By Sola Ogundipe
The National Agency for Food and Drug Administration and Control, NAFDAC, has issued sanctions to Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State, and Emzor Pharmaceuticals Ind. Ltd, Lagos, shut down last week for being implicated in the codeine syrup distribution crisis.
Director General of the Agency, Prof Mojisola Adeyeye, who disclosed this in a press release obtained by Sunday Vanguard, however said the shutdown placed on the companies has been lifted and normal company operations can resume.
According to Adeyeye: “The companies have been charged with administrative fees that are commensurate with the respective violations. 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 NAFDAC boss said embargo has been plced on new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough preparations, and NAFDAC would not issue any permit until further notice.
She said the Agency plans to 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 pronouncements by the Minister of Health.
Adeyeye explained that on her directive, NAFDAC held a high-powered meeting with the executives of the three companies separately on Thursday, May 10, 2018 in Lagos to further the investigation into the codeine manufacture and distribution with possibility of lifting the shutdown of the companies.
“The meetings were led by the Directorates of Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) led the meeting. The three companies cooperated with NAFDAC during the meeting, provided the needed documents, some of which are being verified.
From findings of the investigations, and violations committed by the companies (based on the first inspections conducted on May 3, and BBC documentary), Adeyeye observed that Peace Standard Pharmaceutical Limited, whose team was led to the meeting by the Managing Director, Mr Samual Akinlaja, was cited for “poor distribution practice and misplaced role play of staff.”
She said other observations were that “the Superintendent Pharmacist assumed a function that was not part of his job schedule by attending to an intending customer, while 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.”
According to Adeyeye, Bioraj Pharmaceutical Limited, whose team was led at the meeting with NAFDAC by the Managing Director Mr. Rahamon J. Bioku, was cited for “violation of 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 stated violations, Adeyeye said Bioraj was directed to develop and implement Good Manufacturing Practices including Good Storage Practice.
“The company should ensure the enrollment of competent and qualified personnel for respective positions; develop access control into their premises and a system to monitor distributor’s activities.
“The company is being warned to ensure strict compliance with all written SOPs and should immediately initiate a recall process of the finished products.”
Sunday Vanguard gathered that based on NAFDAC’s inspection of its Ajao Estate facility where only syrups are made, and the BBC documentary, Emzor Pharmaceutical Ind. Ltd. was cited with violations including “inadequate enforcement that led to the accused sales representative shown on the documentary to abscond as well as obstruction and concealment of facts when the NAFDAC team visited the company premises.”
The DG said Emzor was also cited for: “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 and 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 company’s General Managing Director/ Chief Executive Officer, Dr. Stella Okoli, who led the team to the meeting, accepted responsibility for the cited violations, Adeyeye stated.”
She said NAFDAC had forwarded its recommendations to Emzor that, “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.”
Further, the Agency recomended that the company’s Chief Security Officer be invited for interrogation and that 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.”