On Sunday, India’s drug regulator approved Oxford’s COVID-19 vaccine Covishield, produced by the Serum Institute of India, and natively-developed Bharat Biotech covaxin for restricted emergency use in the country, paving the way for massive inoculation.
The approval of the Drugs Controller General of India (DCGI) was granted on the basis of the recommendations of the COVID-19 Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO).
“After a proper review, CDSCO has decided to accept the recommendations of the Expert Committee and therefore, M/s Serum and M/s Bharat Biotech vaccines are approved for restricted use in emergency situations,” said DCGI Dr. V G Somani at a press conference.
Dr Poonam Khetrapal Singh, WHO Regional Director for the South East Asia Region, said, "WHO welcomes the first authorisation for emergency use of the COVID-19 vaccine in the WHO South East Asia Region. The decision taken today by India will help to step up and strengthen the fight against the COVID-19 pandemic in the region.
The Serum Institute of India, the world’s largest manufacturer of vaccines, has joined forces with AstraZeneca to manufacture Covishield.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Medical Research Council (ICMR).
In addition, the authority granted permission to Cadila Healthcare to conduct a Phase III clinical trial of its vaccine candidate in India, Somani said. Source