Thread by @Banjotkaur

So a media report says #DCGI has refuted any causal link between the serious adverse event (SAE) and #SII COVID vaccine trial participant. When we posed ques to the health ministry secy on December 1, he asked us to look into New Drugs and Clinical Trial Rules, 2019 (1/n)

What these Rules say (in case the death hasn't occurred)
1. The sponsor and the investigator shall forward their reports on an SAE to the Central Licencing Authority (DCGI), ethics committee and the head of the institution where the trial was conducted within 14 days of SAE(2/n)

2. The ethics committee shall forward the report and compensation to be given by the sponsor within 30 days of knowing that the SAE had occurred.
3. The DCGI shall pass an order or constitute an expert committee. (3/n)

4. The committee will take a call on causality and compensation, if any, in 60 days.
5. The DCGI, shall pass an order within 90 days.
6. The sponsor shall have to comply with the DCGI order in 30 days.
DO WE KNOW IF THESE RULES FOLLOWED? nothing in the public domain. (4/n)

On Dec 1, ICMR DG did say on stage, while addressing media that there was no causality link. However, on the sidelines, he said, "the final assessment will be done by the DCGI. I would not know when it would be completed.” (5/n)

@LeroyLeo7 asked in the presser if the ICMR endorsed the defamation notice sent to the trial participant. Health secy took that question, and not ICMR DG, and said neither did the govt endorse nor did it not endorse. (6/n)

downtoearth.org.in/test/news/govt…
(December 1) @AnantBhan @amarjesani
(n/n)