Quality Issues with Generic Drugs Out of India?

[medaura]

This is pretty concerning. Intas Pharmaceuticals ltd manufactures at least some of the rapamycin products out of India.

https://www.msn.com/en-us/money/other/tainted-medication-fears-spur-us-defense-department-to-seek-outside-testing/ar-AA1eWX0U

The US Department of Defense entered an agreement with Valisure, an independent lab that’s spotted dangerous chemicals in a variety of widely used pharma and consumer products, to test medications amid surging concerns about generic drug quality and shortages.

Under a multi-year agreement, Valisure will test dozens of drugs for dangerous chemicals and rate manufacturers’ quality to help the department weed out potentially substandard treatments, according to a statement from the Connecticut-based laboratory. The partnership is a cooperative research and development agreement to exchange information, and the Pentagon will not pay Valisure.

Nine out of 10 drugs consumed by Americans are generic, low-cost copies of innovative medications whose patents have expired. Concerns about the generics industry — largely based in India and China — have exploded as the US encounters shortages affecting drugs such as life-saving cancer therapies made at a plant in India found to have major quality shortfalls.

After Covid-19 revealed the US’s dependence on other nations to provide crucial treatments, Congress directed the Defense Department to assess risks to its pharmaceutical supply chain. Bloomberg first reported on the department’s talks with Valisure in June. Drug shortages are at a nine-year high as manufacturers deal with quality issues, difficulty getting supplies and rising demand for certain drugs.

Valisure has gained attention for finding cancer-causing chemicals in drugs and personal-care products such as sunscreen, hand sanitizer and dry shampoo. The heartburn pill Zantac was taken off the market after the lab found a carcinogen in pills in 2019.

Kaiser Permanente, a California-based health system serving 12.7 million Americans, started working with Valisure on additional drug quality checks more than two years ago. However, US regulators at the Food and Drug Administration have pushed back against such independent drug testing, saying that some labs aren’t trustworthy and may spark unwarranted shortages.

The FDA has said that 62% of drug shortages are caused by quality issues stemming from poor manufacturing practices. A current shortage of two drugs, carboplatin and cisplatin, that are used to fight a variety of cancers is linked to a production plant in India operated by Intas Pharmaceuticals Ltd. The company’s plant shut down manufacturing after FDA inspectors found a truckload of shredded documents related to drug quality during a visit late last year.

“Our country’s reliance on active pharmaceutical ingredients and medicines manufactured abroad in China and India has come at significant cost of safety,” US Representative Rosa DeLauro, a Connecticut Democrat, said in the statement from Valisure.

Valisure’s ratings will rely on a scoring system Light helped develop along with other drug safety and shortages experts that was published in March in the Journal of the American Pharmacists Association. The system takes into account the outcomes of FDA inspections and testing of drugs for correct dosage as well as any carcinogens or other toxic compounds.

[RapAdmin]

I hope they share the testing data. This would be very valuable for everyone.

[medaura]

I would have had no trust in the Chinese for manufacturing ingestable consumables of any kind but I did have more trust in the Indians. If there are widespread issues in their main generics contractors that really gives me pause. I know I’m getting real rapamycin as I had all the usual “side effects” to one extent or the other and even my lunulas have entirely disappeared (I’m citing these as evidence in the absence of blood sirolimus data). But now I wonder if I’m getting God knows what along with sirolimus. I’m on vacation in Europe and pretty touch and go but will have to get to the bottom of who manufactures my Indian rapa — no-name-brand siroboon.

[jjrap1]

Speaking of generics … I recently noticed my BP had crept up over that magic 120/ number, and so we bumped my generic telmisartin from 20mg qd to 40mg qd. ‘Just for fun’ I checked the source of the generic (based on the code on the pill), and it’s from Zhejiang Huahai Pharmaceutical Co. Zhejiang Huahai was, in 2018 or 2019, ‘caught’ putting MDMA in their valsartin. Because I’m sort of a China-watcher (have traveled there in the past - prior to the current autocrat - can speak/read some Chinese, etc ) I see the degree of fakery and fraud occurring everywhere there. So excuse my cynocism, but why would drug companies be any different?

Who knows and who really checks these things; does the FDA? I seriously doubt they have the capacity for every generic drug, every manufacturer. I think the valsartin issue was actually discovered internally, not by the FDA or any independent tester so ??? Am I wrong about this? I recently purchased Zydus telmisartin from one of our favorite Indiamart suppliers (from whom I’ve purchased rapa in the past). Actually, I’m more prone to trust Zydus than Huahai!

[Beth]

I listened to Attia interview Katherine Eban about generics and was horrified at what I learned. She wrote bottle of lies. Ep #71 if interested.

#71 – Katherine Eban: Widespread fraud in the generic drug industry

I was very nervous until coming on here and seeing all of you very smart people ordering directly from India or other places, and, in general, being pro generic. I would never would have had the guts, if not for being a lemming and all….

[RapAdmin]

@jjrap1

I checked the source of the generic (based on the code on the pill), and it’s from Zhejiang Huahai Pharmaceutical Co. Zhejiang Huaha

Is this a medication that you purchased in the USA (i.e. a standard generic drug US market) or some online pharmacy?

The USA FDA has some oversight of official generic medications that are imported, but as @Beth mentions, and as reported by Katherine Eban, the oversight is sadly lacking and underfunded - so yes, even regular generics in the USA are more likely to be poor quality than the USA-manufactured (and FDA-checked) medications.

[jjrap1]

@RapAdmin

FDA-checked) medications.

Yep, I got it from the Safeway pharm with a GoodRX coupon.

[desertshores]

When you buy medications from India, first search for them on IndiaMART to see what brands are available. Pick your brand and specify to Jagdish or whomever you are using that you want this brand.

"India is a key hub for pharmaceutical manufacturing, with many major global drug companies establishing manufacturing facilities there. Some of the prominent drug companies with operations in India include:

Pfizer – Pfizer has manufacturing plants in India, focusing on the production of a variety of medicines, including vaccines, generics, and other therapeutic areas.

Novartis – Novartis operates manufacturing facilities in India, mainly producing generics and patented medicines, with a significant focus on both domestic and export markets.

Sanofi – Sanofi has a significant presence in India, including manufacturing facilities for its range of vaccines, diabetes care products, and other medicines.

GlaxoSmithKline (GSK) – GSK operates several manufacturing units in India, producing vaccines, consumer healthcare products, and prescription medicines.

Bristol-Myers Squibb – The company has established production units in India, particularly focused on manufacturing oncology and immunology treatments.

AstraZeneca – AstraZeneca runs manufacturing plants in India, producing a wide range of therapeutic drugs, including those related to oncology, cardiovascular health, and respiratory diseases.

Johnson & Johnson – J&J has significant operations in India, with production facilities for both pharmaceuticals and medical devices.

AbbVie – AbbVie operates in India with a focus on manufacturing treatments for immunology, oncology, and other therapeutic areas.

Eli Lilly – Eli Lilly has facilities in India, focusing on producing insulin and other specialty medicines.

Mylan (now Viatris) – Mylan, which merged with Upjohn (a division of Pfizer) to form Viatris, has a strong manufacturing presence in India, producing generic drugs for both domestic and international markets.

Dr. Reddy’s Laboratories – One of India’s largest pharmaceutical companies, Dr. Reddy’s has extensive manufacturing capabilities in India and abroad, producing generics and active pharmaceutical ingredients (APIs).

Cipla – Cipla is a leading Indian pharmaceutical company that also exports drugs globally. It has significant manufacturing facilities that cater to both the domestic and international markets.

Lupin Pharmaceuticals – Lupin operates several manufacturing facilities in India, specializing in generics, cardiovascular drugs, and antibiotics, among other therapeutic areas.

Sun Pharma – Sun Pharma, one of India’s largest pharmaceutical companies, has multiple manufacturing plants in India and abroad, producing generic drugs, over-the-counter (OTC) medicines, and active pharmaceutical ingredients.

Bayer
Industry: Pharmaceuticals, Life Sciences, and Crop Science
Bayer operates manufacturing facilities in India, producing pharmaceuticals, consumer health products, and agricultural products such as crop protection solutions."

Some German companies, like Boehringer Ingelheim, do not manufacture products in India but sell them there.

Boehringer Ingelheim is the brand of Jardience that I buy from India.
Most of the drugs I buy from India are sourced from major drug suppliers that have recognition from the EU and the US for their generic products.

[jjrap1]

@desertshores: good list; thank you. However, in the present case, looking for telmisartin on Indiamart, I see product from none of these manufacturers! Without knowledge of what generics are even actually sold in the US ( and so in some sense are ‘approved’ ) I’d be at a total loss about what to select!

[CronosTempi]

Why do you say that? I bought Teleact 40 from Sun Pharma. Sun Pharma is on the list desertshores shared. Are you not able to find Teleact anywhere? I bought it from three different vendors - Jagdish RLPharma, SafeOverseas, Forveda. I’m sure you can find other vendors. I received my Teleact 40 from all three, no problem, with a good expiration date. I’m not sure why you are unable to locate any. Have you tried the vendors directly? I prefer not to go through IndiaMart. Just contact the vendors directly, specify the dosage (40mg, 80mg etc), the quantity, and the brand - they should be able to source Teleact from Sun Pharma with no difficulty. The price quotes I was given were very cheap. If I were you, I’d try again, because in my experience you can definitely find telmisartan from a major pharma company in India - as a matter of fact, Sun Pharma is the single largest pharma company in that market.

[DeStrider]

I also don’t trust Chinese companies for anything ingestible. However big Indian pharmacy has been good - brands such as Sun Pharma and Zydus. I wouldn’t touch Siroboon though!

[jjrap1]

@CronosTempi - I went to Indiamart.com and searched for ‘telmisartin 40 mg’. Sun Pharma did not show up, but regardless, I didn’t have that list. I’m sure if you know what you are looking for, you can find it. But I was flying blind. Armed with @desertshores’s list, perhaps I will be more successful next time! @DeStrider: that’s my view as well.

[RapAdmin]

Yes - its a pain to search on IndiaMart - but if you’re persistent you can usually find it. But, saying that, I could not find the Sun Pharma telmisartin product. I do find Glenmark and Cipla - which are reasonably good manufacturers that also export to the US their generic medications.

Note: it helps to find the “brand name” of the drug and search on that. For example "“Telma 40mg” for the Glenmark, and “Telgard 40” for the Cipla.

[desertshores]

@RapAdmin

I could not find the Sun Pharma telmisartin product

Sun Pharma telemisartin is available from Jagdish Nikose. That is the brand I bought.

[jjrap1]

It would be helpful to have, for various oft-used pharmaceuticals, a list of ‘trusted’ Indian pharma companies and brands (whatever ‘trust’ means in this context). E.g. various statins, ezetimibe, bempedoic acid, telmisartin and maybe other ARBS, CCBs, trazodone, SGLT2 inhibitors, and other meds that people commonly use. Then the medically uneducated (like myself) would have a clue what to try to purchase. It seems we’ve more of less done that with rapa.

[DeStrider]

I can pretty much vouch for Jagdish Nikose at RLPharma. He’s my main vendor and has provided quality medications.

[LukeMV]

I was sent this brand of Rapamycin on buy-pharma.md recently, which has always been a reliable supplier, but I have never heard of this company before so I am nervous about using it. I contacted their customer service chat thing and they swore up and down it was good. I just don’t know though. The instruction book it came with was foreign but looked professional.

[DeStrider]

I can’t find anything out about Asher Pharmaceuticals that makes that drug. They’re not listed on the stock exchange and I can’t even Google their web page. Seems like a very very small and unprofessional outfit. I’d be wary too!

Get it tested. Or, take it and get yourself tested. The former is safer, but the latter probably won’t kill you?

[LukeMV]

I have to learn how to send things in for testing. This web site used to send Eris/Biocon so I was surprised that I got a new brand. That being said, I order a lot from them, have received all kinds of different brands, and never once had a problem. So my guess is it’s fine, but still…

Here is what the chat rep said

[Beth]

Excuse me if this has been said a million times, but do you know of an affordable way to send things in for testing? If not expensive, I’d be interested in randomly sending things in on occasion,.