India’s central drug regulator has moved to strengthen oversight of how prescription-only medicines — especially the widely discussed GLP-1 receptor agonists used for obesity and metabolic disorders — are
being marketed and promoted in the country, News18 has learnt.
According to the minutes of the meeting of the Drugs Consultative Committee (DCC), held on March 20 and seen by News18, the expert committee took up the matter after being apprised of an advisory issued by the Central Drugs Standard Control Organisation (CDSCO) against misleading promotion of obesity drugs.
State drug controllers have been put on alert to monitor compliance with approved indications, labelling norms, and ethical marketing practices, with powers to take enforcement action for violations. Separately, the IPC has been tasked with a monthly adverse event review of such drugs for further action.
With key patents around semaglutide, the blockbuster molecule behind drugs like Ozempic and Wegovy, having expired in India last month, Indian pharmaceutical companies have launched more than 50 generic brands, with prices crashing by over 90 per cent.
After deliberation, the expert panel agreed on three specific recommendations.
First, state and Union Territory drug controllers have been asked to “keep a vigil” to ensure that marketing authorisation holders — the companies that hold approvals for these drugs — strictly comply with approved indications, labelling requirements, ethical marketing practices, and applicable risk management plan obligations. The committee specifically flagged that “vulnerable populations” should not be exploited through misleading promotional practices.
Second, states and UTs have been empowered to take effective enforcement action for “significant violations, with intimation to CDSCO.”
Third, the Indian Pharmacopoeia Commission (IPC) has been tasked with compiling a “monthly or bi-monthly review” of adverse events associated with such drugs, for further necessary action.
Why It Matters
GLP-1 receptor agonists such as semaglutide have seen a sharp surge in consumer interest globally and in India, driven in large part by celebrity endorsements, social media promotion, and lifestyle-focused advertising — much of it skirting the boundaries of what is permissible for prescription-only medicines.
Indian regulations prohibit direct-to-consumer advertising of Schedule H and H1 drugs, yet surrogate promotion through wellness content, influencer marketing, and brand partnerships has become increasingly common.
