CDSCO Panel Seeks More Clinical Data from Regenix Drugs on rDNA-Based Insulin Injection

New Delhi: The Subject Expert Committee (SEC), functional under the Central Drugs Standard Control Organisation (CDSCO), has asked Regenix Drugs Ltd to furnish additional clinical data before it can grant manufacturing and marketing approval for Insulin Injection, Soluble (Neutral) IP 100 IU/mL (rDNA origin), intended for the treatment of patients with diabetes mellitus requiring insulin for glucose homeostasis.

This came after the firm presented the results of a complete Phase III clinical trial conducted in India for a grant of permission to manufacture and market Insulin Injection Soluble (Neutral) 100 IU/mL (rDNA origin) in India for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

Insulin Injection Soluble (Neutral) 100 IU/mL (rDNA origin) is a short-acting, human-made insulin used to treat Type 1 and Type 2 diabetes. It works by mimicking the natural insulin produced by the body to help control blood sugar levels, especially after meals. This medication is produced using recombinant DNA technology.

At the recent SEC meeting for endocrinology and metabolism, the expert panel reviewed the results of a complete Phase III clinical trial conducted in India for a grant of permission to manufacture and market Insulin Injection Soluble (Neutral) 100 IU/mL (rDNA origin) in India for the treatment of patients with diabetes mellitus who require insulin for the maintenance of glucose homeostasis.

After detailed deliberation, the committee recommended the firm submit the following data:

1. Complete center/clinical trial site-wise raw data of patients included in the trial.

2. Comparative data of concomitant medications used in both arms during the trial.

3. Comparative data of basal insulin dose provided in both arms during the trial.

4. Details of events, including patient details, where the basal insulin dose was changed during the trial.

5. Comparative raw data of age and body weight of patients enrolled in the trial at the beginning of intervention between both arms.

6. Correlation of insulin dose and anti-insulin antibodies for both arms.

7. Bioanalytical method validation for laboratory procedures measuring Anti-Insulin Antibodies, Hb1Ac levels, and fasting and PP Glucose levels during the trial.

Accordingly, the expert panel suggested that the firm should submit the additional data to CDSCO for further evaluation by the committee.