Nigerian drug regulator blacklists Onifam Laboratories for compliance breaches
Nigeria’s pharmaceutical regulator has banned Onifam Laboratories and its executives from the industry over severe compliance breaches, signaling a stricter enforcement environment for healthcare investors in the region.
The National Agency for Food and Drug Administration and Control (NAFDAC) has placed Onifam Laboratories, its chief executive, directors, and affiliated entities on a regulatory blacklist. Director-General Prof. Mojisola Adeyeye announced the immediate sanctions on Monday, barring the group from all pharmaceutical operations in Nigeria.
The comprehensive ban prevents the blacklisted individuals and corporate entities from participating directly or indirectly in any regulated healthcare business. They are prohibited from obtaining NAFDAC registrations, licenses, or permits, and cannot act as manufacturers, importers, distributors, marketing agents, consultants, or sponsors. The restrictions will remain in force indefinitely until the agency management decides otherwise.
Regulators found that the company circumvented established protocols to improperly register and transfer pharmaceutical products. "The decision follows extensive investigations which established that the company engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and activities that circumvented established regulatory processes," Adeyeye stated.
This enforcement action highlights the operational and compliance risks inherent in Nigeria's healthcare and manufacturing sectors. For investors and corporate executives, the blacklist underscores a zero-tolerance approach toward regulatory shortcuts that compromise product traceability and public safety. The violations specifically contravened the NAFDAC Act and the Drug and Related Products Registration Regulations 2021.
The sanctions arrive as NAFDAC intensifies its broader crackdown on counterfeit medicines and unapproved goods across the country to protect consumers. The regulator recently shut down illegal facilities and seized N350 million in illicit alcoholic beverages in Lagos State. Earlier this year, the agency also confiscated N3 billion worth of fake anti-malaria drugs and cosmetics during an operation at the Trade Fair Market.
NAFDAC additionally forced the voluntary withdrawal of an online male enhancement supplement in March after tests revealed undeclared pharmaceutical ingredients. The agency reiterated its commitment to strict standards and warned that further legal actions may follow to ensure only safe medical products reach the public.
