Professional Documents
Culture Documents
ESSENC
CE - Interna
ational Jourrnal for Envvironmentaal Rehabilitaation and Conservation
n
Volume VI: No. 2 2015 [14
[ – 27] [ISS
SN 0975 - 62722]
[ww
ww.essence-jouurnal.com]
1
Kumar, Amit
A and Singh, Arjun2
Abstractt
Today as a Ayurved da is a paart of a new n mannufacturing (use
( of moddern heating devices,
movemennt towards a global medicine,
m Goood diffferent mechhanized elecctrical devicces) and
Manufacturing Practtices (GMP) for Ayurvedic drugg standaardization (chemical and
medicinees have been n notified unnder drugs and
a insttrumental annalysis for its
i constitueents and
cosmetic act 1940 on 23rd Junee 2000. So thhat struucture) accorrding to natuure of formuulations.
genuine and properlly prepared drugs may be Bessides this thhe evaluatioon is impleementing
provide for
f health caare needs. Foor this purpoose throough therappeutic qualitty by cliniical and
process of
o manufactu uring as to be convenieent, experimental methods
m and toxicity evvaluation
modernizzed and eco -friendly thee evaluationn of by biological
b annd histo-pathhologcal metthods.
the drug for its chem mical characcters, safetyy & Keyywords: Ayyurveda | Good
G Manuffacturing
efficacy are done on o various parameters.
p To Pracctices (GM MP) | drugg standardizzation |
give the reorientation
r n of our anciient indigenoous therrapeutic quallity
wisdom and to catter the needds of modeern Intrroduction
world, itt is necessaary to lean toward som me
In the moddern perio d Phytochhemical
modern methodology of Ayyurvedic drrug
reseearch in Inddia was inittiated by Prrofessor
preparatiion.
Johhn L. Simonnson in 19920 who seerved at
Keeping in view of the above factf this artiicle the Madras Presidency
P College, Madras,
M
will provvide advanceement in the field of drugg Forrest Researrch Institutte, Dehrad un and
For correspondence: Ind ian Institutte of Sciennce, Bangloore. He
1
Regional Drugs
D Testing Laboratory,
L Govvernment of
carrried out i ntensive work
w on e ssential
India, Miniistry of Health and Family Weelfare, oilss. After independen
i ce, effortss were
Chandigarhh (India)
2
Departmennt of Chemistryy, CCRAS, Minnistry of Health
resttarted for revival
r of the Indian system
and Familyy Welfare, Janak k Puri, New Deelhi (India) of medicines.. In 1963 , Governm ment of
Email: aam
mitt80@rediffm mail.com
Ind ia constitutted Ayruvedda committtee with
14
Kumar & Singh/Vol. VI [2] 2015/14 – 27
at different levels for sustainable utilization of available. Also text from laghutrayee i.e.
this resource in order to develop the medicinal Madhava Nidana, Bhav Prakash, Vriksha
plants sector. Ayurveda have been used. Various related
Commenced with a small and traditional websites have been searched. Also collected
production of ayurvedic drugs, now vaidyas from some Ayurvedic manufacturing units. As
are stepping towards social and rural Ayurvedic approach to therapeutics includes
development by adopting scientific quartet-viz.
methodology. Now vaidyas has had the exalted 1- Physician
vision to bring Ayurveda to society in a 2- Drugs
contemporary form and to unravel the mystery 3- Medical attendant
behind haloed and revered Indian Indigenous 4- Patient itself
system of medicine by exploring selecting Ayurvedic System in Ancient Day’s
indigenous herbs. The ancient ayurvedic Also according to Righved drugs has the same
literatures are scientifically validating by importance for physician as a king has for his
subjecting the formulations to modern state. The physician who knows about these
pharmacological/ toxicological safety test and combinations and can provide to the patients
clinical trials to create new drugs and by considering there needs of that era will be
therapies. Healthy life relies on the proper considered best physician as –
union of body, senses (sensory & motor), mind
;=ks"k/kh% leXer jktku% lferkfooA
and soul.
foiz% l mP;rs fHk"kx~
Objective of Review
j{ksgk·ehopkru%AA
1. To study the fundamental concepts of
As according to CHARAK SAMHITA
Ayurvedic drugs preparation in modern
SUTRA STHAN, the emphasize may be given
era.
mainly to drug which has its own importance
2. To spread awareness among
in various forms.
practiceners and drugs manufacturer
and Quality chemist, Scientists. i×pfo/ka d"kk;dYiufefr A
3. To support for the Ayurvedic drug r|Fkk&Lojlk%] dYd%] J`r%] 'khr%]
preparation in India in modern era. Qk.V'psfr A ¼p0lw0 4@4½
Materials and method In the Charak era only five preparations were
For this study ayurveda text has been used to predominately in use concerning to patient and
evaluate the concepts. The text from its disease.
brihattrayee i.e. Charaka Samhita, Sushruta A. Location and surroundings- According to
Samhita and Ashtanga Sangraha, Ashtanga our Ayurvedic text the site should be-
hridaya and their respective commentaries in 1) Holy place
Sanskrit as well as Hindi which were easily 2) At east or north direction of city
16
Kumar & Singh/Vol. VI [2] 2015/14 – 27
3) Away from all types of fear and evils different unit. Today it is not possible to bring
B. Buildings- during ancient days the the whole ayurvedic approach under full
considerable points were- control of physician as it was in ancient time.
So to improve quality, quantity etc. of the
(1) Proper ventilation
drugs, pharmacies and other units are
(2) Strong and lengthy walls
developed. For compliance of good
(3) Having images of Shiva & Parvati manufacturing practices in Ayurveda, the
(4) The working directions were determined as manufacturing plant should have adequate
follows:- space for-
1-Receiving and storing raw materials
2-Manufacturing process area
3-Quality control section
4- Finished goods, packing & storage.
5-Office
6-Rejected goods and drug store and general
requirements
But now some other criteria are also followed
which are as under-
Location and surrounding are so situated and
have such construction as to avoid
What was the wisdom behind selecting specific contamination from open sewage, drain, public
direction for specific work is to researched out. lavatory or any factory which produces
disagreeable or obnoxious odour or fumes or
Ayurvedic System Modern Day’s
excessive soot, dust or smoke etc.
But as the demand of Ayurvedic preparation
But now days the buildings used for factory are
increased with the change of time, the drug
such as to permit production of drugs under
formulation viz. vati, churna, sneh kalpna,
hygienic conditions and must be free from
sandhan kalpna, panchkarma kalpna also were
cobwebs and insects, rodents. They have
took place. Further modification in these
adequate provision of light and ventilation. The
kalpnas were also done as preservatives are
floor and walls should not damp or moist. The
used in kwath kalpna, also fat are converted
premises used for manufacturing, processing,
further into asavas and aristas to fulfill the
packaging and labeling must be in conformity
needs of large population. To sale in large
with the provision of Factory Act.
quantity these drugs can be stored for long
time under controlled condition through The location choose so as to be-
collection, selection, dispensing etc. by
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Kumar & Singh/Vol. VI [2] 2015/14 – 27
available in adequate and superior quality manufacture are carried out, air is filtered
dimensions. The most automated and through bacteria retaining filters (HEPA
sophisticated packing section at today’s Filters) the pressure higher than in the adjacent
Ayurvedic pharmacy includes automatic PLC areas are provided. The filters are checked for
managed packing machine (approx 300 bottles performance on installation and periodically
/minute) and blister pack facilities. Today the thereafter the record of checks is also
ayurvedic pharmacy has well established utility maintained. All the surfaces in sterile
center having generator, boiler having manufacturing areas are designed to facilitate
composite capacity, steam generation with cleaning and disinfection. For sterile
softener and cooling towers and a reciprocal air manufacturing routine microbial counts of all
compression. Ayurvedic, drug manufacturing areas are
Some important manufacturing processes and carried out during operations. Results of such
equipments used in Ayurvedic pharmacy in count against established in-house standards
modern days – Swaras formation – Juice is and record are also maintained.
extracted Raw Materials
Kalk – i.e. paste formation by different matters All raw materials procured for manufacturing
Decocation / Shrat – mixture of raw material are stored in the raw materials store. The
and water is boiled till it remains one fourth of manufacture based on the experience and the
the initial state and shodhan , marasna, jarana, characteristics of particular raw material used
morchana, sanskar, formation of koopy pakva in ayurveda, decide the use of appropriate
rasayna, parpati kalpana, choorna kalpana, containers which would protect quality of raw
sneha kalpana, sandhan kalpana etc. other material as well as prevent it from damage due
important preparation. to dampness, microbiological contamination or
rodent and insect infestation, etc. If certain raw
Anjana/ Pisti: Kharel/ ball mill, sieves/ shifter
materials require such controlled
Churna: Grinder/ disintegrator/ pulverizer,
environmental conditions, the raw materials
powder mixer, sieves/ shifter.
stores may be sub-divided with proper
Ark: Maceration tank, distillation plant, liquid
enclosures to provide such conditions by
filling tank with filter/ filter press, visual
suitable carbonization. While designing such
inspection box.
containers, cabins or areas in the raw materials
Manufacturing Areas
store, care may be taken to handle the
Now a day’s manufacture of sterile Ayurvedic
following different categories of raw material:-
drugs, separate enclosed areas specifically
1. Raw material of metal/mineral origin.
designed for the purpose are in use. These
areas are provided with air locks for entry and 2. Fresh Herbs.
are essentially dust free and ventilated with an 3. Plant extracts and exudates/resins.
air supply. For all areas where aseptic 4. Dry Herbs or plant parts.
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Kumar & Singh/Vol. VI [2] 2015/14 – 27
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Kumar & Singh/Vol. VI [2] 2015/14 – 27
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Kumar & Singh/Vol. VI [2] 2015/14 – 27
and compare actual yield against theoretical 4. To supervise and monitor adequacy of
yield before final distribution of the batch. conditions under which raw materials,
Packaging Material semi-finished products and finished
products are stored.
All packaging material such as bottle jars etc
are stored properly and tested for its bursting 5. Manufacturers who are manufacturing
strength and for its weight by using following patent proprietary Ayurvedic medicines
machines:- provide their own specification and control
references in respect of such formulated
1. Electronic GSM test/weighing balance
drugs.
2. Intelligent bursting strength tester
6. The record of specific method and
3. And the extracts are converted into granules
procedure of preparation, that is,
by electro lab peristaltic pump.
"Bhavana", "Mardana" and "Puta" and the
Quality Control record of every process carried out by the
License is given to provide facility for quality manufacturer is maintained.
control section in his own premises or through 7. The standards for identity, purity and
Government approved testing laboratory. The strength as given in respective
test is done as per the Ayurvedic pharmacopoeias of Ayurvedic medicines
pharmacopoeial standard. Where the tests are published by Government of India are
not available, the test is performed according complied with.
to the manufacturer’s specification or other
8. All raw materials are monitored for fungal,
information available. The quality control
bacterial contamination with a view to
section verify all the raw materials, monitor in
minimize such contamination.
process, quality checks and control the quality
9. Quality control section have a minimum of
of finished product being released to finished
goods store/ware house. Preferably for such 1. One person with Degree qualification
Quality control there is a separate expert. The in Ayurveda as per Schedule II of
quality control section has the following Indian Medicine Central Council Act,
facilities: 1970 (84 of 1970) of a recognized
university or Board.
1. More than 150 sq. feet area for quality
control section is provided 2. Also Bachelor of Pharmacy,
Pharmacognosy and Chemistry
2. For identification of raw drugs, reference
associated with the quality control
books and reference samples
section.
manufacturing record are maintained for
the various processes. Mainly Drugs are checked for its quality by
three departments
3. To verify the finished products, controlled
samples of finished products of each batch 1. Department of Botany
are kept for 3 years. 2. Department of chemistry
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Kumar & Singh/Vol. VI [2] 2015/14 – 27
3. Department of microbiology
Some instrument used by today’s pharmacy to
control of the modern Ayurvedic pharmacy are
as follows
9. Ultra-Violet-flourescent-analysis-cabinet
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Kumar & Singh/Vol. VI [2] 2015/14 – 27
6. Incubator – to grow bacteria, pathogens are large population are fulfilled, also preparation
mainly tested for TAMC (total aerobic becomes more hygienic than used in ancient
microbial content) days, preparation can be kept for larger
7. Refrigerator – duration and can be made more useful having
some other advantage which suits modern
day’s life. Vaidhyas can make stronger
preparation and have greater variability in their
treatment approach because here they have to
make their effective combination and not just
proceed symptomatically. Also modern
techniques are some but dehumanizing today’s
practice of medicine breaking the relationship
between human and nature. Different methods
8. BOD incubator- to test growth of mould and of Aushadhi preparation are adopted then
yeast etc. kept at 25 0C for 7 days return in our text just to increase popularity etc.
9. Fumigator (fumes are checked and which deteriorates the quality of medicine.
formaldehyde is used) Medicinal of properties of instruments metal
are also not considered mainly stainless steel
10. Anaerobic jar – anaerobic bacteria are
instruments are used. So today there is need to
grown as clostridium
adopt modern methodology with considering
11. Digital colony counters
more and more minute, comprehensive
12. Antibiotic zone reader analysis and explanation with proper
13. Strainer reasoning, without ignoring the holistic
14. Mixture approaches of Ayurveda.
15. Magnetic stirrer - to melt media with hot References
plate Dhiman, A.K. (2005): Wild Medicinal
16. Centrifugal Plants of India. Bishen Singh
Mahendra Pal Singh, Dehradun.
17. Electric balance for weighing
WHO (1999): Monographs on selected
All process controls as required under master
medicinal plants, Vol. I, 1-3, WHO,
formula including room temperature relative
Geneva.
humidity, volume filled, leakage and clarity are
Ch.Su.1/15 Charaka Samhita English
checked and recorded.
translation by R.K. Sharma & R.K.
Conclusion Bhagwan Dash by publisher
Yes it is well and good that by using all this Choukhambha Sanskrit Series office,
modern methodology we can save time that is Vol. I.
large preparation in less time and the needs of Chandra, P. Kala, Pitamber, P. Dhyani and
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27