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Monday, November 30, 2020

Expert committee rejects Dr Reddy’s proposal for remdesivir’s full approval

The panel’s suggestions come nearly two weeks after the US Food and Drug Administration approved the drug as a recognised treatment for Covid-19.

By: ENS Economic Bureau | New Delhi | November 3, 2020 2:00:06 am
The recommendations, if accepted by the Central Drugs Standard Control Organisation (CDSCO), would mean that India would not follow the US drug regulator’s lead in granting remdesivir full marketing approval.

A subject expert committee (SEC) under India’s top drug regulatory body has rejected a proposal by Hyderabad-headquartered Dr Reddy’s Laboratories to grant full marketing authorisation for antiviral remdesivir.

The expert panel’s recommendations, which suggest that India should continue with restricted emergency use of the drug, come nearly two weeks after the US Food and Drug Administration approved the drug as a recognised treatment for Covid-19.

The recommendations, if accepted by the Central Drugs Standard Control Organisation (CDSCO), would mean that India would not follow the US drug regulator’s lead in granting remdesivir full marketing approval. “After detailed deliberation, the committee did not recommend for grant of full marketing authorisation and opined that approval for restricted emergency use of the drug should continue,” stated the SEC in its recommendations on October 29. The minutes of the panel’s meeting were made public on Monday.

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