New Delhi: The Drugs Controller General of India (DCGI) on Thursday granted regular market approval to Serum Institute of India’s (SII’s) Covishield and Bharat Biotech’s Covaxin for use in the adult population subject to certain conditions.
The approval was granted under the New Drugs and Clinical Trials Rules, 2019. The market authorisation for Covid-19 vaccines means that they can be authorised for use without reservation and conditions.
Under the conditions, the companies shall submit data of ongoing clinical trials and the Covid-19 vaccines to be supplied for programmatic setting. Adverse event following immunisation will continue to be monitored, the report said.
It is expected that the price of a Covid-19 vaccine dose will be fixed below Rs 275 and additional service charges of Rs 150 to make both the jabs affordable for all.
Recently, the National Pharmaceutical Pricing Authority (NPPA), DCGI, Drug regulators and senior officials of the Union Health Ministry conducted a meeting regarding fixing the prices of Covishield and Covaxin, but no final decision has been taken yet.