For the first time, Indians will soon have access to injectable weight loss drugs, Mounjaro and Zepbound, following approval from the Drug Controller General of India (DCGI). These drugs, which have shown promise in reducing body weight by up to 18%, are expected to offer new hope to those battling diabetes and obesity.
Access to Tirzepatide
The Indian drug regulator’s subject expert committee has recommended the import and marketing of Tirzepatide, sold under the brand names Mounjaro and Zepbound in the US by Eli Lilly. Final approval from the DCGI is pending but anticipated soon. This decision marks a significant development, as the injectable versions of these drugs will be available in India for the first time, contrasting with the existing availability of oral Semaglutide by Novo Nordisk, which is limited to diabetes management and not approved for weight loss.
Mounjaro is primarily aimed at diabetes management, while Zepbound focuses on weight loss. Both drugs will be offered in pre-filled pens for subcutaneous injection. In a statement to The Indian Express, Eli Lilly confirmed, “Eli Lilly has received marketing authorization for Type 2 diabetes indication for Tirzepatide in India. Application for obesity indication is undergoing review by CDSCO. Launch timelines for India have not been confirmed yet.”
Clinical Approval and Trials
The committee has approved the import of single-dose vials and pre-filled pens in six different doses, ranging from 2.5 mg to 12.5 mg. This recommendation is based on two global clinical trials, including significant participation from Indian subjects. In one trial involving adults without type 2 diabetes, participants on the highest dose of Tirzepatide lost an average of 18% of their body weight over 72 weeks. In another trial among those with diabetes, the average weight loss was 12%.
Comparative Advantage of Tirzepatide
Tirzepatide has a unique edge over Semaglutide, as it mimics both the GLP-1 and GIP hormones. GLP-1 receptor agonists like Semaglutide lower serum glucose levels, but Tirzepatide also stimulates insulin production and promotes feelings of fullness, enhancing its weight loss efficacy.
Ensuring Safety and Efficacy
Eli Lilly has been instructed to submit a protocol for a phase IV trial within three months. This trial will monitor the long-term effects of the drug on patients. According to the committee, approval criteria included the design and results of the trials, the inclusion of Indian participants, and whether the drug’s impact on the Indian population mirrored global results. A committee member, speaking anonymously, noted, “The approval is based purely on objective criteria, including whether the trial shows the promised results and whether there are enough participants from India.”
Patient Selection and Usage
Doctors are advised to carefully select patients for these drugs, avoiding those with a history of pancreatic diseases, endocrine disorders, nausea, and vomiting. Lifestyle modifications, such as diet and exercise, should precede drug prescription. “These drugs should be prescribed only when patients can maintain or reduce their weight through lifestyle changes,” the expert said.
Effectiveness and Long-term Considerations
Dr. V Mohan, chairman of Dr. V Mohan’s Diabetes Specialities Centre in Chennai, emphasized the importance of lifestyle changes alongside medication. “These drugs may help knock off the weight initially, but to sustain the weight loss, you will still need a diet, exercise, and sleep discipline,” he said. He also cautioned that fats tend to return once drug use is discontinued, underscoring the need for ongoing lifestyle management.
In conclusion, the approval of Mounjaro and Zepbound in India could be a game-changer for many battling weight issues, providing new medical tools to aid in their journey towards better health.
