LAGOS, NIGERIA — The National Agency for Food and Drug Administration and Control has formally blacklisted Onifam Laboratories Limited, along with its Managing Director and Chief Executive Officer, all members of its board of directors, and all affiliated corporate entities. The sweeping ban, which takes immediate effect, prohibits the firm and its leadership from engaging in any form of pharmaceutical business within the Federal Republic of Nigeria.
The development was formally announced following an extensive investigation conducted by NAFDAC's Investigation and Enforcement Directorate. In an official communication signed by the Director-General of NAFDAC, Professor Mojisola Adeyeye, and presented by the Director of Investigation and Enforcement, Martins Iluyomade, the regulatory authority revealed that Onifam Laboratories engaged in severe breaches of national drug regulations. The infractions include regulatory misrepresentation, the unauthorized transfer and registration of pharmaceutical products, and the systematic circumvention of statutory oversight mechanisms.
By invoking its statutory mandates, NAFDAC has barred the company and its associated executives from applying for, renewing, or benefiting from any registration, license, permit, or certificate issued by the agency. The sanction effectively removes Onifam Laboratories from the Nigerian health and pharmaceutical ecosystem, signaling an intensified zero-tolerance policy against corporate entities that compromise medicine safety standards.
The Scope of Regulatory Violations and Investigational Findings
The regulatory action follows a multi-month investigation that uncovered widespread non-compliance and procedural misrepresentation by Onifam Laboratories Limited. According to official disclosures from NAFDAC management, the company repeatedly misused official approvals, certificates of registration, and Certificates of No Objection outside of their designated legal conditions and authorized scopes.
Investigators established that the pharmaceutical firm engaged in the unauthorized registration, assignment, licensing, and marketing of regulated medicinal products. These activities were carried out by or transferred to entities that lacked the mandatory legal documentation, qualified technical personnel, authorized manufacturing facilities, and valid regulatory standing. By bypassing these statutory requirements, the company created unapproved distribution streams that directly undermined the integrity of the national drug supply chain.
NAFDAC emphasized that such fraudulent practices severely compromise product traceability—a foundational pillar of modern pharmaceutical oversight. When product origin, batch history, and distribution pathways are obscured, regulatory authorities lose the ability to verify drug purity, strength, and safety, thereby exposing patients to potentially unwholesome, substandard, or falsified medical products.
The agency noted that the actions of Onifam Laboratories directly violated the NAFDAC Act (Cap. N1 LFN 2004), the Food, Drug and Related Products Registration Act (Cap. F33 LFN 2004), the Drug and Related Products Registration Regulations 2021, and the Counterfeit and Fake Drugs and Unwholesome Processed Foods Miscellaneous Provisions Act (Cap. C34 LFN 2004).
Comprehensive Statutory Framework and Full Extent of Sanctions
The blacklisting order issued by NAFDAC carries severe operational and legal ramifications for all targeted parties. Under the terms of the executive directive, the prohibition applies universally to Onifam Laboratories Limited, its chief executive officer, members of its board, and any successor, proxy, front, or connected corporate entity identified as having participated in or benefited from the illegal activities.
The affected individuals and corporate bodies are barred from acting in any professional or commercial capacity within the Nigerian pharmaceutical market. This includes operating as manufacturers, importers, exporters, distributors, wholesalers, marketing authorization holders, agents, consultants, promoters, or sponsors of any NAFDAC-regulated product.
To enforce the directive across the country, Professor Adeyeye instructed all NAFDAC zonal directors and state coordinators to initiate immediate surveillance throughout their respective jurisdictions. Field officers have been mandated to monitor distribution outlets, healthcare facilities, and commercial centers to locate, quarantine, and recall all products linked to Onifam Laboratories.
The regulatory body made it clear that the blacklist will remain in force indefinitely until formally reviewed or rescinded by NAFDAC management. Furthermore, the agency stated that it reserves the right to institute further administrative, enforcement, and criminal legal actions against the company's directors to ensure full legal accountability and preserve public health safety.
Urgent Directives for Healthcare Providers, Distributors, and Patients
In light of the immediate blacklisting order, NAFDAC has issued an urgent public health advisory to all healthcare professionals, pharmaceutical distributors, patent medicine vendors, hospital administrators, and consumers across Nigeria. The agency instructed all commercial distributors and retail pharmacies to immediately suspend the procurement, stocking, sale, and distribution of any medicinal products registered by or associated with Onifam Laboratories.
Healthcare providers, including medical doctors, pharmacists, and nurses, have been advised to review their institution's medicine inventories and immediately cease the administration or prescription of the company's products to patients. NAFDAC urged consumers who may currently be using medications supplied by Onifam Laboratories to stop usage immediately and seek clinical advice from qualified medical professionals, particularly if they experience any unexpected adverse reactions.
To maintain active public surveillance, the regulatory agency requested that any suspicious or unwholesome products bearing Onifam Laboratories' branding be reported to the nearest NAFDAC office across the 36 states and the Federal Capital Territory. The agency reiterated the availability of its dedicated reporting channels, including its toll-free hotline, official email alert system, and the Med-safety mobile application designed for real-time reporting of adverse drug reactions and substandard medicines.
Reinforcing Quality Governance in Nigeria's Pharmaceutical Ecosystem
The blacklisting of Onifam Laboratories reflects a broader, ongoing institutional reform strategy led by Professor Mojisola Adeyeye aimed at elevating Nigeria's pharmaceutical regulatory standards to global benchmarks. Since assuming leadership, NAFDAC has prioritized structural accountability, supply chain digitization, and strict enforcement of Good Manufacturing Practice (GMP) protocols.
These institutional efforts enabled NAFDAC to achieve World Health Organization (WHO) Maturity Level 3 status, recognizing Nigeria as possessing a well-functioning and stable regulatory system for medicines and vaccines. The agency is currently working toward achieving WHO Maturity Level 4 and World Listed Authority (WLA) status, a designation that would allow Nigerian-manufactured pharmaceuticals to be traded seamlessly across continental and international markets under the African Continental Free Trade Area (AfCFTA).
To safeguard these hard-won international certifications, NAFDAC has consistently taken stern measures against both domestic and foreign pharmaceutical companies that violate regulatory guidelines. Past enforcement operations have resulted in the blacklisting of foreign manufacturers in Asia and Europe for producing falsified antibiotics, as well as the immediate closure of local facilities operating without valid licenses or proper quality control laboratories.
By taking decisive action against Onifam Laboratories, NAFDAC sends an unequivocal message to all participants in the pharmaceutical sector: commercial operations that compromise product safety, falsify documentation, or evade regulatory oversight will face complete exclusion from the market alongside full statutory prosecution.
