Drug regulator starts rolling reviews to fast-track vaccine

Interim analysis of clinical trial data at pre-defined stages will be conducted by the CDSCO

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Medicine Injection Vaccine
Picture: Pixabay

NEW DELHI: In order to ensure speedy availability of C-19 vaccine in the country, the drug regulator has started accelerated rolling reviews for the vaccine candidates which are in advanced stage of clinical trials.

Rolling review enables the regulator to examine the data generated through clinical trials on a real-time basis instead of waiting for the trials to be over and full data to be made available for evaluation at once.

“Interim analysis of clinical trial data at pre-defined stages will be conducted by the Central Drugs Standard Control Organisation (CDSCO) to facilitate early decision in emergency situa-tion.


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For candidates that have been developed outside of India, the regulator will also consider pre-clinical or clinical data generated outside of the country along with data from bridging studies in India before giving approval,” Drugs Controller General of India (DCGI) VG Somani said.

TOI had reported on November 4 that India may consider rolling reviews of C-19 vaccine clinical trials. In India, the government is expecting to roll out a vaccine for the priority population by early next year.


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