PCN seals 724 facilities in Kwara, warns against unlicensed medicine outlets

The Pharmacy Council of Nigeria (PCN) recently undertook a significant enforcement exercise in Kwara State, sealing 724 pharmaceutical and patent medicine facilities. This action, which followed the inspection of 1,238 premises across ten local government areas, targeted outlets operating without valid PCN licenses, maintaining poor storage conditions, or engaging in unauthorized handling of controlled medicines. The Council's Registrar, Pharm. Ibrahim Babashehu Ahmed, emphasized the critical importance of public patronage of only duly licensed premises to safeguard public health and prevent issues such as treatment failures, antimicrobial resistance, and the diversion of controlled drugs. The exercise underscores the PCN's commitment to upholding regulatory standards under the Pharmacy Council of Nigeria (Establishment) Act 2022.

The recent sealing of 724 pharmaceutical and patent medicine facilities by the Pharmacy Council of Nigeria (PCN) in Kwara State marks a decisive step in the ongoing efforts to sanitize Nigeria's pharmaceutical landscape. This statewide enforcement, which saw the inspection of 1,238 premises, including pharmacies, patent medicine stores, and illegal outlets, highlights the persistent challenges of regulatory non-compliance within the sector. The Registrar of the Council, Pharm. Ibrahim Babashehu Ahmed, issued a stern warning to the public against patronizing unlicensed medicine outlets, underscoring the profound public health implications of such practices.

This enforcement action is not merely an administrative exercise but a critical intervention aimed at protecting citizens from substandard and illicit pharmaceutical products. The breaches identified, ranging from operating without valid licenses to poor storage conditions and unauthorized handling of controlled substances, directly compromise patient safety and contribute to broader public health crises. For legal practitioners, this development necessitates a thorough understanding of the regulatory framework governing pharmacy practice in Nigeria, particularly the powers and responsibilities vested in the PCN.

This article will delve into the statutory and regulatory underpinnings of the PCN's enforcement powers, analyze the nature of the infractions, and discuss the implications for pharmaceutical operators and legal professionals advising them. It aims to provide a comprehensive overview of the legal landscape, emphasizing the imperative for strict adherence to established standards to avoid severe penalties and ensure public welfare.

The regulatory authority for pharmacy practice in Nigeria is primarily vested in the Pharmacy Council of Nigeria (PCN), an agency of the federal government. The PCN's mandate is enshrined in the Pharmacy Council of Nigeria (Establishment) Act 2022, which repealed the earlier Pharmacists Council of Nigeria Act, Cap P17 LFN 2004. This landmark legislation empowers the Council to regulate and control pharmacy education, training, and practice in all its aspects, including the registration and licensing of pharmacists, pharmacy technicians, pharmaceutical premises, and patent and proprietary medicine vendors (PPMVs).

The Act of 2022 significantly strengthened the PCN's enforcement capabilities, introducing stiffer penalties for offenders. Previously, fines for breaches ranged from N250 to N1,000, but the new Act raised these substantially to between N250,000 and N2,000,000. Crucially, the Act explicitly grants the Registrar the power to revoke licenses and seal pharmaceutical premises where offences are committed. Complementing the Act are various regulations, such as the Registration and Licensing of Pharmaceutical Premises Regulations, 22021, which detail requirements for registration, inspection, and enforcement, including provisions for sealing premises that fail to renew their licenses or operate without registration.

The legal framework distinguishes between pharmacies, which must be owned and supervised by registered pharmacists, and patent medicine stores, which are licensed to sell over-the-counter medications and health products under specific guidelines. Both categories are subject to rigorous inspection and licensing requirements, including proper premises, storage conditions, and qualified personnel. The PCN's proactive enforcement, as seen in Kwara State, is a direct application of these statutory powers, aimed at ensuring that all pharmaceutical operations meet the prescribed standards for public safety.

The enforcement exercise in Kwara State, led by PCN Registrar Pharm. Ibrahim Babashehu Ahmed, revealed a range of regulatory breaches across the 1,238 premises inspected. Out of these, 724 facilities were sealed, comprising 68 pharmacies, 542 patent medicine stores, and all 114 identified illegal outlets. The primary infractions included operating without valid PCN licenses, maintaining poor storage conditions, and engaging in the unauthorized handling of controlled medicines. These violations are not merely administrative oversights but constitute serious threats to public health, potentially leading to treatment failures, the development of antimicrobial resistance, and the diversion of controlled drugs for illicit purposes.

The Pharmacy Council of Nigeria (Establishment) Act 2022 provides the legal teeth for these enforcement actions. Section 54 of the Act specifically criminalizes operating a pharmacy without registration, while Section 53 addresses obstruction of pharmaceutical inspection officers and breaking of seals. The Registrar is explicitly empowered to suspend, revoke, withdraw, or cancel licenses in instances of breach, and the Act makes specific provisions for the sealing of pharmaceutical premises where offences are committed. The increased penalties, with fines now reaching up to N2,000,000, reflect the government's resolve to deter non-compliance and ensure a safer pharmaceutical environment.

While the overall rate of illegal operation in Kwara State was noted as relatively low at 9% of inspected premises, the compliance rates among licensed operators varied, with 59.2% of pharmacies fully compliant compared to 43% of patent medicine vendors. This disparity suggests a need for targeted interventions and increased oversight for patent medicine vendors. The PCN's emphasis on public awareness, urging citizens to patronize only licensed premises with visibly displayed PCN licenses, is a crucial aspect of its regulatory strategy.

Furthermore, the legal landscape supports the PCN's robust enforcement. Recent judicial pronouncements, such as the dismissal of fundamental rights suits filed by alleged illegal medicine dealers against the PCN and the Nigeria Security and Civil Defence Corps (NSCDC), affirm the Council's authority to carry out its statutory duties without undue interference. This judicial backing reinforces the PCN's position as the primary regulator, capable of taking decisive action against those who flout pharmaceutical laws and regulations. The collaboration with law enforcement agencies, though not explicitly detailed in this report, is implicitly supported by the PCN Act, which allows for the arrest, investigation, and prosecution of criminal cases under the Act.

The Pharmacy Council of Nigeria's recent enforcement drive in Kwara State serves as a stark reminder to all stakeholders in the pharmaceutical sector of the unwavering commitment to regulatory compliance and public health safety. The sealing of 724 facilities underscores the PCN's readiness to exercise its expanded powers under the Pharmacy Council of Nigeria (Establishment) Act 2022, which provides a robust legal framework for ensuring that only safe, effective, and quality-assured medicines are accessible to the Nigerian populace. Legal practitioners advising clients in the pharmaceutical industry must emphasize the critical importance of strict adherence to licensing requirements, proper storage protocols, and the authorized handling of all pharmaceutical products.

Practitioners should proactively guide their clients on the implications of the PCN Act 2022, particularly concerning the increased penalties for non-compliance, the Registrar's power to revoke licenses, and the specific provisions for sealing premises. Regular audits of operational procedures, timely renewal of premises and practice licenses, and continuous professional development for pharmacists and patent medicine vendors are essential to avoid enforcement actions. The PCN's consistent messaging about patronizing only licensed outlets also highlights the need for businesses to visibly display their valid PCN licenses. As the Council continues its nationwide efforts to sanitize the drug distribution system, vigilance and proactive compliance will be paramount for all pharmaceutical operators to ensure business continuity and contribute to a healthier Nigeria.