An expert committee of India’s drug regulator (CDSCO, under DCGI) has given initial approval for the weight-loss drug tirzepatide. After final regulatory review, US-based Eli Lilly may introduce the drug to the Indian market.
The Development of Various Weight Loss Drugs
The development of weight loss drugs has significantly advanced obesity treatment, especially in the US and Europe. The US Food and Drug Administration (FDA) has approved Wegovy (semaglutide) and Zepbound (tirzepatide) for chronic weight management in adults.
Eligibility for Prescription
Obese individuals: BMI over 30
Overweight individuals: BMI between 27 and 30 with at least one other weight-related health condition (e.g., high blood pressure, high cholesterol, type 2 diabetes)
About Semaglutide and Tirzepatide Drugs
Administration: Both drugs are administered as subcutaneous injections.
Mechanism: These polypeptides increase levels of naturally occurring hormones, such as glucagon-like peptide 1 (GLP-1).
Effect: GLP-1 triggers a sensation of satiety (feeling full) in the brain, and these drugs also help manage glucose levels, aiding in
diabetes treatment.
Differences Between Semaglutide and Tirzepatide:
Semaglutide: Targets only GLP-1 receptors.
Tirzepatide (Zepbound): Boosts both GLP-1 and glucose-dependent insulinotropic polypeptide (GIP), enhancing each other’s
effects for better weight regulation.
Global Trials and Approval in India
Global trials, including participation from Indians, have shown promising results for Zepbound. The CDSCO has granted
regulatory clearance for the drug in India with the condition of conducting a phase IV (post-marketing surveillance) trial to
monitor side effects.
Side Effects and Limitations of Zepbound
Common Side Effects: Nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, injection-site reactions, fatigue,
allergic reactions, belching, hair loss, heartburn.
Serious Risks: Includes potential thyroid tumors and thyroid cancer.
Usage: Not for cosmetic weight loss; intended for chronic use due to the progressive nature of obesity.
Conclusion
Tirzepatide’s approval marks a significant development in India’s efforts to address obesity and related health conditions. With
the ongoing scrutiny through post-marketing surveillance, the drug could offer a new avenue for effective weight management
and diabetes treatment in India.