This story is from December 08, 2020
Shortcuts, compromises on safety standards on Covid-19 vaccine not acceptable: Anand Sharma
NEW DELHI: Senior Congress leader Anand Sharma on Tuesday cautioned the government against any shortcuts while processing the Covid-19 vaccine applications and said any compromise on safety standards and rules will not be accepted.
Pfizer, Bharat Biotech and the Serum Institute of India have applied to the Drug Controller General of India (DCGI) for emergency use authorisation of their Covid-19 vaccine candidates in India and the government will soon take a call on them.
Sharma tweeted, "How can DCGI start processing vaccine applications in violation of rules and protocols? Cautioning the government that human lives and health is involved. No shortcuts and compromising safety standards and rules can be accepted."
Sharma, the deputy leader of Congress in Rajya Sabha and a former union minister, said the news on early arrival of Covid-19 vaccine in India raises hopes and will be uplifting for national confidence, but applications of US pharma giant Pfizer and Bharat Biotech for emergency use authorisation raise fundamental questions and concerns.
"Pfizer has not conducted any trials in India and the company has not got a licence from its country of origin. Bharat Biotech has not completed Phase 3 trials and even not released any interim data on efficacy of vaccine," he claimed.
The Indian arm of US pharmaceutical giant Pfizer had on December 4 sought approval for its vaccine from the central drug regulator, after the firm secured such clearance in the UK and Bahrain.
The Pune-based Serum Institute of India sought the nod for the Oxford Covid-19 vaccine, Covishield, on December 6.
Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its Covid-19 vaccine Covaxin.
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Pfizer, Bharat Biotech and the Serum Institute of India have applied to the Drug Controller General of India (DCGI) for emergency use authorisation of their Covid-19 vaccine candidates in India and the government will soon take a call on them.
Sharma tweeted, "How can DCGI start processing vaccine applications in violation of rules and protocols? Cautioning the government that human lives and health is involved. No shortcuts and compromising safety standards and rules can be accepted."
Sharma, the deputy leader of Congress in Rajya Sabha and a former union minister, said the news on early arrival of Covid-19 vaccine in India raises hopes and will be uplifting for national confidence, but applications of US pharma giant Pfizer and Bharat Biotech for emergency use authorisation raise fundamental questions and concerns.
"Pfizer has not conducted any trials in India and the company has not got a licence from its country of origin. Bharat Biotech has not completed Phase 3 trials and even not released any interim data on efficacy of vaccine," he claimed.
The Pune-based Serum Institute of India sought the nod for the Oxford Covid-19 vaccine, Covishield, on December 6.
Hyderabad-based pharmaceutical firm Bharat Biotech on Monday applied to the central drug regulator seeking emergency use authorisation for its Covid-19 vaccine Covaxin.
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