Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services

Is Dulaglutide legal in India?

ApprovedApproved in India (Eli Lilly) for type 2 diabetes; the expert committee backed adding an age-10-and-over indication in 2024

The regulator has approved it as a medicine.

CDSCO expert-committee minutes from April 2017 describe dulaglutide as an old drug marketed in India, and Lilly's marketing authorisation carried a post-marketing study condition. In December 2020 the committee recommended approval of a new indication already approved by the US FDA, and in May 2024 it recommended adding treatment of type 2 diabetes in patients aged 10 years and older. In July 2026, reviewing a children's trial of another drug, the committee described dulaglutide as a comparator 'not approved in India' for that paediatric population, so whether the paediatric indication was finally granted is not confirmed.

Last verified 2026-09-29 · how we verify

Dulaglutide elsewhere

Sources (5)

  1. 01SEC Metabolism and Endocrinology: 25.04.2017Central Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2017-04-25 · accessed 2026-09-29
  2. 02Recommendations of the SEC (Endocrinology & Metabolism) made in its72nd meeting held on 16.12.2020 at CDSCOCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2020-12-16 · accessed 2026-09-29
  3. 03Recommendations of the SEC Endocrinology & Metabolism made in its 9th/24 meeting held on 09.05.2024 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-05-09 · accessed 2026-09-29
  4. 04Recommendations of the SEC Endocrinology & Metabolism made in its 14th/24 meeting held on 13.08.24 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2024-08-13 · accessed 2026-09-29
  5. 05Recommendations of the SEC (Endocrinology & Metabolism) made in its 17th/26 meeting held on 16.07.2026 at CDSCO HQCentral Drugs Standard Control Organisation (CDSCO), Subject Expert Committee · 2026-07-16 · accessed 2026-09-29