NAFDAC blacklists firm, directors over regulatory violations

The National Agency for Food and Drug Administration and Control has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, all directors, and every affiliated or associated person and entity found to have participated in regulatory violations.

The agency announced the sanction in a press statement issued on Monday, signed by the Director-General/Chief Executive Officer, Prof. Mojisola Adeyeye, saying the blacklisting takes immediate effect following investigations that uncovered multiple breaches of regulatory requirements governing the pharmaceutical sector.

According to the agency, those affected by the blacklist are barred from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC, including obtaining regulatory approvals or operating in various capacities within the industry.

The statement read, “The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd, its Managing Director/Chief Executive Officer, all Directors, and all affiliated or associated persons and entities found to have participated in regulatory violations, with immediate effect.

“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.

“These actions compromise product traceability, weaken accountability, and pose significant risks to public health, in violation of 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.

“Consequently, the affected company and associated persons or entities are prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC. This includes applying for or benefiting from any NAFDAC registration, licence, permit, certificate, or approval, as well as acting as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters, or sponsors of any NAFDAC-regulated product in Nigeria.”