NAFDAC Imposes Sweeping Blacklist on Onifam Laboratories Over Egregious Regulatory Violations

The National Agency for Food and Drug Administration and Control (NAFDAC) has enacted a stringent and immediate blacklist against Onifam Laboratories Limited, its Managing Director, board members, and all associated individuals and entities. This decisive enforcement action stems from a comprehensive investigation that uncovered multiple, significant breaches of Nigeria’s pharmaceutical regulatory framework. The sanctions effectively bar the company and its connected parties from engaging in any pharmaceutical business activities overseen by NAFDAC, with the prohibition remaining in force pending a review of the agency’s decision.

Further legal and administrative actions may be pursued as deemed necessary. Investigations revealed that Onifam Laboratories engaged in practices that fundamentally undermined regulatory integrity. These included the improper utilisation of existing regulatory approvals, irregular management of product registrations and transfers, and deliberate circumvention of established compliance procedures. NAFDAC views these violations as a direct threat to the effective oversight of medicines and the safeguarding of public health.

The identified breaches, as detailed by the regulator, compromise pharmaceutical traceability, erode regulatory accountability, and contravene key legislation. These include the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, and the Drug and Related Products Registration Regulations 2021, alongside other pertinent regulatory guidelines.

As a consequence of these violations, Onifam Laboratories and all implicated individuals are prohibited from obtaining or benefiting from any NAFDAC registration, licence, permit, certificate, or regulatory approval. Furthermore, they are barred from operating in any capacity within Nigeria’s regulated pharmaceutical sector, including as manufacturers, importers, distributors, marketing authorisation holders, consultants, agents, representatives, promoters, or sponsors of NAFDAC-regulated products.

While NAFDAC has not disclosed the specific pharmaceutical products involved in the violations, nor indicated whether criminal charges will be filed, the agency has affirmed its commitment to maintaining rigorous compliance standards across the pharmaceutical industry. It has urged all manufacturers, importers, and stakeholders to strictly adhere to all regulatory requirements, underscoring that the quality, safety, and efficacy of medicines and other regulated products remain paramount. This action is part of NAFDAC’s ongoing intensified campaign against counterfeit and substandard products, following recent seizures of illicit anti-malaria medicines, counterfeit alcoholic beverages, and unsafe health products nationwide.

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