To adequately carried out a full and comprehensive investigation on codeine syrup in Nigeria, the National Agency for Food and Drug Administration and Control (NAFDAC) has shutdown all product lines of Peace Standard Pharmaceutical Limited, Bioraj Pharmaceutical Limited and Emzor Pharmaceuticals Industrial Limited.
The Director General (DG), NAFDAC, Prof Mojisola Adeyeye who disclosed this in Lagos, said due to insufficient evidence gathered and apparent resistance to provide needed documents during an 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 companies involved to allow for a full and comprehensive investigation.
Adeyeye said the reopening of the manufacturing companies will depend on the level of cooperation that is shown during the comprehensive investigation. She said, “Earlier on April 30, 2018, a day before the BBC documentary was aired, having seen the preview, we had a meeting, where we 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.
“Part of our resolutions was that NAFDAC should immediately place an embargo on the issuance of permit to end users of the raw material (a control substance), effective May 1, 2018 and NAFDAC should immediately deploy officers from Inspection and Enforcement Directorate (I&E) to inspect the alleged companies.”
In a bid to avoid further abuse of the syrup, Adeyeye said, “NAFDAC has 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. We have constituted 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. At the meeting, some of the major issues that characterise the current emerging substance abuse issue were identified.
“Issues like the current weakness in the monitoring of production and distribution in the supply of medicines containing narcotic substances such as codeine, inadequate NAFDAC presence at various Entry Ports that has led to significant levels of smuggling together with importation of considerable amounts of products with potential for abuse and attendant non-regulation of such products were identified.
“Other issues raised are the lack of multidisciplinary stakeholder approach to develop strategies and actions to bring these issues under control and inadequate monitoring of open drug markets by PCN, NAFDAC and the Ministry of Health.”
The following strategic actions, according to the DG are to be immediately undertaken to provide a robust and incisive action against the emerging substance abuse epidemic, which are the immediate strengthening of various regulatory frameworks for the control, distribution and supply of codeine containing cough syrups and other controlled substances and the constitution of a joint task force to undertake various relevant pharmacovigilance activities with respect to codeine containing cough syrups and other relevant substances.
“Enforcement of the Ministerial Directive on the ban of issuance of permits and renewals for the various relevant formulations and embankments on an immediate on-the-ground assessment in key areas and communities with high prevalence and potential for vulnerability.
“Undertaking relevant education and awareness campaigns in the mass media to improve knowledge of rational use of medicines and continuing to reiterate the importance and urgency of NAFDAC Statutory presence at all National Entry Ports to enable the comprehensive curtailment of smuggling activities and illicit movement of relevant substances with potential for abuse,” she added.
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