CDSCO expert committee: trial permission recommended for oral semaglutide, 3 more

The meeting

The Subject Expert Committee (SEC) for Endocrinology & Metabolism held its 23rd/26 meeting on 07.10.2026 at CDSCO HQ, New Delhi. CDSCO published the recommendations on 2026-10-23. Three of the four entries below came back to the committee after an earlier SEC recommendation. In each of those, the firm presented a revised protocol or the information the committee had asked for.

What the committee recommended

LY3502970

The company is Eli Lilly and Company India Pvt. Ltd. The firm presented phase III clinical study protocol no. J2A-MC-GZGY amendment a dated 08 May 2026. It also gave the justification and information requested by the SEC after its earlier recommendation dated 16.07.2026. After detailed deliberation, the committee recommended grant of permission to conduct the trial as presented by the firm.

Insulin Degludec (r-DNA origin) injection 100 IU/mL

The company is Lupin Limited. The product is a 3 mL cartridge and pre filled pen. At an earlier meeting, dated 06.08.2026, the firm had presented phase I (PK/PD study) results and a Phase III protocol. This time it presented revised protocol no. ECTS/24/010 Version No.: 01, dated 26 AUG 2026, with the changes the SEC had recommended. The committee recommended grant of permission to conduct the clinical trial as per this revised protocol.

Insulin Degludec and Insulin Aspart (70/30) Injection 100 Units/mL

The company is Alkem Laboratories Ltd. After the earlier SEC recommendation dated 25.08.2026, the firm presented revised protocol no. AR262-25, Version No. 02, Amendment No. 01 dated 23.09.2026. The committee recommended grant of permission to conduct the clinical trial as per the revised protocol. One condition applies: a commercially available IVD ELISA Kit duly approved by CDSCO may be used for C-Peptide estimation.

Semaglutide Tablets

The company is Dr. Reddy's Laboratories Limited. The proposal covers Semaglutide Tablets 1.5 mg, 4 mg and 9 mg (r-DNA origin). The study is a multicentric, prospective, randomized, double-blind, active-controlled, parallel group Phase I/III clinical trial. It would compare the firm's oral semaglutide with RYBELSUS® of Novo Nordisk in adults with inadequately controlled type 2 diabetes mellitus. The protocol ID is IND-NDA38-SEM/2025, Version 4.0; 02-Sep-2026. The committee recommended grant of permission to conduct the clinical trial as per the protocol presented by the firm.

What it means for practice

These entries concern clinical trials, not products for prescribing. If permission is granted, each drug will be studied in India under the protocol the committee reviewed. The Dr. Reddy's trial is set in adults with type 2 diabetes and uses RYBELSUS® as the comparator. For the Alkem insulin trial, the C-Peptide condition applies to the kit used for testing. No change in current prescribing follows from these recommendations.

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.