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.