Dr Rajesh Shah is a well-known homeopath, researcher and teacher and Director of Life Force Homeopathy in Mumbai, India. He is a pioneer of online practice and has treated patients from 180 countries. He has developed many new homeopathic medicines, including those from biological sources such as HIV nosode, Hepatitis C nosode, Mycobacterium Tuberculosis nosode, and more. He has also conducted double-blind, placebo controlled Drug Provings, Clinical trials, experiments in animal models, as well as in-vitro studies with many new homeopathic medicines, doing this in collaboration with reputed institutions such as Haffkine Institute, ICT (UDCT), IIT-B, etc. He has introduced a scientific method of development of nosodes. His research papers are published in peer-reviewed, international journals. He has authored several books, including ‘My Experiences with Ferrum Metallicum’. He is one of the founders and Organizing Secretary of the Global Homeopathy Foundation, which conducted the World Homeopathy Summit in India in April 2015. He is on the advisory committees of CCRH under the Ministry of AYUSH, Govt. of India. Dr. Rajesh has initiated a petition to the Minister, AYUSH for setting up a mechanism for new drug discovery in homeopathy. The petition can be signed and supported at http://chn.ge/2cy7asI
MB: Dr. Shah, welcome to Hpathy! You are the epicenter of the movement to create guidelines for introducing new homeopathic remedies in our pharmacopeias and Materia Medica, especially in India. Why and when did you feel the need to raise this issue on a wider scale?
RS: Thank you, Dr Manish for this interaction. I must start by saying that new drug discovery in homeopathy has been a neglected area, not only in India but also across the world. While I started working on developing new drugs in 1998, it was also observed that there were many issues in the making of old drugs as well, which needed to be addressed. If homeopathy has to stand up as a scientific system of medicine, the core sector of drug development would need serious attention.
As a strategic move, my initial focus is on the new drug discovery; eventually, we shall also look into the challenges with the old or existing drugs in the materia medica. If you want to know how my journey of new drug discovery started, I must say that it started with the first nosode of Mycobacterium Tuberculosis (initial version) developed in 1998. To my surprise, the old nosode Tuberculinum was made around 1880, which was found to be ‘not reproducible’! The fact of ‘non-reproducibility’ of our nosodes was intimidating news to me that opened the windows and doors to my future journey in this space.
MB: Interesting. I have never thought of this. What do you mean by non-reproducibility of nosodes and how does it really matter?
RS: Probably, no one ever thought of the risk, threat, and danger hidden with this imperfection, which will never be accepted in any medical science. Old Tuberculinum was prepared by Swan from the ‘infected lung tissue’ of a ‘suspected case of Tuberculosis’. (Reference: Hering Guiding Symptoms) Let’s examine
- Infected lung tissue: The infected tissue will obviously have specific organisms (presumably Mycobacterium Tuberculosis), and also other tissues and organisms (co-infections), and a large number of proteins and debris.
- Suspected case of Tuberculosis: It was not a confirmed case of tuberculosis, as Robert Koch discovered the organisms two years later in 1882! So, in reality, it is hard to call that nosode ‘Tuberculinum’ as it was much more than the organisms of the disease.
I was stunned at the uncertainty noticed in making of the nosode. I must say that it was an incredible gift by Swan in those years before microbiology emerged as a full-fledged branch. However, we simply carried on with the preparation of Tuberculinum for over 135 years without any review!
It was realized that the Tuberculinum which is available in the market, used by thousands of homeopaths across the world; was probably the same descendent of one made 135 years ago; probably by using the back-potencies, which travelled across oceans, withstanding two world wars…
Most of the pharmacies selling or manufacturing Tuberculinum sourced the back-potencies from ‘other’ pharmacies some years ago. There is no tracking system in place for the source material of such nosodes and other medicines.
MB: So, what is the solution? Can we not make a new Tuberculimum nosode?
RS: Yes, we have to makenew nosodes. In fact, we scientifically developed new Mycobacterium Tuberculosis nosode with many efforts. In that process, I found that there is no well-defined method for making the nosodes, as the nosodes were never re-made but they were always prepared from so called back-potencies. The method shown in the HPI (Pharmacopeia) had many flaws as it was written a few decades ago without any revision.
In this journey, the nosodes as well as the method for preparing the nosodes, were developed. The article on Mycobacterium Tuberculosis nosode was published in the journal ‘Homeopathy’. (https://www.ncbi.nlm.nih.gov/pubmed/27473543) A full method of developing any new nosode was developed and published in IJRH. (https://www.ncbi.nlm.nih.gov/pubmed/27473543)
MB: That is indeed a pioneering work, as you not only found the problem but also the solution, Dr Shah. In that case, you have already travelled some good distance. What is the problem now?
RS: It has taken me over twenty years to travel thus far. The travel time would have been much shorter if the mechanism for new drug discovery was defined in the law. My dream is to have a proper mechanism for new drug discovery in place so that more researchers could introduce new homeopathic drugs and more research could take place; which, in turn, could help the science of homeopathy grow to the next level.
MB: What do you mean by ‘mechanism’ for new drug discovery’?
RS: In conventional medicine (allopathy), there are clear guidelines by DCGI (Drug Controller General of India) and FDA for new drug discovery. Such guidelines are missing in homeopathy. What I mean by a mechanism is the exact roadmap and steps required for making new drug discovery and bringing it to either pharmacopeia and/or making ready for manufacturing, with technical and legal approvals. Since there are no major instances of new drug discovery except some by CCRH, such a mechanism does not seem to be in place. Also, for new drugs in the Nosode (biological source) category, there is absolutely no clarity about the guidelines.
MB: Did you write to the concerned authorities for the required guidelines for new drugs?
RS: Yes, there is a documented story! Over the years I wrote to FDA (Mumbai) for guidelines for new drug discovery. FDA asked me to write to HPL (Homeopathy Pharmacopeia Laboratory, Ministry of AYUSH) for the same. On writing to HPL, after a few months, I received a reply asking me to write to CCRH. I did it. CCRH wrote to me asking me to write to the Ministry of AYUSH. I wrote to AYUSH, and they asked me to write to DCGI. I wrote to DCGI… The whole process took over two years! And you know what, DCGI wrote to me saying they were unable to help; and I must write to FDA. Back to square one! Now, since we have new government, I am hopeful of an answer and guidelines from the Ministry.
MB: So what is the difference between ‘Proving’ a new remedy and ‘mechanism for new drug discovery’?
RS: The homeopaths often believed that ‘proving’ is enough for any new drug discovery. Actually, the steps to new drug discovery should be as follows
- Identification of a new drug substance
- Rationale of use
- Standardization of source material for future use
- Potentization criteria
- Safety check
- Drug proving (Homeopathic Pathogenetic Trial)
- Evaluation in Animal models
- Evaluation in in-vitro models
- Efficacy evaluation:
- Clinical trial
- Clinical evaluation in practice
All the steps may not be required for every new drug discovery.
MB: So, for some of the new drugs, especially the nosodes, that you have introduced, did you undergo some of the above studies?
RS: Mostly, yes. For example, the HIV nosode and Hepatitis C nosode underwent all of the above studies except the animal study. Capsaicin underwent all of the above including animal study. So, the steps would depend on the nature of the source material and other factors.
MB: This is interesting. Do you agree that the most important part of the mechanism is the drug proving?
RS: Well, after conducting several double blind, placebo controlled provings; I would say that drug-proving may not be always required. Did you know that about 30% of the medicines in Boericke’s materia medica are not well proven, and many are not proven at all? There are other ways of identifying the therapeutic indications.
MB: I understand that there are no government guidelines in India yet to add new remedies to our Pharmacopeia and Materia Medica. But are there any laws or guidelines that prevent us from using the newly proved remedies? I know so many homeopaths who order the newer remedies from International pharmacies like Helios and Remedia.
RS: There are no well-defined guidelines for using newly proved remedies. The only guideline in the Drug & Cosmetic Act says that any medicine existing in any other pharmacopeia could be used in India. There are no guidelines to allow or prevent so-called new remedies.
To answer your question on newer remedies from foreign pharmacies, I must say that most of them are not regulated or standardized. I have communicated with many famous pharmacies and have found that they have no scientific information on the source of new medicines. Most of them are not at all standardized. It is unfortunate that the homeopaths have yet to develop the scientific temperament to investigate the source of remedies. We often tend to have blind faith in the remedies!
MB: I read your concern about the source of our nosodes. Can you please elaborate those concerns for our readers?
RS: Yes. The nosodes are very important remedies in our practice. It is time that we pay attention to the sources of major nosodes such as Psorinum, Medorhinum, Tuberculinum, Carcinosin, Variolinum, etc. Psorinum was the first and only nosode prepared by Dr Hahnemann in around 1828 from the discharge collected from the burrow of a scabies infected patient. He also proved the remedy. Now, the problem is that we cannot reproduce Psorinum! We have been using Psorinum made from some back-potencies shared by known or unknown pharmacies for the last 188 years, without any documentation or regulation for its source material. We can only re-make it from fresh biological material, which will be a new medicine and which cannot be prescribed on the symptoms proved by Hahnemann. Please read my remarks on Psorinum in this video: https://www.youtube.com/watch?v=KRzZeWT0DGc&t=2s
Likewise, there are concerns about Medorhinum and Syphilinum. One of the popular nosodes, Carcinosin is also not reproducible. Did you know that Carcinosin was sourced from 28 different cancers, of which we have no documentation? Also, it will be interesting to find that the Carcinosin proving was never conducted systematically. Most of the understanding of Carcinosin is based on clinical cases and certain imaginations! Variolinum is not reproducible as we cannot have small-pox virus anymore. We have many issues, which need serious attention.
Since most of the old nosodes are not reproducible, their manufacturing, storing and selling rules must be monitored to assure the quality and authenticity. We need regulations in place. Also, those nosodes, which cannot be re-produced, need to be re-developed, standardized and proved. We shall need new drug discovery regulation for this herculean process.
MB: Some of the homeopaths might feel that you are challenging the 200-year-old science of homeopathy…
RS: Well, it depends how one looks at it. I am looking at the sustainability of homeopathy over the next 100 years. As you are aware, the skeptics and scientists have challenged homeopathy. In fact, we must realize that homeopathy is the only science which did not upgrade its systems and processes in the last 200 years. In the light of advancement in the areas of microbiology, immunology and medical science, it is high time that we stop using 120 years old nosodes.
MB: And what role does standardization play in ensuring the quality of our potencies?
RS: Our profession has not paid any attention to the standardization of potencies. I have written in detail and proposed the force parameters for standardization of potentization, (http://www.ijrh.org/article.asp?issn=0974-7168;year=2016;volume=10;issue=2;spage=126;epage=132;aulast=Shah). Since Potentization is the only technology used in homeopathy, it is very important that this process is standardized and regulated. Currently, due to lack of regulation, we do not have any idea about the potencies we are using. The homeopathic pharmaceutical industry is largely based on blind-faith.
MB: Do we need to re-produce all the old remedies and then re-prove them?
RS: We may have to re-produce many of the old remedies and re-prove many of them as well. Since we have a dedicated ministry of AYUSH, 188 colleges, and CCRH; it should not be difficult to have re-development of materia medica. Over 400 drugs could be worked out scientifically in about a seven-year time. That will be a real contribution of India to the world. This exercise will be worthwhile for long-term survival and growth of the science of homeopathy.
MB: You have initiated the petition with the Minister AYUSH. Please tell us, how did you think of it and what do you want to achieve through this petition?
RS: In fact, my initiative to get the mechanism for new drug discovery in place has been ongoing for the last seven years. And, I am hopeful that we are very near to its success. About a month ago, I realized that the entire profession should know of gaps in the system, which will help us grow better. My colleague at Global Homeopathy Foundation suggested I start this movement in the form of a petition at www.change.org. In about a hours time, I initiated the petition, and started sharing the vision with over 1 million homeopaths across the world using the social media. The communication has now reached to so many people. I received supportive feedback from the leaders of homeopathy such as Prof George Vithoulkas, and many others. On behalf of Global Homeopathy Foundation, I also met the secretary, AYUSH, Mr Ajeet Sharan and handed over the petition in writing. The ball is now in their court. The petition is still on. I request the readers to check a series of videos on this topic and also sign the petition at http://chn.ge/2cy7asI.
MB: What can we do as a community to bring about the changes that you are striving for?
RS: Individual homeopaths as well as the representatives, associations, schools and institutes can do a lot to bring the desired changes. The first step is to realize the need for such a change. The second step is to come out of inertia and lethargy and support the initiative. Once we are successful in getting the required mechanism in India, it is likely to reflect in other countries such as England, Germany, the United States, Brazil, etc. As regards to contributing by supporting the initiative, every homeopath can help by signing and spreading the links in their social circles such as Facebook, whatsapp groups, etc. I am aware that changes take time, but I believe the change needs to be initiated. It is our responsibility to bring this change for the future of homeopathy.
MB: Is there any draft of the proposed ‘Drug Discovery Mechanism’ or related guidelines or details that the community can review?
RS: A draft is now getting prepared in coordination with the industry experts. It will be made available to the profession for review and suggestions at a suitable time.
MB: How are you proposing the incorporation of copyrights in this mechanism? If you prove a new nosode, do you retain exclusive manufacturing license for it, making this a commercial move?
RS: Copyrights or IPR (intellectual Property Rights) is almost an untouched subject in new drug discovery in India simply due to lacking the mechanism for new drugs, which has not encouraged the researcher to explore this space. In conventional medicine, new molecules may have IPR and they get approved for manufacturing as per guidelines. Similar guidelines need to be designed in homeopathy. This will encourage the pharmaceutical industry to spend more funds for research in homeopathy. Just on proving any medicine or a nosode, one does not get the exclusive commercial rights.
The IPR in homeopathy could potentially encourage much more research and bring huge credit to India.
MB: Thank you Dr. Shah for this elaborate discussion on this vital topic. I am sure after reading this, our community will become more aware of the challenges that we face regarding the source and quality of our medicines and will come together to support your petition to help create a mechanism for new drug discovery and reproving of old nosodes. I urge all our readers to sign the petition.
The petition can be signed and supported at http://chn.ge/2cy7asI
Thank you once again!