Centre Cracks Down on GLP-1 Drug Misuse

Inspections conducted across 49 entities including pharmacies, wholesalers, and clinics to detect violations and misleading marketing practices.

The Centre is set to intensify regulatory surveillance against unethical marketing practices and unauthorised sale of semaglutide-based weight loss drugs, with non-compliance leading to penalties and licence cancellations.

The move comes after Indian drugmakers launched more than 15 generic versions of the glucagon-like peptide (GLP-1) agonist within two days of the molecule losing patent protection in the country.

This led to the price of the GLP-1 drug seeing a 50 to 70 per cent drop compared to innovator drugs Ozempic and Wegovy marketed by Danish drugmaker Novo Nordisk.

GLP-1 Drug Price Crash

GLP-1 agonists are a class of medicines that help regulate blood sugar, increase fullness (satiety), and slow stomach emptying.

This leads to weight loss and improved glucose control in patients with Type-II diabetes and obesity.

'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,' the Union health ministry said.

It warned that these drugs, when used without proper medical supervision, may lead to serious adverse effects and related health risks.

DCGI Enforcement Action Intensifies

To counter this, the Drugs Controller General of India (DCGI), in collaboration with state regulators, has scaled up targeted actions and enforcement activities.

The ministry said that audits and inspections have been conducted 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 unauthorised sale, improper prescription practices, and misleading marketing," officials in the know said.

Licence Cancellation Warning Issued

Further, notices have also been sent to defaulting entities.

It added that regulatory surveillance will continue to be intensified in the coming weeks.

And, non-compliances will be dealt with strictly, with actions including cancellation of licences, penalties, and prosecution under applicable laws.

India GLP-1 Market Growth Surge

Being a prescription-based drug, the Central Drugs Standard Control Organisation (CDSCO) has barred all drugmakers having marketing authorisation from selling GLP-1 agonists or from partaking in any promotional activities.

'It is important to reiterate here that the drug has been approved in India with conditions of prescription by endocrinologists and internal medicine specialists and for some indications by cardiologists only,' the health ministry added.

This comes as there were concerns that the introduction of cheap generics can expand prescription powers of general and consulting physicians (GPs and CPs).

With 101 million people living with diabetes and another 136 million in the prediabetic stage, India is fast emerging as a key market for GLP-1 agonist therapies.

The country has the second-highest number of people with Type-II diabetes after China, alongside rising obesity rates, according to World Health Organization (WHO) estimates.

New launches in the injectable GLP-1 segment, including tirzepatide and semaglutide, have driven a 177 per cent rise in sales over the past year on a moving annual turnover basis.

It is from Rs 571 crore in February 2025 to Rs 1,446 crore in February 2026.

Feature Presentation: Ashish Narsale/Rediff