Expert committee to review full market approval for Covishield, Covaxin
The Subject Expert Committee (SEC) will hold a meeting on Friday to review full market approval for Covid-19 vaccines -- Covaxin and Covishield.
The Drugs Controller General of India (DCGI) is set to review full market approval for Covid-19 vaccines -- Covaxin and Covishield -- on Friday. The Subject Expert Committee (SEC) will hold a meeting around 2 pm to discuss the matter.
Both Covaxin and Covishield are currently only authorised for emergency use in the country.
In an application sent to the DCGI this week, V Krishna Mohan, whole-time Director at the Hyderabad-based company, submitted complete information regarding chemistry, manufacturing and controls, along with pre-clinical and clinical data while seeking regular market authorisation for Covaxin.
The company, however, is yet to submit the full follow-up data of the clinical trial of Covaxin to DCGI, a source told news agency PTI on Thursday.
In October last year, Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), had submitted an application to the DCGI seeking regular market authorisation for Covishield.
In response to the application, the DCGI had asked for some more information, following which Singh last week submitted a response along with all desired data and information to the DCGI.
Meanwhile, Covaxin comprises 12 per cent of the total Covid-19 vaccine jabs administered in the country so far and it is the only vaccine that is being given to youngsters in the age group of 15-18 years, inoculation of whom began from January 3 in the country.
(With inputs from PTI)