“The government’s move for heightened vigilance underscores the growing regulatory focus on post-marketing surveillance of this class of drugs,” a senior official told ET. “The government is working to ensure safety issues are identified, documented, and acted on in timely manner.”
As semaglutide lost its patent protection last month, weight-loss drugs based on this compound are expected to become highly popular due to their affordable, generic pricing. As per market research firm PharmaTrac, the semaglutide market is poised for massive expansion with the obesity drug segment projected to grow to ₹8,000 crore by 2030 from approximately ₹1,500 crore.
The IPC has been asked to prepare a monthly or bi-monthly review report of the side effects.
The matter was taken up in the recent Drug Consultative Committee (DCC) meeting which proposed to strengthen regulatory oversight and enforcement against surrogate advertising of prescription-only medicines, with particular focus on GLP-1 receptor agonists and similar drugs indicated for obesity and metabolic disorders a class of medicines that has seen explosive interest in recent times. The deliberations were triggered by an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) dated March 10, 2026, which flagged concerns around the promotion and advertisement of prescription-only medicines in potential violation of the Drugs and Cosmetics Act, 1940 and the Drugs Rules, 1945. The advisory drew attention to practices that may amount to surrogate advertising.
After detailed deliberation, the DCC agreed on a three-pronged enforcement and surveillance strategy including heightened vigilance by the state and UT drug controllers. “They have been directed to keep a close watch to ensure that marketing authorisation holders strictly adhere to approved indications, labelling requirements, ethical marketing practices, and applicable risk management plan (RMP) obligations,” another official said. The DCC specifically emphasised and stressed that vulnerable populations must not be exploited through misleading or manipulative promotional practices. The states have been authorised to take effective enforcement action for significant violations within their jurisdictions, with the requirement that all such actions are intimated to CDSCO. Similarly, the Indian Pharmacopoeia Commission (IPC) has been tasked with compiling monthly or bi-monthly reviews of adverse events associated with GLP-1 and similar drugs, with an aim to strengthen post-market surveillance.
As GLP-1 drugs grow in popularity, the government’s concern is that people may seek them out without proper medical guidance.
