NAFDAC calls for a multifaceted approach to tackle menace of substandard medicines

…Ridiculously light penalties against offenders make illicit trade attractive —  Prof. Adeyeye

Illicit sales and distribution of substandard and falsified medicines are a global threat that presents huge public health challenges to National Medicines Regulatory Authorities in both developed and developing countries, as well as catastrophic consequences on the local pharmaceutical industry, the National Agency for Food and Drug Administration and Control, NAFDAC Director General, Prof. Mojisola Adeyeye, has said.

Prof Adeyeye warned that the menace of substandard and falsified medicines portends grave financial losses, possible divestment, and close of shop for the pharmaceutical industry and threatens the attainment of the United Nations Sustainable Development Goals, which strive for access to safe, effective, quality, and affordable essential medicines. 

The NAFDAC DG gave the cautions while speaking on “Fighting the scourge of illicit trade in the pharma industry: the role of communication” at the 21st NECCI PR Roundtable in Lagos on Thursday.   In her keynote speech, she described the topic as very apt considering the expeditious need to promote local manufacturing of Active Pharmaceutical Ingredients (APIs) and to move Nigeria from an importer of Finished Pharmaceutical Products (FPPs) to a country where all classes of FPPs are manufactured. 

According to her, these connected activities are key agenda points of the current administration, for which success will engender economic diversification.In today’s world of globalisation, innovations, technological advancement, exponential growth in e-commerce, and global trade facilitation, Prof Adeyeye believes that illicit trade in fake goods has continued to be a significant and growing threat to economies globally, adding that the socio-economic impact of this menace for any nation is enormous. 

‘’In addition to harming the economy generally, it also has the potential to weaken the rule of law and erode public confidence in the government,’’ she said, noting with dismay that when it comes to medicines, the proliferation of Substandard and Falsified (SF) medicines has even greater and significant dangerous public health ramifications as well as detrimental effects on the pharma industry. 

Illegal trade involves the manufacturing, distribution, and sale of goods that are prohibited by domestic and/or international law. It includes dealing with products that, due to their characteristics, are illegal in all or some jurisdictions. 

Due to high demand, she noted that pharmaceuticals are particularly susceptible to falsification, stressing that the enormous financial rewards from dealing in SF medicines have lured domestic and foreign criminal organisations into the illicit business. 

She put the value of global commerce in SF/counterfeit drugs in 2016 at USD 4.4 billion, accounting for 0.84% of all pharmaceutical product imports globally but excludes a sizeable amount of locally produced and consumed SF medicines.  

‘’In the meta-analysis of 96 studies that examined 50 or more samples, totalling 67, 839 drug samples, it was estimated that the incidence of SF medicines in low- and middle-income countries stood at 13.6%. 

The largest incidence was observed in Africa with 18.7% and 13.7% in Asia. According to the WHO Global Surveillance and Monitoring System, the continent of Africa accounted for 42% of the 1,500 incidents of SF and counterfeit medical products recorded between 2013 and 2017. 

The most frequently reported products by member states were antibiotics and antimalarials, which accounted for about 36% of all the products.”

Currently, in Nigeria, she enthused that the quality of medicines has increased; SF antimalarials decreased from 17% to 10%. Prof. Adeyeye warned that medications of all types and classifications are subject to falsification and counterfeiting, adding that generics, branded, OTCs, and Prescription only Medicines (POMs) are impacted.

Even though lifestyle pharmaceuticals are typically the most targeted, the DG pointed out that SF medicines for life-saving purposes are growing at the fastest rate with medicines for treatments of severe conditions like cancer, HIV/AIDS, and malaria being the most common groups.  ‘’They also include antibiotics, painkillers, and medications for the central nervous system, hypertension, and diabetes’’, she said, stressing that all nations, patients of all ages, all therapeutic specialities, human drugs, vaccines, as well as vet drugs are impacted by the illegal trade in SF medications. 

“Even though it is more pronounced in developing nations than in developed ones, she said that the illicit trade in SF medicines has a detrimental impact on the sales and profits of affected companies and long-term economic growth.” She added that It also poses a serious threat to public health because these medications are frequently improperly formulated and may contain dangerous ingredients that will harm patients’ health (kidney and other organ failures), cause treatment failures, drug resistance (especially with antimicrobials and antibiotics), and death.  In addition to increasing the cost of treating individuals who have experienced negative health effects because of using SF medicines, she added that these medicines also place a greater burden on the nation’s healthcare system and erode public confidence in it. 

‘’In general, the illegal trade in SF medicines has a multitude of negative effects on health, society, and the economy, making it more difficult to meet the Sustainable Development Goals (SDGs), especially those that deal with poverty and health outcomes (WTO, 2022).”

Absence of, or existence of weakened National Medicines Regulatory Authority (NMRA), abuse of free trade zones and other lawful trade facilitation mechanisms, uncoordinated drug distribution and supply chain system, drug Hawking and Proliferation of Street / Open Drug Markets, increasing use of postal / courier services for dispatch of small parcels of SF medicines, are identified as some of the challenges responsible for illicit trade in SF medicines.

According to her, the rise in the usage of postal and courier services to move goods has fuelled e-commerce growth as well as the illicit trade in SF medications.  She disclosed that 57 per cent of all product categories that were confiscated between 2014 and 2016 came from postal mailings, while 12% came from rapid courier shipments.  About 10% and 15% of the seizures were related to air and sea transportation, respectively (OECD/EUIPO, 2020). 

She maintained that postal firms lack the professional or technical expertise necessary to identify SF medications offered to them for shipping, adding that it is challenging to identify and halt products in domestic and transnational trade due to the lack of adequate details on shipments for postal/express courier despatch.   ‘’NAFDAC is planning an awareness/sensitization workshop in the first quarter of 2024 on this as well as others relating to SF medicines,” she said. 

She regretted that some nations impose much less severe penalties for falsifying medical items than they do for other crimes, such as drug trafficking, which carries the potential for lengthy prison terms and confiscation of the proceeds of crime, noting that some of the proceeds from the SF drug business are channelled into terrorism financing.  She noted with dismay that dealing in SF medical products is a very lucrative business since it entails little investment with maximum profit with few consequences when suspects are arrested, stressing that this is more so since the world powers expend so much time, energy, effort, and money in fighting narcotic and psychotropic crimes while they pay little attention to pharmaceutical crime. 

“In Nigeria, the highest penalty, on conviction, in dealing with SF medicine is that the suspect will be liable on conviction to a fine not exceeding five hundred thousand naira (N500,000.00) or imprisonment for a term of not less than five years or more than fifteen years or to both such fine and imprisonment,” she said, adding that to make the penalties tougher, the 9th Assembly repealed the C34 Bill for the new Act on Prohibition and Control of Counterfeit Medical Products, Fake Drugs and Unwholesome Processed Foods and Other Related Matters that will be signed into law in the 10th Assembly.

The NAFDAC boss disclosed that the Agency has deployed cutting-edge technologies like the TRUSCAN (handheld device built on Raman spectroscopy) for on-the-spot detection of SF medicines in circulation and at the ports of entry into the country.  ‘’It has formed the basis of our Supply Chain Monitoring, which is a periodic but regular exercise, targeted at on-the-spot checks of medicines along the supply chain.”  She disclosed that this device has recorded immense success at identifying SF medicines that may have infiltrated the supply chain with the attendant consequences of impacting patient safety and security, stressing that the Agency has successfully demonstrated that results from the Truscan® are comparable to those obtained from its wet chemistry laboratory.

Prof. Adeyeye further explained that the Agency has put in place the Clean Report of Inspection and Analysis (CRIA), a Pre-shipment inspection arrangement set up as part of measures by NAFDAC to curb the increasing rate of importation of fake, substandard, and unwholesome finished pharmaceuticals and other regulated products, raw materials, and chemicals from India and China. 

Prof Adeyeye explained that the scheme involves the appointment of independent laboratories in China and India to conduct quality testing of regulated products sampled by the CRIA agents on behalf of NAFDAC before the products are exported to Nigeria, adding that the CRIA system has resulted in stopping of shipment of over 120 SF products from China and India.  

Despite all the regulatory activities, NAFDAC is involved in the community. The Agency started the Youth Against Drug Abuse in collaboration with Young Pharmacists Corps Members.

 The program started in six geographical zones and was stalled during the pandemic. However, the Agency has continued the grass root campaign at secondary school levels through the Parents-Teachers Associations, at orientation camps to reinforce the dangers of abuse or illicit use of drugs. Prof. Adeyeye however, disclosed that effective communication has made NAFDAC more efficient in the way it carries out its operations, adding that NAFDAC has a communication strategy aimed at ‘’ensuring all our processes, procedures, laws, regulations, policies, etc are promptly and effectively communicated to our staff, our stakeholders, and the public’’. 

She however, called for a multifaceted approach in tackling SF medicines, stressing that experiences have shown that no single Agency or country can go on this battle alone, adding that this therefore calls for concerted efforts and collaboration among all stakeholders to curb the menace of SF medicines.