The Centre on Sunday said that six Indian companies — Hetero, Cipla, BDR, Jubilant, Mylan and Dr Reddy’s Labs — have applied to Indian Drug Regulatory Agency, Central Drug Standard Control Organisation (CDSCO) for permission to manufacture and market the Remdesivir drug in India.
In a release, the Health Ministry said that five of these have also entered into an agreement with Gilead, a biopharmaceutical company, which had applied to CDSCO, for import and marketing of Remdesivir on May 29. After due deliberations, permission under Emergency Use Authorization was granted on June 1 in the interest of patient safety and obtaining further data.
“The applications of these six companies 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. 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 the companies,” the release read.
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.
Union Health Ministry on Saturday released an 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 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. Additionally, the first three batches of imported consignments are to be tested and reports submitted to the Central Drug Standard Control Organisation (CDSCO),” said the release. – PTI