Highlights
SEC in CDSCO on Wednesday did not grant EUA to COVID-19 vaccine developed by Oxford-AstraZeneca for use in India.
The SEC also refused to consider the EUA request of Pfizer and Bharat Biotech Pvt Limited.
The SEC is scheduled to meet again on January 1 to hold discussions over this matter.
In a significant development, the Subject Expert Committee (SEC) in Central Drugs Standard Control Organisation (CDSCO) on Wednesday (December 30) did not grant EUA to COVID-19 vaccine developed by Oxford-AstraZeneca for use in India. The SEC also refused to consider the Emergency Use Authorisation (EUA) request of Pfizer and Bharat Biotech Pvt Limited saying that vaccines developed by all these companies will not be given authorisation “yet” as more data is needed.
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Terming the approval for Oxford-AstraZeneca vaccine for use in the UK as a big step forward , AIIMS Delhi Director Dr Randeep Guleria on Wednesday said that India will have the COVID-19 vaccine within days. This is very good news that AstraZeneca got approval for its vaccine by UK regulatory authorities. They have robust data and in India and the same vaccine is being developed by the Serum Institute of India. This is a big step forward not only for India but many parts of the world, Guleria told ANI in an interview. This vaccine can be stored at two to eight degrees centigrade. Therefore it would be easy to store and transportation. Storage can be done using a simple fridge rather than what is required in the Pfizer vaccine of minus 70 degrees centigrade, All India Institute Of Medical Sciences, New Delhi Director Dr Guleria said.
India will have happy New Year with something in hand: DCGI on Covid vax
By IANS |
Published on
Thu, Dec 31 2020 15:27 IST |
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India will have happy New Year with something in hand: DCGI on Covid vax. (Photo Credit: Twitter). Image Source: IANS News
New Delhi, Dec 31 : As India awaits with bated breath for a silver bullet against coronavirus, the Drug Controller General of India (DCGI) on Thursday hinted at the approval of vaccine and said the country will have a happy new year with something in hand.
The drug regulator is currently analysing the data submitted by Serum Institute of India, which is manufacturing Oxford-AstraZeneca vaccine and Bharat Biotech, which is making indigenous vaccine in collaboration with ICMR. The expert panel will convene a meeting on January 1 on this.
As India awaits with bated breath for a silver bullet against coronavirus, the Drug Controller General of India (DCGI) on Thursday hinted at the approval of vaccine and said the country will have a happy new year with something in hand. The drug regulator is currently analysing the data submitted by Serum Institute of India, which is manufacturing Oxford-AstraZeneca vaccine and Bharat Biotech, which is making indigenous vaccine in collaboration with ICMR. The expert panel will convene a meeting on January 1 on this. The industry and research organisation have stood the test of time. It has been a very wonderful experience. Probably, we will have a happy new year with something in hand. That is what I can hint at, Drug Controller General of India (DCGI) V.G. Somani said.
2-MIN READ Happy New Year With Something in Hand : Drug Regulator Hints at Covid-19 Vaccine Approval Soon
A ground staff walks past a container kept at the Cargo Terminal 2 of the Indira Gandhi International Airport, which according to the officials will be used as a COVID-19 vaccine handling and distribution centre. (Reuters)
The assurance from the Drug Controller General of India (DCGI) comes ahead of a crucial meeting of the expert panel on emergency use vaccine authorization, which is set for Friday.
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A vaccine against coronavirus can be approved in India soon, the country’s apex drug regulator hinted on Thursday and said the country will have a “happy new year with something in hand.”