Delhi HC seeks regulator's reply after PIL questions Ozempic, Mounjaro nod
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New Delhi | Mumbai: The Delhi High Court on Wednesday directed India's drug regulator to respond to a public interest litigation (PIL) that raised serious concerns over the approval process followed for the wildly popular anti-diabetes and weight-loss drugs like Ozempic, Mounjaro and Victoza within three months.The order uploaded late Wednesday night noted, "The Drugs Controller General of India shall accordingly take an appropriate decision in the matter and shall address the concerns raised in the writ petition by the petitioner appropriately. The decisions shall be taken by the Drugs Controller General of India on the representation to be preferred by the petitioner under this order within a period of three months.However a senior legal expert representing the petitioner told ET the court disposed of the case with "liberty," which on interpretation means that if the petitioner is not satisfied then the court grants the liberty to file the petition again on the same grounds.The court also noted that the Drug Controller General of India (DCGI) shall consult experts and other stakeholders such as manufacturers of the drugs in question.Notably, Danish drug maker Novo Nordisk's brand Ozempic, though not officially sold in India, has been reported to be easily available in the grey market. Novo Nordisk markets Wegovy for the treatment of obesity, which uses semaglutide, the same ingredient that goes into making Ozempic.Victoza (liraglutide) is another drug from Novo Nordisk prescribed to patients with diabetes while Mounjaro (tirzepartide) is a recently launched drug in India by US-based Eli Lilly for use in patients with both diabetes and obesity.Legal experts told ET the PIL's main contention is that glucagon-like peptide -1 Receptor Agonist (RA) or GLP-1 drugs like semaglutide, tirzepatide, and liraglutide have been granted marketing approval in India for use in weight management.The PIL claimed the official approval was granted to drugmakers despite limited safety data, lack of India-specific clinical trials, and absence of a robust pharmacovigilance or regulatory oversight mechanism.Fitness-tech entrepreneur Jitendra Chouksey filed the 134-page PIL flagging significant risks posed by these medications. It cited studies that highlighted the risks posed by these medications. "United Kingdom reported 82 deaths. Numerous studies have highlighted significant risks posed by these medications including pancreatitis, gastrointestinal damage, thyroid and pancreatic cancers, cardiovascular complications, metabolic dysregulation, and optic neuropathy," it said.The drugs were originally developed and internationally approved for the treatment of type 2 diabetes mellitus. However, over the past few years, they have been repurposed and approved for obesity treatment and chronic weight management, based on short-term efficacy trials, the PIL said.
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Skip Ozempics: Cardiologist shares 5 natural habits for healthy weight loss
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Wegovy Here, Ozempic Next: Big Focus On India's Obesity & Diabetes Crisis, Says Novo's Cai
India is among the top two countries in terms of type 2 diabetes cases and third in terms of obesity; hence, the need for weight loss and anti-diabetic drugs is huge Danish drugmaker Novo Nordisk is working to bring its blockbuster drug Ozempic to India 'as soon as possible", Dr Yan Cai, senior vice president of clinical development, medical affairs, and regulatory affairs for international operations, told News18. Reaffirming the Danish drugmaker's commitment, she noted that India is among the top three countries globally in terms of both obesity and type 2 diabetes prevalence, making it a high-priority market. 'I can reassure that India is a very important market for us. With a large population living with type 2 diabetes, we are committed to bringing Ozempic to India. Wegovy and Ozempic serve different populations—Ozempic is for managing diabetes, while Wegovy is for weight loss," Dr Cai told News18 in an exclusive interaction. When asked about the timelines planned for the launch of Ozempic, she said, 'as soon as possible… it is our commitment." Ozempic, originally developed for type 2 diabetes, shot to global fame as a weight loss sensation—fuelled by Hollywood celebrity endorsements and off-label use. Its surging demand has made it one of the world's best-selling drugs, breaking revenue records and reshaping the global obesity and diabetes treatment market. Talking about the relevance of Wegovy for the Indian market, Cai said, India ranks third globally—after the US and China—in obesity prevalence, with over 200 million people estimated to be obese. 'It is also among the top two countries in terms of type 2 diabetes cases. The magnitude of these conditions is huge. We will continue to offer innovative treatments to help people live healthier lives," she said. According to Dr Cai, Wegovy has proven clinical evidence showing it reduces risks related to heart disease, including stroke and myocardial infarction. 'It is the only anti-obesity drug that provides both weight loss and cardiovascular benefits. For people living with obesity or overweight—and especially those with a history of cardiovascular disease—it offers protective benefits," she said. Wegovy is based on semaglutide, the same molecule used in Ozempic. Dr Cai explained that the molecule has a long history and has been used by over 33 million people worldwide. 'Semaglutide has been tried and trusted over the years in terms of safety. Its profile is well understood," she added. She said Novo Nordisk has been a pioneer in the field of obesity treatment, having started research over 25 years ago. 'With Wegovy now launched and Ozempic in the pipeline, the company sees India as a core focus for future medical innovation." 'We will continue to provide treatments that make a meaningful difference. The scale of obesity and diabetes in India calls for urgent and sustained efforts—and we're committed to being part of the solution." How Wegovy works—The science and the journey Semaglutide is part of a drug class known as GLP-1 receptor agonists. It works by acting on receptors in the brain to suppress appetite, particularly the desire for fatty food. 'We have solid data from both human and animal studies showing reduced cravings. People feel full earlier, eat less, and some patients also tell us that they start choosing healthier foods—like salads—on their own," said Cai. 'It's not just about 'eat less, walk more.' Obesity is a complex disease that needs to be managed holistically—with medication, lifestyle changes, exercise, and an overall support system." She emphasised that Wegovy helps balance energy intake and expenditure. 'It helps control cravings and hunger. People respond differently—some experience rapid weight loss, while others lose weight more gradually." Journey of a patient on Wegovy Starting Wegovy requires a careful dose titration process. Patients typically begin on a low dose, which is gradually increased every four weeks under medical supervision. Some individuals may experience gastrointestinal side effects, such as nausea, especially in the early weeks. 'These side effects are usually mild and transient, and they are a natural reaction to this drug class. Around 50–60% of patients don't experience any symptoms at all," Cai noted. 'Most important is not to drop off too soon. The body adjusts over time." Patients are advised to stay at the same dose for four weeks to allow their body to adapt. Based on Novo Nordisk's data and Dr Cai's own experience, 50% of patients stay at 1.7 mg, while 20–30% titrate up to 2.4 mg, which is the highest dose. 'Cardiovascular benefits kick in at higher doses. My advice is to work with your doctor to find the right dose and continue long enough to receive the full benefit. Cardiovascular improvements can be seen as early as 20 days into treatment, with more visible weight loss beginning around 12 to 16 weeks." In clinical studies, 80–90% of patients achieved clinically significant weight loss, defined as more than 5% of body weight. 'More impressively, over 30% of patients lost more than 20% of their body weight within 6 to 8 months of starting treatment." Is this the right price for Indian market? Wegovy is currently priced between Rs 17,000 and Rs 26,000 per month for five doses. Replying to the question on affordability and price-sensitive Indian consumers, Cai said, 'Novo Nordisk has introduced an India-specific pricing model to make the drug more accessible." top videos View all 'We have ensured that the first three dosing categories are priced the same, so patients don't face financial hurdles early in their treatment. This allows them to sustain the therapy without additional burden," Cai explained. She added that Novo Nordisk is also developing new innovations to target different segments of patients in India, with future drugs to be priced accordingly, hinting that those who cannot afford this treatment can expect other new-age drugs from the company's portfolio in the coming years. Get breaking news, in-depth analysis, and expert perspectives on everything from politics to crime and society. Stay informed with the latest India news only on News18. Download the News18 App to stay updated! tags : diabetes health Obesity Weight Loss Location : New Delhi, India, India First Published: July 05, 2025, 08:00 IST News india Wegovy Here, Ozempic Next: Big Focus On India's Obesity & Diabetes Crisis, Says Novo's Cai | Exclusive
