Nosodes are nothing but the broad-spectrum and widely used homoeopathic preparations derived from biological materials such as different cultures or clinical samples of microorganisms (e.g. bacteria, fungi and viruses) or from parasites, diseased tissues (cancerous tissues) or decomposition products from humans or animals. At about forty-five such type of nosodes have been used by homoeopathic practitioners since 1830. The discovery of itch mite in 1687 noticed scabies as the first disease of humans with a known cause. Again Psorinum (a nosode from the content in scabies vesicle) was the first nosode derived from infected material and was prepared and proved by Hering in 1830. There after so many other nosodes were made between 1875 and 1925. But as far as authenticity is concerned, they were not standardised in terms of source, quality, quantity, purity, count, morphology, characterization and safety etc. Later the homoeopathic pharmacopoeia was evolved from 1825 to 1950 and the Homoeopathic Pharmacopoeia of the United States (1901) prescribed guidelines for preparation of nosodes in standardized form. 

All the major nosodes (Psorinum, Medorrhinum, Syphilinum, Tuberculinum, Bacillinum, Carcinosin, Pyrogen, Lyssin, Variolinum) were prepared before 1901. The symptoms of nosodes commonly found in popular source books like HC Allen’s Materia Medica of Nosodes were actually derived from clinical cases as drug-provings conducted were not sufficient or up to the mark. The study of bacteria, virus, fungi and parasites evolved significantly in the past 50 years in terms of Advancement in Microbiology and standardization techniques, after which the nosodes were not re-made. Again, it has been noticed that no major new nosodes (except Oscillococcinum and Leptospirosis) were introduced from newer organisms such as Human Immunodeficiency virus (HIV), Hepatitis C, polio, herpes, leprosy and dengue.

Objectives

To established scientific background and standardized method of preparation of nosodes using modern technology and to formulate clear guidelines for the same.

With the advancement of microbiology, immunology and cellular biology, it is now essential to standardise the therapeutic source material for preparing nosodes and revised potency preparation parameters needs to be reform, which can help in the following ways.

As per Need of modern scientific era the proposed methodological procedure of nosode preparation is as follows:

• The standardized method of preparation will be reproducible if the guidelines formulated are followed by the pharmacies

• In case of clinical sample, consent from the donor has to be documented.                

Steps to Nosode Preparation

Using this method the following steps have been described with example of one of the nosodes prepared.

Step I

Identification and procurement of source material: Identification and documentation of the authentic source material is essential. Standard tests must be performed and specified confirming the exact organisms. Ethical consideration is compulsory as per regulations for every procedure.

Step II

Nature of material: These preparations are divided in HPI into four groups such as N-I, -II, -III and IV as per the nature of material, whether the organisms are capable of producing endotoxins, exotoxins, made from purified toxins or made from microbes, viruses or clinical material from diseased subjects.

N-I– The preparations made from lysate of micro-organism capable of producing  bacterial endo-toxins; e.g. Salmonella Typhimurium, Escherichia Coli and Staphylococcus.

N-II – The products made from micro-organisms capable of producing exotoxin, e.g. Corynebacterium diphtheriae.                

N-III – The preparation must be made from purified toxin.

N-IV – Preparation made from micro-organisms/ viruses/clinical materials from human convalescents or diseased subjects, e.g. Variolinum, Influenzinum, Psorinum, Syphilinum and Morbillinum. New nosodes sourced from HIV, Hepatitis C and Mycobacterium tuberculosis fall under this group.

Step III

Removal of common co-infection/contamination: Purity of the source material has to be established. All possible contaminants must be removed.

Step IV

Removal/Separation of other components: The nosode if derived from serum, serum expression, centrifugation, and/or filtration is liable to procure the organism from the source material.

Step V

Characterization of source material: The microorganisms which are to be used are essential to be characterised in terms of genotyping and strains, as per the modified recent technology. In case of bacteria-strain characterization and for virus, Genotyping is essential and has been done.

Step VI

Safety

Biosafety: Established biosafety guidelines are recommended with minimum and safe handling, using sealed containers and disposable auto-tip pipettes. Bio-risk assessment is mandatory. The safety of nosode in various potencies must be established as per the guidelines on sterility testing mentioned in Indian Pharmacopoeia or European Pharmacopoeia^. 

Step VII

Mother preparation: Coming to this stage specified quantity of pure culture of one polyvalent nosode or more than one type of organisms can be mixed in vehicle to obtain original stock nosode.

In case where nosode is to be prepared using pure culture where there is documented evidence for its purity one can skip steps III, IV and V.

Step VIII

Quantification: It should be considered mandatory to specify the strength of stock nosode, whenever technology is available.

Step IX

Potentization: The method of potentization is decided depending on the nature of source material e.g. Succussion or trituration (Machine and Method).

• Trituration process can be followed where the size of biological material is macron or visible to naked eye. 

• Whenever the microorganisms are found in micron size, which are generally uniformly spread in the solution, which should be applicable to nosodes derived from virus, bacteria and fungi, Succussion is recommended over trituration. 

• Board of Regulations of Europe recommended the use of succussion for nosodes.

• The heart and liver extract of duck was used for the preparation of Oscillococcinum (Boiron, France) by succussion.

There is a scope for improvement in the conventional method of potentization as far as machine parameters are considered.

Step X

Safety check for human use: To safeguard the human subjects’ participation, it is necessary to establish the safety of the nosode. As per the HPI, issuing of any nosode (6X or below) for therapeutic use or for manufacturing of higher attenuations, the test for sterility as mentioned for aerobic and anaerobic organisms in IP 1964 should be made. Additional precautionary measures as per guidelines must be taken as and when required.

Step XI

Lyophilization: At this stage lyophilisation of the original stock is recommended to allow remaking of the nosodes in future, without any need to repeat initial steps. A centralised depository system could be made in future where standardised raw materials could be preserved for its scientific use.

HIV, Hepatitis C and Mycobacterium tuberculosis are the Nosodes which are prepared by author considering the above parameters and the steps defined. 

Various strains such as Mycobacterium tuberculosis, Mycobacterium bovis (BCG vaccine strain), Mycobacterium avium and multidrug resistant Mycobacterium tuberculosis strains are used by author for making the polyvalent nosode of Mycobacterium tuberculosis. Most of the projects were approved and granted by the ethics committee of ICMR (Indian Council of Medical Research) guidelines.

Safety guidelines regarding use of nosodes was documented with respect to nonexistence of viral copies, DNA material using RT-PCR and ultra-electron microscopy.

Nosodes can be considered as vaccine-like preparation due to its nature of making, where the vaccines are attenuated while the homoeopathic preparations are potentised. But nosodes should not be used as substitutes to the vaccines, moreover it can be used as per homoeopathic and isopathic principles for the treatment of acute and chronic diseases.

There must be improvement in the old nosodes with newer strains using modern technology and standardization and preparation of both old and new nosodes. Highly recommendation of the preparation of nosode using fresh source with appropriate guidelines and documentation in order to ensure reproducibility and future research. The standardization methods of preparation of nosodes will be reproducible if the guidelines recommended are followed by the pharmacies.

1. Reference Allen, H. C. Materia Medica of the Nosodes. Reprinted ed., B Jain Publishers, New Delhi, 1988.

2. Boericke, William. Pocket Manual of Homeopathic Materia Medica. 9th ed., B Jain Publishers, New Delhi, 1981, pp. 540-541.

3. Homoeopathic Pharmacopeia of India. 1st ed., vol. 4, Ministry of Health, Government of India, New Delhi, 1983, pp. 136-137.

4. "Nosodes in homeopathy: Significant and safe, position paper." European Regulations 43 and 44, ECHAMP, 2006, www.echamp.eu/fileadmin/user_upload/Positions/Nosodes_in_Homeopathy.pdf. Accessed 18 Aug. 2013.

5. "Nosodes in homeopathy: Significant and safe, position paper." ECHAMP, 2006, www. echamp. eu/ fileadmin/ user_upload/ Positions/ Nosodes _ in _ Homeopathy. pdf. Accessed 6 Aug. 2013.

6. Safety Issues in the Preparation of Homeopathic Medicines. World Health Organization, 2009. ISBN: 9789241598842.

7. Ethical Guidelines for Biomedical Research on Human Participants. Indian Council of Medical Research, New Delhi, 2006.

8. Shah, Rajesh. "Clinical trial for evaluation of a Hep C Nosode in the treatment for Hepatitis C (HCV) positive participants." Homeopathy, vol. 102, 2013, pp. 207-214.

9. Homeopathic Drug Proving Guidelines. European Committee for Homeopathy, Belgium, 2011.