Asia-Pacific Roundup: TGA tightens rules on medical aesthetic ads after rise in marketing

The Therapeutic Goods Administration (TGA) has stopped allowing the use of terms such as “wrinkle reducing injections” to promote the use or supply of prescription medicines in Australia. TGA took the action to “resolve any inconsistency” after clinics began promoting other classes of medicine.

Historically, TGA has allowed providers of cosmetic health services to make indirect references to prescription medicines in advertisements. Under the “pragmatic approach,” TGA allowed the use of generic non-product specific terms such as “wrinkle reducing injections,” but not references to products or ingredients such as “Botox” or “botulinum toxin,” in the context of promoting services.

The flexibility, which contrasts with Australia’s wider ban on promoting prescription medicines, was intended to “allow cosmetic clinics who offered these services to differentiate themselves from those that did not.”

Recently, clinics and health service providers operating outside cosmetics have tried to take advantage of the flexibility given to providers of medical aesthetic services. TGA has seen references to classes of medicines such as “weight loss injections” and “medicinal cannabis.” The agency has interpreted the ads as promotions for health services that also advertise a therapeutic good.

TGA views the use of terms such as “weight loss injections” in the promotion of health services as unlawful references to prescription medicines. However, that position contrasts with TGA’s historical acceptance of terms such as “wrinkle reducing injections.” The inconsistency has prompted a change at TGA.

“To resolve any inconsistency in interpretation across industry areas, the TGA no longer permits references to terms such as ‘wrinkle reducing injections’ where those terms would result in a reasonable consumer understanding the intention of the content is to promote the use or supply of a prescription medicine,” the agency wrote.

TGA has clarified its position in updated guidance on the advertising of cosmetic injectables. Last year, the agency took the guidance offline to allow it to review the content before re-publishing the text in 2024.

The old guidance said “there are some acceptable general terms [such as ‘anti-wrinkle injections’] that you can use to describe cosmetic injectables in advertisements.” Now, the guidance explicitly prohibits direct or indirect references to prescription-only substances, including terms such as “anti-wrinkle injections.”

TGA has expanded other sections of the guidance, including the text on the compliant promotion of drug compounding services. The guidance now explicitly bans references to pharmacist-only, prescription-only and controlled medicines. TGA has also expanded its advice on advertising vaccination services, including by advising advertisers to avoid “information that might enable consumers to identify a vaccine, or the manufacturer of the vaccine provided with the service.”

TGA Notice, Updated Guidance

DRAP issues alerts after finding more batches of contaminated excipient in Pakistan

The Drug Regulatory Authority of Pakistan (DRAP) has issued two more alerts about batches of the excipient propylene glycol that contain potentially deadly contaminants.

DRAP’s first alert describes the detection of unacceptable levels of ethylene glycol in the seven different samples of propylene glycol that the Federal Inspector of Drugs Lahore sent for analysis. The samples were taken from different containers. Six of the containers were labeled with the same batch number and manufacturer, Dow Chemicals, Thailand. The seventh carried Dow Chemicals, Germany on its label.

“Upon further investigation, it seems that none of the samples were actually manufactured by Dow Chemicals and the labels were false. The analysis reveals that these samples were highly contaminated,” DRAP wrote.

The discovery comes two months after DRAP published an alert about another batch that said Dow Chemicals, Thailand on its label. Since then, the company has “clarified to DRAP that it was not their original product and was falsified by some miscreants,” the agency said. Dow analyzed retained samples of the original product and shared an analysis report to show its compliance with the specifications.

One day later, DRAP sent another alert about a batch of propylene glycol that MKB Pharmaceuticals sent for analysis. The batch, which the label claimed was made by SK Picoglobal, contained ethylene glycol at an unacceptable level, 0.4671%.

DRAP told MKB and any other company that used the contaminated lot to recall all affected finished products. The agency also asked all companies to hold products made with propylene glycol labeled as made by SK Picoglobal. DRAP requested product recalls and holds in relation to the other notice too.

DRAP Alert, More

CDSCO cancels 3 more meetings as new walk-in regulatory clinic makes bumpy start

India’s Central Drugs Standard Control Organization (CDSCO) has canceled three more meetings of its recently created walk-in clinics “due to exigency of work and other official commitments.”

Last month, CDSCO outlined plans to hold walk-in meetings twice a week from 20 February onward. The service, which CDSCO framed as part of the government’s “ease of doing business in India” agenda, was intended to enable the hearing of problems and complaints for “suitable and swift resolution.”

CDSCO canceled the third meeting in late February, one day before it was scheduled to take place. In the first week of March, CDSCO canceled its next three meetings. On both occasions, the agency attributed the cancellation to “exigency of work and other official commitments.”

The latest action means CDSCO has canceled four of the first eight planned walk-in meetings. CDSCO has asked stakeholders from outside Delhi to contact one of its officers to arrange a meeting for another date.

CDSCO Notice

Japanese Pharmacopoeia seeks feedback on uniformity of nasally delivered doses

The Japanese Pharmacopoeia (JP) has released a draft general chapter titled “uniformity of delivered dose of nasal preparations” for consultation.

In the draft, which Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) shared on its website, JP discusses the steps companies can take to ensure the uniformity of the doses delivered by multidose containers of nasally administered medicines. Manufacturers should ensure each dose from a container is consistent and ensure doses from different containers are consistent.

The draft proposes a sampling scheme that would enable a company to show intra- and inter-container consistency. Both separate and combined intra- and inter-container testing are acceptable. A combined scheme could collect the first dose from three containers, the middle dose from four containers and the last dose from three containers to determine the delivered dose.

JP is accepting feedback until 31 March.

PMDA Notice, General Chapter

DRAP switches licenses to import donated medicines to Pakistan Single Window

DRAP has begun handling applications to import and release donated medicines using the Pakistan Single Window (PSW).

PSW is a digital platform that acts as a single-entry point for all import, export and transit-related regulatory requirements. The platform is designed to reduce the time and cost involved in getting the paperwork to do cross-border trade in Pakistan.

DRAP began using the platform for submissions, processing and release orders related to the donation of medicines in Pakistan. Non-governmental organizations and other groups that want to donate medicines to Pakistan now need to use PSW to submit applications for import clearance. The agency has also begun using the platform to receive and process applications for drug import licenses.

DRAP Notice

Other News:

TGA has provided an update on the shortage of Vyvanse in Australia. Takeda has extended the shortage of the 30 mg dose until the end of March because of manufacturing issues. TGA Notice

Asia-Pacific Roundup: TGA tightens rules on medical aesthetic ads after rise in marketing

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