New Delhi: As a surge in cheap generic versions of popular weight loss drugs widens access in India, the country’s top drug regulator has launched a nationwide crackdown on their abuse across the supply chain, conducting audits and issuing notices to violators, the government said on Tuesday. The measures, which could include license cancellations and criminal prosecutions, are likely to be stepped up in the coming weeks.
In a statement, the government said the popular drug GLP-1 (glucagon-like peptide-1) was approved on the condition that it be prescribed only by medical professionals to ensure patent safety. Mint have previously reported on the move by the Drugs Controller General of India (DCGI) to ensure that the anti-obesity drug is prescribed by endocrinologists after raids on ‘wellness centres’ revealed that it was being pushed by individuals without any of the required super-specialty qualifications.
The government said enforcement measures had been significantly expanded in recent weeks at online pharmacy warehouses, drug wholesalers, retailers, wellness and weight loss clinics. “Audits and inspections were carried out at 49 entities. These inspections covered multiple regions across the country and focused on identifying violations related to unauthorized sales, improper prescribing practices and misleading marketing. Notices were also sent to non-compliant entities,” the government said, warning that “regulatory oversight will continue to be intensified in the coming weeks and non-compliance with licenses, prosecutions, prosecution under applicable laws.”
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“It is important to reiterate here that the drug has been approved in India under the condition that it be prescribed by endocrinologists and internal medicine specialists and, for some indications, by cardiologists only,” the Ministry of Health and Family Welfare said in a statement. “Regulatory oversight will continue to be intensified in the coming weeks and non-compliance will be dealt with strictly through measures including license revocation, penalties and prosecution under applicable laws.”
This comes on the back of several domestic pharmaceutical companies, including Sun Pharma, Dr Reddy’s, Alkem, Torrent, Cipla, Zydus Lifesciences and Glenmark, launching generic versions of GLP-1 drug semaglutide after its patent expired in India this month. This has triggered a rush to capture the market, which is expected to grow significantly as India battles a growing obesity epidemic. These launches are expected to reduce treatment costs by 50-70%, thereby significantly increasing availability.
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Following the expiry of the semaglutide patent, Novo Nordisk (Ozempic, Wegovy), Natco (Semanat), Sun Pharma (Noveltreat, Sematrinity) and Dr. Reddy’s (Lunch). Zydus offers Semaglyn, while Alkem sells Obesema and Glenmark offers GLIPIQ and Lirafit. Other notable therapies include Eli Lilly (Mounjaro, Trulicity). These domestic generics offer affordable and accessible options alongside established diabetes and weight management innovator brands.
Inquiries sent to Sun Pharma, Dr. Reddy’s, Alkem, Torrent, Cipla, Zydus Lifesciences and Glenmark related to the ministry’s statement had not received a response till press time.
Established medications
Semaglutide is a well-established drug for type 2 diabetes and weight management, but it carries risks that require professional monitoring. AND Lancet the study predicts that the number of overweight and obese adults in the country will rise from 180 million in 2021 to 449 million by 2050. This trajectory would make India the country with the second highest obesity burden in the world after China.
“With the recent launch of more generic variants of GLP-1-based slimming drugs in the Indian market, there have been concerns about their availability on demand through retail pharmacies, online platforms, wholesalers and wellness clinics,” it said. “Taking cognizance of the situation, the Drug Controller of India in collaboration with state regulatory authorities has initiated a series of targeted actions.”
With India’s semaglutide market expected to reach approximately $347.5 million by 2035, growing at a CAGR of nearly 18%, according to a March CareEdge report, the regulator’s move serves as a critical barrier to ensure that this rapid expansion does not come at the expense of patient safety.
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The government said these drugs, if taken without proper medical supervision, can lead to serious adverse effects and associated health risks. The regulator has therefore intensified the supervision of its unauthorized sale and promotion.
Dr. Monika Sharma, senior endocrinologist at New Delhi-based Aakash Healthcare, said: “This is a very crucial step to ensure that the right patients are taking the drug. Overuse and misuse carry a real risk of complications such as gallstones, risk of dehydration and protein malnutrition,” she said.
The crackdown comes after comprehensive government advice to drugmakers was issued on March 10, 2026, which specifically bans substitute advertising and any form of indirect promotion that could mislead consumers or encourage off-label use.
