Codeine Syrup Crisis: NAFDAC Lifts Shutdown Of Companies Implicated In Codeine Syrup Distribution And Issued Sanctions
The National Agency for Food and Drug Administration and Control had a high-powered meeting with the executives of the companies that were implicated in the codeine syrup distribution on Thursday, May 10, 2018 in Lagos. NAFDAC had separate meetings with the companies – Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State, and Emzor Pharmaceuticals Ind. Ltd, Lagos – to further the investigation into the codeine manufacture and distribution with possibility of lifting the shutdown of the companies.
The Director General, Prof Mojisola Adeyeye gave the directive for the meetings to be held with the companies. The following NAFDAC directorates – Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) led the meeting.
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:
Peace Standard Pharmaceutical Limited: Mr. Samuel Akinlaja, the Managing Director led his team to the meeting. The company was cited for poor distribution practice and misplaced role play of staff.
NAFDAC made the following observations.
- 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: Mr. Rahamon J. Bioku, the Managing Director led his team at the meeting with NAFDAC. 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 has forwarded the following directives to BIORAJ.
- 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.
Emzor Pharmaceuticals Ind. Ltd: Dr. Stella Okoli, General Managing Director and Chief Executive Officer led her team to the meeting. 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
At the meeting, the company 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 have been forwarded to Emzor Pharmaceuticals Ind. Ltd.
- 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.
The three companies cooperated with NAFDAC during the meeting, provided the needed documents, some of which are being verified.
The shutdown of the three companies has been lifted and the normal company operations can resume. However, the companies have been given 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
- As mentioned in the DG’s press release an 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.
National Agency for Food and Drug Administration and Control will 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, in line with the Honourable Minister of Health pronouncements in his press release on the codeine crisis.