CDCSO permits Remdesivir for restricted emergency use on hospitalised COVID-19 patients
The Central Drug Control Standard Organisation (CDCSO), India’s top drug controller has permitted Gilead Sciences for marketing authorization of its anti-viral drug ‘Remdesivir’.
As per a senior government official, the decision was pushed due to the COVID-19 outbreak in the country. The drug has been permitted for the restricted emergency use on hospitalised COVID-19 patients only.
The official also informed that the anti-viral drug will be available in the form of an injection and will be sold on retail on doctor prescription for hospital use. As per Gilead Sciences, the drug benefits in the treatment of COVID-19.
CDSCO on permitting Remdesivir:
After the consultation with an expert committee, CDSCO granted the Remdesivir drug to be given in emergencies in laboratory-confirmed COVID-19 patients in India.
US Food and Drug Administration (FDA) had also issued an emergency use authorization for the investigational anti-viral drug Remdesivir for treating the laboratory-confirmed or suspected COVID-19 in adults or children hospitalized with severe disease.
The government official while informing that all new drugs have to undergo clinical trials to get approval for marketing in India also mentioned that the drug regulator has approved Remdesivir under Special Provisions of the New Drug and Clinical Trials Rules 2019. It provides a waiver of clinical trials in special circumstances.
The drug regulator body had also received three applications from three Indian pharmaceutical companies- Hetero labs, Cipla, and BDR Pharmaceuticals to manufacture and sell the anti-viral drug in India.
Demand for Remdesivir by other agencies:
Gilead Sciences had earlier informed that they have entered into non-exclusive licensing agreements with pharmaceutical firms which also includes three domestic majors- Jubilant Life Sciences, Cipla, and Hetero for the manufacture and distribution of the anit0viral drug.
India’s apex medical research body- Indian Council for Medical Research (ICMR) had also mentioned that Remdesivir had also been used during the Ebola outbreak and there are chances that it might slow down the COVID-19 replication.
As per an article published in the New England Journal of Medicine informed that the two out of three critically-ill COVID-19 patients had shown sign of improvements when they were administered with Remdesivir drug by the doctors.