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COVID-19: Remdesivir included as ‘investigational therapy’ only for restricted emergency use, clarifies Health Ministry

An updated Clinical Management Protocol for COVID-19 has been released by the Ministry of Health and Family Welfare on 13 June 2020 in which the drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use purposes along with off label use of Tocilizumab and Convalescent Plasma.

SNS | New Delhi |

There are reports in a section of the media regarding the use of Remdesivir as part of the Clinical Management Protocol for COVID-19 and its availability in the country.

An updated Clinical Management Protocol for COVID-19 has been released by the Ministry of Health and Family Welfare on 13 June 2020 in which the drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use purposes along with off label use of Tocilizumab and Convalescent Plasma.

The said protocol also clearly mentions that the use of these therapies is based on limited available evidence and limited availability at present. Use of Remdesivir under emergency use may be considered in patients with moderate disease (those on oxygen) but with no specified contraindications.

This drug has still not been approved (market authorization) by the US Food and Drug Administration (USFDA) where like India it continues only under an Emergency Use Authorization.

Restricted Emergency Use of drugs in the country for treatment of suspected or laboratory-confirmed COVID-19 in adults and children hospitalised with severe disease is subject to the following conditions:

1. Written informed consent of each patient required

2. Results of additional clinical trials to be submitted

3. Active surveillance data of all treated patients to be submitted

4. Risk management plan along with active post-marketing surveillance and reporting of serious adverse events also to be submitted

5. Additionally, the first three batches of imported consignments are to be tested and reports submitted to the Central Drug Standard Control Organisation (CDSCO).