If anyone is interested in a true story about generics, this is an eye-opening read:
What was shocking to me, was not just the company’s overwhelming need to be Number One, but that they cared so little even for their fellow countrymen, let alone the rest of the world.
And yes, because the situation still continued a decade or more after the whistleblower came forward, I am very wary of generics, especially those manufactured in India…
Most pharma companies seem to source mainly from India … I always asked for the brand not chemist own etc now regardless of the price all are from India so save $2 by sticking to chemist own.
If they had country of origin on them how would that affect your purchases?
What medicine approved by the TGA does not have the ingredients on the pack?
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One of the most terrible of outcomes related to the supply and promotion of pharmaceuticals lies at the feet of a multinational European manufacturer. Not from products manufactured in Asia but at one well respected centre of of enterprise and technology.
‘Thalidomide | Science Museum
I’m not convinced the country a pharmaceutical is sourced from should be the principle reason for purchasing or not that brand of product. The expertise and responsibility for Australia in deciding which products to allow in by type and brand/supplier is with the TGA. I’m reassured and very comfortable using generic product.
I’m also surprised at how little our understand may be of the world be live in. Suggesting pharmaceuticals from any country/source can or cannot be relied upon without substantiating evidence achieves little. Profit driven outcomes that deliver adverse consumer outcomes can be attributed to modern businesses where-ever they are located. Just ask those who purchased a VW branded diesel powered light vehicle.
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For a while in the last years of working, I was taking Modafinil in order to remain awake to do the job. Sadly, Modafinil was not (and still is not as far as I know) on the PBS, and a month’s supply cost $130 or so depending which pharmacy you went to (Having a script is one thing but you don’t get PBSed med). So I found a source online, it was much cheaper than the $130, I was able to get 6 months supply at a time for $90. It worked for me. I don’t take it now but if I found I needed to, I’d go back to online purchases. The company I was buying from was an Indian one, and I can’t remember the name now, but it was familiar to me, at the time. Alas, they are no longer selling online.
The saddest part of this is that if I had narcolepsy I would be prescribed dexamphetamine, because its cheaper for the government to subsidise, than modafinil which does the same job without side effects or habituation.
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All true but not relevant to this topic. It is hard to get anybody to specify the reason for their fears but it looks like the concern is not getting what they paid for due to poor quality control, contamination, wrong dose or similar.
I don’t think we are talking about drugs that were not tested properly in the first place or a system that didn’t require confirmation of safety for pregnant women for a drug prescribed for them. Of course somebody may leap into this and declare that was what they had in mind in wanting to have different labelling.
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But why? You can assume that we have not read the book so we don’t know why you are saying this.
Totally agree.
As I understand it the high cost of branded meds is due to the millions it costs to do the ‘research and development to bring a new drug to market’. And there’s a ‘patent’ on the drug for many years (20 years?) to recoup the costs.
I don’t know if it would help me to know the country of manufacturing of my generic brand cholesterol lowering tablets, only a blood test can tell my doctor if it’s working 
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But why?
This transcript is a good overview of the book’s contents.
The FDA had oversight on these companies, and yes, I realise it’s from a US perspective. For me, it shows precedent (given not EVERY company will go down the same path), and the sheer scale of the industry. Maybe I naively believed that the FDA were quite the force to be dealt with, and this shows how astray things can go.
Also, this story showed me just how difficult it is to formulate a generic that performs ‘exactly’ like the ‘Brand’, and what was involved in getting to, supposedly, that point.
Do you have the same reservations for name branded medicines? For example do you have more or less trust in Pfizer, Moderna, AstraZeneca, Novartis, Merk, Roche, … , … because of their country of incorporation? Their country(s) of manufacturing?
How is that QA vs locale any different from the generic manufacturers?
There are cases and individuals where ‘exactly’ matters although anecdotally the medical field seems to have ascertained close enough is good enough for almost everyone but not everyone, hence the ‘dispense as written’ constraint on some scripts.
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There are some interesting anecdotes there about the history of the FDA and some Indian manufacturers. The Ranbaxy scandal was 18 years ago and the company has been defunct for 8 years.
I wonder if there is any information available about the quality of overseas-made drugs sold in Australia today. Is the history provided by Eban relevant to us now? I don’t know, it comes down to what the US FDA, the local TGA and regulatory authorities of other drug importing counties have been up to since then.
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I don’t own this book-I borrowed it from my local library, so I cannot quote directly. It is a couple of years since I read it, so I can only comment on my recollected opinion.
After the initial company’s FDA approval ‘expired’, there was a race to be the first generic approved, as this had beneficial exclusivities attached. This is where the due care went out the window.
I don’t have any idea of the TGA’s approval conditions, or whether they physically inspect these plants, but if they could run rings around the FDA, does the TGA have a better chance at an honest outcome?
I’m sure we’ve all worked somewhere where we get a phone call or email to say the boss is going to visit, so there’s a mad clean-up to present the best face.
By the FDA having to give notice before their inspections, this allowed all manner of cover-up.
There probably are instances of big brand companies sending faked data to the FDA, but they would be unable to copy data that wasn’t there before.
And I agree that there are some side effects from any/all drugs, some mortifyingly bad. But without being able to go into specific issues that were in the book, which helped my understanding of how some generics are not equivalent in their effects to the brand drug, then I am merely expressing my own conclusions.
Is there a much greater concern at present with the supply of pharmaceuticals?
Ninety per cent of medication sold in Australia is imported; the vast majority comes from Europe and the United States.
