Health
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 capable of compromising public health.
The agency’s Director-General, Prof. Mojisola Adeyeye, disclosed this on Monday in Lagos at a news briefing held on Monday at NAFDAC Investigation and Enforcement Directorate office in Apapa.
Adeyeye said evidence showed the company engaged in regulatory misrepresentation, improper use of approvals, certificates and activities capable of undermining product traceability, accountability and the integrity of Nigeria’s medicines regulatory system.
The D-G, represented by Dr Martins Iluyomade, NAFDAC Director of Investigation and Enforcement, said the acts violated the NAFDAC Act, Cap. N1 LFN 2004, the Food, Drug and Related Products.
She said the company’s action also violated Act Cap. F33 LFN 2004, the Drug and Related Products Registration Regulations 2021 and applicable guidelines.
Adeyeye added that NAFDAC found improper registration, assignment, licencing, 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.
“Through our investigation, we discovered the company is involved in misuse of approvals and certificates of No Objection outside their approved purpose and conditions is misrepresentation,” he said.
The agency’s boss noted that further investigation uncovered circumvention of regulatory controls through 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.
“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.
Adeyeye, who reiterated the agency 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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Tags: NAFDAC Onifam laboratory