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Herbals
1. Herbals
Presented By:
Shashank N
1st M Pharm
Pharmaceutical Regulatory Affaris
Dept Of Pharmaceutics
JSS College Of Pharmacy,Mysuru.
1
Presented To:
Dr. Balamuralidhar .V
Assistant professor
Pharmaceutical Regulatory Affaris
Dept Of Pharmaceutics
JSS College Of Pharmacy,Mysuru.
2. Contents :
• History And Origin
• Definitions
• Classification
• Regulation
• Registration And Rules
• GMP
• Manufacturing and its license
• Guidelines on import
• Comparison
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3. History And origin:
• THE WORD HERBAL DERIVED FROM
LATIN:HERBA(GRASS,HERB)
• Herbal medicines are plant-based medicines made
from differing combinations of plant parts e.g. leaves,
flowers or roots.
• Herbals were first among the literature to produced in
ancient egypt,china ,india,and europe
Herbal medicine can be Ayurveda, Siddha,and Unani.
• 500,000 species of plants on this earth today and only
about 5000 have been studied for their medicinal
applications
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4. Contd…
• 25% of today’s prescription drugs contain compounds
isolated from plants.
• WHO estimates that herbal remedies are most frequent
used therapies worldwide and 80% (4 billion) of world
population uses them for primary health care.
• Herbals forms are of: Infusion, Decoction, Tincture,
Syrup, etc….
4
5. Ayurveda:
• The word "ayurveda" is Sanskrit: आयुर्वेद, Ayurveda,
meaning knowledge of life and longevity.
• Ayurveda has historically divided bodily substances
into five classical elements
5
6. Siddha:
• An ancient system of medicine prevalent in South
India.
• The word Siddha comes from the Tamil word for
perfection.
• Part of the holy trinity of Indian medicine.
• Siddha considers the body, mind, and spirit to be
equally important.
• Agastyar is considered the first siddha and the guru of
all siddhars;
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7. Unani:
• Unani system of Medicine owes its origin to Greece..
• “Hippocrates” ‘father of Unani medicine’.
• A/c to principles of Unani,body is made up of 4
proximal qualities.
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8. Definitions:
• Herbal Medicine: Herbal medicine is the oldest and
still the most widely used system of medicine in the
world today. It is medicine made exclusively from
plants.
• Traditional medicine (TM): is the sum total of
knowledge, skills and practices based On the theories,
beliefs and experiences indigenous to different
cultures, whether Explicable or not, used in the
maintenance of health as well as in prevention,
diagnosis , Improvement or treatment of physical and
mental illnesses.
8
9. Classification of herbals medicine:
• Category 1:Indigenous Herbal Medicines.
• Category 2:Herbal Medicines in Systems.
• Category 3:Modified Herbal Medicines.
• Category4:Imported Products with a Herbal
Medicine Base.
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11. Regulation:
• In India, Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha
and Homoeopathy (AYUSH) is responsible to regulate the herbal
medicines.
• Guidelines Are given by AYUSH for herbal medicines in India And
Also Drugs And Cosmetics Act 1940 And Rules 1945
Rules Relating To Ayurvedic, Siddha, Unani Drugs As Per The Drugs
And Cosmetics Rules:
• Part XVI: Describes the guidelines for the manufacture for sale of
Ayurvedic (including Siddha) or Unani drugs.
• Part XVII: Discusses labeling, packing and limit of alcohol in
Ayurvedic (including Siddha) or Unani drugs.
• Part XVIII: Provide details of Government Analysts and Inspectors for
Ayurvedic (including Siddha) or Unani drugs.
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12. Registration and rules:
• In India, for registration and getting license for sale of the
herbal drugs Form 24 D i.e. Application for the grant or
renewal of a license to manufacture for sale of Ayurvedic/
Siddha or Unani drugs is submitted to regulatory
authorities..
• A treasury Challan amounting to Rs. 1000/- in case of new
license and Rs. 1200/- in case of renewal of license.
• Name of drugs to be manufactured (with details) Names,
qualifications and experience of technical staff employed
for manufacture and testing of Ayurvedic (including
Sidha) or Unani.
• Application for issue of a Registration Certificate shall be
made to the licensing authority in Form 40.
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13. 13
FORM 40
(See rule 24-A)
Application for issue of Registration Certificate for import of drugs into India under the
Drugs and Cosmetics Rules 1945
I/We*_________________________________________________________
___________________________ (Name and full address) hereby apply for the grant of Registration Certificate for the manufacturer, M/s. ___________________(full address
with telephone, fax and E-mail address of the foreign manufacturer) for his premises, and manufactured drugs meant for import into India.
1. Names of drugs for registration.
1 * * *
1 * * *
1 * * *
`2. I/We enclose herewith the information and undertakings specified in Schedule D (1) and Schedule D(II) duly signed by the manufacturer for grant of Registration
Certificate for the premises stated below.
3. A fee of_______________for registration of premises, the particulars of which are given below, of the manufacturer has been credited to the Government under the Head of
Account "0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines” under the Drugs and Cosmetics Rules, 1945-Central vide Challan No.________
dated__________________(attached in original).
4. A fee of__________________for registration of the drugs for import as specified at Serial No. 2 above has been credited to the Government under the Head of Account
"0210-Medical and Public Health, 04-Public Health, 104-Fees and Fines" under the Drugs and Cosmetics Rules, 1945-Central vide Challan No._______,
dated___________. (attached in original).
5. Particulars of premises to be registered where manufacture is carried on:
Address (es)___________
Telephone No.___________ Fax__________________ _
E-mail_______________
I/We* undertake to comply with all terms and conditions required to obtain Registration Certificate and to keep it valid during its validity period.
Place: __________
Date: ___________
Signature__________
Name____________
Designation_______
Seal/Stamp of manufacturer or his authorised Agent in India.
(Note: In case the applicant is an authorised agent of the manufacturer in India, the Power of Attorney is to be enclosed).
14. 14
FORM 24-D
[See Rule 153]
Application for the grant / renewal of a license to manufacture for sale
of Ayurvedic / Siddha or Unani drugs.
1. I/We …………………………………………………………………
of …….…………………………………………………………………
hereby apply for the grant / renewal of a license to manufacture
Ayurvedic (including Siddha) or Unani drugs on the premises situated
at …………………………………………………………………………
………………………………………….…………………………………
…………………………………………………………………….
2. Names of drugs to be manufactured (with details)
3. Names, qualification and experience of technical staff employed for
manufacture and testing of Ayurvedic (including Siddha) or Unani drugs
i. ………………………………..
ii. ………………………………..
iii ………………………………..
iv ………………………………..
v ………………………………..
4. A fee of rupees………………..has been credited to the Government
under the head of account……………………….and the relevant
Treasury Challan is enclosed herewith.
Date…………………………… Signature………………………..
(applicant)
NOTE—The application should be accompanied by a Plan of the
premises.
15. FORM 26E1
(See rule 155B)
Certificate of Good Manufacturing Practices (GMP) to
manufacture of
Ayurveda, Siddha or Unani drugs
Certified that manufacturing unit licensee, namely
......................situated at ................
State .................. License No........................... comply with
the requirements of Good Manufacturing Practices of
Ayurveda-Siddha-Unani drugs as laid down in Schedule T of
the Drugs and Cosmetics Rules, 1945.
This certificate is valid for a period of three years.
Date :....... Signature………..
Place : .... Designation……
Licensing Authority for Ayurveda/ Siddha/ Unani Drugs.
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16. 16
FORM 8
(See rule 24)
Application for license to import drugs (excluding those specified in Schedule X) to the Drugs and
Cosmetics Rules, 1945
I/We*....................................................... (Name, full address with telephone, fax and E-mail address) hereby apply for a licence to import drugs specified
below manufactured by M/s.......................................... (Name, full address with telephone, fax and E-mail address).
2. Names of the Medical Device (s) to be imported:
(1)
(2)
(As mentioned in Form 41)
3. I/We* .................................................... enclose herewith an undertaking in Form 9 dated ………… signed by the manufacturer as required by rule 24 of
the Drugs and Cosmetics Rules, 1945.
4. I/We* ................................................... enclose herewith a copy of Registration
Certificate concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No.....................dated ..................
issued through M/s. .............................( Name, full address with telephone, fax and E-mail address)................................valid up to................................ .
5 I/We*.................................................... hold a valid wholesale license for sale or distribution of drugs or valid license to manufacture drugs, under the
provisions of the Act and rules made there under. A copy of the said license is enclosed.
6. A fee of..................has been credited to Government under the Head of Account "0210- Medical and Public Health, 04-Public Health, 104-Fees and Fines"
under the Drugs and Cosmetics Rules, 1945 - Central vide Challan No......................... dated................ (Attached in original)
Place: __________
Date: ___________
Signature of the Indian Agent
(Name & Designation)
Seal / Stamp
18. The Good Manufacturing Practices Are
Prescribed To Ensure That:
• Raw materials used in the manufacture of drugs are authentic,
of prescribed quality and are free from contamination.
• The manufacturing process is as has been prescribed to
maintain the standards.
• Adequate quality control measures are adopted.
• The manufactured drug which is released for sale is of
acceptable quality.
• To achieve the objectives listed above, each licensee shall
evolve methodology and procedures for following the
prescribed process of manufacture of drugs which should be
documented as a manual and kept for reference and inspection.
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20. 1. Factory Premesis:
• The manufacturing plant should have adequate space for:-
I. Receiving and storing raw material.
II. Manufacturing process areas.
III. Quality control section.
IV. Finished goods store.
V. Office
VI. Rejected goods/drugs store
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21. 2.General requirements:
A. Location And Surrounding
B. Buildings
• The building used for factory shall be such as to permit
production of drugs under hygienic conditions and should be
free from cobwebs and insects/rodents..
• The premises used for manufacturing, processing, packaging
and labeling will be in conformity with the provisions of the
Factory Act. It shall be located so as to be:
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22. I. Compatible with other manufacturing operations that may be
carried out in the same or adjacent premises.
II. Adequately provided with working space to allow orderly
and logical placement of equipment and materials to avoid
the risk of mix-up between different drugs or components
thereof and control the possibility of cross contamination by
other drugs or substances and avoid the risk of omission of
any manufacturing or control step.
III. Designed, constructed and maintained to prevent entry of
insects and rodents.
IV. Interior surface (walls, floors and ceilings) shall be smooth
and free from cracks and permit easy cleaning and
disinfection. The walls of the room in which the
manufacturing operations are carried out shall be impervious
to and be capable of being kept clean.
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23. C. Water Supply.
D. Disposal of Waste.
E. Containers’ Cleaning.
F. Stores
(F-A)
All raw materials procured for manufacturing will be stored in
the raw materials store.
While designing such containers, cabins or areas in the raw
materials store, care may be taken to handle the following
different categories of raw materials:-
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24. (1) Raw material of metallic origin.
(2) Raw material of mineral origin.
(3) Raw material from animal source.
(4) Fresh Herbs.
(5) Dry Herbs or plant parts.
(6) Excipients, etc.
(7) Volatile oils/perfumes & flavours.
(8) Plant concentrates/extracts and exudates/resins.
• Each container used for raw material storage shall be properly
identified with the label which indicates name of the raw
material, source of supply and will also clearly state the status
of raw material such as ‘UNDER TEST’ or ‘APPROVED’ or
‘REJECTED’. The labels shall further indicate the identity of
the particular supply in the form of Batch No. or Lot. No. and
the date of receipt of consignment.
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25. (F)(B) Packaging Materials.
(F)(C) Finished Goods Stores.
G. Working space.
H .Health clothing and sanitation and hygiene of workers.
I. Medical services.
J. Machinery and equipment.
K.Batch manufacturing Records.
L.Distribution records.
M.Record of market complaints.
N.Quality control
There should be 150sq ft area for quality control section.
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26. Requirements for sterile products:
A. Manufacturing areas.
B. Precaution against contamination and mix.
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27. PART II
LIST OF RECOMMENDED MACHINERY, EQUIPMENT AND
MINIMUM MANUFACTURING PREMISES REQUIRED FOR THE
MANUFACTURE OF VARIOUS CATEGORIES OF AYURVEDIC,
SIDDHA SYSTEM OF MEDICINES.
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Sr no Category of medicine Minimum
manufacturing
space required
Machinery
/equipment
recommended
1200 sq ft covered
area with separate
cabins partitions for
each activity.
Additional 400sq ft
added for Unani if
manufactured
1 Churna/ Nasya, Manjan /lepa
kwath churn
200 sq ft Grinder/
disintegrator/
pulverize/ powder,
mixer , sieves
,shifter
28. 28
3 Tablets 100 sq ft Ball mill, mass mixer
/powder mixer,
granulator drier / tablet
compressing machine
and sugar coating
4 Kajal 100 sq ft Karthan lamps for
collection of Kajal ,
tipple roller mill , end
runner mill, sieves ,ss
patila filling/ packing
manufacturing room
should be provided with
exhaust fan with UV
lamps
5 Capsules 100 sq ft Air conditioner , de
humidifier , hygrometer,
thermometer , capsule
filling machine.
29. 29
6 Ointment/marahm
pasai
100 sq ft Tube filling machine,
crimping/Medicine/ointm
ent mixer ,End runner/
mill (where required),ss
patila
7 Asava /arishta 100 sq ft 200 sq ft
8 Each manufacturing
unit will have separate
area for bhatti,
furnaces, boilers, putta
This will have proper
ventilation, removal of
smoke, prevention of
flies, insects dust etc
31. Manufacturing licenses
• To manufacture Ayurvedic / Herbal product in India, we need a
license from AYUSH. The Ministry of AYUSH is located at
INA and The AYUSH Department of Delhi is located in Tibbia
college, Karol Bagh.
• Below are 3 types of manufacturing licenses issued by
AYUSH :
• 1. Complete Manufacturing License.
• 2. Loan License.
• 3. Contract Manufacturing / Third party manufacturing / White
label Manufacturing / Product to Product manufacturing.
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32. Complete Manufacturing License
• It is a full fledged manufacturing license. In this case you will
be both marketing and manufacturing the product.
Requirements:
• The manufacturing unit should be GMP certified.
• 2 Ayurvedic experts and 2 Pharmacist.
• Should have all the manufacturing and packaging machinery.
• Drug inspectors come for regular inspection of premises.
• Other paper work.
• Example:
Marketed & Manufactured by:
My Company Pvt Ltd
My address, New Delhi, 110001
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33. Loan license
• Loan License is a manufacturing license where you loan a manufacturing
unit of a third party manufacturer to make your products.
• You will have to apply for a Loan license with a GMP certified
manufacturer and it will be issued.
Requirements :
• Need to have a premise with 3 min rooms.(1 room for raw material
storage, 1 for finished material storage and 1 for office.)
• company should be registered in same state as the manufacturer.
Example:
• Marketed by:
My Company Pvt Ltd
My address, New Delhi, 110001
• Manufactured by:
My company Pvt Ltd
Manufacturing company address, Noida, UP
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34. 34
FORM 24E
(See rule 154A)
Application for grant or renewal of a loan license to manufacture for sale
Ayurvedic (including Siddha) or Unani Drugs
1. I / We*...........................................................................of**................................hereby
apply for the grant / renewal of a loan license to manufacture Ayurvedic (including Siddha) or
Unani Drugs on the premises situated at...................………………………………………….. Drugs and
Cosmetics Rules, 1945 204
C/o***............................................................................…………………………………………
2. Names of drugs to be manufactured (with details).
3. The names, qualifications and experience of technical staff actually connected with the manufacture and
testing of Ayurvedic (including Siddha) or Unani drugs in the manufacturing premises.
4. I / We* enclose,
(a) A true copy of a letter from me/us to the manufacturing concern whose manufacturing capacity is intended to
be utilized by me / us.
(b) A true copy of a letter from the manufacturing concern that they agree to lend the services of their competent
technical staff, equipment and premises for the manufacture of each item required by me/us and that they
shall maintain the registers of raw materials and finished products separately in this behalf.
(c) Specimen of labels, cartons of the drugs proposed to be manufactured.
5. A fee of Rs......................................................has been credited to Government under
the head of account....................................and the relevant Treasury Challan is enclosed
herewith.
Date...................................... Signature......................………]
(applicant)
* Enter here the name of the proprietor, partners or Managing Director as the case m
35. GUIDELINES ON IMPORT AND EXPORT
PROCEDURES
• DOCUMENTATION :
• The authorized importer shall be required to furnish customs
and DRA officials with:
• 1. certified copies of documents issued by the relevant DRA
attesting that the importer is :
• (a) an authorized importer (produce a valid Pharmaceutical
Import License)
• (b) importing a medicine that is duly authorized/ licensed
(produce a valid product license)
• 2. batch certificate issued by the manufacturer in conformity
with the requirements of WHO Certification Scheme.
• 3. relevant invoice or bill together with an import permit or
export permit.
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36. CRITERIA FOR ISSUE OF AUTHORISATION TO
IMPORT
• The criteria for issue of a pharmaceutical import license shall
entail that:
• (a) there are suitable premises, facilities and equipment for
proper pharmaceutical warehousing
• (b) there are suitably qualified pharmaceutical personnel that
shall oversee the quality assurance i.e. pharmacist and
pharmacy technologist/technician
• (c) there are suitable arrangements, programmes and systems
for procurement, storage, documentation, stock surveillance
and distribution.
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37. APPLICATION FOR ISSUE OF AN IMPORT
PERMIT
• (a) generic name or International Non-proprietary Name (INN)
• b) strength and dosage form.
• (c) name and strength of each ingredient; in case of a product
containing more than one ingredient.
• (d) trade name or proprietary name; if any
• (e) pharmacopoeia specification of the medicine, where
applicable .
• (f) total quantity to be imported.
• (g) name and address of the supplier.
• h) name and address of the manufacturer.
• (i) country of origin .
• (j) route of entry .
• (k) licence/ registration number.
• (l) cost, insurance, freight (CIF) value .
• (m) expected date of arrival. 37
38. 38
License No.
Registration No.
Pharmaceutical Import License
Messrs (Name of Importer)…………………………………………………………………
…………………………………………………………………………………………………
………………………………………….. of (address i.e. Plot No. Street/Road, Town/City.
P.O. Box) ……………………….…..……………………………………..……
…………………………………………………………………………………………………
…………………...…..…..….….……… ………………………………………………
…………………………………………….………………………….…………………...
Carrying on business as
………………………………………………..….………….……………..……………………
…………... Are hereby authorized to Import Pharmaceutical Products (Medicines, herbal
medicines and allied substances) into the Country during the calendar
year……………………..…………………..……………………………………
Name of Supervising Pharmacist …………………………………………………..
Registration Certificate No: ………………………………………………..
Conditions imposed by the Pharmaceutical Regulatory Authority (refer to notes overleaf).
This license is valid from……….. to…
Registrar of medicines ……………..
Date Issued ………………………… Date
stamp
39. Imports Of Drugs For Personal Use
• The drugs shall form part of a passenger's bona fide baggage
and shall be the property of, and be intended for, the exclusive
personal use of the passenger.
• The quantity of any single drug so imported shall not exceed
one hundred average doses.
• The quantity to be imported is reasonable in the opinion of the
licensing authority and is covered by prescription from a
registered medical practitioner;
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40. FORM 12A
(See rule 36, Second Proviso)
Application for the issue of a permit to import small
quantities of drugs for personal use
I, .........................................resident of
..............................................................by
occupation.................................................hereby apply for a
permit to import the drugs
specified below for personal use
from....................................................................
I attach a prescription from a registered medical practitioner
in regard to the need for the said drugs.
Name of drugs Quantities
Date............................... Signature...........................
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41. IMPORT OF CONTROLLED
SUBSTANCES:
An application for a license to import/export controlled substances will be made to
the respective Drug Regulatory Authorities in the prescribed form backed by
legislation.
The import and export authorizations shall contain at least the following
information:
(a) name of controlled substance(s) (if available, the International Nonproprietary
Name)
(b) quantity to be imported/exported expressed in terms of anhydrous base content
(c) name & address of the importer and exporter
(d) period of validity of the authorization
(e) route of entry/exit through which importation/exportation shall be effected
(f) number and date of the corresponding import/export authorization and the name
of the competent authorities of the importing/exporting countries by whom it was
issued
(g) strength and dosage form.
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42. FORM 8A
(See rule 24)
Application for license to import drugs specified in Schedule X to the Drugs and
Cosmetics
Rules, 1945
I/We* ...............................(full address with telephone number, fax number and e-mail
address) hereby apply for a license to import drugs specified below manufactured by M/s....................................... (full address with
telephone no, fax and e-mail no.).
2. Name of the drugs to be imported: Drugs and Cosmetics Rules, 1945 178
(1)
(2)
(3)
3. I/We* ........................................enclose herewith an undertaking in Form 9 dated……………signed by the manufacturer as
required by rule 24 of the Drugs and
Cosmetics Rules, 1945.
4. I/We* ...........................................enclose herewith a copy of Registration Certificate
concerning the drugs to be imported in India, issued under Form 41 of the rules, vide Registration Certificate No dated issued
through M/s.
................................................(name and full address) ............................……………
valid upto………………………………
5. I/We* .............................hold a valid wholesale license for sale or distribution of drug or license to manufacture drugs, under the
provisions of the Act and rules made there under. A copy of the said license is enclosed.
6. A fee of..........................has been credited to Government under the Head of Account
"0210 - Medical and Public Health, 04- Public Health, 104- Fees and Fines" under the
Drugs and Cosmetics Rules 1945 - Central vide Challan No....................... dated ................. (attached in original).
Signature.................................
Name.....................................
Designation.............................
Seal/Stamp of Manufacturer's agent in India.]
Place: ......
Date: ...........
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43. FORM 10A
(See rules 23 and 27)
License to import drugs specified in Schedule X to the Drugs
and Cosmetics Rules, 1945
License Number............................. Date…………………….
...............................................................................................................(Name and full
address of
the importer) is hereby licensed to import into India during the period for which the
license is
in force, the drugs specified below, manufactured by M/s...................................... (name
and
full address) and any other drugs manufactured by the said manufacturer as may from
time to time be endorsed on this license.
2. This license shall be in force from............................. to..........................unless it is
sooner suspended or cancelled under the said rules.
3. Names of drugs to be imported.
Place:......................
Date: .....................
Licensing Authority
Seal/Stamp
43
45. 45
Herbal Allopathy
Its more than just a medical
knowledge system ; literally the
meaning of the word “Ayurveda”
is Science Of Life .its a science
with philosophy.
Essentially a medical Knowledge
system.
Essential to study Vyakarana
(grammar) and taraka (logic) to
understand the ayurveda concepts
Essential to study pure sciences
like physics ,chemistry, biology.
Based on holistic Based on reductionist
46. Allopathic approach
• Should be monitored by health
care professional
• Is chemically derived.
• Works to oppose and suppress
symptoms
• Most often comes with risk of
side effects
• Is best suited for emergencies or
in “preservation of life “
Holistic approach
• Should be used as part of healthy
life
• 100% natural
• Works to suppress the bodys
natural healing abilites
• Is hypo allergic and free of any
negative side effects
• Best suited for health and
condition management and for
long term relief
46
