The National Agency for Food and Drugs Administration (NAFDAC) has revealed the findings of its investigation into the complicity of three pharmaceutical companies in the country in the codeine abuse crisis.
The company on Saturday announced that following the conclusion of investigations and meetings with the affected companies, it has decided to lift the temporary shutdown but that the companies – Emzor Pharmaceuticals, Bioraj Pharmaceuticals and Peace Standard Pharmaceuticals – will only operate in line with the following sanctions:
- All production of codeine syrup should be stopped immediately until further notice. 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
- The companies are to pay administrative fees that are commensurate with the respective violations.
According to NAFDAC, the findings of the investigations, and violations committed by the companies (based on the first inspections conducted on May 3, and BBC documentary), are stated below:
Emzor Pharmaceuticals Ind. Ltd, Lagos
Based on NAFDAC’s inspection of the company’s Ajao Estate facility where only syrups are made, and the BBC documentary, Emzor Pharmaceutical Ind. Ltd. company was cited with the following violations:
Inadequate enforcement that led to the accused sales representative shown on the documentary to abscond
Obstruction and concealment of facts when the NAFDAC team visited the company premises.
Poor GMP that includes poor document retrieval system and un-reconciled record system in the utilization of codeine sulfate
Inconsistencies in the shipping documents of finished products
Lack system in of monitoring of the accredited distributors
According to NAFDAC, at the meeting on Thursday, Emzor brought some of the documents such as shipping documents and list of accredited distributors that were not provided during the inspection. The company was asked to provide the staff that absconded. The GMD/CEO accepted responsibility for the cited violations.
The following directives were forwarded to the company:
The Agency should arrest, if need be declare as wanted, and investigate the Sales Representative indicted in the BBC documentary to ascertain his level of culpability in the illegal distribution of Codeine cough syrup. The company should furnish the Agency with all relevant information about him.
The Chief Security Officer of the company should be invited for interrogation.
The company’s GMP should be improved and verifiable
There is a need to reconcile the list of the company’s accredited distributors with the names on the stock card in in order to ensure GDP
The company should be made to develop a system to monitor distributor’s activities.
Peace Standard Pharmaceutical Limited, Ilorin, Kwara State
The company was cited for poor distribution practice and misplaced role play of staff.
NAFDAC observed that:
The Superintendent Pharmacist assumed a function that was not part of his Job schedule by attending to an intending customer.
Good Distribution Practice (GDP) was not strictly implemented by the company.
The company has been warned to ensure strict compliance with all written standard operating procedures (SOP).
From the outcome of the inspection, the company’s documentation process was adequate as the records from the raw materials store, in process and finished products were properly reconciled.
Bioraj Pharmaceutical Limited, Ilorin Kwara State
NAFDAC declared that based on the documentary and discussions, the company violated GDP by not monitoring the accredited distributors, a worker colluded with a sacked staff to illegally distribute codeine syrup that was allegedly stolen from the company. The company was also cited for bad storage practice or poor good manufacturing practice
Based on the above violations, NAFDAC said:
The company should develop and implement Good Manufacturing Practices including Good Storage Practice.
The company should ensure the enrollment of competent and qualified personnel for respective positions.
The company should develop access control into their premises.
The company should develop a system to monitor distributor’s activities.
The company is being warned to ensure strict compliance with all written SOPs.
The company should immediately initiate a recall process of the finished products.
NAFDAC acknowleged that during the meeting, the three companies, led by Dr. Stella Okoli (General Managing Director/CEO, Emzor) Mr. Samuel Akinlaja (Managing Director, Peace Standard) and Mr Rahamon J. Bioku (Managing Director, Bioraj), cooperated with NAFDAC and provided the needed documents, some of which are being verified.