The National Agency for Food and Drug Administration and Control (NAFDAC) has wielded the big stick against Onifam Laboratories Ltd, blacklisting the pharmaceutical company, its Managing Director/Chief Executive Officer, all directors, and every affiliated person or entity linked to what it described as serious regulatory violations.
The sweeping sanctions, which take immediate effect, followed what the agency said were extensive investigations that uncovered regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and actions designed to circumvent established regulatory processes.
According to NAFDAC, the violations undermine product traceability, weaken accountability within the pharmaceutical supply chain and pose significant risks to public health, contrary to the provisions of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021, and other regulatory guidelines.
In a statement signed by its Director-General, Prof. Mojisola Adeyeye, the agency announced that the affected company and all associated persons or entities are henceforth barred from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC.
The blacklist prohibits them from applying for or benefiting from any NAFDAC registration, licence, permit, certificate or approval. They are also forbidden from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of any NAFDAC-regulated product in Nigeria.
“The blacklist shall remain in force until otherwise directed by NAFDAC Management,” the agency said.
NAFDAC warned that it reserves the right to initiate additional regulatory, administrative, enforcement and legal actions where necessary to protect public health and preserve the integrity of Nigeria’s medicines regulatory system.
Reaffirming its commitment to strict enforcement of pharmaceutical regulations, the agency urged operators in the sector to comply fully with all applicable laws and regulatory requirements.
“NAFDAC remains resolute in ensuring that only safe, quality and properly regulated medical products are available to the Nigerian public,” Adeyeye stated.
