Serum Institute of India (SII), on October 25, had applied to the Drugs Controller General of India (DCGI) seeking regular market authorization for the vaccine.
Over 100 crore Covishield doses have been given in India and abroad which is a testimony of its safety and efficacy, Serum Institute has informed the DCGI which had sought more data for granting full marketing approval to the Covid vaccine, official sources said on Tuesday.
Covishield is currently authorized for emergency use in the country. Serum Institute of India (SII), on October 25, had applied to the Drugs Controller General of India (DCGI) seeking regular market authorization for the vaccine.
The drug regulator in December sought more data and documents for it. Following this, Prakash Kumar Singh, the Director, Government and Regulatory Affairs at SII, recently submitted a response along with more data and information.
In addition to the successful completion of phase 2/3 clinical study in India, till now, more than 100 crore doses of Covishield vaccine have been administered to the people in this country and worldwide, Singh is learnt to have stated in the response.
Such a large-scale vaccination with Covishield and containment of COVID-19 infection is in itself a testimony of the safety and efficacy of the vaccine, he said.
“It is a matter of pride for us that we have been a part of the world’s largest vaccination drive under the dynamic and visionary leadership of our Prime Minister Narendra Modi.
“Under the kind guidance of Union Health Minister Mansukh Mandaviya, Team Government of India and leadership of our CEO Adar C Poonawalla, Team SII has been working relentlessly to manufacture and supply Covishield for making the world’s largest COVID-19 vaccination drive successful,” Singh is learnt to have stated in the reply.
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