Trainings and Discussions by Dr. Rajesh Shah
Talks and training by Dr Shah (includes Whatsapp discussions)
The inventor of new medicines, Dr Rajesh Shah, will be available for talks and training. The talks will be for half or full days, or maybe one hour of introductory talk. The talks will introduce the concept, offer basic guidelines on the use of medicines. Those institutions, colleges, associations, and groups looking for exploring new avenues could drop a mail to biosimilia@gmail.com with some basic details.
Online training modules will be developed and shared in due course.
Whatsapp group discussions:
Dr Shah’s talks at various places often end in Whatsapp groups where he also answers questions by group members. Following group discussions will be shared shortly:
- Hyderabad, Telangana group (29th January 2017)
- Nashik, Maharashtra group (February 2017)
- Trivandrum, Kerala group (10th April 2017)
- Talk at HRI conference, Malta (9th June 2017)
- Talk at George Vithoulkas Academy, Alonissos, Greece (13th June 2017)
- Talk on New Drug Research: Challanges and Oppotunities, Chennai (20 August 2017)
- Talk on New Drug Development at Father Mullers Homeopathic Medical College and Hospital, Mangalore (October 2017)
1. Hyderabad group discussion
What is the necessity of new drugs in the homeopathic way when we get results with so-called old medicines?
Ans: To get better results in practice.
Is it only for palliation or towards the highest ideal cure? Can anyone give reference right from Hahnemann time till date that through Homeopathy highest ideal cure achieved (not theoretically)? Can the new drugs will able to do that?
Ans: As homeopaths, we believe in individualization. So if we generalize the diseases and prescribe new medicines then we may hope for some positive results.
Can we club your new medicines with anti-miasmatic medicines and constitutional or whatever it will be? Have you observed any drug relationships with other drugs?
Ans: The new drugs are like any other existing drugs. They could be deep acting, constitutional medicines e.g. HIV Nosode, Hep C nosode, Mycobacterium Tub Nosode, etc. Or they could be acute medicine such as Capsaicin. Yes, they can be clubbed with other remedies as required.
The new drugs have relationships with old drugs based on the symptoms they have produced in provings. I’ve already discussed all the relationships in this group earlier.
Procedure to be followed to prove new drugs in the present times. The legal issues for new drugs. Kindly inform us of the protocol and registration related to the clinical trial.
Ans: Procedure for drug proving is given by CCRH and ECH (European Committee for Homeopathy).
For a new drug’s proving:
- Standardization of the substance
- Ethics Committee (EC) approval
- The EC has to be formed as per ICMR guidelines
- Recruitment of volunteers after signing Informed Consent forms
- Very detailed protocol to be followed
- Various investigations before and after the provings
These are some of the important steps.
One has to plan a drug proving project in such a way that the data becomes relevant and acceptable for a peer-reviewed journal.
Also, if you are planning to work on a ‘new’ drug’s proving, there are many factors to be kept in mind, depending on the source material.
About ‘healthy’ prover, I personally feel that it’s almost impossible to get 100% healthy prover.
For practical purposes, prover should be free from any physical, mental disease, having a healthy lifestyle. (No addiction, etc. ) All basic investigations must be normal.
In the case of HIV and Hep C provings, we got all provers screened for HIV, TB, Hep C, LFT, RFT, BS, etc. Consideration of miasm is not required for provers.
Another important point is that we opted for giving a placebo for initial 7 days to all provers, and eliminated those symptoms proved with placebo as well as after the drug.
CTRI registration for every drug proving and a clinical trial is mandatory.
It can be done at http://ctri.nic.in/Clinicaltrials/login.php
HIV nosode proving article: https://www.karger.com/Article/Pdf/435845″ https://www.karger.com/Article/Pdf/435845
Hepatitis C nosode drug proving: https://www.ncbi.nlm.nih.gov/m/pubmed/23870381/” https://www.ncbi.nlm.nih.gov/m/pubmed/23870381/
It may be noted that these articles are published in peer-reviewed journals.
Every proving has taken over 18 months or more.. HIV nosode making took 2 years.. and proving other 2 years.
Another important point is that we opted for giving a placebo for initial 7 days to all provers, and eliminated those symptoms proved with placebo as well as after the drug.
Legal issue for new drugs:
Well, you all will be surprised to know that there is no clarity about how to introduce new homeopathic medicines in our regulation.
For new allopathic medicines, there are rules; which are missing for new homeopathic medicines. The Drug & Cosmetic Law has ill-defined instructions.
After working on developing about 100 new medicines, I wanted to bring them to the use of the profession; and found a lacuna.
In the last 8 years, I could not get any clear reply from FDA, HPL, CCRH, Ayush, DCGI on how to introduce a new medicine.
By the way, many new medicines have been introduced in the profession without clear rules. I wanted a system in place.
So, we at GHF initiated a petition to the ministry requesting to set a mechanism for new drug discovery.
Did you know that the Tuberculinum that you use in your practice was actually made 135 years back; and ‘probably’ you are using the descendant of something ‘presumably’ made around 1878? And, there are no tracking records! Think..
New Tuberculinum
I’m happy to share the new version of Tuberculinum which was made at India’s premium Haffkin institute, which also makes BCG and polio vaccines. They prepared New Tub nosode.
The news hit the first page of Times of India in Mumbai 2 years back. Let me assure, the newer versions will be more effective.
As one tends to stick to old phones and avoids adopting smartphones, with the apprehension of losing comfort; same with the new versions of nosodes!
The 1st by Swan: must be having ‘probably’ the Mycobacterium organisms + many other bacteria such as streptococcus, staphy, E. coli, klebsila, etc+ lung tissue + pus+ lot many proteins+ debris.
All of the above in unknown quantity, unknown quality.
Also ‘probably’ Myco Tub organisms.. why probably? Because this Tub was prepared at least 5 years before Robert Koch discovered the Myco Tuberculosis organisms!!!
No 2, is Bacillinum for the sputum. Again, the sputum will have an uncounted number of Myco Tub, uncharacterized bacteria, some other bacteria, proteins, etc.
Now, No. 3, used by Kent.. sourced from the cattle’s tissues. Again, what will be the content of the source? We don’t know because it was made 110 years ago when microbiology and histopathology were evolving.
So we have 3 varieties of tubs used in our practice. The source materials in all if they could be debated.
Now, two more questions….
a. Are we using the same Tub used by Swan, Burnett, and Kent?
If yes, how do we assume and assure that the back potencies of the ‘same’ material (1875, 1885, 1900) have reached your pharmacy/clinics in Hyderabad, after two World wars??
How logical is it for us to use the medicines, which are presumed to be the descendants of something made over 100 years? And.. and, do we continue using the same for next 100, 200, 300 years???
b. If we are not using the source in option 1, then what are we using? Is the Tub re-made by the manufacturers?
How to make new nosodes?
Ans: We developed a protocol for making nosodes in a standardized way. Since no major new nosode was made in recent years, the exact method is not laid down.
A 17 step method was developed, using which anyone could make nosodes in the future.
Those interested could read the steps in detail in this published article.
Hhttp://www.ijrh.org/article.asp?issn=0974-7168;year=2014;volume=8;issue=3;spage=166;epage=174;aulast=Shah” http://www.ijrh.org/article.asp?issn=0974-7168;year=2014;volume=8;issue=3;spage=166;epage=174;aulast=Shah
It may be noted that this method is a gift from India to the homeopathy profession.
It took us almost two years and a team of scientists including immunologists, pharmacologists, virologist, legal experts, and homeopaths… the method was developed in 2008.
Using this method following major nosodes were made:
- HIV nosode
- Hepatitis C nosode
- Mycobacterium Tuberculosis nosode
- Cancer nosode
- Malaria nosode
- Some more..
It took us over 5-7 years
Religion requires ‘faith’ as science calls for ‘trust’. There is a thin line of difference.
Is it not authentic for the preparation of drugs?
Ans: I’ve gone through the pharmacopeia, all the source material medical, etc.
The Pharmacopoeia lists:
- The method of preparation
- Symptoms and monograms
To cut it short, I’ll give one example. The Homeopathic Pharmacopoeia of India (HPI) describes the method of preparation of nosodes.
The most important question: How many pharmacies in India have ‘prepared’ the nosodes as per the HPI method?
Dear Doctors, you are all in confusion about Homoeopathic Science as such. You have not understood the Organon of medicine properly.
In today’s world, we cannot simply say that ‘going back to Organon’ is the answer to everything. Please don’t take me wrong.
Organon should not be taken as bible or Gita. It’s a rule book and fundamental philosophy; of the highest value. However, Hahnemann himself updated it 5-6 times.?
Source of nosodes in current practice?
Ans: 1. They make it from back potencies which are ‘supposed’ descendants of 135 years preparation from Europe/America, via GERMANY/U.K….. ….. KOLKATA…to Mumbai or H’bad.
In this case, all the skepticism as discussed in last few days will be applicable.
2: In case the pharmacopeia are preparing the nosodes as per the said guidelines… do you know WHAT WOULD THAT MEAN?
Yes, in that case, (which is not the reality), every Tuberculinum nosode will be a new/different nosode!! Did you realize it?
Million-dollar question.
Which Tub are we using? 1st or 3rd? (2nd is Bacillinum)
We are using 1st and 3rd.
Now, next million-dollar question….!
What is the difference between the symptoms of 1, 2, and 3?
The Mental symptoms of Tuberculinum:
- Hyperactive child.
- Desires to travel
- Delirium that he is ugly
- Hopelessness, 8. Aversion to mental work.
- Cosmopolitan
- Sensitive to music
- Anticipatory anxiety (4)
- Restlessness (4)
- Fear of dogs(2)
- Running amok (3)
- Dissatisfied
- Changing
- Anticipatory anxiety (4)
- Restlessness (4)
- Fear of dogs(2)
- Running amok (3)
- Dissatisfied
- Changing mind
Marks in Synthetic repertory
The fact is that not a single mental symptom (or hardly any) was ever found in the drug proving of the 1st and 2nd Tuberculinum!!
Yes, the initial description of Tub was given by Hering in volume 9, where NOT A SINGLE mental symptom was produced!!
All the metals of Tub are derived from miscellaneous Clinical experience, WHICH CANNOT BE COUNTER AS THE MM symptoms.
Apart from signing the petition and enrolling for trials what is the role of ours in this regard? When are you going to start the provings in mass level through doctors?
Ans: We don’t have a plan and cannot do ‘mass proving’.
Also, we have already conducted very systematic provings of all the new medicines I’ve decided to share with the profession in phase 1, except one medicine. All provings are published.
What I expect from your role as practitioner is to
- Be aware of the gaps in system
- Break fixed beliefs
- Transform from ‘faith’ to ‘trust’, making homeopathy more ‘trustworthy’ than ‘faith healing’ in the eyes of the scientists and society.
- Support the movement I’ve started for the growth of homeopathy as science.
- Be more open minded!
- Use the new medicines in the collaborative project and create statistical records of cases. We are going to make these new medicines available almost for free
- If any group/college is willing to participate in drug proving, we can take up a collaborative project. We have significant experience in scientific drug proving.
- I’ve worked in and developed over 100 new medicines which are helping only my patients. Now, I want to make them accessible to the entire profession.
We are also working on helping the ministry to bring required regulation for correcting gaps at various levels. Will need everyone’s support.
Another area where you all could help is to spread a word to various groups about the need for changes.
I’m planning to give about 10 talks per year on new drug discovery subject; started from Hyderabad.
How about the mentals developed? If they are not found during proving?
Ans: Some of the mentals are certainly found during provings.
In Tuberculinum, no major commonly known mental was found in the proving. Similarly, in carcinosin; and many other medicines.
Please read TF Allen and Constantine Hering’s volumes to learn the actual mentals in provings.
How is it deep-acting medicine?
Ans: The decision of any remedy being superficial or deep acting is to be made on the basis of its inherent ability to affect the human body. This is best judged from
- Toxicological effects
- Microbial effects.
E.g. To understand the depth of Tuberculinum, we have to study pathophysiology the organisms produce, which makes it a very deep acting remedy.
The proving symptoms are usually superficial; it’s hard to determine the depth from provings.
Metals, nosodes, chemicals, animal products are deeper than plants; except highly toxic plants.
Do you know which remedy produced vitiligo in drug proving?
Ans: Actually, no remedy ever produced vitiligo in proving.
Ars and Nit act are great remedies for vitiligo because they produce vitiligo as a toxicological effect.
I use Hydroquinone often for vitiligo.
How to get Hydroquinone?
Ans: Currently we will make 3-4 new medicines available to all from this new portal. It’s under construction. However, you can register now. We shall allow 50 people to register in the 1st phase. It’s all free, but by invitation.
http://www.biosimilia.com/” www.biosimilia.com
Does hydroquinone cure vitiligo completely or it gives good results?
Ans: Hydroquinone is one of the important remedies which could help many cases of vitiligo; it can’t claim to ‘cure’ all cases.
Please be informed that vitiligo is a deep-seated, autoimmune disease of multifactorial aetiology. Please do not expect it to ‘cure’ all cases of vitiligo.
I suggest 30, 50 and 200c potencies.
After registering with you, do we have to use only the drugs of your choice or can we club it with our own choice along with your drugs and assess the results?
Ans: Both options possible, as per the choice of the physician. The only condition is that you have to report accordingly. In some cases, you might like to use it alone, in some in addition to constitutional medicine.
2. Nashik group discussion
How is Carcinosin less than the new cancer nosode and what parts or sources have you taken to prepare the cancer nosode or the hepatitis C nosode?
Ans: I can tell you about the new cancer nosode; which is made up of 6 single tissues of different cancer tissues, as shown in the conference. Also, we made a combination of all 6 tissues with due documentation. The currently available Carcinosin is my favorite nosode since 3 decades; which was prepared by DM Fobiester and some provings done by Templeton, et all.
From my written communication with all the manufacturers of it in the UK., etc. I learned that it was sourced from 28 different tissues, about 60- 70 years back. Some of the members could write to Nelson, Ainsworth, B & T, Waleda, Helios, etc. (From their websites) and investigate the source; and share with the group.
Are there any research papers to justify indications for cancer and HIV nosodes?
Ans: I will be happy to share the method of HIV and Hepatitis C nosodes. The method for both was identical, a 17 step method. Following are the links for the 4 articles published about the nosode preparations:
http://www.ijrh.org” www.ijrh.org
http://www.ijrh.org/article.asp?issn=0974-7168;year=2014;volume=8;issue=3;spage-166;epage=174;aulast=Shah” http://www.ijrh.org/article.asp?issn=0974-7168;year=2014;volume=8;issue=3;spage-166;epage=174;aulast=Shah
Dr. Shah, it has been observed that there is a shortage of bowel nosode, can you help us regarding the same?
Ans: I have not studied the making of bowel nosodes. We can definitely undertake this research at some point. Currently, I would like to complete the range of major new nosodes. I will be happy to help if some institutions are willing to undertake the project on bowel nosodes.
What is the scope of formulations of new medicines? Will the formulation hamper the original disease state?
Ans: This may turn out to be a sensitive issue, but I would like to answer it. By formulation do you mean a combination of different medicines used at the same time in any patient right? In my opinion, use of combination of medicines is a choice of the attending physician, who should have liberty to decide it on the basis of
- The complexity of the case
- Nature of the pathology/ ies
- Matching of the similarity
- Intensity of the symptoms
- Time in hand to allow the medicine to work
- Totality of the symptoms available at a point
The answer to sub-question: Will the formulation hamper the original disease state?? You mean suppression? In my opinion, it is not likely to. I personally feel that there are many misconceptions about the use of more than one medicine. However, we could discuss and take expert opinions of the senior homeopaths after we are done with the New drug discovery matter
How do the combinations from reputed pharmas like reckweg R11 etc act? Are they really effective?
Ans: Personally, I have no experience with such products. I would be happy if the homeopathic pharmas learn to conduct clinical trials using the formulations, comparing with constitutional experts and placebo.
Are all the medicines mentioned in the pharmacopoeia standard? Eg: Is Lachesis 30 the “ actual Lachesis 30” which was potentised some many years back?
Ans: In my study, I have found that there is a big possibility that most or many of our potencies sold across the counters may not be the exact potencies. For example, Lachesis 30 or Psorinum 30 are less likely to be 30c, but may be much more than 30c, as there are produced from back potencies of original dilution prepared many years ago.
How do you justify the standardization of the new research medicines in pharmacopeia?
Ans: Since the new drugs are made recently, as per the scientific methods; we have complete information on the source, quality, characterization, quantity, etc. In other words, they are ‘standardized’. Following is the link for the standardization of nosodes. The standardization it not only for the nosodes but all the new medicines.
https://www.ncbi.nlm.nih.gov/pubmed/27473543″ https://www.ncbi.nlm.nih.gov/pubmed/27473543
Will the research medicines get added into the pharmacopeia in the near future?
Ans: I have submitted the new medicines material to AYUSH for required processing for adding them to the Pharmacopeia
What is the source of the HIV nosode? Can it be given in all the cancers? For which cancers is it really beneficial?
Ans: The HIV nosode is not necessarily used only against the HIV infection. In my practice, I used HIV nosode for a range of autoimmune diseases like rheumatoid arthritis, psoriasis, etc, as well as cancer, recurring fevers and more. This is just like using Tuberculinum for arthritis, migraine as well as tuberculosis.
Similarly, Hepatitis C nosode is useful against cirrhosis of liver and cancer, besides its use in Hepatitis C. So, friends there is no need to block the progress in the new drug discovery simply under the pretext of Isopathy. We need to outgrow such a narrow thinking process.
How do we view modalities, sensations, emotional, and other individualizing factors in vivo and in vitro studies?
Ans: The research in an animal model and in vitro model must be viewed independently of individualization parameters.
The study has created scientific evidence:
- Law of similars proved in animal model
- Objective evidence of the effect of high dilutions
- Definite anti-inflammatory efficacy proved.
- For individualistic symptoms, please refer to extensive drug proving of Capsaicin.
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