up to five years in jail.

To combat counterfeit medicines, the Act introduces new tracking systems, including mandatory lot certification for vaccines and biological products, and a listing mechanism for medicines not yet fully registered.

It also gives regulators powers to enforce minimum distance requirements between pharmacies in an effort to improve equitable access to medicines across the country.

For the first time, cosmetic products fall under formal regulatory control, with heavy penalties for unlicensed manufacturing or distribution. The Minister of Health is also empowered to ban harmful imports through statutory instruments.

Officials say the law is designed to modernise Uganda’s pharmaceutical governance, close regulatory gaps and restore public confidence in the safety of medicines.

The President also assented to several other laws, including reforms in copyright, energy efficiency, employment, forensic science and judicial administration, signalling a broader legislative push toward institutional strengthening and regulatory enforcement.

With the new law in place, Uganda is positioning itself for a more robust, accountable and safety-driven health system, one that authorities hope will decisively curb the dangers posed by fake and substandard medicines.