Codeine Syrup: NAFDAC Lifts Shutdown Of Emzor, Two Others

FILE PHOTO: NAFDAC Office, Abuja.

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has lifted the shutdown its earlier ordered on three pharmaceutical companies over the codeine syrup scandal.

The companies include Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industry Limited.

NAFDAC in a statement signed on Saturday by the Director General, Professor Mojisola Adeyeye, said this decision was reached after meeting of high-powered executives of the companies that were implicated in the codeine syrup distribution.

“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,” the statement read in part.

Adeyeye gave the directive for the meetings to be held with the companies following NAFDAC directorates – Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) who led the meeting.

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NAFDAC had separate meetings with the companies – Peace Standard Pharmaceutical Limited and Bioraj Pharmaceutical Limited in Ilorin, Kwara State, and Emzor Pharmaceuticals Industrial Limited, Lagos.

The sanctions given to the companies ordered that all production of codeine syrup should be stopped immediately until further notice. It also instructed that an hold should be placed on the active pharmaceutical ingredient and the already made codeine syrups stands.

Also, all codeine products are to be recalled and the process verified through audit trail verified by NAFDAC.

“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,” the statement read further.

NAFDAC said a stakeholders meeting on the codeine crisis will also be held to develop a road map for the supply chain distribution and the future of codeine syrup manufacturing, in line with the Minister of Health, Issac Adewole’s pronouncements in his press release on the codeine crisis.

Codeine Syrup: NAFDAC Shuts Down Emzor, Two Other Pharmaceutical Companies

 

FILE PHOTO: NAFDAC Office, Abuja.

 

The National Agency for Food and Drug Administration and Control (NAFDAC) has shut down three pharmaceutical companies over the codeine syrup scandal.

The companies include Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industry Limited.

Director-General of the Agency, Professor Mojisola Adeyeye in a statement on Monday said the companies will remain shut to allow for a full and comprehensive investigation.

Among the allegations levelled against the closed companies include refusal to abide by regulations on the distribution of certain medications.

“Due to insufficient evidence gathered and apparent resistance to provide needed documents during our inspection on May 2, 2018 at the respective companies in Ilorin and Lagos, respectively, it has become necessary to shut down all product lines of the three companies – Peace Standard Pharmaceutical Limited. Plots 3 & 8, Adewole Industrial Estate, Lubcon Avenue, Ilorin, Kwara State; Bioraj Pharmaceutical Limited. No 405 Kaima Road, Ilorin, Kwara State and Emzor Pharmaceuticals Ind. Ltd., Ajao Estate, Lagos.  This is to allow for a full and comprehensive investigation.  The three companies, therefore, remain closed,” the statement read in part.

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The reopening of the manufacturing companies according to Adeyeye will depend on the level of cooperation that is shown during the comprehensive investigation.

The statement added further that Adeyeye had earlier called for an emergency meeting with the PMG-MAN Executive to discuss critical issues relating to Codeine-containing cough syrup together with other controlled substances.

Also, a Task Force to be made up of NAFDAC Directors- Registration and Regulatory Affairs; Narcotics and Controlled Substances; and Drug Evaluation and Research. Members of PMG-MAN in the Committee included the Executive Secretary of PMG-MAN, Fidson Healthcare; May & Baker PLC; and Emzor Pharmaceutical Industries was constituted by the DG.

“A team of nine NAFDAC officers (two from Drug and Evaluation Research – DER and seven from Investigation & Enforcement – I&E) and ten mobile police officers were sent to Ilorin, Kwara state on May 2, 2018 to carry out investigational inspection at the companies of the two different pharmaceutical companies that are licensed to manufacture codeine-containing syrup, and which were implicated in the BBC documentary,” the statement added.

A documentary by BBC recently exposed the addiction of some Nigerians, mostly youths, to codeine and reported the complicity of some pharmaceutical companies.