CDSCO Withdraws COVID-19 Indication For Baricitinib Tablet At Eli Lilly’s Request

India’s top drug regulator, the Central Drugs Standard Control Organisation (CDSCO) has withdrawn the COVID-19 indication for Baricitinib Tablets 2 mg and 4 mg, following a request from the pharma manufacturer, Eli Lilly. The move effectively removes the drug’s use for treating COVID-19 in emergency situations from regulatory guidance in India.

The notice, issued on October 23, 2025 by the CDSCO, states that the decision pertains solely to baricitinib’s indication for COVID-19 and does not affect its approved therapeutic uses for conditions such as rheumatoid arthritis and alopecia areata.

The CDSCO, India’s apex regulatory authority for pharmaceuticals is responsible for the approval of drugs and conduct of clinical trials, the formulation of drug standards, and the regulation of imported medicines to ensure their quality and safety. It also coordinates with State Drug Control Departments to maintain uniformity in the enforcement of drug regulations across the country.

In November 2021, the CDSCO had given a nod to 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 (ECМО).

According to the sources, Eli Lilly had formally requested the withdrawal of the indication, citing changes in the treatment landscape and the decreasing need for emergency-use medicines developed during the height of the pandemic.

Health authorities worldwide, including the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have in recent years revised or withdrawn their emergency authorisations for baricitinib in the management of COVID-19.

The CDSCO’s decision reflects a broader shift in COVID-19 management, driven by the widespread availability of vaccines, improved treatment protocols, and the emergence of new viral variants. These developments have significantly reduced the reliance on repurposed or emergency-use drugs that were critical during earlier phases of the pandemic which had swept the world, infecting and killing many.

In late 2022 and early 2023, the EMA had observed that the available clinical data no longer demonstrated a meaningful benefit for baricitinib in hospitalised COVID-19 patients. The agency concluded that evidence was insufficient to establish a positive benefit–risk balance, prompting Eli Lilly to withdraw its application for continued authorisation in the European Union.