The National Agency for Food and Drug Administration and Control (NAFDAC) has officially blacklisted Onifam Laboratories, a pharmaceutical company, over multiple regulatory violations that compromise drug safety and public health. The decision was announced in a statement signed by NAFDAC Director General Prof. Mojisola Adeyeye, who cited serious breaches including the production of unregistered pharmaceutical products and failure to adhere to Good Manufacturing Practices (GMP).
Details of the Violations
According to NAFDAC, Onifam Laboratories was found to be manufacturing and distributing drugs without valid product registrations, a direct violation of the agency's mandate to ensure all pharmaceutical products are safe, effective, and of good quality. Inspections revealed that the company's facilities did not meet the required GMP standards, posing a risk to consumers. "The company has consistently failed to comply with regulatory requirements, and this blacklisting is necessary to protect public health," Prof. Adeyeye stated.
Impact of the Blacklisting
The blacklisting means that Onifam Laboratories is prohibited from producing, importing, exporting, or distributing any NAFDAC-regulated products. All previously registered products are now cancelled, and the company must recall all its products from the market within 14 days. NAFDAC has directed all stakeholders, including distributors and healthcare providers, to cease transactions with the company immediately. This action affects multiple drug brands manufactured by Onifam, potentially disrupting supply chains for essential medicines.
Regulatory Enforcement and Public Safety
NAFDAC emphasized that this enforcement is part of its ongoing efforts to sanitize the pharmaceutical sector and ensure compliance with established regulations. The agency urged the public to report any suspicious products or activities related to Onifam Laboratories. "We will not tolerate any compromise on drug safety," Adeyeye added. This blacklisting serves as a warning to other manufacturers that regulatory breaches will be met with severe consequences.
Background on Onifam Laboratories
Onifam Laboratories is a Nigerian pharmaceutical company involved in the production of various generic drugs. The company has previously faced regulatory actions, but this is the most severe penalty imposed. NAFDAC's database shows that the company had several product registrations that were either expired or non-compliant. The agency's investigation uncovered systematic failures in quality control and documentation.
Next Steps for the Company
To be removed from the blacklist, Onifam Laboratories must address all violations, pay applicable fines, and undergo a fresh inspection to demonstrate compliance with GMP. The company must also submit a corrective action plan approved by NAFDAC. Until then, the blacklisting remains in effect, effectively shutting down its operations. NAFDAC has indicated that it will monitor the situation closely and take further action if necessary.
