CDSCO expert committee: no Phase III waiver for Alkem semaglutide

The meeting

The Subject Expert Committee (SEC) for Endocrinology & Metabolism held its 21st/26 meeting on 17.09.2026 at CDSCO HQ, New Delhi. The recommendations were published on 2026-09-29. The committee considered proposals from several CDSCO divisions. This report covers four of them: two phase III trial protocols, one Package Insert update and one request for a clinical trial waiver.

What the committee recommended

Survodutide

M/s. IQVIA RDS (India) Private Limited presented phase III clinical study protocol no.1404-0115 version no. 3.0 dated 26 June 2026. After detailed deliberation, the committee recommended grant of permission to conduct the trial as presented by the firm.

LY3298176 + LY3841136

Eli Lilly and Company India Pvt. Ltd. presented phase III clinical study protocol no. J7C-MC-YQAA amendment b dated 16 June 2026. After detailed deliberation, the committee recommended grant of permission to conduct the trial as presented by the firm.

Soliqua® SoloStar® (Fixed Ratio Combination of Insulin Glargine and Lixisenatide 100U + 50mcg/33mcg)

M/s. Sanofi Healthcare India Private Limited proposed an update to the Package Insert based on CCDS version v8 dated 04th December 2025. The update covers posology and method of administration, undesirable effects and clinical efficacy. The committee recommended approval of the proposed updates to the Package Insert. One condition applies. The Package Insert should clearly include the maximum dose of premixed insulin used or allowed in the clinical study, and the corresponding dose-conversion instructions to Soliqua® SoloStar®. The firm shall submit the revised package insert to CDSCO for further evaluation.

Semaglutide solution for injection

M/s. Alkem Laboratories Limited asked for a Phase III clinical trial waiver for an additional indication. The indication is to reduce the risk of major adverse cardiovascular (CV) events (CV death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established CV disease and either obesity or overweight, together with a reduced calorie diet and increased physical activity. The firm stated that the reference semaglutide injection of r-DNA/biological origin has had this indication in India since 25.02.2025. The committee noted that the proposed product is of synthetic origin. It also noted that the firm did not present any clinical data supporting the efficacy of its product in this indication. The committee did not recommend the Phase III clinical trial waiver.

What it means for practice

• For survodutide and LY3298176 + LY3841136, the committee recommended grant of permission to conduct the phase III trials as presented by the firms. The source gives no trial results for either.
• For Soliqua® SoloStar®, the committee recommended approval of the proposed updates. The revised Package Insert still has to be submitted to CDSCO. It should include the maximum dose of premixed insulin and the dose-conversion instructions.
• For Alkem's semaglutide, the committee did not recommend the Phase III trial waiver for the cardiovascular risk indication. The reasons recorded are that the product is of synthetic origin and that the firm presented no clinical data supporting efficacy in this indication.

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.