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The ministry clarified that remdesivir has been included as an “investigational therapy” only for the purpose of restricted emergency use following 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.
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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.
According to the statement six Indian companies– Hetero, Cipla, BDR, Jubilant, Mylan and DR Reddy’s Labs have also applied to CDSCO for permission to manufacture and market the drug in India.
Five of these have entered into an agreement with Gilead Sciences.
“These applications are being processed by the CDSCO on priority and in accordance with the laid down procedures.The companies are at various intermediate stages of inspection of manufacturing facilities, verification of data, stability testing, emergency laboratory testing as per protocol etc,” the statement said.
Being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data need to be provided by the companies.
The CDSCO is awaiting the data and is providing complete support to these companies. It has already waived off the requirement of local clinical trials for these companies by invoking emergency provisions.
The regulatory processes are being facilitated and expedited by CDSCO, it said.