GENEVA, Switzerland — One in 10 medicines in low- and middle-income countries are substandard or falsified, a pervasive health crisis the World Health Organization (WHO) estimates kills over one million people globally each year.

As the cost in millions of lives and billions of public health dollars from falsified medicines rises, member states at the 78th World Health Assembly agreed on Monday to postpone crucial reforms to WHO’s mechanism to combat these dangerous products.

Citing a need for “extended meetings” to develop a new framework and “theory of change,” the assembly deferred reforms to the WHO Member State Mechanism on Substandard and Falsified Medical Products (MSM) until at least late 2025.

The mechanism’s steering committee will meet for annual talks in November 2025, then present findings to the WHO executive board in January 2026. The board will then submit recommendations to the 79th World Health Assembly, where nations will finally vote on the reforms they delayed Monday.

The bureaucratic timeline means effective measures remain stalled until at least May 2026.

Until then, what Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products, termed an “urgent need for coordinated international response” remains unmet.

“This issue remains one of the most pressing challenges to public health worldwide,” Nakatani told the assembly, pointing to recent tragedies involving contaminated cough syrups, the alarming rise of falsified weight-loss drugs mimicking semaglutide—the diabetes medication known as Ozempic that has become a cultural phenomenon for weight loss—and synthetic opioids infiltrating medicine supplies.

The delay leaves the international response to the falsified medicines epidemic in a holding pattern as the lucrative illicit trade fueling the crisis generates unprecedented profits.

Estimates place the counterfeit medicine market’s value at up to $432 billion per year—more than 200 times WHO’s annual budget—making pharmaceuticals the world’s largest illicit activity ahead of human trafficking, arms sales, and narcotics.

Countries will continue their national efforts to combat the falsified medicines crisis despite the stalled reforms.

Yet within this crisis, as nations seek funding for domestic surveillance systems, WHO has acknowledged it lacks the resources to provide the support countries need. WHO officials said widespread cuts to global health, humanitarian aid, and development assistance worldwide complicate funding for both the global mechanism and essential domestic capacity building.

“Given the financial crisis facing WHO and countries,” said Dr Alex Ross, Director of Organisational Learning at WHO, the reforms being postponed include revisiting the scope and priorities of the mechanism.

Despite Ross’s frank assessment of the funding gap, the WHO’s review of the falsified medicines mechanism endorsed by member states in Geneva offers no specific budget figures or targets to address the “financial sustainability concerns” it repeatedly cites.

The shortfall will hit the most vulnerable countries hardest as they struggle to fund surveillance improvements amid stretched public health budgets and lack resources to strengthen regulatory systems that could better protect their populations from the threat of counterfeit medicines.

Africa bears the heaviest burden, with an estimated 18.7% prevalence of falsified and substandard medicines—nearly double the average in low- and middle-income countries worldwide.

“Millions of people in Africa continue to die from preventable causes due to substandard and falsified medical products,” the African bloc, representing the continent’s 47 nations, told the assembly.

A 2023 UN Office on Drugs and Crime report documented a devastating toll in sub-Saharan Africa alone: 267,000 annual deaths from falsified antimalarial drugs and 169,000 from fake antibiotics for childhood pneumonia.

“These are not isolated events,” Nakatani warned the assembly. “These are symptoms of the systemic vulnerabilities in the regulatory oversight, supply chain security, and global information sharing.”

A global problem

Rutendo Kuwana, WHO’s team lead for substandard and falsified medicines incidents, quantified the cost to health systems at a UN side event during the assembly, placing estimated losses at $75 million to $200 million each year treating victims of these faulty medical products.

“We have issued several product alerts recently, including with regards to some contaminated medicines and toxic syrups that caused the deaths of more than 300 children,” Kuwana said.

The children’s deaths he referenced include over 300 who died in 2022 in The Gambia, Indonesia, and Uzbekistan from cough syrups contaminated with diethylene glycol and ethylene glycol—industrial solvents used in place of pharmaceutical-grade ingredients.

The situation is deteriorating: in 2023, the number of substandard and falsified incidents reported to WHO doubled compared to 2019.

Beyond contaminated medicines, Kuwana warned of the alarming rise of nitazenes, synthetic opioids more powerful than fentanyl that have been linked to a surge in overdose deaths across Europe and North America, with UK authorities reporting a spike in nitazene-related fatalities in 2024.

“People are purchasing illegal narcotics and taking them, assuming they contain ecstasy or something like it, but they are also adulterated with these nitazenes,” Kuwana said.

“This is not only in LMICs but in high-income countries,” he added. “No country is immune.”

A Failing System

WHO officials told the assembly that the agency’s evaluation of the falsified medicines mechanism, presented to its executive board in January, reinforced long-held concerns about its efficacy.

“It confirms what many of us have long observed, that while the mechanism remains a vital platform, persistent challenges, particularly in securing sustainable funding and ensuring consistent engagement, continue to hinder its full potential,” said Dr Chikwe Ihekweazu, WHO Regional Director ad interim for Africa.

He noted that “public awareness of the dangers of substandard and falsified products is still low” and “many countries lack robust surveillance systems for emerging threats such as adulteration of medicines with highly potent and dangerous synthetic opioids.”

Despite the challenges, progress is being made.

Forty-five of 47 African nations now have focal points integrated into WHO’s surveillance system, a significant increase from just five at the time the report was presented to the executive board in January, leading to 39 alerts between 2020 and 2025.

National Success Stories

Nigeria exemplifies what aggressive national action can achieve.

The country’s drug regulatory agency has conducted inspections of over 11,000 shops, seized and destroyed more than 140 trucks of banned or unregistered products, and developed risk-based classifications for domestic manufacturers, Dr Adebisi Jaiyeoba, Deputy Director of Nigeria’s National Agency for Food and Drug Administration and Control said in Geneva.

Nigeria is promoting local production of six key medicines to reduce dependence on imports vulnerable to counterfeiting.

Dr Ketut Putu Yasa, head of the Indonesian College of Thoracic and Cardiovascular Surgery, described the scope of the challenge: “This is a global health emergency.” He called for more coordinated regulatory systems across countries and greater supply chain transparency.

In the Eastern Mediterranean region, conflict and fragile health systems have created ideal conditions for counterfeit medicines to flourish—one example of many global hotspots.

War disrupts regulatory oversight, destroys supply chains, and creates desperate populations willing to accept medicines from questionable sources. Yemen’s situation is particularly dire, with reports indicating that significant proportions of medicines enter through illicit channels, exacerbated by the country’s civil war since 2014.

The problem extends across Western Asia, where a Global Initiative Against Transnational Organized Crime report found that up to 35% of the region’s medicines—from antibiotics and vaccines to insulin and chemotherapy drugs—are illicitly sourced. Countries including Iraq, Lebanon, Syria, Turkey, and Iran face severe medicine shortages that criminal networks exploit.

The economic desperation fueling this trade creates a vicious cycle: counterfeit medicines cost 10 to 50 times more than legitimate versions when addressing shortages, yet are also sold at below-market prices to attract buyers who cannot afford genuine drugs. This dual market traps both the desperate and the economically vulnerable.

“Substandard and falsified medications compromise the effectiveness of healthcare, increase morbidity and mortality and erode public trust in health services,” the Eastern Mediterranean regional bloc declared. “Unfortunately, such products are circulating with increasing frequency due to limited regulatory capacity, exacerbated by the COVID-19 pandemic.”

“Conflicts and fragile health systems have all contributed to this problem,” the bloc stated.

Youth Joins the Fight

Experts in the field also emphasised engaging patients and youth as key to combating falsified medical products.

“We need to ensure patients’ voices are part of surveillance, planning and evaluation,” said Dani Mochi, CEO of the International Alliance of Patients’ Organizations, noting that patients can aid awareness, report dangerous products, and advise regulatory agencies.

Tanushree Jain, Chairperson of Public Health for the International Pharmaceutical Students’ Federation, called for “intergenerational solutions” and suggested a dedicated fund for youth engagement.

“Allow youth champions to act as local leaders to fight [substandard and falsified] products,” Jain urged. “They can play a pivotal role… and energize and mobilize their peers.”

Image Credits: Guilhem Vellut, Maayan Hoffman.