Danger of substandard and falsified medical products is real and growing

Shobha Shukla / Bobby Ramakant *

In 2017, a report by the World Health Organization (WHO), "A study on the public health and socioeconomic impact of substandard and falsified medical products," showed that 10% of medical products in low- and middle-income countries were substandard or falsified, indicating substantial under-recording and a much larger problem confronting us.

“Estimated spending on substandard and falsified medicines in low- and middle-income countries (based on wholesale level sales) is over US$ 30.5 billion. The WHO estimates that between 70,000 to 170,000 deaths are caused by substandard and falsified antibiotics in children under 5 who were suffering from pneumonia per year,” said Dr Philip Mathew, Technical Officer (AMR) at the AMR Awareness, Campaigns, and Advocacy team of the WHO in Geneva.

In the Indian state of Bihar, one of the biggest killers of people living with HIV (who have advanced HIV disease) are antimicrobial resistant bacterial infections like cryptococcal meningitis, said Leena Menghaney, a noted lawyer who is known for her stellar contribution towards helping improve access to essential medicines and healthcare services. “So, on one hand we have a large number of people who are directly adversely impacted by lack of access to medicines and on the other hand, we have those who are dealing with drug-resistant infections.”

Equitable access to early and accurate diagnostics and prompt treatment with right medicines is a herculean and growing challenge, especially in the Global South countries. The challenge deepens considering that antimicrobial resistance (AMR) is among the top 10 global health threats. AMR is fuelled by misuse or overuse of medicines in human health, animal health, livestock, poultry, and food and agriculture, due to which easy to treat common infections are becoming difficult to treat (or even incurable). To make matters worse, if diagnostics or medicines are substandard or falsified, it further jeopardises public health and social justice.

What is a substandard and falsified medical product?

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.

Minimum Inhibitory Concentration (MIC) of antimicrobial medicines is the lowest concentration of an antimicrobial at which a disease-causing pathogen’s (such as bacteria, virus, fungi or parasite) growth is completely inhibited. “The sub-therapeutic concentrations of antimicrobial medicines can actually result in antimicrobial concentrations below MICs,” said Dr Mathew. In such cases, not only does the person suffer and the risk of infection spread increases, but risk of AMR also shoots up.

“When there is no active pharmaceutical ingredient in medicines, then these so-called ‘medicines’ (classified as falsified medical products) lead to persisting infections, leading to greater morbidity, greater likelihood of emergence of drug resistance, further spread of infections, loss of income, increased healthcare spending, economic losses to the country. It also fuels public mistrust in formal systems of medicine,” added Dr Mathew.

No treatment and AMR

“Suboptimal dosing or treatment duration can allow bacteria to adapt and develop resistance, which can lead to increased transmission of drug-resistant strains during longer infectious periods. Poor quality antimicrobials can result in treatment failure and development of AMR, depending on the product content,” said Dr Mathew. In addition, health systems must effectively rule out any possibility of shortages and stockouts of medicines needed by the people.

Governments should engage communities in QC

Leena Menghaney advocates for engaging affected communities in the process of ensuring Quality Control (QC) of medicines, instead of government’s drug regulatory authorities doing so without any equitable community engagement. “Communities can alert drug regulatory authorities and health programmes on substandard and falsified medicines,” she said.

She shared a recent example to illustrate her point: “In 2024, networks of people living with HIV in India came forward to report that after a new batch of medicines had come, pills of the lifesaving antiretroviral therapy were very bitter and breaking. We used these testimonies to write to the drug regulatory authorities in India, and the National AIDS Control Programme of the Ministry of Health and Family Welfare. Within a week, action was taken. These medicines were withdrawn, and supply was reinstated from a WHO pre-qualified medicine supplier.”

Bioequivalence and stability are important too

Leena further added that “Often procurers of medicines are dependent on Quality Control (QC) systems, which means they take some samples from a particular batch that is being delivered and test those samples. They learn if the sample had any contamination and if it had enough active pharmaceutical agent (which is the raw material that goes into making of the drug). But QC system does not tell us if the drug is bioequivalent or if it is stable enough to withstand higher temperatures or humidity. Currently, our procurers and health ministries have invested in QC systems. We are requesting them to treat QC as a process. For example, procurers can define quality by demanding bioequivalence with certain months of stability data.”

She cited another example of a recent tender document from the government of India’s National TB Elimination Programme to procure three new anti-TB drugs, but quality standards listed are different for each of them.

“Governments are right in being very conscious of preserving newer drugs so that these are not misused or overused. But we cannot ignore lack of access to older medicines. Penicillin is one of the drugs that was needed for treating sexually transmitted infections (STIs) and the government’s national AIDS programme was struggling to procure it. Finally, the government consolidated the demand and one of the manufacturers (government’s public sector manufacturing unit) met it,” said Leena.

The Trinity Challenge of GBP 1 Million Competition

WHO’s Dr Philip Mathew called for multisectoral collaboration to address the challenges posed by substandard and falsified medicines. “We need effective collaboration between a range of partners- not just within a country but also globally and a robust system of information sharing.” Technological innovations to effectively address the challenge posed by substandard and falsified medicines could be very effective, said Dr Mathew. The Trinity Challenge has announced a GBP 1 million competition to spur technological innovations in the Global South to address this problem.

ICMR’s Dr Kamini Walia agrees: “We must build the capabilities of regulators (and local manufacturers), in part by introducing innovative surveillance technologies, to help mitigate substandard and falsified medicines, including antimicrobials, which in turn helps combat AMR. We also need to improve the global medicines supply chain to ensure quality standards of medical products and practices everywhere, including in low- and middle-income countries, thereby helping to combat AMR.”