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Sunday, 13 May 2018

NAFDAC REVERSES CLOSURE OF EMZOR AND OTHERS, IMPOSES ADMINISTRATIVE FEES


Barely a week after Emzor Pharmaceuticals Limited, Peace Standard Pharmaceutical Limited, and Bioraj Pharmaceutical Limited were sealed off by NAFDAC after being implicated in the codeine syrup crisis, the regulatory agency has finally reached a decision to lift the shutdown.
Professor Mojisola Adeyeye, NAFDAC’s Director General, stated in a press release issued today that the decision was reached after a meeting was held between NAFDAC’s directorates of Investigation and Enforcement (I&E), Drug Evaluation Research (DER) and Narcotics and Controlled Substances (NCS) and representatives of the affected companies.
Following this development, therefore, normal activities may now resume at the company’s factories located in Kwara and Lagos States.
Adeyeye, however, noted that the investigation still continues. All production of codeine-containing syrup has been indefinitely suspended, even as administrative fines of undisclosed sums were imposed on the three companies.
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.
NAFDAC has also suspended all “new applications for permit or renewals for the importation of codeine as an active pharmaceutical ingredient for cough syrup preparations.”
As we reported, NAFDAC shut down Emzor and two other companies after conducting an inconclusive investigation. Emzor Pharmaceuticals Limited on Wednesday, however, reacted to the development, stating that only one arm of their production line was sealed off by the regulatory agency.
The company also alleged that it has no idea what their violation was, as NAFDAC gave no explanations prior to shutting down their production line. Meanwhile, in the latest development, NAFDAC clarified that the shutdown became necessary because the affected companies all failed to provide some documents to officials during the inspections that happened prior to the shutting down of the factories in Lagos and Kwara States.
Recall that the entire controversy had begun following a BBC documentary (Nigeria’s deadly codeine cough syrup epidemic) which exposed a worrisome trend of Nigerians’ addiction to codeine-containing cough syrups. The documentary had prompted the government to take action by banning the products.

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