Cipla, Hetero approach DCGI seeking waiver of Clinical Trial of Remdesivir in India: Report
New Delhi: With pharma companies across the country making efforts to get the first-mover advantage in bringing potential coronavirus treatments, two pharma firms, Cipla and Hetero have now approached the authorities to seek a clinical trial wavier for introducing remdesivir in India, a recent report in Economic Times has pointed out.
Medical Dialogues had earlier reported about Gilead Sciences' Ebola drug, Remdesivir that had shown positive results against coronavirus in Clinical Trials
Based on its results, the U.S. Food and Drug Administration 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.
However, there is limited information known about the safety and effectiveness of using remdesivir to treat people in the hospital with COVID-19, the investigational drug was shown in a clinical trial to shorten the time to recovery in some patients.
In India, Gilead has tied up with various pharma companies for the production of the drug, CIPLA, and Hetero being one of them. These companies have now approached the DCGI seeking exemption from a clinical trial, a prerequisite necessary for the launch of any drug in India
" The matter will be taken to the subject expert committee, which will decide on the marketing authorisation and if clinical trials can be waived in an emergency situation of a pandemic", persons familiar with the matter told Economic Times
Previously, DCGI VG Somani had informed media persons that remdesivir will only be available in the market when it shows certain signs of being useful and beneficial in the treatment of Covid-19 affected victims.