Hours after India's drug regulator approved indigenously developed 'Covaxin' of Bharat Biotech, Congress leaders raised concern over the grant of permission for the restricted use of Covaxin without its phase 3 trials.
Congress leaders asked the government to explain why mandatory protocols and verification of data has been dispensed with and warned the approval was premature'.
Congress leader Anand Sharma said the issue of granting authorisation to Bharat Biotech's vaccine needs to be taken carefully.
Congress MP Shashi Tharoor and Jairam ramesh also expressed apprehensions over approval to Covaxin, saying it has not yet had phase 3 trials.
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