I am not surprised, the original EUA in India was

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“There was a long discussion on itolizumab but most members felt that there is no substantial evidence yet to include it in the national COVID-19 clinical management guidelines,” sources in the task force told The New Indian Express.

The EUA granted by the Central Drugs Standards Control Organisation (CDSCO) to this drug, originally developed for auto-immune skin disease psoriasis, for moderate to severe COVID-19 cases earlier this month had sparked a controversy as the approval was based on a very small phase 2 trial with just 30 patients.

Later, it also emerged that the drug regulator had waived the manufacturer from doing a phase 3 trial considered crucial for generating scientific evidence for a therapeutic intervention as they include a large number of subjects and allowed it to move to phase 4 trial directly which includes post-marketing surveillance.

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