Evaluating The TGA Warning Article on Counterfeit Indian Ivermectin
Last Updated on November 7, 2024 by Primary Researcher
Executive Summary
- Australia’s TGA boldly declared that many of the best-selling brand names for Indian-manufactured Ivermectin are counterfeit.
- This article evaluates these claims.
Introduction
In March of 2022, Australia’s TGA Therapeutic Goods Administration, which is the Australian drug regulator akin to the US FDA, published a very short article warning that their study had found that all of the major versions of Ivermectin manufactured in India were counterfeit.
The TGA Warning Article on Counterfeit Ivermectin
The following quotes are from the article TGA cautions consumers over counterfeit ivermectin.
“The products – Iverheal-12 and Iverjohn-12 – are labelled as containing 12mg of the active pharmaceutical ingredient ivermectin, however laboratory testing has confirmed that they contain less than the declared amount of ivermectin written on the labels. In December 2021, the TGA published a warning about imports of ivermectin. At that time, three products that listed ivermectin on the label were also found to be counterfeit (Iversun-12, Covimectin-12, Ivilife-12).”
Important Point #1: Which Version of These Brand Names Was Tested?
This is an important question because any company in India can manufacture Ivermectin and sell it under the brand names Iverheal, Iverjohn, Iversun, Covidmectin, and Ivilife. There are many other brand names for Ivermectin as well.
The TGA article does not attempt to explain this fact in its warning. I think these are the biggest brand names of Ivermectin made in India, so this would mean the TGA is saying that all of them are counterfeit. There are many different manufactured versions of these brand names, so some specificity on the part of the TGA would be necessary.
Why is a Brand Name Not Owned by A Single Manufacturer in India?
Any manufacturer in India can do this because a brand name in India does not mean the same thing as a brand name in the US, Europe, Australia, etc., as the laws on things like intellectual property are completely different in India. This is explained in the article Why Chemotherapy That Costs $70,000 in the U.S. Costs $2,500 in India.
Why does Gleevec, a leukemia drug that costs $70,000 per year in the United States, cost just $2,500 in India?
It’s seemingly simple. Gleevec is under patent in the U.S., but not in India. Accordingly, Novartis, its Swiss-based manufacturer, may prevent competitors from making and selling lower-cost versions of the drug in the U.S., but not in India. Last week, India’s highest court rejected an application to patent Gleevec. While the legal issue in the case is important — the patentability of modifications to existing drugs under Indian law — the impact of the decision will likely be broader than just that issue, escalating a long-simmering fight over patented cancer medications in emerging markets. Rejecting the Gleevec patent application is not the only step that the Indian government has taken to circumvent patents on cancer drugs. Last year, India issued a compulsory license on Nexavar, a late-stage kidney and liver cancer treatment, enabling a local drug firm to produce a generic version of this medicine without the permission of Bayer, the patent holder. India has recently announced plans to grant compulsory licenses on another leukemia drug and two breast cancer therapies.
This completely different view of intellectual property law is generalized to many parts of Asia, as explained in the following quotation.
Indonesia recently issued a compulsory license for a treatment for liver cancer-causing hepatitis B. China and the Philippines amended their pharmaceutical patent laws, making it easier for those governments to take similar measures as India.
Therefore, there are many versions of each all called Iverheal or Iverjohn, Iversun, etc. — all produced by different manufacturers. Remember, the active pharmaceutical ingredient or API does not come from India. In most cases, the API comes from China. China outcompeted India in this area decades ago.
The Work Done by Indian Manufacturers
The Indian manufacturer mixes the purchased API with excipients — other inputs to the pill, and then produces the pill and packages the item. Then, the product is given a name. The Indian manufacturer pays no royalty for the name and can choose any name they like.
We tested several versions of these brands and found differences between them; however, they all contained Ivermectin. The question was how much or how high the match was to the original Merck product. This overall topic is called bioequivalence, and I cover it in the article Our Ivermectin Bioequivalence Testing.
After our testing, we worked with Summit Products to carry the Ivermectin that scored the highest among the groups they tested. As we do more testing, we may switch to a different version.
Important Point #2: Where is the Information About the TGA Ivermectin Test?
Something that is quite appalling, and which I did not see uncovered in any of the reporting of the TGA announcement is there is no mention of the test that the TGA claims to have performed. I searched using multiple search engines and I could only find a reference to the TGA article at the Drug Office of Hong Kong.
But this has nothing to do with the test. Where is the information about the test?
- I searched the TGA website using different keywords related to Ivermectin and testing and again found no mention of any test besides the initial TGA article.
- The TGA warning article was published in March of 2022. I searched their site over two years after this warning article was published and found nothing related to the test.
- It is quite apparent at this point that the TGA plans to never publish the test, or in fact any details about the test.
Australian taxpayers apparently paid for the TGA to perform bioequivalence testing, so shouldn’t Australians and the world get to see this test or at least some description of it? Is really the point of the test to keep it internal? Is the test a matter of Australian national security, or is it a matter of public health?
The entire article/press release from the TGA on this topic is only 265 words. In replying to this TGA article, I require roughly 4000 words (including the quotes of course).
The TGA’s failure/disinterest to provide a link to the test, or publish anything about the test is highly unprofessional.
Interestingly, the TGA can get away with this.
Important Point #3: Versions That Contain Less Than the Declared Amounts of Ivermectin?
Let’s go to this part of the paragraph:
“confirmed that they contained less than the declared amount on the labels.”
Ok — how much less? Notice it is not stated.
There is a pattern here where the TGA only seems comfortable in making statements in this press release that can’t be verified. The TGA would have used lab equipment to measure the bioequivalence so they could quote numbers.
The TGA is not worried about providing evidence because it relies on its authority to make its point.
The Universal Variance With Indian Manufactured Drugs
What the TGA does not tell you, and what neither they nor the FDA are interested in discussing, is that generic drugs made in India frequently differ from the original. I cover this topic in a series of articles that are the least viewed on the site. These articles can be viewed from the Brightwork Drug Sourcing Article Index. Several subscribers have told me these articles are quite boring. I would have to go into the website statistics to see how many subscribers have ever viewed them, but it is depressingly low.
The TGA and FDA little discuss this topic of bioequivalence, and the FDA in the past has denied that this is a problem. They also make claims of testing drugs that are made outside of the US that they do not follow through on. The book Bottle Of Lies by Katherine Eban completely exposes this fact. It is yet another area of drug regulation and drug safety that the FDA falls down the stairs on. I cover this topic in the article The Myth of the FDA Properly Inspecting Indian and Chinese Drug Manufacturing Plants and the article How the FDA’s Generic Bioequivalence Testing is Fake.
Essentially, the FDA, and I assume the TGA. However, I have not investigated this specific topic in detail (but all of the health agencies/drug regulators tend to behave similarly) and have been telling people not to worry about the bioequivalent and excipient (the other stuff in the pill) variance from the original version. That is, they tell the public not to worry about it — until the topic is a drug they don’t want (or should I say the pharmaceutical companies, as the FDA and TGA do what pharmaceutical companies tell them).
At that point — all of a sudden, the topic of bioequivalence is brought up. How convenient.
Ivermectin Versus Other Drugs Made in India?
The TGA will not issue such a warning on a generic drug made in India that the pharmaceutical industry wants you to purchase.
I guessed this but then tested my guess as I performed a search for a TGA warning on Indian manufactured. I tested for the following drugs. These are drug “superstars” and are very profitable for the pharmaceutical industry.
- Antidepressants
- Statins
- Chemotherapy drugs
When I searched, I could not even find TGA in the results for these searches.
Now it is time for a question. What makes Ivermectin produced in India any different than any other drug produced in India from the perspective of bioequivalence?
The answer is nothing.
Drugs like antidepressants, statins, or chemotherapy drugs do not magically become more bioequivalent because they are not Ivermectin.
However, the TGA will not test those Indian-manufactured drugs, or if they do test, they do not report bioequivalence differences — because they are drugs that the TGA wants to allow into the country. Although I have no information about the TGA’s test, if the TGA did do testing, they only exposed something that applies to all drugs — but which they do not want the public to know. The reason this seems like such a significant item is the public is nearly entirely unaware that this issue applies to other drugs made in India.
Now, the TGA could have explained this, but of course, they didn’t, as it would have made their declaration regarding Ivermectin seem odd and as if they were singling out Ivermectin — which is exactly what they were doing.
How I Discovered the TGA is Protecting Australians from Turmeric
I typed “Indian” into the TGA search engine, and I did not find what I was looking for — whic is any articles on warnings for any other Indian-manufactured pharmaceutical. But interestingly, I did find this article Medicines containing turmeric or curcumin – risk of liver injury
Turmeric is on our List of Recommended Items to Help Prevent and Fight Cancer.
I take Turmeric every day, as does everyone at Brightwork. Turmeric is used liberally throughout India (which is why it came up in the search results). It is credited with improving health in India. Here is a quote from that article.
The TGA has received 18 reports of liver problems experienced by consumers taking products containing Curcuma longa (turmeric) and/or curcumin up to 29 June 2023. Nine of these reports had enough information to suggest a liver injury that may have been caused by the Curcuma longa (turmeric) or curcumin product. Of these, in 4 cases there were no other ingredients likely to have contributed to the liver injury. Two of these cases were severe, including one that had a fatal outcome.
Really?? Liver injury caused by Tumeric — are we joking? Cancer patients are getting their livers and lungs smashed regularly by immunotherapy drugs — which the TGA does not create warnings from, and Australians are being informed about Turmeric?
The drug companies don’t like Turmeric as it’s not a drug. And what the pharmaceutical companies don’t like, the TGA does not like.
Here, an agency is writing a warning on turmeric when hazardous drugs like Keytruda and other immunotherapy are being broadly used without such warnings by the TGA. The TGA has lost the plot in terms of safeguarding public health, and its agenda is clear.
I searched the TGA website for a similar warning on Keytruda and found no articles. Of course, such an article would make Merck angry, and Merck is a future employer for many of the top brass at the TGA. So am I to take from the TGA’s focus in terms of the articles that I publish that I should be more concerned about Turmeric than Keytruda?
Because if that is the TGA’s position, that would be insane.
Read this article on Keytruda’s side effects and see which is more dangerous. The Massive Cover Up on Keytruda Immunotherapy Side Effects.
The Reality of Pharmaceutical Supply Chain Interdependence with India and China
The TGA, like the FDA, is under pressure to allow low-cost generics of the approved drugs into the country, and India is the largest manufacturer of drugs in the world. The number one consumer market for drugs is the US, with 5% of the world’s population consuming 55% of all drugs manufactured in a year. Furthermore, about 80% of the active pharmaceutical ingredient (API) is also made in developed countries, most of which are in China. So Merck’s Ivermectin, made in the US, may also contain Chinese API. You would not know, and there is no way to find out.
The following quote from Consumer Reports is illustrative.
Plus, when you consider that about 80 percent of all raw drug ingredients used to make medications we take in the U.S. come from other countries, it is very difficult to know where all the components of a medication come from, regardless of where it was manufactured.
“These days it can be very hard to track where your drugs come from,” said Barbara Young, Pharm.D, editor of consumer-medication information for the American Society of Health-System Pharmacists. “There’s not even always a straight line from the manufacturer. Sometimes drugs are repackaged and rebranded along the way.”
According to Victor Curtis, R.Ph, senior vice president of pharmacy at Costco Wholesale. “Pharmaceutical manufacturers don’t disclose the country of origin on the product’s label,” Curtis said. “And, if contacted, some will disclose what country the medication came from and some will not.”
It is important to note that this Consumer Reports article was published in 2014, so ten years later, globalization of the drug supply has only increased, so the numbers listed here will only go up in 2024.
Why We Performed Our Testing
The problem with the bioequivalence of drugs produced in India, combined with the much higher expense of Ivermectin produced outside of India, was the original reason for us to perform our Ivermectin testing. Subscribers were telling us they could not afford the Ivermectin made in countries like the US or Germany.
This gets to the next important point.
Important Point #4: Are Drugs With a Lower Than Advertized MG of API Counterfeit?
This is the claim by the TGA, but the answer is no. That does not make those drugs counterfeit, and it just means they contained less Ivermectin than the Merck original. There is variance and more variance among Indian manufacturers — which was the reason for Brightwork’s Ivermectin testing program in the first place.
First, the TGA is incorrect because drugs have variances in the amount of active pharmaceutical ingredients, which does not make them counterfeit. The fact that the TGA, with their resources and supposed lab testing results, won’t discuss the variance from the Merck original should be considered a major red flag.
Remember also that the Merck version is much more expensive. Anyone is free to buy Merck’s Ivermectin. However, most subscribers have a problem justifying the expense, particularly for long-term use. Our recommended Ivermectin combines lower cost (although not the lowest cost) and good quality. But anyone is free to buy any Ivermectin they like.
Why Did the TGA Write this Article/Press Release?
Was the purpose of this article by the Australian government really to inform the public about a real concern? That would be impossible. This is because the lack of context that the TGA provided results in what amounts to essentially false information. While it is not surprising that if the TGA did the test, there was a variance from the Merck version of Ivermectin, so much information was left out that the reader came out with a false impression.
- The overall article is very deceptive.
- This article is not concerned with what is true but with modifying behavior based upon incentives that the TGA does not declare to the reader of the article or press release.
My conclusion is that the purpose of this article is the same as all articles from governments on Ivermectin — which is to undermine faith in Ivermectin.
To prove this point, let’s quickly review a few other claims made by the TGA about Ivermectin in different articles.
I will give a synopsis of each rather than get into detail. You will quickly observe a pattern.
TGA Ivermectin Article Example #1
This article is a repeat of the FDA’s position. It contains false information that Ivermectin is not effective against covid when it was THE most effective drug against covid.
See this quote.
Oral ivermectin also has the potential to cause severe adverse events in persons, particularly when taken in high doses that have recently been described in social media and other sources for the prevention or treatment of COVID-19 infection. These include, for example, severe skin reactions accompanied by fever, chills and aching muscles, severe blisters and bleeding in the lips, eyes, mouth, nose and genitals, worsening asthma and swelling of the face, legs, ankles and feet.
This repeats the FDA’s false claim about people taking animal-sized doses of Ivermectin. As with the TGA warning article, the FDA never provided evidence for these claims. They only said they had reports of some cases of this.
Since the covid pandemic, the FDA has lost a series of court cases regarding its statements and policies regarding Ivermectin, which I cover in the article The FDA Continues to Have its Court Determined Misleading Ivermectin Article Unchanged and the article How The FDA Was Forced in Court to Admit that Ivermectin Can be Used for Covid. Essentially, the FDA has been humiliated in court and overstepped the legally set boundaries. Thank God these boundaries exist becuase the health authorities and drug regulators have become increasingly power-hungry and believe they have the right to dictate to the public rather than serve the public interest.
And as I said, these entities are merely marionettes of the pharmaceutical companies and medical device manufacturers. Would Pfizer mandate their drugs if they were legally allowed to and have a future where people are given vaccines or chemotherapy against their will? You know they would.
Court Mandated Chemotherapy
This video shows a 17-year-old girl who has been mandated to take chemotherapy. The statistics used in this segment are exaggerated regarding chemotherapy’s life extension — however, remember, this segment was produced on CBS, which is highly dependent upon pharmaceutical advertising.
The direction of the medical system in the US and in many other countries is to move to mandated treatment for adults as well. A problematic precedent for this adherence to the CDC vaccine schedule — which is now mandatory in some schools to be enrolled. Once mandated treatment is established in one area, it begins to migrate to the types of treatment. Recall the pressure on everyone to get the covid vaccine, which helped no one and caused significant health damage. This is why, for example, as I cover in the article False Media Fact Checks on the Low Degree of Vaccination and of Autism in the Amish, the Amish have a major disagreement with the US medical system.
TGA Ivermectin Article Example #2:
New restrictions on prescribing ivermectin for COVID-19
This is a copy of the FDA policy of pressuring doctors not to prescribe Ivermectin off-label — primarily for covid. It could have been written by the same author as the FDA.
TGA Ivermectin Article Example #3:
Removal of prescribing restrictions on ivermectin
This article, published in May 2023, showed the TGA backpedaling on the restrictions, removing them from the Poisons Standard. The following is a quote from this article.
The restriction on ivermectin was introduced in September 2021 because of concerns about the safety of consumers using ivermectin without health advice to treat COVID-19, widespread use of ivermectin instead of approved vaccines and treatments for COVID-19, and potential shortages of the medicine for approved uses.
This considers the evidence and awareness of medical practitioners about the risks and benefits of ivermectin and the low potential for any shortages of ivermectin for its approved uses. Also, given the high rates of vaccination and hybrid immunity against COVID-19 in Australia, use of ivermectin by some individuals is unlikely to compromise public health now.
This statement is ludicrous. As the vaccines did nothing against covid, and we are now living with the side effects, and the cover-up by the medical authorities, as I cover in the article If The Covid Vaccines Are Safe Why Did The FDA And Drug Companies Ask for 75 Years To Produce Documents on Them?
Can the TGA actually tell anyone with a straight face that the vaccines were safe and necessary and that they had a good safety profile?
The TGA, like the FDA, prevented the public from accessing Ivermectin so that the pharmaceutical companies could more effectively promote and make money from the vaccines. If Ivermectin had been recognized for its effectiveness against covid in the first place, the vaccines could not have been granted emergency use authorization by the FDA — which is why the efficacy of any therapeutic had to be denied. Ivermectin would have cost the vaccine manufacturers hundreds of billions of dollars in lost sales. The state’s reason the TGA restricted Ivermectin is not the real reason because the real reasons they did this had nothing to do with public safety. However, they hide behind faux public safety concerns to defend their action.
Hopefully, these other TGA articles demonstrate that the TGA behaves like the FDA regarding Ivermectin. Furthermore, the TGA does not work for Australians. It works for pharmaceutical companies, just like the FDA. No drug regulator in the world is not controlled in this way.
Conclusion
Analyzing articles from the health authorities on Ivermectin or even things like Turmeric has become quite repetitive. Their warnings are designed to reduce competition against their preferred drugs. The TGA warns the Australian public against Ivermectin, and for the same reason, they warn the public against Turmeric. The TGA is the FDA or EMA (European Medicine Agency) — another pharmaceutical and medical device manufacturer marketing front end masquerading as a public health entity.
The Valuable Evidence Provided by the TGA
This is my first article on the TGA. However, I quickly found that the TGA is a valuable website, primarily because it is more evidence of the collisional nature of the health authorities, as the information is the same as that on the FDA’s website. It is more proof that pharmaceutical companies control every drug regulator.
When I analyzed the TGA’s website and articles, I was right every time I predicted what the TGA’s position would be before performing a search for articles. If the TGA were independent of the pharmaceutical companies, I would not be able to guess correctly every time, regardless of the topic I searched for.
Does the TGA Develop the Content For Its Articles?
The TGA has roughly 600 employees, which is much less than the FDA’s 17,000 employees, and the TGA’s articles and statements appear to be simply rephrasing from those on the FDA website. I kept finding FDA policies that were also TGA policies and published at around the same time as the FDA policies. I like the TGA website because while the information is the same as that published at the FDA, I find the TGA articles to be much better written and more concise. This efficient writing allows me to read the articles from the TGA site and understand them very quickly.
I now consider the TGA’s website an excellent source — not to find out what is true — but to find out what the pharmaceuticals want the public to think is true.
*Assistance in this article from Steve Thorne at Summit Product