The Government of India has laid out guidelines for the Restricted use of vaccines in Emergency situations. The guidelines also allow the ready-to-use vaccine to be fully utilized from 1st May.
On the 15 th April, 2021, the National Expert Group on Vaccine Administration for the COVID-19 recommended the authorization for the emergency use of COVID-19 vaccine, which is already approved for restricted use by US FDA, EMA, UK MHRA, PMDA Japan, or listed in WHO Emergency Use Listing.
The vaccines used should follow the guidelines mentioned in the National COVID-19 vaccination programme. The first 100 individuals vaccinated should be monitored for safety for 7 days. Within 30 days of approval of the vaccine, the applicant should initiate post-approval bridging clinical trials.
The ready-to-use vaccines will be allowed to be fully utilized from 1 st May 2021 as per the guidelines on Liberalized Pricing and Accelerated National COVID-19 Vaccination Strategy published by the Ministry of Health and Family Welfare.
Any private or government entity who wishes to import Covid-19 vaccine for vaccination needs to follow the following process:
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