Electoral Bond Scam Part XVII : Poor Quality of Pharma

 Another Look into Fakeer's Jhola : Pharma Companies warned or banned In US are ruling Indian medical scene thanks to Electoral Bonds

The Off-the-Mark Glenmark scandal :

We find a report of Reputed Glenmark Pharmaceuticals, receiving an US FDA Inspection failure report (Form 483) in Godi Media "Business standard" who actually copied from company's press release. This news report of 2022 says Glenmark had 6 Observations, never mentioning "Quality Standard Failure". If somebody isn't aware of what (Form 483) is, he might as well think, they won 6 awards. 

Why am I criticising the Media, because they forgot to mention or deliberately suppressed the fact that Same US FDA inspectors gave 5 non-compliance observations for Glenmark's Goa Unit .. Instead they blabbered are Glenmark's last balance sheet, revenue increases in that financial year and market capital and what not..

What was in it? The FDA Form 483 for Goa Unit of Glenmark Pharmaceuticals? Let me show you (if I can, any accredited member of Press can too).

US FDA Report writes in their 14 page inspection report and I quote:

DURING AN INSPECTION OF YOUR FIRM WE OBSERVED:  
OBSERVATION 1 

Investigations of an unexplained discrepancy and a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug  products that may have been associated with the specific failure or discrepancy.

OBSERVATION 2

There are no written procedures for production and process controls designed to assure that the drug  products have the identity, strength, quality, and purity they purport or are represented to possess.

OBSERVATION 3

Laboratory controls do not include the establishment of scientifically sound and appropriate test  procedures designed to assure that drug products conform to appropriate standards ofidentity, strength,  
quality and purity. 

Procedures to ensure accurate and consistent integration of chromatographic peaks have not been established.

OBSERVATION 4

Batch production and control records do not include complete information relating to the production and  control of each batch.  

Procedure 19PD672 requires compression machine operators to calculate the tablet reject limits based  on batch specific data from machine set-up. However, operators are using preset values without calculating the batch specific limits. If changes are made to the reject limits, these calculations are not  documented in the batch record or reviewed to determine if the parameters were set correctly to reject tablets that may not meet specifications.

OBSERVATION 5

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.

These are damning indictments for any Pharma company, specially never expected out of Glenmark facility. Such Form 483 issues could lead to "Serious warning letter" followed by "cancellation of licences" or invite class action lawsuits in US, which can bankrupt a company. That's the threat to the corporate side ... but they represent serious health hazards to everyone to take medication produced in these places, be they be American or Indian or be they be of any other nationalities. 

As expected, Glenmark got a Serious warning letter from US FDA.

FDA demanded strong action plans from Glenmark within 15 days and citing pretty much every single Observations in that form 483. No "Serious Warning Letter" actually lists all Form 483 issues in normal practice.

Being very long in Pharma business, Glenmark Pharmaceuticals knew that if the news of this warning is truly exposed in Indian Media, the damage it will do to its reputation in domestic Indian market will be irreparable and irreversible. Doctors may stop prescribing its drugs. So they decided to purchase Electoral Bonds worth  9.75 crore (9 one crore bonds, 7 ten lakh bonds, 5 One lakh bonds in denomination) on 11th November, 2022 about 2 weeks in advance of getting serious warning letter and gave it all to one Political party that basically controls Indian Media . 

Which Party do you think I have in Mind? Of all of it went to Fakeer's jhola Or BJP.. who else controls "Godi Media"!

How did they know 2 weeks before the issue of the letter? Every Pharma insider knows that serious warning letter comes about 6 months from the issue of

How did Godi Media report these serious non-compliances found in US FDA inspection? Let me show that as well,

 A 3 minute read quoting PTI full of inaccuracies, omissions and half-truths. Serious Warning letter doesn't come like that.. the process is..

Step One: Warning comes in Form 483 issued to senior most official at the facility on last day of Inspection.

In this case, US FDA observed in Form 483 and repeated in "Serious Warning Letter" and I quote

1. 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).

A. Your investigations into rejected batches failed to extend to other batches, dosage strengths, and drug products for tablet compression machine settings.

From 2018 to 2021, you rejected 14 batches of 0.1mg and 0.2mg strength desmopressin acetate tablets for out-of-specification (OOS) results for (b)(4) and content uniformity results. You implemented additional stratified sampling and conducted engineering batches to simulate the root cause for the failures for both dosage strengths. Although you attributed the content uniformity failure to the lack of defined compression parameters for desmopressin acetate 0.1mg batch 20210776, you failed to test other batches or drug products that used the same (b)(4) process and compression equipment

Step Two: Pharma companies write back with a comprehensive plan to mitigate the non-compliance issues. 

 Glenmark wrote in reply to that specific issue and admitted the mistakes which was quoted in the Serious Warning as :

In your response, you acknowledged batches were rejected for the 0.1mg and 0.2mg desmopressin acetate tablets and that you did not apply the corrective actions for the compression parameters for your 0.2mg strength tablets. As a result of this inspection, you conducted a retrospective review and discovered a failing stratified sample assay result for desmopressin acetate 0.2mg tablets batch 20220121 and initiated a voluntary recall of this batch on June 10, 2022. However, your response did not adequately address your firm’s failure to investigate the assay failure and market impact at the time of its occurrence and it did not include an overall management strategy for improving all phases of your investigations.

Step Three: if FDA is either not convinced or dissatisfied with companies plan, only then FDA gives a Serious Warning Letter.

Lets continue with that single Observation 1 of Form 483, FDA demanded detailed plans as it does in cases of "Flawed Quality Control Processes" and I quote:

In response to this letter, provide the following:

    A comprehensive independent assessment of the overall system for investigating deviations, discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system to include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, corrective action and preventive action (CAPA) effectiveness, quality oversight, and written procedures. Address how your firm will ensure that all phases of investigations are appropriately conducted.

    An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigations trends, improves the CAPA program when needed, implements final quality assurance decisions, and is fully supported by executive management.
 

Step Four: Company now has to show that they have taken action and then FDA reevaluates that and either gives a closeout letter or inspects again.

Now Food and Drug Administration is not the only US law enforcement agency, Glenmark had problem with, Department of Justice (DoJ) included Glenmark in a price fixing investigation, in 2020... here is the DoJ Press Release. 

I haven't heard any Indian Government to run an Anti-trust suit against these Drug company cartels.. Price-fixing of Medicines is rampant in India as well. Why do you think, home-made generic drugs cost so much in India. 

In 2023, Glenmark admitted wrongdoing and price-fixing charges brought in by DoJ and agreed to pay $30 Million in Fine .. Another DoJ press release is the proof of that..

Besides that a fantastic report on Pharma companies and Electoral Bond purchases came out in Indian News Portal, Scroll and I quote:

Glenmark received five notices for its substandard drugs between 2022 and 2023. Four of these were issued by the Maharashtra Food and Drugs Administration, which flagged its blood pressure regulating medicine Telma as substandard, mostly failing a dissolution test.

But Did You Ever hear that Glenmark was investigated for Price-fixing in India or they recalled any batch of Medicines in Domestic market (India)?

Glenmark however recalled a lot of medicines from US, after the FDA warning..

Curious Case of Natco Pharma :

In last 5 years this company has spent 69.25 crores on Electoral Bonds and gave it all local parties TDP, BRS, Jana Sena, YSR Congress and national parties like Congress and BJP . 

Basically they were looking for escape from Prosecution in US in anti-trust  lawsuits..

Natco decided to use bluster and Electoral Bonds to defend itself in India about the lawsuit. 

But we find they were issued an "Serious warning letter" by US FDA as well and faced lots of non-compliances in the Form 483s.

This year, NATCO received the warning letter from US FDA on 8th April. I quote the most significant parts of Warning Letter below:

The U.S. Food and Drug Administration (FDA) inspected your drug manufacturing facility, Natco Pharma Limited, FEI 3004540906, at Kothur Village Rangareddy, Telangana, India, from October 9 to 18, 2023.

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)).

2. Your firm failed to thoroughly investigate any 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 firm’s investigations into unexplained discrepancies were inadequate. Your quality unit (QU) failed to thoroughly investigate all finished product batches and components associated with unexplained discrepancies.

These Warning letters didn't come overnight, Natco received lots of Non-compliance notices and only thing they did was to stop production at the affected facility. 

 This was a 27 page long Form 483 from US FDA citing 8 very damaging Non-compliances.

The non-compliances were the following:

1. Equipments and Utensils are not cleaned and maintained in proper intervals to prevent Contamination. 

2.  Responsibilities and Procedures of Quality control unit are either not in writing or they are not followed. 

3.  Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and  followed. 

4.  There is a failure to thoroughly review  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. (OOS : Out Of Specification testing)

5. Separate or Defined areas to prevent contamination or mix-ups are deficient regarding  operations related to aseptic processing of drug products.

6.  Written records are not always made of investigations onto any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications.

7. Appropriate controls are not exercised over computers and related systems to assure that the changes in Master production and control records and other records  are instituted by authorised personnel.

8. Your firm failed to establish adequate written procedures for production and process controls designed to assure that  the drug products have the identity, strength, purity and quality that they are purported or represented to possess.

Indian Health Ministry knew about all these as US FDA tells both Central and State agencies about their visits.. Only thing Mr. Fakeer did was to put his share of Electoral Bonds inside his Jhola. Out of 33 crore NDA parties got, 17 crore went to BJP alone ..

Don't you think this nearly 70 crore expenditure would have been better spent on improving their quality control unit?

Electoral Bond Scam XVI : Pharma round up

 A Deep Look Inside Fakeer's Jhola 

More dirty truths about our Pharma Sector and Incompetent Media failing to report FDA observations in detail and Fakeer's Extortion of Pharma companies.

I thought I would quickly tick off the rest of Pharma companies who bought large amount of Electoral Bonds and gave to BJP,  but I'm having no such luck. Even API manufacturers like Divi's Laboratories had serious FDA warnings and Non-compliance Observations.

DIVI'S LABORATORIES and Troubles with US FDA (2016-2017)

So he is worth 7 times the annual revenue of his firm .. Revenue remember is not profit.. but these are the sign of times in middle of Bipartisan "Global Stock Market" bubble. But this now, but we need to rewind a little bit to December, 2016 to find a really bad US FDA (CFR 483) inspection report.

This 18 page report was prepared after inspection of Divi's Laboratories' Vishakhapatnam Unit II from 29th November to 6th December, 2016. Let me quote from the report, what and how serious these non-compliances were.. because no Media in India has covered them. Those days you could not copy-paste directly from FDA'S CFR 483 reports. But in recent reports one can copy-paste, still our Media never reads them, instead they merely copy-paste from every Pharma companies' press release.

These were the observations:

1. Proper controls are not exercised over computerised systems used for analytical testing to ensure drug products meet their specified quality attributes.

A. Your firm engages in extensive use of "Inhibit Integration" and other anomalous integration techniques for assessing US APIs such that unknown impurities are disregarded without scientific justifications. Furthermore, unknown impurities are not assessed or reported.

In a neatly formatted tabular format US FDA cited 48 such cases regarding 9 products/APIs and concluded that "inhibit integration" was used to mask unknown impurities. 

They even cited peculiar chromatograph spikes suggesting impurities. Regarding Chromatographic systems US FDA reports cite and I quote:

B. 60 of your R&D division's chromatographic systems do not have audit trails enabled or enabled audit trails on November 27, 2016, the day before the initiation of US FDA inspection.

.. and .. that November 27 was a Sunday, so technicians came on a Holiday to enable audit trails??

Furthermore, we observed drug products from production at R&D ... we noted obscurely named sequences chromatographic sequences in these systems.

They cite 8 such examples . 

 Observation No. 2:

Facilities and equipments are not maintained to ensure the purity, quality,  strength and identity of APIs.

The report cited 6 examples. 

3. Your R&D division guides quality and production to commence activities inconsistent with CGMPs

The report cited 9 such cases . 

 4. Failure to conduct a thorough investigation.

They cite cases of complaints about quality on 28th and 30th June, 2016.

5. Documentation and records are either not maintained or inaccurate/ falsified. 

You can find the details of 4 cases in the screenshot that I've attached above.

Well, there wasn't much noise in the Media till this resulted in an Import Warning for Divi's Laboratories next year,  that too, in Foreign Press. 

To resolve those issues, Both US FDA and Divi's Lab agreed to have the facilities re-inspected on September 2017, but this time a 5 page FDA CFR 483 report cited 6 CGMP non-compliances. 

As your can see, Observation Number 1 is actually a repeat observation as it was noted as Observation number 2 in 2016 report.  Observation number 2 is actually a much detailed observation number 4 of last report, as was the new Observation number 3.

But new and old non-compliances were put in the backburner as Geopolitical needs conflicted with scientific scrutiny and in 2020, when every Pharma companies' dream "PANDEMIC" arrived, every sort of restrictions were lifted by both Trump and then by Biden.

In fact, Even New York Times printed an article which was syndicated and circulated throughout the world about concerns on Joe Biden's pick of US FDA chief, Robert Califf ..

I thought "Clinical trial" was a multi discipline exercise, where professionals from various fields offer their expertise to verify the usefulness of a drug or therapy.. but never heard someone is a "Clinical Trialist" .. well, he has the controls of Nuclear missiles, so I guess Biden can call anybody anything.

2023: Election in Telangana and Califf visit to India and subsequently to Divi's factory. 

As Elections in Telangana was coming closer, Hyderabad based Divi's Laboratories bought 20 crore in Electoral Bonds on 5th July, 2023 gave it to local ruling BRS.

Then came the news that US FDA Commissioner would be visiting India and many Pharma companies started courting BJP so that they would arrange a meeting or a factory visit by Robert Califf and BJP run health ministry happily put Party's interest before Country's Interest and Interest of Humanity at large.

Protocols be damned, Califf visits various manufacturing units and "Godi Media" reported these visits with much pomp and gala.

On 11th October, 2023, Divi's Laboratories purchased 35 more One Crore denomination Electoral Bonds and gave cool 30 Crore to BJP.

I have no idea whether Robert Califf knew that BJP is charging Money for his visit to manufacturing units. 

Califf's visit was just a tour and not a technical inspection.. as "Clinical Trialist" professionals are not qualified to a quality or process audit of a pharmaceutical manufacturing unit :)

Was this 30 crore payment a bribe or extortion by BJP? Godi and corrupt Indian Media would never ask? Why would a company with 520 cr

Meanwhile, Robert Callif had his own scams to do.. On returning to Washington, he batted for Generic Drug Making Dollar Billionaires (as claimed by Forbes and ranked by Bloomberg Billionaires Index) and said "Generic Drug prices should be hiked" as Indian Billionaires (just a handful though) asked him.

Dr. Reddy's Laboratories and the tale-tell episodes of Electoral Bond purchases, Product recalls from International markets and Russian vaccine production and troubles with Regulators. 

It isn't hard to find any news of Dr. Reddy's Laboratories getting a hard knock from Drug product Regulators, in International Pharma managizes and portals. Those are the only places to look, as Indian Media and press are totally in collusion with Pharma companies as well as being technically incompetent and completely morally bankrupt.

Good news for Dr. Reddy's is that I could not find any US FDA serious warning letters to them in last 5 years, unlike in 2015 when they had 3 plants named in a serious warning letter and had to voluntarily recall starting in 2016 other drugs as well as this report still recalls. 

Here is an excerpt from news report covering the serious warning letters.

US FDA wasn't the only regulator unhappy with Dr. Reddy's then, in 2017, German regulators were unhappy with them too.

Although the German regulators were happy with the corrective plans Dr. Reddy's proposed subsequently. 

In early 2019, Dr. Reddy's suffered a massive jolt when US FDA inspection at  bachupally plant got 11 Non-compliance Observations including 4 repeat observations. https://www.fiercepharma.com/manufacturing/dr-reddy-s-racks-up-more-repeat-violations-at-bachupally-formulations-plant

But in spite of these observations, their sales at US markets did not slow down.. Indian Pharma companies have a secret weapon,  India also exports Doctors to US, although they are not wrapped in boxes and sent in a container... and Doctors prefer to use drugs and brands they are familiar with.. preferably for a long time.

So Dr. Reddy's bought Electoral Bonds worth 7 crores to be in good books of ruling TRS (now called BRS) on 8th May 2019 and gave them those..

Meanwhile Dr. Reddy's were hit by two voluntary drug recall in US ( and only in US), first was a case of mislabeling of Levetiracetum on 4th February, 2019.

Next in 2020, on 26th March, when injection ampules of Phytonadione Injectable Emulsion, were breaking and shattering..

On 2019, we find FDA slapped fourth Form 483 (for Bollam plant) for that year on Dr. Reddy's where 5 serious Non-compliance noted as reported by Fiercepharma:

The non-compliances were something FDA had warned Dr. REDDY'S before like Product complaints are not thoroughly investigated, OOS testing not conducted properly... to .. Records not made available to FDA investigators.

Then came the Pandemic, Dr. Reddy's Laboratories tied up with Russian Gamaleya National Research Institute of Epidemiology and Microbiology to manufacture and conduct stage trials of Covid19 vaccine named SputnikV! In case you forgot that I'm giving a screenshot of a Forbes India article.

 Conducting Clinical trials in India are a golden opportunity for any Pharma company in the world, No clinical trial ever failed in India on Covid (even those using herbal concoctions) and everyone gets the required and desired outcome mentioned at the time design of clinical trial study.

On April 13, 2021 .. DGCI approved Sputnik V as 3rd Covid19 vaccine, well, when applied through that PMCARES route, DGCI never said no to anyone during Pandemic.  Ha ha ha.. DGCI expert supposedly approved the Phase III Clinical trials of Sputnik V, without seeing the phase 1 and phase 2 study design and detailed results.

Remember at that time, Covid19 vaccines were not free at all, A single dose of AstraZeneca or Sputnik would cost around One thousand rupees in all major cities of India.  Every vaccine taker had to register themselves with a Government database costing Rs. 350, an one time fee to get a Vaccination (Stupidity) Certificate which carried Don Fakeer's photo instead of Vaccinated person's photo.

But Indian Urban Population no longer thought Russian vaccine is a good idea and they chose the Oxford-AstraZeneca vaccine instead of SputnikV, but they exported this vaccine to Russia and other countries of Russian influence. 

Dr. Reddy's were Back to Electoral Bond purchases, on 1st July, 2022 SBI bond purchase records show, "DR REDDYS LABORATORIES LIMITED"  purchased 4 bonds worth One Crore and gave 3 of them to Telegu Desham Party and 1 Crore of BJP. 

 Similarly on 6th October, 2022 , as "DR.REDDY'S LABORATORIES LTD" they purchased 25 One Crore EBs (Electoral Bonds) for BRS and 2 One Crore EBs for BJP. 

From these data it seems that BJP's contributions were like in "Local taxes are extra" mode.

10 November, 2022, as "DR.REDDY'S LABORATORIES LTD" they purchased 15 One Crore EBs of which 12 crore went to Fakeer's Jhola as donations to BJP and 3 Crore went to Congress party. 

Incidentally their profit dropped that quarter too but pleasing political parties are more important than pleasing the stupid retail shareholder, who keeps clinging to the share certificates in hope that one day they will become "Uber Rich" with that.

2023 Began well for Dr. Reddy's are they bought generic formulation and other US assets from Mayne Pharma

Deal was worth US$ 105 million. Also we learned that an Overseas Subsidiary of Dr. Reddy's "Aurigene Pharmaceutical Services" was to invest $40 million in a Dr. Reddy's plant at Hyderabad, India; from another Fiercepharma report. 

Don Fakeera was extremely annoyed with Dr. Reddy's as they were paying others in Millions and did not offer to pay more money in Electoral Bonds. So this happened later in November 2023... IT raids people from "Real Dr. Reddy's" family, many of whom are shareholders but not on Companies board.

Isn't it stupid of Finance Ministry to promote prevention of Double taxation and then raid major shareholders of Major Pharma company, whose overseas profits are there in the books of Overseas companies in Delaware and other tax havens.. They should have raided the CEO, Mr. Erez Israeli instead.. ha ha ha.. these are the official Directors.. Not too many Reddys are present. 

Now this Deccan Chronicle report of Income Tax raid is from November 13 and on November 17, 2023, Dr. Reddy's Laboratories Ltd buys 21 Electoral bonds

and gives 10 of them to Don Fakeer's Jhola and BJP encashed them on  23rd November.. IF THIS IS NOT A CLEAR CASE OF EXTORTION via INCOME TAX PEOPLE,  then the word Extortion should be removed from all dictionaries. 

As if to register a protest, Dr. Reddy's gave remaining 11 Electoral Bonds to Congress party, who would win the Telangana election in 2023 by decimating BJP and its allies. 

I know this post is getting very long, but there are more bond purchases and US FDA CFRs (I had to read 16 of them, to give you the excerpts) to cover,

The 27th October, 2023 CFR 483 noted 10 Federal Regulation Non-compliance Observations at Bachupally plant.. yup the same plant that FDA was unhappy with in 2019.

Some of the Observations are repeat non-compliances as well. 

• Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.  

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

Specifically, There is a lack of adequate evaluation of equipment conditions upon preventative maintenance, equipment cleaning, and line clearance.

• Determinations of conformance to appropriate written specifications for acceptance are deficient for  drug products.  

Specifically, determination of conformance to written specifications are deficient for TAMC (Total  Aerobic Microbial Count) test and TYMC (Total Yeast and Mold Count) test conducted for purified water and drug products. (whow)

• There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of  its components to meet any of its specifications whether or not the batch has been already distributed.  

Specifically, the quality unit failed to investigate deviations and investigations thoroughly that could  potentially impact the patient safety and product quality.

So you see, these observations are actually critical non-compliances of norms as a result of which end products can potentially can harm any human being, not only the American consumers. This 23 page PDF cited 10 such issues.

No matter how many Technical problems they have, they are not exempt from paying Political parties.. Don Fakeer's ally Telegu Desham got 10 crore in Electoral Bonds which Dr. Reddy's purchased on this very year, on 4th January, 2024.

Would these parties go and clean equipments and utensils in Dr. Reddy's plants .. No way, none are technically qualified to do that.. this isn't dishwashing at a tea-stall. 

Let's end this Medical thriller by giving you the news of another Dr. Reddy's recall (only in US, sorry Canada and others) of a drug used in treating Phenylketonuria on 23rd April, 2024 due to Sub-potency.

If only Robert Califf, Commissioner of FDA spent more time reading CFR reports than touring...

Electoral Bond Scam Part XV : US FDA catches Pharma Adulteration

 More Rotten and Trash Pharma In Fakeer's Jhola

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The warning letter summarized all these issues and highlighted: 

1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

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

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

4. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). 

5. Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). 

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

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

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

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

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

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

Weird patterns of Electoral Bond purchases of Sun Pharmaceuticals:

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

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

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

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

First 5 digits are for Bank Code,

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

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

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

But  back to Sun Pharmaceuticals story:

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

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

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

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

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

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

IndiaMart.com says: 

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

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

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

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

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

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

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

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

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

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

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