Semaglutide Access in Asia: Why BMI Alone Misses Millions at Risk
She is 53, “normal” weight, and has already had a heart attack. A drug proven to prevent the next one is about to become affordable in her country, India.
But she may not be able to access it given that of a line drawn for someone else, on another continent. A billion people are about to find themselves on the wrong side of it.
On March 24, the patent on semaglutide – the active ingredient in the celebrated GLP-1 drugs Ozempic and Wegovy – expires in India. This opens the door for generic versions, potentially driving down prices by as much as 90%, and putting within reach a drug proven to reduce the risk of major cardiovascular events by 20%.
However, the rulebook determining who qualifies for this potentially life-saving medication was written based on data from a different population. In a region where 5.2 million people lose their lives to cardiovascular disease each year, the current eligibility criteria may exclude those who would benefit most.
The BMI Threshold and the ‘Thin-Fat’ Phenotype
The U.S. Food and Drug Administration (FDA) approved semaglutide for cardiovascular risk reduction in patients with a body mass index (BMI) of 27 or higher. This threshold was established by the authors of the SELECT trial, whose participant pool was 84% white and only 8% Asian. The authors themselves acknowledged in the supplementary appendix to their study that South Asians experience greater cardiometabolic risk at lower BMIs. Crucially, the trial did not include individuals with a BMI below 27 – precisely where the risk concentrates for Asian populations.
This gap isn’t a minor oversight. It represents a fundamental disconnect between the data used to establish treatment guidelines and the physiological realities of a significant portion of the world’s population. In South and Southeast Asian populations, cardiovascular risk and visceral fat accumulation often initiate at BMIs well below 27. This phenomenon, known as the “thin-fat phenotype,” describes individuals who appear normal weight but carry significant amounts of visceral fat – the dangerous fat that accumulates around the organs and releases inflammatory compounds that silently damage arteries.
Semaglutide preferentially reduces visceral fat, accounting for roughly a third of the drug’s overall cardiovascular benefit. Applying a BMI threshold designed for a different population could inadvertently exclude those who stand to gain the most from this medication.
A Regulatory Crossroads for India
India’s Central Drugs Standard Control Organisation (CDSCO) has received a committee recommendation to study semaglutide’s cardiovascular benefit in Indian patients. However, it has not yet defined who should receive it. If Indian regulators adopt the FDA’s BMI threshold of 27, they risk importing a standard that doesn’t reflect the unique cardiometabolic profile of their population. A nationally representative study found that 43% of Indian adults are metabolically obese despite having a BMI below 25.
While off-label prescribing is technically permitted in India, accessing such a prescription requires finding a specialist aware of the thin-fat phenotype and willing to advocate for the patient. These specialists are scarce, particularly outside major cities.
Beyond Access: Affordability and Infrastructure
Even with the anticipated price reduction from generic versions, affordability remains a significant barrier. Semaglutide is not currently included on India’s National List of Essential Medicines, meaning patients must pay entirely out of pocket. While generics will dramatically lower the cost, a monthly dose could still consume a substantial portion of an average rural income. Affordable on paper doesn’t always translate to affordable in practice.
expanding access requires more than just lower prices and appropriate prescriptions. Robust infrastructure is needed to monitor patients for potential side effects, such as muscle loss, which can be a concern with GLP-1 drugs in leaner populations. Access to bloodwork and specialist care isn’t always readily available, particularly in rural areas.
Waist Circumference: A More Relevant Metric?
Fortunately, a readily available and informative metric exists: waist circumference. For nearly three decades, the scientific community has recognized waist circumference as a clinical vital sign for predicting metabolic syndrome and cardiovascular risk. A waist-to-height ratio above 0.5 flags individuals at increased risk – the “invisible sick.”
A national consensus of Indian cardiologists has recommended using waist circumference – rather than BMI alone – to identify patients with cardiovascular disease who may benefit from semaglutide. Korea’s obesity guidelines too recommend a lower BMI threshold (23) for initiating GLP-1 pharmacotherapy.
The World Health Organization (WHO) recognized the require for different thresholds decades ago, stating that cardiovascular and metabolic risk assessment for Asian populations should begin at a BMI of 23. More than half of adults studied across Southeast Asia – in the Philippines, Malaysia, Thailand, Myanmar, and Singapore – meet this definition of normal weight obesity. Applied to the region’s adult population, that prevalence would imply roughly 1 billion people carrying unrecognized cardiovascular risk.
A preliminary meta-analysis suggests that GLP-1s like semaglutide may reduce cardiovascular events nearly twice as effectively in Asian patients as in white patients. And the need is greater, too – heart disease in Asia strikes nearly a decade earlier than in the West, claiming people during their peak productive years.
What’s Next?
The coming months will be critical. Indian regulators must decide whether to adopt a BMI threshold that reflects the unique cardiometabolic risks of their population or import a standard designed for a different demographic. The decision will determine whether this potentially life-saving medication reaches those who need it most. Alongside regulatory decisions, investment in healthcare infrastructure – including access to specialists and diagnostic testing – will be essential to ensure equitable access and safe monitoring. The tape measure offers a simple, readily available tool to identify individuals at risk, but it’s only the first step.
Aditi Kantipuly, M.D., is a preventive medicine and public health resident at McGill University and visiting scholar at the University of New Mexico. She is currently working with policy stakeholders in India on access to cardiovascular medicines. Peter Singer is VK Rajah visiting professor of medical ethics at the Centre for Biomedical Ethics, National University of Singapore, and Ira W. DeCamp professor of bioethics, emeritus, Princeton University. His books include “Practical Ethics,” “The Life You Can Save,” and “The Most Solid You Can Do.”
