NEW DELHI: India's drug regulator has tightened surveillance against the unauthorised sale and promotion of weight-loss drugs, amidst concerns over its widespread misuse and easy availability in the market.
The move from the Drugs Controller of India on Tuesday came after dozens of Indian drug manufacturing companies flooded the market with the cheaper generic versions of Ozempic and Wegovy - used for type 2 diabetes and weight loss - after the patent for semaglutide expired last week.
Emphasising that patient safety remains paramount, the drug controller cautioned that the misuse of weight loss drugs without clinical oversight can lead to severe health complications.
“Citizens are advised to use such medications only under the guidance of qualified medical practitioners,” the statement from the Union Health Ministry said.
In recent weeks, the Central Drugs Standard Control Organisation (CDSCO) scaled up its enforcement activities.
The ministry said the Drugs Controller, in collaboration with state regulators, has initiated a series of targeted actions to curb possible malpractices across the pharmaceutical supply chain and prevent unauthorised sales and use.
Audits and inspections were conducted at 49 entities, including, online pharmacy warehouses, drug wholesalers, retailers, wellness and slimming clinics.
“These inspections spanned multiple regions across the country and focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing,” the statement added.
Further, notices have also been sent to defaulting entities.
The ministry said that with the recent introduction of multiple generic variants of GLP-1-based weight loss drugs in the Indian market, concerns have emerged regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics.
“These drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks,” the statement said.
On March 10, 2026, the drug regulator issued a comprehensive advisory to all manufacturers, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.
Speaking with TNIE, Dr Rajeev Jayadevan, former president of Indian Medical Association (IMA) Cochin and Convener of the Research Cell, Kerala, said these injections are to be taken only with prescription, and require follow up of a doctor.
“Weight loss will stop as soon as the injections are stopped, and the weight is usually gained back. As with any medication, there can be rare side effects. However, for the person actually suffering from it, it is not “rare." And that’s one reason why close medical supervision is important,” he said.
“Taking these drugs as a shortcut to weight loss, without making sustained improvement in one’s diet and lifestyle is not a lasting solution,” Dr Jayadevan said.
As the patent expiry ended last week, over 40 Indian drug manufacturers have entered the market, and are set to launch over 50 brands, eying the lucrative weight-loss and diabetes market.
According to the Lancet studies, India is facing an alarming obesity surge, with roughly 180 million adults overweight or obese in 2021. By 2050, it is projected that 449 million people or nearly one-third of the population could be obese, putting India among the world's highest-burden nations, requiring urgent policy intervention.
What is more alarming is as per the World Obesity Atlas 2026 India ranks second globally for children living with overweight and obesity, with estimates indicating that by 2040, as many as 20 million children in the age group of 5-9 years will be living with obesity, and 56 million in the same age group will be living with overweight.
According to the 2023 Indian Council of Medical Research-India Diabetes (ICMR-INDIAB) study, there are an estimated 101 million people in India with diabetes, 136 million pre-diabetics and 315 million people with hypertension in 2021. Experts said the number could exceed 125 million by 2045.
The drug regulator further said in the statement that it is “important to reiterate here that the drug has been approved in India with conditions of prescription by Endocrinologists and Internal Medicine Specialists and for some indications by Cardiologists only.”
“Regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt with strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws,” it added.
Semaglutide, the molecule behind global brands like Ozempic and Wegovy, is a GLP-1 receptor agonist used to treat Type 2 diabetes and aid weight loss.
As the patent expired, the Indian market was flooded with various generic versions, with some costing as low as Rs 325 per week.