Remdesivir, convalescent plasma use based on limited available evidence: Health Min

NEW DELHI: A day after allowing the use of antiviral drug remdesivir and off-label application of tocilizumab and convalescent plasma in moderate cases of COVID-19, the Union health ministry on Sunday said the "use of these therapies is based on limited available evidence at present". The ministry clarified that remdesivir has been included as an "investigational therapy" only for the purpose of restricted emergency use fol

lowing certain news reports regarding the use of the drug as part of the clinical management protocols for COVID-19 and its availability in the country. 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 a set of conditions. Written informed consent of each patient is required before the use while results of additional clinical trials, active surveillance data of all treated patients, risk management plan along with active post-marketing surveillance and reporting of serious adverse events have to be submitted. "Additionally, first three batches of imported consignments are to be tested and reports submitted to Central Drug Standard Control Organisation (CDSCO)," the ministry said.

Use of remdesivir under emergency use authorisation may be considered in patients at moderate stage of the disease, that is those on oxygen support, but with no specified contraindications, according to the health ministry's revised 'Clinical Management Protocols for COVID-19' issued on Saturday.

On Sunday, the ministry said the drug has still not been approved (market authorization) by the US Food and Drug Administration (USFDA), where like India it continues only under emergency use authorization.

The ministry said Gilead Sciences had on May 29 applied to the Indian Drug Regulatory Agency, CDSCO, seeking nod for import and marketing of remdesivir.

After due deliberations, permission under emergency use authorization was granted on June 1 in the interest of patient safety and obtaining further data.