The National Agency for Food and Drug Administration and Control (NAFDAC) has placed Onifam Laboratories Limited and several of its key officials on its blacklist over alleged violations of pharmaceutical regulations.
The decision, which takes immediate effect, prevents the company, its Managing Director/Chief Executive Officer, board members and other affiliated individuals or entities from participating in any pharmaceutical activities regulated by the agency.
According to NAFDAC Director-General, Prof. Mojisola Adeyeye, the action followed investigations that uncovered several alleged breaches of the agency’s regulatory guidelines.
The agency accused the company of engaging in regulatory misrepresentation, misusing NAFDAC approvals and certificates, improperly registering and transferring pharmaceutical products, and attempting to bypass established regulatory procedures.
NAFDAC said these alleged actions could weaken product traceability, reduce accountability and pose serious risks to public health.
The agency added that the alleged violations contravene the provisions of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021, as well as other relevant regulatory guidelines.
As part of the sanctions, the affected company and individuals have been barred from applying for or benefiting from any registration, licence, permit, certificate or approval issued by NAFDAC.
They are also prohibited from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, consultants, promoters or sponsors of products regulated by the agency.
NAFDAC stated that the blacklist will remain in force until further notice, adding that it may impose additional administrative, regulatory or legal measures where necessary to protect public health and preserve the integrity of Nigeria’s pharmaceutical sector.
The agency reaffirmed its commitment to ensuring that only safe, quality and properly regulated medicines are available to Nigerians, while urging stakeholders in the pharmaceutical industry to comply strictly with all regulatory requirements.
Source: NAFDAC.
