India has a multi-step approval process for new pharmaceuticals in order to guarantee their safety and effectiveness. A noteworthy development is the recent recommendation for Eli Lilly’s Mounjaro (tirzepatide). The import and sale of this medication for diabetes and obesity should be permitted, according to a panel of experts appointed by the Indian government. This decision will have a significant impact on the nation’s public health.Mounjaro, sometimes referred to as tirzepatide chemically, is a member of the GLP-1 receptor agonist therapeutic class. These medications were first created to help people with type 2 diabetes manage their blood sugar levels. GLP-1 receptor agonists, which include tirzepatide and other medications like Wegovy and Ozempic from Novo Nordisk, function by imitating the GLP-1 hormone, which improves blood sugar regulation by stimulating insulin production and inhibiting glucagon release.
These medications not only lower blood sugar levels but also significantly affect weight reduction. They lessen overall food consumption by slowing down digestion, which helps patients feel fuller for longer. Because they help with both blood sugar regulation and weight loss, GLP-1 receptor agonists are a well-liked option for treating obesity and diabetes.
An essential step in the approval procedure for drugs is the recommendation made by the Subject Expert Committee. The Central Drugs Standard Control Organization (CDSCO), India’s drug regulator, receives advice from this panel about medication approval and clinical trial design. The June 19 notification stated that the committee’s recommendation was to approve the import and marketing of tirzepatide for the treatment of chronic weight control, provided Eli Lilly completed a Phase 4 clinical trial first. Post-marketing surveillance, or phase 4 trials, are crucial for tracking a drug’s long-term effects after it is made available to the general population.
Given that type 2 diabetes and obesity are prevalent in India, the prospective approval of Mounjaro is very noteworthy. As per the World Obesity Federation Atlas, by 2035, 11% of adult Indians are expected to be obese. Additionally, type 2 diabetes cases are second highest in India among all countries in the world. The availability of Mounjaro may be a potent tool for managing these conditions, enhancing many people’s quality of life.
The expert panel’s decision is a significant step in the right direction, but before Mounjaro can be sold in India, a number of regulatory obstacles must be overcome. Lilly is required to provide the regulatory bodies with the necessary manufacturing and control data. To guarantee that the medication can be produced reliably and securely, this data is essential.
SOURCE:
THE PRINT
