Banjot Kaur Profile picture
Mar 3 7 tweets 2 min read
TRUST DRUG CONTROLLER: Paul's response in @MoHFW_INDIA press conference today, responding to a question why no data in public domain on #Corbevax
Thanks @monikareporter for asking a pointed question.
Paul: "Corbevax, clearly, the EUA has been given for adult and children. Be rest assured that the data has been by drug regulator. Be also rest assured for both these groups is being reviewed by the NTAGI because we work in tandem."+
"It is also expected that the company would be placing the data in the scientific journals. We hope it would be done soon. We encourage them. It is a matter of practise of this nation that science that comes out should be presented to the world." +
"Certainly the data has been seen and appropriate decision has been taken. NTAGI will take a decision on the opportune time."+
"Based on this the decision on (how to) use corbevax vaccine would be taken.
Yes, we hve placed order of a certain quantum that has been delivered. The vax wil find a way in the national prog. But how best to use it and when to use it and well in time to use before expiry date"+ is a journey (of taking a decision) very much on. A decision will follow at appropriate time.

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More from @Banjotkaur

Mar 1
UNTIMELY death of a loved one, even if it has happened more than a decade ago, is an extremely difficult fact to come to terms with. Two days ago a friend and I, out of nowhere, went discussing about last 11 days of another friend who died for want of a liver transplant+
She was our batchmate during graduation at a Varanasi univ. She continued to pursue Master’s from there, I moved to Delhi. We were 21. One fine day during our PG days, we got to know she was suffering from liver cirrhosis—otherwise a totally fit person.
This was 4 days after she got was with ‘jaundice' and we kept talking—we thought it would be just fine.

4 days later got a call saying ur friend has bcm unconsciousness from somebody who knew her. I dialled friends in the univ.With their help she got admitted at the varsity hosp
Read 16 tweets
Dec 4, 2020
At times, one has to write just to record for the history. That, a country's regulator invites media for webinar on clinical trials and when a question is asked, the reply is this 👇
"My request was to limit the question regarding understanding the processes involved. About the specifics of the things you are questioning, there are forums…there are weekly press conferences by department / ministry. This question can be asked there."…
Other issues related to CTs which were asked but were not taken up due to 'paucity of time':

The composition of ethics committees of institutions where these trials are going on

The role Central Drugs Standard Control Organisation’s own subject expert committee
Read 4 tweets
Dec 3, 2020
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)
Read 7 tweets
Apr 4, 2020
We know the idea of asking reporters to put quests on @MoHFW_INDIA WA group before #pressers has been farcical. Not only quests are cherry-picked, hardly 1 or 2 are taken up. Here's a thread of quests which went #unanswered on #Apr_3. #IndiaFightsCoronavirus by #GaggingPress.
1.Out of all the tests done in India so far, can Dr Gangakhedkar clarify how many individual people been tested,and how many second, third, fourth tests etc have been done?- Some states have announced they will expand testing criteria from ICMR's criteria. Are they allowed?
2. Will those positive results be accepted by the Centre?
3. How many ILI and SARI patients come up in hospitals across the country over the last two weeks?Also, how many samples of such patient have sentinel surveillance been conducted on?
4. How many Docs are tested positive
Read 15 tweets

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