Mumbai: The Drugs Controller General of India (DCGI) has allowed the Pune-based Serum Institute of India (SII) to manufacture its COVID-19 vaccine ‘Covishield’. The manufacture of the vaccine was approved when the drug regulator approved the Oxford COVID-19 vaccine Covishield against coronavirus for restricted emergency use in the country.
Along with Covishield, DCGI developed Swadeshi of India Biotech. Approved for limited use for Covaxin ‘.
Drugs Controller General of India grants permission to Serum Institute of India to manufacture its COVID-19 vaccine 'Covishield' pic.twitter.com/qRX3ZI9xai
— ANI (@ANI) January 4, 2021
The DCGI said yesterday that it is approving the restricted emergency use of two coronavirus vaccines after receiving recommendations from a COVID-19 Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).
“After adequate examination, CDSCO has decided to accept the recommendations of the expert committee and accordingly, M/s Serum and Bharat Biotech vaccines are being approved for restricted use in emergency situations,” DCGI VG Somani told the media, adding “Serum and Bharat Biotech vaccines have to be administered in two doses”.
“We will never approve anything if there is even a slight safety concern. Vaccines are 110 per cent safe. Some side effects like mild fever, pain and allergies are common to every vaccine,” he said.
The drugs regulator clarified after concerns about the efficacy and safety of covaxin.
Covishield has been developed by the UK’s University of Oxford and pharmaceutical giant AstraZeneca and is being manufactured by the SII, the largest vaccine manufacturer in the world.