MIL-OSI Australia: Listed medicines containing Andrographis paniculata requiring warning statements

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Source: Australian Department of Health

Background

Listed medicines may be subject to a compliance review at any time while they remain on the Australian Register of Therapeutic Goods (ARTG). This allows us to determine the compliance of these medicines with relevant regulatory requirements.

Listed medicines are only permitted to contain low risk ingredients from a pre-approved list. Although these ingredients are considered low risk to the general adult population, some ingredients still require warning statements to alert consumers of potential unwanted side-effects.

One tool that we use to ensure the safety of listed medicines is by using warning statements on the medicine label. Medicines that contain the herbal ingredient Andrographis paniculata require the following two warning statements:

  • ‘Andrographis may cause allergic reactions in some people. If you have a severe reaction (such as anaphylaxis), stop use and seek immediate medical attention.’ (or words to that effect).
  • ‘Andrographis may cause taste disturbance including loss of taste. If you develop any adverse symptoms, stop use and seek medical advice.’ (or words to that effect)

The absence of these warning statements in medicines that contain Andrographis paniculata may result in consumers delaying medical attention/advice should they experience an allergic reaction or taste disturbances after taking the medicine.

As such, we will be selecting listed medicines that contain Andrographis paniculata for compliance review to ensure that they display these warning statements.

I am a sponsor, what should I do?

The Therapeutic Goods (Permissible Ingredients) Determination contains the list of ingredients allowed by the TGA for use in listed medicines and any specific requirements (such as warning statements) for each ingredient.

If you are a sponsor of a listed medicine which contains Andrographis paniculata, you are encouraged to:

  • re-evaluate the presentation of the goods including the medicine label, particularly for the warning statements required for your medicine.

If your medicine is selected for review, you will receive a Request for Information notice. This notice will contain an explanation of the review process, outline the information you are required to submit and relevant due dates for your response.

What will the TGA do?

We will commence desktop compliance reviews for a selection of listed medicines that contain Andrographis paniculata and therefore require warning statements, in the third quarter of 2022. These may either be selected randomly or on the basis of regulatory intelligence.

We will send sponsors of these medicines a Request for Information notice informing them of the commencement of the review and outlining the information sponsors are required to submit. Upon receipt of the information provided by sponsors, we will assess the medicine against listing requirements, with particular focus on the required warning statements.

If no compliance deficiencies are identified for a selected medicine, the review will be concluded and there will be no further regulatory action. If deficiencies are identified, the medicine may be recalled and/or the sponsor will be given an opportunity to address the deficiencies. Additionally, enforcement actions (such as the cancellation of the medicine from the ARTG, issuing of infringement notices, etc.) may be taken.

Should sponsors cancel their listing rather than respond to the Request for Information notice, we may still request certain documentation to be provided to ensure that certifications made at the time of listing were correct.

A summary of the outcomes from this compliance activity will be published after the conclusion of the reviews.

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