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The National Agency for Food and Drug Administration and Control (NAFDAC) is pleased to note the Honourable Speaker of the House of Representatives’ concern about Substandard and Falsified medicines (SF), and the urge to use Mobile Authentication Scheme (MAS) to detect counterfeit medicines.
The MAS was deployed by NAFDAC in 2010 as an anticounterfeiting tool to curb the menace of substandard and falsified medical products. The medicines identified for implementation and enforcement in the first stage of the MAS scheme are antimalarials and antibacterials. These classes of medicines are selected as a result of high incidence of counterfeiting and the impact on public health. However, The scheme was not fully implemented by all relevant stakeholders despite several enforcement deadlines issued by NAFDAC for compliance.
The position of the members of House of Representative that Standard Organization of Nigeria (SON) and Consumer Protection Council (CPC) should ensure implementation of MAS scheme is ultra vires. This is because it is outside the purview of these sister agencies to implement the use of MAS on NAFDAC regulated products. The products involved in MAS Scheme are products already registered by NAFDAC and which the Agency (following its mandate) has decided to control the authenticity and distribution.
However, in an effort to strengthen the implementation and enforcement of MAS and also maintain a robust database for evidence-based decision-making, NAFDAC is collaborating with Clinton Health Access Initiative (CHAI) to monitor a limited number of essential medicines.
For the selected drugs, NAFDAC and CHAI are organizing a stakeholders meeting in July 2018 to present the MAS Guidelines to the public. The Nationwide campaign on MAS implementation and enforcement is to commence after the presentation of the guidelines to the public.
The suggestion by the Honourable Speaker to use MAS for all drugs regulated by NAFDAC is noble, and in line with the Agency’s ultimate agenda. However, a lot of staffing and funding will be needed for full implementation. The limited authentication that is being undertaken currently for the two classes of drugs by NAFDAC sometimes result in overwhelming calls to the drug information specialists at NAFDAC secretariat. Considering the fact that NAFDAC has over 11,000 registered drug products, the manpower that will be needed to authenticate all drugs will be enormous. In addition, the information technology unit of NAFDAC will also need to network with NAFDAC offices in the 36 States in all six geographical zones and Abuja. Therefore, NAFDAC will need to expand the drug information center with higher bandwidths and computers. I will implore the National Assembly to fund NAFDAC to achieve this noble and necessary cause that the Honourable Speaker had suggested.
In addition, all manufacturers will also need to retrofit their labeling lines in order to accommodate the MAS codes. This is attainable except that the manufacturers will need a tax break in order to accommodate these changes, knowing that, in Nigeria, all manufacturing equipment pieces, all raw materials are imported. Therefore I will urge the Honourable Speaker to facilitate tax break for manufacturers. This will improve trade and encourage more local manufacturing, knowing the importance of safeguarding the health of the public.
Prof Mojisola Christianah Adeyeye
DG NAFDAC
