This approval is subject to the condition that the firm conduct a Phase IV study and that the protocol submission be done within three months of importing and marketing approval.
This came after the firm presented a proposal for the grant of permission to import and market the biphasic insulin aspart injection IP 100 units/mL with the results of a global clinical trial, including study data on Indian patients.
Insulin aspart is a short-acting, manmade version of human insulin. It works by replacing the insulin that is normally produced by the body and by helping move sugar from the blood into other body tissues where it is used for energy. It also stops the liver from producing more sugar.
Short-acting insulin analogues such as aspart, glulisine, and lispro are thought to be better than regular human insulin due to faster absorption and a faster onset of action.
Biphasic human insulins are mixtures of human neutral protamine Hagedorn (NPH) insulin and soluble human (Regular) insulin. The mealtime component of biphasic human insulins, soluble human insulin, has a delayed onset of action and a prolonged duration.
At the recent SEC meeting for Endocrinology and Metabolism held on October 19 and 20, 2022, the expert panel reviewed the proposal presented by drug major Sanofi for the grant of permission to import and market biphasic insulin aspart injection IP 100 units/mL with the results of a global clinical trial, including study data on Indian patients.
After detailed deliberation, the committee recommended the grant of approval to import and market the drug with the condition that the firm should conduct a Phase IV study and that the protocol should be submitted to CDSCO within three months of import and marketing approval.
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