NAFDAC Blacklists Onifam Laboratories, Directors Over Regulatory Infractions

• NAFDAC blacklists Onifam Laboratories Ltd, its Managing Director, directors and affiliated entities over alleged regulatory violations, with the sanction taking immediate effect.

• Agency says investigations uncovered regulatory misrepresentation, misuse of approvals and certificates, improper registration and transfer of pharmaceutical products, and deliberate circumvention of regulatory procedures.

• Company and affected persons barred from obtaining NAFDAC licences, registrations, permits and certificates or participating in any NAFDAC-regulated pharmaceutical business across Nigeria.

• Regulator warns the blacklist remains in force until further notice and says additional enforcement, administrative and legal measures may be taken to safeguard public health.

July 20, () — The National Agency for Food and Drug Administration and Control (NAFDAC) has blacklisted Onifam Laboratories Limited, its Managing Director/Chief Executive Officer, all members of its board of directors, and every affiliated or associated individual and entity found to have participated in regulatory violations, following what it described as extensive investigations into the company’s operations.

The sanction, which takes immediate effect, effectively excludes the company and all affected individuals from participating in any pharmaceutical business regulated by NAFDAC pending further directive from the agency.

In a statement signed on Monday by its Director-General/CEO, Prof. Mojisola Adeyeye, the agency said its investigations established that Onifam Laboratories engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, as well as activities that deliberately circumvented established regulatory procedures.

According to NAFDAC, the alleged infractions compromise product traceability, weaken accountability within the pharmaceutical supply chain and expose the public to significant health risks.

The agency said the company’s actions violate the provisions of the NAFDAC Act, the Food, Drug and Related Products (Registration, etc.) Act, the Drug and Related Products Registration Regulations 2021 and other applicable regulatory guidelines governing pharmaceutical products in Nigeria.

Far-Reaching Sanctions

As part of the blacklist, Onifam Laboratories and all affected persons are prohibited from participating, either directly or indirectly, in any pharmaceutical business regulated by NAFDAC.

The prohibition extends to applying for or benefiting from any NAFDAC registration, licence, permit, certificate or approval.

It also bars them from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters or sponsors of any product regulated by the agency.

The sweeping sanctions equally apply to affiliated companies and associated entities found to have been involved in the regulatory violations.

NAFDAC stated that the blacklist would remain in force until otherwise directed by its management.

The agency further warned that it reserves the right to initiate additional regulatory, administrative, enforcement and legal actions where necessary to protect public health and preserve the integrity of Nigeria’s medicines regulatory system.

It stressed that the action reflects its determination to ensure strict compliance with pharmaceutical regulations and deter practices capable of undermining the safety and quality of medicines available to Nigerians.

Commitment to Public Health

Reaffirming its commitment to safeguarding public health, NAFDAC urged all stakeholders in the pharmaceutical sector to comply fully with applicable laws and regulatory requirements.

The agency maintained that only safe, quality-assured and properly regulated medicines should be manufactured, imported, distributed and sold in Nigeria, warning that any attempt to bypass regulatory procedures would attract decisive sanctions.

The blacklist of Onifam Laboratories marks one of the agency’s strongest recent enforcement actions and underscores its resolve to strengthen regulatory oversight, improve accountability within the pharmaceutical industry and sustain public confidence in Nigeria’s medicines regulatory framework.