The National Drug and Health Products Authority Bill, 2025, has been presented for First Reading by the Minister of State for Health (General Duties), Hon. Anifa Kawooya.
The Bill purposes to transform Uganda’s drug and health product regulation by setting up a robust authority to oversee medicines, medical devices, cosmetics, and nutritional supplements.
Kawooya explained that the Bill addresses deficiencies in the National Drug Policy and Authority Act of 1993, which has not been significantly updated despite advancements in the health sector.
“The 1993 law is outdated. With new technologies, evolving health professions, and World Health Organisation (WHO) standards, our regulatory framework must modernise,” she said during the plenary sitting on Thursday, 04 September 2025 chaired by Speaker Anita Among.
The minister added: “Our citizens face risks from unregulated drugs, cosmetics, and devices. This Bill equips Uganda to regulate, test, and recall harmful products, safeguarding public health.”
The current law does not regulate pharmacies in health units, vaccine lot releases, drug recalls, or illegal premises, and it excludes cosmetics, medical devices, and nutritional supplements. “These gaps hinder the National Drug Authority’s ability to protect public health,” she further noted.
Key features of the Bill include setting up the National Drug and Health Products Authority, regulating drug registration, manufacturing, distribution, import/export, pharmacies, drug shops, and vaccine lot releases.
The Bill will also govern clinical trials and strengthen pharmacovigilance for manufacturers, healthcare professionals, and the authority.
It will also oversee medical devices, including classification, licensing, and defect reporting.
Additionally, the Bill will regulate cosmetics, targeting products with parabens, phthalates, hydroquinone, retinoids, or sunscreens, including public health products, nutritional supplements, enforcement powers, and administrative provisions.
The Speaker referred the Bill to the Committee on Health for review, urging swift action. “Under Rule 135, this Bill is referred to the Health Committee. I urge the committee to expedite its scrutiny and report back within the parliamentary calendar,” Among directed.
If enacted, the Bill will repeal the 1993 Act and unify health product regulation under a strengthened authority with expanded powers.
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