The Minister of Health, Dr Jane Ruth Aceng, has presented the National Drug and Health Products Authority Bill, 2025 to the Parliamentary Committee on Health, setting the stage for major reforms in the regulation of medicines and health products in Uganda.
The Bill seeks to establish the National Drug and Health Products Authority, transforming the current National Drug Authority into a stronger regulator with an expanded mandate.
With 14 parts and 122 clauses, the Bill sets out provisions for the regulation of drugs, pharmacies, clinical trials, pharmacovigilance, medical devices, cosmetics, nutritional supplements, and the establishment of a national laboratory for testing medicines and health products.
Appearing before the committee chaired by Dr Joseph Ruyonga on Wednesday, 17 September 2025, the minister said that the reforms are urgent.
She explained that the current law, enacted in 1993, has never been amended despite major changes in the health sector.
“The health sector has evolved significantly over the years and the requirements of World Health Organisation (WHO), the impact of technological advancements and the need to regulate related health products have created the need to revise the mandate and functions of the National Drug Authority,” she noted.
The Bill also provides for stricter penalties, powers to withdraw substandard or falsified products, and collaboration with global regulatory agencies.
According to Aceng, central to the reforms is Uganda’s quest to achieve World Health Organisation Maturity Level 3 (WHO ML3) for national regulatory systems.
“This amendment is critical not only to align Uganda’s legal framework with international best practices but also to fast-track the attainment of the World Health Organisation’s Maturity Level 3 (ML3) for national regulatory systems,” she said.
She added that achieving ML3 status would enable Uganda to participate more fully in global health procurement platforms such as the Global Fund, GAVI and UNICEF, while boosting local pharmaceutical manufacturing and attracting investment.
Committee members, however, raised concerns about regulation and enforcement.
Hon. Isaac Otimigiw (NRM, Padyere County) questioned how the Bill would address widespread access to over-the-counter medicines and supplements.
“In terms of enhancement supplements like Viagra, are sold openly and we have received cases where things have gone wrong. How will the Bill strengthen this matter?” he asked.
Hon. Samuel Opio, the Kole North County MP wondered if there would be duplication of roles between the new authority and the Uganda National Bureau of Standards, which has previously regulated nutritional supplements.
Meanwhile, Hon. Timothy Batuwa (FDC, Jinja South Division West) urged government to safeguard the independence of the proposed authority.
“Since the issue of health is scientific, the new authority’s independence must be maintained so that decisions to do with lives are not political,” he said.
Source:Parliament of Uganda
