The Pharmaceutical Society of Uganda (PSU) has clarified that under the recently passed National Drug and Health Products Authority Bill, 2025, supervision of drug production must be carried out by registered pharmacists, dismissing claims that pharmaceutical scientists are being sidelined.
In a statement, PSU Secretary Dr. Stephen Lutoti emphasized that the new law strengthens the regulatory framework for medicines, cosmetics, medical devices, nutritional supplements, and public health chemicals.
“The new law removes loopholes that have long hindered the National Drug Authority (NDA) from achieving World Health Organization (WHO) Maturity Level 3 status. This is a mark of a stable, well-functioning, and integrated regulatory system,” Dr. Lutoti said.
“Only a handful of countries in Africa have attained this level, and now Uganda is on a path to join them.”
He addressed concerns about Clause 31 of the bill, which requires a pharmacist to supervise drug production.
“There is nothing like leaving out a qualifying pharmaceutical scientist. Any person whose training meets the minimum standards for a pharmacy degree is eligible for registration as a pharmacist in Uganda,” Dr. Lutoti explained.
According to PSU, pharmacists are uniquely trained at the intersection of science and patient care.
“Unlike many other scientists, pharmacists are educated not only in chemistry and biology, but also in pharmaceutics, pharmacology, toxicology, and clinical use of medicines. This integrated knowledge allows them to oversee the entire lifecycle of a drug—from formulation to patient use,” he said.
Dr. Lutoti also highlighted the importance of professional accountability in drug manufacturing.
“Safe and effective medicines do not happen by chance. They are the result of strict systems, scientific discipline, and professional oversight. One of the most important safeguards is ensuring that drug manufacturing is supervised by a pharmacist,” he said.
The Pharmaceutical Society of Uganda clarified that other scientists, including chemists, engineers, biotechnologists, and pharmaceutical microbiologists, remain essential in production, but operate under the leadership of a pharmacist.
“The pharmacist acts as the integrator—ensuring that all scientific inputs align with the ultimate goal of producing safe and effective medicines for human or animal use,” Dr. Lutoti added.
He further emphasized the ethical responsibility of pharmacists.
“Pharmacists are bound by professional codes that prioritize patient safety. Their decisions are not only technical but also ethical. This is crucial in situations where commercial pressures might conflict with quality standards.”
PSU encouraged all eligible scientists to apply for registration as pharmacists to strengthen Uganda’s pharmaceutical sector.
“Pharmacist supervision is not about limiting participation—it is about ensuring leadership by the most appropriately trained professional,” Dr. Lutoti said.
“Other scientists remain indispensable, but their contributions are most effective within a system guided by pharmaceutical professional expertise.”
