Hand sanitiser and the Therapeutic Goods Administration

The response by TGA (part of the Department of Health) to the COVID‐19 pandemic has been an exemplar in collaboration and engagement. The TGA has engaged with international regulators, other Commonwealth agencies, jurisdictions and industry, health professional and community stakeholders with a focus on continuous improvement. The TGA’s adaptive regulation of hand sanitisers over the last 16 months is a good example of best practice performance.

From the beginning of the COVID‐19 emergency, good hand hygiene was one of the actions
Australians were asked to do to ‘stop the spread’. This led to an extraordinary increase in demand for hand sanitisers and the threat of major shortages in hospital and health care settings. As of early 2020 all hand sanitisers containing alcohol and making claims such as ‘for use in clinics and hospitals’ or ‘effective against viruses’ were regulated as therapeutic goods, and required individual evaluation by the TGA. Although regulatory approvals were greatly facilitated as many parts of the TGA moved to 7 day‐a week operation, the requirement for new producers of hand sanitisers to establish medicines‐standard manufacturing facilities for hand sanitisers would have meant at least a 6 month delay until Australian demand could have been met.

Working together with, and considering the approaches of, international regulators such as the US
Food and Drug Administration, Health Canada and the World Health Organisation – it was agreed that as long as manufacturers made sanitisers to particular recipes ‐ specified ingredients, and adhering to certain manufacturing, labelling, presentation and advertising requirements, the products could be permitted to be used in both healthcare settings and consumer use.

Within days, in March 2020, the TGA working with the ACCC and the Australian Industrial Chemical
Introduction Scheme, and with feedback from the Department of Industry, Science, Energy and
Resources made a legislative instrument to exclude specified hand sanitisers from the Therapeutic
Goods Act 1989 to enable their urgent manufacture and supply within Australia.

Simultaneously, gin and whisky distilleries, breweries and other business dependent on hospitality services faced major losses in income following significant restrictions on tourism and movement.
Readily able to generate alcohol for hand sanitiser for health care settings, the industry was primed to fill demand. A flurry of media reported delighted innovative distillers filling the pent up demand and being able to re‐employ staff.

Nevertheless, there were some overly enthusiastic adopters. Members of the public, businesses state health authorities and SafeWork Australia alerted the TGA that some hand sanitisers were being packaged in food and drink containers. As well as being unlawful under state and territory workplace laws, the TGA moved quickly to ban hand sanitisers in containers from which children could potentially mistake for drink. The warning statement ‘DO NOT DRINK’ was also added.
Working with the ACCC and the National Measurement Institute, the TGA continues to monitor sanitiser quality and efficacy through post‐market surveillance and testing of the products.

As well as developing new educational resources for industry and advertisers, the TGA stepped up monitoring of inappropriate advertising claims around hand sanitisers and other products promoted for protection against or treatment of COVID. Rapid compliance action was taken to protect the public – and since the start of the pandemic the TGA has issued more than 145 infringement notices related to COVID‐19 product advertising or importation totalling over $1.5 million.

Through effective collaboration and engagement, the TGA was able to quickly develop and implement a pragmatic regulatory solution to address the significant shortage of hand sanitisers whilst ensuring that the safety, efficacy and quality of these products was not compromised.

Video transcript

As COVID started to take hold in Australia the demand for hand sanitiser rose. As did the threat of shortages in hospital and health care settings.

Prior to March 2020 all hand sanitisers containing alcohol and making claims such as ‘effective against viruses’ required individual evaluation by the TGA.

Working with its stakeholders (ACCC, AICIS, DISER, SafeWork, WHO, USFDA) the TGA set simple and clear guidelines for meeting Australian standards, opening the market to innovation.

Distilleries, breweries and other business dependent on hospitality that were losing income during COVID lockdowns benefitted.