Seema Haribhai
PFD Report
Partially Responded
Ref: 2022-0208
2 of 4 responded · Over 2 years old
Response Status
Responses
2 of 4
56-Day Deadline
22 Nov 2022
Over 2 years old — no identified published response
About PFD responses
Organisations named in PFD reports must respond within 56 days explaining what actions they are taking.
Source: Courts and Tribunals Judiciary
Coroner’s Concerns
Medicines and Healthcare Products Regulatory Agency (MHRA) I am aware that one of the treating hepatologists from the Royal Free Hospital attempted to report this matter to the MHRA under the yellow card scheme, but was in some difficulty because he could not identify which drugs or drug combinations had been prescribed and had caused the liver injury. However, I now have the statement of the treating Ayurvedic practitioner detailing the medicines prescribed, and so I attach this in the hope that it will assist you. Ayurvedic Professionals Association The Ayurvedic practitioner who prescribed the medicines that killed Seema Haribhai told me that she had undertaken a five year degree and a one year post graduate training to enable her to practise Ayurvedic medicine. However, when she first discovered that her patient had developed a yellow discolouration, whilst she recognised that the liver was probably responsible, she did not recognise that the cause might be her own prescription. She did not advise the only course of action with the potential to save Seema Haribhai’s life: an immediate cessation of all the herbal remedies. Even when she gave evidence in court, the Ayurvedic practitioner did not seem to canvass the possibility that the medicines she had prescribed could have caused harm. She had at one stage advised her patient to have a routine blood test, but she had not at any stage advised immediate attendance at a hospital emergency department. It appears from the evidence I heard in court that Ayurvedic practitioners do not necessarily have the possible complications of Ayurvedic treatment as part of their routine frame of reference. All medicines can cause harm, even those that are herbal based. Department of Health I heard evidence at inquest that Ayurvedic practitioners are not in any way regulated. Even those who are members of the Ayurvedic Professionals Association receive as little as two hours of continuing professional development training per annum. The medicines prescribed by Ayurvedic practitioners are manufactured abroad. I did not hear evidence of any quality control. The Enterprise Practice Seema Haribhai made an appointment with her general practitioner, explaining that she had taken Ayurvedic medicines, and complaining of yellow skin and yellow eyes. The doctor she consulted asked to see a photo of her face and ordered a blood test. However, the GP did not record the detail of the history, he did not record exactly when the yellow discolouration first appeared, and he did not record the absence of any other signs and symptoms. He did not ask for attendance at the surgery so that he could perform a physical examination. He did not advise immediate cessation of the Ayurvedic medicines. The GP consultation was on 5 November, the blood test was conducted on 9 November, the results came back to the surgery on 10 and 11 November, and an appointment was booked for 15 November. Meanwhile, same day admission to hospital was arranged on 15 November solely because a nurse had noted the blood test result at a routine rheumatology appointment. The blood test result was so abnormal that, even without examination, the consult rheumatologist saw no option but immediate admission.
Responses
Response received
View full response
Dear Ms ME Hassell, Please see below, the Ayurvedic Professional Association (APA) response to Regulation 28: Prevention of Future Deaths, following the tragic death of Seema Haribhai. The APA and its members would firstly like to offer sincere condolences to the family of Seema Haribhai. Introduction The APA is a voluntary members association with an elected committee and as such it has no powers to regulate the Ayurvedic profession. The APA was established as, and it remains an unincorporated association with the sole purpose of representing Ayurveda as practiced within the UK. The APA promotes the practice of safe and authentic Ayurveda with a view to improving health and well-being, by and through its membership sharing knowledge and best practice in accordance with the APA’s constitution, which can be found at: https://apa.uk.com Representing Ayurvedic Practitioners throughout the United Kingdom 1 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
The APA encourages professional development and it seeks to provide support to its members, as well as using its website to offer the public a platform from which to find trained Ayurvedic professionals in their area. It is within this context that the APA responds to your PFD. Ayurveda background Ayurveda is a traditional system of medicine as practiced and taught in India. Ayurveda is regulated in India by The Ministry of Ayush (AYUSH), which was formed on the 9th of November 2014 with a vision of reviving the profound knowledge of ancient systems of medicine and ensuring the optimal development and propagation of the AYUSH systems of healthcare. Earlier, the Department of Indian System of Medicine and Homoeopathy (ISM&H) formed in 1995, was responsible for the development of these systems. It was then renamed as the Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in November 2003 with focused attention towards education and research in Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy https://main.ayush.gov.in/about-the-ministry Regarding whether the APA can identify if the Ayurvedic herbs used by the Dr. in this instance, who holds a Bachelor of Medicine and Surgery (BAMS) degree from India, had the potential to cause harm, AYUSH is likely to be the only authority able to answer this question and it may be helpful if the PFD could also be directed to AYUSH via the Indian High Commission. AYUSH can be contacted via its website at:
If it will assist the Coroner, the APA will be happy to make this representation to AYUSH. Representing Ayurvedic Practitioners throughout the United Kingdom 2 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
Regulation Ayurveda is not currently regulated in the UK, something the APA had campaigned for in the past. Consequently, the APA has no power to oversee, or control how individual's practice other than through advice and guidance. However, as an association, the APA has taken this incident very seriously and has investigated as far as possible how this unfortunate event occurred in order to alert its members and prevent a reoccurrence. In addressing the specific points directed to the APA in your PFD report:
i. Ayurvedic practitioners training On receipt of her application for APA membership, the APA requested sight of the Dr’s BAMS degree and internship certificates, which were received and recorded. We have investigated more and cannot find evidence of the postgraduate certificate even though mentioned in your report and court document. The Dr was accepted as Category A APA member in accordance with the APA’s category classification. As with all APA members the APA also requested evidence of the Dr’s current insurance.
ii. Recognising risks to patients The APA provides its members with webinars with guest speakers on a variety of Ayurvedic topics, as a way of keeping members abreast of developments in Ayurvedic practice, but the APA is not a training organisation, nor does the APA accredit any Ayurvedic curriculum. APA members have received recognised training and qualifications from recognised external accredited training providers and the APA satisfies itself that the individuals applying for membership are qualified by an outside training Institute and insured to practice at the appropriate level. UK Ayurveda courses are accredited by organisations such as the Federation of Holistic Therapists and The Complementary Medical Association. The BAMS degree in India is accredited by the National Commission for Indian System of Medicine (India Curriculum):
• https://www.fht.org.uk/welcome-to-accreditation
• https://www.the-cma.org.uk/Articles/Join-The-CMA-as-a-College and-get-all-these-benefits-4708/ Representing Ayurvedic Practitioners throughout the United Kingdom 3 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
Identifying potential harm from herbal remedies is part of members' training. In terms of whether the APA can identify if the Ayurvedic herbs used by the BAMS Dr in this case had the potential to cause harm, the APA would again refer the Coroner to AYUSH. The APA has a Pharmacopoeia document that is available to all APA members as part of its information programme. All APA members are encouraged to familiarise themselves with the content of all documentation that the APA provides. Members are made aware of this documentation both on joining the APA and annually thereafter. Within the pharmacopoeia documentation there are references to possible adverse effects from some known drug/herb interactions and some known herb contraindications. This information is not exhaustive, however, possible complications form part of all APA members initial training. The APA does operate a voluntary yellow card adverse event reporting system under which is designed to be completed by the member and emailed to relevant authorities and the APA for escalation if needed, this did not happen with this incident. A report on the regulation of herbal medicines and practitioners, 26th March 2015, by; Prof.
attachment_data/file/417768/Report_on_Regulation_of_Herbal_Medicines_an d_Practitioners.pdf provides that: “Some herbal sector representative bodies have attempted to collect data on adverse reactions to herbal medicines using the Yellow Card system used for conventional drugs but the number of reports is relatively small and it is not clear whether this is because there are few adverse reactions or whether the low numbers recorded are due to under-reporting”. Representing Ayurvedic Practitioners throughout the United Kingdom 4 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
iii. Recommending medical advice/treatment As previously mentioned, the APA is a member’s association for pre-trained professionals who have undergone extensive training that includes them being able to identify situations where they (a BAMS Dr.) may need to advise on whether their patient needs more urgent medical attention, specifically a medical intervention. In the case of the BAMS Dr involved in this incident, this training is set to the curriculum set by the National Commission for Indian Systems of Medicine as she held a BAMS degree. Details of the training provided to BAMS doctors can be found at https://ncismindia.org, but it is not within the APA’s remit to provide individual advice on treatment protocols.
iv. Consideration of possible complications Although the APA conducts regular webinars with guest speakers on Ayurvedic topics including herbs, this is simply an opportunity for these members to undertake Continued Professional Development as the APA is not a training organisation. As a part of their training, APA members are taught to consider possible complications and this should therefore be within their routine frame of reference. In terms of identifying potential harm from herbal remedies, again this is covered in the members training, which is beyond the APA’s remit. In this case, the BAMS Dr was trained in India under the BAMS curriculum, as set out by the NCISM India and approved by AYUSH. Safety and potential harm in using herbs is covered in the Dravya Guna (Indian medicine pharmacopoeia). Within the APA’s pharmacopoeia document, there are references to known possible adverse effects from drug/herb interactions, as well as to the voluntary yellow card adverse event reporting form. The Herbs mentioned in this incident are all of Indian origin and as such they come under the remit of the Indian High Commission and imports. The APA has no control over herbs or treatments given by its members. However, the APA committee has in the past considered an approved supplier scheme of herbs for members, but as APA membership is voluntary it was found that it would be very difficult to enforce. Representing Ayurvedic Practitioners throughout the United Kingdom 5 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
In order to prevent future deaths, the APA will, within 90 days, write to the Indian High Commission to suggest that Indian herbal imports could benefit from a review and ask the Commission to consider its role in the import of Indian herbs into the UK. The APA believes that all herbs sold in the UK should, at the very least, display the botanical name as well as the Ayurvedic common name, to ensure correct identification of all herbal material and reduce the risk of potential harm by misidentification. The APA will, within 90 days, petition the Food Standards Agency to change UK labelling to require herb labelling to display both the botanical and common name of herbs. We trust that the above information adequately responds to your PFD report in this case. However, please do not hesitate to contact the President if the APA can be of further assistance in this case.
The APA encourages professional development and it seeks to provide support to its members, as well as using its website to offer the public a platform from which to find trained Ayurvedic professionals in their area. It is within this context that the APA responds to your PFD. Ayurveda background Ayurveda is a traditional system of medicine as practiced and taught in India. Ayurveda is regulated in India by The Ministry of Ayush (AYUSH), which was formed on the 9th of November 2014 with a vision of reviving the profound knowledge of ancient systems of medicine and ensuring the optimal development and propagation of the AYUSH systems of healthcare. Earlier, the Department of Indian System of Medicine and Homoeopathy (ISM&H) formed in 1995, was responsible for the development of these systems. It was then renamed as the Department of Ayurveda, Yoga, and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) in November 2003 with focused attention towards education and research in Ayurveda, Yoga and Naturopathy, Unani, Siddha, and Homoeopathy https://main.ayush.gov.in/about-the-ministry Regarding whether the APA can identify if the Ayurvedic herbs used by the Dr. in this instance, who holds a Bachelor of Medicine and Surgery (BAMS) degree from India, had the potential to cause harm, AYUSH is likely to be the only authority able to answer this question and it may be helpful if the PFD could also be directed to AYUSH via the Indian High Commission. AYUSH can be contacted via its website at:
If it will assist the Coroner, the APA will be happy to make this representation to AYUSH. Representing Ayurvedic Practitioners throughout the United Kingdom 2 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
Regulation Ayurveda is not currently regulated in the UK, something the APA had campaigned for in the past. Consequently, the APA has no power to oversee, or control how individual's practice other than through advice and guidance. However, as an association, the APA has taken this incident very seriously and has investigated as far as possible how this unfortunate event occurred in order to alert its members and prevent a reoccurrence. In addressing the specific points directed to the APA in your PFD report:
i. Ayurvedic practitioners training On receipt of her application for APA membership, the APA requested sight of the Dr’s BAMS degree and internship certificates, which were received and recorded. We have investigated more and cannot find evidence of the postgraduate certificate even though mentioned in your report and court document. The Dr was accepted as Category A APA member in accordance with the APA’s category classification. As with all APA members the APA also requested evidence of the Dr’s current insurance.
ii. Recognising risks to patients The APA provides its members with webinars with guest speakers on a variety of Ayurvedic topics, as a way of keeping members abreast of developments in Ayurvedic practice, but the APA is not a training organisation, nor does the APA accredit any Ayurvedic curriculum. APA members have received recognised training and qualifications from recognised external accredited training providers and the APA satisfies itself that the individuals applying for membership are qualified by an outside training Institute and insured to practice at the appropriate level. UK Ayurveda courses are accredited by organisations such as the Federation of Holistic Therapists and The Complementary Medical Association. The BAMS degree in India is accredited by the National Commission for Indian System of Medicine (India Curriculum):
• https://www.fht.org.uk/welcome-to-accreditation
• https://www.the-cma.org.uk/Articles/Join-The-CMA-as-a-College and-get-all-these-benefits-4708/ Representing Ayurvedic Practitioners throughout the United Kingdom 3 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
Identifying potential harm from herbal remedies is part of members' training. In terms of whether the APA can identify if the Ayurvedic herbs used by the BAMS Dr in this case had the potential to cause harm, the APA would again refer the Coroner to AYUSH. The APA has a Pharmacopoeia document that is available to all APA members as part of its information programme. All APA members are encouraged to familiarise themselves with the content of all documentation that the APA provides. Members are made aware of this documentation both on joining the APA and annually thereafter. Within the pharmacopoeia documentation there are references to possible adverse effects from some known drug/herb interactions and some known herb contraindications. This information is not exhaustive, however, possible complications form part of all APA members initial training. The APA does operate a voluntary yellow card adverse event reporting system under which is designed to be completed by the member and emailed to relevant authorities and the APA for escalation if needed, this did not happen with this incident. A report on the regulation of herbal medicines and practitioners, 26th March 2015, by; Prof.
attachment_data/file/417768/Report_on_Regulation_of_Herbal_Medicines_an d_Practitioners.pdf provides that: “Some herbal sector representative bodies have attempted to collect data on adverse reactions to herbal medicines using the Yellow Card system used for conventional drugs but the number of reports is relatively small and it is not clear whether this is because there are few adverse reactions or whether the low numbers recorded are due to under-reporting”. Representing Ayurvedic Practitioners throughout the United Kingdom 4 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
iii. Recommending medical advice/treatment As previously mentioned, the APA is a member’s association for pre-trained professionals who have undergone extensive training that includes them being able to identify situations where they (a BAMS Dr.) may need to advise on whether their patient needs more urgent medical attention, specifically a medical intervention. In the case of the BAMS Dr involved in this incident, this training is set to the curriculum set by the National Commission for Indian Systems of Medicine as she held a BAMS degree. Details of the training provided to BAMS doctors can be found at https://ncismindia.org, but it is not within the APA’s remit to provide individual advice on treatment protocols.
iv. Consideration of possible complications Although the APA conducts regular webinars with guest speakers on Ayurvedic topics including herbs, this is simply an opportunity for these members to undertake Continued Professional Development as the APA is not a training organisation. As a part of their training, APA members are taught to consider possible complications and this should therefore be within their routine frame of reference. In terms of identifying potential harm from herbal remedies, again this is covered in the members training, which is beyond the APA’s remit. In this case, the BAMS Dr was trained in India under the BAMS curriculum, as set out by the NCISM India and approved by AYUSH. Safety and potential harm in using herbs is covered in the Dravya Guna (Indian medicine pharmacopoeia). Within the APA’s pharmacopoeia document, there are references to known possible adverse effects from drug/herb interactions, as well as to the voluntary yellow card adverse event reporting form. The Herbs mentioned in this incident are all of Indian origin and as such they come under the remit of the Indian High Commission and imports. The APA has no control over herbs or treatments given by its members. However, the APA committee has in the past considered an approved supplier scheme of herbs for members, but as APA membership is voluntary it was found that it would be very difficult to enforce. Representing Ayurvedic Practitioners throughout the United Kingdom 5 Phone +44 (0) 1273 500 492, Email info@apa.uk.com, Web www.apa.uk.com Limited Company No. 05391909, Registered in England
In order to prevent future deaths, the APA will, within 90 days, write to the Indian High Commission to suggest that Indian herbal imports could benefit from a review and ask the Commission to consider its role in the import of Indian herbs into the UK. The APA believes that all herbs sold in the UK should, at the very least, display the botanical name as well as the Ayurvedic common name, to ensure correct identification of all herbal material and reduce the risk of potential harm by misidentification. The APA will, within 90 days, petition the Food Standards Agency to change UK labelling to require herb labelling to display both the botanical and common name of herbs. We trust that the above information adequately responds to your PFD report in this case. However, please do not hesitate to contact the President if the APA can be of further assistance in this case.
Response received
View full response
Dear Coroner Hassell,
Regulation 28: Prevention of Future Deaths report Seema Pravin HARIBHAI
Thank you for your e-mail of 11th July 2022 regarding a Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Seema Haribhai, I am sorry for the delay in responding. The report raised a matter of concern that one of the treating hepatologists from the Royal Free Hospital attempted to report this matter to the MHRA under the yellow card scheme but was not able to submit a report online, as they did not have any details for the herbal products taken by the patient.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health and Social Care (DHSC) with responsibility for the regulation of medicinal products and traditional herbal medicinal products that hold a traditional herbal registration (THR) in the UK.
In the UK, reports of adverse reactions suspected to be associated with the use of a medicine are submitted to the MHRA via the Yellow Card scheme. Reports can be submitted by healthcare professionals, patients or family or carers on behalf of patients. The Yellow Card scheme is voluntary and reports can be submitted when there is a suspicion that a medicinal product or combination of products has caused a side effect. Reports are used alongside other safety information and help the MHRA to monitor the safety of products and take action if safety issues are identified. In addition to the electronic form for completing a Yellow Card, concerns about medicinal products can be raised via our free helpline (0800 731 6789) or via customer services by email (mhracustomerservices@mhra.gov.uk) or telephone (0203 080 6000)
In order to complete a Yellow Card report, details of the specific product or products suspected to have caused the adverse reaction must be provided along with an identifiable patient and reporter in order for a case report to be assessed. Using the additional information provided in the statement from , the herbal practitioner, regarding the Ayurvedic products provided, a yellow card report has been created with the reference number
There is no statutory definition of ‘herbal practitioner’ in the UK. Anyone - irrespective of qualifications or experience - can practice herbal medicine in the UK and, after making a diagnosis and forming a judgment about the treatment required, can prepare and supply herbal medicine to a member of the public following a one to one consultation. There are a number of voluntary registers of herbal practitioners which require that certain standards of practice and education are met, but membership of these registers is not a legal requirement.
The exemptions in the Human Medicines Regulations 2012 that apply are:
• Regulation 3 (6) of the Human Medicines Regulations 2012 provides an exemption from the need for a manufacturer’s licence and a marketing authorisation for a herbal product that is made up and supplied by a herbal practitioner on the premises following a one to one consultation with a member of the public.
• Regulation 3 (9) of the Human Medicines Regulation 2012 states that the herbal medicinal product is not manufactured or assembled on a large scale or by an industrial process.
• Regulation 241 of the Human Medicines Regulations 2012 allows herbal practitioners to prepare certain herbal medicinal products themselves on their premises using a range of single or multiple herbal ingredients following a one to one consultation, providing certain additional requirements are met.
The herbal practitioner has provided details of the ingredients she suggested and refers to these as food supplements and herbs. It is not clear from the herbal practitioner’s statement if the preparations were made up under the herbalist exemption or whether they were recommended to the patient and then purchased elsewhere or if in fact it was a combination of both i.e. recommended and the practitioner provided herbs.
There are restrictions on what substances can be used by herbal practitioners to prepare unlicensed herbal medicines. Schedule 20 of the Human Medicines Regulations lists substances which are restricted or prohibited for use in unlicensed herbal products prepared by practitioners. None of the ingredients included in the herbal practitioners statement are included on the list of restricted ingredients.
However, it is important to note that the products referred to in the herbal practitioners statement are not licensed by the MHRA and therefore we are not able to comment on the quality control of the products taken by Seema Haribhai or any medicinal claims that may have been made for these products.
The MHRA continually monitor safety and ensure that possible side effects which have been recognised to occur with use of a medicine or tradition herbal remedy are appropriately described in the authorised product information. Unfortunately, as none of the products listed as being suggested to Seema Haribhai are authorised by the MHRA, we cannot comment on
what information that may have been provided with these products regarding their safety or possible side effects.
There is published literature regarding a risk of hepatotoxicity associated with traditional Ayurvedic herbs1,2 and this information would be taken into account if any of these products were submitted for authorisation by the MHRA.
No changes are proposed to the Yellow Card scheme as it is essential to have information about the specific products involved in order to assess the specific safety concern. The healthcare professional involved in the patients care did not have details of the herbal products taken and therefore could not complete the online form for the Yellow Card scheme. However, their concern about the safety of the herbal products could have been raised with the MHRA through multiple other routes while further details of the products were sought from the herbal practitioner either by the original reporter or the MHRA, if the MHRA were provided with the herbal practitioner’s details.
The exemptions in the Human Medicines Regulations 2012, allow herbal practitioners to produce and supply herbal medicines following a one to one consultation with the patient. The MHRA has no regulatory oversight over products provided under this exemption.
I hope this information is of assistance.
Regulation 28: Prevention of Future Deaths report Seema Pravin HARIBHAI
Thank you for your e-mail of 11th July 2022 regarding a Regulation 28 Report to Prevent Future Deaths following the inquest into the death of Seema Haribhai, I am sorry for the delay in responding. The report raised a matter of concern that one of the treating hepatologists from the Royal Free Hospital attempted to report this matter to the MHRA under the yellow card scheme but was not able to submit a report online, as they did not have any details for the herbal products taken by the patient.
The Medicines and Healthcare products Regulatory Agency (MHRA) is the executive agency of the Department of Health and Social Care (DHSC) with responsibility for the regulation of medicinal products and traditional herbal medicinal products that hold a traditional herbal registration (THR) in the UK.
In the UK, reports of adverse reactions suspected to be associated with the use of a medicine are submitted to the MHRA via the Yellow Card scheme. Reports can be submitted by healthcare professionals, patients or family or carers on behalf of patients. The Yellow Card scheme is voluntary and reports can be submitted when there is a suspicion that a medicinal product or combination of products has caused a side effect. Reports are used alongside other safety information and help the MHRA to monitor the safety of products and take action if safety issues are identified. In addition to the electronic form for completing a Yellow Card, concerns about medicinal products can be raised via our free helpline (0800 731 6789) or via customer services by email (mhracustomerservices@mhra.gov.uk) or telephone (0203 080 6000)
In order to complete a Yellow Card report, details of the specific product or products suspected to have caused the adverse reaction must be provided along with an identifiable patient and reporter in order for a case report to be assessed. Using the additional information provided in the statement from , the herbal practitioner, regarding the Ayurvedic products provided, a yellow card report has been created with the reference number
There is no statutory definition of ‘herbal practitioner’ in the UK. Anyone - irrespective of qualifications or experience - can practice herbal medicine in the UK and, after making a diagnosis and forming a judgment about the treatment required, can prepare and supply herbal medicine to a member of the public following a one to one consultation. There are a number of voluntary registers of herbal practitioners which require that certain standards of practice and education are met, but membership of these registers is not a legal requirement.
The exemptions in the Human Medicines Regulations 2012 that apply are:
• Regulation 3 (6) of the Human Medicines Regulations 2012 provides an exemption from the need for a manufacturer’s licence and a marketing authorisation for a herbal product that is made up and supplied by a herbal practitioner on the premises following a one to one consultation with a member of the public.
• Regulation 3 (9) of the Human Medicines Regulation 2012 states that the herbal medicinal product is not manufactured or assembled on a large scale or by an industrial process.
• Regulation 241 of the Human Medicines Regulations 2012 allows herbal practitioners to prepare certain herbal medicinal products themselves on their premises using a range of single or multiple herbal ingredients following a one to one consultation, providing certain additional requirements are met.
The herbal practitioner has provided details of the ingredients she suggested and refers to these as food supplements and herbs. It is not clear from the herbal practitioner’s statement if the preparations were made up under the herbalist exemption or whether they were recommended to the patient and then purchased elsewhere or if in fact it was a combination of both i.e. recommended and the practitioner provided herbs.
There are restrictions on what substances can be used by herbal practitioners to prepare unlicensed herbal medicines. Schedule 20 of the Human Medicines Regulations lists substances which are restricted or prohibited for use in unlicensed herbal products prepared by practitioners. None of the ingredients included in the herbal practitioners statement are included on the list of restricted ingredients.
However, it is important to note that the products referred to in the herbal practitioners statement are not licensed by the MHRA and therefore we are not able to comment on the quality control of the products taken by Seema Haribhai or any medicinal claims that may have been made for these products.
The MHRA continually monitor safety and ensure that possible side effects which have been recognised to occur with use of a medicine or tradition herbal remedy are appropriately described in the authorised product information. Unfortunately, as none of the products listed as being suggested to Seema Haribhai are authorised by the MHRA, we cannot comment on
what information that may have been provided with these products regarding their safety or possible side effects.
There is published literature regarding a risk of hepatotoxicity associated with traditional Ayurvedic herbs1,2 and this information would be taken into account if any of these products were submitted for authorisation by the MHRA.
No changes are proposed to the Yellow Card scheme as it is essential to have information about the specific products involved in order to assess the specific safety concern. The healthcare professional involved in the patients care did not have details of the herbal products taken and therefore could not complete the online form for the Yellow Card scheme. However, their concern about the safety of the herbal products could have been raised with the MHRA through multiple other routes while further details of the products were sought from the herbal practitioner either by the original reporter or the MHRA, if the MHRA were provided with the herbal practitioner’s details.
The exemptions in the Human Medicines Regulations 2012, allow herbal practitioners to produce and supply herbal medicines following a one to one consultation with the patient. The MHRA has no regulatory oversight over products provided under this exemption.
I hope this information is of assistance.
Report Sections
Investigation and Inquest
On 30 December 2022, I commenced an investigation into the death of Seema Haribhai, aged 37 years. The investigation concluded at the end of the inquest earlier today. I made a determination that Seema Haribhai died as a consequence of the administration of Ayurvedic medicines intended to treat psoriatic arthritis. I recorded a medical cause of death of: 1a) sepsis 1b) recurrent intestinal ischaemia 2 idiosyncratic Ayurvedic drug induced liver injury (treated with transplant)
Circumstances of the Death
Seema Haribhai suffered with psoriatic arthritis that was becoming increasingly disabling. She was concerned at the potential effects of conventional medication and so consulted an Ayurvedic practitioner, who prescribed an array of herbal based remedies. She took these, developed liver failure as a consequence, and died some weeks later.
Copies Sent To
, Ayurvedic practitioner
, general practitioner
, hepatologist, Royal Free Hospital
, rheumatologist, Northwick Park Hospital
Care Quality Commission for England
NHS England & NHS Improvement
Professor Chris Whitty, Chief Medical Officer for England
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Data sourced from Courts and Tribunals Judiciary under the Open Government Licence.