The National Agency for Food and Drug Administration and Control (NAFDAC) has banned Onifam Laboratories Ltd. after investigations showed they broke important rules that could harm public health.
The agency’s Director-General, Mojisola Adeyeye, shared this news on Monday during a briefing at NAFDAC’s Investigation and Enforcement Directorate in Apapa, Lagos.
Martins Iluyomade, the Director of Investigation and Enforcement, spoke on behalf of Ms Adeyeye. He said the investigations found that the company misrepresented its regulatory status. Onifam misused approvals and certificates, which hurt product traceability, accountability, and the overall integrity of Nigeria’s medicine regulation system.
She noted that the company violated the NAFDAC Act, Cap. N1 LFN 2004, and the Food, Drug and Related Products laws.
According to Ms Adeyeye, Onifam also broke the Act Cap. F33 LFN 2004, which covers Drug and Related Products Registration Regulations 2021 and other guidelines.
She added that NAFDAC found issues with registration, assignment, licensing, and marketing of pharmaceutical products by companies that did not have the needed documents.
“In carrying out NAFDAC’s duty to regulate and control the importation, manufacture, advertisement, distribution, sale, and use of drugs and related products, Onifam Laboratories Ltd. is banned immediately,” she said.
“Through our investigation, we found that the company misused approvals and certificates of No Objection outside their approved uses, which is misrepresentation.”
The agency head also noted that further checks revealed the company avoided regulatory rules by importing, distributing, marketing, or sponsoring products against NAFDAC’s approved processes.
She said all affected individuals and entities cannot engage in any pharmaceutical business regulated by NAFDAC until further notice.
“All parties involved with Onifam cannot apply for, get, renew, modify, transfer, or benefit from any NAFDAC registration, licence, permit, certificate, or approval.
“They are also not allowed to act as manufacturers, importers, distributors, representatives, agents, consultants, promoters, marketing authorisation holders, or sponsors of any product regulated by NAFDAC.
“They are barred from taking part in any NAFDAC-regulated activity in Nigeria until we give more instructions,” she added.
The agency confirmed that the ban would last until they say otherwise. They also mentioned they could take more regulatory, enforcement, administrative, and legal actions to protect public health.
Ms Adeyeye, who repeated NAFDAC’s promise to protect the health of Nigerians, said the agency will keep working to maintain the integrity of Nigeria’s pharmaceutical regulatory system.
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