Weighty issues: India's rush to make weight-loss drugs demands user caution

Indian pharmaceutical companies are preparing for weighty gains when the patent for semaglutide, the active pharmaceutical ingredient (API) used in drugs for weight loss and the treatment of diabetes, lapses in 2026 in 100 countries, including India, Canada, and Brazil. Sold by Novo Nordisk under the brand names Ozempic and Wegovy, the drugs have proven to be blockbusters for the Danish pharma major, generating $25 billion in revenues in 2024 alone. No surprise, then, that Indian drugmakers have spotted a huge opportunity and are preparing to launch significantly cheaper generic versions of semaglutide. All the major names of the domestic industry — Dr Reddy’s, Biocon, Sun Pharma, Cipla, Lupin, and Aurobindo Pharma — are reported to be ramping up in-house and contract manufacturing capabilities to produce injectable and oral formulations. Though both the market opportunities and the benefits for consumers from the availability of cheaper generics are significant, they need to be weighed against the risks. 

The global market for weight-loss drugs is estimated at $100 billion by the end of the decade. In India alone, the market has seen a fivefold increase over the past five years and is valued at $73 million. The rapidly expanding proportion of diabetic and overweight people is likely to power this growth for some time. According to the International Diabetes Federation, India has a “significant diabetes epidemic”; one in four people with diabetes globally comes from India. Obesity, too, is reaching epidemic levels, thanks to rising prosperity, sedentary lifestyles, carb- and fat-rich diets, and increasing junk food consumption. The prospect of generics that could be 80 or 90 per cent cheaper could, therefore, see a sustained boom for generic manufacturers. 

The road to this prosperity may be paved with hurdles. Novo Nordisk could well resort to the time-honoured practice of evergreening to extend the life of the semaglutide patent, blocking the entry of generics. It is currently suing Dr Reddy’s and Bengaluru-based OneSource Specialty Pharma in the Delhi High Court for marketing semaglutide, citing patent infringement. Elli Lilly, which sells its diabetes and weight-management drugs under the brand names Mounjaro and Zepbound, respectively, is reportedly exploring follow-on patents for the API tirzepatide, which expires in 2036, focused on delivery devices, formulations, and methods of treatment. 

At the same time, the rapid expansion of contract manufacturing to service the market without adequate safety checks is a critical hazard for domestic majors — the recent scandals over children’s cough medication made in franchised units offer a cautionary tale. User caution is another potential problem. Both drugs need to be taken under strict medical supervision and in tandem with a dietary and exercise regimen. Without this, patients can suffer serious side-effects — from reduced kidney functioning to chronic gastrointestinal issues. In a country where prescription drugs are readily available over the counter and the proclivity for self-medication widely practised, the chances of weight-loss drugs being consumed without a doctor’s recommendation are high. This is especially so among affluent Indians, who could indiscriminately consume these drugs as a panacea for obesity without following the vital dietary restrictions and falling prey to serious related ailments.  It is critical, therefore, for the drug regulator to monitor the manufacture and distribution of these off-patent drugs to ensure that they do not spark a secondary health emergency.