In a notification, the Drugs Controller General of India has stated that vaccines which have been approved for restricted use by US FDA, EMA, UK MHRA and PMDA Japan and under the WHO Emergency Use Listing (EUL) and where millions of individuals have been vaccinated, the requirement of conducting post-approval clinical trials and the requirement of testing every batch of the vaccine by Central Drugs Laboratory (CDL), Kasauli can be exempted.
However, scrutiny and review of their summary lot protocol and certificate of analysis of the batch shall be undertaken by CDL, Kasauli for batch release as per standard procedures and the requirement of assessment of the first 100 beneficiaries for first 7 days for safety outcomes before the vaccine rolled out for further immunisation programme and other procedures for applications will remain the same.
This means that Pfizer and Moderna vaccines will not require clinical trials in India.
India on Wednesday reported 1,32,788 new COVID-19 cases as 3,207 more patients succumbed to the coronavirus in the last 24 hours, Union Health and Family Welfare Ministry said.
India’s overall tally of Covid-19 cases now stands at 2,83,07,832 with 17,93,645 active cases and 3,35,102 deaths so far.
(With IANS inputs)
Published : June 03, 2021
By : The Statesman/ANN