Codeine Syrup Crisis: NAFDAC Shuts Three Pharmaceutical Companies

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The National Agency for Food and Drug Administration and Control (NAFDAC) has shut down all the product lines of the three pharmaceutical firms being investigated for illegal distribution of codeine-containing cough syrup.

The NAFDAC Director General, Prof. Mojisola Adeyeye listed the affected companies as: Peace Standard Pharmaceutical Limited, Ilorin; Bioraj Pharmaceutical Limited, Ilorin; and Emzor Pharmaceuticals Industry Ltd, Lagos.

NAFDAC shuts 3 companies
Codeine cough syrup

Prof. Adeyeye, who spoke through a press release from her office, explained why it became imperative for the agency to take the bold step, as the officials of the firms allegedly failed to provide necessary documents during the inspection conducted by NAFDAC officials on 2 May, 2018 at their various companies in Ilorin and Lagos, respectively.

The statement reads in part:

“Due to insufficient evidence gathered and apparent resistance to provide needed documents during our inspection on 2 May , 2018 at the respective companies in Ilorin and Lagos,  it has become necessary to shut down all product lines of the three companies – Peace Standard Pharmaceutical Limited, Plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited,  No 405 Kaima Road, Ilorin, Kwara State and Emzor Pharmaceuticals Ind. Ltd, Ajao Estate, Lagos.  This is to allow for a full and comprehensive investigation. The three companies therefore remain closed.

“The reopening of the manufacturing companies will depend on the level of cooperation that is shown during the comprehensive investigation”, she asserted.

Prior to the drastic decision of the agency, it was stated that the NAFDAC DG had issued a directive to all stakeholders involved in the production of codeine-containing medicines, to hold an emergency meeting on how to strengthen the weakness in the control of the manufacturing and distribution of codeine-containing medicines.

The stakeholders are: Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG- MAN); Pharmacists Council of Nigeria (PCN); Pharmaceutical Society of Nigeria (PSN); National Agency for Food and Drug Administration and Control (NAFDAC);  National Drug Law Enforcement Agency (NDLEA) and Association of Community Pharmacists of Nigeria (ACPN).

Still on how to stem the tide on the illegal distribution of the drug,  it was further stated that  Prof. Mojisola Adeyeye called for an emergency meeting with the PMG-MAN executives  to discuss critical issues relating to codeine- containing cough syrup together with other controlled substances.

The Director General further constituted a Task Force to be made up of NAFDAC Directors- Registration and Regulatory Affairs; Narcotics and Controlled Substances; and Drug Evaluation and Research. Members of PMG-MAN in the committee included the Executive Secretary of PMG-MAN; Fidson Healthcare; May & Baker PLC; and Emzor Pharmaceutical Industries.

Going forward, the agency sent a team of nine NAFDAC officers (2 from Drug and Evaluation Research and 7 from Investigation & Enforcement) and ten mobile police officers to Ilorin, Kwara State on 2 May, 2018 to carry out investigational inspection at the companies of the two pharmaceutical companies that are licensed to manufacture codeine-containing syrup, and which were implicated in the BBC documentary.

The document revealed that the same investigational inspection by a different NAFDAC team took place on the same day and time as the Ilorin companies at the manufacturing facility of Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos.

The focus of the assignment was to access and monitor from records the utilization, sales and effective distribution of the codeine containing cough syrups to the end users.

However, the agency discovered that executives of the affected companies were not willing to comply with the enforcement team, as they delayed in producing the necessary documents for the inspection. Hence, the temporary closure of the companies, the statement revealed.

While the companies remain closed, the stakeholders will be in regular discussion with the agency, as full investigation continues.

 

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