PUBLIC NOTICE ON BLACKLISTING ONIFAM LABORATORIES LTD AND ASSOCIATED PERSONS/ENTITIES FROM PHARMACEUTICAL BUSINESS ACTIVITIES
Following NAFDAC investigations, evidence established that Onifam Laboratories Ltd engaged in regulatory misrepresentation, improper use of approvals/certificates, and activities that could compromise product traceability, accountability, and public health. These acts constitute violations of the NAFDAC Act, Cap. N1 LFN 2004, the Food, Drug and Related Products (Registration, etc.) Act Cap. F33 LFN 2004, the Drug and Related Products Registration Regulations 2021, and other applicable NAFDAC guidelines on registration, Good Manufacturing Practice, storage and distribution.
Key findings include:
- Regulatory misrepresentation: misuse of NAFDAC approvals, certificates and Certificates of No Objection outside their approved purpose and conditions.
- Improper registration/transfer: registration, assignment, licensing, marketing or control of pharmaceutical products by entities lacking the requisite documentation, qualified personnel, authorisation, facilities or regulatory standing.
- Circumvention of regulatory controls: facilitation of importation, distribution, marketing or sponsorship of regulated products contrary to approved NAFDAC processes.
- Public health risk: conduct prejudicial to product traceability, accountability of marketing authorisation holders and the integrity of Nigeria’s medicines regulatory system.
In exercise of NAFDAC’s statutory mandate to regulate and control the importation, exportation, manufacture, advertisement, distribution, sale and use of drugs and related regulated products, and pursuant to the NAFDAC Act Cap. N1 LFN 2004; Food, Drug and Related Products (Registration, etc.) Act Cap. F33 LFN 2004; Drug and Related Products Registration Regulations 2021; and Counterfeit and Fake Drugs and Unwholesome Processed Foods (Miscellaneous Provisions) Act Cap. C34 LFN 2004. Onifam Laboratories Ltd is hereby BLACKLISTED with immediate effect.
The blacklist applies to Onifam Laboratories Ltd, its Managing Director/Chief Executive Officer, all Directors, and any affiliated, associated, successor, proxy, front, related or connected entities identified by NAFDAC as having participated in, facilitated, benefited from or derived advantage from the regulatory violations.
Until further notice, affected persons and entities shall not:
- engage directly or indirectly in any pharmaceutical business regulated by NAFDAC;
- apply for, obtain, renew, vary, transfer or benefit from any NAFDAC registration, licence, permit, certificate or approval;
- act as manufacturer, importer, distributor, representative, agent, consultant, promoter, marketing authorisation holder or sponsor of any NAFDAC-regulated product; or
- participate in any NAFDAC-regulated activity in Nigeria.
This blacklist shall remain in force until otherwise directed by NAFDAC Management. NAFDAC reserves the right to take further regulatory, enforcement, administrative and legal actions necessary to protect public health and preserve the integrity of Nigeria’s pharmaceutical regulatory system.
All NAFDAC zonal directors and state coordinators are hereby directed, by this notification, to watch out for further instructions on all products registered by Onifam Laboratories Ltd.
NAFDAC implores distributors, suppliers, wholesalers, healthcare providers, and patients to exercise caution and vigilance throughout the supply chain to avoid the distribution, sale, administration, and use of products registered by Onifam Laboratories Ltd. All medical products must be obtained from genuinely authorized/licensed suppliers. The products’ authenticity and physical condition should be carefully checked.
If you are selling or using any products registered or distributed by Onifam Laboratories Ltd, please stop immediately and report to the nearest NAFDAC office. If you or someone you know has used any of the company’s products and experienced any adverse reactions or events, we strongly advise seeking immediate medical attention from a qualified healthcare professional.
Healthcare professionals and consumers are advised to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of the medicinal product to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med-safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
Prof. Mojisola Christianah Adeyeye FAS
Director General
