Another look inside Fakeer's Jhola : Pay to become RBI's part-time Director, More Pharma under US FDA scanner
If you don't know who the other guy is, He is Pankaj Ramanbhai Patel son of Ramanbhai Patel, founder of Cadila Laboratories and He is presently in Top 300 in Bloomberg's Billionaire Index. His father made him study Masters in Pharmacy, which he passed .. So he knows what US FDA Non-compliance Observations are.. unlike other Pharma barons of India.
He was the Managing Director of Cadila , which turned into ZydusCadila and now he heads the Zydus group, while his father's business partner and Co-founder Indravahan Modi's Son, (no relation with Mr. Fakeer) Rajiv Modi heads Cadila Pharmaceuticals. Second Generation of Entrepreneurs, you know.. can't keep their fathers' teammates.
Without further Ado, let's turn to the love letters US FDA wrote to Pankaj Patel citing serious breaches in drug manufacturing processes.
SERIOUS WARNING LETTER TO PANKAJ PATEL, CHAIRMAN, CADILA HEALTHCARE LIMITED :
Do note the clever Interoperability and interchange of two brand names, Cadila Healthcare is housed and headquartered at Zydus Tower, that's Too clever by half, I tell you. The umbilical cord was still not cut then..
At that time, he was also the President of FICCI, a chamber of commerce known for its love of crony capitalism.
May I remind you, US FDA was writing to qualified Masters of Pharmacy professional also.. He should have known the ramifications of following observations: (Source: FDA Warning Letter )
1. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a))
such practices (I should say malpractices) could contaminate drug products batch after batch, as US FDA also found out..
2. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
3. Your firm failed to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).
Poor Aseptic Behavior
4. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing areas (21 CFR 211.42(c)(10)(iv)).
US FDA also gave them URLs for building good aseptic behaviour and protocols .. but also warned that US FDA had found such practices in Cadila facilities in two other inspection visits. So these are
What was Cadila Pharmaceuticals' response to US FDA's CFR 473 notices.. Well, they said, "WE WILL NOT EXPORT THIS FACILITY'S PRODUCTS TO USA, (WE WILL SELL CONTAMINATED DRUGS IN INDIA) .. (WE HAVE A FRIENDLY PM, WHO MIGHT TAKE SOME BRIBES.. BUT WON'T OBJECT TO SELLING THEM AT EVEN HIGHER PRICE... Mother swear)" .. parts kept within brackets were not put in black & white.. it is what they were possibly contemplating!
To this response, FDA warned that if Cadila or any successor Brand (Zydus may be) wishes to resume export of drugs.. they must first resolve at these pending CGMP issues.
One can not beat a person with shoes in a letter but, this FDA warning letter came very close, very very close.
What did ZydusCadila do, did they stop exporting drugs to US? Oh! Don't be silly.. they were selling same Injectables under Zydus brand name..
But as expected, impurities were noted as crystals were found and Zydus had to recall whole lot of drugs.
As for Cadila, they managed to get a close-out letter (meaning they have changed their ways and adhered to all orders and suggestions of FDA) only in 2022 and it was addressed to Pankaj Patel's son, who is now Managing director of Zydus.
In fact, US FDA address this close-out letter to both Cadila and Zydus... treating both entities as one and same.
OK! What about Debt and Charges scenario:
Well, for those industrial houses who have Central Government in one back pocket and RBI in another, debts aren't a big issue..
But :
Cadila Pharmaceuticals has a total of Rupees 34,864,370,000 (3486 crore 43 lakh 70 thousand only :) ) in assets under charge.
Zydus Lifesciences has one gigantic charge of 1500 crore held by ICICI Bank.
There are many dozens of companies registered at Cadila and Zydus offices, I won't go into details of those.
Like every other hyper-nationalist Indian Billionaire, they also have offices in US and yes, their US operations are based in New Jersey and Corporate HQ in Delaware: Zydus Holding Inc.
And Cadila has its holding company in British Tax Haven, "Isle of Man".
So typical of Mr. Fakeer's illustrious friends from Industry & Commerce!
PANDEMIC: A TIME TO PROFITEER FOR THE SCRUPULOUS
Apparently Mr. Fakeer (who never studied basic college level chemistry or Biology, forget Pharmacology) visited Zydus Biotech Park on 28th Nov, 2020 to learn about DNA vaccine against Covid19. He said so in a Tweet, and PMO ordered PIB to give a press release, I present the screenshot here..
Some job PIB (Press Information Bureau) guys have... copying and pasting the Fakeer's tweet and embedding them in an HTML and calling it a Press release. Ha ha ha...
How did Mr. Fakeer learned all about DNA vaccine of an RNA virus, by being flanked by Pankaj Patel and his son (to his left) and a manager with a laptop open for this Media photoshoot.. picture was released by Mr. Fakeer in his tweet:
Anyway this vaccine was not approved in any developed country, but Government of India approved them anyway ... but that came, much much later..
Till now, no country in the world has officially acknowledged adverse effects coming from vaccines administered by them on their own population. But this ZyCov-D vaccine approval was to come later, much later.
Despite protests from scholars including Nobel laureates, WHO and Dr. Fauci had pushed Remdesivir as a possible medicine to reduce chances of possible intensive care treatment.
This Godi Media report said, Gilead Pharma (CNBC TV18, misspelled the name as Gland Pharma, after all, they are Godi Media), Mylan and Cadila were already manufacturing (which was still Gilead's "Proprietary Drug") Remdesivir in India and Gilead has now given licenses to total of 7 Pharma companies to Produce this Drug. Cadila was too clever by half and created a new brand name and trademark for it, Remdac (TM).
Propaganda machines tried hard to hide WHO's November 2020 press release against giving Remdesivir to already Hospitalized patients..
Yet, ICMR forced Doctors to prescribe Remdesivir en masse for Hospitalised Covid19 cases. And although Covid19 has long been removed from WHO's recommendations in Covid case, some doctors still do.
In 2021, Reports started pouring in that conditions of patients' conditions started deteriorating after receiving treatment of Remdesivir.
This report was published only after Bihar state's drug regulator found contamination in Cadila's one Batch... such was the clout of Pharma companies minting money under the protection of Don Fakeer.
there was a common thread; the patients at both hospitals had received remdesivir from the same batch, coded V100167. It was manufactured by the Gujarat-based firm Zydus CadilaBihar’s regulator identified the cause. Their testing found Cadila’s batch V100167 to contain bacterial endotoxins which cause fever, chills and life-threatening septic shock.
Finally, Government of India in the middle of Remdesivir controversy of Cadila's RemDac (Remdesivir) approved Zydus Cadila's ZyCov-D vaccine. Despite buying favourable articles in foreign press like in Nature (through its powerful and secret partnerships with Bayer), no other developed country approved it:
What was most disturbing that for the age-group 12-18, this was the only vaccine available.
Electoral Bond Purchases of Zydus and RBI Directorships:
On 10th October, 2022 .. Zydus Heathcare bought 18 Electoral Bonds worth 1 crore each and gave all of them to BJP.
Was this for Remdesivir or Zycov-d? Neither.. this was a payment for getting a seat in RBI's board of Directors:
In 2022, some changes came in Zydus top management, Pankaj had stepped down as MD of many firms in favour of his Son .. a succession.
And Don Fakeera nominated his four most trusted cronies into RBI's board of directors.
Crony capitalists in (Central Bank) RBI's board of Directors in nothing new. But we never had evidence that paid Money to the ruling party at the same year or later. I present the evidences:
Zydus purchase screenshot (from page 212 of Bond purchase PDF):
The BJP Encashment screenshots: (somehow BJP or SBI stacked the Electoral Bonds according to the invisible Bond numbers ... and the entries of 15th October redemption became strewn across 3-4 pages, pages 318 to 321 of Bond Redemption PDF):
Mahindra & Mahindra purchased 25 Electoral bonds of One Crore each on 27th January, 2023:
Prior to this purchase, Mahindra group had just one purchase of One Crore Bond from TechMahindra which they gave to Aam aadmi party.. So to whom do you think these 25 crores went? Congre... Dream On, MahaAnand Mahindra gave whole lot to Fakeer's jhola.. BJP encashed every single one of them.
The gentleman from south was probably little hesitant, but TVS Mobility Private Limited purchased 16 One bonds worth One crore each on 11th October 2023:
And bought 10 crore more on 10th January, 2024 (yes, just 4 months ago)
And gave all of them to BJP.
What about the fourth guy, you may ask? He is Don Fakeera's Boss's right hand man .. payments between them don't happen in Electoral Bonds .. He is the Luca Brossi of the Corporate Underworld.. do you know in which all Companies' Board of Directors, he sits..
Don't read the company name aloud, just say Aa.. Aa.. , that's it.. Don Fakeera and Vomit Shah are very touchy about it. Don't say, I didn't warn you.
RBI Directorships are now a "Pay for Play" scam. (Google "Pay for Play scam", I didn't invent this term).
But Don Fakeera must know, Pankaj Patel's Zydus also gave 3 Crore to Congress party, just after he gave 18 crore to BJP.. What? That Congress Politician is now in BJP.. oh, I didn't know that.. but the money went to Congress party's bank account.
And Don Fakeera must know, Zydus gave 8 crore to Sikkim Krantikari Morcha.. what about that?
Meanwhile US FDA continues to find faults in Zydus' facility, like this one in 2023.
What the hell, Another one? Ten non-compliance Observations this time!!!
One month of collating data and after that US FDA found time to fire another salvo at Zydus.
Right now Godi Media is saying, "Only 10 Observations" .. they never say "CGMP non-compliance". As if US FDA observations are "Rosgulla" or "Samosa" or some other tasty Indian snack .. See how Times of India reported it..
I'm not holding back this post to include details which will appear in US FDA website in a few days.. because you must know the truth..
Instead let me tell you about the previous FDA 473 "observations" for another Zydus facility in Gujarat at Motada (dated : 27th March, 2024). You can download it from US FDA website.
Observation 1
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Specifically,
A. From May 2023 until December 2023, your fnm manufactured and distributed human drng products intended to be sterile when your environmental monitoring program for viable Inicroorganisms was not in a state of control. During this time period, you documented 337 action level environmental monitoring excursions for bacterial and fungal recoveries in Grade-A and B aseptic processing areas for aseptic filling line] to include critical aseptic filling areas, equipment, and personnel. Your firm's actions in response to the environmental monitoring excursions are inadequate...
B. Your firm's airflow visualization studies (smoke studies) are inadequate for aseptic filling line] as they use insufficient smoke to demonsb'ate unidirectional airflow and they demonstrate inadequate aseptic technique as exampled below:
insufficient smoke was noted in the 2021 smoke studies videos to include:
OBSERVATION 2
Procedures designed to prevent microbiological contamination of diug products purporting to be sterile are not written and followed.
Specifically,
A. On 3/21/2024 we inspected the aseptic filling line ... (and gave a detailed account of non-compliance with CGMP norms)
B. Your firm's sterility test procedure is inadequate as it only instructs QC microbiologists to observe for microbial contamination via turbidity. Procedure 0318-SOP-QC-00085 does not include instrnctions for evaluation of samples for atypical microbiological growth that can
present as other than turbidity (suspensions, particles, filaments).
Holes in the ceiling of Zydus Factory, Water leakage marks everywhere as USFDA found :
OBSERVATION 3
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
Specifically,
A. On 3/20/2024, we inspected the HVAC mechanical space and the aseptic filling line ceiling. The roof of the building that covers this area was noted to have multiple holes and visible light to the exterior of the building.
B. On 3/20/2024, we inspected the QC microbiology storage room (controlled non-classified, CNC) and noted what appeared to be mold on and around the air vent in the ceiling of the room. Your firm stores various QC microbiology supplies in room.... to include testing canisters for drug product sterility and environmental monitoring plates utilized for aseptic filling line.
C. Various areas within your facility were observed to have what appeared to be water stained ceilings indicative ofprior water leakage events to include:
• CNC hallway leading into lina production area
• Laboratory change room .
• Corridor between retain storage roomand material storage room .
• Drug product retain storage room
OBSERVATION 4
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.
Do you think Godi Media Scums like CNBCTv18, MoneyControl, ET or Business (sub) Standard will ever tell the truth about, Zydus' facility at Motada Gujarat?
No they won't, I'm personally feeling quite helpless seeing the state of affairs of Indian Pharma majors. What more to add..
In conclusion, I wish that you never have to encounter these adulterated medicines made by greedy pharma barons.
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