New Delhi: India’s drug regulator has audited 49 entities—including online pharmacy warehouses, wholesalers, retailers, and clinics—and issued notices for violations related to unauthorised sale, improper prescription practices, and misleading marketing of GLP-1 anti-obesity drugs.
The Union Health Ministry said Tuesday that the Drugs Controller General of India (DCGI), acting alongside state regulators, scaled up surveillance after multiple generic versions of GLP-1 (glucagon-like peptide-1) drugs entered the domestic market.
GLP-1 drugs mimic a natural gut hormone to regulate blood sugar, and suppress appetite, making them effective for both diabetes management and weight loss. The class has surged in global popularity, with brands such as Ozempic and Wegovy, developed by Denmark-based Novo Nordisk, and Mounjaro, developed by US-based Eli Lilly and Company, driving demand.
The enforcement push follows the patent expiry of semaglutide—the active ingredient in Ozempic and Wegovy—in India, which set off a rush of cheaper generics. Dr. Reddy’s Laboratories, Sun Pharmaceutical Industries, and Glenmark Pharmaceuticals have all launched semaglutide generics at prices ranging from roughly Rs 1,200 to Rs 4,200 per month.
While the price drop has widened access, it has exposed regulatory gaps—particularly in digital pharmacies and informal wellness clinics where oversight is harder to enforce.
The ministry said the 49 audits had identified violations including unauthorised sale, improper prescription practices, and misleading marketing. It did not specify how many entities were found flouting the norms.
“Notices have also been sent to defaulting entities,” it said, warning that non-compliance would invite “strict action including cancellation of licences, penalties, and prosecution under applicable laws”.
Surveillance, it added, would continue to be intensified in the coming weeks.
The crackdown on sales is matched by a clampdown on promotion. On 10 March, the ministry issued an advisory that “explicitly prohibit[s] surrogate advertisements and any form of indirect promotion that could mislead consumers or encourage off-label usage” of GLP-1 drugs. It cautioned pharmaceutical companies against marketing these prescription medicines through print, television, digital platforms, or influencer channels, and flagged that so-called “disease awareness” campaigns or celebrity endorsements that create brand recall could also be treated as indirect promotion and attract regulatory action.
Judicial pressure has added urgency to the enforcement effort.
A petition filed in the Delhi High Court raised concerns about gaps in approval processes and the growing off-label use of GLP-1 drugs for weight loss.
In July last year, a HC bench of Chief Justice D.K. Upadhyaya and Justice Tushar Rao Gedela directed the Central Drugs Standard Control Organisation (CDSCO) to examine the safety and licensing of these medicines within three months. On 17 March, the court issued notices to the Centre, the DCGI, and the CDSCO on a contempt plea, alleging inaction on those directions. The matter is now listed for hearing in May.
Chetali Rao, a senior scientific and legal researcher with the non-profit Third World Network, said the crackdown needed to be consistent. “Enforcement should go beyond sporadic or episodic crackdowns and address the larger systemic issues–particularly aggressive marketing practices, weak prescription oversight and increased commercialisation of drugs being used for lifestyle purposes instead of medically defined needs,” she said.
Rao called for stronger accountability across the supply chain, with stricter monitoring of prescribing practices by doctors and dispensing practices by pharmacists, to ensure the medicines are used only where clinically appropriate. “Without stronger safeguards, there is a risk that these drugs are diverted away from patients who need them for diabetes, towards profit-driven weight loss markets. There is also a need that enforcement in the GLP-1 space applies equally to originator and generic companies,” she said.
The ministry stressed that GLP-1 drugs in India are approved only for prescription by endocrinologists and internal medicine specialists, and by cardiologists for certain indications. “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,” it had said.
(Edited by Prerna Madan)