Amid the rising coronavirus cases in India, Pune-based pharma firm Serum Institute of India (SII) on Sunday (December 6) applied to the Drugs Controller General of India (DCGI) seeking emergency use authorisation for Oxford-AstraZeneca Covid-19 vaccine in the country. SII cited "unmet medical needs due to the pandemic" and "interest of the public at large," as the reasons for seeking emergency use authorisation.
It is to be noted that SII is currently conducting the third phase trial of the Oxford Covid-19 vaccine, Covishield. The SII is working jointly with Indian Council of Medical Research (ICMR) to conduct the clinical trials across the country.
ICMR had recently said that 40 million doses of the vaccine were already developed by SII under the at-risk manufacturing and stockpiling license it obtained from the DCGI.
Earlier, Pfizer India had submitted an application to the Drugs Controller General of India (DCGI) seeking an emergency-use authorisation for its Covid-19 vaccine in the country. It is to be noted that Pfizer India's parent company Pfizer has already got emergency-use clearance in the UK and Bahrain.
Pfizer India, in its application submitted to the DGCI, has sought permission from the regulator to import the vaccine for sale and distribution in the country, sources said, adding that the pharma giant has also sought the waiver of clinical trials on Indian population in accordance with the special provisions under the New Drugs and Clinical Trials Rules, 2019.
The application was submitted by Pfizer India on December 4 to the DCGI seeking emergency use authorization (EUA) for its Covid-19 vaccine in India. It is learnt that Pfizer India has submitted the EUA application in Form CT-18 for grant of permission to import and market Pfizer-BioNTech's Covid-19 vaccine in India.
On Wednesday (December 2), the UK became the first country to approve the Pfizer/BioNTech vaccine against Covid-19.