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Covaxin, Covishield given normal new drug permission in adult population with conditions: Health Minister

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New Delhi | January 27, 2022 7:20:50 PM IST
Union Health Minister Dr Mansukh Mandaviya on Thursday said that the Central Drugs Standard Control Organisation (CDSCO) has now upgraded the permission for Covaxin and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions.

Taking to Twitter, the Union minister wrote, "The Central Drugs Standard Control Organisation (CDSCO) has now upgraded the permission for COVAXIN and Covishield from restricted use in emergency situations to normal new drug permission in the adult population with certain conditions."

"The conditions include supply for programmatic settings including registration on the CoWin platform and to continue to submit safety data on a six-monthly basis," Mandaviya tweeted.

Meanwhile, the union minister also said that the government's drive for free COVID-19 vaccination will continue.

According to CDSCO, the proposals for regular market approval were reviewed by it in consultation with the Subject Expert Committee (SEC) for COVID-19. After detailed deliberation, the committee recommended updating the status of approval of COVID vaccines -- Covishied and Covaxin from Restricted use in an Emergency situation to the New Drug permission as per rules in the adult population with conditions.

The vaccines are for sale or for distribution under New Drugs and Clinical Trials (NDCT) Rules, 2019 in adult population with the conditions that the Firm shall submit data of overseas ongoing clinical trials of the product with due analysis on six monthly basis or as and when available, whichever is earlier.

Secondly, the vaccine shall be supplied for programmatic setting and all vaccinations done within the country will be recorded on CoWIN platform and AEFI, AESI shall continue to be monitored. The firm shall submit the safety data including Adverse Events Following Immunization (AEFI) and Adverse Events of Special Interest (AESI) with due analysis on six-monthly basis or as and when available, whichever is earlier as per NDCT Rules. 2019.Covishield is manufactured by Pune-based Serum Institute of India while Covaxin is manufactured by Hyderabad-based Bharat Biotech. (ANI)

 
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