We must stay vigilant on false patent extensions and the non-clinical use of weight-loss drugs

In 2013, India’s Supreme Court had set a precedent on patent ‘evergreening’ by way of offering it in a different form; it dismissed Novartis’s claim that its new variant of Glivec (effective against leukemia) deserved a separate patent from its original formulation since it offered better bioavailability and therapeutic efficacy without back-up evidence.

For drugs, India now follows product patents in line with World Trade Organization norms, but does not indulge Big Pharma the way the US and EU often do by allowing patent extensions on flimsy grounds.

The original molecule of Ozempic lost its patent monopoly last year and its specific formulations will go off-patent in March 2026. The court has let Dr Reddy’s make and export a generic version of semaglutide to markets where the drug has no patent shield, while barring sales in India until that point.

This is how it ought to be. India is a relatively poor country that cannot let drugs stay expensive for too long, as patent rollovers ensure, and must let generic-drug rivalry drive down prices to the extent possible. Letting Novo Nordisk’s injectables rule our market longer could set a precedent that other pharma players could exploit to keep vital medicines out of popular reach.

Mounjaro, Eli Lilly’s brand of another weight-loss drug called tirzepatide, was launched this March. In just over half a year, it had toppled GlaxoSmithKline’s antibiotic Augmentin as India’s largest selling medicine by value, with sales reported at ₹100 crore in October. This reveals huge demand for drugs that promise to help people knock off weight.

India is also the world’s diabetes capital, with type-2 diabetes estimated to afflict 100 million people, with millions more pre-diabetic. Considerable numbers are obese as well. Drugs like Mounjaro and Ozempic combat both diabetes and obesity, which share afflictions such as metabolic syndrome and elevated insulin resistance. The two have been observed to be beneficial in treating both conditions.

Beyond clinical cases, though, many people may be drawn by the slimming potential of the ‘GLP-1 agonists’ of these drugs. GLP-1 stands for Glucagon-Like Peptide-1 and an ‘agonist’ is a chemical that plugs into a cellular receptor to create a response. In this case, such activation can suppress appetite, raise the sensation of satiety and reduce calorie intake.

Given the widespread practice of drugstores selling prescription medicines like over-the-counter drugs, we can assume that significant extra demand for GLP-1 drugs could arise from would-be slimmers outside the ambit of formal treatment for specific conditions.

Fitness is not just a major lifestyle concern, but also a driver of much commerce in the name of wellness. If these drugs gain currency as a tool to bypass the need of discipline for a prudent balance of calorie intake and expenditure via exercise, the sale of these drugs could zoom once they go off patent and generic rivalry crushes market prices.

For genuine patients, we need such medicines available cheaper. As of now, they are quite costly. But we must also ensure the sign-off of doctors through proper ‘Rx’ rule enforcement and promote awareness of their possible side-effects, some of which could be harmful. In general, the risk of mass-market drug misuse should refocus our attention on retail regulation as much as public education.