The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, all directors, and affiliated individuals and entities over regulatory violations, with immediate effect.
The agency said the decision followed extensive investigations which uncovered multiple breaches of regulatory requirements, including misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, as well as activities that circumvented established regulatory processes.
In a press release issued on Monday, NAFDAC said the violations compromise product traceability, weaken accountability, and pose significant risks to public health, contrary to the 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.
According to the agency, the blacklist bars the company and all affected persons or entities 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 regulated pharmaceutical products in Nigeria.
NAFDAC stated that the blacklist would remain in force until otherwise directed by its management, adding that it reserves the right to take further regulatory, administrative, enforcement and legal actions where necessary to protect public health and safeguard the integrity of Nigeria’s medicines regulatory system.
The agency reaffirmed its commitment to maintaining the highest standards of regulatory compliance and urged stakeholders in the pharmaceutical sector to strictly adhere to all applicable laws and regulations.
It added that it remains committed to ensuring that only safe, quality and properly regulated medical products are available to the Nigerian public.