Semaglutide Patent Expiry in India Raises Access Questions Beyond Price
The patent on semaglutide — the active ingredient in Ozempic and Wegovy — expires in India on March 24, potentially cutting prices by up to 90% and bringing a proven cardiovascular risk-reducing drug within reach for millions. But access may be blocked not by cost, but by a BMI threshold designed for Western populations.
The FDA approved semaglutide for cardiovascular risk reduction in patients with a BMI of 27 or higher, based on the SELECT trial which was 84% white and only 8% Asian. Yet cardiovascular risk and visceral fat begin accumulating at much lower BMIs in South and Southeast Asian populations — a phenomenon known as the "thin-fat phenotype."
More than half of adults across Southeast Asia meet the definition of normal weight obesity, implying roughly 1 billion people carrying unrecognized cardiovascular risk. A meta-analysis found GLP-1s like semaglutide reduced cardiovascular events nearly twice as effectively in Asian patients as in white patients.
India's drug regulator has received a recommendation to study semaglutide's cardiovascular benefit in Indian patients but has not yet defined who should receive it. If India adopts the FDA's BMI threshold of 27, it risks importing a standard that ignores Asian physiology. A nationally representative study found 43% of Indian adults are metabolically obese despite having a BMI below 25.
India's GLP-1 drug market could grow from roughly 10 billion rupees in 2025 to 50 billion rupees by 2030, with generic versions likely priced around 5,000 rupees per weekly injection versus significantly higher for branded therapy.
The writers, preventive medicine and public health researchers, argue that India's regulator should not simply adopt Western BMI thresholds but should develop criteria appropriate for its population.