CDSCO expert committee: Phase III trial of degludec/aspart mix recommended

The meeting

The SEC (Endocrinology & Metabolism) of CDSCO held its 24th/26 meeting on 22.10.2026 at CDSCO HQ, New Delhi. The recommendations were published on 2026-10-29. Each numbered entry in the record is a separate proposal from a company, followed by the committee's recommendation. This report covers one entry: a premixed insulin from M/s. G.C. Chemie Pharmie Ltd.

What the committee recommended

Insulin degludec and insulin aspart injection 100 units/ml (Insulin Degludec 70% and Insulin Aspart 30% Injection)

M/s. G.C. Chemie Pharmie Ltd. presented two items. The first was the Phase I Clinical Study Report (Study No.: AR136-24). This was a double blind, randomized, two-treatment, two-sequence, two-period, single dose, crossover, pharmacokinetic and pharmacodynamic bioequivalence study. It compared the company's product with Ryzodeg (Insulin degludec/Insulin aspart) 100 units/mL of Novo Nordisk A/S. The study was done in healthy, adult, human male subjects, using the euglycemic clamp technique under fasting conditions.

The second item was a proposal to conduct a Phase III clinical trial (Protocol Number: CT26-002, Version 1.0). The trial is described as prospective, multi-center, randomized, open-label, parallel group and active-controlled. It will evaluate efficacy, safety and immunogenicity in adult participants with Type II Diabetes Mellitus. The reference drug is Ryzodeg100 units/ml (Insulin degludec 70% /Insulin aspart Injection 30%) of Novo Nordisk India Private Limited.

After detailed deliberation, the committee noted the results of the Phase I clinical study. It also recommended grant of permission to conduct the proposed Phase III clinical trial as per the presented protocol.

What it means for practice

This is a recommendation about a clinical trial, not about marketing. The committee recommended grant of permission to conduct a Phase III trial of the G.C. Chemie Pharmie product in adults with Type II Diabetes Mellitus, with Ryzodeg100 units/ml (Novo Nordisk India Private Limited) as the reference drug.

The source gives no Phase I or Phase III results. It says only that the committee noted the Phase I results. The Phase III trial is designed to look at efficacy, safety and immunogenicity, and those findings are not yet available.

About these updates: the Subject Expert Committee advises the Drugs Controller General of India (DCGI). Its recommendations are not final approvals; the final decision rests with the DCGI.