Kampala, Uganda: The Pharmaceutical Society of Uganda has clarified that only licensed pharmacists are mandated to supervise drug manufacturing under the newly passed National Drug and Health Products Authority Act, dismissing claims that the law sidelines other scientists.
The clarification, issued by PSU Secretary Dr Lutoti Stephen in a statement dated March 31, comes amid growing public debate over Clause 31 of the law, which assigns supervision of pharmaceutical production to pharmacists.
Dr. Lutoti emphasized that the requirement is rooted in science, patient safety, and global regulatory standards, not exclusion. “Safe and effective medicines do not happen by chance. They are the result of strict systems, scientific discipline, and professional accountability,” he stated.
He added: “A pharmacist is uniquely trained at the intersection of science and patient care… This integrated knowledge allows them to understand the full life cycle of a drug, from formulation to its effects in the human body.”
According to PSU, pharmacists combine expertise in pharmaceutics, pharmacology, toxicology, and clinical application, making them best suited to oversee manufacturing decisions that directly affect public health.
No exclusion of qualified scientists
Responding to concerns from sections of the scientific community, Dr. Lutoti dismissed claims that pharmaceutical scientists are being locked out. “There is nothing like leaving out a qualifying pharmaceutical scientist,” he clarified.
“Any person who holds a qualification that meets the minimum standards approved by the National Council for Higher Education can be registered as a pharmacist in Uganda.”
He noted that scientists who do not meet the threshold can still participate in production as technical personnel, while those seeking supervisory roles can upgrade their qualifications. “With additional training covering the courses they have not done, they can be registered as pharmacists to supervise drug production,” he added.
What the new law changes
The National Drug and Health Products Authority Act, recently passed by Parliament, replaces and strengthens Uganda’s existing legal framework under the Pharmacy and Drugs Act.
The law expands regulation beyond medicines to include cosmetics, medical devices, nutritional supplements, and public health chemicals, aligning Uganda with international best practices.
PSU says the reforms are critical for Uganda to attain World Health Organization Maturity Level 3 (ML3), a benchmark that defines a “stable, well-functioning, and integrated regulatory system.”
Only a few African countries have achieved this level, which allows nations to effectively regulate medicines, support local pharmaceutical manufacturing, and even participate in vaccine production oversight.
“The new law has removed loopholes in the existing framework… meaning it will now be possible for Uganda to achieve ML3 status,” Dr Lutoti noted.
He stressed that drug manufacturing is a high-risk, highly controlled process that demands professional accountability.
“Drug manufacturing is not just about producing a chemical compound. It involves ensuring that every batch is safe, effective, and of consistent quality,” the statement reads. “Small errors in formulation, contamination, or storage conditions can lead to serious harm.”
Dr Lutoti further emphasized the ethical responsibility placed on pharmacists: “A pharmacist is trained and obligated to place patient welfare above all else… their decisions are not only technical but also ethical.”
He strongly pointed out that globally, pharmaceutical production is supervised by pharmacists who are legally responsible for product quality.
This model ensures accountability, with a clearly identifiable professional guaranteeing that medicines meet required standards before reaching patients. “Modern pharmaceutical manufacturing is multidisciplinary… but leadership must rest with the most appropriately trained professional,” Dr Lutoti said.
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