Codeine: NAFDAC reopens firms indicted in syrup distribution

The National Agency for Food, and Drug Administration and Control (NAFDAC) yesterday lifted the shutdown order on three pharmaceutical companies closed on May 7 for production of codeine cough syrups.

The affected firms are: Emzor Pharmaceuticals Ind. Ltd Lagos; Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State.
NAFDAC’s Director-General Prof. Mojisola Adeyeye, in a statement, gave the directive following meetings with the companies and its directorates of Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS).

She also stated the affected companies have been charged administrative fees “commensurate with the respective violations.”

The agency also ordered immediate stoppage of codeine syrups until further notice while investigations continue.
“Therefore, the hold placed on the active pharmaceutical ingredient and the already made codeine syrups stands. NAFDAC will monitor the compliance.
“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- NAFDAC will not issue any permit until further notice.”

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

The agency also noted that the stakeholders meeting was in line with the Minister of Health pronouncements in his press release on the codeine crisis.
NAFDAC also directed Emzor pharmaceutical Ind. Ltd to arrest the sales representative indicted in the BBC documentary or declare him wanted for investigation.