The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd over regulatory violations.
In a statement on Monday, NAFDAC Director-General and Chief Executive Officer, Mojisola Adeyeye, said the company’s managing director, chief executive officer, directors and affiliated persons participated in the violations.
“The decision follows extensive investigations which established that the company engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and activities that circumvented established regulatory processes,” she said.
She stated that the actions compromised product traceability, weakened accountability and posed significant risks to public health, in violation of the NAFDAC Act (Registration, etc.), the Drug and Related Products Registration Regulations 2021, and other applicable regulatory guidelines.
Ms Adeyeye said the affected company and associated persons or entities were prohibited from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC.
“This includes applying for or benefiting from any NAFDAC registration, licence, permit, certificate, or approval, as well as acting as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters, or sponsors of any NAFDAC-regulated product in Nigeria,” she said.
She added that the blacklist would remain in force until otherwise directed by NAFDAC management.
Mrs Adeyeye noted, “The agency also reserves the right to take further regulatory, administrative, enforcement, and legal actions as necessary to safeguard public health and preserve the integrity of Nigeria’s medicines regulatory system.”
