India cracks down on misuse of weight-loss drugs across supply chain

AS a surge in low-cost generic versions of popular weight-loss drugs widens access in India, the country's top drug regulator has launched a nationwide crackdown on their misuse across the supply chain, conducting audits and sending notices to violators, the government said on Tuesday.

Action, which could include licence cancellation and prosecution, is likely to be stepped up in the coming weeks, it said.

In a statement, the government said the popular drug GLP-1 (glucagon-like peptide-1) had been approved on the condition it would be prescribed only by medical experts to ensure patient safety.

Mint reported earlier about the Drugs Controller General of India (DCGI) stance to ensure that the anti-obesity drug was prescribed by endocrinologists after raids on ‘wellness centers’ had revealed it was being pushed by individuals without any requisite super-specialty qualifications.

The government said enforcement action has been significantly scaled up across online pharmacy warehouses, drug wholesalers, retailers, wellness and slimming clinics in recent weeks. “Audits and inspections were conducted at 49 entities.

These inspections spanned multiple regions across the country and focused on identifying violations related to unauthorised sale, improper prescription practices, and misleading marketing. Notices have also been sent to defaulting entities," the government said, warning that "regulatory surveillance will continue to be intensified in the coming weeks, and non-compliances will be dealt with strict actions, including cancellation of licences, penalties, and prosecution under applicable laws.”

“It is important to reiterate here that the drug has been approved in India with the condition of prescription by endocrinologists and internal medicine specialists and for some indications by cardiologists only," the health and family welfare ministry said in a statement.

"Regulatory surveillance will continue to be intensified in the coming weeks and non-compliance will be dealt with strictly, including cancellation of licences, penalties, and prosecution under applicable laws.”

This comes in the backdrop 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 following its patent expiry in India this month. This has triggered a rush to capture a market that is projected to grow significantly, as India battles a rising obesity epidemic. These launches are expected to lower treatment costs by 50–70%, significantly increasing accessibility.

Following semaglutide’s patent expiry, India’s market features Novo Nordisk (Ozempic, Wegovy), Natco (Semanat), Sun Pharma (Noveltreat, Sematrinity), and Dr. Reddy’s (Obeda). Zydus offers Semaglyn, while Alkem markets Obesema and Glenmark provides GLIPIQ and Lirafit. Other major therapies include Eli Lilly (Mounjaro, Trulicity). These domestic generics offer affordable, accessible options alongside established innovator brands for diabetes and weight management.

Queries sent to Sun Pharma, Dr Reddy’s, Alkem, Torrent, Cipla, Zydus Lifesciences and Glenmark related to the ministry's statement did not get a response until press time.

Established medication

Semaglutide is a well-established medication for type-2 diabetes and weight management, but it carries risks that require expert monitoring. A Lancet study predicts 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 world's second-highest burden of obesity after China.

“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,” the statement said.

“Taking cognizance of the situation, India’s drugs controller, in collaboration with state regulators, has initiated a series of targeted actions.”

With India's semaglutide market projected to reach approximately $347.5 million by 2035, growing at a CAGR of nearly 18% as per the CareEdge report of March, the regulator’s move serves as a critical guardrail to ensure this rapid expansion does not come at the cost of patient safety.

The government said that these drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks. Therefore, the regulator has intensified its surveillance against its unauthorized sale and promotion.

Dr Monika Sharma, a senior endocrinologist at New Delhi-based Aakash Healthcare, said, “It’s a very essential step to ensure the drug gets used by the right patients. Excessive and improper use carries a real risk of complications like gall bladder stones, risk of dehydration and protein malnutrition,” she said.

The crackdown comes after a comprehensive government advisory was put out for the drug manufacturers on 10 March 2026, explicitly prohibiting surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage.