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Standardization
of Homoeopathic Drugs
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For
laying down standards for identity, purity and testing
of homoeopathic drugs, Govt. of India, Ministry of Health
& Family Planning had constituted a Homoeopathic Pharmacopoeia
Committee in 1962 with objectives:-
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1.
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To preserve a Pharmacopoeia of Homoeopathic drugs
whose therapeutic usefulness have been proved
on lines of the American, German and British Homoeopathic
Pharmacopoeia. .
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To
lay down principles and standards for preparation
of Homoeopathic Drugs. |
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To
lay down tests of identity, quality & purity. |
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Such
other matters as are identical and necessary for
preparation of Homoeopathic Pharmacopoeia. |
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Functions of the Homoeopathic Pharmacopoeia
Committee were further enlarged by the ministry of Health
& Family Planning also to prepare.
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1.
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A pharmaceutical codex in order to give such detailed
information on drugs which are normally not given
in pharmacopoeias e.g. constituents, uses etc
and
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To prepare standards on nosodes.
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For
laying down standards for identity and purity and for
testing of homoeopathic drugs, Govt. of India had set
up a Homoeopathic Pharmacopoeia Laboratory at Ghaziabad
in the year 1975. Important functions which Homoeopathic
Pharmacopoeia Laboratory is to discharge include:
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1.
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Laying down of standards for identity and purity
of Homoeopathic Drugs. Finding out indigenous
substitutes for foreign Drugs.
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Verification of pharmacopoeial standards, done
elsewhere, for adoption or improvement of standards
or updation of standards.
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Testing of samples of Homoeopathic Drugs for identity
and quality under different provisions of Drugs
and cosmetics act and rules. Testing of samples
referred by drug control authorities, port authorities,
state Government etc.
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Survey and collection of samples of Homoeopathic
Drugs for verification of quality and adulteration
trends of drugs marketed.
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Maintenance of a medicinal plants garden with
preference to plants used in Homoeopathy. Cultivation
and introduction of medicinal plants.
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Survey and collection of Medicinal Plants.
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Maintenance of a preference herbarium and a museum.
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To import orientation to all India state / central
Government Drug Authorities, Drug inspectors,
Drug Analysts, Pharmacists etc. In methods of
standardization, identification and testing of
Homoeopathic Drugs and application of various
provision of Drugs Act.
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To act as central drugs laboratory for Homoeopathic
Drugs for whole of India.
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To perform functions of Government analyst for
state Government and when desired by them.
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For correct identity, enforcement and maintenance of
quality of Homoeopathic Drugs, suitable provisions have
been made in the drugs & cosmetics act 1940 & rules
1945.
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Status
of Homoeopathic Medicines in Drugs and cosmetics act,
1940 and rules, 1945 and status of Homoeopathic Pharmacopoeia
Laboratory.
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Homoeopathic medicines are defined under rule
2 (dd) of Crugs and Cosmetics rule, 1945.
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Standards of Homoeopathic Medicines to be complied
for manufacture, for sale, distribution or import
are covered under second schedule of the drugs
& cosmetic act (item no. 4a).
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New homoeopathic medicines are included under
rule 30 aa and rule 85-c.
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Minimum
requirement for good manufacturing are included
in schedule m1.
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Standards
of ophthalmic preparations come under schedule
ff (rule 126 a).
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Homoeopathic
pharmacopoeia laboratory, Ghaziabad is to function
as central drugs laboratory w.r.t. Homoeopathic
Drugs under section 6 of the act under sub rule
7 of rule 3 a.
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Anybody can get medicines tested under sections
26.
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Under section 26 a central govt. Can cancel license
of manufacturing a drugs, if therapeutic claims
are not genuine.
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Procedures
for labeling and packing of Homoeopathic Medicines
are included in rule 32 a, rule 106 a and rule
105 b (part ix - a).
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Rule 85b covers manu-facture of mother tinctures,
potencies or potencies from back potencies. Application
for which is made under form 24 c.
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11. |
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Rule 85 c and 30 aa covers manufacture of new
Homoeopathic Drugs.
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12.
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Manufacture
by pharma-cists (shop keepers) of potencies is
allowed only from back potencies under rule 85
d.
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13. |
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Retail is covered under rule 67 c. Application
be made under form 20 c. Single drugs.
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14. |
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Though whole sale is covered under rule 67 c,
but application is made under form 20 d. Single
drugs.
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15.
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Licensing
authority for issue of license for Homoeopathic
Medicines lies with the state government as per
rule 67 a & 85 b.
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16.
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Schedule
k, item 31 provides permission for sale of some
selected Homoeopathic Drugs through any registered
retail dealer of medicine licensed under rule
61. Item 31 (schedule k) includes some 32 single
homoeopathic medicines in pills in 30 c potency
in original sealed packs; 12 biochemics tissue
remedies; 4 ointments and arnica hair oil.
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| Standards
of Homoeopathic Drugs |
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VOLUME
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NO
OF MONOGRAPHS
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YEAR OF PUBLICATION
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HPI
VOL. I
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180
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1971
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HPI
VOL. II
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100
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1974
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HPI
VOL. III
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105
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1978
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HPI
VOL. IV
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107
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1984
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HPI
VOL. V
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114
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1987
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HPI
VOL. VI
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104
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1991
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HPI
VOL. VII
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105
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1999
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HPI
VOL. VIII
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101
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2000
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TOTAL
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916
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