14
` Ayurve GMP p Kumar, A Received Abstract Today a movemen Manufac medicine cosmetic genuine provide f process o moderniz the drug efficacy give the r wisdom world, it modern preparati Keeping will prov ESSENC Volume V For corres 1 Regional India, MinChandigar2 Departmeand Family Email: aam edic drugs perspective Amit 1 and S : August 31, 2 t as Ayurved nt towards turing Pract es have been act 1940 o and properl for health ca of manufactu zed and eco for its chem are done o reorientation and to cat t is necessa methodolo ion. in view of vide advance CE - Interna I: No. 2 2015 [ pondence: Drugs Testing L istry of Health h (India) nt of Chemistry y Welfare, Janamitt80@rediffm productio e ingh, Arjun 2015 Accep da is a pa a global m tices (GMP) n notified un n 23rd June ly prepared are needs. Fo uring as to -friendly the mical charac on various p n of our anci ter the need ary to lean gy of Ay the above f ement in the ational Jour [14 – 27] Laboratory, Goand Family We y, CCRAS, Min k Puri, New De mail.com on in indig 2 pted: Octobe art of a n medicine, Go for Ayurve nder drugs a e 2000. So th drugs may or this purpo be convenie e evaluation cters, safety parameters. ient indigeno ds of mode toward som yurvedic dr fact this arti field of drug rnal for Env vernment of elfare, nistry of Health elhi (India) genous sys r 31, 2015 new ood dic and hat be ose ent, n of y & To ous ern me rug icle g man diff drug inst stru Bes thro exp by b Key Prac ther Intr In res e Joh the For Ind car r oil s res t of Ind vironmenta stem in mo Online: Dece nufacturing ( ferent mech g standa trumental an ucture) accor sides this th ough therap erimental m biological an ywords: Ay ctices (GM rapeutic qual roduction the mod earch in Ind hn L. Simon Madras P r est Resear ian Institut r ied out i s . After i t arted for r medicines . ia constitut al Rehabilita odern day ember 31, 201 (use of mod hanized elec ardization nalysis for i rding to natu he evaluatio peutic qualit methods and nd histo-path yurveda | G MP) | drug lity dern perio dia was ini t nson in 19 Presidency r ch Institut t e of Scien ntensive w i ndependen r evival of . In 1963 t ed Ayruved ation and C [ISS [ww ys - Review 15 dern heating ctrical devic (chemical its constitue ure of formu on is imple ty by clini toxicity ev hologcal met Good Manuf g standardiz d Phytoch t iated by Pr 920 who s e College, M t e, Dehrad nce, Bangl o work on e ce, effort s the Indian , Govern m da commit t onservation SN 0975 - 6272 ww.essence-jou 14 w for devices, ces) and and ents and ulations. ementing ical and valuation thods. facturing zation | hemical r ofessor erved at Madras, un and ore. He ssential s were system ment of t ee with n 2] urnal.com]

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Page 1: Ayurvedic drugs production in indigenous system in modern ... · Ayurvedic drugs preparation in modern era. 2. To spread awareness among practiceners and drugs manufacturer and Quality

`

Ayurve

GMP p

Kumar, A Received

Abstract

Today a

movemen

Manufac

medicine

cosmetic

genuine

provide f

process o

moderniz

the drug

efficacy

give the r

wisdom

world, it

modern

preparati

Keeping

will prov

ESSENC

Volume V

For corres 1Regional DIndia, MiniChandigarh2Departmenand FamilyEmail: aam

edic drugs

perspective

Amit1 and S

: August 31, 2

t

as Ayurved

nt towards

turing Pract

es have been

act 1940 o

and properl

for health ca

of manufactu

zed and eco

for its chem

are done o

reorientation

and to cat

t is necessa

methodolo

ion.

in view of

vide advance

CE - Interna

I: No. 2 2015 [

pondence:

Drugs Testing Listry of Health h (India)

nt of Chemistryy Welfare, Janak

mitt80@rediffm

productio

e

ingh, Arjun

2015 Accep

da is a pa

a global m

tices (GMP)

n notified un

n 23rd June

ly prepared

are needs. Fo

uring as to

-friendly the

mical charac

on various p

n of our anci

ter the need

ary to lean

gy of Ay

the above f

ement in the

ational Jour

[14 – 27]

Laboratory, Govand Family We

y, CCRAS, Mink Puri, New De

mail.com

on in indig

2

pted: Octobe

art of a n

medicine, Go

for Ayurve

nder drugs a

e 2000. So th

drugs may

or this purpo

be convenie

e evaluation

cters, safety

parameters.

ient indigeno

ds of mode

toward som

yurvedic dr

fact this arti

field of drug

rnal for Env

vernment of elfare,

nistry of Health elhi (India)

genous sys

r 31, 2015

new

ood

dic

and

hat

be

ose

ent,

n of

y &

To

ous

ern

me

rug

icle

g

man

diff

drug

inst

stru

Bes

thro

exp

by b

Key

Prac

ther

Intr

In

rese

Joh

the

For

Ind

carr

oils

rest

of

Ind

vironmenta

stem in mo

Online: Dece

nufacturing (

ferent mech

g standa

trumental an

ucture) accor

sides this th

ough therap

erimental m

biological an

ywords: Ay

ctices (GM

rapeutic qual

roduction

the mod

earch in Ind

hn L. Simon

Madras P

rest Resear

ian Institut

ried out i

s. After i

tarted for r

medicines.

ia constitut

al Rehabilita

odern day

ember 31, 201

(use of mod

hanized elec

ardization

nalysis for i

rding to natu

he evaluatio

peutic qualit

methods and

nd histo-path

yurveda | G

MP) | drug

lity

dern perio

dia was init

nson in 19

Presidency

rch Institut

te of Scien

ntensive w

independen

revival of

. In 1963

ted Ayruved

ation and C

[ISS

[ww

ys - Review

15

dern heating

ctrical devic

(chemical

its constitue

ure of formu

on is imple

ty by clini

toxicity ev

hologcal met

Good Manuf

g standardiz

d Phytoch

tiated by Pr

920 who se

College, M

te, Dehrad

nce, Banglo

work on e

ce, efforts

the Indian

, Governm

da committ

onservation

SN 0975 - 6272

ww.essence-jou

14 

w for

devices,

ces) and

and

ents and

ulations.

ementing

ical and

valuation

thods.

facturing

zation |

hemical

rofessor

erved at

Madras,

un and

ore. He

ssential

s were

system

ment of

tee with

n

2]

urnal.com]

Page 2: Ayurvedic drugs production in indigenous system in modern ... · Ayurvedic drugs preparation in modern era. 2. To spread awareness among practiceners and drugs manufacturer and Quality

Kumar & Singh/Vol. VI [2] 2015/14 – 27 

15 

a view to maintain the uniform standards in

preparation of drugs and to prescribe the

working standards for compound

formulations including tests for identifying

purity and quality of the drugs.

Phytochemical research work has been

encouraged by establishment of Central

Drug Research Institute (CDRI), Lucknow

and Central Institute of Medicinal and

Aromatic Plants (CIMAP), Lucknow.

National Chemical Laboratory Pune,

Regional Research Laboratory, Jammu,

Hyderabad and Johrat are working in this

field. Pharmacopoeial Laboratory for

Indian Medicines established at Ghaziabad

is serving as a center for standard setting

cum drug testing laboratory for Indian

medicine including the Ayurveda.

Similarly, the Central Council of Indian

Medicine was established for working on

Ayurvedic, Siddha and Unani system of

medicines. Besides, National Institute of

Ayurveda was established in 1976 at Jaipur

(Rajasthan) in collaboration with

Government of Rajasthan which is working

as a national centre for promoting the

Ayurveda.

Traditional systems of medicine have become

a topic of global importance. Current estimates

suggest that, in many developing countries, a

large proportion of the population relies

heavily on traditional practitioners and

medicinal plants to meet primary health care

needs. Although modern medicine may be

available in many countries, herbal medicines

or phyto-medicines have often maintained

popularity for historical and cultural reasons,

concurrently, many people in developed

countries have begun to turn to alternative or

complementary therapies, including medicinal

herbs.

The medicinal properties of plant species have

made an outstanding contribution in the origin

and evolution of many traditional herbal

therapies. These traditional knowledge systems

have started to disappear with the passage of

time due to scarcity of written documents and

relatively low income in these traditions. Over

the past few years, however, the medicinal

plants have regained a wide recognition due to

an escalating faith in herbal medicine in view

of its lesser side effects compared to allopathic

medicine in addition the necessity of meeting

the requirements of medicine for an increasing

human population. Through the realization of

the continuous erosion of traditional

knowledge of plants used for medicine in the

past and the renewed interest at the present

time, a need existed to review this valuable

knowledge of medicinal plants with the

purpose of developing medicinal plants sectors

across the different states in India. Our major

objectives therefore were to explore the

potential in medicinal plants resources, to

understand the challenges and opportunities

with the medicinal plants sector, and also to

suggest recommendations based upon the

present state of knowledge for the

establishment and smooth functioning of the

medicinal plants sector along with improving

the living standards of the underprivileged

communities. The review reveals that northern

India harbors a rich diversity of valuable

medicinal plants, and attempts are being made

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

16 

at different levels for sustainable utilization of

this resource in order to develop the medicinal

plants sector.

Commenced with a small and traditional

production of ayurvedic drugs, now vaidyas

are stepping towards social and rural

development by adopting scientific

methodology. Now vaidyas has had the exalted

vision to bring Ayurveda to society in a

contemporary form and to unravel the mystery

behind haloed and revered Indian Indigenous

system of medicine by exploring selecting

indigenous herbs. The ancient ayurvedic

literatures are scientifically validating by

subjecting the formulations to modern

pharmacological/ toxicological safety test and

clinical trials to create new drugs and

therapies. Healthy life relies on the proper

union of body, senses (sensory & motor), mind

and soul.

Objective of Review

1. To study the fundamental concepts of

Ayurvedic drugs preparation in modern

era.

2. To spread awareness among

practiceners and drugs manufacturer

and Quality chemist, Scientists.

3. To support for the Ayurvedic drug

preparation in India in modern era.

Materials and method

For this study ayurveda text has been used to

evaluate the concepts. The text from

brihattrayee i.e. Charaka Samhita, Sushruta

Samhita and Ashtanga Sangraha, Ashtanga

hridaya and their respective commentaries in

Sanskrit as well as Hindi which were easily

available. Also text from laghutrayee i.e.

Madhava Nidana, Bhav Prakash, Vriksha

Ayurveda have been used. Various related

websites have been searched. Also collected

from some Ayurvedic manufacturing units. As

Ayurvedic approach to therapeutics includes

quartet-viz.

1- Physician

2- Drugs

3- Medical attendant

4- Patient itself

Ayurvedic System in Ancient Day’s

Also according to Righved drugs has the same

importance for physician as a king has for his

state. The physician who knows about these

combinations and can provide to the patients

by considering there needs of that era will be

considered best physician as –

;=ks"k/kh% leXer jktku% lferkfooA

foiz% l mP;rs fHk"kx~

j{ksgk·ehopkru%AA

As according to CHARAK SAMHITA

SUTRA STHAN, the emphasize may be given

mainly to drug which has its own importance

in various forms.

i×pfo/ka d"kk;dYiufefr A

r|Fkk&Lojlk%] dYd%] J`r%] 'khr%]

Qk.V'psfr A ¼p0lw0 4@4½

In the Charak era only five preparations were

predominately in use concerning to patient and

its disease.

A. Location and surroundings- According to

our Ayurvedic text the site should be-

1) Holy place

2) At east or north direction of city

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

17 

3) Away from all types of fear and evils

B. Buildings- during ancient days the

considerable points were-

(1) Proper ventilation

(2) Strong and lengthy walls

(3) Having images of Shiva & Parvati

(4) The working directions were determined as

follows:-

What was the wisdom behind selecting specific

direction for specific work is to researched out.

Ayurvedic System Modern Day’s

But as the demand of Ayurvedic preparation

increased with the change of time, the drug

formulation viz. vati, churna, sneh kalpna,

sandhan kalpna, panchkarma kalpna also were

took place. Further modification in these

kalpnas were also done as preservatives are

used in kwath kalpna, also fat are converted

further into asavas and aristas to fulfill the

needs of large population. To sale in large

quantity these drugs can be stored for long

time under controlled condition through

collection, selection, dispensing etc. by

different unit. Today it is not possible to bring

the whole ayurvedic approach under full

control of physician as it was in ancient time.

So to improve quality, quantity etc. of the

drugs, pharmacies and other units are

developed. For compliance of good

manufacturing practices in Ayurveda, the

manufacturing plant should have adequate

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

contamination from open sewage, drain, public

lavatory or any factory which produces

disagreeable or obnoxious odour or fumes or

excessive soot, dust or smoke etc.

But now days the buildings used for factory are

such as to permit production of drugs under

hygienic conditions and must be free from

cobwebs and insects, rodents. They have

adequate provision of light and ventilation. The

floor and walls should not damp or moist. The

premises used for manufacturing, processing,

packaging and labeling must be in conformity

with the provision of Factory Act.

The location choose so as to be-

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

18 

A. Compatible with other manufacturing

operations that may be carried out in the

same or adjacent premises.

B. Working space must be provided

adequately with to allow orderly and

logical placement of equipment and

materials to avoid the risk of mix up

between different drugs.

C. The flooring shall be smooth & even and

shall be such that as not to permit retention

or accumulation of dust or waste products.

D. The fire safety measures and proper exits

must be there.

Water supply- pure and potable quality of

water must be used. Adequate provision of

water for washing the premises are also be

made. Disposal of water-From the

manufacturing sections and labs the waste

water and the residues which might be

prejudicial to the workers or public health

must be disposed of after suitable treatment as

per guidelines of pollution control authorities

to render them harmless.

Stores-proper ventilated free from dampness

and independent adequate space for storage of

different types of material and finished

products is essential with a view to stability of

the drugs.

General perspectives of Modern Pharmacy

Now a day’s pharmacy has utilized modern

empirical and scientific system under

traditional norms to rediscover comprehend

and validate ayurved’s miracle secrets. Cutting

edge technology is employed to create

pharmaceutical grade of ayurvedic products.

Now the pharmacies are producing quality

phyto - pharmaceutical drugs .To monitor

quality the principals of good manufacturing

practices (GMP), good packaging practices

(GPP), good laboratory practices (GLP),good

agricultural practices (GAP), good harvesting

practices (GHP), are rigorously and

meticulously followed in the manufacturing of

efficient and pristine quality ayurvedic

medicines. Now a day’s PLC controlled herbal

extraction plant commissioned in the pharmacy

is used for extracting from the various parts of

the medicinal plant like leaves, flower, seeds,

barks, roots and rhizomes.

SCADA technology is being used under

controlled environmental condition of

temperature and pressure. The extract

concentration is achieved under vacuum drying

preserving the maximum valued contents of

the herbs. To put it succinctly, this unit extracts

the product with maximum recovery of the

active ingredients in the extract since thermal

degradation is totally avoided.

Ayurvedic medicines with several quality

circles and special project terms working on

total quality management (TQM) projects

make quality a mission and a byword at

modern pharmacy. The manufacturing

facilities of today’s pharmacy include to high

light the prominent, automatic, high speed

spray drug, pilot extraction plant and main

extraction plant. The fluid bed processor for

rapid fluidization and tablet compression

machines having an hourly capacity of lacks

tablet further expedite the production process.

The high speed mixture, grinder and fluid bed

techniques tends for uniform homogenization

of the product and the cleaning ,crushing and

pulverizing equipments make raw material

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

19 

available in adequate and superior quality

dimensions. The most automated and

sophisticated packing section at today’s

Ayurvedic pharmacy includes automatic PLC

managed packing machine (approx 300 bottles

/minute) and blister pack facilities. Today the

ayurvedic pharmacy has well established utility

center having generator, boiler having

composite capacity, steam generation with

softener and cooling towers and a reciprocal air

compression.

Some important manufacturing processes and

equipments used in Ayurvedic pharmacy in

modern days – Swaras formation – Juice is

extracted

Kalk – i.e. paste formation by different matters

Decocation / Shrat – mixture of raw material

and water is boiled till it remains one fourth of

the initial state and shodhan , marasna, jarana,

morchana, sanskar, formation of koopy pakva

rasayna, parpati kalpana, choorna kalpana,

sneha kalpana, sandhan kalpana etc. other

important preparation.

Anjana/ Pisti: Kharel/ ball mill, sieves/ shifter

Churna: Grinder/ disintegrator/ pulverizer,

powder mixer, sieves/ shifter.

Ark: Maceration tank, distillation plant, liquid

filling tank with filter/ filter press, visual

inspection box.

Manufacturing Areas

Now a day’s manufacture of sterile Ayurvedic

drugs, separate enclosed areas specifically

designed for the purpose are in use. These

areas are provided with air locks for entry and

are essentially dust free and ventilated with an

air supply. For all areas where aseptic

manufacture are carried out, air is filtered

through bacteria retaining filters (HEPA

Filters) the pressure higher than in the adjacent

areas are provided. The filters are checked for

performance on installation and periodically

thereafter the record of checks is also

maintained. All the surfaces in sterile

manufacturing areas are designed to facilitate

cleaning and disinfection. For sterile

manufacturing routine microbial counts of all

Ayurvedic, drug manufacturing areas are

carried out during operations. Results of such

count against established in-house standards

and record are also maintained.

Raw Materials

All raw materials procured for manufacturing

are stored in the raw materials store. The

manufacture based on the experience and the

characteristics of particular raw material used

in ayurveda, decide the use of appropriate

containers which would protect quality of raw

material as well as prevent it from damage due

to dampness, microbiological contamination or

rodent and insect infestation, etc. If certain raw

materials require such controlled

environmental conditions, the raw materials

stores may be sub-divided with proper

enclosures to provide such conditions by

suitable carbonization. While designing such

containers, cabins or areas in the raw materials

store, care may be taken to handle the

following different categories of raw material:-

1. Raw material of metal/mineral origin.

2. Fresh Herbs.

3. Plant extracts and exudates/resins.

4. Dry Herbs or plant parts.

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

20 

5. Raw material from animal source.

6. Excipients etc.

7. Volatile oils/perfumes & flavours.

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 the

consignment.

All the raw materials shall be sampled and got

tested either by the in house Ayurvedic,

experts (Quality control technical person) or by

the laboratories approved by the Government

and shall be used only on approval after

verifying. The rejected raw material should be

removed from other raw material store and

should be kept in separate room. Procedure of

`First in first out should be adopted for raw

materials wherever necessary. Records of the

receipt, testing and approval or rejection and

use of raw material shall be maintained.

The following test are performed in this stage-

S. No.

Tests

1.

Description Colour Odour Taste (if necessary) Identification Macroscopic Microscopic Powder analysis

2.

Foreign matter Loss on drying at 1050 C Total - ash Acid - insoluble ash

Water soluble ash Sulphated ash pH value Volatile Oil(if any)

3.Particle size Bulk density Tap density

4. Water -soluble extractives 5. Alcohol -soluble extractives

6.TLC/HPLC/HPTLC-Profile with marker (where ever possible)

7.Assay-for Constituents (Marker, Major compounds like Alkaloids, flavonoids/saponins compounds

8.

Test for heavy/toxic metals Lead Cadmium Mercury Arsenic

9.

Microbial contamination Total viable aerobic count Enterobacteriaceae Total fungal count

10.

Test for specific Pathogen E coli Salmonella spp. S.aureus Pseudomonas aeruginosa

11.

Pesticide residue Organochlorine pesticides Organophosphorus pesticides Pyrethroids

12. Test for Aflatoxine (B1,B2,G1,G2)

For extraction and mid products-during extraction the extract is collected at various time interval and the same test as mentioned above along with shelf life study are performed with the extract.

For final product –final analysis is carried out for different products like powders, Bhasmas, tablets etc. in different steps-

S. No.

Tests

1. Description 2. Colour

Odour Taste

3. Loss on drying at 105 oC Total- ash Acid insoluble ash

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

21 

Total solid pH Volatile oil Water -soluble extractives Alcohol -soluble extractives

4.. Weight/ml. Refractive index at 250C Viscosity Iodine value (where ever applicable) Saponification value Acid value Total fatty matter

5. Test for heavy/toxic metals Lead Cadmium Mercury Arsenic

6. Microbial contamination Total viable aerobic count Total enterobacteriaceae Total fungal count

7. Test for specific pathogen E. coli Salmonella spp. S. aureus Pseudomonas aeruginosa

8. Pesticide residue Organochlorine pesticides Organophosphorus pesticides Pyrethroids

9. Test for aflatoxine (B1,B2,G1,G2) 10. TLC/HPLC/HPTLC-Profile with marker

(where ever possible) Assay-for Constituents (Marker, Major

compounds like Alkaloids, flavonoids/saponins compounds

11.

Tablets/Capsules: Uniformity of weight Disintegration time Friability(if tablet) Hardness if tablet) Preservative(if any) Binders(if any) Diluents(if any)

12. Shelf life.

Batch Manufacturing Records

The license maintain batch manufacturing

record of each batch of Ayurvedic drugs

manufactured irrespective of the type of

product manufactured (classical preparation or

patent and proprietary medicines).

Manufacturing records are available to provide

an account of the list of raw materials and their

quantities obtained from the store, tests

conducted during the various stages of

manufacture like taste, colour, physical

characteristics and chemical tests as necessary

or indicated in the approved books of

Ayurveda mentioned in the First Schedule of

the Drugs and Cosmetic Act, 1940 (23 of

1940). These tests include any pharmacopoeial

test adopted by the manufacturer in the raw

material or in the process material and in the

finished product. These records are signed by

Production and Quality Control Personnel

respectively. Details of transfer of

manufactured drug to the finished products

store including dates and quantity of drugs

transferred along with record of testing of the

finished product, if any, and packaging,

records are maintained. Only after the

manufactured drugs have been verified and

accepted quality are allowed to be cleared for

sale. The record of date, manpower, machine

and equipments used are maintained.

Precautions against microbial

contamination and mix

Manufacturing operations are carrying out in a

separate block of adequately isolated building.

Pressure differential in the process area are

used. a suitable exhaust system is provided.

Laminar flow sterile air systems for sterile

products are designed. The germicidal

efficiency of UV lamps is checked and

recorded indicating the burning hours or

checked using intensity. Expert technical staff

approved by the Licensing Authority checks

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Kumar & Singh/Vol. VI [2] 2015/14 – 27 

22 

and compare actual yield against theoretical

yield before final distribution of the batch.

Packaging Material

All packaging material such as bottle jars etc

are stored properly and tested for its bursting

strength and for its weight by using following

machines:-

1. Electronic GSM test/weighing balance

2. Intelligent bursting strength tester

3. And the extracts are converted into granules

by electro lab peristaltic pump.

Quality Control

License is given to provide facility for quality

control section in his own premises or through

Government approved testing laboratory. The

test is done as per the Ayurvedic

pharmacopoeial standard. Where the tests are

not available, the test is performed according

to the manufacturer’s specification or other

information available. The quality control

section verify all the raw materials, monitor in

process, quality checks and control the quality

of finished product being released to finished

goods store/ware house. Preferably for such

Quality control there is a separate expert. The

quality control section has the following

facilities:

1. More than 150 sq. feet area for quality

control section is provided

2. For identification of raw drugs, reference

books and reference samples

manufacturing record are maintained for

the various processes.

3. To verify the finished products, controlled

samples of finished products of each batch

are kept for 3 years.

4. To supervise and monitor adequacy of

conditions under which raw materials,

semi-finished products and finished

products are stored.

5. Manufacturers who are manufacturing

patent proprietary Ayurvedic medicines

provide their own specification and control

references in respect of such formulated

drugs.

6. The record of specific method and

procedure of preparation, that is,

"Bhavana", "Mardana" and "Puta" and the

record of every process carried out by the

manufacturer is maintained.

7. The standards for identity, purity and

strength as given in respective

pharmacopoeias of Ayurvedic medicines

published by Government of India are

complied with.

8. All raw materials are monitored for fungal,

bacterial contamination with a view to

minimize such contamination.

9. Quality control section have a minimum of

1. One person with Degree qualification

in Ayurveda as per Schedule II of

Indian Medicine Central Council Act,

1970 (84 of 1970) of a recognized

university or Board.

2. Also Bachelor of Pharmacy,

Pharmacognosy and Chemistry

associated with the quality control

section.

Mainly Drugs are checked for its quality by

three departments

1. Department of Botany

2. Department of chemistry

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3. Department of microbiology

Some instrument used by today’s pharmacy to

control of the modern Ayurvedic pharmacy are

as follows

1. Disintegration test machine

2. Friable test apparatus – to find how much it

breaks in the transport which should not be

more than 1%.

3. I R moisture balance (infrared) – with in 15

min. it tells moisture content

DIGITAL AUTOMATIC TAP/BULK

DENSITY TEST APPARATUS

4. Bulky density apparatus – in this it is seen

that how much the drug becomes dense

when the specific quantity of the drug is

pulled within given time limits

5. Muffle furnace – to find out total ash

after ignition

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6. Vaccume Drying Oven/ LOD (Loss in

drying)

7. Sieve shaker – to find in how much mess

churna sieves

8. Vaccum Dessicator – silica is kept to

absorb moisture

9. Ultra-Violet-flourescent-analysis-cabinet

10. U.V. Lamp (U.V. fluorescence analysis) –

measurement of hydrogen ions to find RF

11. Double distillation unit for water (KMNO4

used as germicide)

12. Water bath to concentrate

13. Ethanol recovery (residue settle down)

14. Oxalate assembly (ten times more

distillation than ethanol recovery takes

place)

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15. Rotatory vaccume evaporator

16. Polarimeter to find out optical rotation

17. Clevenger for essential oil extraction

18. HP-TLC for Separation, Identification and

assay

Some Instruments are used against

microbial contamination are as follows

1. Laminar air flow (LF) – inoculation poring,

sampling, sticking, spreading are done hyper

filter is used

2. Autoclave – to sterile the media steam is

used here, plate growth is discarded and fungus

etc., are removed

3. Water bath – 1. to melt media , 2. for growth

of bacteria

4. U.V. - VIS spectrometer for concentration of

solvent

5. Hot air oven pipettes etc. are sterile kept at

150-180 0C for three hours

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6. Incubator – to grow bacteria, pathogens are

mainly tested for TAMC (total aerobic

microbial content)

7. Refrigerator –

8. BOD incubator- to test growth of mould and

yeast etc. kept at 25 0C for 7 days

9. Fumigator (fumes are checked and

formaldehyde is used)

10. Anaerobic jar – anaerobic bacteria are

grown as clostridium

11. Digital colony counters

12. Antibiotic zone reader

13. Strainer

14. Mixture

15. Magnetic stirrer - to melt media with hot

plate

16. Centrifugal

17. Electric balance for weighing

All process controls as required under master

formula including room temperature relative

humidity, volume filled, leakage and clarity are

checked and recorded.

Conclusion

Yes it is well and good that by using all this

modern methodology we can save time that is

large preparation in less time and the needs of

large population are fulfilled, also preparation

becomes more hygienic than used in ancient

days, preparation can be kept for larger

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

of Aushadhi preparation are adopted then

return in our text just to increase popularity etc.

which deteriorates the quality of medicine.

Medicinal of properties of instruments metal

are also not considered mainly stainless steel

instruments are used. So today there is need to

adopt modern methodology with considering

more and more minute, comprehensive

analysis and explanation with proper

reasoning, without ignoring the holistic

approaches of Ayurveda.

References

Dhiman, A.K. (2005): Wild Medicinal

Plants of India. Bishen Singh

Mahendra Pal Singh, Dehradun.

WHO (1999): Monographs on selected

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translation by R.K. Sharma & R.K.

Bhagwan Dash by publisher

Choukhambha Sanskrit Series office,

Vol. I.

Chandra, P. Kala, Pitamber, P. Dhyani and

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Bikram, S. Sajwan (2006): Developing

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