Substandard products are those that do not meet quality standards and specifications, often due to poor manufacturing practices and/or inadequate quality control. According to the WHO, substandard and falsified or counterfeit medical products affect people all around the world. They pose significant threats to public health globally. They can be ineffective in treating the illness, as they may contain incorrect ingredients or incorrect dosages. They can even be directly harmful to patients if they contain contaminants or toxic substances. They may be indirectly harmful through increased risk of antimicrobial resistance (AMR).
Dr Kamini Walia, a distinguished senior scientist at Indian government's prestigious Indian Council of Medical Research (ICMR) and Scientific Chairperson of Global AMR Media Alliance (GAMA) said in a special session of AMR Dialogues that "Antimicrobial resistance is the ability of an organism (like bacteria, virus, fungi or parasite) to resist the killing effects of an antimicrobial medicine (like antibiotic, antiviral, antifungal or antiparasitic). Almost 5 million people die every year due to AMR with one-fifth of these deaths directly attributed to drug resistance. If we do not prevent AMR then it is likely to be associated with the deaths of 10 million people per year by 2050, at a cost of US$ 100 trillion to the global economy through loss of productivity."
Dr Walia underlined the rampant misuse and overuse of antimicrobials in animal health, livestock and poultry sector too. "60% of antimicrobials produced are used in livestock and poultry sectors. Resistant pathogens like Salmonella, E Coli, S aureus, Campylobacter, Klebsiella, and Enterococcus make way to human beings through food chain and food products which have animal origin." She also said that though there is some scientific evidence, but more large-scale evidence is needed to better understand the extent to which drug-resistant pathogens from animal sector impact human beings.
What drives the dark and deadly supply of substandard and falsified medical products?
Dr Philip Mathew of the WHO points out that there are several drivers of substandard and falsified medical products. "Weak regulatory systems, complexity of supply chains, lack of access to affordable medicines, which forces people to access suboptimal ones, weak health systems, among others all contribute towards it."
Dr Mathew said that "If people are not covered by Universal Health Coverage, then they are more likely to have out-of-pocket health expenditure - and may look for options to cut down on their medical expenses. Informal sources of getting medical products may be relatively cheaper than formal ones. So, all of this contributes to use of substandard and falsified medical products. The problem is further complicated by the level of corruption, and lack of consumer awareness and education."
A few months ago in December 2024, the WHO had launched its report "Global surveillance and monitoring system for substandard and falsified medical products" with data from 2017-2021.
"This report signalled the alarming rise in the number of reported incidents of substandard and falsified medical products, including a wide range of essential medicines, such as antimicrobials, oncology medicines and vaccines. During 2017-2021 period, 877 incidents of substandard and falsified medical products were recorded, with an average annual increase of 36.3%. The potential impact on increase in antimicrobial resistance cannot be understated," added Dr Mathew.
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