PTI
New Delhi
The GLP-1 based weight loss drugs are prescription medications used to treat type 2 diabetes and obesity but carry serious side effects and must only be taken under the supervision of a qualified medical specialist, the government said on Wednesday.
Highlighting that multiple variants of GLP-1 drugs have been recently introduced in the Indian market, and concerns have emerged regarding their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics, the government said the CDSCO has intensified its regulatory surveillance against its unauthorised sale and promotion and warned stricter inspections and surveillance will continue in the coming weeks.
“Businesses that break the rules will face license cancellation, fines, and legal action,” it said.
The GLP-1 drugs (glucagon-like peptide-1 receptor agonists) are developed to treat both type 2 diabetes and obesity by correcting hormonal imbalance – stimulating insulin release and suppressing excess glucagon -to bring blood sugar back under control.
The drugs regulate blood sugar and appetite and are also used to treat obesity. Essentially, they slow down the gastric emptying, increasing the feeling of fullness. This decreases patients’ appetites and thereby leads to their weight loss, an official statement said.
To prevent unauthorised sale, unsupervised use, and other malpractices, the Drug Controller of India has intensified its regulatory surveillance, warning that the drugs can lead to serious side effects if not taken under strict medical supervision, it said. In India, GLP-1 drugs can only be prescribed by endocrinologists, internal medicine specialists, and cardiologists-they cannot be purchased over the counter, it underlined.
The drugs carry a wide range of side effects – from common symptoms like nausea and vomiting to severe complications including pancreatitis, kidney injury, and bowel obstruction.
These risks make it essential that GLP-1 drugs are only taken under the supervision of registered medical practitioner/specialists.
While the first GLP-1 medication was approved by the United States’ Food & Drug Administration in 2005, many new ones have recently become very popular in treating diabetic and obese patients.
Some GLP-1 medications available in the market currently are Semaglutide injection, Semaglutide tablets, Liraglutide, Tirzepatide, Dulaglutide, Exenatide, Exenatide extended Release.
Most of these medications are administered via pre-filled injection pens, although some (like oral semaglutide) are available in tablet form, the statement said.
To ensure that people do not take GLP-1 drugs without medical prescription and to curb malpractices, Drug Controller General of India, in collaboration with State Drug Controllers have taken several actions.