Concern over quality and safety standards of traditional Chinese medicines (2001/0448) - 27 September 2001

The Medicines Control Agency (MCA) will today begin consulting on proposals to extend the list of potent or toxic ingredients which are not permitted in unlicensed herbal medicines. It has called upon the UK traditional Chinese medicines (TCMs) sector to improve the quality and safety standards of its medicines.

The current list of ingredients restricted in unlicensed medicines dates from 1977 before use of traditional Chinese and Ayurvedic (Indian) medicines was widespread in the UK.

The MCA continues to find potentially dangerous and illegal ingredients in TCMs. Recently TCMs have been found to include:

• Aristolochia, which was associated with two cases of renal failure in the UK in 1999. This toxic ingredient is also known to cause cancer. A 1999 sampling exercise by MCA identified several dozen products containing Aristolochia.
• Mercury and arsenic compounds.
• Prescription only steroids. There have been repeated instances, often involving skin preparations for eczema and psoriasis. People often use TCMs because they do not want licensed medicines which often contain steroids.

Professor Alastair Breckenridge, Chairman of the CSM said:

"We recognise that many people value herbal remedies, such as traditional Chinese medicines and are keen that people carry on having the choice to use them. However, there is clear evidence that standards used in the production of some TCMs on the UK market are, at best, unreliable. While many individual remedies are unlikely to pose any threat to public health, I am concerned that we continue to find further examples of TCMs containing potentially dangerous and often illegal ingredients.

There is no reliable way for the public to identify those TCMs which could be unsafe. In the light of this evidence we are unable to give the public any general assurances as to the safety of TCMs on the UK market. That is why the MCA has called upon, and are working with, the UK traditional Chinese medicines sector to improve the quality and safety standards of its medicines.

When buying TCMs people should always be aware of the possibility of low quality or illegal products. They should not take them if they are not labelled and include a list of ingredients in English. Even then, clear labelling is not in itself a guarantee of good quality standards. When seeing their doctor or pharmacist people should always inform them that they are taking a herbal remedy.

If people have any immediate concerns or have suffered an adverse reaction which they think may be due to a TCM or other herbal remedy they should contact NHS Direct on 0845 4647 or seek advice from their local pharmacist or GP."

Initiatives already in progress to address these problems include: plans to improve the regulation of herbal medicines and the herbalist profession; enforcement by MCA of the existing law; and updated guidance (which is to be translated into Chinese for the ethnic medicines sector).

Welcoming the continuing co-operation from the ethnic medicines sector Professor Breckenridge said:

"Ultimately public confidence in TCMs can only be maintained if the sector itself makes rapid progress in introducing systematic and assured quality controls throughout the supply chain. Nothing less than this can justify public confidence that remedies are safe and of reliable quality".

In a joint statement, representatives from the Register of Chinese Herbal Medicine, Association of Traditional Chinese Medicine, The Chinese Medical Institute and Register and the Society of Chinese Medicine (UK) said:

"We are absolutely committed to compliance with the law and to the protection of public safety, in which quality control is paramount. We are working closely with the Chinese Medicine Association of Suppliers in order to uphold the highest standards in herbal products, and disciplinary action will be taken against any member of our associations who is found to be putting the public at risk".

Media enquiries to Gary Tempest in the Department of Health Media Centre, telephone 020-7210 5821 or by e-mail to gary.tempest@doh.gsi.gov.uk

NOTES FOR EDITORS

1. The MCA is an Executive Agency of the Department of Health. It is responsible for licensing medicinal products; monitoring the safety of medicines on the market; monitoring and inspecting the standards of manufacture and wholesaling of medicines.

2. The Committee on Safety of Medicines (CSM) is an independent committee of experts that advises Government on the safety, quality and effectiveness of medicines.

3. In certain circumstances, herbal remedies sold in the UK may be exempt from the normal requirement for a product licence. This is a longstanding arrangement under Section 12 of the 1968 Medicines Act. There are no systematic safety or quality requirements for such remedies. However, a number of specific herbal ingredients are restricted in such remedies. For example Aristolochia species are prohibited in unlicensed medicines and Aconite if used internally is a prescription only medicine.

4. What action is being taken by the MCA?

Improved regulation:

• The MCA is pressing in Europe for the proposed traditional medicines directive which would recognise and regulate traditional remedies. We understand that the Commission intend to bring forward formal proposals.
• The MCA is reviewing the UK medicines law which applies where practitioners consult and make up herbal remedies.
• The MCA has begun consultations with the ethnic medicine sector on an update of the list of restricted herbal ingredients.
• The Government has announced support for the statutory self regulation of the herbalist profession.

Information and guidance

• The MCA has produced guidance "Traditional ethnic medicines, public health and compliance with medicines law" (July 2001). The guidance has recently been extended and is being translated into Chinese to make it more accessible to the TCM community.

Enforcement

• The MCA has an active programme of enforcement in this sector. Since 2000 there have been three successful prosecutions (relating to steroids and arsenic) in TCMs and 13 formal cautions have been issued, mostly relating to the illegal inclusion of ingredients, such as steroids, in TCMs. Further action is in progress.

5. The MCA Ethnic Medicines Forum was established in 2000. It aims to encourage and assist the UK ethnic medicines sector to achieve improvements to safety and quality standards in relation to unlicensed ethnic medicines in advance of any improvements to the statutory regime which emerge from other current policy initiatives. Representatives of the Traditional Chinese Medicines and Ayurvedic sector, including suppliers, manufacturers and practitioners in the UK form part of this forum, as well as the MCA and other bodies in the herbal medicines sector with experience of operating self regulatory arrangements.

6. The four TCM practitioner organisations which issued a joint statement are (with contact details, where available):

• The Register of Chinese Herbal Medicine (Nick Lampert: telephone 0121-442 2059).
• The Chinese Medical Institute and Register (CMIR)(Prof Mei: telephone 020 7388 5783).
• The Association of Traditional Chinese Medicine (Dr Chen Jing Hua: telephone 0186-741719).
• The Society of Chinese Medicine (UK).

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