Editorials

WHO report on the safety issues in the preparation of homeopathic medicines

Manish Bhatia
Written by

WHO report on the safety issues in the preparation of homeopathic medicines

In February 2010, the World Health Organization (WHO) published a report on the ‘Safety issues in the preparation of homeopathic medicines‘. Since then I have received many messages about parts of it being against homeopathic fundamentals. I decided to give it a thorough reading and explore the philosophical and scientific problems in the document.

The first thing I realized, was that this is an excellent step towards standardization of homeopathic remedies globally. The document underlines the differences in different homeopathic pharmacopeias and the need for standardization so that the potencies prepared in different countries do not vary much. I feel that international homeopathic bodies should come together to create a new and updated pharmacopoeia, which gets accepted by all participating countries gradually.

Another good thing is that this document is very thorough and covers different aspects of quality control of homeopathic medicines in detail. It gives a good structure that homeopathic pharmaceutical companies should follow for better quality control.

One criticism that I had come across was that this report has been prepared by non-homeopaths. Contrary to this belief, I found that the report has been examined by many leading homeopathic bodies and their advice and suggestions have been incorporated in this report. The full list of people instrumental in creating this report can be seen in Annexure 1 of this report.

Now let us come to the problem areas. If you read the report alone, there is very little negative to point to. It is the annexure, where the little details that matter are hidden.

The first thing that struck me was the way homeopathic remedies were defined. Section 2.1 gives an introduction about homeopathic medicines as:

Homeopathic medicines are based on the principle that high dilutions of potentially active molecules retain a memory of the original substance.

This is not true! Homeopathic medicines are based on the principle of symptom-similarity. They ‘memory’ concept is just one of the many hypotheses put forward to explain the action of homeopathic remedies. It should not be described as a definite principle.

Apart from this, there are three potential areas of concern:

  1. Comments about the safety of Nosodes, Sarcodes and Remedies derived from toxic substances.
  2. First safe preparation.
  3. Recommended source of animal remedies.

Potential Safety Hazard

The bias about the potential harmfulness of homeopathic remedies sourced from biological materials is stated in the preface of the report itself. Dr. Xiaorui Zhang, Coordinator, Traditional medicines, W.H.O., writes in the preface:

Sometimes, a homeopathic medicine made from source material, such as a mother tincture, is administered in the most concentrated form. Secondly, homeopathic medicines are made from a wide range of natural or synthetic sources: minerals and chemicals, but also plant materials, including roots, stems, leaves, flowers, bark, pollen, lichen, moss, ferns and algae; microorganisms, including fungi, bacteria, viruses and plant parasites; animal organs, tissues, secretions and cell lines. Human materials may include tissues, secretions, hormones, and cell lines. Some of these source materials constitute potential safety hazards,even at high dilutions.

I absolutely agree that some of these substances do constitute a safety hazard in material doses and very low attenuations, but where is the proof that they are a potential toxic hazard even at high dilutions? This is merely an assumption. There has never been a recorded case, where homeopathy remedies prepared according to the authorized pharmacopeias and practiced by qualified homeopaths have resulted in any serious injury to the patient or spread of any infection. If the W.H.O. is concerned about safety of high dilutions, they should test homeopathic remedies in high potencies for potential carriers of biological diseases, or conduct some long-term research trials for the same. Without a single known case of harmfulness of high dilutions and no research to deduce the same, the statement that homeopathic remedies can be hazardous in high dilutions, is frivolous at best!

First Safe Preparation

To minimize the possible safety hazards of homeopathic remedies, the report proposes to identify the first safe preparation of each homeopathic remedy and only the potencies above that first safe preparation should be available in the market.

This sounds like a decent idea but has many hidden implications to it. Mercury, Arsenic, Stramonium, Lachesis, Vipera etc are all toxic in crude form. The document does not specify how the first-safe preparation should be ascertained. Are the remedies deemed safe once there is not even a trace of the original substance detectable? If that be the case, we will lose most of our remedies in lower potencies (below 12C)!

One should remember that the toxicity not only depends upon the level of dilution but also upon the amount/volume of the substance consumed. So, while Lachesis or Arsenic-album 3C might have some traces of the original toxin, their toxicity actually depends upon the dose consumed.

One should also remember that most conventional drugs are ‘toxic’ in large doses. So it is not the toxicity of the original substance but the ‘dose’ that ultimately matters. Homeopathic remedies are usually given in very small quantities and as such do not have any potential toxic effect. Still, if control is required by health authorities, then two things can be done:

  1. Low potencies of highly toxic substances can be made available only on prescription of a qualified and registered homeopath.
  2. The packaging volume of such potencies can be restricted to a relatively safe level, say 10 ml to 30ml.

Section 3.2 deals with the animal or human derived source material. It states:

Adequate and validated procedures such as filtering, pasteurization, sterilization or precipitation have to be used depending on the individual raw material, contamination or pathogenic load, especially to establish the first safe preparation. The dilution process alone is not sufficient to establish microbial, viral or TSE safety.

This again looks reasonable but ignores the spirit of homeopathic provings. Will the Lac humanum, Lac def, Lac can be the same if prepared from pasteurized milk? Will your Bacillinum, Medorrhinum, Syphilinum, Tuberculinum etc. be the same if prepared after sterilizing the tissue or using deactivated microorganisms cultured in laboratories? (see section 4.1.5 and 5.3 of annexure 3)

I think instead of sterilizing and pasteurizing the source material, the right thing would be to test samples of the recommended first-safe preparations for any active pathogens.

Recommended source of animal remedies

Section 4.1.1 of Annexure 3 gives guidelines about the source of homeopathic remedies of animal origin. It states:

Healthy animals should be used for the production of homeopathic medicinal products unless properly justified. Whenever possible, donor animals should be held in closed breeding and production herds. Wild animals should be avoided as far as possible.

If all remedies prepared from animal source are derived from captive animals, the remedy picture of the medicine thus derived is unlikely to match the remedy picture that came up during the original proving. The diet, life-style, experiences and behavior of animals kept in captivity vary significantly from their wild counterparts. Most homeopaths believe that it is not merely the material substance, the quantifiable tissue that matters. The totality of the source also reflects in the remedy picture. If the totality of the source varies considerably from the one used in our initial provings, how can the remedy picture remain the same?

The same applies to the plant remedies too. The mineral content and the quantity and quality of the biologically active substances in a cultured plant may vary a lot from the one taken from the wild.

I think it is necessary that homeopathic bodies reflect further on these suggestions and work together to modify such recommendations coming from W.H.O.

In general there is a lot of good information in this report and every homeopath should go through it once. You can get a copy of this report here:

http://www.who.int/medicines/areas/traditional/Homeopathy.pdf

or

http://www.who.int/medicines/areas/traditional/prephomeopathic/en/index.html

It is a good initiative towards standardization and acceptance of homeopathic remedies. Some points do need further clarification, deliberation and modification, to conform to homeopathic principles and practices.

If you find the issues raised above a valid concern, please take out five minutes from your busy schedule and write to your national homeopathy organizations to take up these issues with W.H.O.

Do send us your comments and feedback at mail@hpathy.com

Manish Bhatia

Editor,

Homeopathy 4 Everyone


About the author

Manish Bhatia

Manish Bhatia

- CEO, Hpathy Medical Pvt. Ltd.
- Homeopathy physician.
- Lecturer of Organon & Homeopathic Philosophy.
- Founder Director of Hpathy.com
- Editor, Homeopathy 4 Everyone
- Member, Advisory Board, Homeopathic Links
- Member, Center for Advanced Studies in Homeopathy
- Co-author - Homeopathy and Mental Health Care: Integrative Practice, Principles and Research
- Author - Lectures on Organon of Medicine vol 1 & 2
- For consultation, seminars or clinical training, write to asha@hpathy.com

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30 Comments

  • Thank you Dr. Bhatia’s for that excellent editorial that analyzed the WHO report on homeopathy, pointing out its useful suggestions and alerting us to its serious flaws.

    With suggestions, such as standardizing homeopathic potencies globally and improving quality control the report appears to be a gift to the homeopathic community, but considering the source, I believe it is a Trojan Horse with poison pills buried in it.

    Not long ago, W.H.O staff jumped on the bandwagon of a rabid anti-homeopathy group and condemned the use of homeopathy for serious diseases in third world countries. In spite of numerous appeals from homeopathy organizations, the WHO never apologized. More recently, some WHO advisors helped fuel a pandemic scare which earned over a billion dollars for pharmaceutical companies. It turned out that these advisors had accepted kickbacks from those companies. The WHO secretary-general refused to reveal their names and claimed she did so to “ensure transparency”!

    What is the WHO up to now? With recent developments in physics, the critics of homeopathy are on shaky ground calling it placebo. I believe they’ve decided to try another strategy and build a case that the remedies are dangerous. The next step would be a repressive control over the manufacture and use of remedies. Consider the regulation that passed in France, outlawing the manufacture of nosodes.

    Some of the restrictions the WHO report suggested would vitiate important remedies, make them unavailable, or inhibit their use by competent lay homeopaths who are not “registered”.

    The WHO should be busy regulating conventional drugs which are one of the leading causes of death. Why are they instead focusing on homeopathy?
    National homeopathy organizations may be powerless to defend against this disguised attack, because the WHO does not have to answer to them. As has been demonstrated recently, it will answer to the political and financial will of Pharma.

    Alan V. Schmukler

    • Very true Alan! This is a double-edged sword. There is good in it in terms of quality management and there is bad in it in terms of minute clauses that can be used to stifle the availability of several homeopathic remedies. I hope this editorial will help our organizations to pursue the matter further.

      Manish

  • Its always good to hear good reports especially since there has been an attack ever since Hahnemann time. Thank you for reporting this news.

  • Sai Ram. A very thorough analysis from your side. Quite objective. I hope WHO and the people who prepared the report will pay serious attention to your comments.

    Swamy

  • Another very disturbing yet subtle attempt to chop away at the roots of homeopathy.

    How could anyone complain at these attempts to keep us ‘safe’?

    Yes, of course, we do not want to poison patients. Pot, kettle, black.

    But of course, these ideas have nothing to do with safety.
    In a self-contradictory way they come from the same faction which claims that remedies are nothing but water, the same faction that will correctly tell you that “toxicity is in the dose”.

    One only has to follow what has happened in nutritional medicine, to S-adenosyl-methionine (SAMe), after it was noted in trials that it is effective against depression & cancers, or to Borax, when it was found to be essential to prevent osteoprosis & arthritis. These & an increasing list of others are now effectively unavailable.
    The more a medical trial succeeds in CAM, the more likely it is to be taken away from us.

    Oh, and why do they (and some of ‘us’) go on talking about ‘dilutions’? What we do is to correctly termed ‘potentisation’. Mere dilutions are not going to work in the same way, if at all.

    Of course, one way for the trolls to ‘prove’ that homeopathy “DOES NOT WORK!!!” is by making important remedies completely unavailable, or rendering them impotent!

    I might add, that when I prepare my own remedies, I do not necessarily adhere to the conventional centesimal scale. I believe there is a whole extra dimension of efficacy to be gained by varying the ratio of dilution & number (& quality) of succussions, much in the same way as when LM potencies were first tried.

  • Oh, and I might add: Where is the need?

    Where is the crying need?

    Where is the multitude people poisoned by homeopathic remedies?
    (Compared to those dying annually from iatrogenesis.)

    I can think of only one case in recent years where a technician used poor procedures when preparing & injecting autopathic remedies, regrettably infecting a raft of patients . To be honest, it was not really a fault of homeopathic preparation, but of cross-contamination.

  • An excellent article! Thank you for bringing this issue to our attention. I will read the WHO article. I think you are right in suggesting that we should speak out about it.

    PS. I wonder what they would make of the preparation of the remedy Pyrogen?????

  • Two angles to look into this recent move by WHO regarding the regulatory and safety measures involved in Homoeopathy medicines.

    Firstly this shows that WHO has come to the grounds (Or has needed to come to the grounds) that, Homoeopathy is not Placebo (They will not waste time in giving Safety Regulations for Placebos, right!)

    Secondly, it is also very righteously correct that there needs to be a common standard to have in the preparation of medicines.

    Some manufacturers are using Extra Neutral Alcohol and some are using some other kind of alcohol.

    Some people say that so and so pharmacy is not preparing good medicine and some say the other is the best.

    Some say that German made potencies are the best in such a way that the 200 Centicimal potency prepared in India is qualitiwise equivalent to 30 Centicimal potency of the German Manufacturers.

    Why is this so? And this are the forward standing questions when international Recognised bodies ask – Dear Homoeopathic Brother, are you unique / Consistent / everyone follows you in the same way?

    So this is where we have to get Standardised and this is one of the points we should not betray.

    Remains the point of safety measures, we all are fighting against the forces which are trying to shut us down and I am quite happy to tell a recent news (which most of us must have already heard) that The United Kingdom Government has not banned Homoeopathy from its NHS and people have the complete right to choose which treatment they would prefer. Moreover, The Royal London Homoeopathic Hospital is now included under the University College Hospitals and £20m makeover which stands to be a substantial development in Homoeopathy.

    I will put up this report of WHO in our college Sonajirao Kshirsagar Homoeopathic Medical College, Beed, Maharashtra and let know what reactions and analysis come up from the College.

    Thanks and Regards

    Dr. Apurva Tamhane

    • RE your cooment “…. I am quite happy to tell a recent news (which most of us must have already heard) that The United Kingdom Government has not banned Homoeopathy from its NHS and people have the complete right to choose which treatment they would prefer. Moreover, The Royal London Homoeopathic Hospital is now included under the University College Hospitals and £20m makeover which stands to be a substantial development in Homoeopathy.”
      I am sorry to tell you that this news is not what it seems. The UK govt have not banned homeopathy it is true – but they have put the power for the funding of homeopathy into the hands of regional – and soon to be local administrative bodies at the GP level – who have been lobbied by the anti-homeopathy campaigners – many have already withdrawn funding and refused referrals to the homeopathic hospitals. Others are threatening to do so. The history of this is long and complex and the fight far from over.
      As for the Royal London Homeopathic Hospital I fear your news is very out of date – the RLHH has been under Univ College Hospitals for many years and as a result has been whittled down to less than one floor of what was once a 4 floor building. The Inst of Neurology and Great Ormond St Hospital have claimed the rest of the hospital’s space. And the £20m makeover you mention happened several years ago – and possibly indirectly at least helped its demise – it became a very attractive site.
      The future of homeopathy in the UK is FAR from secure – and the UK homeopathic community is having to work every single day to keep patient choice on the table.

  • very very informative and well analysed article. i do hope that few pharma or national homeopathic bodies will see logic in your analysis and will be able to take the matter further up !

  • has this article, in fact a response to the WHO report been sent to the authors of that WHO report? It seems to me that it should be relevant to do so and see what their answers are… AND both published publicly…

  • I endorse the safty of homeopathic medicines. As few pharmacies have started preparing hepatitis 200. I don’t understand, how the homeopathic pharmacies have extracted the virus? How can you sure Tuberculinum 200 does not have T.B Bacteria? What do we administer in Tuberculinum 200? A living bacteria or something else? If bacteria then why vaccination concept is not acceptable to homeopaths.

    • “How can you sure Tuberculinum 200 does not have T.B Bacteria”?

      Is Tuberculinum 200 made from living or dead bacteria, it does´t matter because if we talk 200 C potens, which is general. In solution is definitely free any tuberculinum bacteria. After 12 C potens, there´s not with any molecular from the mother medicine and if there have´t any molecular from mother medicine then there have´t any tuberculinum bacteria also.

  • Thank you Dr. Bhatia for your meticulous work and analysis here. It would seem to me this report should be referred to all Homeopathy teaching colleges globally and responded to by them asap, as well of course the many individual practitioners.

    As someone has mentioned earlier, there is a real danger here of losing nosodes and other especially useful remedies if this is not replied to carefully. I have little doubt who (WHO) is behind this report. When the likes Of Margaret Chan see the need to cover up, it’s raises suspicions automatically, that the people responsible for the report are involved in the Pharma industry.

    If we do not bother to respond, things will quietly proceed and many of us will be left unable to practice, and those who still can will be severaly limited. I’m not sure if the standardisation of the remedies, while helpful, may not be the biggest priority.

  • Actually, there is an organisation called HOMINT, to which many homoeopathic pharmacies are members, which already has standardised preparations. Members are – among others – VSM Netherlands, Boericke and Tafel, USA. Boiron France and Spain. Willmar Schwabe and DHU Germany, and quite a few others, which I do not remember by heart. So the WHO, should put up or shut up, especially after the Swine Flue debacle, of which it is known they are in the pocket of Big Pharma. To the WHO I say, Get a life!!!

  • Dear Dr Bhatia ~ Thank you for due diligence in this investigative report concerning the WHO and Homeopathy. Please let us know what we can do in this regard for securing the availability of all homeopathic remedies for use to the public and practicing homeopaths. What are the channels for us to contact the WHO with the information that properly defines homeopathy and the homeopathic method?

    with gratitude,
    Debby

  • God bless you Dr.Bhatia for the yeoman service you are providing to humanity. Do not pay attention to these Drug Industry charlatans when they attack homeopathy as their nefarious plans are neutralized by homeopathy success and they cannot sell their expensive modern days poisons!!

    I am a lay practitioner and have treated some of the rare diseases and I do it pro bono publico. These include diabetes, hypertension, skin cancer, Non-hodgkin lymphoma, recently Parkinson’s disease. I also have treated successfully GERD or Acid reflux.

    Keep up the good work with your Magazine and more POWER to you!

  • Dear Dr, Manish,
    Thank you and congratulations to your sincere efforts of publishing this article from WHO report. I suggest this should be given to major newspaper as news of approval of WHO for Homeopathy as a science. What still needs to do is that various scientific research experiments should be done by using common standard and uniform protocols by getting proper approval of AYUSH an authentic approval body and this will give proper recognisation to homeopathy
    Moreover request should be made to all practitioner about making tall claims with proper scientific research and proper data collection,

    Dr. N.V.Pai Mumbai

  • Dear Dr. Manish,
    It is surprising to clinicians of modern medicines that even though the lot of literature has been published against homeopathic medicines and way it is being given to patients, still there are thousands of people in whole world who still have faith in homeopathic medicines.So the time has come to gather all practitioners, researcher,pharmacists as well as people who have faith in homeopathic medicines to openly share their experiences(both good and bad ) in news papers for the information large section society.

    Dr. N.V.Pai Mumbai

  • Dear Sir,
    To avoid the points given in report and to maintain a certain lavel why do’not we adopt LM potency.
    I have been using this potency for the lst 30 year, got best results and speedy recovery.

  • DR.L.SENTHILKUMAR, SAYS:
    PONDICHERRY.
    Augest 20/2010:at.4.15pm

    Dear Beloved.
    God Bless You! Dr.Bhatia for the excllent report concerning the WHO and “HOMEOPATHY”.Once Agin congratulations to your sincere efforts,

    I suggest this should be given to major news paper nes of WHO for “HOMEOPATHY”
    as a needs science.

    Well analysed article THANK YOU for bringing this issue to our attention i will read the WHO article. all teaching colleges golbally and responded to by them
    as well ofcoures the many individual practioner. it’s my Heart full thank
    keep up the good with your valuable magazine and more success for you.
    I Wish u all success
    I LOVE U
    DR.L.SENTHILKUMAR
    PONDICHERRY
    THANK U

  • Dear Dr,
    Very informative artical . WHO took up the work of stanandrisation of homoeopathic pharmocopea , its nice . At least world body accepted the values of homoeopathy . But a watch by worlds leading homoeopathic pharmacies organisations and homoeopaths is must .Principally every thing regarding homoeopathy must be in the hands of homoeopaths .

    dr.anil kumar kulshreshtha .

  • marvellous, excellent,educative work by dr. manish bhatia,HAHNEMANN SAHIB ki sachi sewa,GOD Bless you,you are serving for HOMOEOPATHY with missionary zeal, WHO article is informative,THAKS. DR. ANIL SHARMA MD,Ph.D(PSYCHOLOGY)-RESEARCH SCHOLAR

  • I endorse your view that this report of W.H.O is a very positive development, and we have to give a serious thought and importance to .
    1.Standarisation of our Manufacturing process- Lets have a stand that Potentisation is an manufacturing process only, lets not talk about high or low dilution,for the presence
    2.SAFE PREPARATION / POTENTIAL SAFETY HAZARDS. At Government Homoeopathic Pharmacopeia Laboratory Ghaizabad India study has been done on this subject under the guidance of Dr P.N.VERMA, where in safe dispensing potency have been recorded, but there is lack of awareness of the same, yes it could constitute potential safety hazards , and we have to work on this .
    3.The recommendation mentioned should be taken up in right spirit, for further improvement

  • Dear Bhatia
    you are serving for HOMOEOPATHY with missionary zeal,excellent and educative work i always expect from you personally. Standarization ofpreparation of homoeopathic medicines is more important in our system and we will congratulate WHO if they do.We want from them a better work on homoeopathy. Dr Haridas Ghosh Dhaka Basngladesh.14.09.2010

  • Dear Dr.Bhatia

    Thank you so much for your nice efforts in defining the weak and strong points of WHO report. I believe we should be more united in our practice. Standardizing is a very crucial necessity in this field and other fields of Homeopathy Medicine. Since the sensitivity of WHO seems to be high, our unity in the way of standardizing is better to be higher. Anyway if WHO is really aware of its universal duty towards public health it should be more sensitive about conventional medicines non of which are proved properly. We should suggest WHO to have a research study about proving conventional medicines on conventional personnel before entering the world market. Why is WHO not considering the true health of patients all over the world by testing the conventional medicines on animals and patients in some third world countries?
    Why don’t they ask temselves that Devine Homeopathic Remedies are first proved on homeopaths and those who are volunteer and of certain age preferably 18-45 and not suffering from evidenced mental and physical disorders?
    WHO is a universal organization who has universal responsibility towards us and all other people who are more than 6000000000.WHO SHOULD be free of all pressures of those who are against the safest method of healing,i.e. Classical Homeopathy.
    My Best ,S.Sadeghi Hom.Physician