Just when the weight-loss party was kicking into high gear, the drug regulator has made an entry.
The Drugs Controller General of India (DCGI) has asked states to ensure that endocrinologists - specialists in hormones and endocrine glands - alone can prescribe these medicines, two officials aware of the matter said. The directive, which draws attention to manufacturers' advice in this regard, follows a crackdown on certain "wellness centres" in Delhi and Gurugram, where unqualified individuals were found prescribing the drug.
Novo Nordisk's blockbuster semaglutide, famed for its weight-loss properties, went off-patent on Friday, triggering an avalanche of affordable copycats from Sun Pharmaceuticals, Zydus Lifesciences, Dr. Reddy’s Laboratories, Alkem Laboratories, Torrent Pharmaceuticals, Glenmark Pharmaceuticals and others. Alarmed about the potential for misuse, the DGCI issued the directive to state licensing authorities at a meeting of the Drugs Consultative Committee (DCC) last week, two people aware of the matter said.
“This specific drug carries a warning that it must be administered only under the supervision of an endocrinologist to ensure that complex metabolic side-effects are properly regulated. There is a concern that if other medical professionals begin prescribing it, they may not be able to properly manage its side-effects,” one of the two officials cited above said, requesting anonymity.
Obsesity burden
According to a Lancet study, India could have the world's second-highest obesity burden by 2035, with 449 million overweight and obese people by 2050, when a third of the country's population will be obese. Affordable generics cut treatment costs by 50-70% and significantly improve patient access nationwide.
A CareEdge report estimates India's current semaglutide market at $24 million, growing at a CAGR of 17.8% to reach $400 million by 2030. However, while semaglutide is trusted for type-two diabetes and weight management, it carries risks that require expert monitoring. The DCGI move serves as a critical guardrail to ensure that this rapid expansion does not endanger patient safety.
According to Dr K. Srinath Reddy, former president of the Public Health Foundation of India, these drugs are also associated with muscle loss (sarcopenia), bloated stomach, nausea and vomiting, as well as anxiety and depression. "Sarcopenia can lead to increased frailty and dangerous falls in the elderly. Since stoppage after weight loss can result in rebound weight gain, long-term therapy may be needed,” Reddy said.
“States are doing extensive vigilance, and have been told to ensure sales occur only through valid prescriptions from certified endocrinologists because it’s very necessary; otherwise, there will be a lot of misuse. It feels like apart from diabetes patients, those interested in weight loss are more interested in this. Last week, raids were conducted in East Delhi, and one was in South Delhi at a wellness centre," the second official said, pointing out the drug label specifically says only an endocrinologist can prescribe it.
Legal action
The new directive follows an earlier DCGI advisory banning the surrogate promotion of prescription drugs, particularly weight-loss medications. Social media campaigns guaranteeing results while downplaying diet and exercise may face legal action under the Drugs Rules, 1945.
Queries emailed to the spokespersons of the health ministry and DCGI remained unanswered. Sun Pharma, Dr. Reddy’s, Alkem, and Glenmark, Novo Nordisk did not respond to queries.
While drugmakers such as Dr. Reddy’s and Alkem have advised patients to consult doctors since semaglutide is a prescription drug, endocrinologists say indiscriminate usage is a matter of concern.
Dr. Ambrish Mithal, chairman and head of endocrinology and diabetes at Max Healthcare said, “The recent patent expiry of semaglutide has triggered an intense race in the pharmaceutical market, with numerous companies launching products within just 24 hours. We are seeing a concerning shift where semaglutide is being treated as a cosmetic or 'lifestyle' drug rather than the potent metabolic medication it actually is.”
‘Right step’
Calling the DCGI directive the "right step", Mithal said only an endocrinologist an internal medicine doctor will understand the metabolic nuances and potential long-term impacts that a wellness centre might overlook. "Countries like Portugal emphasize that semaglutide must remain a 'supervised prescription drug. As prices continue to drop and the drug becomes more available, the temptation for misuse at the retail and wellness level will only increase,” Dr. Mithal added.
The directive aims to stop the misuse of these drugs for purely cosmetic purposes, Dr. Reddy said. “Modern weight-drugs, which are analogues of the naturally produced gut hormones, are very effective in promoting weight loss in obese individuals and also provide substantial benefits in reducing cardiometabolic risk.. “For these reasons, this treatment should be limited to persons with severe obesity who are unable to lose weight with diet and exercise or have a high level of cardio-metabolic risk. DCGI’s directives limiting the prescribing rights will help to curtail ‘faddist’ prescriptions by doctors who are unfamiliar with the indications and adverse effects of these drugs," he said.
Yet another medical industry expert disagreed.
Dr. Dilip Bhanushali, national president of the Indian Medical Association of 400,000 doctors said, “Although the drug regulator recommended prescriptions be limited to endocrinologists, internal medicine physicians with experience in treating diabetes and managing diabetic cases should also be authorized to prescribe the drug due to the limited number of specialists available in the country.”