Electoral Bond Scam XVI : Pharma round up

 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...

Electoral Bond Scam Part XV : US FDA catches Pharma Adulteration

 More Rotten and Trash Pharma In Fakeer's Jhola

Curious case of Sun Pharmaceuticals and Sun Petrochemicals and Electoral Bond:

Since you must be knowing Sun Pharmaceuticals as a cheap generic drug manufacturer, let's start with FDA's CFR 473 page.. and I find 15 records of Sun Pharmaceuticals and had to download them and go through more than hundred pages of Non-compliance of Sun Pharmaceuticals from 2016 to till date.

Don't worry I will not fill this post with all of these non-compliance details, but it is important to highlight some as Indian Media has never ever critiqued any Pharma major for their shortcomings. Let's start with the inspection reports of Sun Pharmaceutical Industries' Halol plant located at Gujarat:

Inspection happened between Nov 17 - December 1, 2016 and it details 9 Non-compliance Observations on its December 1st report and those are:

1. Field Alert Reports were not submitted within three working days of receipt of Information regarding bacteriological contamination and significant chemical, physical or other change or deterioration in a distributed drug product.

The report cited 6 instances including 5 cases of Buproprion HCl tablets failing dissolution tests on 5-May-2015, 9-Oct-2916, 21-Apr-2016, 28-July-2016 and 1-Aug-2016.

2. Drug products do not bear an expiration date determined by appropriate stability data to assure, they meet applicable standards of identity, strength, quality and purity at the time of use.

Once again they cite examples of Buproprion HCl tablets of various strengths (150 mg and 200 mg) bearing mark of expiry date after 24 months of production, but 24 month showed 18-24 month time range, a batch showing multiple dissolution test failures.

3. Testing programs are not adequately designed to assess the stability characteristics of drug products. 

4. The establishment of test procedures, including any changes thereto, are not adequately reviewed and approved by quality control unit. 

5. The Accuracy of Test methods has not been established. 

It specifically cites dissolution test methods of some tablets mentioned in company's own records, where tests are mentioned but no evaluation criteria was mentioned.

6. Scientifically sound and appropriate laboratory control mechanisms are not established to assure the components,  drug product containers, clossures, in-process materials, or drug products confirm to appropriate standards of identity, strength, quality and purity. 

7. The responsibilities and procedures applicable to the quality control unit are not fully followed.

8. Changes to written procedures are not drafted, reviewed and approved by appropriate organisation unit.

9. Appropriate controls are not exercised to assure that the changes to documents related to the manufacture of drug products are instituted only by authorised personnel.

Last two are basically damning IT and data security issues but first 7 are serious indictments of every department from R&D to manufacturing to Quality control unit.

Such reports can be expected of a newbie or startup but not from a Pharma Major led by CHAIRMAN OF IIT-BOMBAY.

Oh! Sorry,  I didn't tell you that in 2016, Modi's HRD Ministry headed by illustrious education failure Smriti Irani put Sun Pharmaceuticals MD as chairman of IIT-BOMBAY, and he wasn't alone IIT-Delhi chairman became Mr. K. M. Birla and IIT-Guwahati chairmanship went to Rajiv I. Modi of Cadila.. 

Whom did he replace, Eminent nuclear scientist Anil Kakodkar, who resigned in disgust as HRD Minister, Smriti Irani wanted to put an undeserving person as a Director of IIT. 

Dr. Kakodkar famously said "I have other (better) things to do in life (than to argue to someone like Smriti Irani)" .. a veteran of Pokhran I & II, winner of all kinds of Padma awards and head of Atomic Power Commission surely has better things to do.

Therefore I wasn't elated when a fellow Calcutta University graduate (different college & streams though) Mr. Sanghvi was put into IIT Bombay, as Chairman. Specially when his own Science based enterprise is getting so many Non-compliance from an inspection from US FDA. Cadila was also not faring very well as I discussed in my last post.

Anyway, Sun Pharmaceuticals continued  to ignore Quality control in their medicine manufacturing plants, the last published inspection reports of their Dadra Nagar Haveli plant just last year showed ..

6 non-compliances this time and most are repeat Non-compliances. But this observation number 6 is unique:

OBSERVATION 6  
Reserve samples from representative sample lots or batches of diug products selected by acceptable  statistical procedures are not examined visually at least once a year for evidence of deterioration.  
Specifically,  
A) Each lot of Controlled/Reserve (Retain) samples of drug products is not examined at least once a  4 year for the evidence of deterioration and physical defects. Your firm's rationale based on (redacted) for the  selection of limited number of batches is not justifiable while there are significant gaps identified in your  film's Quality and Production Systems along with several repeated product quality complaints pertaining  to count variability, broken, half tablets, and lack of efficacy.

Now this time Sun Pharma can't even say US FDA is being racist, because the inspector himself is a person of Indian Origin. 

But you never hear a pip squeak from Indian regulators, Dadra and Nagar Haveli is an Union territory.. yet Central Government in India stays silent.

This is really worrying because US FDA gave Sun Pharmaceuticals a "Serious warning letter No.  320-23-08" dated December 15, 2022 and amended that on 2023 .. clearly still not satisfied by Sun Pharmaceuticals' response. 

Remember I started by detailing Non-compliances found in Halol plant of Sun Pharmaceuticals, well after that Sun Pharma wrote that they would comply with US FDA's recommendations and US FDA came to Halol plant for a fresh inspection from April 26 to May 9, 2022. And this time US FDA found 10 CGMP and general Quality control non-compliance issue.

The warning letter summarized all these issues and highlighted: 

1. Your firm failed to establish and 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)).

2. Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas (21 CFR 211.42(c)(10)).

3. Your firm failed to use equipment in the manufacture, processing, packing, or holding of drug products that is of appropriate design, adequate size, and suitably located to facilitate operations for its intended use and for its cleaning and maintenance (21 CFR 211.63).

4. 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). 

5. 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)). 

And they complained about Sun Pharmaceuticals' Ineffective Quality Management and total lackadaisical attitude towards CGMP violations.

This wasn't all, US FDA had issued an Import Alert against almost all Sun Pharmaceuticals products for USA on 7th December, 2024.

Why was Indian Drug Controlling Agencies and state FDA's silent about Bad manufacturing practices of Sun Pharmaceuticals?

Surely, a practice that could lead to a drug of lower quality and efficacy is a harmful to an Indian as it is to an American!

I can think of only two reasons, firstly, just like US FDA allowed few drugs to be exempt from Import restrictions fearing a shortage of those drugs in market;  Same concerns are valid for India also.

Second is the political clout these companies enjoy, which they have generated by giving Donations by Electoral Trusts and Electoral Bonds. 

Weird patterns of Electoral Bond purchases of Sun Pharmaceuticals:

On 15th April, 2019 .. A company named "SUN PHARMA LABORATORIES LIMTED" purchased 20 Electoral Bonds of 1 crore in denomination from a branch with code "300" and for which SBI gave them a unique reference number (URN) "00300201904150000001203" after doing KYC.

 Immediately after that you would find 6 more Bond purchases on same day by "SUN PHARMA LABORATORIES LTD"  from  SBI  Branch "691" and given another URN "00691201904150000001196" . One Bond of 1 crore denomination and 5 Electoral Bonds each worth Rs. 10 lakh each.

On 8th May, we find "SUN PHARMA LABORATORIES LTD" has purchased 10 more Electoral Bonds worth 1 crore each from branch number "300" and this time SBI allocated them another URN "00300201905080000001388" ..

So that So called URN is not a company specific "Unique Identification Number", it is a crappy code designed by Fakeer's SBI (Stupid Bank of India) that can be easily deciphered:

First 5 digits are for Bank Code,

Next 8 digits are for date of KYC (first 4 are Year of KYC, next two are for  month and last two are day of the month).

Next 10 number are a running serial number of KYC registration in that branch.

 Remember this codification pattern as we show in later posts that SBI didn't release all the Electoral Bond purchases and Redemptions. 

But  back to Sun Pharmaceuticals story:

All of these bond purchases had one thing in common, all went to Fakeer's jhola ie. to say, Donated to BJP who happily encashed them on 20th April 2019 (See Screenshots of the Bond redemption PDF below)

And on 14th May 2019 for the Bond purchases of May 2019.

This summarises Sun Pharma story, but that would be a half-baked story if we do not focus this group's other activity Sun Petrochemicals:

In Zuabacorp's Sun Petrochemicals profile page, you can find many Directors are common between these two companies proving that they are part of same business conglomerate. 

From 2018, We find this news of Reliance Industries Limited selling its entire stake in Cambay basin exploration sites to Sun Petrochemicals.. hmm, where Mukesh Ambani can't see profits, Dilip Sanghvi is going to find it.. hmmm,  hmmm..

Okkey-Dokey,  if chairman of IIT-BOMBAY says so .. ha ha ha.. Actually this company, Sun Petrochemicals is closely linked with Reliance Industries.. how?

IndiaMart.com says: 

"Sun Petrochemicals Private Limited was founded in 1999 as a partnership with the erstwhile Indian Petrochemicals Corporation Limited (IPCL), now part of Reliance Industries Limited to manufacture acetylene carbon black from acetylene gas through the petrochemical route."

 Not entirely correct though, because we know that Sun Petrochemicals was registered in 1995 and even took a loan of 50 lakhs from Icici bank in 1996. 

On May, 2022 ... A news broke that Sun Petrochemicals won a Single Oil & Gas exploration zone in Petroleum Ministry's OLAP-VI bids ..

This is damn funny, suddenly this Pharma group has become Oil drillers. .. where ONGC became big winner as they have given Oil Rig purchase contracts to another big Electoral Bond purchaser "Megha Engineering Group" which I have discussed in Part II and part III of Fakeer's jhola.. earlier..

On 15th November, 2022 a strangely named company "SUN OILNATURAL GAS DIV SUN PETRO P. " and for whom SBI had issued an unique code, URN "00300202211150000002710" bought 8 Electoral Bonds. What is this Scam of SBI where they deliberately misspelled Company name after a supposedly thorough KYC checking process?

Of course we know, Sun Petrochemicals was initially known as "Sun Oil & Natural Gas" but that was long time ago..

 Anyway,  4 of these One Crore Bonds found their way in Fakeer's jhola. Kickbacks or Coincidence? 

Again in January 2024, News broke about OLAP-VIII prospective Oil & Gas block awards and again Sun Petrochemicals won a block.

Tender offer happened in July, 2022 and Sun Oil Natural Gas gave Electoral Bonds in November 2022. Cool .. very suave mode of Ernest money deposit.

Meanwhile, although Sun Pharma who does not have mammoth outstanding debt unlike their competitors in that sector; Sun Petrochemicals has quickly amassed outstanding charges of Rs. 450 crore.

What can we say, A conglomerate known for Pharmaceuticals is now getting warning after warning from globally acknowledged regulator and now has decided to be "oil and gas prospector" .. Well,  good luck with that.

Electoral Bond Scam Part XIV : Pharma Rot stink reaches RBI board

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 Cadila

Bihar’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.

Did they recall any capsule from Indian Markets? huh.. they probably sell those recalled medicine in Indian market. 

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.