NAFDAC blacklists Onifam laboratories over regulatory breaches

By Chioma Obinna

The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, members of its board of directors and other affiliated individuals and entities over alleged regulatory violations.

The agency said the sanction, which takes immediate effect, bars the company and the affected individuals from participating, directly or indirectly, in pharmaceutical activities regulated by NAFDAC.

In a statement issued on Monday, the Director-General of NAFDAC, Prof. Mojisola Adeyeye, said investigations by the agency uncovered multiple violations of regulatory requirements governing the pharmaceutical sector.

According to the statement, 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.

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

The agency stated that the alleged actions contravened provisions 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.

Under the sanctions, the affected company and individuals are prohibited from applying for or benefiting from any registration, licence, permit, certificate or approval issued by NAFDAC.

They are also barred from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of products regulated by the agency.

NAFDAC said the blacklist will remain in force until further notice, adding that it reserves the right to impose additional regulatory, administrative or legal measures where necessary to safeguard public health and protect the integrity of Nigeria’s medicines regulatory system.

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.

It added that its enforcement efforts are aimed at ensuring that only safe, quality and properly regulated medical products are available to the Nigerian public.