India joins US, UK to approve market authorisation for COVID vaccines

The Drugs Controller General of India's (DCGI) on Thursday granted regular market approval to Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin COVID-19 vaccines for use in the adult population. India has now become the only country after the UK and the US to have granted market authorisation to COVID-19 vaccines. Previously, the UK had granted market authorisation to AstraZeneca while the US had granted market authorisation to Pfizer for their COVID-19 vaccines. 

Union Health Minister Dr Mansukh Mandaviya has stated that The Central Drugs Standard Control Organisation (CDSCO) has upgraded the permission for Covaxin and Covishield COVID -19 vaccine from restricted use in emergency situations to normal new drug permission in the adult population

Mandaviya explained on Twitter that there are certain conditions attached with the authorisation up-gradation. 

"The @CDSCO_INDIA_INF 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," wrote Mandaviya. 

He added that 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." 

The Drugs Controller General of India's (DCGI) approval came after the Subject Expert Committee (SEC) on COVID-19 of the Central Drugs Standard Control Organisation (CDSCO) on January 19 recommended granting regular market approval to the Serum Institute of India's (SII's) Covishield and Bharat Biotech's Covaxin for use in adult population subject to certain conditions.

Covaxin and Covishield were granted Emergency Use Authorisation (EUA) on January 3.  

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