Court Jails Illegal Pharmacy Operators As Psn Raises Alarm Over Fake Drug Crisis

The Federal High Court in Nigeria has delivered two landmark judgments, convicting operators of illegal pharmaceutical facilities in Ibadan and Calabar. These rulings, lauded by the Pharmaceutical Society of Nigeria (PSN), represent a significant advancement in the nation's ongoing battle against fake and substandard drugs and quackery within the healthcare system. The convictions, particularly one involving an eight-year imprisonment for operating an unregistered pharmacy and employing unqualified personnel, underscore the judiciary's commitment to enforcing pharmaceutical regulations. This development reinforces the authority of the Pharmacy Council of Nigeria (PCN) and the National Agency for Food and Drug Administration and Control (NAFDAC), sending a clear deterrent message to illicit drug operators and highlighting the critical need for strict adherence to the Pharmacy Council of Nigeria (Establishment) Act, 2022, and other relevant drug laws to safeguard public health.

Nigeria's healthcare landscape has long grappled with the pervasive menace of fake and substandard drugs, a crisis that poses severe threats to public health and erodes confidence in the pharmaceutical sector. In a significant stride towards sanitising the drug distribution system, the Federal High Court recently delivered two landmark judgments, convicting operators of illegal pharmaceutical facilities in Ibadan and Calabar. These rulings have been met with widespread commendation from the Pharmaceutical Society of Nigeria (PSN), which described them as a major breakthrough in the fight against pharmaceutical quackery and the proliferation of counterfeit medicines.

The judgments, particularly the case of *Federal Republic of Nigeria v. Ezea Isidora Kamchukwube and three others* in Calabar, where an operator received an eight-year imprisonment sentence for operating an unregistered pharmacy and engaging unqualified personnel, signal a renewed judicial resolve to enforce regulatory compliance. This article delves into the legal implications of these convictions, examining the statutory framework underpinning pharmaceutical regulation in Nigeria, the roles of key regulatory bodies, and the broader impact of these judicial pronouncements on practitioners and the public health system.

The regulatory framework governing pharmaceutical practice and drug administration in Nigeria is primarily anchored in several key legislations. Central to this framework is the Pharmacy Council of Nigeria (Establishment) Act, 2022, which establishes the Pharmacy Council of Nigeria (PCN) as the statutory body responsible for regulating all aspects of pharmacy practice and business, including the registration and licensing of pharmacists and pharmaceutical premises. The Act outlines stringent requirements for operation, professional conduct, and disciplinary measures for non-compliance.

Complementing the PCN Act is the National Agency for Food and Drug Administration and Control (NAFDAC) Act Cap N1 LFN 2004, which empowers NAFDAC to regulate and control the manufacture, importation, exportation, distribution, advertisement, sale, and use of food, drugs, cosmetics, medical devices, and other regulated products. The Federal High Court holds exclusive jurisdiction to try offences under the NAFDAC Act. Furthermore, the Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act, often referred to as the Fake Drug Act, criminalises the possession and sale of fake drugs and prohibits their sale in unauthorised locations. Section 2.2 of this Act unequivocally designates the PCN as the appropriate licensing authority for pharmaceutical premises.

The proliferation of illegal drug outlets and the circulation of fake drugs have been a persistent challenge in Nigeria, with estimates suggesting millions of unregistered pharmaceutical premises operating nationwide. This crisis has been exacerbated by weak enforcement in the past and the delegation of Patent and Proprietary Medicine Vendors' licences to local governments, which led to an explosion of unregulated outlets. The recent judgments, therefore, represent a critical enforcement push by regulatory bodies like the PCN, supported by the PSN, to address these systemic issues and restore sanity to the drug distribution chain.

The recent Federal High Court judgments mark a pivotal moment in the enforcement of Nigeria's pharmaceutical laws. The case in Calabar, *Federal Republic of Nigeria v. Ezea Isidora Kamchukwube and three others* (Suit No. FHC/CA/76C/2025), resulted in an eight-year imprisonment sentence for the principal operator and three others. The convictions were based on violations of Sections 32(2), 54(1), 54(2), and 53(d) of the Pharmacy Council of Nigeria (Establishment) Act, 2022, which pertain to operating pharmacies without registration and allowing unqualified persons to dispense drugs. This specific citation of the PCN Act 2022 highlights the direct application of the updated legislation in holding illegal operators accountable.

The significance of these judgments lies not only in the punitive measures but also in their deterrent effect. The PSN has consistently advocated for stronger enforcement and stiffer penalties, noting that previous sanctions were often insufficient to deter offenders. The increased fines under the new PCN Establishment Act, from N250,000 to N2 million, coupled with substantial jail terms, reflect a growing commitment to making illegal pharmaceutical operations a high-risk venture. This aligns with NAFDAC's long-standing call for more punitive punishments for those involved in illicit and falsified drugs, recognising the severe public health consequences of such activities.

While the Federal High Court has exclusive jurisdiction over offences under the NAFDAC Act, its role in prosecuting violations of the PCN Act, as seen in the Calabar case, underscores its broad mandate in safeguarding public health. The judgments also bring to the fore the critical role of the Superintendent Pharmacist, as mandated by the PCN Act 2022, in ensuring regulatory compliance, safe drug sourcing, patient counselling, and overall quality assurance in pharmaceutical premises. The absence of such qualified supervision is a direct violation that these judgments aim to curb.

However, challenges persist. The PSN has raised concerns about widespread regulatory abuse, particularly in some states where certain groups, allegedly with government backing, unlawfully assume powers to register pharmaceutical facilities, thereby perverting the PCN Act 2022 and the Fake Drug Act. This highlights a critical gap in enforcement consistency and the need for inter-agency collaboration and political will to ensure that all levels of government respect the exclusive legislative powers of the federal government on drug matters, as enshrined in Item 21 of Part I of the Second Schedule of the 1999 Constitution. The sheer volume of unregistered outlets, estimated to be over three million, compared to fewer than 50,000 registered ones, indicates the monumental task ahead for regulatory bodies.

Previous cases, such as the sentencing of Paul Uche for importing fake drugs or Osita Paul Ely for manufacturing them, demonstrate a history of judicial action against drug counterfeiters. However, the recent judgments, with their emphasis on illegal operation of premises and engagement of unqualified personnel under the PCN Act 2022, broaden the scope of enforcement and target the structural deficiencies that enable the fake drug crisis. The court's decision to discharge and acquit the defendants on counts related to unlawful unsealing of premises, due to evidence that law enforcement officers had authorised reopening, also highlights the importance of clear communication and coordination among regulatory and security agencies to prevent conflicting directives.

The recent convictions by the Federal High Court against illegal pharmacy operators represent a significant victory for public health and regulatory enforcement in Nigeria. These judgments, particularly the eight-year imprisonment handed down in the Calabar case, send an unequivocal message that operating outside the established legal framework for pharmaceutical practice will attract severe consequences. They reinforce the authority of the Pharmacy Council of Nigeria (PCN) and underscore the judiciary's commitment to upholding the provisions of the Pharmacy Council of Nigeria (Establishment) Act, 2022, and the Fake Drug Act.

For legal practitioners, these rulings highlight the increasing importance of robust compliance frameworks for clients in the pharmaceutical sector. Due diligence in licensing, personnel qualifications, and adherence to operational standards is no longer merely a regulatory formality but a critical shield against criminal liability. The PSN's call for stricter penalties and enhanced enforcement mechanisms suggests that regulatory scrutiny will only intensify. Practitioners should advise clients to review their operations meticulously, ensuring full compliance with all relevant statutes and regulations, and to be prepared for more aggressive enforcement actions from bodies like the PCN and NAFDAC. The ongoing fight against fake drugs and quackery demands a concerted effort from all stakeholders, with the judiciary now clearly signalling its readiness to play a decisive role in safeguarding the health of the Nigerian populace.