Uganda Parliament Approves Major Overhaul of Medicines Regulation

Uganda’s Parliament passed the National Drug and Health Products Authority Bill, 2025, on March 26, 2026, during its Third Reading. This legislation sets up a dedicated body to regulate the production, import, export, distribution, and use of medicines and health products nationwide.

The new law modernizes the 1993 framework, extending oversight to vaccines, diagnostics, biologicals, medical devices, cosmetics, public health items, and nutritional supplements. It includes a ‘listing’ system for better tracking of certain products and requires ‘lot release’ certification for vaccines and similar items before market entry.

Key features allow the authority to approve unregistered drugs under strict rules, such as clinical trials, research, personal needs, or compassionate use in crises. Health Minister Jane Ruth Aceng highlighted its role in handling outbreaks and urgent treatments without bureaucratic delays.

Penalties are severe: up to 10 years in prison or Shs200 million fines for unlicensed manufacturing or distribution, similar for illegal imports. Drug ads need authority approval, with violators facing up to 15 years jail or Shs400 million fines (Shs3 billion for companies).

Pharmacies must be licensed and supervised by qualified pharmacists, while drug shops face up to five years imprisonment if unlicensed. Cosmetics are now regulated, with Shs200 million fines for unlicensed operations and ministerial powers to ban harmful imports.

Additional measures combat counterfeits through unique drug identifiers, minimum distances between pharmacies for fair access, and stricter enforcement against improper medicine handling.

Health Committee Chair Joseph Ruyonga stressed balancing tight controls with patient needs, distinguishing pharmacies from drug shops to uphold standards.

Source: Parliament of Uganda