Changing Face of Homoeopathic Pharmacy

1. Changing Face of Homoeopathic Pharmacy Lecture by Dr. P. N. Varma

2. Changing face of Homoeopathic Pharmacy • The basis of homoeopathic medicine is Experimental Pharmacology (Proving as known in homoeopathy). • This essentially calls for that the raw material should be one used in the proving

3. Standards are fixed to ensure that the aim of original drug is achieved It takes into consideration. • Organon aphorisms 264 to 287 • The availability of situation • Pharmaceutical aspects of preparation without losing the original medicinal power

4. Organon aphorisms 264 – 287 further elaborate the aim

5. Standard products… • In other words standard products, in natural form, in its totality, in dose to initiate mechanism of cure by qualitative action mainly in “dose” which does not have side effects. • Methods for testing the products for their purity and absence of impurity form the basis of pharmacopoeia.

6. Pharmacopoeias Dr. Caspari (1825) and Dr. Willmar Schwabe (1872) did leave pharmacopoeias but it was AHP 1897 which seriously dealt with individual drugs, its identification & preparation . HPUS 1941 was taken up by the FDA Act 1938 (In India Drugs were controlled in 1940). HPI came in 1971 with methods of preparation and 180 monographs of drugs. With this the homoeopathic pharmacy shifted from “art” to “science”.

7. Legal aspects of homoeopathy in India Homoeopathy in India comes under Drugs and Cosmetics Act. It recognises the following pharmacopoeias: • Homoeopathic Pharmacopoeia of India (HPI) • British Homoeopathic Pharmacopoeia (BHP) • Homoeopathic Pharmacopoeia of United States (HPUS) • German Homoeopathic Pharmacopoeia (GHP) French homoeopathic pharmacopoeia is not recognised, but it has valuable information on nosodes and organotherapies (sarcodes)

8. The Drugs and Cosmetics Rules 1945 “Homoeopathic medicines” include any drug which is recorded in Homoeopathic provings or therapeutic efficacy of which has been established through long clinical experience as recorded in authoritative Homoeopathic literature of India and abroad and which is prepared according to the techniques of homoeopathic pharmacy and covers combination of ingredients of such Homoeopathic medicines but does not include a medicine which is administered by parenteral route.

9. Sources of homoeopathic drugs

10. Sources…

11. Nosodes – methods of preparation N1 for the lysate of bacteria producing endotoxins (e.g.. Typhoid, paratyphoid, e.coli) N2 for bacteria producing exotoxins (e.g.. diphtheria) N3 for pure organisms (e.g. tuberculinum pure culture) N4 for preparations from tissues (e.g. psorinum, bacillinum)

12. Gradual enforcement of Act & Rules Homoeopathic medicines were defined in Drug Rules (Rule 2 dd) 1969 Homoeopathic pharmacopoeia covered in the second schedule of the act 1978

13. Homoeopathic drug proving (HPI Volume 1) • Controlled experiment • On relatively healthy volunteers • Substances should be prepared as per general methodology mentioned in the pharmacopoeia • Experiments should be in varying doses to produce the data called ‘proving’ • On the scheme and pattern to constitute Materia Medica Provings are the basis of Materia Medica • Experiments should be carried only to extent of causing gross temporary reversible alterations and sense perceptible objective signs.

14. Unique characteristics of homoeopathic drug standards • The raw material should be same as used in the proving. • Method of preparation should be one adopted by the prover. This in turn means: • Go for the correct species, adopt microscopic / histopathological studies. • Fix the percentage of active & limits for inactive constituents and aducterants.

15. Process has a bearing on the quality Trituration - particle size 10 micron at 1x level Tincture - fresh or dry plant - size of cut or fineness of the powdered material - percolator packing - percentage of extraction solvent - rate of percolation - time of maceration

16. Supplementary but essential standards Ash values Extractive values Saponification values Reaction (pH) of known strength solution Foreign matters Moulds, fungus, bacterial, pesticide residue TLC Rf values Tincture, odour, taste, colour & dry residue

17. Triturations / tablets • Insoluble basic drug materials (1:10 or 1:100) with lactose • Triturated by hand or machine. Particle size of the basic drug material in the final decimal or centesimal dilution has to be below 10 µm for 80%; no drug particle should be more than 50 µm. • Trituration time: Minimum 1 hour. • One third of the lactose is given into the mortar, then the basic material is added; finally the remaining vehicle in two equal portions is added and triturated.

18. Triturations / tablets contd… • For tabletting permitted excipients are only starch – concentrated up to 10 percent and magnesium stearate in concentrations up to 2 percent. • Granulation if necessary has to be done with saturated lactose solution, starch paste or ethanol. • Tablets are single doses containing 250 mg of the trituration. The weight of excipients goes additional.

19. Lowest potencies – legal limits of prescription

20. Lowest potencies – legal limits of prescription contd… • All arsenic, barium, mercury and lead – not below 3x • All nosodes - not below 6x (3rd potency) for trading, not below 6th potency in practice • All snake, viper, spider, toad and insect poisons - not below 3x (exceptions in India – Blatta orientalis Q) • Phytochemicals (HCN glyc.) etc. – not below 6x

21. Acidum aceticum, nitricum, picrinicum and sulphuricum Apis mellifica Bromine Creasole Gelsemium Hydrastis Iodium Physostigma Rauwolfia Secale cor. Zincum aceticum Special storage conditions (up to 3x)

22. Arsenic Acid fluric (hydrofluric) Atropine sulph Chininum ars. Lachesis Naja Nitroglycerine Merc. Iod. Flv. Merc. Iod. Rub. Phosphorus Stringent storage condition (up to 3x)

23. Level of testing in homoeopathic drugs Biochemic drugs - up to 6x; up to 12x by plasma Triturations - up to 6x; up to 12x by plasma Mother tinctures - up to 4x; up to 6x by HPLC Mother tinctures - up to 2x in combinations Combination drugs - up to 2x Ointments, hair oils, eye drops, etc. Dilutions - up to 6x

24. Level of testing in homoeopathic drugs Contd… • Molecules are present at best up to level 12C or 24x • But clinical response is visible even above 24x in • Human being • Animals • Bacteria • Plants • Biological response can be demonstrated on polygraph and other sensitive equipments used in experimental pharmacology

25. No. of homoeopathic drugs covered by different materia medica & other literature

26. No. of homoeopathic drugs covered by different materia medica & other literature contd…

27. OLD METHOD – No more used Hahnemannian classification of mother tincture preparation

28. New concept: On uniform drug strength… Materia Medica Pura Vol II pg 30 or Chronic Diseases pg 182 : • “In order to make alcoholic medicinal substances of uniform strength and to obtain from them determinable dilution follow….” BHP part I pg 11 & 12 : • “In every substance the dry crude substance is to be taken as starting point for calculation of strength.”

29. German Homoeopathic Pharmacopoeia

30. German Homoeopathic Pharmacopoeia Contd…

31. German Homoeopathic Pharmacopoeia contd…

32. German Homoeopathic Pharmacopoeia contd…

33. French Homoeopathic Pharmacopoeia Gemmotherapie (extraction in glycerine) – 56 Organotherapie (parts of the body – similar to sarcodes) – 261 Lithotherapie (from crude minerals) - 43

34. Quotation from HPI Vol II “The old Hanemannian method of preparation has been discarded in favour of a new uniform method with specific drug strength which takes in to consideration the moisture content of the drug, thus eliminating the variation in standards. This method (the new uniform method of preparation of tincture as mentioned in the General Instructions for preparation in Homoeopathic Pharmacopoeia) is applicable to most* of the drugs and has been accepted by the committee”. *A few exceptions have been taken care in the individual monograph

35. GMP There have been amendments to Drug Rules in October 2006 affecting homoeopathic medicines – Good Manufacturing Practices (GMP)

36. GMP Government now differentiates single medicines and formulationsIt now differentiates indirectly low potencies and high potencies

37. GMP • It now requires that the containers should be neutral glass • In the manufacturing area no spitting, smoking, chewing, littering, etc. are permitted.

38. GMP A standard operating practices (SOPs) is required for all processes, drugs and material movements.

39. GMP The manufacturer shall use back-potencies procured from licensed manufacturers and the firm shall maintain proper records of purchase or shall prepare own back-potencies with records.

40. GMP • Different droppers shall be used for different medicines and different potencies. • Potentisation shall be done using Hahnemannian method (change of bottle at each stage of potentisation)

41. GMP In case of formulation the following has been added: • Compound formulations shall preferably be in liquid and solid forms and the potency of the ingredients shall be in detectable quantity preferably be in 3x except in case of highly poisonous material and toxins which should not be below 6x. • The ingredient shall be compatible to each other. • Complete pharmacopoeial name of each ingredient shall be printed on the label along with composition.

42. GMP In case of Laboratory Controls the following the following has been added: • Tests as per the pharmacopoeia and requirements shall be carried out on products and materials. • The stability of the products shall be established by proper methods. • Sterility tests, wherever applicable, shall be carried out. • Control samples shall be preserved for not less than three years after the last sales.

43. GMP For the first time expiry date for homoeopathic medicines has been prescribed.

44. Thank you.