Thread by @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?

His reply: During pandemic, we could have an indigenous vaccine…after initial capacities of manufactures were exhausted, expansion and plant upgradation was needed… it takes time.. corrective action doesn’t happen overnight. For full reply, refer to his ans at 1.00.04 in video

All vaccine manufacturers expanded their capacities after a point. ALL. Out of 11 WHO approved vaccines, only #covaxin has been suspended due to deficiencies in good manufacturing practises. Therefore it was difficult to make sense of his answer.

He said not a word about findings, that was asked; forget about the way forward since the suspension still holds and WHO said in July to @TheWireScience that manufacturing practises remain “unacceptable”. The vaccine continues to be used in India.

On the sidelines, he asked me why should not the WHO share the report with you (why put onus on CDSCO) when I told him the WHO told @TheWireScience in April and in July it is only a country’s drug regulatory authority that can share the reports.

He also claimed it was “just a draft report” and all was well. Asked, why not put that in public domain saying it was a draft he did not say much.

WHO has never said it was a draft rpt and if it was draft it ought to have been challenged which never happened.

But he didn’t say that CDSCO was did not have these reports or was not aware of it — something what CDSCO said in RTI replies to @PriyankaPulla and @OfficialSauravD.

Saurav’s complaint case in CIC against CDSCO PIO for lying on record in RTI led CIC issuing a show-cause notice.

This was @TheWireScience report in August on WHO’s continued suspension that was put in place in April. WHO said it had rejected company’s corrective action plan and manufacturing practises continued to remain unsatisfactory
google.com/amp/s/science.…

This was the April report of @TheWireScience that went into the details of suspension and what possible violations of good manufacturing practises could mean.

science.thewire.in/health/who-cov… (n/n)

Correction: DCGI’s full reply at 1:04:00 in the video.