The Drugs Controller General of India (DCGI) on Tuesday approved India’s first indigenous drug against COVID-19 manufactured by Genoa Biopharmaceuticals for restricted emergency use for people aged 18 years and above, official sources said on Tuesday. Developed mRNA vaccine has been approved. While other mRNA vaccines need to be stored at sub-zero temperature, Genova’s mRNA vaccine can be stored at 2-8 degrees, an official source told PTI.
The drug regulator has also approved Serum Institute’s COVID-19 vaccine Kovovax for restricted emergency use in children aged 7 to 11 years, subject to certain conditions. DCGI’s approval comes after CSDCO’s subject expert committee on COVID-19 last week recommended emergency use authorization to Covovax for the age group of 7 to 11 years and two-dose m-RNA vaccine of Gennova for 18 years and above has come, said the official source.
Official sources said that on March 16, Prakash Kumar Singh, director of government and regulatory affairs at Serum Institute of India (SII), had given an application to the DCGI in this regard. The expert panel in its last meeting in April had sought more data from the Pune-based firm on the application. DCGI approved Kovovax on December 28 for restricted use in emergency situations in adults and on March 9 in the age group of 12 to 17 years, subject to certain conditions. The country began vaccinating children aged 12-14 from March 16.
The nationwide vaccination campaign was launched on January 16 last year, in which health workers were vaccinated in the first phase. The vaccination of frontline workers started from February 2 last year. The next phase of COVID-19 vaccination began on March 1 last year for people above 60 years of age and 45 years and above with specified co-morbid conditions. India started vaccination for all people above 45 years of age from 1st April last year. Following this, the government decided to expand its vaccination campaign by allowing everyone over the age of 18 to be vaccinated against the viral disease from May 1 last year.
The next phase of vaccination began on January 3 for adolescents in the age group of 15-18 years. India began giving preventive doses of vaccines to health care and frontline workers and people aged 60 and above from January 10. Precautionary dosing of COVID-19 vaccines for all people above 18 years of age began on April 10 at private immunization centres.