Most recents (9)

The Hindu

@the_hindu

#JustIn | CDSCO and State Drug Controller #Haryana have stopped all the manufacturing activities of M/s. Maiden Pharmaceuticals Limited at #Sonepat on 11.10.2022 on grounds of deficiencies found in local inspection. | @BShajan reports

The #HealthMinistry has formed a four member panel to look into the details shared by #WHO on 66 children's deaths in #Gambia. | @BShajan reports

The committee will, after examining and analysing, adverse event reports, causal relationship and all related details shared by #WHO, suitably advise and recommend #DCGI about further course of action. | @BShajan reports

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Banjot Kaur

@Banjotkaur

Today was the first appearance of India’s #DCGI on a public platform after the WHO suspended the supply of #BharatBiotech’s #Covaxin to UN due to quality issues it found in its manufacturing practises, in March this year (1/n)

It was at @CPR_India dialogues series where the discussion was happening about regulation of various health aspects in India. I asked him ( at 1.01.20) since WHO had already submitted the inspection report; also the Bharat Biotech’s corrective plan and

WHO’s rejection of it, would he divulge the key findings of both reports (submitted in Apr and Jul) and since this was the issue of larger public interest, would he like to put these reports in public domain?

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Banjot Kaur

@Banjotkaur

The #WHO on April 2 issued a statement saying the supply of #Covaxin to UN agencies had been suspended due to "deficiencies in good manufacturing practices". There were not mny details. In an email, they have now told @TheWireScience the following : science.thewire.in/health/who-cov… (1/n)

"Problems were detected in some parts of the manufacturing process. SOME CHANGES WERE MADE after the emergency-use license was granted but were not submitted to the national drug regulator and WHO for evaluation and validation."

The WHO still didn't specify what were those changes. Whether those changes were related to increase the yield, or on the front of raw materials or due to some other reason--we don't know. A GMP expert said major changes, if done post approval, have to be informed.

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NewsBytes

@NewsBytesApp

India's 1st coronavirus vaccine for kids could be ready by September, said Dr. Randeep Guleria, AIIMS chief said. "COVAXIN's data for children after completion of Phase 2/3 trials will be available by September, approval is expected the same month."
newsbytesapp.com/news/india/cov…

For context, AIIMS-Delhi had this month started screening children for the clinical trials of COVAXIN. A week before that, AIIMS-Patna had begun this jab's clinical trials on children. #AIIMS #clinicaltrial

Further, #BharatBiotech, which developed this vaccine, had last month obtained permission from the Drugs Controller General of India to carry out its trials on children. COVAXIN is India's only fully indigenous COVID-19 jab so far. #DCGI

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JayEnAar

@GorwayGlobal

I am deeply disappointed at T Jacob John. It is a smear to say that everyone who asked Qs of #DCGI when they 'approved' #Covaxin was anti-Indian is such patent nonsense as to be unworthy of rebuttal. To bring 'nationalism' into science is disgraceful.
deccanherald.com/national/much-…

I now learn that the "emergency-use approval" of Covaxin means, iot cannot be generally used but if someone desperately needs it then he can get it under trial conditions. This is disingenuous and garbled nonsense. No one desperately needs a vaccine except PEP in HepB or rabies

PEP is post-exposure prophylaxis. @BharatBiotech has in fact completed its planned recruitment of 26k subjects and within 12 weeks we will have the first cut efficacy data. Where was the need to rush with this spurious disingenuous play on words?

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Business Insider India🇮🇳

@BiIndia

"It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion.": tweets PM Modi

#CovidVaccine | #DCGI granting approval to vaccines of #SerumInstituteofIndia and #BharatBiotech accelerates the road to COVID-free nation: PM Modi

(PTI)

#CovidVaccine | India's drugs regulator approves #Oxford's #COVID19vaccine #Covishield and Bharat Biotech's #Covaxin for restricted emergency use

(PTI)

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Banjot Kaur

@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)

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alan

@alan27808766

1)India’s Covaxin may not be Indian enough, or worse!
Bharat Biotech (BB) announced that it had developed a vaccine against the novel coronavirus, named Covaxin, together with the Indian Council of Medical Research (ICMR) and
#BharatBiotech #Covaxin
science.thewire.in/health/how-ind…

2)National Institute of Virology (NIV), Pune.The company had also received permission from the Drug Controller General of India (DCGI) to begin human trials.
ICMR transferred the strain NIV had isolated to Biotech Bharat on May 9.
#NationalInstituteofVirology

3)The company published its press release on June 29. There were only 50 days in between, during which the company would have developed the inactivated vaccine, conducted pre clinical animal trials (with mice and hamsters),
ndtv.com/india-news/cor…

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