InvestorQ : Why has the DCGI ordered Serum Institute to refrain from any testing for now?
vidhya Laxmi made post

Why has the DCGI ordered Serum Institute to refrain from any testing for now?

Answer
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sarah Leo answered.
2 weeks ago


DCGI, the nodal Indian drug regulator, has instructed Serum Institute based out of Pune to immediately to suspend recruitment for its clinical trials of AstraZeneca's potential COVID-19 vaccine. The freeze will stay till further orders from the DCGI.

The DCGI has also called for increased safety monitoring of those already vaccinated with the experimental vaccine. Astra and Oxford stopped the tests after one of the volunteers administered showed some health concerns.

While Serum Institute has already put the trials on hold even before the DCGI order, the DCGI order places further restrictions on the trials. Now, the DCGI has also called upon the vaccine maker for details on the suspension of trials overseas.

It may be recollected that the DCGI had given approval to Cyrus Poonawala’s Serum Institute to run mid-stage and late-stage clinical trials on AstraZeneca’s COVID-19 vaccine candidate to determine its safety and ability to trigger immune response in users.