The Central Drugs Standard Control Organization (CDSCO) has formally acknowledged the withdrawal of the approved indications of Baricitinib Tablets (2mg & 4mg) for the treatment of COVID-19, effective October 23, 2025.
The withdrawal was requested by the manufacturer, M/s. Eli Lilly and Company (India) Pvt. Ltd., and relates specifically to the permissions granted for its use in emergency situations during the pandemic.
Withdrawn COVID-19 Indications
The CDSCO’s order confirms the withdrawal of the following specific emergency use indications for Baricitinib Tablets:
- Original Combination Use: Baricitinib, in combination with Remdesivir, for the treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). (Approved via permission no. IMP/FF/SND/69/2021 dated May 3, 2021).
- Standalone Use: Baricitinib for treatment of coronavirus disease 2019 (COVID-19) in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). (Approved via permission no. IMP/SND/21/000104 dated November 15, 2021).
Continued Marketing for Other Uses
The CDSCO clarified that Baricitinib Tablets (2mg & 4mg) may continue to be marketed for its other previously approved indication, Rheumatoid arthritis. The withdrawal is specific only to the COVID-19 indications that were granted for restricted use in emergency situations.