The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd. following investigations that revealed regulatory misrepresentation and other violations that could compromise public health.
The agency’s Director-General, Mojisola Adeyeye, announced the decision on Monday during a news briefing at NAFDAC’s Investigation and Enforcement Directorate in Apapa, Lagos.
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Represented by the agency’s Director of Investigation and Enforcement, Martins Iluyomade, Ms Adeyeye said investigations revealed that the company engaged in regulatory misrepresentation, including the improper use of approvals and certificates, as well as activities that undermined product traceability, accountability and the integrity of the country’s medicines regulatory system.
She said the company’s actions violated the NAFDAC Act, Cap. N1 LFN 2004, the Food, Drug and Related Products.
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She said the company’s action also violated the Act Cap. F33 LFN 2004, the Drug and Related Products Registration Regulations 2021 and applicable guidelines.
Ms Adeyeye added that NAFDAC found improper registration, assignment, licensing, marketing or control of pharmaceutical products by entities lacking required documentation.
“In exercise of NAFDAC’s statutory mandate to regulate and control the importation, manufacture, advertisement, distribution, sale and use of drugs and related regulated products, Onifam Laboratories Ltd. is hereby blacklisted with immediate effect,” she said.
“Through our investigation, we discovered the company is involved in the misuse of approvals and certificates of No Objection outside their approved purpose and conditions, which is misrepresentation.”
The agency’s boss noted that further investigation uncovered circumvention of regulatory controls through the importation, distribution, marketing, or sponsorship of regulated products, contrary to approved NAFDAC regulatory processes.
She said all affected persons and entities would not engage directly or indirectly in any pharmaceutical business regulated by the agency until further notice.
“All affected entities of Onifam will not apply for, obtain, renew, vary, transfer or benefit from any NAFDAC registration, licence, permit, certificate or approval.
“They are also prohibited from acting as manufacturers, importers, distributors, representatives, agents, consultants, promoters, marketing authorisation holders or sponsors of any NAFDAC-regulated product.
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“They are also barred from participating in any NAFDAC-regulated activity in Nigeria pending further directives from the agency’s management,” she said.
The agency said the blacklist would remain in force until otherwise directed, adding that it reserved the right to take further regulatory, enforcement, administrative and legal actions to protect public health.
Ms Adeyeye, who reiterated the agency’s commitment to safeguard the health of the nation, said NAFDAC would continue to preserve the integrity of Nigeria’s pharmaceutical regulatory system.
(NAN)
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