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.
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