CDSCO Allows Eli Lilly to Withdraw Covid-19 Indications of Baricitinib in India

CDSCO Allows Eli Lilly to Withdraw Covid-19 Indications of Baricitinib in India

The Central Drugs Standard Control Organisation (CDSCO) has approved Eli Lilly India’s request to withdraw the Covid-19 indication of its rheumatoid arthritis drug, baricitinib tablets (2 mg and 4 mg). The decision marks the end of baricitinib’s emergency use authorization for coronavirus disease-2019 (Covid-19) treatment in India, nearly four years after its initial approval.

Background: Baricitinib’s Covid-19 Authorization in India

The present Drugs Controller General of India (DCGI) first granted restricted emergency use approval for baricitinib on May 3, 2021, allowing its use in combination with remdesivir for the treatment of suspected or confirmed Covid-19 cases among hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).However, as the pandemic situation improved and Covid-19 cases sharply declined, Eli Lilly sought to withdraw this indication voluntarily.

CDSCO’s Official Confirmation

The regulatory authority acknowledged Eli Lilly’s request and confirmed that baricitinib tablets (2 mg and 4 mg) will no longer be available for restricted emergency use against Covid-19.

“However, baricitinib tablets may continue to be marketed for their approved indication in moderate to severe active rheumatoid arthritis, as per existing licensing conditions,” stated Dr. Rajeev Singh Raghuvanshi, Drugs Controller General of India (DCGI).

Regulatory Significance

The withdrawal of Covid-19 indications for baricitinib underscores India’s transition from emergency authorizations to standardized regulatory oversight under the Drugs and Cosmetics Act and allied rules. It also reflects CDSCO’s evolving role in maintaining pharmacovigilance, ensuring that drugs approved under restricted emergency use are periodically reviewed for efficacy and safety once the health crisis stabilizes.

Click here to know more and access the official guidance document

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