A Deep Look Inside Fakeer's Jhola
More dirty truths about our Pharma Sector and Incompetent Media failing to report FDA observations in detail and Fakeer's Extortion of Pharma companies.
I thought I would quickly tick off the rest of Pharma companies who bought large amount of Electoral Bonds and gave to BJP, but I'm having no such luck. Even API manufacturers like Divi's Laboratories had serious FDA warnings and Non-compliance Observations.
DIVI'S LABORATORIES and Troubles with US FDA (2016-2017)
So he is worth 7 times the annual revenue of his firm .. Revenue remember is not profit.. but these are the sign of times in middle of Bipartisan "Global Stock Market" bubble. But this now, but we need to rewind a little bit to December, 2016 to find a really bad US FDA (CFR 483) inspection report.
This 18 page report was prepared after inspection of Divi's Laboratories' Vishakhapatnam Unit II from 29th November to 6th December, 2016. Let me quote from the report, what and how serious these non-compliances were.. because no Media in India has covered them. Those days you could not copy-paste directly from FDA'S CFR 483 reports. But in recent reports one can copy-paste, still our Media never reads them, instead they merely copy-paste from every Pharma companies' press release.
These were the observations:
1. Proper controls are not exercised over computerised systems used for analytical testing to ensure drug products meet their specified quality attributes.
A. Your firm engages in extensive use of "Inhibit Integration" and other anomalous integration techniques for assessing US APIs such that unknown impurities are disregarded without scientific justifications. Furthermore, unknown impurities are not assessed or reported.
In a neatly formatted tabular format US FDA cited 48 such cases regarding 9 products/APIs and concluded that "inhibit integration" was used to mask unknown impurities.
They even cited peculiar chromatograph spikes suggesting impurities. Regarding Chromatographic systems US FDA reports cite and I quote:
B. 60 of your R&D division's chromatographic systems do not have audit trails enabled or enabled audit trails on November 27, 2016, the day before the initiation of US FDA inspection.
.. and .. that November 27 was a Sunday, so technicians came on a Holiday to enable audit trails??
Furthermore, we observed drug products from production at R&D ... we noted obscurely named sequences chromatographic sequences in these systems.
They cite 8 such examples .
Observation No. 2:
Facilities and equipments are not maintained to ensure the purity, quality, strength and identity of APIs.
The report cited 6 examples.
3. Your R&D division guides quality and production to commence activities inconsistent with CGMPs
The report cited 9 such cases .
4. Failure to conduct a thorough investigation.
They cite cases of complaints about quality on 28th and 30th June, 2016.
5. Documentation and records are either not maintained or inaccurate/ falsified.
You can find the details of 4 cases in the screenshot that I've attached above.
Well, there wasn't much noise in the Media till this resulted in an Import Warning for Divi's Laboratories next year, that too, in Foreign Press.
To resolve those issues, Both US FDA and Divi's Lab agreed to have the facilities re-inspected on September 2017, but this time a 5 page FDA CFR 483 report cited 6 CGMP non-compliances.
As your can see, Observation Number 1 is actually a repeat observation as it was noted as Observation number 2 in 2016 report. Observation number 2 is actually a much detailed observation number 4 of last report, as was the new Observation number 3.
But new and old non-compliances were put in the backburner as Geopolitical needs conflicted with scientific scrutiny and in 2020, when every Pharma companies' dream "PANDEMIC" arrived, every sort of restrictions were lifted by both Trump and then by Biden.
In fact, Even New York Times printed an article which was syndicated and circulated throughout the world about concerns on Joe Biden's pick of US FDA chief, Robert Califf ..
I thought "Clinical trial" was a multi discipline exercise, where professionals from various fields offer their expertise to verify the usefulness of a drug or therapy.. but never heard someone is a "Clinical Trialist" .. well, he has the controls of Nuclear missiles, so I guess Biden can call anybody anything.
2023: Election in Telangana and Califf visit to India and subsequently to Divi's factory.
As Elections in Telangana was coming closer, Hyderabad based Divi's Laboratories bought 20 crore in Electoral Bonds on 5th July, 2023 gave it to local ruling BRS.
Then came the news that US FDA Commissioner would be visiting India and many Pharma companies started courting BJP so that they would arrange a meeting or a factory visit by Robert Califf and BJP run health ministry happily put Party's interest before Country's Interest and Interest of Humanity at large.
Protocols be damned, Califf visits various manufacturing units and "Godi Media" reported these visits with much pomp and gala.
On 11th October, 2023, Divi's Laboratories purchased 35 more One Crore denomination Electoral Bonds and gave cool 30 Crore to BJP.
I have no idea whether Robert Califf knew that BJP is charging Money for his visit to manufacturing units.
Califf's visit was just a tour and not a technical inspection.. as "Clinical Trialist" professionals are not qualified to a quality or process audit of a pharmaceutical manufacturing unit :)
Was this 30 crore payment a bribe or extortion by BJP? Godi and corrupt Indian Media would never ask? Why would a company with 520 cr
Meanwhile, Robert Callif had his own scams to do.. On returning to Washington, he batted for Generic Drug Making Dollar Billionaires (as claimed by Forbes and ranked by Bloomberg Billionaires Index) and said "Generic Drug prices should be hiked" as Indian Billionaires (just a handful though) asked him.
Dr. Reddy's Laboratories and the tale-tell episodes of Electoral Bond purchases, Product recalls from International markets and Russian vaccine production and troubles with Regulators.
It isn't hard to find any news of Dr. Reddy's Laboratories getting a hard knock from Drug product Regulators, in International Pharma managizes and portals. Those are the only places to look, as Indian Media and press are totally in collusion with Pharma companies as well as being technically incompetent and completely morally bankrupt.
Good news for Dr. Reddy's is that I could not find any US FDA serious warning letters to them in last 5 years, unlike in 2015 when they had 3 plants named in a serious warning letter and had to voluntarily recall starting in 2016 other drugs as well as this report still recalls.
Here is an excerpt from news report covering the serious warning letters.
US FDA wasn't the only regulator unhappy with Dr. Reddy's then, in 2017, German regulators were unhappy with them too.
Although the German regulators were happy with the corrective plans Dr. Reddy's proposed subsequently.
In early 2019, Dr. Reddy's suffered a massive jolt when US FDA inspection at bachupally plant got 11 Non-compliance Observations including 4 repeat observations. https://www.fiercepharma.com/manufacturing/dr-reddy-s-racks-up-more-repeat-violations-at-bachupally-formulations-plant
But in spite of these observations, their sales at US markets did not slow down.. Indian Pharma companies have a secret weapon, India also exports Doctors to US, although they are not wrapped in boxes and sent in a container... and Doctors prefer to use drugs and brands they are familiar with.. preferably for a long time.
So Dr. Reddy's bought Electoral Bonds worth 7 crores to be in good books of ruling TRS (now called BRS) on 8th May 2019 and gave them those..
Meanwhile Dr. Reddy's were hit by two voluntary drug recall in US ( and only in US), first was a case of mislabeling of Levetiracetum on 4th February, 2019.
Next in 2020, on 26th March, when injection ampules of Phytonadione Injectable Emulsion, were breaking and shattering..
On 2019, we find FDA slapped fourth Form 483 (for Bollam plant) for that year on Dr. Reddy's where 5 serious Non-compliance noted as reported by Fiercepharma:
The non-compliances were something FDA had warned Dr. REDDY'S before like Product complaints are not thoroughly investigated, OOS testing not conducted properly... to .. Records not made available to FDA investigators.
Then came the Pandemic, Dr. Reddy's Laboratories tied up with Russian Gamaleya National Research Institute of Epidemiology and Microbiology to manufacture and conduct stage trials of Covid19 vaccine named SputnikV! In case you forgot that I'm giving a screenshot of a Forbes India article.
Conducting Clinical trials in India are a golden opportunity for any Pharma company in the world, No clinical trial ever failed in India on Covid (even those using herbal concoctions) and everyone gets the required and desired outcome mentioned at the time design of clinical trial study.
On April 13, 2021 .. DGCI approved Sputnik V as 3rd Covid19 vaccine, well, when applied through that PMCARES route, DGCI never said no to anyone during Pandemic. Ha ha ha.. DGCI expert supposedly approved the Phase III Clinical trials of Sputnik V, without seeing the phase 1 and phase 2 study design and detailed results.
Remember at that time, Covid19 vaccines were not free at all, A single dose of AstraZeneca or Sputnik would cost around One thousand rupees in all major cities of India. Every vaccine taker had to register themselves with a Government database costing Rs. 350, an one time fee to get a Vaccination (Stupidity) Certificate which carried Don Fakeer's photo instead of Vaccinated person's photo.
But Indian Urban Population no longer thought Russian vaccine is a good idea and they chose the Oxford-AstraZeneca vaccine instead of SputnikV, but they exported this vaccine to Russia and other countries of Russian influence.
Dr. Reddy's were Back to Electoral Bond purchases, on 1st July, 2022 SBI bond purchase records show, "DR REDDYS LABORATORIES LIMITED" purchased 4 bonds worth One Crore and gave 3 of them to Telegu Desham Party and 1 Crore of BJP.
Similarly on 6th October, 2022 , as "DR.REDDY'S LABORATORIES LTD" they purchased 25 One Crore EBs (Electoral Bonds) for BRS and 2 One Crore EBs for BJP.
From these data it seems that BJP's contributions were like in "Local taxes are extra" mode.
10 November, 2022, as "DR.REDDY'S LABORATORIES LTD" they purchased 15 One Crore EBs of which 12 crore went to Fakeer's Jhola as donations to BJP and 3 Crore went to Congress party.
Incidentally their profit dropped that quarter too but pleasing political parties are more important than pleasing the stupid retail shareholder, who keeps clinging to the share certificates in hope that one day they will become "Uber Rich" with that.
2023 Began well for Dr. Reddy's are they bought generic formulation and other US assets from Mayne Pharma
Deal was worth US$ 105 million. Also we learned that an Overseas Subsidiary of Dr. Reddy's "Aurigene Pharmaceutical Services" was to invest $40 million in a Dr. Reddy's plant at Hyderabad, India; from another Fiercepharma report.
Don Fakeera was extremely annoyed with Dr. Reddy's as they were paying others in Millions and did not offer to pay more money in Electoral Bonds. So this happened later in November 2023... IT raids people from "Real Dr. Reddy's" family, many of whom are shareholders but not on Companies board.
Isn't it stupid of Finance Ministry to promote prevention of Double taxation and then raid major shareholders of Major Pharma company, whose overseas profits are there in the books of Overseas companies in Delaware and other tax havens.. They should have raided the CEO, Mr. Erez Israeli instead.. ha ha ha.. these are the official Directors.. Not too many Reddys are present.
Now this Deccan Chronicle report of Income Tax raid is from November 13 and on November 17, 2023, Dr. Reddy's Laboratories Ltd buys 21 Electoral bonds
and gives 10 of them to Don Fakeer's Jhola and BJP encashed them on 23rd November.. IF THIS IS NOT A CLEAR CASE OF EXTORTION via INCOME TAX PEOPLE, then the word Extortion should be removed from all dictionaries.
As if to register a protest, Dr. Reddy's gave remaining 11 Electoral Bonds to Congress party, who would win the Telangana election in 2023 by decimating BJP and its allies.
I know this post is getting very long, but there are more bond purchases and US FDA CFRs (I had to read 16 of them, to give you the excerpts) to cover,
The 27th October, 2023 CFR 483 noted 10 Federal Regulation Non-compliance Observations at Bachupally plant.. yup the same plant that FDA was unhappy with in 2019.
Some of the Observations are repeat non-compliances as well.
- Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
Specifically, There is a lack of adequate evaluation of equipment conditions upon preventative maintenance, equipment cleaning, and line clearance.
- Determinations of conformance to appropriate written specifications for acceptance are deficient for drug products.
Specifically, determination of conformance to written specifications are deficient for TAMC (Total Aerobic Microbial Count) test and TYMC (Total Yeast and Mold Count) test conducted for purified water and drug products. (whow)
- There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
Specifically, the quality unit failed to investigate deviations and investigations thoroughly that could potentially impact the patient safety and product quality.
So you see, these observations are actually critical non-compliances of norms as a result of which end products can potentially can harm any human being, not only the American consumers. This 23 page PDF cited 10 such issues.
No matter how many Technical problems they have, they are not exempt from paying Political parties.. Don Fakeer's ally Telegu Desham got 10 crore in Electoral Bonds which Dr. Reddy's purchased on this very year, on 4th January, 2024.
Would these parties go and clean equipments and utensils in Dr. Reddy's plants .. No way, none are technically qualified to do that.. this isn't dishwashing at a tea-stall.
Let's end this Medical thriller by giving you the news of another Dr. Reddy's recall (only in US, sorry Canada and others) of a drug used in treating Phenylketonuria on 23rd April, 2024 due to Sub-potency.
If only Robert Califf, Commissioner of FDA spent more time reading CFR reports than touring...
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