New Delhi, January 3: The Drug Controller General of India (DCGI), country's apex regulatory authority for medicinal products, on Sunday approved Oxford's COVID-19 vaccine Covishield and Bharat Biotech's Covaxin for restricted emergency use in India. This means vaccines of Serum Institute of India and Bharat Biotech have been granted permission for restricted use in emergency situation by the drug regulator. The Drugs Controller General of India Dr VG Somani made this announcement at a press conference at 11 am today.
Somani said that the Subject Expert Committee has recommended allowing restricted use of COVID-19 vaccines developed by Serum Institute of India and Bharat Biotech. So far in India, Covishield and Covaxin have received clearance from a key expert panel. Adding further, he said, "We'll never approve anything if there is slightest of safety concern. The vaccines are 100 per cent safe. Some side effects like mild fever, pain & allergy are common for every vaccine. It (people may get impotent) is absolute rubbish". Bharat Biotech's Covaxin Gets CDSCO Panel Nod, India's 2nd Vaccine Candidate to Receive Emergency Use Approval.
Here's the tweet:
Vaccines of Serum Institue of India and Bharat Biotech are granted permission for restricted use in emergency situation: DCGI pic.twitter.com/fuIfPQ9i7B
— ANI (@ANI) January 3, 2021
The Serum Institute of India (SII), Bharat Biotech and Pfizer had applied to the DCGI seeking emergency use authorisation for their COVID-19 vaccine candidates and had been awaiting approval. On Saturday, an expert panel of the Central Drugs Standard Control Organisation (CDSCO) had recommended granting permission for restricted emergency use of the indigenously developed COVID-19 vaccine Covaxin with certain conditions. This came a day after the panel gave similar direction for the Oxford COVID-19 vaccine.
The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield' while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.On December 31, the DCGI had said that India is likely to have a COVID-19 vaccine in the New Year. Speaking at a webinar organised by the Department of Biotechnology, V G Somani of the DCGI said the most important thing is that the industry and research organisations have stood the test of time.