Draft National Drugs Bill Presented to Parliament’s Health Committee
The proposed legislation seeks to establish the National Drug and Health Products Authority, transforming the current National Drug Authority [NDA] into a more robust regulatory body with an expanded mandate
KAMPALA, September 19, 2025 – 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, paving the way for major reforms in the regulation of medicines and health products in Uganda.
The proposed legislation seeks to establish the National Drug and Health Products Authority, transforming the current National Drug Authority [NDA] into a more robust regulatory body with an expanded mandate.
Comprising 14 parts and 122 clauses, the Bill outlines provisions for the regulation of drugs, pharmacies, clinical trials, pharmacovigilance, medical devices, cosmetics, nutritional supplements, and the establishment of a national laboratory for the testing of medicines and health products.
Appearing before the committee, chaired by Dr Joseph Ruyonga, on Wednesday, Dr Aceng stressed the urgency of the reforms. She noted that the existing law, enacted in 1993, has never been amended, despite significant developments in the health sector.
“The health sector has evolved considerably over the years. The requirements of the World Health Organization [WHO], the impact of technological advances, and the growing need to regulate related health products necessitate a review of the National Drug Authority’s mandate and functions,” she said.
The Bill introduces stricter penalties, grants powers to withdraw substandard or falsified products from the market, and promotes collaboration with international regulatory agencies.
Dr Aceng emphasised that at the heart of the proposed reforms is Uganda’s ambition to achieve WHO Maturity Level 3 [ML3] for national regulatory systems.
“This amendment is crucial not only for aligning Uganda’s legal framework with international best practices, but also for accelerating progress towards achieving WHO Maturity Level 3,” she said.
She added that attaining ML3 status would enable Uganda to participate more fully in global health procurement platforms such as the Global Fund, Gavi, and UNICEF, while enhancing local pharmaceutical manufacturing and attracting investment.
However, committee members raised concerns around regulation and enforcement.
Isaac Otimigwe, Member of Parliament for Padyere County, questioned how the Bill would address the widespread and unregulated access to over-the-counter medicines and supplements.
“Enhancement supplements like Viagra are openly sold, and we’ve received reports of adverse incidents. How will the Bill address such issues?” he asked.
Samuel Opio, Member of Parliament for Kole North County, raised the possibility of overlapping mandates, particularly between the new authority and the Uganda National Bureau of Standards, which currently plays a role in regulating nutritional supplements.
Meanwhile, Timothy Batuwa, Member of Parliament for Jinja South Division West, called on the government to ensure the independence of the proposed authority.
“Health is a scientific issue. The independence of the new authority must be safeguarded to ensure decisions affecting lives are based on science, not politics,” he said.
Funding for the new authority will be sourced from the NDA’s retained revenues, budgetary support from the Ministry of Health, contributions from development partners, and revenues generated through regulatory activities.
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