India’s weight-loss frenzy is under the scanner, with the blockbuster drug semaglutide facing fresh scrutiny after hundreds of suspected complications were flagged, said two government officials in the know, with medical experts noting that about half the users report some side-effects. The ongoing review could lead to tighter norms, including label changes, safety warnings and stricter prescription rules.
Amid the hype surrounding these glucagon-like peptide-1 (GLP-1) receptors' efficacy for weight loss, the government has documented around 400 reports of adverse drug reactions (ADRs) potentially linked to the medication that is now being clinically evaluated, the officials said. These reports have been documented since the drug's launch in India last year.
The government collects data from healthcare professionals as well as direct consumer reports. This reporting of ADRs is being done through dedicated state-level monitoring centres that report to the Centre.
The Indian Pharmacopoeia Commission (IPC), health ministry’s apex body responsible for setting drug standards, is evaluating these cases with reported side-effects, including gastrointestinal distress—severe nausea and persistent vomiting—and major dermatological issues.
After its investigation, the commission will submit its findings to the apex drugs regulator, the Drugs Controller General of India (DCGI), for further action.
The scrutiny follows the Centre's directive to states to ensure that this anti-obesity drug can be accessed only on only prescription by endocrinologists, internal medicine specialists and for some indications by cardiologists, as reported by Mint earlier.
To be sure, semaglutide has been in use globally for nearly a decade. The drug debuted globally in 2017 with the US launch of Ozempic to manage type-2 diabetes. The dedicated weight-loss version, Wegovy, was introduced in 2021.
“IPC has received around 300-400 reports for semaglutide potentially causing adverse drug reactions. We have received these reports from people and are currently evaluating each case to establish a temporal relationship between the adverse event and the medication," said a government official cited above, requesting anonymity.
"Every report is being clinically evaluated, especially since semaglutide's duration of action is short and it is typically excreted from the body within five to six hours. Once this clinical evaluation is complete, the IPC will submit its findings to the regulator for necessary action,” the official added. “We will tell the regulator, and the regulator will issue any necessary notices or changes to the package insert or labelling. Our responsibility is to inform the public.”
Several pharmaceutical companies, including Sun Pharma, Zydus Lifesciences, Dr. Reddy’s Laboratories, Mankind, Torrent, Glenmark, and Zydus Lifesciences, launched generic versions of semaglutide following the patent expiry of innovators such as Novo Nordisk and Eli Lilly in India. These companies have already been sensitized about the strict marketing and distribution protocols.
While semaglutide is an established medication for type-two diabetes and weight management, it carries risks that require expert monitoring. The Indian Pharmacopoeia Commission’s move serves as a guardrail to ensure the rapid expansion does not threaten patient safety.
“The Indian Pharmacopoeia Commission (IPC) has already reported several adverse drug reactions associated with semaglutide…We have issued an advisory directing drug inspectors to remain vigilant as the surge in online advertisements for weight loss are deeply worrisome," said an official at a state-level drugs regulator. "These treatments cannot be self-administered. However, we see platforms offering semaglutide through online consultants to bypass traditional prescription barriers.
This state official said while these firms do hire medical professionals to fulfill legal formalities in online prescriptions, the potential for drug misuse is high and it calls for a more coordinated regulatory response, the official said. “We are working to sensitize the public," the official added.
The health ministry had issued a detailed advisory for manufacturers on 10 March 2026, wherein it prohibited surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.
Pharmacutical firms agree this prescription-only therapy should be monitored closely.
Sheetal Arora, promoter and chief executive officer at Mankind Pharma Ltd said, “As access to semaglutide expands in India, it is critical that safety, oversight, and responsible use remain central to how this therapy is introduced and adopted… Semaglutide is a prescription-only therapy and should be initiated and monitored under the guidance of a qualified healthcare professional.”
Queries emailed to the health ministry spokesperson on 3 May and the DCGI on 4 May did not elicit any response until press time. Queries sent to Sun Pharma, Dr Reddy’s Laboratories, Glenmark, Novo Nordisk, Eli Lilly, Zydus Lifesciences remained unanswered until press time.
Prescribing tight supervision
Health experts say almost half the people taking semaglutide develop well-documented side effects.
“Almost half of the people taking semaglutide develop well-documented side effects such as nausea, vomiting, or constipation. There is nothing unexpected here," said Dr. Ambrish Mithal, chairman of the endocrinology department at Max Superspeciality Hospital, Saket, New Delhi. “In my practice, we provide a full exercise prescription and a complete diet plan; it is not a simple ‘quick fix’.”
These side-effects can get serious. "While increased awareness has improved patient compliance, it is a reality that about 5% of Indian patients must discontinue the drug because they cannot tolerate these gastrointestinal effects,” the endocrinologist said underscoring the threat from unsupervised use.
“These medications are remarkably beneficial and have changed how we look at chronic disease, but they must be used scientifically. It is crucial to distinguish between proper medical use and misuse; these drugs can be dangerous without specialist supervision or for those with contra-indications like a history of pancreatitis or medullary thyroid cancer,” Mithal said.
Some experts say the incidence of such adverse drug reactions is low. “The most prevalent side-effects are gastrointestinal, such as nausea, vomiting, constipation and diarrhea, which are well-documented and affect roughly 10-20% of the patient population," said Dr. Atul Gogia, a senior consultant in the internal medicine department of Sir Ganga Ram Hospital in New Delhi. “The significance of the ADR data depends entirely on the ‘denominator’ of total users. If 300-400 cases occur among hundreds of thousands of patients, the incidence remains low at less than 1%, though higher rates would warrant serious concern.”
Dr. Gogia, however, concurred on the need for close monitoring. "Because many of the current Indian formulations are recent additions with limited long-term data, the usage of these drugs should be closely monitored under the direct observation of an expert, recognized doctor,” he said.
India’s rising obesity burden, along with the recent price cuts that have made semaglutide more accessible, is fuelling a rush to tap a market seen at $347.5 million by 2035, according to Grand View Research.