After setback, Serum Institute allowed to resume Oxford's co
Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...Now open: Certificate Course in Management of Covid-19 by Govt. Of Gujarat and PlexusMDKnow more...
Get authentic, real-time news that helps you fight COVID-19 better.
Install PlexusMD App for doctors. It's free.
Drugs Controller General of India (DCGI) Dr. VG Somani has permitted the Serum Institute of India (SII) to resume trial of the coronavirus vaccine candidate, being developed by the University of Oxford, revoking the last week's order that halted the process.

The Pune-based firm was, however, directed to take extra precautions. Effectively, the order directing SII to stop recruitment of candidates was also withdrawn.

• SII approached DCGI seeking permission, regulator accepted request

15 September: DCGI's permission came after SII furnished recommendations of the Data Safety Monitoring Board in the UK and India, as demanded by the regulator earlier, and sought approval for re-starting recruitment for the phase 2 and phase 3 trials.

Dr. Somani in its reply to SII said the letter was "carefully examined." While giving the requisite permission, DCGI asked SII to submit medication details.

• Resume trial, but follow conditions: DCGI to SII

In the order, DCGI told SII it can recommence the trial dated August 2, 2020, according to the already approved protocol and under the provisions of New Drugs and Clinical Trials Rules, 2019.

The regulator also asked SII to scrupulously follow conditions "such as extra care during screening, additional information in the informed consent, and close monitoring for similar events during the study follow-up."

• Background

September 11: DCGI had directed Serum Institute of India to suspend any new recruitment in phase two and three clinical trial of the Oxford COVID-19 vaccine candidate till further orders in the backdrop of pharma giant AstraZeneca pausing the clinical trials in other countries because of "an unexplained illness" in a participant in the study.

Source: https://www.newsbytesapp.com/timeline/india/66102/311765/sii-gets-approval-to-resume-vaccine-trial
Dr. T●●●●z H●●●●●●i and 1 others like this
Like
Comment
Share