Due to insufficient evidence gathered and apparent resistance to provide needed documents during an inspection carried out by officials of the National Agency for Food and Drug Administration and Control (NAFDAC), NAFDAC has shut down three companies – Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limit and Emzor Pharmaceuticals Industry Limited.
According to a statement issued from the office of the Director-General, NAFDAC, Prof. Mojisola Adeyeye on Monday, “This is to allow for a full and comprehensive investigation” into the activities of the three companies”
It will be recalled that the Federal Ministry of Health (FMOH) directed NAFDAC to ban with immediate effect further issuance of permits for the importation of codeine as an active pharmaceutical ingredient for cough preparations. It followed a BBC documentary that allegedly implicated an official of Emzor selling a codeine cough syrup without a prescription.
While stating that the three companies would, therefore, remain closed, Adeyeye said the reopening of the manufacturing companies would depend on the level of cooperation that will be shown during the comprehensive investigation.”
Giving the genesis of the shutdown, Adeyeye said a day before the BBC documentary aired on April 30, 2018, she had a meeting with technical directors of NAFDAC where she outlined the steps to be taken to strengthen the weakness in the control of the manufacturing and distribution of codeine-containing medicines as demonstrated in the documentary.
These include the NAFDAC immediately placing an embargo on the issuance of a permit to end users of the raw material (a control substance), effective May 1, 2018, NAFDAC immediately deploying officers from Inspection and Enforcement Directorate (I&E) to inspect the alleged companies, among other measures.
The director general also noted that the stakeholders involved in the production and regulation of codeine-containing products should hold a meeting as quickly as possible. “The stakeholders include Pharmaceutical Manufacturers Group of Manufacturers Association of Nigeria (PMG- MAN), Pharmacists Council of Nigeria (PCN), Pharmaceutical Society of Nigeria (PSN), NAFDAC, National Drug Law Enforcement Agency (NDLEA) and Association of Community Pharmacists of Nigeria (ACPN).”