NAFDAC bans Onifam laboratories due to non-compliance with regulations

The National Agency for Food and Drug Administration and Control, NAFDAC, has taken drastic action against Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, and other affiliated individuals and entities, due to alleged breaches of regulatory requirements, effectively blacklisting them from participating in pharmaceutical activities.

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This sanction, which is immediate, prohibits the company and affected individuals from engaging directly or indirectly in any pharmaceutical activities regulated by NAFDAC, as announced by the agency's Director-General, Prof. Mojisola Adeyeye, in a statement issued on Monday.

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According to Prof. Mojisola Adeyeye, investigations conducted by NAFDAC uncovered multiple regulatory infractions, including misrepresentation, misuse of approvals and certificates, improper registration and transfer of pharmaceutical products, and attempts to circumvent established regulatory processes.

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These alleged violations have severe consequences, including undermining product traceability, weakening accountability, and posing significant risks to public health, as they contravene provisions of the NAFDAC Act and other applicable regulatory guidelines.

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The NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, and the Drug and Related Products Registration Regulations 2021 are among the laws and guidelines that the alleged actions have contravened, prompting the agency to take swift action.

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As a result of the sanctions, Onifam Laboratories Limited and the affected individuals are barred from applying for or benefiting from any registration, licence, permit, certificate, or approval issued by NAFDAC, effectively limiting their involvement in the pharmaceutical sector.

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Furthermore, they are prohibited from operating in various capacities, including as manufacturers, importers, distributors, and marketing authorisation holders, among others, in relation to products regulated by the agency.

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The blacklist will remain in effect until further notice, with NAFDAC reserving the right to impose additional measures to protect public health and the integrity of Nigeria's medicines regulatory system.

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NAFDAC has reaffirmed its commitment to ensuring compliance with regulatory standards, urging stakeholders in the pharmaceutical sector to adhere strictly to relevant laws and guidelines to ensure the availability of safe and quality medical products to the Nigerian public.