NAFDAC blacklists firm, directors over regulatory violations

The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, along with its Managing Director, all directors, and any affiliated persons or entities involved in regulatory violations. This immediate sanction follows investigations that uncovered multiple breaches of pharmaceutical sector regulations.

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The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd, its Managing Director/Chief Executive Officer, all Directors, and all affiliated or associated persons and entities found to have participated in regulatory violations, with immediate effect.

According to NAFDAC Director-General Prof. Mojisola Adeyeye, the company engaged in regulatory misrepresentation, misused approvals and certificates, and improperly registered and transferred pharmaceutical products. These actions, the agency stated, compromise product traceability, weaken accountability, and pose significant risks to public health, violating several acts and regulations.

The blacklist bars the affected company and individuals from directly or indirectly participating in any pharmaceutical business regulated by NAFDAC. This includes applying for or benefiting from any NAFDAC registration, license, permit, certificate, or approval. They are also prohibited from acting as manufacturers, importers, distributors, marketing authorization holders, agents, representatives, consultants, promoters, or sponsors of any NAFDAC-regulated product in Nigeria.

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These actions compromise product traceability, weaken accountability, and pose significant risks to public health, in violation of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021, and other applicable regulatory guidelines.

NAFDAC emphasized that the blacklist will remain in effect until otherwise directed and that the agency reserves the right to impose further sanctions if necessary to safeguard public health and maintain the integrity of the regulatory framework.

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Consequently, the affected company and associated persons or entities are prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC.