CDSCO expert committee: Virchow liraglutide and Roche petrelintide trials

The meeting

The Subject Expert Committee (SEC) for Endocrinology & Metabolism held its 22nd/26 meeting on 23.09.2026 at CDSCO HQ, New Delhi. Its recommendations were published on 2026-10-19. This report covers four entries: three phase III trial protocols for petrelintide and one proposal for liraglutide injection.

What the committee recommended

Petrelintide (protocol no. CC46368)

M/s. Roche Products (India) Private Limited presented phase III clinical trial protocol no. CC46368, version no. 1.0 dated 27 May 2026. After detailed deliberation, the committee recommended grant of permission to conduct the trial as presented by the firm. No extra condition was listed.

Petrelintide (protocol no. CC46369)

The same firm presented phase III clinical trial protocol no. CC46369, version no. 1.0 dated 27 May 2026. The committee recommended grant of permission to conduct the trial as presented, with two conditions. First, a fundus examination should be done at the screening stage for all subjects. The results must not be older than one month for subjects being screened and planned for enrolment. Second, standard procedures and guidelines should be defined across all sites to manage subjects who have a hypoglycaemia episode during the trial.

Petrelintide (protocol no. CC46446)

M/s. Roche Products (India) Private Limited also presented phase III clinical trial protocol no. CC46446, version no. 2 dated 06 July 2026. The committee recommended grant of permission to conduct the trial as presented, with the same two conditions: a fundus examination at screening, with results not older than one month, and standard hypoglycaemia management procedures across all sites.

Liraglutide Injection (r-DNA origin) 6 mg/mL (3 mL cartridge)

M/s. Virchow Biotech Private Limited proposed permission to manufacture and market this product. The proposal was based on a Phase III clinical trial (Protocol Number: VBLG01/2024-CT1, Report No. 01/ VBLG01/2026-CT1). The firm conducted the trial to compare efficacy, safety and immunogenicity of VBLG01 with Victoza in adults with type 2 diabetes mellitus. The committee recommended grant of permission to manufacture and market for the indication "as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus". This is subject to conduct of a Phase IV study.

What it means for practice

A recommended trial permission means the drug is expected to be studied in India under the protocol the firm presented. For CC46369 and CC46446, trial sites would need to follow the two conditions on fundus examination and hypoglycaemia management.

For liraglutide, the committee's wording limits the recommended indication to improving glycaemic control in adults with type 2 diabetes, as an adjunct to diet and exercise. The Phase IV study is a condition attached to the recommendation.

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.