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Drug regulator begins reviewing to speed up vaccination | India News

NEW DELHI: In order to ensure the rapid availability of the Covid-19 vaccine in the country, the drug regulator has initiated ongoing accelerated reviews for candidate vaccines that are in an advanced stage of clinical trials.
Ongoing review enables the regulator to examine the data generated through clinical trials in real time rather than waiting for the trials to finish and the full data to be immediately available for evaluation.
“The Central Organization for the Control of Medicines Standards will carry out an intermediate analysis of data from clinical trials in predefined stages to facilitate early decision-making in emergency situations. For candidates that have been developed outside of India, the regulator will also consider preclinical or clinical data generated outside the country along with data from bridging studies in India before giving approval, ”said the Comptroller General of Medicines of India (DCGI ) VG Somani. .
TOI had reported on Nov. 4 that India may consider continued reviews of Covid-19 vaccine clinical trials. In India, the government hopes to launch a vaccine for the priority population early next year.

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