Drug regulator tightens checks on GLP-1 supply chain amid misuse concerns

India's drug regulator on Tuesday said it has stepped up surveillance of the supply chain for GLP-1-based weight loss drugs, as the entry of multiple generic versions raises concerns over unauthorised sales and misuse across retail and online channels.

The move comes days after semaglutide and other GLP-1 therapies went off-patent in India, triggering a wave of launches and wider availability of the drugs, which are used for diabetes and increasingly for weight management. Multiple domestic companies have launched lower-cost versions in recent days, significantly expanding availability across markets.

The Drugs Controller General of India (DCGI), in coordination with state regulators, has initiated targeted enforcement actions across the pharmaceutical distribution network, including online pharmacies, wholesalers, retailers and wellness clinics, the government said in a statement.

Inspections have been carried out at 49 entities, including online pharmacy warehouses, drug wholesalers, retailers and 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. Notices have also been sent to defaulting entities.

The regulator has also issued an advisory to manufacturers prohibiting surrogate advertisements and any indirect promotion that could mislead consumers or encourage off-label usage.

The intensified oversight comes amid concerns that the drugs are being made available on demand through retail pharmacies, online platforms, wholesalers and wellness clinics, often without adequate medical supervision. GLP-1 drugs are classified as prescription medicines in India and are not meant for over-the-counter sale.

The regulator emphasised that patient safety remains paramount, warning that misuse of weight loss drugs without clinical oversight can lead to serious adverse effects and related health risks. Citizens have been advised to use such medications only under the guidance of qualified medical practitioners.

Demand for these therapies has been rising, particularly in urban markets, driven by their use in both diabetes and weight management. Health experts say that while lower-cost versions may improve access, the therapies are not without limitations.

"These medications suppress appetite and delay the rate at which food leaves the stomach, which leads people to consume less food. However, they do not address the underlying drivers of weight gain," said Dr Vanita Rahman, internal medicine physician at the Physicians Committee for Responsible Medicine (PCRM).

She added that side effects such as nausea, vomiting, bloating and abdominal discomfort are common, and that many patients discontinue therapy within a year due to side effects, cost or limited efficacy.

The regulator reiterated that the drug has been approved in India with the condition of prescription by endocrinologists and internal medicine specialists, and for some indications by cardiologists only.

Regulatory surveillance will continue to be intensified in the coming weeks, and non-compliances will be dealt with strictly, including cancellation of licences, penalties and prosecution under applicable laws.

The development comes at a time when the GLP-1 segment is expanding rapidly following patent expiries, increasing availability even as regulators move to ensure that wider access does not translate into misuse.