NAFDAC blacklists Onifam Laboratories, bans firm from pharmaceutical business

The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director and Chief Executive Officer, directors and affiliated persons over what it described as serious regulatory violations within Nigeria’s pharmaceutical sector.

The regulator said the blacklist takes immediate effect and bars the company and all affected individuals and entities from participating, directly or indirectly, in any pharmaceutical business regulated by the agency.

According to a statement issued on Monday, the decision followed extensive investigations which found that the company engaged in regulatory misrepresentation, the misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and other activities that circumvented established regulatory processes.

NAFDAC said the violations compromised product traceability and accountability within the medicines supply chain and posed significant risks to public health, contrary to the provisions of the NAFDAC Act, the Food, Drugs and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021 and other applicable laws.

As part of the sanctions, Onifam Laboratories and all associated persons and entities are prohibited from applying for or benefiting from any NAFDAC registration, licence, permit, certificate or approval.

The blacklist also prevents them from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of any NAFDAC-regulated product in Nigeria.

The agency said the sanctions would remain in force until otherwise directed by its management, adding that it reserved the right to pursue additional regulatory, administrative and legal actions where necessary.

NAFDAC said the enforcement action forms part of its efforts to strengthen regulatory compliance, protect public health and preserve confidence in Nigeria’s medicines regulatory system.

“The agency remains resolute in ensuring that only safe, quality and properly regulated medical products are available to the Nigerian public,” the statement said.