Nigeria’s pharmaceutical industry has come under renewed regulatory scrutiny after the country’s drug regulatory agency imposed sweeping sanctions on a pharmaceutical company over alleged violations of industry rules.
The National Agency for Food and Drug Administration and Control (NAFDAC) announced that it has blacklisted Onifam Laboratories Limited, its Managing Director and Chief Executive Officer, members of its board of directors, and several affiliated individuals and entities for alleged regulatory breaches.
According to a statement issued by NAFDAC Director-General, Prof. Mojisola Adeyeye, the decision followed investigations that uncovered multiple alleged violations of pharmaceutical regulations. The agency said the sanctions take immediate effect and prohibit the company and the affected individuals from participating, directly or indirectly, in pharmaceutical activities regulated by NAFDAC.
The regulator alleged that the company engaged in regulatory misrepresentation, misuse of NAFDAC approvals and certificates, improper registration and transfer of pharmaceutical products, and actions intended to bypass established regulatory procedures.
NAFDAC warned that such practices could undermine product traceability, weaken accountability within the pharmaceutical supply chain, and pose significant risks to public health. The agency stressed that strict compliance with regulatory standards is essential to ensuring that medicines available to the public are safe, effective, and of high quality.
Under the sanctions, the affected company and individuals are barred from applying for or benefiting from any registration, licence, permit, certificate, or approval issued by NAFDAC. They are also prohibited from operating as manufacturers, importers, distributors, marketing authorisation holders, agents, representatives, consultants, promoters, or sponsors of products regulated by the agency.
The regulator said the alleged actions contravened 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.
NAFDAC added that the blacklist will remain in force until further notice and warned that additional regulatory, administrative, or legal measures could be introduced if necessary to protect public health and preserve the integrity of Nigeria’s medicines regulatory system.
The agency reaffirmed its commitment to enforcing pharmaceutical regulations and urged manufacturers, importers, distributors, and other stakeholders across the sector to comply fully with all relevant laws and regulatory requirements.
The latest action highlights Nigeria’s ongoing efforts to strengthen oversight of the pharmaceutical industry, improve medicine safety, and reinforce public confidence in the country’s healthcare system. It also sends a strong message that regulatory violations capable of endangering consumers or weakening the integrity of the pharmaceutical supply chain will attract firm enforcement measures.
