CDSCO Panel Asks Regenix to Submit Additional Trial Data for Insulin Injection Approval
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has deferred its decision on the approval of Insulin Injection Soluble (Neutral) 100 IU/ml (rDNA origin) proposed by Regenix Drugs Ltd., recommending the firm to submit additional documentation before further deliberation.
The proposal, submitted for the manufacture and marketing of the insulin formulation in 10 mL vials, 3 mL cartridges, and 3 mL cartridges in disposable pens, is intended for patients with diabetes mellitus requiring insulin to maintain glucose homeostasis. The application was supported by results from a Phase III clinical trial conducted in India.
At the SEC (Endocrinology and Metabolism) meeting held on April 29, 2025, the committee conducted a detailed review but did not grant approval. Instead, it recommended the firm to submit the following:
1. Complete clinical trial data including breakdown by Type 1 and Type 2 diabetes patients.
2. Rationale for sample size calculation involving both patient types.
3. List of investigators along with details of any concomitant medications used.
4. Information on how hypoglycemia was managed during the study.
The firm is required to submit these documents to CDSCO for further evaluation in a subsequent meeting.
Insulin is a hormone made by the islet cells of the pancreas. Insulin controls the amount of sugar in the blood by moving it into the cells, where it can be used by the body for energy.
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