President Museveni has assented to the National Drug and Health Products Authority Bill, 2025, ushering in sweeping reforms aimed at strengthening Uganda’s regulation of medicines and health-related products.
Signed on Wednesday, the law establishes the National Drug and Health Products Authority as the central body responsible for regulating all drugs and health products in the country, replacing the outdated 1993 legal framework.
The new legislation significantly broadens regulatory oversight to include vaccines, diagnostics, biologicals, medical devices, cosmetics, public health products, and nutritional supplements.
Lawmakers say the reforms are intended to improve drug safety, strengthen enforcement mechanisms, and address long-standing challenges such as counterfeit medicines, poor storage practices, and weak post-market surveillance.
Under the new framework, the Authority will regulate the manufacture, importation, exportation, distribution, and use of all medicines and health products in Uganda.
Manufacturing or distributing drugs without a licence now attracts up to 10 years in prison or fines of up to Shs200 million.
Illegal importation of medicines carries equally severe penalties for both individuals and corporate entities.
The law also introduces strict controls on pharmaceutical advertising. All drug advertisements must be approved by the Authority, and products cannot be promoted beyond their registered or approved uses.
Offenders risk fines of up to Shs400 million or imprisonment of up to 15 years, while corporate violations may attract penalties of up to Shs3 billion.
A key provision under Clause 21 allows the Authority to authorise the use, importation, or distribution of unregistered drugs under controlled conditions, including clinical trials, scientific research, personal use, and compassionate use during emergencies.
Minister of Health Dr Jane Ruth Aceng said the provision is intended to improve access to life-saving treatments, especially in emergency situations.
“This will cater for situations like outbreaks and allow patients with life-threatening conditions to access potentially lifesaving treatments that may otherwise be delayed by lengthy approval processes,” she said.
The Chairperson of Parliament’s Health Committee, Joseph Ruyonga, said the exemptions were necessary but should be carefully applied to maintain safety standards.
“The exemptions should be expanded to include compassionate use, extraordinary circumstances, and approved scientific education and research,” the committee noted in its report.
The law further requires all pharmacies to be licensed and operated under the supervision of qualified pharmacists.
Operating outside the legal framework attracts fines and imprisonment, while unlicensed drug shop operators face up to five years in jail.
Parliament also highlighted risks associated with improper storage and dispensing of medicines, stressing the need for professional oversight in pharmaceutical services.
To improve tracking and eliminate counterfeit drugs, the law introduces a “listing” system for medicines that are not fully registered and requires mandatory lot release certification for vaccines, biologicals, and diagnostics before they enter the market.
It also empowers regulators to enforce minimum distance requirements between pharmacies to promote more equitable access to pharmaceutical services.
For the first time, cosmetic products are brought under formal regulatory control. The law imposes fines of up to Shs200 million for manufacturing or distributing unlicensed cosmetics and allows the Minister of Health to ban harmful imports through statutory instruments.
Officials say the reforms are aimed at modernising Uganda’s pharmaceutical governance system, closing regulatory loopholes, and strengthening public health protection through stricter enforcement and accountability.
The President also assented to several other bills, including the Copyright and Neighbouring Rights (Amendment) Act, 2026, the Energy Efficiency and Conservation Act, 2026, the Non-Performing Assets Recovery Trust (Repeal) Act, 2024, the Employment (Amendment) Act, 2025, the Forensic and Scientific Analytical Services Act, 2026, the Public Enterprises Reform and Divestiture (Amendment) Act, 2024, and the Magistrates Courts (Amendment) Act, 2026.
