Australian pharmacies will be banned from making replicas of drugs like Ozempic.
Ozempic is an injectable type 2 diabetes treatment. Its popularity as a weight-loss medication has led to a global supply shortage.
It’s led to an increase in pharmacies making replica medications that imitate the effects of Ozempic. The Federal Government has announced it will outlaw this practice from October.
It follows growing concern over the safety of pharmacy-made medications, which face fewer approvals than imported/branded drugs.
Ozempic replicas banned
GLP-1RAs are a type of medication used to regulate blood sugar levels. They are present in drugs like Ozempic and Mounjaro.
The global shortage of these drugs is not forecasted to ease until next year.
To meet demand, some pharmacies have ‘compounded’ their own medications for patients. The Government believes at least 20,000 Australians are using these replicas, with most taking the drugs for weight loss.
Replica ban
From October, chemists will not be allowed to make medications that contain GLP-1RAs.
However, they can still sell legitimately supplied Ozempic and Mounjaro to Australians who have been prescribed the drugs by a GP or specialist.
Drugs created in-pharmacy don’t face the same scrutiny as products approved by the Australian Therapeutic Goods Administration (TGA). Similar concerns have also been raised by the Food and Drug Administration in the U.S.
Next steps
The Government said the 1 October ban gives patients time to prepare alternate medication plans.
Health Minister Mark Butler said the measure would “protect Australians from harm and save lives”, adding that “the risk of not acting” against replica products was “far greater” than keeping the status quo.
The ban was supported by several health bodies across Australia, including the TGA and Diabetes Australia.