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 XII : Money Raining In Torrents

 Another Look inside Fakeer's Jhola

A Large Pharma Company converted into a multi-national Conglomerate in last 20 years by unsecured loans: The Torrent Group 

Now Torrent Group has bought a huge amount of Electoral Bonds and mostly give to Mr. Fakeer's party, the ruling BJP. For this group at least, nobody can say these donations were "Bribes or Extortions" .. because the group's top management is considered a friend of current Prime Minister since the time when he was made Gujarat state's Chief Minister. The current PM's policy of removing life-saving Drugs from price control regime, has benefited Pharma Barons immensely .. the sick and the poor be dammed, pharma is a big profitable business now.. So I would rather consider these payments as "Kickbacks" or "Commission" payment of a supporter, who benefited immensely because of his policies.

You can see Don Fakeer attending an "Entire Political Science Workshop" with his most friendliest Crony Capitalists in the picture above.

Did I say, Torrent Pharmaceuticals Limited is now a multinational company? Yes, I did.. And there are sufficient proof available:

They have Torrent Pharmaceutical Inc based in New Jersey, USA.. but their overseas operations are more dependent of Tax havens like Malta or USA's very own, Delaware.. these companies are called "Torrent Pharma" and all other "Torrent Pharma" named companies of US are branch offices of Delaware based "Torrent Pharma" which also operates as  base  for other countries in Latin America. They are established in a very clever way, so that profit or losses, assets or liabilities of these tax haven based entities would never effect their Indian counterpart or vice versa. 

I have found 22 active companies with "Torrent Pharma" name, which is also a registered trademark of Torrent Pharmaceuticals Limited. So profits from overseas sales can be stored in these companies or even Money can be laundered out of India. Every CFO in the world knows it.

I know, nobody is going to like this investigative post, not in India, not USA .. who these days are dependent on crappy generic drugs to provide "Affordable Healthcare Act" services. Look how this company benefited from Modi's 2nd term, Pandemic and Biden presidency in its last 5 years stock performance. 

But 3 successive US presidents (Obama, Trump, Biden) and 2 US Fed chairs (Bernanke, Yellen) has created a gigantic stock market bubble, so that Market Capital is no longer a good yardstick of measuring "Corporate Ability to Deliver Goods". Anyway Hardcore "Right wing Industrialists" are now benefiting from "Western Socialist Leaders' " ( Hardcore capitalists, they are themselves) "some medicine is better than no medicine" style healthcare.

What no news report will tell you that, this company,  Torrent Pharmaceuticals has outstanding open charges amounting to Rupees 95,964,837,500 (that's more than 9596 crore) and that's just the capital of its borrowings ..

Torrent Power has outstanding loans amounting to Rs.  179,051,062,000 (that's more than 17905 Crore). But Corrupt Mainstream Godi Media won't tell you this.. they will be busy peddling misinformation that "Torrent Power" has signed "4 non-binding MoU with BJP ruled Gujarat Government" which will make them richer than Elon Musk and Bill Gates combined.. well almost..

First it was just a "Memorandum of Understanding" and not a license or agreement and secondly, it is Non-binding.. which relegates it from the category of News to Tea time gossip. 

Nevertheless such bogus "Business News" has  been cornerstone of Stock market rallies in India and look where they took this bubble.. in 5 years.. look "Business today", the stock has rallied 521.34% in 5 years and its debts rallied too.. thanks to a most inept and corrupt media.

Another company of this group, Torrent Investments limited has taken more than Rs.  30,278,800,000 in open charges. Remember these loans are sitting there and getting bigger with accrued interests.

The Group has started making LLPs in India these days, Limited Liability Partnerships .. hoping to join the construction sector. 

The founder of Torrent was a good Pharma specializing industrialist, having himself worked in Pharma company before opening Torrent Pharmaceuticals in 1970s .. but the current leadership is Second generation industrialist and clearly lacks the knowledge or vision of their father,  Uttam Mehta.

But this won't be covered as the Torrent group's Brothers are ranked within Top 400 in Bloomberg Billionaire Index as of today.. Thanks mainly to Stock Market Bubbles prevailing in the world. 

If you combine the family wealth together, they could climb to top 150. But for every Billionaire in the world, the maxim is :

"Debt belongs to the company, 

Wealth belongs to the big shareholders"

Even dear Michael Bloomberg is no exception.

Needless to say, they were nowhere in the Billionaire Index 10 years ago, even 5  years ago. "Proximity to power is extremely profitable", another Maxim from Crony Capitalist's Handbook!

 We are nearing the chronology section of Electoral Bond purchases, but I have to quote US FDA's warning letter to Torrent Pharmaceutical Inc because then you will get a true picture of that company's standing in 2018 as expressed by this letter in 2019.

And I would like to quote further from the letter about their discrepancies..

"1. 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).

Your (b)(4) water system was not adequately designed, controlled, maintained, and monitored to ensure it consistently produced water that met (b)(4) Water, (b)(4) specifications and appropriate microbial limits. Among the sanitary design deficiencies in the water system were multiple dead legs and threaded pipe connections.

Notably, your firm isolated Burkholderia cepacia from manufacturing equipment rinse samples. An investigation identified your water system as the source of the contamination. Subsequent sampling of your water system revealed an adverse pattern of B. cepacia contamination in your pretreatment and downstream distribution system.

Pharmaceutical water must be suitable for its intended use and routinely tested to ensure ongoing conformance with appropriate microbiological attributes. Systems that produce water for manufacturing and cleaning are critical determinants of the quality and safety of your drug products."

 (Specially when) "Your firm produced drug products such as rectal suppositories and oral solutions with this inadequate (b)(4) water system. Until recently, you also produced nasal solutions with this system."

It appears this warning letter came only after Torrent Pharma produced a lackadaisical response to the 2018 Non-Compliance Observations as the warning letter goes on to say, "Your response stated that the design of the pipes and fittings, along with multiple deadlegs, contributed to the (b)(4) water system contamination. We acknowledge that you decided to decommission and replace the water system. However, in your response, you proposed to procure and use a temporary system until you install a permanent replacement system.Your response lacked sufficient interim measures to ensure the water generated from your temporary system meets appropriate quality standards for (b)(4) water. Your response also lacked sufficient detail about the design of the temporary and new water systems, and your plan to properly monitor and maintain each system.

In response to this letter, provide:
• a comprehensive, independent assessment of the design of your (b)(4) water systems (both temporary and permanent), as well as your program for ongoing control and maintenance.

• a thorough corrective action and preventive action (CAPA) plan, ..."

Next US FDA also observed and I quote "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).

You lacked an adequate investigation into failing microbiological results from your (b)(4) water system.

For example, investigation 18-EVE-117, from December 2018, revealed that your firm’s water testing method was inadequate to reliably detect the presence of B. cepacia in your (b)(4) water system. A significant trend of microbiological deviations in the system emerged after you adjusted your sampling and testing procedures in December 2018 to be more capable of detecting B. cepacia. You did not sufficiently extend the investigation to potentially affected marketed batches until months after you detected the adverse pattern of objectionable microbial contamination, and several weeks after our inspection. The initial investigation also did not adequately address the significance of water system design deficiencies."

US FDA also alleged, "Quality Systems

Your firm’s quality systems are inadequate. For guidance on establishing and maintaining CGMP-compliant quality systems, see FDA’s guidances" and then goes on to Guide them on how to become CGMP (Current Good Manufacturing Practice) compliant. 

US FDA charged them of selling New drugs without proper licence and FDA Approval:

"Unapproved New Drug Charges

Inspection of your firm and review of the information your firm submitted to FDA’s Drug Registration and Listing System revealed that your firm caused the introduction into interstate commerce of “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” in violation of sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a).

Your “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” are “drugs’ within the meaning of section 201(g) of the FD&C Act, 21 U.S.C. 321(g)(1) because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals and/or an article (other than food) intended to affect the structure or any function of the body of man or other animals. Examples of claims and statements observed in your product labeling that establish the intended use (as defined in 21 CFR 201.128) of the product include, but may not be limited to, the following:

Phenobarbital Oral Solution, USP, Phenobarbital 20mg and Alcohol 13.5% (NDC 16571-330), product labeling:
“INDICATIONS AND USAGE
A. Sedative
B. Anticonvulsant – For the treatment of generalized and partial seizures”
Hydrocortisone Acetate Suppositories 25mg (NDC 59741-301), product labeling:
“INDICATIONS AND USAGE
Hydrocortisone acetate are indicated for use in inflamed hemorrhoids, post-irradiation (factitial) proctitis; as an adjunct in the treatment of chronic ulcerative colitis; cryptitis; and other inflammatory conditions of anorectum and pruritus ani.”

Further, as labeled, these drugs are “new drugs” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p) because they are not generally recognized as safe and effective under the conditions prescribed, recommended, or suggested in the labeled uses. As new drugs, “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” may not be legally marketed and distributed in the United States absent approval of an application filed in accordance with section 505(a) or (j) of the FD&C Act, 21 U.S.C. 355(b) or (j)."

US FDA also observed, that both PHENOBARBITAL and   HYDROCORTISONE ACETATE are misbranded.

ed:

 "  Misbranding Charges

“PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” are misbranded under section 502(f)(l) of the FD&C Act. According to section 502(f)(l) of the FD&C Act, 21 U.S.C. 352(f)(1), a drug is misbranded if, among other things, it fails to bear adequate directions for their intended use(s). “Adequate directions for use” means directions under which a layman can use a drug safely and for the purpose for which it is intended (See 21 CFR 201.5).

“PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” are intended for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners and, therefore, are prescription drugs as defined in section 503(b)(1) of the FD&C Act, 21 U.S.C. 353(b)(1).

Because the conditions for which your products are intended require the professional supervision of a practitioner licensed by law to administer drugs for such conditions, adequate directions for use cannot be written so that a layman can use them safely for their intended uses. Your “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg” are not exempt from the requirement that their labeling bear adequate direction for use under 21 CFR 201.100(c)(2) or 21 CFR 201.115 because no FDA approved applications are in effect for your “PHENOBARBITAL ORAL SOLUTION, USP” and “HYDROCORTISONE ACETATE SUPPOSITORIES, 25 mg.” Thus, your products’ labeling fails to bear adequate directions for their intended uses, which causes the products to be misbranded under section 502(f)(l) of the FD&C Act, 21 U.S.C. 352(f)(1)."

And this letter is ended with marking a CC to Torrent Pharma Inc office in Ahmedabad.

So Torrent's Pharmaceutical water was contaminated with microbes, did you hear a pip squeak about that in Indian Media?.

 Well, you haven't heard about US FDA's warning letter post inspection of  Torrent Pharmaceuticals Limited Dahej facility (FEI 3010228235) in Gujarat during a March 11–19, 2019, inspection and inspection of Torrent Pharmaceuticals Limited, FEI 3005029956, at Ahmedabad-Mehsana Highway, Taluka-Kadi, Indrad, Gujarat from April 8 to 16, 2019.

This time they again noted basic "Protocol of Process Validation" violation at Both Indrad and Dahez facilities. They write and I quote directly: 

"1.    Your firm failed to follow written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(b)).

Your firm did not appropriately follow your written and approved process validation (PV) protocol which required quality attributes to be met for “three consecutive” batches to qualify an alternate active pharmaceutical ingredient (API). Several PV batches using a new alternate API were manufactured for Losartan Potassium Tablets USP 50 mg and USP 100 mg without appropriately following your protocol.

Specifically, after the first of the three PV batches failed for dissolution, assay, and (b)(4), your firm added a fourth batch which was outside of your written protocol. However, the fourth batch also failed specifications for dissolution. Multiple out-of-specification (OOS) investigations were initiated and quality rejected all four PV batches.

You developed a new interim protocol to justify commercial use of the alternate API and circumvented your original protocol, even though you had data demonstrating your process was not capable of producing quality material using the new alternate API. Numerous Losartan Potassium Tablets USP 50 mg and USP 100 mg commercial batches were manufactured with this new alternate API and released to the U.S. market despite the PV failures. In addition, multiple batches of Losartan Potassium were recalled for unacceptable amounts of nitrosamine impurities."

How many doctors in India was made aware of these irregularities? None , I guess.. Yet Indian doctors prescribe Losartan Potassium by the truckloads for Hypertension. 

They have observed that Torrent was unable to ascertain root cause of quality test failures as detailed in their letter, 

"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).

Your investigations into OOS testing results were inadequate. Multiple OOS investigations related to assay, (b)(4), and dissolution were closed without assignable root cause, or lacked adequate scientific justification for root cause. Despite the inadequate OOS investigations, your firm disregarded initial failing OOS results and released batches based on retested results.

For example, OOS investigation OOS/IN/F/FP/17/238 for Losartan Potassium and Hydrochlorothiazide (HCTZ) Tablet (b)(4) for batch number BP02D026 was initiated on July 4, 2017, due to a high HCTZ assay value. The result was super potent, (b)(4)%, versus a (b)(4)–(b)(4)% specification. This OOS result was confirmed during your phase I laboratory investigation without establishing a root cause. During your phase II investigation, neither a manufacturing nor laboratory error was conclusively identified. Despite no assignable root cause, the initial high OOS results were invalidated and the (b)(4) was released based on retested reserve sample results. The resulting finished product batch was distributed to the U.S. market. 

Multiple examples of improperly invalidating initial failing OOS results were also observed in other drug products. In addition, your firm has a high percentage rate (60–70%) for invalidated initial OOS test results between January 2017 and March 2019."

 What was Torrent  Pharmaceuticals Limited doing when  US FDA was visiting their factories?

They were busy buying Electoral Bonds!

On 7th May, 2019, Torrent Pharmaceuticals Limited bought Electoral Bonds worth 2.5 Crore (2 One Crore bonds and 5 bonds of 10 lakhs) and gave 1.5 crore to BJP and Torrent Power bought EBs worth 7.5 crore (7 One crore denomination Bonds and 5 bonds of 10 lakh) and  gave them to BJP. BJP encashed them on 10th May, here are the details from Bond redemption PDF, this is for 1 crore bonds 

This is the screenshot for redemption of EBs of 10 lakh denomination, those bonds with TL as prefix and 3 digited Bond numbers, those are from Torrent group.

Somehow One Electoral Bond purchased by Torrent Pharma, came to Aam Aadmi Party .

And look what Newslaundry.com had reported, Maharashtra State Government under BJP's Devendra Fadnavis gave tax relief to Torrent Power:

on May 27, 2019, the state government issued a government resolution that said the Bhiwandi Municipal Corporation need not collect property tax worth Rs 285 crore, including interest and fines, from Torrent Power.

The resolution said: “As the state government has come to the conclusion that recovering such property tax is not ultimately in the interest of the citizens of Bhiwandi, the state government is directing the municipal corporation to withdraw all proceedings to recover property tax from Torrent Power.”

The resolution was issued after Torrent Power informed the state government that recovering property tax would lead to “higher tariffs that would not be in favour of citizens”. Soon after, local citizens started a campaign accusing Torrent Power of running “mafia kind of operations” in Bhiwandi.

If investing 7.5 crore gives a return of 285 crore property tax relief then, its a great business vehicle for cronyism.

 Now the Torrent group didn't stop at that 10 crore, On 10th May they bought another 5 crore of Electoral Bonds in the name of Torrent Pharmaceuticals Limited and gave them to BJP. By that time, Torrent Pharmaceutical knew that they are getting Non-compliance report from US FDA. And BJP encashed them on 14th May, 2019

This screenshot of 5 lines from Bond Redemption PDF proves that.

Then came the 1st  October 2019, they bought 12 One Crore denomination Bonds, 5 with Torrent Pharmaceutical name (all went to BJP) and 7 with Torrent Power. ( 2 went to NCP, 5 to BJP).  BJP encashed them on 11th October as it can be found in page number 118 of Bond redemption PDF.

Top 10 lines in this screenshot with Bond 38xx are from Torrent group. The date is important here, remember on 8th October, US FDA issued the Warning letter of serious Non-compliance in Torrent Pharmaceutical's Indrad and Dahez facilities, which must have reached Government of India's Health Ministry by 9th October.. but instead of starting a fresh investigation in India, BJP decided to encash 10 crores of Torrent group's Electoral Bonds!!!

What affects the health of Americans adversely, affects the health of Indians in India also.. How did BJP forget that?

On 3rd October, 2019 .. Torrent power bought 3 EBs worth One crore each .. they were not sure of BJP coming back to Power for the 2nd time in Maharashtra elections it seems,  so they wanted to be in Good books of NCP and Shiv Sena..

Then came the Pandemic.. despite of all US FDA warnings about Torrent Pharmaceuticals, when then US President Trump met with Billionaires of India.. Modi put Mehta brothers in front and centre with Gautam Adani, Mukesh Ambani et al during "Namaste Trump" gala blitz. Remember neither Modi nor Trump acknowledged the worldwide Pandemic spreading possibility of COVID19 in early 2020.

2021: More Electoral Bond purchases, donations to BJP and Congress, Thermal Power manufacturer buys Wind farms, More FDA test failures.

On 7th of April, Torrent Power Limited buys 7.5 crores in Electoral Bonds and gives them to BJP.  On the same day, same branch, presumably by the same person, another 7.5 crore worth Electoral Bonds were purchased by Torrent Pharmaceuticals .. both sets were identical in denomination structure,  7 Bonds of One crore and 5 bonds of Ten lakhs in denomination.  What however was not identical was the recipients, BJP got 2.5 crore and their arch nemesis, Congress party got 5 crore. 

So Torrent group has paid to all 3 parties in then ruling Coalition government of Maharashtra, Shiv Sena, NCP and Congress.. some friend Modi got.. ha ha ha.. In spite of paying BJP's opposition,  the bulk load of Electoral Bonds were still going to BJP.

In September, the news of Torrent Power buying CESC's wind power company came up .. CESC the Calcutta Electricity Supply Corporation for some strange reason was operating wind farms in Gujarat, Rajasthan and Madhya Pradesh, and Torrent power bought that financed mainly by IDBI TRUSTEESHIP SERVICES LIMITED loans ..

 This was a reprint of Press release of Torrent Power, so the debt part didn't get the news light ...

What didn't made the News is that, Maharashtra FDA found a sample of Nikoran I.V. did not contain Nicorandil at all.

 

Although every state is supposed to have an Food and Drug Administration and are supposed to routinely check food and drugs sold in the state. Many of states' FDA have a website, where you can only download License application forms .. Even Ayurvedic Drug licenses too (like one from Gujarat) for Patanjali style Voodoo products ... if you want further information, you have to file a Right To information (RTI) and maybe they will give some reply.

Only Maharashtra FDA website has a search facility where you can find which Food or Drugs failed a test. Under Drugs and Cosmetics Act, 1940, the testing authority have give details in a Form ( Form 13) and I have screenshot taken the relevant part, because this is important. 

Nicorandil I V is administered only when a patient is experiencing severe Anginal pain (heart related chest pain) and it is a life saver. If it does not contain Nicorandil, the patient may die in all probability.

Yet No Major Outcry went out.. No cardiologist came to know about this. See I told you, "Proximity to Power pays well in plutocracy".

AND THE MOST FUNNY THING THAT GOES ON INDIA IS, US FDA is Welcomed by Indian government and Indian Pharmaceutical companies to conduct in process verification of Manufacturing practices... but STATE RUN FDA can only test the final product and can have no say in CGMP guidelines. Only Meat Vendors, Fish sellers and Butchers, they have lots of talk, action and bluster,  when it comes to Big Pharma, they become pussycat.

 But they have to entertain US FDA delegation and accompany them as US Embassy tweets tell us..

 One can also clearly see the lackadaisical attitude of US FDA under Joe Biden.

 2022: Electoral Bond Bonanza from Torrent group..

On 3rd January, Torrent Power bought 3 One crore denomination Bonds and gave 1 Bond to BJP and 2 Bonds to AAP ..

But the real Bonanza was coming on, 7th January, 2022.

Torrent Pharmaceuticals bought 10 Electoral bonds of 1 crore denomination and gave 7 of them to BJP and 3 to Samajwadi Party  ..

Torrent Power similarly bought 7 one crore bonds for BJP but they also bought 100 Electoral Bonds worth Ten Lakh each and gave them to BJP. 

They could have just bought 10 bonds worth 1 crore, instead of buying 100 , Ten lakh bonds. Don't worry I won't put screenshots of 100 bonds (Page 235 to 238 of Bond Redemption PDF for 10 lakh EBs) .. BJP encashed them all by 12th January, 2022 .

It was Bonanza time for Torrent Pharmaceuticals as well, they just issued 1:1 bonus shares and doubled up the market capitalisation... every dumb shareholder was happy, Every Market watchdog sleeping on the pillow made by Electoral Bonds.. Every Media house gleefully salivating at the prospect of upcoming arrival of box of sweets.

 

Making money out of thin air in speciality of Indian Stock market.. normally availability of more shares drive down share prices and here it climbed up 7%.

With 114% increase in market cap, what did they do.. The company took a loan of 450 crore from HDFC Bank. These loan taking are never covered with Fanfare as Bonus share offerings do. When the paid up share capital was only 84.62 Crore, any loan above 50 crore should have been disclosed to the stock exchange.

This is why I say, Indian Stock market is a GIANT BUBBLE.. They market cap of a company should truly reflect the value within the company. You can't play up in cahoots of corrupt and the cronies.

 So we get this news that Solar Energy Corporation of India, gave a wind energy project to Torrent Power who were mainly Coal and Gas fired Thermal power generators. Ever since Modi restructured 'Renewable Energy Ministry', every single such project was going to his cronies. In present day, almost 2 years time has passed.. nobody knows, how many wind turbines are commissioned or how much energy this wind farm is producing..

On 10th October,  2022 ..  Torrent Group was on Electoral Bond buying spree again, Torrent Pharmaceuticals bought 15 One crore EBs and gave all of them to BJP..

Torrent Power bought 23 EBs of One crore denomination and gave 13 of them to BJP, and surprise, surprise .. 5 Crore each to Congress and AAP. 

Why are they paying to the opposition of BJP? Well, Being a close friend of "Herr Dictator", they probably know the importance of opposition.. and besides its from the loaned money from Indian Banks, HDFC and IDBI  ... Do you think they intend to pay these loans back? Besides they gave 28 crore to BJP in this tranche, don't forget that.

 2023 : surfing among Stock market bubble for Torrent group, amidst Maharashtra FDA finding more Sub-standard Drugs Produced by Torrent Pharmaceuticals.

This Test Result from 15th February 2023 shows that Torrent Pharmaceuticals' Lopamide has failed in Dissolution Test in Maharashtra FDA labs .. No Media picked it up. No Doctors knew about it.

This is super sad news, if Diarrhoea treating drugs fail in dissolution tests .. you can only play checkers with it, no point in taking them, as it will come right out with faeces.

 But Torrent Pharmaceuticals were in loan taking spree in 2023, let quality of drugs be dammed... Bankers of the country have no basic knowledge of Chemistry, forgot Pharmacology.. ha ha ha..

So HDFC gave 350 crores, IDBI Trusteeship gave 500 crores, even good forsaken HSBC gave 543 crores to Torrent Pharma between February to May of 2023.

Meanwhile Torrent Power has completed takeover electricity supply facilities at Union Territory of Dadra Nagar Haveli , Daman and Diu .. (presumably under "La Fakeera Garage Sale" scheme) .. but can one tiny Union Territory justify the Stock Market rise of its shares..

Ever since Hindenburg research exposed the energy sector bubble, Cronies in SEBI, NSE, BSE has been fuelling up Adani and other power sector players like Tata or Torrent.. 

See what happens when, you cover up a big lie with a bigger lie.. the whole sector has huge insurmountable debt and impractical market capitalization.

What more can go wrong in this sector?!!!

2024: Torrent Group pays a huge cache to BJP and surprisingly their stocks jump higher.. Coincidences or CRONincidences ?

Yes, their payment to BJP via Electoral Bonds continued upto January,  

On 9th January, 2024 .. Both Torrent Pharmaceuticals and Torrent Power bought 15 Electoral Bonds each worth One crore rupees .. and all 30 crore went to BJP. 

On 10th January, 2024 .. Again Torrent Pharmaceuticals and Torrent Power bought 10 Electoral Bonds each worth One crore rupees .. and all 20 crore went to BJP.

Was this for staying silent on suspicious and possible insider trading in Stock Market?

Was it for encouraging BJP's Media cell to write platitudes for the group in corrupt mainstream media? Like.. this one published on 12th January:

Well this kind of reports, never mention debt situation of the company or how many drugs are sub-standard...

What happens when these bubbles go bust? Who will bail out the banks, common man.. isn't it?

Is India forever doomed to be a plutocratic system with a bunch of crony oligarchs ripping off poor Indians, under a crazy dictatorial regime?

SBI's Biggest Fraud in Independent India: Electoral Bond

 Stupid Indian Media can't even Analyse SBI's fraudulent Data: Even Supreme Court Lordships are all at sea, seeing such large data.

Corrupt SBI bankers were banking that if they toss a few company names, Indian Media won't check the completeness of this data and that has happened. Indian Media is busy gobbling up the names and even showcasing "Corrupt Companies" who donated "Electoral Bonds" (as Supreme Court has suggested for "Quid Pro Quo" deals) as "Top Political Donors".

So let's analyse what SBI has done :

They handed over two INCOMPLETE reports saved as PDF files and Election Commission Of India has released them in "as is" form on the website . 

Technically , it didn't take SBI back-office guys even 10 minutes to do it.

First let us look at the donor file:

 

Just a 3 column report, showing Purchase date, Purchaser Name and Denomination mentioned in that Electoral Bond. 

The data is arranged by Purchase date (earliest first) and then Name of the Purchaser (arranged alphabetically) and then perhaps by THE HIDDEN ELECTORAL BOND ID .

Every line denotes a single Electoral Bond.

 132 Electoral Bonds of Rs. 1000

  220 Bonds of Rs. 10,000

  2228 Electoral Bonds of 100,000 ( 1 lakh)

  4620 Bonds of 1 million rupees (10 lakh)

 11671 whooping number of Bonds of 10 million (1 crore) each.

Note: Earliest data here is from 12/April/2019. Which is in the middle of "Electoral Bond" sale ahead of last Parliamentary election in the year of 2019. Why Supreme court allowed "half of an election cycle" data, is beyond me.

In this dataset published by Election Commission, SBI cashed out More money to Parties than the Bonds they sold.

Or Deliberately gave incomplete data:

Let us look at the data of encashing of Bonds now.. lets start at page one of the PDF shall we!

 

 Just a 3 column report, showing date of Encashment, Party Name and Denomination mentioned in that Electoral Bond.

The data is arranged by Date (earliest first) and then Name of the Party (arranged alphabetically) and then perhaps by THE HIDDEN ELECTORAL BOND ID . Note that AIADMK name comes at the top in Page 1 only because of Alphabetical ordering of this list.

Here also the first entry is from 12th April, 2019.

Every line denotes a single Electoral Bond.

 103 Electoral Bonds of Rs. 1000 each

  219 Bonds of Rs. 10,000

These two data for lower denominations are marginally lower than bonds sold as investigative journalists bought a few to check what is inside the so called "Anonymous Bonds" ..

  2526 Electoral Bonds encashed of denomination of Rs. 100,000 ( 1 lakh) against 2228 Bonds sold, that's an excess of 298 Bond certificates.

  5366 Bonds of 1 million rupees (10 lakh) cashed out by SBI while they only sold 4620 bond certificates in the same date period.  Excess of 746 certificates.

 12201 , that's 536 massive number of excess Electoral Bonds of 10 million (1 crore) denomination encashed by SBI as they sold that grand number of 11671 .

So SBI has hidden over 1500 Electoral Bond Purchases amounting to values of over 600 crores from the period of 12th April, 2019. If only the Lordships knew HOW TO ADD NUMBERS hidden in a PDF files, they would have figured it out themselves. Or SBI must have paid over 600 crore to some political party on their own.

 Fraud started from DAY 1, that is, 12/April/2019.. 517 Electoral Bonds were encashed from SBI, while only 279 Electoral Bonds were sold that day by SBI.

Pattern continues on next day also, 15/April/2019, only 187 Electoral Bonds sold by SBI but 248 Electoral Bonds encashed by various Political parties. 

16/April/2019, 392 bonds encashed while SBI sold only 350 Electoral Bonds.

 

Proving beyond any doubt that SBI has indeed hidden Electoral Bond data, especially who purchased such bonds ..

Rejoinder: Supreme Court has indeed picked up issues with this list, as critical "Unique Electoral Bond ID" is missing, when I was busy doing analysis of the data.  But SBI has furnished Incomplete Data and I guess nobody added the total of Both lists and noticed the discrepancy as yet. 

 

In spite of different font size,  this should have been obvious to all as Purchase data in released in 337 page PDF while encashment data is released in 426 page PDF.

 

 So SBI has hidden at least 1550 Electoral Bond Purchase data and the value of those Bonds are at Least 613 crore 57 lakh 61 thousand rupees. AT LEAST!!!