No clinical trials required in India for global Covid-19 vaccines
New Delhi
02-June-2021

Photo: IANS
Globally available Covid 19 vaccines can now be launched in India without the requirement of post approval clinical trials and testing every batch of the vaccine.
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 nod is likely to apply first to Pfizer and Moderna vaccines. AstraZeneca's Covishield and Russia's Sputnik have already been approved. It is not clear whether the Chinese vaccines will come under this ambit or they will apply in India.
This is being done to augment the increased availability of imported vaccines for meeting the national requirements even though the domestic manufacturing is being lifted. -IANS
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