CODEINE ABUSE: NAFDAC fines, reopens implicated pharma companies

The National Agency for Food and Drug Administration and Control (NAFDAC) has reopened three pharmaceutical companies that were implicated in the illegal manufacture and distribution of syrups containing codeine.

The three companies, Peace Standard Pharmaceutical Limited, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited, Kaima Road, Ilorin, and Emzor Pharmaceuticals Industrial Limited, Ajao Estate, Lagos, were closed on May 7.

Mojisola Adeyeye, Director-General of NAFDAC, had said the companies were shut for failure to provide needed documents during the organisation’s inspection in Ilorin and Lagos on May 2.

However, in a statement on Saturday, Adeyeye said the directive to lift the shutdown followed meetings held with the companies and its directorates of investigation and enforcement (I&E), drug evaluation research (DER) and narcotics and controlled substances (NCS).

According to NAFDAC, the production of codeine syrup is to be stopped immediately until further notice while investigations continue.

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“Therefore, the hold placed on the active pharmaceutical ingredient and the already made codeine syrups stands. NAFDAC will monitor the compliance,” Adeyeye said.

“All codeine products are to be recalled and the process verified through audit trail verified by NAFDAC.

“Embargo has been placed on new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough preparations, i.e., NAFDAC will not issue any permit until further notice

“The companies have been charged with administrative fees that are commensurate with the respective violations.”

NAFDAC said it would hold a stakeholders meeting on the codeine crisis in a few days to develop a roadmap for the supply chain distribution and the future of codeine syrup manufacturing.

The federal government in April announced a ban on the production and import of cough syrup containing codeine.

 

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