The Drug Controller General of India (DCGI) has given conditional market approval to companies for Covishield and Covaxin. But the vaccine will not be available at the medical store. Vaccines can be purchased from hospitals and clinics only. Vaccination data has to be submitted to DCGI every six months. The data will also be updated on the Covin app.
India's drug regulator on Thursday approved the regular sale of the Covid 19 vaccines Covishield and Covaxin for use in the adult population, subject to certain conditions. Approval has been given under the New Drugs and Clinical Trials Rules, 2019. Under the conditions, firms will submit data on vaccines to be supplied for ongoing clinical trials and programmatic settings. Monitoring for any adverse event will continue after vaccination.
Mansukh Mandaviya also gave information
At the same time, Union Health Minister Dr. Mansukh Mandaviya said that the Central Drugs Standard Control Organization (CDSCO) has now upgraded the permission of Covaxin and Covishield from restricted use in emergencies to the permission of generic new drugs in the adult population with certain conditions.
was recommended on January 19
Serum Institute of India (SII) for use in an adult population subject to certain conditions after approval of Drug Controller General of India (DCGI) by Subject Expert Committee (SEC) on COVID-19 of Central Drugs Standard Control Organization (CDSCO) on 19 Jan. K Covishield and Bharat Biotech's Covaxin were recommended for approval for regular market sale.
Both companies had submitted data and information
On October 25, Prakash Kumar Singh, director of government and regulatory affairs at SII, had submitted an application to DCGI seeking permission to sell Covishield in the market regularly. Singh had recently submitted more data and documents after DCGI had sought more data and documents from the Pune-based company. He had said that such large-scale vaccination and prevention of corona infection with Covidshield is in itself proof of the safety and efficacy of the vaccine.
Meanwhile, in an application sent to DCGI, V Krishna Mohan, the whole-time director at Hyderabad-based Bharat Biotech, had submitted clinical data as well as complete details of chemistry, manufacturing, and control, seeking approval to launch Covaxin.
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