New Delhi: Union Health Ministry on Sunday said that drug Remdesivir has been included as an “investigational therapy” only for restricted emergency use on COVID-19 patients.
In a release, the Ministry of Health and Family Welfare intimated the updated Clinical Management Protocol for COVID-19, 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 highlighted 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,” said the release.
However, there are certain conditions to be met, as per the release, for the restricted emergency usage of the drug.
“Written informed consent of each patient required, results of additional clinical trials to be submitted, active surveillance data of all treated patients to be submitted, risk management plan along with active post-marketing surveillance and reporting of serious adverse events also to be submitted. Additionally, the first three batches of imported consignments are to be tested and reports submitted to the Central Drug Standard Control Organisation (CDSCO),” added the release.
Health Ministry in the release said that Gilead, a biopharmaceutical company, had applied to the Indian Drug Regulatory Agency, namely CDSCO, for import and marketing of Remdesivir on May 29 and after due deliberations, permission under Emergency Use Authorization was granted on June 1 in the interest of patient safety and obtaining further data.
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