The War Against Counterfeit Medicine: My Story

Chapter 18 - Future Plans/Work In Progress Recommendations and Conclusion

299 CHAPTER 18 FUTURE PLANS/WORK IN PROGRESS RECOMMENDATIONS AND CONCLUSION Future Plans In charting a new course for the future, NAFDAC should consolidate on its present gains, work towards surmounting all outstanding constraints, improve on its administrative and operational capacities and explore new approaches to enhance efficiency and effectiveness. To achieve this, there is the need to consider the following critical areas: Regular Interaction with Stakeholders In addition to consolidating and continuing with the ongoing interactions with various stakeholders through workshops, seminars, meetings, etc, NAFDAC should extend these interactions to every Local Government Area in Nigeria in its grassroots sensitisation campaign. At one point, plans were under way for a workshop for Local Government Chairmen from the 774 Local Government Areas across the country. We had a meeting with the President of the Association of Local Governments of Nigeria (ALGON), Chief Baver Dzeremo, in July, 2006. The plans did not materialise due to logistical reasons. More aggressive campaigns are required for chemical marketers to prevent the re-occurrence of tragedies such as the My Pikin incident. Laboratories The establishment of mini-laboratories at all designated ports of entry for on-the-spot testing to detect counterfeit medicines and other substandard regulated products, must be pursued vigorously. When fully implemented, this will reduce the delays in the current practice of sending samples from the ports to various laboratories for full analysis, since only products or raw materials which require further testing, would be delayed and sent to the laboratories. We had concluded plans to buy field testing kits from Mr Tom Woods of Woods International in collaboration with Ahura Scientific, USA. We were at the stage of making payments when I left NAFDAC. Our other plansincluded the establishment of laboratory facilities of 300 The War Against Counterfeit Medicine international standards in all the geopolitical zones of the country and new specialised laboratories, such as a Biochemical Laboratory, to enhance NAFDAC’s ability to collaborate effectively with relevant international organisations, such as the United Nations Office of Drugs and Crime. There must be a strategic plan to develop expertise in the detection of Genetically Modified Foods, regulation of the irradiation of food and the expansion of facilities for the detection and quantification of contaminants, bacteriological typing (such as Listeria, E. coli 0157), Mad Cow Disease (BSE) detection, Dioxins & PCB detection and Immuno Assay Techniques. It has been proposed that NAFDAC’s laboratories should serve as reference laboratories in the West African sub-region, in collaboration with IAEA, the WHO, FAO and other relevant international organisations. This is a huge opportunity that must be driven to a logical conclusion. Registration and Regulatory Affairs There is the need to fully computerise and streamline NAFDAC registration and other processes, to further reduce the turn-around time to the barest minimum. Specifically, NAFDAC should fully implement the SIAMED computer network programme for drug registration, as recommended by the WHO. Providing Security Features to Safeguard Regulated Products The development of tamper-proof security systems for the protection of NAFDAC’s regulatory instruments, such as registration numbers, receipts, certificates, staff identity cards and permits was NAFDAC’s priority. The Agency explored various product security options, including the use of tamper-evident holograms for regulated products. NAFDAC is already using holographic labels to protect its certificates and other sensitive documents. We also set in motion a series of processes and initiatives to achieve the use of a serialised holographic label option on all NAFDAC registered products, starting with medical products, to secure the registration numbers in order to prevent them from being faked. These serialised holographic labels, which are in use in many countries, are powerful anti-counterfeiting devices. Given Nigeria’s situation and desperate attempts by drug counterfeiters to continue to circumvent the law and NAFDAC’s efforts, the use of holograms is the most viable option. In the process of planning for the working of holographic labels in Nigeria, two NAFDAC staff were sent to Malaysia to study the use of this device for two weeks. Thereafter, we held meetings with various stakeholders on the modalities for the _ _Future Plans/Work in Progress Recommendations and Conclusion 301 implementation in which we had reached an advanced stage. We also commenced discussions with M-Pedigree of Ghana for the use of an SMS messaging system in cross-checking the NAFDAC registration number of registered products. They commenced discussions and negotiations with PMG–MAN at our instance...