Serum Institute applied for full market approval of Covishield, says CEO Adar Poonawalla

Serum Institute of India (SII) CEO Adar Poonawalla on Friday said the company has applied to Central Drugs Standard Control Organisation (CDSCO) and health ministry for granting full market authorisation to its Covishield vaccine.

Taking to Twitter, SII CEO Adar Poonawalla said the government has enough data for full market authorisation now and the supplies of the COVID-19 jab in the country have exceeded 1.25 billion and therefore the company has applied to the CDSCO for the permission.

Also Read: COVID-19: India's vaccination coverage crosses 143.15 cr, says Health Ministry

"Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission," Poonawalla tweeted.

Supplies of the COVISHIELD vaccine in India, have exceeded 1.25 billion doses. The government of India now has enough data for full market authorisation, and therefore @SerumInstIndia has applied to the @CDSCO_INDIA_INF (DCGI) and @MoHFW_INDIA for this permission.

— Adar Poonawalla (@adarpoonawalla) December 31, 2021

Serum Institute had earlier this month sought India's drug regulator's approval for Covishield as a booster dose citing adequate stock of the vaccine in the country.
 
In an application to the Drugs Controller General of India (DCGI), Prakash Kumar Singh, the Director, Government and Regulatory Affairs at Serum Institute of India (SII) cited that the UK's Medicines and Healthcare products Regulatory Agency has already approved the booster dose of AstraZeneca ChAdOx1 nCoV-19 vaccine, sources told PTI.

Also Read: Serum to reduce Covishield production by at least 50% from next week, says Adar Poonawalla: Report