AGENCIES / NEW DELHI
India’s Union Health Ministry has said that the drug Remdesivir has been included in d Clinical Management Protocol for COVID-19 as an investigational therapy only for restricted emergency use purposes.
The Ministry said, the protocol released by it, also clearly mentioned that the use of these therapies is based on limited available evidence at present.
It said, use of Remdesivir under emergency use may be considered in patients with moderate disease but with no specified contra-indications. The Ministry’s clarification came in the wake of media reports regarding the use of Remdesivir as part of the Clinical Management Protocol for COVID-19, and its availability in the country.
The Ministry further said that this drug has still not been approved by the US Food and Drug Administration (USFDA), where like India it continues only under an Emergency Use Authorization. Gilead company had applied to the Indian Drug Regulatory Agency, Central Drug Standard Control Organisation (CDSCO) for import and marketing of Remdesivir on 29th May this year. The Ministry said, after due deliberations, permission under Emergency Use Authorization was granted on 1st of this month in the interest of patient safety and obtaining further data.
It said, six Indian companies have also applied to CDSCO for permission to manufacture and market the drug in the country. These applications are being processed by the CDSCO on priority and in accordance with the laid down procedures. The Ministry said, being an injectable formulation, testing for assay, identity, impurities, bacterial endotoxin test and sterility become very critical for patient safety and this data needs to be provided by companies.
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 Ministry said, the regulatory processes are being facilitated and expedited by CDSCO.
