NAFDAC Blacklists Onifam Laboratories, Directors Over Regulatory Violations

• NAFDAC has blacklisted Onifam Laboratories Limited, its CEO, directors and affiliated entities over alleged regulatory violations, barring them from participating in any pharmaceutical business regulated by the agency.

The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, all members of its board of directors, and every affiliated or associated person or entity linked to the company’s regulatory violations.

The agency announced the sanction in a statement issued on Monday by its Director-General, Prof. Mojisola Adeyeye, saying the decision takes immediate effect following investigations that uncovered multiple breaches of Nigeria’s pharmaceutical regulations.

According to NAFDAC, the company was found to have engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and activities designed to bypass established regulatory processes.

The agency said the violations undermine product traceability, weaken accountability, and pose serious risks to public health, contrary to 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.

As part of the sanctions, Onifam Laboratories and all affected individuals and entities are prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC.

The ban covers applying for or benefiting from any NAFDAC registration, licence, permit, certificate or approval, as well as operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of NAFDAC-regulated products in Nigeria.

NAFDAC stated that the blacklist will remain in force until the agency decides otherwise and warned that additional regulatory, administrative, enforcement or legal actions could be taken if necessary.

“The blacklist shall remain in force until otherwise directed by NAFDAC Management. The Agency also reserves the right to take further regulatory, administrative, enforcement and legal actions as necessary to safeguard public health and preserve the integrity of Nigeria’s medicines regulatory system,” the statement said.

The agency reaffirmed its commitment to maintaining strict regulatory compliance and urged stakeholders in the pharmaceutical industry to adhere to all applicable laws and guidelines.

NAFDAC noted that the latest action forms part of its ongoing crackdown on pharmaceutical manufacturers, importers and distributors involved in regulatory infractions, as it seeks to eliminate substandard and falsified medicines from the Nigerian market.

The agency added that it remains committed to ensuring that only safe, high-quality and properly regulated medical products are made available to Nigerians.