Sun Pharma gets DCGI nod for generic semaglutide, plans India launch post patent expiry

Preparing to enter India’s obesity and metabolic care market, Sun Pharma on Friday said it has received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of semaglutide injection in the country.

The nod covers semaglutide injection indicated for chronic weight management in adults, to be used alongside a reduced-calorie diet and increased physical activity. Sun Pharma said the product will be launched under the brand name Noveltreat after the expiry of the semaglutide patent in India.

The approval follows a review of a Phase III clinical trial conducted in India. Noveltreat will be available in five dose strengths of 0.25 mg/0.5 mL, 0.5 mg/0.5 mL, 1 mg/0.5 mL, 1.7 mg/0.75 mL and 2.4 mg/0.75 mL, with a maintenance dose of 2.4 mg administered once weekly. The product will be delivered through a prefilled pen for accurate dosing.

“Obesity and diabetes have emerged as two of the most pressing health challenges confronting India and GLP-1 based therapies can play a meaningful role in addressing this growing burden,” said Kirti Ganorkar, Managing Director, Sun Pharma.

“Noveltreat meets global quality standards and is supported by robust Indian clinical evidence on efficacy and safety for weight management. As India’s largest pharmaceutical company with leadership in cardiometabolic therapies, we are committed to improving access to generic semaglutide across the country after the patent expiry,” Ganorkar said.

GLP-1 receptor agonists such as semaglutide have seen rising global demand due to their expanding role beyond diabetes into obesity and broader metabolic conditions. In India, the opportunity is determined by both disease prevalence and access constraints.

Data cited by the company show that nearly one in four Indians aged 15–49 is overweight or obese, according to the National Family Health Survey-5. Separately, the ICMR-INDIAB 17 study published in 2023 estimated that more than 101 million people in India are living with diabetes, with a significant proportion failing to achieve recommended glycaemic control targets.

“GLP-1 receptor agonists like semaglutide are an important scientific advancement for overall metabolic health, not just weight,” said Dr Unnikrishnan A G, Chief Endocrinologist and CEO, Chellaram Diabetes Institute.

“These treatments should be combined with appropriate lifestyle measures such as diet and physical activity and taken under close medical supervision. We are seeing growing patient interest in this therapy, and improved accessibility will help address unmet needs,” he said.

Sun Pharma had earlier received DCGI approval, in December 2025, to manufacture and market semaglutide injection for the treatment of adults with inadequately controlled type 2 diabetes mellitus. That product will be launched under the brand name Sematrinity, also after patent expiry, the company said.