The DCGI (Drugs Controller General of India) gave its nod for the regular market use of Covishield, the vaccine developed by the Serum Institute of India (SII) and Covaxin, the vaccine developed by Bharat Biotech, on Thursday.
This authorisation of the vaccine for regular market use implies that it can be administered and authorised without reservation. The approval was authorised under the New Drugs and Clinical Trial Rules, 2019. The conditions require the companies to submit all data of the ongoing clinical trials. The COVID-19 vaccines are to also be supplied for the programmatic settings. Any adverse event following the immunization will be monitored accordingly.
The prices of the two indigenously manufactured has not been fixed yet in the meeting which saw the participation of the NPPA (National Pharmaceutical Pricing Authority), the Drugs Controller General of India, Drug regulators, and the senior officials from the Union Health Ministry. The price of one vaccine is expected to be fixed below Rs. 275 and an additional service charge of Rs. 150 will be charged to make the jabs affordable and accessible to all.
The approval by the DGCI was given after the SEC (Subject Expert Committee) on Coronavirus of the CDSCO (Central Drugs Standard Control Organisation)) recommended the granting of regular market approval to Covaxin and Covishield for use in the adult population only subjected to certain conditions, on January 19.
The application for the seeking of regular market authorisation was sent by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India on October 25, 2021. The DCGI, in response, had sought some additional data and documents from the Serum Institute, which was eventually submitted by Prakash. On the safety and efficacy of the vaccine, he had said that such large-scale vaccination with Covishield is in itself a testimony to the safety of the vaccine.
V Krishna Mohan, whole-time director at Bharat Biotech, in an application sent to the DGCI, had submitted full information including the chemistry, manufacturing, controls, pre-clinical data and clinical data when he sought the approval for regular market authorisation of Covaxin. Both the vaccines were granted the EUA (Emergency Use Authorization) on January 3.
After the approval, people will finally be able to buy the vaccines from hospitals and clinics, and the data related to the vaccination will be uploaded on the Co-Win application. The vaccination data will be sent to the DGCI twice a year as well.
