The expiry of semaglutide’s patent in India marks a turning point in the country’s public-health trajectory. Once accessible only to a narrow, affluent patient base, GLP-1 receptor agonists — best known through brands such as Ozempic and Wegovy — are set to become dramatically cheaper as domestic manufacturers introduce generic drugs at scale. As many as 50 brands are likely to become available, reducing the cost by at least a third to a fifth of the price point. In a country grappling with diabetes and an obesity epidemic, the prospect of wider access, particularly for middle- and lower-income patients, is an unequivocal gain. In conjunction with lifestyle changes, these drugs regulate Type-2 diabetes, aid sustained weight loss and lower cardiovascular risk, offering a multi-pronged intervention for metabolic diseases. At a time when India’s healthcare system is overstretched, prevention through affordable medication could ease a mounting disease burden.

Yet, the very reasons that make these drugs transformative also make them susceptible to misuse. With companies working on their own versions, India risks an explosion of brands that outpaces regulation and clinical scrutiny. The drugs’ reputation for rapid weight loss has already evoked interest among those who may not be medically eligible. GLP-1 drugs carry side effects and are not designed for casual or cosmetic use. There is also a deeper scientific concern: Global prescribing thresholds, such as BMI cut-offs, are based largely on Western populations and may sit uneasily in the Indian context, where metabolic risks develop at lower body weights. Monitoring of outcomes, adverse effects and long-term use in a population that differs significantly from those in which these drugs were first studied is crucial. An unregulated rollout could widen inequities.

The challenge, therefore, is to create necessary firewalls that ensure the advantages of easy access are not squandered. The Central Drugs Standard Control Organisation (CDSCO) classifies GLP-1 medicines as Schedule H drugs. A valid prescription is mandatory for their procurement. In practice, however, India’s over-the-counter culture often subverts procedure. Tighter prescription protocols, robust pharmacovigilance systems and clearer eligibility criteria are essential guardrails. Advertising, too, must ensure that a serious therapy is not repackaged as a lifestyle shortcut. CDSCO has already issued an advisory to manufacturers to that effect. If India can match affordability with regulatory foresight, it can set a global standard in equitable care.

© Indian Express