Thread by @d_s_thakur

So here is the backstory on this excellent piece from @PrabhaRaghavan. This is a long thread, so please bear with me.

@CDSCO_INDIA_INF stonewalled us for over two years before they gave us an unsigned copy of this report (sans annexures) 15 hrs before the CIC hearing 1/n

https://twitter.com/PrabhaRaghavan/status/1267589581915869184

2/n Here is the Parliamentary Standing Committee Report from 2012 that pointed out serious lapses in how certain drug approvals were granted: http://164.100.47.5/newcommittee/reports/englishcommittees/committee%20on%20health%20and%20family%20welfare/59.pdf
@Teensthack @rdivia

3/n One of the drugs in question was Buclizine, which originally was approved as an anti-histamine; was surprisingly approved later for an additional indication as an "appetite stimulant" - targeted mainly at children. @Apothecurry @VikasReports @anupsoans @sunilattavar @BLRrocKS

4/n Except that many doctors pointed out that the lack of appetite in kids was not a disease.
@sanjaynagral @shahalam13 @spkalantri
The DCGI set up a committee, in 2013, under the Chairmanship of Dr. Mohapatra to investigate and fix responsibility of the suspicious approvals

5/n granted by past DCGIs. The final report was surprisingly never published. @nit_set @samar11 @pash22 @scleroplex @Apothecurry

@preddy85 tried to get a copy of the report in 2015 but we were stonewalled by the @MoHFW_INDIA
@shaileshgan @AnjaliB_ @johriamrita @suchetadalal

6/n The DCGI rejected our RTI application and its appeal on the grounds that the report of the Committee was "untraceable".

Missing files are an offense under the Public Records Act and a legal inquiry in such cases is a must. @VinitaDeshmukh @nikhilmkss @Moneylifers @AnooBhu

7/n It took two years for the Central Information Commission to schedule a hearing. Fifteen hours before the hearing, the DCGI's office emailed @preddy85 an unsigned, uncertified copy of the report. @grumpeoldman @GenericIPguy @netshrink @AnantBhan @VidyaKrishnan @dawalelo

8/n The DCGI's office said in their submission to the CIC that they waited 2 years to ask Prof. Mohapatra for a copy. Wonder why?
Well, read it Here for yourself: dineshthakur.com/wp-content/upl…
@PriyankaPulla @RemaNagarajan @sujakrao @DesirajuKeshav @SonaliVaid @chitraSD @malini_aisola

9/n One reading of the report will tell you why they suppressed it - it is totally scandalous. It pinpoints and names three former DCGIs for their role in granting dubious drug approvals. @Singh10Seema @kaunain_s
Another drug which was a subject of the Mohapatra Committee was

10/n the FDC “Aceclofenac + Drotaverine”. Recall the big litigation when the government, acting on the Kakote Committee Report banned 344 such irrational FDCs in December 2017. Ever wonder why there was so much focus on banning these combinations with no scientific and clinical

11/n rationale compared to understanding why and how they got on the market in the first place?

Here, take a look:

12/n In 2004, when I was investigating the fraud at Ranbaxy, I discovered that the letters of approval from the DCGI’s office for specific drugs for India were type-written/printed in the company.

Sadly, I was not allowed to take these documents when I resigned. @KatherineEban

13/n The CIC has taken cognizance of the Ministry's conduct and has ordered remedial actions in its order: dineshthakur.com/wp-content/upl…

Why is it so difficult to get access such important reports which have a disproportionaite impact on #publichealth @swagata_y @priyakamal

14/n More importantly what action does the Ministry of Health intend to take vis-a-vis these former DCGIs?

Should we ask what the accountability should be of the DCGIs toward the people of India? @PMOIndia

15/n Should mala fide decisions that put the health of children at risk be protected by qualified immunity? The CDSCO still does not make its decisions on drug approvals public. We don’t know on what basis such approvals are granted. Is this acceptable? @saliltripathi @Mundra08