New Delhi: The first batch of the newly-approved experimental drug for coronavirus, Remdesivir, is all set to begin sale in India and the first batch of 20,000 vials have been sent to the four worst-hit states – Delhi, Maharashtra, Tamil Nadu and Gujarat – along with Telangana, where it is being manufactured. Also Read - Singapore Reports 136 New COVID-19 Cases in 24 Hours, Total Tally at 44800
On Thursday morning, Delhi woke up to surpass Mumbai as the worst-affected city in the country, with positive cases crossing the 70,000-mark. Mumbai had 69,528 cases of COVID-19 infection as of this morning. Also Read - Kerala Lockdown News: State Imposes Triple Lockdown in Thiruvananthapuram From Monday For One Week, Secretariat Won’t Function
However, there is still hope for both of these cities as the Drug Controller General of India (DCGI) gave permission to Hyderabad-based drug manufacturer Hetero, as well as, Cipla to start marketing the antiviral drug under “restricted emergency use”. Also Read - Grim Milestone: India Overtakes Russia as 3rd Worst COVID-hit Nation in World
The drug regulator, however, asserted that a written informed consent of each patient is required before the use of Remdesivir and results of additional clinical trials, active post-marketing surveillance data and reporting of serious adverse events have to be submitted to the government.
As a result, the drug will not be sold in retail stores, but only through hospitals and government orders.
The Union health ministry, in its ‘Clinical Management Protocols for COVID-19’, recommended the use of the Remdesivir on patients in moderate stage of the disease that is, those on oxygen. The drug has been included as an “investigational therapy” only for restricted emergency use purposes.
Cipla and Hetero Labs have already entered into non-exclusive licensing agreements with US pharma giant Gilead Sciences, which is the patent holder of the drug Remdesivir.
Besides Hetero and Cipla, three other firms BDR, Jubilant, Mylan and DR Reddy’s Labs have also applied to CDSCO for permission to manufacture and market the drug in India and are still awaiting permission.