The Pharmaceutical Society of Nigeria (PSN) has hailed the recent landmark judicial judgement reinforcing drug regulatory enforcement. Nigerian chemists have commended the convictions of unregistered pharmacy operators in Ibadan and Calabar as a significant milestone in strengthening pharmacy jurisprudence and safeguarding public health in Nigeria.
PSN Praises Historic Court Rulings On Illegal Drug Practice
“This development is a historic judicial pronouncement that will strengthen the enforcement of pharmacy and drug laws in Nigeria,” Daily Independent said.
The Society, in a statement signed by its President, Pharm. Ayuba Ibrahim Tanko, commended the Federal High Court, Ibadan, for punishing an unlicensed operator of a patent medicine business on 26 May 2026.
The PSN further cited another judgement in suit No. FHC/CA/76C/2025 in which the Federal High Court in Calabar sentenced an operator of unregistered pharmacy with three others for operating unlicensed pharmaceutical premises and allowing unregistered workers to dispense pharmaceuticals.
The Society said the rulings were a clear signal of toughened regulatory enforcement in Nigeria’s pharmaceutical sector.
PSN raises concern on illegal practice, quackery
The Society voiced worry over continuing allegations of uncontrolled training and illegal activity within the healthcare field, when individuals claim to be professionally competent after acquiring qualifications through illicit or informal methods.
PSN said these procedures are usually carried out in private hospitals, pharmacies and other health care facilities without ethical supervision, in gross violation of the existing regulatory framework regulating pharmaceutical practice in Nigeria.
Such acts are a danger to the public health and contravene many statutory laws relating to the distribution of drugs and control of pharmacy,” it cautioned.
Drug laws and regulatory failures highlighted
The PSN highlighted that Nigeria’s drug laws, particularly the Fake Drug Act, are explicit in their proscription of possession and distribution of fake medications, with Section 1 prescribing stiff penalties of up to life imprisonment.
The Society also referenced Sections 2.1 and 2.2 of the Act which ban sale of pharmaceuticals in unapproved places such as markets, kiosks, motor parks, cars and other non-approved establishments.
It said that ‘Section 2.2 of the Act plainly states that the Pharmacy Council of Nigeria (PCN) is the statutory licensing authority for the regulation of pharmaceutical practice.
PSN emphasised that the law regulations are to ensure safe and controlled drug distribution in the country.
Judicial Momentum Seen In Enforcement Of Pharmacy Law
The Society pointed out that, while in some instances some parts of the Fake Drug Act have been applied with isolated convictions, recent court judgements indicate a more vigorous enforcement of the broader pharmacy legislation.
The verdicts in Ibadan and Calabar, it said, are a resurgence of the judicial readiness to mete out penalties to unlawful pharmaceutical activities.
PSN said the development was a move in the right direction for increasing regulatory compliance and boosting public health safety.
Regulatory Issues in Some States
PSN also discovered regulatory issues in Cross River and Akwa Ibom States where it accused of regulatory functions being assumed by unlicensed groups who register pharmacy facilities under the moniker “Pharmaceutical Chemists.”
The Society said the activity was a breach of the PCN Act 2022 (as amended) and the Fake Drug Act.
It warned that unregulated actions could undermine national regulatory standards and threaten the integrity of pharmaceutical services.
PSN also congratulated the Pharmacy Council of Nigeria for its continuous crackdown on unlawful pharmaceutical practices across the country.
Drug Regulation: A Constitutional and Public Health Priority
The Society re-echoed that drug control holds a crucial role in Nigeria’s constitutional and healthcare system.
It observed that pharmaceutical practice is mentioned under Item 21 of Part I of the Second Schedule of the 1999 Constitution which puts drug topics in the Exclusive Legislative List.
The PSN said the designation was in recognition of the delicate nature of medication delivery and the requirement for centralised regulatory oversight in line with worldwide best practices.
The statement said most responsible governments in the world exercise tight control over drug regulation because of its direct effect on public health.
Historical Background and the Development of Regulation
PSN alluded to the previous advances on the regulatory framework for the pharmaceutical sector in Nigeria, particularly the delegation of licensing authority to local governments during the previous reforms in the health sector.
It said the decentralised structure led to regulatory fragmentation and the spread of unregistered pharmaceutical premises across the country.
Today, the Society estimated that Nigeria has over three million pharmaceutical outlets, of which less than 50,000 are legitimately recognised in the manufacture, importation, distribution and retail operations.
It identified this disparity as a key regulatory problem that requires urgent addressing.
Appeal to strengthen professional autonomy
PSN cautioned that the encroachment on the professional autonomy of chemists is a threat to good health care delivery and will impair the regulatory enforcement.
It asked all stakeholders in the public and commercial sectors, including politicians, investors and healthcare administrators, to acknowledge the necessity of structured pharmaceutical governance.
The Society reiterated that all facilities involved in storage and dispensing of pharmaceuticals must operate rigorously in accordance with recognised regulatory frameworks.
Supervision And Control Of Pharmaceutical Premises
PSN has emphasised the crucial role of Superintendent Pharmacists in the safe and legal running of pharmacies.
Proper oversight in the drug distribution chain must be ensured to ensure safety standards and to safeguard customers from poor or unsafe medicine, it said.
The Society also pointed out that the healthcare facilities must comply with the restructuring criteria on the operations of pharmaceutical operations.
Pharmacy Practice Legal Framework
The Society detailed the legal basis for the supervision of pharmacies from 1990 to 2022, citing the Poisons and Pharmacy Act, Cap 535 of the Laws of the Federation.
It spoke of the need to sell dispensers and chemists to keep accurate records and to exercise personal management of pharmaceutical establishments.
PSN also cited judicial precedents such as the Federal High Court verdict in Dr Akin Oke & Others against Pharmacists Council of Nigeria (1996), which supported the notion of direct professional control over pharmaceutical operations.
It emphasised that compliance with these regulations is still the cornerstone of professional accountability.
CODE OF ETHICS AND CONDUCT FOR PROFESSIONALS
PSN emphasised that the pharmacy profession is regulated by a Code of Ethics stipulating that Superintendent Pharmacists must have direct management of pharmacy operations.
It said such executives are required to ensure legal, ethical and professional standards in all pharmaceutical activities.
“Superintendent Pharmacists are responsible for the day-to-day operational control of their premises and are responsible for the outcomes of their premises and are required to be physically present to provide effective supervision,” the Society said.
Regulatory Strengthening And PCN Act 2022
The Society pointed out the salient features of the PCN Act 2022, particularly Section 29, which requires all pharmaceutical premises to be operated under the direct supervision of a Superintendent Pharmacist.
It said the Act empowered the Pharmacy Council of Nigeria to regulate pharmaceutical activities in public and private sectors.
“The law enhances accountability within the pharmaceutical profession and improves regulatory enforcement across the country,” PSN said.
It said the position of Superintendant Pharmacists was now firmly established as vital to safe pharmaceutical practice.
Superintendent Pharmacists – Role And Responsibilities
Superintendent Pharmacists were the key executives responsible for the professional, operational and regulatory control of pharmaceutical institutions, said PSN.
They handle pharmacy management, license monitoring, inventory management, quality assurance, patient care, personnel supervision and regulatory compliance.
They also ensure secure sourcing of medicines, adequate storage, pharmacovigilance compliance and responsiveness to drug safety alerts.
Their job is key to protecting public health and ensuring safe access to medicines, the Society said.
Public Health, Safety and Governance
PSN stated Superintendent Pharmacists play a key role in putting in place safe operational processes, including standard protocols for dispensing, storage and counselling.
They also have the responsibility to ensure medicine authenticity, correct disposal, regulatory compliance and constant audit of pharmaceutical procedures.
The Society also said that oversight includes workforce adequacy, business continuity planning and patient-centred care initiatives.
Urge for tougher legal action
The PSN recommended the National Assembly to revisit and stiffen penalties under the existing drug legislation, particularly the Fake Drug Act, to make deterrence against violators more effective.
Weak enforcement measures, it cautioned, might result in further breaches of pharmaceutical standards.
The Society also urged for a harder line against individuals and institutions involved in unlawful practices of pharmaceuticals in public and private health care systems.
Conclusion : Drug law enforcement reinforcers
PSN said the recent judgements of the courts were a major step towards improving the pharmaceutical regulatory system of Nigeria.
The decisions reiterated the significance of the stringent implementation of drug legislation to safeguard public health and ensure professional responsibility, it said.
The Society expressed it support for PCN in its continued efforts to crackdown on unlawful activities in the pharmaceutical sector and enhance the safe delivery of pharmaceuticals across the country.
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