As generic versions enter Indian market, DCGI intensifies regulatory surveillance to prevent unethical sale of weight loss GLP-1 drug
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The Drugs Controller General of India (DCGI) has intensified regulatory surveillance against the unauthorised sale and promotion of weight loss drug semaglutide (GLP-1 class of drug).
The expiry of patent protection Danish drug major Novo Nordisk had on semaglutide on March 20th had seen the launch of multiple generic variants of the drug by domestic pharmaceutical majors in India. The drug companies that have already launched or planning to launch generic brands of semaglutide include Dr Reddy's , Sun Pharma , Zydus , Torrent , Natco , Alkem etc.
The apex drug regulator said the move is meant to ensure ethical pharmaceutical practices in the supply chain of GLP-1 drugs.
“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. Taking cognizance of the situation, India’s 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”, an official statement said.
DCGI's comprehensive advisory
Earlier, on March 10, 2026, DCGI had 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.
As part of scaling up the enforcement activities, the regulators recently carried out audits and inspections 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 unauthorized sale, improper prescription practices, and misleading marketing. Further, notices have also been sent to defaulting entities.
The DCGI said the misuse of weight loss drugs without clinical oversight can lead to severe health complications and advised citizens to use such medications only under the guidance of qualified medical practitioners.
The drug has been approved in India with condition of prescription by Endocrinologists and Internal Medicine Specialist and for some indications by Cardiologists only.
The regulators said regulatory surveillance will continue to be intensified in the coming weeks and non-compliances will be dealt strictly with actions including cancellation of licenses, penalties, and prosecution under applicable laws.