In a significant development, the country's top drug controller the Central Drug Control Standard Orgsation (CDCSO) has given permission to Gilead Sciences for marketing authorization of its anti-viral drug Remdesivir "only for restricted emergency use" on hospitalized COVID19 patients, according to a senior government official.
"The decision was pushed due to the coronavirus outbreak in the country. Remdesivir would be available in form of an injection and will only be sold on retail by the prescription of a doctor for hospital use," the official told .
As per Gilead Sciences, the drug claims to benefit in the treatment of COVID-19.
CDCSO after consultation with an expert committee has granted the Remdesivir drug only to be given in emergencies in laboratory-confirmed COVID-19 patients in India.
Even, US Food and Drug Administration (FDA) has issued an emergency use authorization for the investigational antiviral drug Remdesivir for the treatment of suspected or laboratory-confirmed Covid-19 in adults and children hospitalized with severe disease.
"The drug regulator has approved Remdesivir under special provisions of the New Drug and Clinical Trial Rules 2019 which provides a waiver of clinical trials in special circumstances," said the official adding that all new drugs have to undergo clinical trials to get approval for marketing in India.
Recently, Gilead Sciences, in a press statement, said that they have entered into non-exclusive licensing agreements with pharmaceutical firms including three domestic majors Cipla, Jubilant Life Sciences and Hetero for manufacture and distribution of the anti-viral drug.
Besides, the drug regulator body has also received three applications from three Indian pharmaceutical compes - Cipla, Hetero Labs and BDR Pharmaceuticals to manufacture and sell the anti-viral drug in India.
"CDCSO has granted permission to Gilead Sciences for marketing authorization of its anti-viral drug Remdesivir to be used for COVID-19 patients in a hospital set up only. The decision was pushed due to coronavirus outbreak in the country. The Remdesivir would be available in the form of injection and will only be sold on retail by the prescription of a doctor for hospital use," the official said.
"The drug regulator has approved Remdesivir under special provisions of the New Drug and Clinical Trial Rules 2019 which provides waiver of clinical trials in special circumstances," said the official adding that all new drugs have to undergo clinical trials it gets approval for marketing in India.
Recently, Gilead Sciences in a press statement said that they have entered into non-exclusive licensing agreements with pharma firms including three domestic majors Cipla, Jubilant Life Sciences and Hetero for manufacture and distribution of Remdesivir.
Even India's apex medical research body- ICMR has also stated that Remdesivir has also been used during Ebola outbreak and it may slow down the covid19 replication. Meanwhile, WHO is conducting 'solidarity trial' to determine its efficacy for COVID19 treatment.
An article published in the New England Journal of Medicine stated that two out of three critically ill COVID-19 patients showed signs of improvement when they were administered Remdesivir drug.
Meanwhile, the drug regulator has received three applications from three Indian pharmaceutical compes - Cipla, Hetero Labs and BDR Pharmaceuticals to get permission to manufacture and sell Remdesivir in India.
( With inputs from ANI )