The National Agency for Food and Drug Administration and Control (NAFDAC) has formally blacklisted Onifam Laboratories Ltd, along with its Managing Director/CEO, all directors, and any affiliated individuals or entities implicated in the case, effective immediately.
The move follows a detailed investigation that uncovered a pattern of regulatory breaches at the company, including misleading representations to the agency, unauthorized use of NAFDAC-issued approvals and certificates, and irregularities in how pharmaceutical products were registered and transferred. NAFDAC also found evidence that the company sidestepped standard regulatory checks altogether.
In its notice, the agency warned that these practices put patient safety at risk by making it harder to trace where products come from and by weakening the oversight systems meant to protect the public. The violations were said to breach several pieces of legislation, including the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, and the 2021 Drug and Related Products Registration Regulations.
As a result of the ban, Onifam Laboratories and everyone connected to the case are now locked out of the pharmaceutical industry in Nigeria. They cannot apply for, renew, or benefit from any NAFDAC registration, licence, or certificate, and are barred from operating in any capacity tied to regulated products whether as manufacturers, importers, distributors, agents, or sponsors.
NAFDAC indicated that the sanction has no fixed end date and will stay active until its management decides otherwise. The agency also left the door open for further action, including administrative, legal, or enforcement measures, should they become necessary to protect the integrity of the country’s medicines system.
In a direct appeal to the public, NAFDAC urged anyone currently using or selling Onifam-branded products to discontinue immediately and report the matter to the nearest NAFDAC office. Consumers who experience any adverse reaction after using the company’s products were advised to seek medical care right away.
The Director-General of NAFDAC, Prof. Mojisola Adeyeye, signed off on the notice, reaffirming the agency’s position that only properly vetted and safe medical products should reach Nigerian consumers.
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