Painkillers containing codeine will no longer be available over the counter from 2018, the federal drug regulator has announced.

Key points: Painkillers containing codeine will no longer be available over the counter from 2018

Painkillers containing codeine will no longer be available over the counter from 2018 Extra regulation is already enforced in the United States, Japan and most of Europe

Extra regulation is already enforced in the United States, Japan and most of Europe TGA says the move is to reduce the number of consumers addicted to codeine

The Therapeutic Goods Administration's (TGA) principal medical officer, Dr Tim Greenaway, said the medication will change from Schedule 2 or 3 to Schedule 4 in February 2018 because consumers frequently became addicted to codeine.

"It's important that people realise that the decision's been taken based on safety predominantly and based on the risk of abuse," Dr Greenaway said.

"Medication that are available over the counter or through pharmacies should be substantially safe and not subject to abuse."

"This is clearly not the case with codeine."

The move will bring Australia into line with the United States, Japan and most of Europe.

The decision has been criticised by a peak pharmaceutical group, Australian Self Medication Industry (ASMI), which argued the drug should be kept available over the counter but with real-time monitoring system in place.

"Our view is that the decision put forward is a very blunt a very broad brush approach to the problem and I think we would have liked to have seen the opportunity for more targeted measures," ASMI's chief executive Deon Schoombie said.

"Nobody disputes the fact that there are risks associated with products that have codeine…but the vast majority of people who've been using these products use it appropriately."

The concerns have been rejected by Dr Greenaway, who said the monitoring system proposed by the industry was "illogical" and didn't stack up.

"The decision's been made on the basis of patient safety; the bottom of pharmacies, for example, is not a consideration that has been taken into account," Dr Greenaway said.

The TGA said misuse of over-the-counter codeine products contributes to severe health outcomes, including "including liver damage, stomach ulceration, respiratory depression and death".

Dr Greenaway said an Australian study using coronial data showed there had been over 1,400 deaths in a little over a decade.

Products containing codeine will remain available without prescription from pharmacies until February, 2018.

The TGA said the timeframe would allow consumers with chronic pain to discuss alternative treatments with their doctors.

It said patients could use alternative over-the-counter products such as paracetamol or ibuprofen, or cough and cold medicines that do not contain codeine.

The regulator said there was "little evidence" low-dose codeine medicines were "any more effective for pain relief or cough than similar medicines without codeine".