Lack of manufacturing country on medicines


I went to buy some Paracetamol and was disappointed to see the packaging not
stating where the items were manufactured

Eg Panadol (GlaxoSmithKline)
Paracetamol (Nyal)

See image of packaging where they only state either the marketing or packed in
Australia.

Isn’t it a requirement by law to state where it is made or sourced? Our food has better labeling.

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Unfortunately only for food…

All other products it is voluntary, but if it is included, the information can’t be misleading (must be accurate) otherwise they would breach labelling requirements.

I believe that most consumer products should have labelling indicating its origin. I can understand that some products it may be hard to do (such as complex products of many parts which may have multiple origins).

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The TGA tracks pharmaceuticals via the sponsor, ie the company shown on the label that received approval from the TGA for import and sale. As a listed and regulated product set the sponsor appears to have some freedom to import from whatever country or manufacturer plant they wish so long as they do not contravene the sponsorship filing. Australian manufactured product is rare; most multinational drug companies have sales and marketing locally, a few a modest research presence, almost none manufacture much if anything locally.

According to a Wikipedia entry these are the 15 countries that exported the highest dollar value worth of drugs and medicines during 2020.

  • Germany: US$60.8 billion (14.9% of total exported drugs and medicines)
  • Switzerland: $48.1 billion (11.8%)
  • Belgium: $31.1 billion (7.6%)
  • France: $28.4 billion (7%)
  • Italy: $27.2 billion (6.7%)
  • United States: $24.7 billion (6.1%)
  • Ireland: $23.1 billion (5.7%)
  • Netherlands: $19.8 billion (4.9%)
  • United Kingdom: $18.7 billion (4.6%)
  • India: $17 billion (4.56%)
  • Denmark: $16.7 billion (4.1%)
  • Spain: $10.9 billion (2.7%)
  • Sweden: $8.9 billion (2.2%)
  • Canada: $7.6 billion (1.9%)
  • Slovenia: $7.3 billion (1.8%)

If one includes medical products (eg masks, et al) China reportedly has about 20% of the global export market in 2022.

It is opaque how to specify meaningful origin/manufacture because as with many products the raw or precursor materials needed in say the USA or Israel or India, etc, might come from China or India or the USA for example, or somewhere else.

This two year old defence magazine article summarises Australia’s situation

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Yes. Country of Origin and ingredients, for a wider range of products than is currently mandated.

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Seems like their is an opening for a barcode scanner app that searches database for this kind of information for ease of use at point of purchase until the slow wheels of law catch up?

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Many years ago, after pharmacists were unable to tell me the country of manufacture of several meds, both otc and PBS, I wrote to the TGA and was told this information was “commercial in confidence” (!)

That was before the 1st Rudd Govt and that Govt did something to improve matters, although I can’t remember exactly what. Just that it was not exactly on point, something to do with challenging bureaucratic responses.

I gave up and decided that all I could do was reject generic meds and stick to branded ones - on the theory that big pharmas were probably safer and also a known (and well- resourced) defendant in a worst case scenario.

As far as I know, and your post confirms, country of manufacture is still for the most part shrouded in mystery. Why? It seems to me to be at least as important to know where your meds are made as where your food comes from.

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It is and possibly the TGA doesn’t know for each batch produced. Many multinational pharmaceutical companies have plants in a number of countries around the world and it is possible each batch comes from different countries (different plants), with raw ingredients from the same or different origin. This could be the reason why they chose not to put country of origin as the country of origin can change quickly, along with the source of raw ingredients.

While pharmaceutical quality may be the the same irrespective of the country of origin, consumers might have different views on what pharmaceuticals from a particular country means, including from a developed or developing countries.

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Not all the generic makers are related to majors, but some are through acquisitions and mergers or developed as business strategy. Are you aware Sandoz, one of the most prominent generic brands in Australia is a division of Novartis? In the USA Pfizer sells generics via its Greenstone subsidiary.

Why? Generics have become more widely accepted year after year and the majors have embraced them to maintain or grow their own revenues.

Scepticism about generics continues, and there seem to be isolated cases where slight manufacturing differences between branded and generic medicines affect an individual but under doctor supervision that is identified and the chemist is directed to only dispense the branded product.

I have exclusively been using generics for about 40 years with no apparent negative affect. My partner had qualms about a generic a few years back so got the name brand for the refills with no changes from the generic. Some reactions to generics could be similar to a placebo affect where the suspicion causes the symptom rather than the generic medicine. Yet if one is concerned it is best to be safe and query the doctor and chemist.

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For me, scepticism about generics comes in two parts.

  1. No manufacturer is prepared to put their name and reputation to it (unless you go through a potential web of companies to find out and even then the information may not be available).
  2. It can be a perfectly fine product 19 times in a row but, since it could have come from any manufacturer in any country, that is irrelevant to whether it is fine the 20th time.

I am also concerned about contents other than the active ingredient. It seems to me (unscientifically) that the packaging is less likely to get updated to reflect any such changes if the product is generic.

I am fine buying generic computer peripherals and the like. If it doesn’t work or dies, you return it / chuck it. I am not so chill about what medicines go into my body. :wink:

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Are you aware the brand names on generics are as much those of the manufacturer as are any other branded medicines? eg Sandoz and so on.

The same would be true for any branded or generic (regardless of how branded) medicine. It is how each does QA, and the evidence indicates all the reputable manufactures have very high QA standards in all of their plants.

From the TGA
https://www.tga.gov.au/community-qa/generic-prescription-medicines-fact-sheet

and perhaps easier on the eyes, the US FDA

https://www.fda.gov/drugs/generic-drugs/generic-drug-facts

Some concerns have merit and others perhaps not so much, at least on the ‘evidence’ as posted.

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Do you refuse to eat no-names cornflakes because they don’t declare themselves? Why assume failure to identify the source automatically means lesser quality?

It would be interesting to find out how many generic drugs are made by big name companies, or a division of it, but the company takes care not to damage the cash cow of the named brands of their equivalents. When you look at examples like paracetamol and compare the price of named and unnamed versions it is clear there is something in a name and that in some cases they don’t smell as sweet - at least to the bean counters.

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I think it is fair to say that if you buy anything based on price, then you are taking an increased risk. Branded products such as the Panadol brand of paracetamol do cost more. But whether we are actually buying the perception of quality or buying better quality and reduced risk depends on whether the company selling the branded product is maximising quality or maximising profit. That company is most likely balancing the two but the balance may change from time to time.
In any case, we are depending on the company and the TGA to monitor quality and safety. If the government attempts to economise on resourcing such instrumentalities we increase the risk of problems.
Not being especially risk averse, I always choose generic medicines when available. For medicines like paracetamol or ibuprofen on the supermarket shelf, I will usually avoid the cheapest brand. However, a more expensive brand may only be more expensive to enable the supplier to offer more frequent or deeper (e.g. half price) specials! Even ‘cheapest’ is not easy to assess!

I haven’t seen any evidence of this regarding generic medicines. Can anybody find a study of quality errors in medicines such as impurities, inaccurate dosage or any other? Does it show generics are more likely do be inferior than name brands?

Aligning price with quality in this case tends to ignore the reason that name brands are more expensive; they start out while the maker still holds exclusive rights and can charge whatever the market will stand. They persist because they have a name in the market place and even when the active ingredient becomes free to manufacture by others the product lines are continued at a higher price because people will still pay it.

I have an elderly relative who would not consider buying any milk but Dairy Farmers even when it is consistently more expensive. If asked why, the answer is ’ it’s better quality’ but he cannot tell the difference - except for the label.

Choice have looked at name versus noname medicines a couple of times and not come up with any data that nonames are inferior quality.

Getting back to the main topic. According to Choice most generics sold in Australia are made in India. Does this actually matter? Why?

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That is why I am happy to buy generics as there is no evidence of increased risk.

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I would use unbranded (or, equally, homebranded) products sparingly. Not refusal across the board but with caution, medicines or foods.

That’s probably the key question.

Yes, if it is made by a company that also sells a branded version of the same medicine then it might well be the same product, in which case there shouldn’t be a difference in quality 1. But it might not be made by such a company and it can be difficult to know exactly who made it.

1 When a fab makes computer chips, they test them at the rated speed. If the chip works, it is sold as the product it is supposed to be. If the chip doesn’t work, it is tested at a lower speed and if it works at a lower speed, it is sold as a lesser, cheaper product. I would hate to think that manufacturers of medicines take the same approach. :slight_smile:

To be honest, aspirin and paracetamol would be two medicines where the generic is OK to me.

The key word is “reputable”. With a generic, noone’s reputation is on the line. You don’t even know who the manufacturer is, in order to assess whether they are reputable.

Of course the government likes generics because it reduces the burden on the taxpayer.

That is not true because even generics have branding on the packaging. While one could argue the brand is not (always) the manufacturer the brand would be interested in maintaining its reputation. All my generic scripts are Sandoz products for example, a division of Novartis.

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As a brief aside, my recollection of the more routinely used products dispensed within the hospital system, public or private reflect plainer packaging. They may come from one of the very well promoted product brands or well known genetic brand labels. A decision likely made by the hospital administration when issuing term contracts.

On generics and knowing the source. Arrotex is reputedly Australia’s largest supplier of generics also supplying products using the Arrow, Apotex, Chemists’ Own and ApoHealth brand names. It’s relationship with the Canadian generic producer Apotex is reflected in the product branding. Likely there are multiple sources and strategies behind the brand names.

P.S.
Hardly anonymity?

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Well it is always possible that reputation is the only thing that keeps the makers in line, it is also possible it isn’t. How to decide?

We might also assume that the TGA is asleep at the wheel and is ineffective checking quality of medicines, imported or otherwise.

And we might also assume there have been failures at all levels and bad medicine has been imported from nameless sources and foisted on the public of Oz. But where are all the reports of that happening?

The upshot is that, so far, for either generic or imported medicines, or both, all we have is suspicion that they might be inferior. I do not say all these drugs are perfect but that we have no data about it right now.

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I think you’ll find that NO pharmaceutical lists the other (non-active) ingredients on the packaging, which is one of my pet peeves. Mainly because pharmaceutical manufacturers include all sorts of garbage (sometimes purely to make the tablet look ‘nice’) that if it was clearly stated on the package then more people may object and we could have safer medicines.

In any case the full ingredient list is available on the https://www.nps.org.au/ website (and I think on a government website). so would presumably be updated as changes occur.

You will find that some generics are identical to branded products. One way to see this is to look up the ingredients. If they are identical (and listed in the exact same way) then the products are made by the same company.

A case in point is the PPI ‘omeprazole’ with brand name ‘Losec’

Losec ingredients (and other info) listed here:
https://www.nps.org.au/medicine-finder/losec-tablets#full-pi

If you then look at the generic ‘Acimax’, you will see that it is identical to Losec so obviously manufactured by them and marketed as a generic to capture the market-share that won’t pay a premium for a brand name:
https://www.nps.org.au/medicine-finder/acimax-tablets#full-pi

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Generic and brand name medicines have exactly the same active ingredients. The main difference being branded medicines are/were protected by patents until such time the parents expired, allowing generic medicine manufacturers to also produce medicines with the same active ingredients. It is summed up well here:

A minor difference not affecting the medicines efficacy are the non-active ingredients used to form the medicines. These can be different to between branded and generic medicines and is important to those with known allergies to some compounds.

If one doesn’t have allergies, one’s body will have exactly the same result whether branded or generic medicines are taken. The difference to such individuals will be the impact on the hip pocket, as generic medicines can be significantly cheaper than branded medicines.