Parliament has approved the National Drug and Health Products Authority Bill, 2025, ushering in major reforms in the regulation of medicines and health products. The new law includes provisions permitting the controlled use of unapproved drugs in life-threatening situations.
The Bill, passed at its Third Reading, establishes the National Drug and Health Products Authority as the main institution responsible for overseeing the regulation, control, and supervision of the manufacture, import, export, distribution, and use of medicines and other health-related products in Uganda.
This legislation replaces the outdated 1993 legal framework and broadens the Authority’s mandate to include a wider range of products such as vaccines, diagnostics, biologicals, medical devices, cosmetics, public health products, and nutritional supplements.
Parliament also introduced tougher penalties to address illegal practices within the pharmaceutical sector. Producing or distributing medicines without a licence will now attract penalties of up to 10 years’ imprisonment or fines of up to Shs200 million. Similarly, unlawful importation of drugs will result in heavy fines and jail terms for both individuals and companies.
The law further strengthens regulation of drug advertising. Under Clause 46, all advertisements must first be approved by the Authority, and no product may be marketed as a drug unless it is officially registered or promoted for approved uses. Offenders risk fines of up to Shs400 million or imprisonment of up to 15 years, while companies may face fines of up to Shs3 billion.
A key aspect of the reforms, outlined in Clause 21, allows the Authority to authorise the use, importation, or distribution of unregistered drugs under strict conditions. These include clinical trials, scientific research, personal use, and compassionate use during emergencies. The Minister of Health, Jane Ruth Aceng, noted that this provision is intended to respond to urgent public health needs.
She explained that the measure will cater for situations such as disease outbreaks and enable patients with life-threatening conditions to access potentially life-saving treatments that might otherwise be delayed due to lengthy approval processes.
The Chairperson of the Committee on Health, Joseph Ruyonga, told Parliament that the amendments strike a balance between strict regulatory control and urgent patient needs. The committee also recommended expanding exemptions to include compassionate use, extraordinary circumstances, and approved scientific research and education.
In addition, the law introduces a new “listing” system to enhance tracking and oversight of medicines that may not undergo full registration. It also requires mandatory “lot release” certification for vaccines, biologicals, and diagnostics before they are made available on the market.
Parliament further strengthened oversight of pharmacies and drug shops. Clause 28 requires all pharmacies to be licensed and operated under the supervision of a qualified pharmacist. Operating outside these regulations attracts fines and imprisonment, while unlicensed drug shop operators risk penalties including up to five years in jail.
The Health Committee emphasised the need for strict regulation due to the risks associated with improper storage, sale, and dispensing of medicines. It stressed that drug shops must operate strictly within the limits set by law and should not dispense medicines they are not authorised to handle, highlighting the importance of clearly distinguishing them from pharmacies to maintain professional standards.
The new law also extends regulatory oversight to cosmetic products, imposing a fine of Shs200 million on anyone found manufacturing or distributing cosmetics without a licence. Additionally, the Minister of Health has been granted powers to ban the importation of harmful cosmetic products through statutory orders published in national newspapers.
Lawmakers noted that these reforms are aimed at addressing long-standing challenges such as counterfeit medicines, weak enforcement, and gaps in post-market surveillance. The law also introduces requirements for medicines to carry unique identifiers to improve traceability and combat counterfeiting, while empowering regulators to enforce minimum distance requirements between pharmacies to promote fair access to services.
