First hand sanitiser ‘round table’ held in Australia looks at costs and availability, while TGA cuts legislative red tape on manufacturing to facilitate urgent and continued supply
Last Friday, the first hand sanitiser round table was led by the Minister for Industry, Science and Technology, Karen Andrews, with participation of the John Skerritt, Head of the TGA and other key players in the hand sanitiser supply chain.
“The Minister noted that they have received reports of hand sanitiser being sold for five times the normal price,” said Consumer Healthcare Products (CHP) Australia, which attended the meeting.
“She was keen to understand if there were costs of manufacture causing these issues, or if this was price gouging in the supply chain.
“These meetings will continue weekly to resolve the issues impacting supply. The key issues are the availability of packaging, bottles/caps/pumps and the availability of carbomer thickeners. The local supply of Ethanol B.P. appears to have been resolved.”
As the COVID-19 crisis began to hit Australia, several mainstream media outlets pointed the finger at pharmacies for “jacking up” the prices of masks as well as hand sanitiser.
The Age quoted a pharmacy manager who said that this price increase was “just being passed on through suppliers,” and a supplier which was attempting to manage risk of exhausting stock through increasing prices to the retailer.
Minister Andrews said manufacturers had already significantly increased their output of hand sanitiser and more was being done to grow that even further.
“I want to stress to Australians that we have the capacity and the raw ingredients here to continue to meet the increased demand,” she said.
“Industry, with the help of government, is stepping up to meet the challenges being thrown at us by this virus.
“Our government will continue to do what it takes to ensure supply and increase domestic production of medical protection equipment – from sanitiser to masks to ventilators.
“We also need the community to play their part by not stockpiling. There is no need for people to have huge volumes of hand sanitiser at home.”
Meanwhile a new legislative instrument has been published – the Therapeutic Goods (Excluded Goods—Hand Sanitisers) Determination 2020 – which excludes specified hand sanitisers from the operation of the Therapeutic Goods Act 1989 in order to facilitate the urgent and continued supply of hand sanitisers in Australia in response to the COVID-19 emergency.
From 28 March 2020, production of hand sanitiser can now proceed without the requirement of TGA approval or notification, on condition that one of the two recipes developed by the World Health Organization and endorsed by the US Food and Drug Administration are used.
Provided that the exact formulation and other requirements are followed, this formulation is permitted for use in both healthcare facilities and consumer use.
“This exclusion will facilitate the urgent and continued supply of large volumes of hand sanitisers in Australia,” says the TGA.
The final formulation of the hand sanitiser must contain only the following ingredients:
- EITHER ethanol 80% v/v (pharmacopoeial grade or food standard grade) OR isopropyl alcohol 75% v/v (pharmacopoeial grade) in an aqueous solution;
- sterile distilled water or boiled cold water;
- glycerol 1.45% v/v (pharmacopoeial grade);
- hydrogen peroxide 0.125% v/v (pharmacopoeial grade); and
- does not contain any other active or inactive ingredients, including colours, fragrances or emollients.
There are strict requirements for labelling of these products. Manufacturers must also test the alcohol concentrations of each batch, manufacture under sanitary conditions and maintain production record-keeping.
The products will continue to be regulated as consumer goods under Australian Consumer Law.
Hand sanitisers that are regulated by the TGA (ie. those not regulated as ‘cosmetics’ and those not excluded by the special provisions outlined above) must be manufactured by TGA-licensed manufacturers in accordance with the principles of Good Manufacturing Practice (GMP).
“This is because they are used in higher risk situations (hospitals, aged care facilities ) and/or make claims on killing specific organisms, and so their quality and performance is much more critical than for example in domestic use,” explains the TGA.
Irrespective of whether a product is covered under the new Excluded Goods Determination, the TGA emphasises that manufacturers cannot make a therapeutic use claim that directly or indirectly refers to COVID-19.
New advice about hand sanitisers, including details of the above emergency measures for production of large volumes of hand sanitiser for consumer and commercial use, has been published on the TGA website.
A follow-up roundtable is reportedly scheduled for this week.