The National Agency for Food and Drug Administration and Control (NAFDAC) has imposed an immediate blacklist on Onifam Laboratories Limited, its Managing Director, board members and all affiliated individuals and entities over multiple regulatory violations uncovered during an investigation.
The enforcement action bars the company and those connected to it from participating in any pharmaceutical business regulated by NAFDAC. The sanctions will remain in place until the agency reviews its decision, while additional legal and administrative actions may be introduced where necessary.
Investigations by the regulator found that the company engaged in several practices that breached Nigeria’s pharmaceutical regulatory framework, including the improper use of regulatory approvals, irregular handling of product registrations and transfers, and activities that circumvented established compliance procedures. Brandspur Brand News understands that NAFDAC considers the violations a threat to effective oversight of medicines and public health protection.
According to the agency, the identified breaches undermine pharmaceutical traceability, weaken regulatory accountability and contravene provisions 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.
As part of the sanctions, Onifam Laboratories and all affected individuals are prohibited from obtaining or benefiting from any NAFDAC registration, licence, permit, certificate or regulatory approval. They are also barred from operating as manufacturers, importers, distributors, marketing authorisation holders, consultants, agents, representatives, promoters or sponsors of products regulated by the agency in Nigeria.
While announcing the decision, NAFDAC did not reveal the specific pharmaceutical products linked to the violations or indicate whether criminal charges would be filed. However, it stated that further enforcement measures could be taken if circumstances require.
The regulator reaffirmed its commitment to maintaining strict compliance across Nigeria’s pharmaceutical industry and urged manufacturers, importers and other stakeholders to adhere to all regulatory requirements. It stressed that safeguarding the quality, safety and effectiveness of medicines and other regulated products remains a top priority.
The latest action forms part of NAFDAC’s broader campaign against counterfeit medicines and other illegal products. In recent months, the agency has intensified enforcement operations, including the seizure of fake anti-malaria medicines, counterfeit alcoholic beverages and unsafe health products in different parts of the country.
