Parliament passes reforms on medicines

KAMPALA – Parliament has passed the National Drug and Health Products Authority Bill, 2025, paving the way for sweeping reforms in the regulation of medicines and health products, including provisions that allow the controlled use of unapproved drugs in life threatening situations.

The Bill, passed at Third Reading on Thursday, 26 March 2026, establishes the National Drug and Health Products Authority as the central body responsible for regulating, controlling, and supervising the manufacture, importation, exportation, distribution, and use of drugs and other health products in Uganda.

The legislation replaces the outdated 1993 framework and significantly expands the authority’s mandate to cover a broader range of products, including vaccines, diagnostics, biologicals, medical devices, cosmetics, public health products, and nutritional supplements.

Parliament also adopted stringent penalties aimed at curbing illegal practices across the pharmaceutical sector.

Manufacturing or distributing drugs without a licence will now attract penalties of up to 10 years imprisonment or fines of up to Shs200 million. Illegal importation of drugs will similarly draw heavy fines and custodial sentences for both individuals and companies.

The law further tightens controls on drug advertising. Under Clause 46, all drug advertisements must be approved by the authority, and no product may be promoted as a drug if it is not registered as such or for uses outside its approved purpose. Violators face fines of up to Shs400 million or imprisonment of up to 15 years, while corporate entities risk fines of up to Shs3 billion.

At the heart of the reforms is a key provision under Clause 21, which permits the authority to authorise the use, importation, or distribution of drugs that are not registered under strict conditions. These include clinical trials, scientific research, personal use, and “compassionate use” in emergencies.

Minister of Health, Hon. Jane Ruth Aceng, who tabled the Bill for its second reading, said the provision is intended to address urgent public health needs.

“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 the Committee on Health, Hon. Joseph Ruyonga, told the House that the amendments strike a necessary balance between strict regulation and urgent patient needs.

“The exemptions should be expanded to include compassionate use, extraordinary circumstances, and approved scientific education and research,” the committee noted in its report.

In addition, the law introduces a new “listing” system to improve traceability and oversight of medicines that may not undergo full registration, alongside mandatory “lot release” certification for vaccines, biologicals, and diagnostics before they are placed on the market.

Parliament also reinforced regulation of pharmacies and drug shops. Clause 28 requires all pharmacies to be licensed and operated under the supervision of a qualified pharmacist. Operating outside the law attracts fines and imprisonment, while unlicensed drug shop operators face penalties including up to five years in jail.

The health committee emphasised that strict regulation is necessary given the risks associated with improper storage, sale, and dispensing of medicines.

“It is important to ensure that drug shops operate only within the limits permitted by law and do not engage in dispensing medicines they are not authorised to handle,” the committee noted in its report, stressing the need to clearly distinguish drug shops from pharmacies to preserve professional standards.

The new law also extends regulatory control to cosmetic products, with Parliament imposing a fine of Shs200 million on any person found manufacturing or distributing cosmetics without a licence.

Additionally, the health minister has been granted powers to prohibit the importation of certain cosmetic products deemed harmful. Such prohibitions will be issued through statutory orders published in newspapers of nationwide circulation.

Lawmakers said the reforms are designed to address longstanding challenges, including counterfeit medicines, weak enforcement, and gaps in post-market surveillance.

The law also introduces requirements for drugs to carry unique identifiers to enhance traceability and combat counterfeits, while empowering regulators to enforce minimum distance requirements between pharmacies to promote equitable access.