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..

In conclusion, I wish that you never have to encounter these adulterated medicines made by greedy pharma barons.

Electoral Bond Scam Part XIII : Pay to Party & Adulterate Medicine

 

Another look inside Fakeer's Jhola : Pharma Rot and Electoral Bond loot.

How promising Pharma industry is going the dangerous ways of making Sub-standard but cheap medicine... with Electoral Bonds as a bribe giving mechanism..

Very recently, you might have found the news about Natco Pharma being served a Serious Warning Letter by US FDA in a small corner of business news section of your newspaper.. they obviously didn't say how much Electoral Bonds they purchased and gave to whom.. But let's start alphabetically and I'm keeping at cut off of Electoral bond purchases worth 5 crore.

1. ALEMBIC PHARMACEUTICALS LIMITED. 

This company is based in Vadodara, Gujarat and apparently they are so close to presently ruling BJP that they have even named the road on which their headquarters are based as "Alembic Road"

I personally don't know much about this entity but I find many of their directors, although not from Medical or Pharmacological background are also Directors of other companies. These are names of  the illustrious lot.

 

Their registered address is "ALEMBIC ROAD, VADODARA GJ 390003 IN"

Although Gujarat Government has lovingly named the road after this company.. inside they have spawned other businesses also.. Following companies also use same Alembic building as registered address of their company and have one or more directors common with Alembic Pharmaceuticals:

SHRENO ENGINEERING LIMITED : For Household Appliance Manufacturing

GALLUP LIFE PRIVATE LIMITED: For Social Work

VIRSAD TRADING PRIVATE LIMITED

Sierra Healthcare, Sierra Investments, Zeppelin Systems and Quick Flight...any exotic name will do..

I only mentioned these because it shows that they are in business of doing business.. not specifically aligned with Pharma business and in fact, they are all linked with Alembic Limited.. a century old group. Now you know why SBI deliberately garbled up its name as "ALEMBICPHARMACEUTICALSLINCLRTGS"

It's not difficult to find Alembic Pharmaceuticals' troubles with FDA ... like in 2021 ..  Alembic pulls blood pressure generic after complaint reveals labeling mix-up

The India-based company received a market complaint that a single 30-count bottle with a 20 mg label instead contained 40 mg tablets, according to a notice posted by the FDA.  

Patients who take a double dose of the hypertension med over a prolonged period of time could suffer low blood pressure, worsening kidney function or a potentially life-threatening elevation of potassium levels, Alembic warned.

Now Indian Consumers might not be familiar with the concept of "Pulling back of products from the shelves" or "Product Recall" .. but it is common practice that companies recognize their mistakes and buy the faulty products back or replace them with genuine products. Even Indian companies are forced to do so in west, because the consumer protection laws are very strong. 

On October 2022, a much more serious warning came from US FDA... as Fierce Pharma magazine reported:

Immediately after that Alembic Pharmaceuticals started buying Electoral Bonds and giving them over to BJP. 

This is a company that needed money to change the processes of their Oncology Injectable formulations unit at Panelav, Gujarat but they chose to spend on Electoral Bonds instead. 

On 14th November, 2022 ... Alembic bought 6 bonds worth 1 crore and 2 bonds of 10 lakh worth and gave all of them to BJP. Full amount: 6.2 Crore.

On 25th January, 2023 .. Alembic  bought 3 bonds worth 1 crore and 5 bonds of 10 lakh worth and gave all of them to BJP. Full amount: 3.5 Crore 

On 5th July, 2023 .. Alembic bought  5 bonds of 10 lakh worth and gave all of them to BJP.

Total payment in 3 tranches: Rs. 10.2 Crores. Somehow it looks like a 10 crore bribe paid over instalments. 

Did BJP make good of the promise of making the US FDA non-compliance observations go away.  Not at all  US FDA is still breathing fire on them.. specially their US offices  .. Oh! Didn't I tell you, like all good Gujarat based companies.. their US operations are based in New Jersey..

And so ... BJP managed the local crisis for them.. no drugs were found to be faulty in India, no inquiry on their processes and recall.. forget recall. 

2. Aurobindo Pharma:

The episode regarding their Electoral Bond purchases, I've already detailed in Part V of Electoral Bond Scam. But I forgot to give much credence to its US FDA non-compliance news ..

But digging deeper, I found they were not just NCs from inspection reports .. in fact this firm has received 3 SERIOUS WARNING LETTERS from US FDA.

First Serious warning letter is dated 20th June, 2019 and US FDA found significant deviations from "Common Goods Manufacturers Practices" (CGMP) in their plant at Srikakulam District, AP. The inspection was carried from February 4 to 9, 2019.

The deviations included :

1.  Failure to extend investigations to other batches that may have been associated with a specific failure or deviation.

2. Failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications.

US FDA also noted that they didn't have any CGMP professional at that plant and warned them in harshest words.

Failure to Comply with Submission Requirements for Supplements and Other Changes to an Approved (b)(4)

1.  Changes to methods or controls were not reported to FDA through a supplement to an approved (b)(4). (21 CFR 314.97(a) and 314.70(c)(6)(i))

Now such words coming from the Director of Office of Manufacturing Quality,, Office of Compliance of Center for Drug Evaluation and Research can't be taken lightly.. They also said they wanted to review the practices at Unit I, Unit XI and Unit IX as they found same observations earlier. 

Only on 2nd October, 2023 .. Aurobindo Pharma managed to satisfy US FDA and get a closeout letter.

SECOND Serious warning letter is dated January 12, 2022. US FDA said in Unit I of Aurobindo Pharma the APIs are adulterated.

 it appears that FDA inspected this facility on August 2 to August 12, 2021 ... gave them Form 483 Non-compliance notices and Aurobindo Pharma gave a clever but insufficient response to that notice on August 12 itself.

This serious warning letter came after US FDA reviewed both Form 483 issues and Aurobindo's response. Issues were all very critical:

1. Failure to evaluate the potential effect that changes may have on the quality of your intermediates and API.

 2. Failure of your quality unit to ensure that critical deviations are investigated and resolved.

Repeat Deviations at Facility

In a previous Regulatory Meeting held July 29, 2019, FDA cited similar CGMP deviations. You proposed specific remediation for these deviations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

 Again Aurobindo Pharma got their 3rd mention in a Serious warning letter from US FDA, which was issued to online drug pharmacy,     rxshopmd.com  registered at Cyprus for misbranding drugs.. on 15th February, 2022.

As the current law states, in online pharmacy, the website is responsible for the drug description and branding... although it is well-known that drug manufacturers themselves provide the description. 

 

The Drug in question was Hivus-LR manufactured by Aurobindo Pharma.. a combination Lopinavir and Ritonavir. Quite early in the Pandemic, a randomized clinical trial found that this Lopinavir-Ritonavir does not have any therapeutic benefits on hospitalized SARSCOV2 (Covid19) patients.. https://www.nejm.org/doi/10.1056/NEJMoa2001282

During the Pandemic, Indian Pharma companies minted money by falsely claiming "Remdesivir" and "Molnupiravir" were drugs to cure Covid19. They still can't, on the contrary, there are sufficient evidence that these drugs actually worsened the Covid19 patient's condition.

While Remdesivir has been withdrawn now, Molnupiravir is still a good source of income for Pharma companies. It is only the mildness of Omicron sub-variants that has stopped the Pandemic and made late entrant Molnupiravir look good. AND DO YOU KNOW SOMETHING,  same CGMP non-compliant units of Aurobindo Pharma are major producers of cheap (Only in dollar terms) Molnupiravir.

3. ALKEM LABORATORIES  Ltd:

This is a Pharma company that I'm aware of, as I have myself taken medicines prepared by them in sicknesses, large and small. I didn't knew who the owners were or their political inclinations as those are immaterial to a patient. 

So I looked up on Zuabacorp to find who the directors were and the debt charges on the company. 

What surprised is that the debt or charges mentioned.. a huge ... Rs. 35,355,400,000 .. that is 3535.54 Crores..

This meant they must have invested or doing business in US dollars, as their website also said.. if there were "World wide web" in 1920s .. this kind of webpage would have been common..

French West Africa was a French colony,  true that they still use West African Franc as currency.. but all those constituents of that Colony has long been Independent of French colonial rule. Its good that they don't have French version of their website, otherwise lots of people would have boycotted their products.

East Africa was a British Colony,  and they have gained independence long back, Kenya got its independence well before this Alkem Laboratories was set up.

Colonial mindset and Bigotry is something shameful that resides highly among "India's Uber Rich" ...

Then I found this 16 page FDA report (you can download from their website) on Alkem's compliance or rather Non-compliance of standard practices:

 

The FDA gave 17 observations after visiting (in 2018) their manufacturing plant at Daman to Alkem's President - Quality and Compliance and first observation is :

1. There is no Quality Control Unit.  (Functional)

Remaining observations were:

2. The quality control unit lacks the responsibility and authority to approve or reject all components,  in process materials and drug products. (Repeat Observations)

3. Laboratory Controls do not include the establishment of scientifically sound and appropriate specifications, sampling plans and test procedures designed to assure that drug products confirm to appropriate standards of Identity, strength, quality and purity (Repeat Observations).

4. The responsibilities and procedures  applicable to the quality control unit are not fully followed:  (Repeat Observations).

They even cited examples of insufficient "Out Of Specification" testing...

5. Written stability testing program is not followed ( Repeat Observation) :

They found 45 samples stored in a room without temperature control or monitoring.

6. Laboratory records do not include complete data derived from all testing, examinations and assay necessary to assure compliance with established specifications and standards. Electronic records are used, but they do not meet the standards required to ensure they are trustworthy, reliable and general equivalent to paper records. (Repeat Observation)

17 Non-compliances in Total..

Quite naturally, such manufacturing practices would result in drug products which are "variable in quality" ... And since only Maharashtra FDA shares its results with the public..

I turned to them to find, Alkem's Ondem-4 failed dissolution test:

Immediately after that what was Alkem's response: 

Alkem Laboratories purchased 15 One Crore denominated Electoral Bond on 14th November, 2022 and gave them to BJP.

Did any Indian Media highlight such failures then? Did Alkem got rescued from US FDA troubles as well as not as they got out Indian FDA radars?

No, not at all. US FDA again gave damming warning to Alkem just a week back.

So you see, Bribes don't help in long run..

This was about their Baddi, Himachal Pradesh based plant and was inspected in March, 2024. This time report was 17 page long and contained damning evidence of their laxed processes and protocol. 

 So you see, company after company, inspection after inspection.. same lackadaisical attitude from this Pharma sector.

There are so many more that need to scanned for participation in this Electoral Bond scam.  Next 2 or 3 posts have to be about Pharma companies.  

Stay awake, Stay Alert.. and don't forget Electoral Bond Scam, just because elections are here.

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?