WHO issues critical warning on fake diabetes, obesity drugs amidst rising demand

The World Health Organization (WHO) has issued a medical product alert concerning falsified semaglutides, medicines used to treat Type 2 diabetes and obesity. This alert pertains to three falsified batches of the brand Ozempic, detected in Brazil and the United Kingdom in October 2023, and in the United States in December 2023.

Increased Reports of Falsified Medicines

The WHO's Global Surveillance and Monitoring System (GSMS) has been tracking an increase in reports of falsified semaglutide products globally since 2022, marking this as the first official notice following the confirmation of these reports.

“WHO advises healthcare professionals, regulatory authorities, and the public to be aware of these falsified batches of medicines,” said Dr Yukiko Nakatani, WHO Assistant Director-General for Access to Medicines and Health Products. “We call on stakeholders to stop any usage of suspicious medicines and report them to relevant authorities.”

Semaglutides, including Ozempic, are prescribed to lower blood sugar levels in people with Type 2 diabetes and reduce the risk of cardiovascular events. They are available as weekly injections or as daily oral tablets and are increasingly prescribed for weight loss due to their appetite-suppressing effects. However, the rising demand for these medicines has led to increased reports of falsification, posing health risks. 

Health Risks of Falsified Semaglutides

Falsified semaglutide products may lack necessary active ingredients, leading to unmanaged blood glucose levels or weight issues. In some cases, these products may contain undeclared active ingredients, such as insulin, causing unpredictable health risks, the global health agency said.

Semaglutides are not part of WHO-recommended treatments for diabetes management due to their high cost, which limits their feasibility for widespread use in resource-limited settings. More affordable treatments with similar effects on blood sugar and cardiovascular risk are available. WHO is currently developing guidelines on the potential use of GLP-1 receptor agonists (GLP-1 RAs), including semaglutides, for obesity treatment in adults. GLP-1 RAs are a class of medications used to lower blood sugar and support weight loss.

A GLP-1 receptor is a protein on cells in the pancreas and brain. It helps regulate blood sugar and appetite. When activated by the GLP-1 hormone, it stimulates insulin release, slows digestion, and reduces hunger, aiding in diabetes and weight management.

In India, the issue of falsified medicines is particularly concerning. Dr Rajeev Gupta, Director of Internal Medicine at CK Birla Hospital, Delhi, highlighted the risks: “The World Health Organization’s warning about falsified medicines for diabetes and weight loss is a critical issue, especially as demand for these drugs rises globally, including in India. Recently, fake injectable semaglutide has surfaced due to supply chain pressures for Wegovy, a drug used for both diabetes control and weight loss.”

India Scenario

India faces a public health crisis with a growing burden of obesity and diabetes. The national family health survey-5 (NFHS-5) 2019-2021 estimated that over 16% of adults in India have diabetes. Studies suggest that 70% of the population is overweight or obese, with a notable gender disparity towards women. This trend, driven by factors like urbanisation and lifestyle changes, is projected to worsen. Medical experts warn that if the current trajectory continues, India could face a substantial healthcare burden exacerbated by obesity-related illnesses.

In response to this growing crisis, there has been a significant surge in the popularity of weight loss drugs. Medications such as orlistat, phentermine, and more recently, liraglutide, have found a burgeoning market among Indian consumers. These pharmacological solutions promise rapid weight loss by suppressing appetite, reducing fat absorption, or increasing energy expenditure.

Calls for Stronger Regulation

Weight loss drugs are appealing to a demographic looking for quick fixes due to the demanding nature of their daily lives, which often precludes consistent physical activity and strict dietary adherence. However, healthcare professionals caution against over-reliance on these medications. They stress that while such drugs can assist in weight management, they are most effective when combined with lifestyle modifications, including diet and exercise.

Dr Anoop Misra, Chairman of Fortis C-DOC Hospital for Diabetes and Allied Sciences, emphasised the need for strong regulation: “I have recently seen a few patients where locally bought drugs did not produce desired results. We need strong regulation to allow only standard weight loss drugs since there is an increasing market for these drugs.”

Counterfeit drugs often pass through some Arab countries before reaching India, posing health risks. Maintaining a strict cold chain is crucial for these medications to retain efficacy, but this is often neglected, leading to large-scale fraud and potential harm to patients. While injectable semaglutide is not available in India, the oral form, Rybelsus, is available, and there have been no reports of fake Rybelsus in India so far.

“Ensuring the integrity of our drug supply is essential to protect patients and maintain trust in our healthcare system. Addressing this issue is crucial for public health and safety,” added Gupta.