What are GLP-1 Drugs?

India’s apex drug regulator, the Central Drugs Standard Control Organization (CDSCO), has issued an advisory stating that the GLP-1 drug semaglutide must be sold only on the prescription of a registered medical practitioner, ahead of the expected launch of its generic versions in the Indian market.

Semaglutide was first approved for the treatment of Type 2 Diabetes by the U.S. Food and Drug Administration (FDA) in 2017. The drug later gained widespread popularity due to its off-label use for weight loss. A higher-dose formulation was officially approved by the FDA in 2021 for treating Obesity.

The drug and its successor Tirzepatide, developed by Eli Lilly and Company, entered the Indian market last year.

US FDA Warning to Novo Nordisk

In a related development, the U.S. FDA has issued a warning letter to Novo Nordisk over failures in reporting suspected adverse side effects associated with the GLP-1 drugs Ozempic and Wegovy.

What are GLP-1 Drugs?

Glucagon-like peptide-1 (GLP-1) is a hormone produced in the gut that:

• Stimulates insulin release
• Reduces glucagon levels
• Increases feelings of fullness

GLP-1 receptor agonists mimic this hormone and are used primarily to manage type 2 diabetes. Besides regulating blood sugar, these drugs have been shown to produce significant weight loss in individuals with obesity and are being studied for potential benefits in cardiovascular disease and substance use disorders.