NAFDAC Blacklists Onifam Laboratories Over Alleged Drug Regulation Breaches

(NAFDAC Officials. Photo Credit: Aljazirah Nigeria Newss)

Due to alleged infractions of Nigeria's pharmaceutical regulatory framework, Onifam Laboratories Limited, its Managing Director and Chief Executive Officer, members of its board of directors, and other related individuals and entities have been placed on a blacklist by the National Agency for Food and Drug Administration and Control (NAFDAC).

The corporation and all impacted parties are prohibited from directly or indirectly engaging in any pharmaceutical operations governed by NAFDAC, according to the agency's announcement that the sanctions go into force immediately.

The decision was contained in a statement issued on Monday by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, who said investigations carried out by the agency uncovered several breaches of regulatory requirements governing the pharmaceutical industry.

According to the statement, the alleged infractions include regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, as well as actions allegedly designed to circumvent established regulatory procedures.

NAFDAC explained that these alleged violations compromise product traceability, weaken accountability within the pharmaceutical supply chain, and pose potential risks to public health.

The agency stated that the actions allegedly contravene 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 governing pharmaceutical operations in Nigeria.

As part of the sanctions, Onifam Laboratories Limited, its Managing Director, directors and other affected persons have been barred from applying for or benefiting from any licence, permit, registration, certificate or approval issued by NAFDAC.

The blacklist also bars them from operating in any capacity as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of products regulated by the agency.

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

The agency stressed that maintaining strict compliance with regulatory standards remains essential to ensuring that only safe, quality and properly regulated pharmaceutical products are available to Nigerians.

NAFDAC reaffirmed its commitment to enforcing existing laws and regulations across the pharmaceutical sector, urging manufacturers, importers, distributors and other stakeholders to comply fully with all regulatory requirements.

The agency added that its ongoing enforcement actions are aimed at protecting consumers, strengthening confidence in Nigeria's medicines regulatory system, and preventing practices capable of endangering public health.