NEW DELHI: The Indian government has significantly ramped up regulatory surveillance and inspections to curb the unauthorised sale and promotion of GLP-1 based weight loss drugs, which are prescription medications carrying serious side effects and meant for supervised use in treating type 2 diabetes and obesity.
Information was available with The Chenab Times indicating that multiple variants of these drugs have recently entered the Indian market, leading to concerns about their on-demand availability through retail pharmacies, online platforms, wholesalers, and wellness clinics. In response, the Central Drugs Standard Control Organisation (CDSCO) has intensified its regulatory oversight, with stricter inspections and surveillance set to continue in the coming weeks. Businesses found violating regulations face license cancellation, fines, and legal action.
GLP-1 drugs, or glucagon-like peptide-1 receptor agonists, are designed to manage type 2 diabetes and obesity by regulating hormonal imbalances. They stimulate insulin release, suppress excess glucagon, and thereby help control blood sugar levels. These medications also slow down gastric emptying, increasing the sensation of fullness and consequently reducing appetite, which aids in weight loss.
The Drug Controller of India has stressed that these drugs can lead to severe side effects if not taken under strict medical supervision. In India, GLP-1 drugs are exclusively prescribed by specialists such as endocrinologists, internal medicine specialists, and cardiologists, and cannot be purchased over the counter. The government statement highlighted that while GLP-1 drugs represent a significant medical advancement, their misuse without clinical oversight can result in severe health complications.
Potential side effects range from common issues like nausea and vomiting to more serious complications including pancreatitis, kidney injury, and bowel obstruction. These risks underscore the critical need for these medications to be administered only under the care of registered medical practitioners or specialists.
The United States Food & Drug Administration first approved a GLP-1 medication in 2005, and several newer formulations have gained popularity recently for treating diabetic and obese patients in India. Available medications include Semaglutide (in injection and tablet forms), Liraglutide, Tirzepatide, Dulaglutide, Exenatide, and Exenatide extended-release. Most are administered via injection pens, though oral forms exist.
To prevent the use of GLP-1 drugs without a prescription and to combat malpractices, the Drug Controller General of India, in conjunction with State Drug Controllers, has initiated several measures. On March 10, a comprehensive advisory was issued to all drug manufacturers, directing them to cease misleading advertisements and any promotional activities that could encourage the non-prescription use of GLP-1 drugs.
In recent weeks, 49 businesses across India, including online pharmacy warehouses, drug wholesalers, retailers, and weight loss clinics, have undergone audits and inspections. These nationwide investigations focused on identifying violations related to unauthorised sales, improper prescription practices, and misleading marketing campaigns. Notices have already been issued to entities found to be in breach of regulatory guidelines.
The Chenab Times News Desk