PSU rejects claims new law sidelines pharmaceutical scientists

The Pharmaceutical Society of Uganda (PSU) has defended new legal provisions requiring that drug production in Uganda be supervised strictly by registered pharmacists, amid growing concerns from some professionals that the law could sideline qualified pharmaceutical scientists.

The PSU said in a statement that the requirement under the National Drug and Health Products Authority Bill, 2025 is necessary to strengthen Uganda’s regulatory system and improve the quality of medicines. 

The society argued that pharmacist-led supervision is a key condition for the country to attain the World Health Organisation’s Maturity Level 3 status, which reflects a stable and effective regulatory framework.

The clarification follows a heated debate around Clause 31 of the Bill. Some stakeholders, including members of the Association of Pharmaceutical Scientists in Uganda, had earlier raised concerns that the provision could exclude pharmaceutical scientists from playing supervisory roles in drug manufacturing. 

Reports also indicate that discussions around the clause intensified, with some professionals questioning whether the law fairly recognises the role of non-pharmacist scientists in the pharmaceutical value chain. 

However, PSU has firmly rejected these claims. The society maintains that no qualified pharmaceutical scientist is being left out, as long as their academic training meets the minimum standards required for registration as a pharmacist. 

According to PSU Secretary Dr. Stephen Lutoti, anyone with a recognised degree in pharmacy or pharmaceutical sciences can qualify for registration, provided their training aligns with standards approved by the National Council for Higher Education.

The society further explained that pharmaceutical manufacturing is a highly technical and sensitive process that requires not only scientific knowledge but also an understanding of patient safety and clinical outcomes. 

“Pharmacist supervision in drug manufacturing is not about limiting participation, it is about ensuring leadership by the most appropriately trained professional,” he said

“By combining scientific expertise, regulatory knowledge, and patient-centered responsibility, pharmacists provide a critical safeguard in the production of medicines. Other scientists remain indispensable, but their contributions are most effective within a system guided by pharmaceutical professional expertise.”

Dr Lutoti emphasised that pharmacists are uniquely trained to bridge the gap between laboratory science and patient care, making them best suited to oversee production.

While insisting on pharmacist-led supervision, PSU acknowledged that other scientists, including chemists, engineers, and biotechnologists, remain essential in the manufacturing process. However, their work must be coordinated under the leadership of a pharmacist to ensure safety, quality, and regulatory compliance.

The organisation also urged scientists who meet the necessary requirements to seek registration as pharmacists, rather than view the law as exclusionary.