Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services
Is Elamipretide (SS-31) legal in India?
Not approved as a medicine here.
Elamipretide is a mitochondria-targeting peptide that the US regulator approved for Barth syndrome. The CDSCO expert-committee records reviewed (2015 to September 2026) show no marketing application or permission for it. Under the New Drugs and Clinical Trials Rules, 2019, a drug that the Central Licensing Authority has not approved is a 'new drug' and may not be made for sale or distribution without permission, and CDSCO has used this rule to direct State Drug Controllers to act against other unapproved products (for example, enclomiphene in August 2026).
Last verified 2026-09-29 · how we verify
Elamipretide (SS-31) elsewhere
Sources (2)
- 01Manufacturing and marketing of unapproved drug products containing Enclomiphene and its combinations (sets out the New Drugs rule for unapproved products)Central Drugs Standard Control Organisation (CDSCO) · 2026-08-10 · accessed 2026-09-29
- 02CDSCO Subject Expert Committee (SEC) recommendations index (records reviewed 2015 to September 2026)Central Drugs Standard Control Organisation (CDSCO) · 2026-09-23 · accessed 2026-09-29