Provisions relating to sale of Homoeopathic Medicines

1. LEGISLATION
IN RELATION TO
HOMEOPATHIC PHARMACY
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2. Origin of Pharmaceutical Legislation in India
1927: In a resolution Council of States to the Governor-
General urged all govts. to control indiscriminate use of
drugs & to legislate for standardization of prepn & sale of
drugs.
Govt of India appointed Drug Enquiry Committee with
Col R N Chopra as its Chairman to:
a) enquire import, manufacture or sale of defective drug
in india
b) recommend steps to control
c) recommend legislation to restrict the profession of
Pharmacy to qualified persons
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3. Recommendation of Chopra Committee:
• A central law to control drugs & pharmacy profession
• Set up testing labs in all states to check quality of drugs
• Appoint Advisory Board to Govt in making rules to carry
out the objectives of the Act
• Set up courses for training of pharmacist & prescribing
minimum qualifications for registration
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4. Recommendation of Chopra Committee:
• Registration of every patent & proprietary medicine
• Bring crude drugs & also combined medicines used in
indigenous system under control
• Develop drug industry in India
• Reduce manufacturing in Medical Stores/Depots
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5. Evolution of the Concept of Pharmacy as part
of Health Care System
Bhore Committee
In October 1943, Govt of India appointed Sir Joseph
Bhore to survey on existing position of health care
delivery organization in India
& to make recommendations for future developments
Bhatia Committee
In 1953 Major Gen S L Bhatia appointed to enquire into
the working of pharmaceutical industry to recommend
steps for further improvement
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6. Evolution of the Concept of Pharmacy as part
of Health Care System
Hereby following Acts introduced:
• Drugs & Magic Remedies (Objectionable Advertisements)
Act, 1954
• Medicinal & Toilet Preparations (Excise Duties) Act, 1955
• Narcotic Drugs & Psychotropic Substances Act & Rules,
1985
Mudaliar Committee
In June, 1959 Dr A Lakshmanswamy recommended
Indigenous drug preparations to bring under Drugs &
Cosmetics Act,1940
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7. Evolution of Drug Policy in India
Drug (Display of Prices) Order, 1962 – 1st policy paper
concerned with controlling prices of drugs
Drug (Display & Control) Order, 1966 – approval of
govt. before increasing price and fixing of prices of new
drugs
Hathi Committee: Report of Jaisukh Lal Hathi Committee
covered all aspects of licensing, price control, imports,
role of foreign sector, quality control etc. and encouraged
both indigenous industry & foreign multinationals
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8. Homoeopathic medicine
Homoeopathic medicines include any drug whichis
recorded in homoeopathic provings or the therapeutic
efficacy of which has been established through long
clinical experience as recorded in authoritative
homoeopathic literature of India or abroad and which is
prepared according to techniques of Homoeopathic
Pharmacy but does not include a medicine which is
administered by parenteral route.
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9. Manufacture, sale & distribution of homoeopathic
medicines are governed by:
• Drugs & Cosmetics Act,1940 (Act 23 of 1940) & its
amendments
• Drugs & Cosmetics Rules,1945 & its amendments
• Narcotic Drugs & Psychotropic Substances Act & Rules,
1985 (Act 81 of 1985)
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10. • Drugs & Magic Remedies (Objectionable Advertisements)
Act, 1954 (21 of 1954)
• Drugs & Magic Remedies (Objectionable Advertisements)
Rules, 1955
• Medicinal & Toilet Preparations (Excise Duties) Act, 1955
(Act16 of 1955)
• Drugs (Prices Control) Order, 1995
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11. Drugs & Cosmetics Act, 1940
It was passed on 10th April, 1940
To regulate the import into, manufacture, distribution &
sale of drugs & cosmetics in the country
It contains:
6 Chapters – Chapter I, Chapter II, Chapter III,
Chapter IV, Chapter IVA, & Chapter V
2 Schedules – First Schedule & Second Schedule
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12. Drugs & Cosmetics Act, 1940
• Chapter I: Introductory – Short title, extent,
commencement, definitions, etc.
• Chapter II: Drugs Technical Advisory Board, Central
Drugs Laboratory, & Drugs Consultative Committee
• Chapter III: Import of Drugs & Cosmetics
• Chapter IV: Manufacture, Sale & Distribution of Drugs &
Cosmetics
• Chapter IVA: Provisions Relating To Ayurvedic, Siddha &
Unani Drugs
• Chapter V: Miscellaneous
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13. Drugs & Cosmetics Act, 1940
• First Schedule:
Part A – Ayurvedic & Siddha Systems
Part B – Unani Tibb Systems
• Second Schedule: Standards To Be Complied With By
Imported Drugs & By Drugs Manufactured For Sale,
Stocked/Exhibited For Sale/Distributed
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14. PART VI – A
Sale of Homoeopathic Medicines
67A: (1) Licensing authority appointed by State Govt.
(2) Application for the grant / renewal of a licence
in Form 19B, with a fee of Rs.250/- within 6
months of expiry
with a fee of Rs.250/- + Rs.50/-
after 6 months of expiry
(3) If damaged/Lost duplicate copy on Rs 50/-
67B: Power to sign licences & such other powers to any
person under the control of Licensing authority
with the approval of the State Govt.
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15. 67C: Forms of licences to sell drugs
Licence issued in Form 20C / 20D
67D: Sale at more than one place
Application for & issue of separate licence in
respect of each place
67E: Duration of licence
5 yrs. from the date it is granted / renewed
67EE: Certificate of renewal
Application for renewal of Form 20C & 20D
Licence issued in Form 20E
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16. 67F: Conditions to be satisfied before a licence granted
(1) Premises are clean & the sale premises are in
charge of a person who has been dealing in
Homoeopathic Medicines
(2) Any person , if aggrieved by the Licensing
authority may within 30 days from the grant of
the receipt of such order appeal to the State Govt.
67G: Conditions of licence
(1) Premises for sale of medicines clean
(2) Sale to be conducted under the supervision of
a person competent to deal in Hom.Medicines.
(3) To permit an Inspector to inspect & furnish
such information as he may require.
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17. 67G: Conditions of licence
(4) To maintain records of purchase & sale of
Hom.Medicines. containing alcohol with
names & addresses of parties.
(5) To maintain records of purchase & sale of
Hom.Medicines. containing alcohol over 30ml for
pot. medicines & 60ml for Qs.
(6) To maintain an Inspection Book in Form 35 to
enable an Inspector to record his impressions.
67GG: Additional information to be furnished
Documentary evidence in respect of the ownership/
occupation on rental / other basis of the premises.
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18. 67H: Cancellation & suspension of licences
(a) Licensing authority may, after issuing a
show- cause notice, cancel/suspend licence
for a certain period
(b) Appeal to State Govt. with in 3 months,
whose decision is final.
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19. PART VII – A
Manufacture for sale of Homoeopathic Medicines
85A: Manufacture on more than one premises
Application for & issue of separate licence in
respect of each place.
85B: Application for licence to manufacture
(1) Application for grant/renewal of licences
to made in Form 24C to the Licensing
authority appointed by the State Govt.
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20. 85B: Application for licence to manufacture Hom Medicines
(2) Application in Form 24C shall accompany
(a) a fee of Rs.200/- for the manufacture of
Hom. Qs & pot. medicines & an inspection fee
of Rs.100/- for 1st inspection & Rs,50/ in case
of inspection for renewal.
(b) a fee of Rs.200/- for the manufacture of Hom.
pot. medicines & an inspection fee of Rs.100/-
for 1st inspection & Rs,50/ in case of
inspection for renewal.
(c) a fee of Rs.200/- for the manufacture of
pot. medicines from back potencies of
pharmacies already licensed & an inspection
fee of Rs.100/- for 1st inspection & Rs,50/ in
case of inspection for renewal.
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21. 85B: Application for licence to manufacture Hom Medicines
(3) Application for renewal after expiry but within 6
months with a fee of
(a) Rs.200/- + Rs.100/- per month & an inspection
fee of Rs,50/ for the manufacture of Hom. Qs &
pot. medicines.
(b) Rs.200/- + Rs.100/- per month & an inspection
fee of Rs,50/ for the manufacture pot. medicines
(c) Rs.200/- + Rs.100/- per month & an inspection
fee of Rs,50/ for the manufacture of pot.
edicines from back potencies of pharmacies
already licensed.
(4) A fee of Rs.50/- to be paid for the duplicate copy.
5) To manufacture additional items a fee of Rs.50/-
to be paid for each additional item.
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22. 85C: Application to manufacture New Hom. Medicine
(1) No New Hom. Medicine shall be manufactured
unless it is approved by the Licensing authority
mentioned in Rule 21.
(2) To produce documents & evidence when
applying to the Licensing authority for assessing
the therapeutic efficacy of the medicine
including the minimum proving carried out with
it.
(3) To produce evidence when applying to the
Licensing authority that the New Hom. Medicine
has already been approved.
85D: Form of licence to manufacture Hom. Medicine
Licence issued in Form 25C.
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23. 85E: Conditions for grant / renewal of licence
(1) Manufacture shall be conducted under the direction
& supervision of at least one full time competent
technical staff.
(2) Factory premises shall comply with the reqts. &
conditions specified in Schedule M-I.
(i) Have arrangements for identifying raw materials
& for testing Qs.
(ii) Make arrangements with some institution
approved by LA.
(4) Premises shall be distinct & separate from the
residential area.
(5) Shall not manufacture Hom. Medicine
simultaneously with drugs of other system.
(6) Make arrangements for proper storage.
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24. 85EA: Inspection before grant / renewal of licence
To inspect premises, plant, appliances, process of
manufacturing, standardizing, testing & professional
qualification.
85EB: Report by Inspector
Inspector shall forward a detailed report to LA.
85EC: Grant / refusal of licence
(1) Granted if LA is satisfied
(2) If not satisfied LA shall reject the application &
inform the applicant of the reasons.
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25. 85ED: Further application after rejection
Within 6 months from the rejection one can apply
after fulfilling the conditions with deposit of Rs.250/-
as inspection fee.
85EF: Appeal to the State Govt.
Aggrieved person may within 90 days apply
85F: Duration of licence
5 yrs. from the date it is granted / renewed
85G: Certificate of renewal
Application for renewal in Form 25C
Licence issued in Form 26C
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26. 85H: Conditions of licence
(a) To provide & maintain staff & premises as
specified in Rule 85E
(b) To allow an Inspector to inspect the premises &
take samples
(c) To allow an Inspector to inspect registers &
records & supply such information as he may
require
(d) To maintain an Inspection Book in Form 35 to
enable an Inspector to record his impressions
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27. 85H: Conditions of licence
(e) To comply following conditions in respect of Qs:
(i) to identify crude drugs & keep record of
identification for 5 yrs
(ii) to determine total solids of Qs & keep record
for 5 yrs
(iii) to determine alcohol content of Qs & keep
record for 5 yrs
(iv) to use clean, neutral glass containers
(v) to maintain hygienic condition during the
process of manufacture, storage & handling
(ea) To add no colour to any Hom. Medicine
(f) To maintain records of Hom. Medicines.
containing alcohol & the qtys. with names &
addresses of parties for 5 yrs
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28. 85HH: Additional information to be furnished
Documentary evidence in respect of the ownership/
occupation on rental / other basis of the premises
85-I: Cancellation & suspension of licences
(1) Licensing authority may, after issuing a show-
cause notice, cancel/suspend licence for a certain
period
(2) A licensee may apply within 3 months of the date
of order against that order to the State Govt
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29. PART IX – A
Labelling & Packing of Homoeopathic Medicines
106A: Manner of labelling of Homoeopathic Medicines
(A) To appear following particulars either printed or
in indelible ink in a conspicuous manner on the
label of the innermost container & any other
covering of the packing
(i) the words ‘Homeopathic Medicine’
(ii) name of the medicine
(a) for drugs included in pharmacopoeias the
name specified in particular
pharmacopoeia
(b) for other drugs, the name descriptive of
the real nature of the drug
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30. 106A: Manner of labelling of Homoeopathic Medicines
(A) (iii) potency of the Homoeopathic medicine
either in decimal, centesimal or millesimal
system
(iii-A) in case of Hom. medicine containing
two/more ingredients, the name of each
ingredient with its potency & proportion in
metric system
(iv) name & address of manufacturer / seller
(v) alcohol in % by volume, if the container is
30ml / more
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31. 106A: Manner of labeling of Homoeopathic Medicines
(B) In addition to the above label shall display the
following
(i) a distinctive batch number by the words
“Batch No.” or “batch” or “Lot Number” or
“Lot No.” or “Lot” or any distinguishing prefix
(ii) manufacturing licence number by the words
“Manufacturing Licence Number” or “Mfg.
Lic. No.” or “M.L.”
(C) No Hom. medicine containing a single ingredient
shall bear a proprietary name
106B: Prohibition of quantity & percentage
No Hom. medicine containing more than 12%
alcohol v/v shall be packed & sold in packing more
than 30ml except to hospitals / dispensaries in
packing not more than 100ml
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32. Dr.A.B.Ram Jyothis MD (Hom)
Reader
Department of Homoeopathic Pharmacy
Athurasramam NSS Homoeopathic Medical College
Phone No: 9497053705
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