U.S. firm Eli Lilly unveils drug for obesity, diabetes

Sub: Sci

Sec: Health

Context:

American pharmaceutical giant Eli Lilly and Company introduced Mounjaro (tirzepatide) in India after receiving marketing authorization from the Central Drugs Standard Control Organisation (CDSCO).
India has around 101 million people with diabetes. The growing demand for GLP-1 class drugs in India, driven by diabetes and obesity management, is creating a multi-billion-dollar market, with semaglutide set to go off-patent in 2026 and Novo Nordisk’s Rybelsus holding a dominant 65% share.

About Mounjaro:

Mounjaro is a drug designed for the management of obesity, overweight, and Type 2 diabetes.
In controlled clinical trials, adults using Mounjaro alongside diet and exercise experienced significant weight loss.

Mechanism of Action:

Mounjaro activates two important hormone receptors in the body:
- GIP (Glucose-dependent Insulinotropic Polypeptide)
- GLP-1 (Glucagon-like Peptide-1)
These hormones play a crucial role in regulating blood sugar levels and controlling appetite, making Mounjaro an effective treatment for both diabetes and obesity.

Central Drugs Standard Control Organisation (CDSCO):

CDSCO is the national regulatory authority for pharmaceuticals and medical devices in India.
CDSCO was established in 1966 and is headquartered in New Delhi.
The Drugs Controller General of India (DCGI)heads CDSCO.
It operates under the Directorate General of Health Services, Ministry of Health and Family Welfare.

Major functions of CDSCO:

Responsible for ensuring the safety, efficacy, and quality of drugs and medical devices under the provisions of Drugs and Cosmetics Act, 1940.
Responsible for the approval of vaccinesand managing the regulatory framework for the medical devices sector.
Approves new drugs and clinical trials.
Works with state drug regulators and other health authorities to ensure compliance with regulations.
Controls the quality of imported drugs in the country.