- Regulatory green light clears path for affordable GLP-1 therapy in chronic obesity care
- Generic semaglutide to be launched post patent expiry under brand ‘Noveltreat’
- Approval backed by successful Phase III Indian clinical trial
- Move strengthens Sun Pharma’s leadership in cardiometabolic therapies
NE BUSINESS BUREAU
MUMBAI, JAN 24
Sun Pharmaceutical Industries Limited (Reuters: SUN.BO, Bloomberg: SUNP IN, NSE: SUNPHARMA, BSE: 524715, “Sun Pharma” and includes its subsidiaries and/or associate companies) has received approval from the Drugs Controller General of India (DCGI) to manufacture and market a generic version of semaglutide injection in India for chronic weight management.
Semaglutide, a glucagon-like peptide-1 (GLP-1) receptor agonist, is indicated for chronic weight management in adults as an adjunct to a reduced-calorie diet and increased physical activity. The approval marks a significant milestone in expanding access to globally proven obesity therapies in India.
Sun Pharma will launch the generic semaglutide injection under the brand name Noveltreat after the expiry of the semaglutide patent in India. The DCGI approval follows a comprehensive review of a Phase III clinical trial conducted in India, demonstrating the product’s efficacy and safety.
Noveltreat will be available in five dose strengths — 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 recommended maintenance dose of 2.4 mg once weekly. The medication will be administered via an easy-to-use prefilled pen designed to ensure accurate and convenient dosing for patients.
“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. 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,” said Kirti Ganorkar, Managing Director, Sun Pharma.
Highlighting the broader clinical significance of GLP-1 therapies, Dr. Unnikrishnan A G, Chief Endocrinologist and CEO, Chellaram Diabetes Institute, said, “GLP-1 receptor agonists like semaglutide are an important scientific advancement for overall metabolic health, not just weight. These treatments should be combined with appropriate lifestyle measures such as diet and physical activity. They should be taken under close medical supervision. We are seeing growing patient interest in this therapy, and improved accessibility will help address unmet needs.”
In December 2025, Sun Pharma had also received DCGI approval to manufacture and market semaglutide injection for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise. That product will be launched under the brand name Sematrinity, following the expiry of the semaglutide patent in India.
GLP-1 Class of Drugs
GLP-1 receptor agonists are a class of medications widely used in the treatment of type 2 diabetes mellitus (T2DM) and obesity. Therapies such as semaglutide are considered highly effective in improving glycaemic control and promoting weight loss, while also reducing cardiovascular and renal morbidity and mortality.
India’s Growing Obesity and Diabetes Burden
According to the National Family Health Survey-5 (NFHS-5), nearly one in four Indians aged 15–49 years is overweight or obese. Obesity is linked to multiple comorbidities, including metabolic and cardiovascular disorders, increased cancer risk, and higher morbidity and mortality. Experts stress the need for timely screening, effective pharmacological therapy, sustained lifestyle interventions, and long-term weight maintenance to improve health outcomes.
The ICMR-INDIAB-17 study (2023) estimates that 101.3 million people in India are living with diabetes. Many patients remain at risk of serious complications such as blindness, kidney failure, amputations, and heart attacks, with nearly 64% failing to achieve HbA1c targets. This underscores the urgent need for comprehensive diabetes management strategies incorporating newer and more effective therapies.
