The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd, its Managing Director, all directors and associated entities from engaging in any pharmaceutical business regulated by the agency over what it described as serious regulatory violations capable of endangering public health.
The agency said investigations established that the company engaged in regulatory misrepresentation, improper use of approvals and certificates, unlawful registration and transfer of pharmaceutical products, as well as actions that compromised product traceability, accountability and the integrity of Nigeria’s medicines regulatory system.
The directive is contained in a press release signed by the Director-General of NAFDAC, Prof. Mojisola Adeyeye, made available to ThelensNG on Monday.
According to NAFDAC, the regulatory action followed investigations which found that Onifam Laboratories misused NAFDAC approvals, certificates and Certificates of No Objection beyond their approved purposes and conditions.
The agency also accused the company of facilitating the registration, assignment, licensing, marketing and control of pharmaceutical products through entities lacking the required documentation, qualified personnel, regulatory authorisation and appropriate facilities.
NAFDAC further alleged that the firm circumvented established regulatory procedures by facilitating the importation, distribution, marketing and sponsorship of regulated products contrary to approved processes.
“Following NAFDAC investigations, evidence established that Onifam Laboratories Ltd engaged in regulatory misrepresentation, improper use of approvals/certificates, and activities capable of compromising product traceability, accountability, and public health.”
The agency stated that the actions violated 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 applicable guidelines governing product registration, Good Manufacturing Practice, storage and distribution.
“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. NI 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”.
According to the agency, the blacklist extends beyond the company to include its Managing Director/Chief Executive Officer, all directors, and any affiliated, associated, successor, proxy, front, related or connected entities identified as having participated in, facilitated or benefited from the regulatory violations.
NAFDAC said the affected individuals and entities would, until further notice, be prohibited from engaging directly or indirectly in any pharmaceutical business under its regulation.
They are also barred from applying for, obtaining, renewing, varying or transferring any NAFDAC registration, licence, permit, certificate or approval.
The agency further prohibited them from acting as manufacturers, importers, distributors, representatives, agents, consultants, promoters, marketing authorisation holders or sponsors of any NAFDAC-regulated product, or participating in any NAFDAC-regulated activity in Nigeria.
NAFDAC said the blacklist would remain in force until otherwise directed by its management.
The agency added that it reserved the right to take further regulatory, enforcement, administrative and legal actions deemed necessary to protect public health and preserve the integrity of Nigeria’s pharmaceutical regulatory system.
