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DCGI rejects DRL's proposal, denies full marketing rights for Remdesivir

Emergency use authorisation to continue; recently, WHO had raised doubts about efficacy of drug in treatment of Covid-19 patients

remdesivir, coronavirus, drugs, covid, pharma
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Dr Reddy's had presented the proposal along with clinical data for change in regulatory approval status for remdesivir injection from restricted emergency use to full marketing authorisation.

Sohini Das Mumbai
After the US drug regulator approved Gilead's antiviral drug remdesivir (Veklury) as treatment for Covid-19 amid reservations from the World Health Organization, the Indian regulator on Monday turned down a proposal by Dr Reddy's Laboratories for full marketing authorisation of remdesivir for Covid-19 patients. 

The Drug Controller General of India (DCGI) has said that the emergency use authorisation of the drug will continue. 

Recently, WHO had noted that the Recovery Trial led by them showed that remdesivir along with drugs like Hydroxychloroquine and Interferon had not significant benefits for hospitalised Covid-19 patients. 

The Covid-19 subject expert committee (SEC) of the