The Pharmaceutical Society of Uganda (PSU) has called on scientists who meet the minimum requirements for registration as pharmacists in Uganda to apply for membership and formal registration.
PSU is the national professional body for pharmacists, established under the Pharmacy and Drugs Act. It is governed by a Council mandated to uphold the highest practicable standards of pharmacy practice in Uganda.
Dr. Lutoti Stephen, Secretary of the Pharmaceutical Society of Uganda, applauded Parliament for passing the National Drug and Health Products Authority Bill, 2025. He noted that the new law strengthens the regulatory framework for drugs, cosmetics, medical devices, nutritional supplements, and public health chemicals.
“The law is a key requirement for our drug regulatory agency to attain the World Health Organization (WHO) Maturity Level 3 (ML3), a level of regulatory proficiency that the National Drug Authority (NDA) has long aspired to but has been hindered from achieving due to gaps in the current legal framework,” he said.
He added that the newly passed law closes existing loopholes, making it possible for Uganda to achieve ML3 status.
According to WHO, Maturity Level 3 is defined as “a stable, well-functioning, and integrated regulatory system.” Only a few countries in Africa have attained this level,some of which Uganda’s NDA has supported largely due to having stronger regulatory frameworks.
Countries that reach this level are recognized for their capacity to authorize medical products, conduct market surveillance, and effectively monitor safety events across a wide range of health products, including locally manufactured vaccines. This milestone is expected to promote growth in Uganda’s pharmaceutical sector and expand markets for locally produced medicines and healthcare products.
Dr. Lutoti also addressed Clause 31 of the Bill, which stipulates that supervision of drug production must be carried out by a registered pharmacist.
“A pharmacist is any person registered as such under the Pharmacy and Drugs Act,” he emphasized.
He explained that the PSU Council has consistently admitted individuals holding a Bachelor’s degree in Pharmacy or Pharmaceutical Sciences, provided their training meets the minimum standards approved by the National Council for Higher Education (NCHE).
“Any person whose qualification meets these standards is eligible for registration as a pharmacist in Uganda. It is therefore misleading to suggest that qualifying pharmaceutical scientists are being excluded,” he noted.
WHO guidelines state that personnel responsible for supervising pharmaceutical production and quality control must possess appropriate scientific education and practical experience as defined by national legislation. This education typically includes chemistry, biochemistry, chemical engineering, microbiology, pharmaceutical sciences and technology, pharmacology, toxicology, physiology, and related disciplines.
Additionally, such personnel must have adequate practical experience in manufacturing and quality assurance, often gained through a supervised preparatory period. This enables them to exercise independent professional judgment based on scientific principles in addressing real-world manufacturing challenges.
They must ensure that pharmaceutical products meet required standards of safety, identity, strength, quality, and purity. Individuals acting in their absence must possess equivalent qualifications and experience.
Dr. Lutoti clarified that scientists who do not meet these requirements can still contribute as technicians in drug production and analysis. However, overall supervision must remain the responsibility of a pharmacist. He added that graduates whose training lacks core pharmaceutical science components may qualify for registration after undertaking additional training.
“Therefore, the narrative that the Bill excludes qualified scientists from pharmaceutical manufacturing is not accurate,” he said.
He emphasized that safe and effective medicines are the result of rigorous systems, scientific discipline, and professional accountability not chance. A key safeguard is ensuring pharmacist-led supervision in drug manufacturing.
“A pharmacist is uniquely trained at the intersection of science and patient care,” he explained. “Beyond chemistry and biology, pharmacists are equipped with knowledge in pharmaceutics, pharmacology, toxicology, and clinical application of medicines. This enables them to understand the full lifecycle of a drug from formulation to its effects in the human or animal body.”
He noted that the World Health Organization recognizes industrial pharmacy as a core domain of pharmacy practice, with pharmacists responsible for ensuring that medicines are consistently produced and controlled according to quality standards.
Drug manufacturing, he stressed, goes beyond producing chemical compounds. It requires ensuring that every batch is safe, effective, and consistent. Even minor errors in formulation, contamination, or storage can have serious consequences. Pharmacists are specifically trained to anticipate and mitigate such risks from a patient safety perspective.
Globally, pharmaceutical manufacturing systems reflect this need, with pharmacists legally accountable for product quality. This ensures clear responsibility for verifying that each batch meets required standards before reaching patients.
Dr. Lutoti further emphasized that requiring pharmacist supervision does not exclude other scientists. Pharmaceutical manufacturing is inherently multidisciplinary, involving chemists, biotechnologists, engineers, microbiologists, and data scientists, all of whom play vital roles under the leadership of a pharmacist.
“The pharmacist serves as the integrator, ensuring that all scientific inputs align with the ultimate goal of producing safe and effective medicines,” he said.
He also highlighted the ethical dimension of pharmacy practice. Pharmacists are bound by professional codes that prioritize patient safety, enabling them to make decisions that balance technical requirements with ethical considerations, especially where commercial pressures may arise.
For the public, this framework provides assurance. While patients may not witness the manufacturing process, they rely on the safety of medicines. Knowing that a trained pharmacist oversees production strengthens trust in the system.
Pharmacist supervision in drug manufacturing is not about limiting participation but about ensuring leadership by the most appropriately trained professionals. By combining scientific expertise, regulatory knowledge, and patient-centered responsibility, pharmacists provide a critical safeguard in medicine production. Other scientists remain indispensable, but their contributions are most effective within a system guided by pharmaceutical professional expertise.
