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India drug regulator approves ‘restricted’ emergency use of Remdesivir in severe COVID-19 patients

India drug regulator approves ‘restricted’ emergency use of Remdesivir in severe COVID-19 patients
The Indian drug regulator has granted an Emergency Use Authorisation to Gilead Inc’s anti-viral drug Remdesivir for treatment in hospitalised, severe COVID-19 patients.
Central Drugs Standard Control Organisation (CDSCO) has granted the approval, with safety protocols, for ‘restricted’ emergency use of Remdesivir for a five-day treatment protocol.
Confirming the development, Lav Agarwal, Joint Secretary, Ministry of Health & Family Welfare  said, “Based on available evidence the approval has been given, however I do not have access to that evidence.”
Emergency use authorisation allows the ‘restricted’ use of unapproved drugs for treatment of illness in public health emergencies. EUA does not mean a formal approval for the use or marketing of the drug. India has 198,706 cases of COVID-19 and has reported 5,598 deaths as of June 1.
Remdesivir is US drug maker Gilead Sciences’ anti-viral drug which is seen as a potential therapy for COVID-19. Clinical trials are ongoing to study the safety and efficacy of this patented drug.
India is part of the Solidarity Trials led by the World Health Organisation that is assessing use of Remdesivir for COVID-19 treatment. The Indian Council of Medical Research had earlier said remdesivir may inhibit the SARS-CoV-2 replication.
On Monday, Gilead Sciences had reported Phase 3 SIMPLE trial results that found that hospitalised Covid-19 patients on the drug were 65 percent more likely to see clinical improvement by the eleventh day compared with those who were not on the drug.
Remdesivir is an injectable drug and hence has to be administered in a hospital setting under medical supervision.
Four Indian companies, Cipla, Jubilant Lifesciences, Hetero Drugs and Mylan have signed a non-exclusive licensing agreement with Gilead for manufacture and sale of the drug in 127 countries, including India.
However, as of now none of these companies have formal approval from the drug regulator to make and sell the drug in India.
The drug has received Emergency Use Authorization (EUA) by the USFDA for treatment of hospitalised COVID-19 patients in the United States. Japan has approved the drug, under Veklury brand, for COVID-19 treatment in severely-ill patients.
Central Drugs Approval is for use in both adults and children as per reports.
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