However, this approval is subject to the condition that the drug should be sold by retail under the prescription of an Endocrinologist or internal medicine specialist only and the firm should conduct a Phase-IV clinical trial for which the firm should submit Phase IV clinical trial protocol within 3 months of approval of the drug for review by the committee.
This came after the firm presented the proposal for a grant of permission for the import and marketing of Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg per 0.5ml solution for injection in a single-dose prefilled pen along with a global Phase-III clinical trial the report in which India is one of the participating countries.
Both glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 are peptide hormones involved in glucose homeostasis: they promote glucose-stimulated insulin secretion from the pancreatic beta-cells.
Tirzepatide binds to GIP and GLP-1R with high affinity. In vitro, tirzepatide has a comparable GIP receptor binding affinity to native GIP and five times lower GLP-1R affinity than native GLP-1.
At the recent SEC meeting for Endocrinology and Metabolism held on the 20th and 21st of April 2023, the expert panel reviewed the proposal presented by drug major Eli Lilly for the grant of permission for importing and marketing of the Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg per 0.5ml solution for injection in a single-dose prefilled pen along with a global Phase-III clinical trial a report in which India is one of the participating countries.
The committee noted that Tirzepatide is approved in the USA, European Union, Australia, Japan, Switzerland, Canada, UAE, Kuwait, Qatar, Saudi Arabia, and the United Kingdom.
After detailed deliberation, the committee recommended for grant of permission to import and market the drug Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg per 0.5ml solution for injection in a single dose prefilled pen subject to following conditions:
1. The drug should be sold by retail under the prescription of an Endocrinologist or internal medicine specialist only.
2. The firm should conduct a Phase-IV clinical trial for which the firm should submit Phase-IV clinical trial protocol within 3 months of approval of the drug for review by the committee.