Transcript Slide 1

Changing Face of
Homoeopathic Pharmacy
Lecture by Dr. P. N. Varma
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
Standards are fixed to ensure that
the aim of original drug is achieved
It takes into consideration.
a)
Organon aphorisms 264 to 287
b)
The availability of situation
c)
Pharmaceutical aspects of preparation
without losing the original medicinal
power
Organon aphorisms 264 – 287
further elaborate the aim
Genuineness, authenticity and standard quality
(unimpaired strength)
§ 264 –
265
The product should be in natural & crude state
§ 266
Prepared as per methods of… (homoeopathic
pharmacopoeial technique)
§ 267
Used in dose sufficient to initiate the drug action
§ 283
Material quantity MT and minor variation is of no
significance (provided not used for
pharmacological effects)
§ 284
Dilution or potentisation increases effect
§ 286-287
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.
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”.
Legal aspects of homoeopathy
in India
Homoeopathy in India comes under Drugs and Cosmetics
Act. It recognises the following pharmacopoeias:
1. Homoeopathic Pharmacopoeia of India (HPI)
2. British Homoeopathic Pharmacopoeia (BHP)
3. Homoeopathic Pharmacopoeia of United States (HPUS)
4. German Homoeopathic Pharmacopoeia (GHP)
French homoeopathic pharmacopoeia is not recognised, but
it has valuable information on nosodes and
organotherapies (sarcodes)
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.
Sources of homoeopathic drugs
Earlier
Now
Plant sources
Allersodes
Animal sources
Minerals
Nosodes
Sarcodes
Imponderabilia
Isodes (tautopathic
medicines can be
classified along with
isodes as the method
of preparation is same)
Sources…
Sarcodes
Properly identified healthy organs or
tissues
Needs healthy certificate & genuinity by
experts before a drug is made (legal need)
Imponder- No more vague. In revision series of HPUS
abilia
like for X-Rays. 1 liter or 1 kg is exposed to
1000 X-Ras rads to make basic material for
use. It is then diluted as 1/100 and product
is equalant to 2x
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
bacillinum)
from
tissues
(e.g.
psorinum,
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
Homoeopathic drug proving (HPI
Volume 1)
1.
Controlled experiment
2.
On relatively healthy volunteers
3.
Substances should be prepared as per general
methodology mentioned in the pharmacopoeia
4.
Experiments should be in varying doses to produce the
data called ‘proving’
5.
On the scheme and pattern to constitute Materia
Medica Provings are the basis of Materia Medica
6.
Experiments should be carried only to extent of causing
gross temporary reversible alterations and sense
perceptible objective signs.
Unique characteristics of
homoeopathic drug standards
1. The raw material should be same as used in
the proving.
2. Method of preparation should be one
adopted by the prover.
This in turn means:
1. Go for the correct species, adopt microscopic
/ histopathological studies.
2. Fix the percentage of active & limits for
inactive constituents and aducterants.
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
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
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.
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.
Lowest potencies – legal limits
of prescription
Name of the drug
Legal position
Antim. ars.
Not below 3x
Ars. Alb.
Not below 3x
Ars. Iod.
Not below 3x
Ars. Sul. Flv.
Not below 2x
Ars. Sul. Rub.
Not below 2x
Baryta carb.
Not below 3x
Baryta mur.
Not below 3x
Bufo rana
Not below 3x
Calcarea ars.
Not below 3x
Lachesis
Not below 6x
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
Special storage conditions (up
to 3x)

Acidum aceticum, nitricum,
picrinicum and sulphuricum



Hydrastis

Iodium

Physostigma

Rauwolfia

Secale cor.

Zincum aceticum
Apis mellifica
Bromine

Creasole

Gelsemium
Stringent storage condition (up
to 3x)

Arsenic

Naja

Acid fluric

Nitroglycerine
(hydrofluric)

Merc. Iod. Flv.

Atropine sulph

Merc. Iod. Rub.

Chininum ars.

Phosphorus

Lachesis
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
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
No. of homoeopathic drugs covered by
different materia medica & other literature
Materia medica
No. of drugs covered
Materia Medica Pura –
Hahnemann
75 approx.
Lectures on Materia Medica –
J. T. Kent
206
Encyclopedia of Pure Materia
Medica – T. F. Allen
720
Dictionary of Practical Materia
Medica – J. H. Clarke
1010
Pocket Manual of
1235 + 200 in footnote
Homoeopathic Materia Medica
and Repertory – W. Boericke
No. of homoeopathic drugs covered
by different materia medica & other
literature
contd…
Homoeopathic Pharmacopoeia 845 (total no. of monographs
of India
is 916, but it has repetition of
many drugs in subsequent
volumes)
Homoeopathic Pharmaceutical 101
Codex, volume 1
Homoeopathic
pharmacopoeial list (Govt. of
India)
2373
HPI drug documentation file
4400
OLD METHOD – No more used
Hahnemannian classification of
mother tincture preparation
Class
Ratio of vehicle
Drug
strength
Drug under the class
Class I
Juice:alcohol 1:1
1/2
Belladonna
Class II
Plant:alcohol 3:2
1/2
Thuja
Class III
Plant:alcohol 1:2
1/6
Scilla
Class IV
Dry Plant:alcohol 1:5
1/10
Spigelia
Class V A
Aqueous solution 1:9
1/10
Acid phos
Class V B
--do– poisonous 1:99
1/100
Hydrocyanic acid
Class VI A
Alcoholic solutions 1:9
1/10
Chromic acid
Class VI B
--do– poisonous 1:99
1/100
Arsenicum
Class VII
Trituration 1:9
1/10
Strychninum ars.
Class VIII
--do– liquid subs. 1:99
1/100
Petroleum
Class IX
--do– veg & animal 2:99
2/101
Agaricus
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.”
German Homoeopathic
Pharmacopoeia
Proportion
Drug strength
I
Juice + alcohol 86%
1:1
II A
Fresh drug + alcohol 86%
1:2
II B
Fresh drug + alcohol 30%
III A
Fresh drug + alcohol 60%
III B
Fresh drug + alcohol 73%
1:2
III C
Fresh drug + alcohol 43%
1:2
Maceration
Method
1:2
1:2
German Homoeopathic
Pharmacopoeia
Contd…
Method
Proportion
Drug
strength
IV A
Dry drug : alcohol 1:9
1/10
IV B
Dry drug (animal products) : alcohol 1:9
1/10
VA
Solutions – alcohol, water or glycerol 1/10 or 1/100
1/10 or 1/100
VB
Solution aqueous water for injection 1/10 or 1/100
1/10
VI
Trituration 1/10 or 1/100
1/10
VII
Trituration of MT or MS 1x
VIII
Liquid from trituration 8x or 4C
VIII B
Liquid from trituration – in water for injection
IX
Tablets permitted starch up to 10% calcium bihanate or
magnesium stearate 2%
German Homoeopathic
Pharmacopoeia
contd…
Method Proportion
Drug
strength
X
Granules
XI
Liquid dilution for injection
XII A
External application MT (alcohol 30-43%)
1/10
XII B
External application MT (alcohol 73%)
1/10
XII C
External application MT (alcohol 20%)
1/10
XII D
External application MT in oil 60-70°C 4 hours
XII FL
External application MT in oil under CO2 37°C
7 days
Ointments – antioxidants, stabilizers are not
permitted
XIII B
German Homoeopathic
Pharmacopoeia
contd…
Method
Preparation
XIV
Suppositories – antioxidants, stabilizers are not permitted
XV
Eye drops – Isotonic, sterile, preservatives permitted
XVI
Mixtures
XVII A
LM potencies
XVII B
LM potencies in granules
XVIII A,B,C,D,E&F
Heat treated liquid tinctures
XIX A,B,C,D,E&F
Refluxed tinctures
XX
Refluxing and cooling – Rh MT
XXI, XXII, XXIII& XXIV
For different set of alcohol % - Rh MT
XXV to XXXVIII
Spagric MTs – fermented products
XXXVII to XXXIX
Coated granules
XL (40)
Potentised mixtures
XLI to XLVI
Nasal drops, i.v. drops, etc
French Homoeopathic
Pharmacopoeia
Gemmotherapie (extraction in glycerine) – 56
Organotherapie (parts of the body – similar to
sarcodes) – 261
Lithotherapie (from crude minerals) - 43
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
GMP
There have been amendments to
Drug
Rules
in
October
2006
affecting homoeopathic medicines
– Good Manufacturing Practices
(GMP)
GMP
Government
now
differentiates
single medicines and formulations
It now differentiates indirectly low
potencies and high potencies
GMP

It now requires that the containers
should
be
neutral
glass

In the manufacturing area no
spitting,
smoking,
chewing,
littering, etc. are permitted.
GMP
A
standard
operating
practices
(SOPs) is required for all processes,
drugs and material movements.
GMP
The manufacturer shall use backpotencies
procured
manufacturers
and
from
the
licensed
firm
shall
maintain proper records of purchase or
shall prepare own back-potencies with
records.
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)
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.
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.
GMP
For the first time expiry date
for homoeopathic medicines
has been prescribed.
Thank
you.