NAFDAC Reopens Emzor, others as Culprit Bolts
Drug Regulatory Agency, NAFDAC Saturday reopens Emzor and two Pharmaceutical companies indicted in the codeine saga as a culprit bolts away.
NAFDAC Director General, Professor Mojisola Christiana Adeyeye in statement approved the reopening of Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited both located in Ilorin, Kwara State but maintained suspension of further production of codeine based syrups in all three companies.
However, the staff of Emzor Pharmaceutical Chukwunonye Madubuike who is the business Development officer has reportedly bolted away thus making NAFDAC to ask Emzor to declare him wanted.
Leading the company to a meeting with NAFDAC,, General Managing Director and Chief Executive Officer Mrs. Stella Okoli and her team were slammed with obstruction and concealment of facts when the NAFDAC team visited the company premises.
The company was also charged with possession 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 of system in of monitoring of the accredited distributors.
NAFDAC has issued directive to the management of the company “to 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, (while), the Chief Security Officer of the company should be invited for interrogation”, the statement notes
According to Professor Adeyeye, the decision to reopen the three companies followed the findings of the investigations by the agency in which the leaderships of the companies admitted their culpability in the illegal violations of the illegal sales of codeine syrup.
According to Adeyeye, the Managing Director of Peace Standard Pharmaceutical, Mr. Samuel Akinlaja, led his team to the meeting in which the company was cited for poor distribution practice and misplaced role play of staff.
The company was 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, the statement also noted.
The Managing Director of Bioraj Pharmaceutical: Mr. Rahamon J. Bioku, led his team to the meeting with the agency and was I dusted for violating Good Manufacturing Practices GMP by not monitoring the accredited distributors and for a worker colluding with a sacked staff to illegally distribute codeine syrup that was allegedly stolen from the company.
The company was instructed to develop and implement Good Manufacturing Practices including Good Storage Practice.
The company was also charged to ensure the enrollment of competent and qualified personnel for respective positions, develop access control into their premises as well as develop a system to monitor distributor’s activities.
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 three companies cooperated with NAFDAC during the meeting, provided the needed documents, some of which are being verified.
The three companies have been charged with administrative fees that are commensurate with the respective violations, Adeyeye was credited in the statement .
