India’s drug regulators are ramping up oversight of rapidly growing weight-loss and diabetes treatments, particularly GLP-1 receptor agonists, as demand increases and cheaper generic versions prepare to enter the market.
The Indian Pharmacopoeia Commission, operating under the Ministry of Health, has been tasked with systematically collecting and analysing adverse event reports associated with these drugs. The move is intended to strengthen post-marketing surveillance and ensure that any safety risks are identified and addressed promptly.
Officials say the initiative is part of a broader regulatory effort to keep pace with the expanding use of these therapies, especially as affordability improves.
With the patent expiry of semaglutide, a key component in widely used weight-loss drugs, lower-cost generics are expected to become available, potentially widening access while increasing the risk of misuse.
Authorities have also stepped up enforcement through the Drug Controller General of India. It recently conducted inspections targeting unauthorised sales and promotions.
In recent weeks, 49 entities nationwide, including online pharmacy warehouses, wholesalers, retailers and weight-loss clinics, were audited.
The inspections focused on identifying violations such as sales without prescriptions, improper prescribing practices and misleading marketing.
Notices have been issued, with warnings that continued non-compliance could lead to licence cancellations, financial penalties and legal action.
The government has reiterated that only qualified specialists are permitted to prescribe these medications. These include endocrinologists, internal medicine experts and cardiologists.
On March 10, manufacturers were also directed to halt misleading advertisements and promotions that could encourage unsupervised use.
How GLP-1 Drugs Work
GLP-1 receptor agonists are used to treat type 2 diabetes and are increasingly prescribed for weight loss. They function by stimulating insulin secretion and reducing appetite through delayed gastric emptying.
Authorities have highlighted risks ranging from nausea and vomiting to more serious complications. These include pancreatitis, kidney injury and bowel obstruction.
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