Popular thyroid drug comes under a cloud; company responds (India ONLY)

[helvella]

A somewhat confusing article about what seems to be a fake Abbott Thyronorm levothyroxine in India.

Am posting for several reasons:

• Anyone who receives levothyroxine in, or directly or indirectly from, India needs to be aware.

• I posted about Acme being just about to get approval in Canada though Genix.

• Interest in the amazing scale in this claim: Almost 32% of Indians suffer from various kinds of thyroid disorders, specifically hypothyroidism and hyperthyroidism, according to a survey by SRL Diagnostics.

Other than the first, there really is no other reason to continue reading!

Popular thyroid drug comes under a cloud; company responds

Almost 32% of Indians suffer from various kinds of thyroid disorders, specifically hypothyroidism and hyperthyroidism, according to a survey

The Federal

3:55 PM, 4 July, 2022Updated 4:32 PM, 4 July, 2022

A popular drug used for hypothyroidism Thyronorm has been flagged as “Not of Standard Quality” by the Telangana drug controller.

The drug is however not the one produced by Abbott India, a unit of Chicago-based Abbott Laboratories which said the name Abbott was missing in entries made by the drug controller’s list and it only mentions that the drug was produced by “Acme Generics LLP” in Himachal Pradesh.

The drug controller’s report said the “sample does not comply with identification and assay of Thyroxine sodium tablets IP (Drug Nil),” as per the Indian Pharmacopoeia 2018, which along with the Central Drugs Standard Control Organisation (CDSCO) sets the standards for quality of drugs.

Rest of article - and you do need to read it carefully if you might be affected by the issues - available here:

thefederal.com/health/popul...

The basic story might be published in many places.

[nellie237]

This is not the 1st scandal surrounding levo produced in India is it? I think the last one was something about lack of controls cleaning the production line. I believe India are working hard to grow this area of revenue too.

"Almost 32% of Indians suffer from various kinds of thyroid disorders" Who knew! I've read quite a few thyroid studies from India..........should have realised really. I know that they have an awful lot of diabetics.........makes sense.

[helvella Administrator Thyroid UK in reply to nellie237]

No - not the first problem in India. Though it could be that this is entirely a matter of fake and neither Abbott nor Acme have done anything wrong.

In which case, protection of supply chains would appear critical. Stop fake stuff getting distributed - which is what a lot of changes (e.g. to packaging), in many places, have been directed against. That and things like environmental control (temperature being so important for many medicines).

[nellie237 in reply to helvella]

Now that you mention it my Aristo 100mcg packaging has just changed. Instead of 2 strips of 14 per box, all 28 are on the same strip. I've got to admit I didn't think anything of it. Maybe I should pay more attention in future.

[helvella Administrator Thyroid UK in reply to nellie237]

Have they changed the name at all?

I noticed the other day that it has now also been given a "brand" name.

Aristo – Levothyroxine Aristo tablets

Aristo – Vencamil tablets Levothyroxine Sodium

[nellie237 in reply to helvella]

The wording/colour etc is identical (my daughter still has the old ones to compare). The only difference is the shape of the new box is more square.

Levothyroxine Aristo

100 micrograms (in pinky/purple)

tablets

levothyroxine sodium

Oral use

28 tablets..................................................................................................ARISTO

I've just been quite pleased and surprised that I've been given the same brand for a long time now.