NAFDAC blacklists Onifam Laboratories over regulatory breaches

The National Agency for Food and Drug Administration and Control (NAFDAC) has taken stringent action against Onifam Laboratories Limited, blacklisting the company, its Managing Director/CEO, board members, and affiliated entities. This decision stems from multiple alleged violations of regulatory requirements governing Nigeria's pharmaceutical sector.

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The alleged infractions include regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and actions aimed at circumventing established regulatory processes.

According to NAFDAC Director-General Prof. Mojisola Adeyeye, the agency's investigations uncovered significant infractions. These include regulatory misrepresentation, improper use of NAFDAC approvals and certificates, flawed product registration processes, and deliberate attempts to circumvent established regulatory procedures. NAFDAC stated that these actions compromise product traceability, weaken accountability, and pose potential risks to public health.

The sanctions, effective immediately, bar the blacklisted parties from any direct or indirect involvement in pharmaceutical activities regulated by NAFDAC. This prohibition extends to applying for or benefiting from any NAFDAC registration, license, permit, certificate, or approval. They are also barred from operating as manufacturers, importers, distributors, marketing authorization holders, agents, representatives, consultants, promoters, or sponsors of regulated products.

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NAFDAC said the alleged violations undermine product traceability, weaken accountability and pose risks to public health.

NAFDAC emphasized that the blacklist will remain in effect indefinitely, and the agency reserves the right to impose further measures if necessary to protect public health and the integrity of the nation's medicine regulatory system. The agency reiterated its commitment to ensuring compliance and urged all stakeholders in the pharmaceutical sector to adhere strictly to all relevant laws and guidelines, ensuring that only safe, quality, and properly regulated medical products reach the Nigerian public.

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The agency reaffirmed its commitment to ensuring compliance with regulatory standards and urged stakeholders in the pharmaceutical sector to adhere strictly to relevant laws and guidelines.