Nigeria’s National Agency for Food and Drug Administration & Control (NAFDAC) on Saturday, 12 May 2018 decided to make a U-turn on its earlier decision made four days ago to shut down Emzor Pharmaceutical Industries Lagos, Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State over their involvement in the codeine syrup crisis.
According to a statement released by NAFDAC, the decision to change the earlier move was reached after the Director-General, NAFDAC, Prof. Mojisola Adeyeye held a meeting with the companies and its directorates of Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS).
The companies were cited for the following violations:
Peace Standard Pharmaceutical Limited
The Director-General of the Agency, Prof Mojisola Adeyeye cited “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 DG of NAFDAC said that “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
Adeyeye cited “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.”
Adeyeye adviced that “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.”
Emzor Pharmaceutical Industries Limited
NAFDAC Boss cited “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.”
NAFDAC has recommendations 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.”
The agency further recommended 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 order to ensure GDP. The company should be made to develop a system to monitor distributor’s activities.”
What was the decision reached by NAFDAC
According to a statement released by the agency, the three companies are to stop the production of codeine immediately while further investigations continue.
“Therefore, the hold placed on the active pharmaceutical ingredient and the already made codeine syrups stands. NAFDAC will monitor the compliance,” the statement says.
The report also revealed that all codeine products already in the market would be recalled and the process would be verified by NAFDAC. NAFDAC will also not issue any permit for the importation of codeine until further notice.
“Embargo has been placed on new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough preparations,” the statement said further.
It further reads that the three companies were sanctioned and have been charged with administrative fees that are commensurate with the respective violations.
Vanguard newspapers also reported that the agency noted that the stakeholders meeting was in line with the Minister of Health’s pronouncements in his press release on the codeine crisis.