National Agency for Food and Drug Administration and Control (NAFDAC) has over 11,000 registered drug products, but the manpower that would be needed to authenticate all the drugs under the Mobile Authentication Service (MAS) scheme would be enormous. APPOLONIA ADEYEMI reports
Some members of the House of Representatives recently raised the alarm over Substandard and Falsified (SF) medicines in circulations while calling on the Standard Organisation of Nigeria (SON) and Consumer Protection Council (CPC) to ensure the implementation of the Mobile Authentication Service (MAS) scheme. The call is laudable considering the persistent menace fake and unwholesome medicines pose to the consumers of health products in the country. It’s a known fact that modern technology has made the production of SF medicines very easy while the ability to detect the fake products by laymen, has waned tremendously. This has put consumers of medicines at a serious disadvantage, often leading to morbidly and the untimely death of many victims.
A counterfeit medication or a counterfeit drug is a medication or pharmaceutical product which is produced and sold with the intent to deceptively represent its origin, authenticity or effectiveness.
A counterfeit drug may contain inappropriate quantities of active ingredients, or none, may be improperly processed within the body and an example of this is its absorption by the body, may contain ingredients that are not on the label (which may or may not be harmful), or may be supplied with inaccurate or fake packaging and labeling.
The World Health Organisation (WHO) estimates that in wealthy economies, counterfeits account for less than one per cent of the market value, but as much as 50 per cent of internet sales are counterfeit.
However, in emerging economies, counterfeits are estimated at 10 per cent whilst, in some parts of the developing world, including Nigeria, counterfeit drugs are put at about 30 per cent. What this means is that about 30 per cent of the medicines in circulation is substandard. It may be more considering that many of such drugs being smuggled into Nigeria come in through illegal channels, with majority of them being brought in from Asian countries. The reason why many more people go into counterfeiting of products including medicines is clear.
According to the former Director General of the National Agency for Drug and Drug Administration and Control (NAFDAC), Dr. Paul Orhii, the recent global offensive against the illicit narcotic trade led by United States of America (USA) and Mexico, has resulted in drug barons increasingly directing their resources into the less risky and more lucrative drug counterfeiting business-creating international syndicates and making drug counterfeiting more global, sophisticated and militarised. He said, “The Pharmaceutical Security Institutes data estimates that drug counterfeiting is a $75 billion business while the World Customs Service puts it at $200 billion business annually.”
It is this bad and that is why fake and falsified medicines business is thriving. While NAFDAC operatives enforcing the mandate of the Agency sometimes track the illicit medicines as they are being brought in, many still escape the vigilance of law enforcement agencies including the Nigerian Customs Service (NCS), the Nigerian Immigration Service (NIS), among others, and are ultimately brought in for sales and distribution by laymen, 90 per cent of whom constitutes the open drug markets in the country.
It is this worrisome situation that prompts the intervention ofthe Speaker of the House of Representatives, Yakubu Dogara as a strategy to stem the thriving drug counterfeiting business in the country. Dogara’s call is in line with global practices by drug manufacturers and distributors that are increasingly investing in countermeasures, such as traceability and authentication technologies, to try to minimise the impact of counterfeit drugs.
However, considering that implementing the use of MAS on NAFDAC regulated products falls under the purview of NAFDAC, the Agency stepped in to fill the gap.
The MAS was deployed by NAFDAC in 2010 as an anticounterfeiting tool to curb the menace of SF medical products. The medicines identified for implementation and enforcement in the first stage of the MAS scheme are antimalarials and antibacterials because of their high incidence of being counterfeited and their impact on public health. However, the scheme was not fully implemented by all relevant stakeholders despite several enforcement deadlines issued by NAFDAC for compliance.
A major challenge of implementing the MAS scheme, according to the Director General of NAFDAC, Prof. Christiana Mojisola Adeyeye was poor budgetary allocation to the Agency. While calling on the National Assembly to increase NAFDAC funding, Adeyeye said it would empower the Agency to implement the MAS scheme, which would help consumers distinguish genuine drugs from fake medicines.
She said, “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, Adeyeye said the manpower that would be needed to authenticate all the drugs would be enormous.
She said, “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 its Drug Information Center (DIC) with higher bandwidths and computers.”
Similarly, the director general said all manufacturers would also need to retrofit their labeling lines in order to accommodate the MAS codes.
Furthermore, Adeyeye said, “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.” She urged the Speaker to facilitate tax break for manufacturers as well.
In addition, NAFDAC in partnership with Clinton Health Access Initiative (CHAI) recently presented guidelines to strengthen the implementation and enforcement of the MAS scheme by stakeholders in Nigeria.
The guidelines, presented in Lagos last week was aimed to ensure that the MAS is reactivated and applied to all drugs purchased in the country in order to curb the menace of fake and counterfeit drugs.
Unveiling the guidelines, the director general, NAFDAC, said the MAS scheme was one of the anti-counterfeiting strategies to detect substandard and falsified medical products imported or manufactured in the country, adding that the guidelines would strengthen its implementation and enforcement by stakeholders in Nigeria.
She said although, some challenges were encountered during the process of implementation, which include absence of formal Memorandum of Understanding (MoU) with service providers, reporting template and the guidelines for the procurement of the MAS scheme, a steering committee was reconstituted to address the issues.
Adeyeye noted that the reporting template was developed and circulated to MAS service providers to enhance reporting of its activities, adding that the guidelines, published with the support of CHAI spells out the roles and responsibilities of stakeholders, especially Holders of Certificate of Registration, the scheme’s service providers and NAFDAC.
She, however, noted that MAS provides a platform to empower over 167 million subscribers on the mobile network (GSM) to verify the genuineness of antimalarials, antibiotics and other medicines currently on the scheme, calling on the regulatory agency’s stakeholders to use the guidelines to ensure adequate compliance with its provision.
Representing Country Manager, CHAI, the Programme Manager, Dr. Chizoba Fashanu said implementation and regulatory framework of the MAS project, which should have been reviewed for a long time was the problem, adding the organisation was working with stakeholders to support the development of the guidelines and its structure, in order to reduce Nigeria’s underperformance in drugs.
“If we don’t get drugs right we expose Nigerians to poor quality and financial hardship. High cost of drugs impoverished a country,” she said. On his part, the National Chairman, Association of Community Pharmacists (ACPN) Samuel Adekola said community pharmacists would ensure the MAS scheme was implemented to ensure the promotion of quality drugs in all communities across the nation.
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