NAFDAC blacklists Onifam Laboratories over regulatory violations

The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Ltd, its Managing Director and Chief Executive Officer, directors, and all affiliated individuals and entities found to have been involved in regulatory violations.

The agency disclosed the decision on Monday, July 20, in a public statement signed by its Director-General and Chief Executive Officer, Prof. Mojisola Adeyeye, saying the sanctions took immediate effect.

NAFDAC added that the blacklist would remain in force until its management decides otherwise and warned that it could impose additional regulatory, administrative, enforcement and legal measures where necessary to protect public health and uphold the integrity of Nigeria’s medicines regulatory system.

What they are saying

NAFDAC said investigations found that Onifam Laboratories engaged in regulatory misrepresentation, misused the agency’s approvals and certificates, improperly registered and transferred pharmaceutical products, and bypassed established regulatory procedures.

• “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.”

According to the agency, the violations undermine the ability to trace pharmaceutical products, weaken regulatory accountability and create significant public health risks. It said the company’s actions contravened 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 regulatory guidelines.

NAFDAC reiterated its commitment to enforcing strict regulatory standards across Nigeria’s pharmaceutical sector and urged manufacturers, importers and other stakeholders to comply fully with existing laws and regulatory requirements. It added that it remains focused on ensuring only safe, quality and properly regulated medical products reach the Nigerian public.

More insights

As part of the sanctions, Onifam Laboratories, its directors and all associated individuals or entities have been barred from participating, directly or indirectly, in any pharmaceutical business regulated by NAFDAC.

The restrictions prohibit them from applying for or benefiting from any NAFDAC registration, licence, permit, certificate or approval. They are also barred from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of any product regulated by the agency in Nigeria.

While announcing the sanctions, NAFDAC did not disclose the specific pharmaceutical products involved in the violations, the duration of its investigations or whether any criminal prosecutions would follow, indicating only that further enforcement and legal actions may be taken where necessary.

What you should know

NAFDAC is Nigeria’s regulatory agency responsible for ensuring that food, medicines, cosmetics, medical devices, chemicals and packaged water meet prescribed safety, quality and efficacy standards before they are manufactured, imported, distributed or sold.

The latest enforcement action comes amid an intensified crackdown by the regulator on counterfeit medicines and other illegal products across the country.

• In April, the agency uncovered and shut down two illegal facilities producing counterfeit and adulterated alcoholic beverages in Lagos State, seizing fake products valued at about N350 million.
• Earlier in February, NAFDAC confiscated more than 10 million doses of counterfeit anti-malaria medicines and cosmetic products worth approximately N3 billion during an enforcement operation at the Trade Fair Market in Lagos.

In March, the regulator also alerted Nigerians to the recall of MR.7 SUPER 700000 capsules, a male enhancement supplement marketed online, after tests detected undeclared pharmaceutical ingredients in the product, prompting the manufacturer to voluntarily withdraw all available batches.