1.

Pharmacognostic study

Pharmacognostic study (macroscopic and microscopic) study of

the sample and it’s powder are to be carried out as per the
routine procedure and an attempt will be made to point out
diagnostic characteristics.

2. Physico-chemical parameters

Following parameters can be selected:

i. Foreign matter
ii. Loss on drying
iii. Total ash
iv. Acid insoluble ash
v. Alcohol soluble extractive
vi. Water soluble extractive
vii. Qualitative test for the presence of different group of
compounds
viii. Volatile oil content (in case of volatile oil containing
drugs)
ix. Hexane/Pet. ether extract (in case of fixed oil containing
drugs).

x. Assay :
It is very difficult to determine purity and strength of
herbal drugs like assay in modern medicine. Because in
most of the cases the actual therapeutic compound is not
known and may not be due to the single compound but it
 may be due to the combined effect of different chemical
compounds present in it. Moreover, the seasonal
variation, ontogenic variation of herbal drugs is a well-
known fact. It can be tried to find out from the available
literature about the important/major therapeutic
ingredients present in the sample. Then attempt can be
made to evolve some assay procedure wherever possible,
e.g. determination of total alkaloid content in major
alkaloid containing drugs.

xi. Chromatographic study :

Different chromatographic studies like T.L.C., HPTLC,
HPLC, G.C., can be carried out to evolve suitable
chromatographic pattern.

A. COMPOUND FORMULATIONS

For the standardization of compound formulations, which

contain number of ingredients, it is very difficult to set
parameters to control these preparations with a view to
ensure uniform therapeutic efficacy. In such cases control
over raw materials and manufacturing process is very
important.

In Ayurvedic system of Medicine various types of

formulations are used. The parameters to be used for their
analysis is to be decided considering their composition, use
and method of manufacturing. Some of the common
parameters which can be utilized are:

i. Description
ii. Loss on drying
iii. Ash value
iv. Acid insoluble ash
v. Water soluble extractive
vi. Alcohol soluble extractive
vii. Qualitative tests for identification of different group of
chemical compounds, if possible

a) In case of Churna preparations, where plant parts have

been used directly, Pharmacognostic study are to be
carried out for pinpointing some specific characters
which may be helpful for identification of the raw
materials.
b) In case of Asavas and Aristhas, parameters like total
solid content, pH, specific gravity and alcohol content
are to be included.
c) Arka is a liquid preparation containing volatile
constituents of the raw materials. Hence, parameters like
matter volatile contents along with pH and specific
gravity are to be included for the analysis of Arka
preparations.
d) For preparations like Ghrta and Oil the additional
parameters like Refractive index at a specific
temperature, acid value, saponifaction value and iodine
value are to be included.
e) Weight variation test, disintegration time are two
important and essential tests which have to be carried out
for any tablet pill/capsule.
 f) For Avaleha type of preparations where ghee and sugar
are used, sugar content pet. ether/hexane soluble
extractive values are to be included for their analysis.
g) For the preparations like Bhasma, Parpati, Rasansadhi, etc. the ash
analysis is to be carried out and based on it’s result and the
composition certain inorganic constituents can be selected for their
assay. For Example. Gandhake, tankana, hingula and rasa are the
non-herbal ingredients of Mrtyunfaya Rasa. Hence, assay for
mercury, sulfur and borax are to be carried out for it’s analysis.

I. Test for heavy metals :

For exporting the drugs the data on heavy metals contents may be

needed. The tests for heavy metals can be carried out as per I.P.

II. Microbial load :

If not properly collected and stored, herbal drugs can be a very goo media
for the microbes to grow.

Hence, the microbial load and the limit of certain pathogenic micro
organisms in the final products has to be carried out.

Spectrophotometric Analysis.

Though invisible spectrophotometer is not very specific the spectra

sometimes can be used successfully for identification purposes. This
method of analysis can also be used for developing certain assay
methods.

Use of Infra-red spectra for the analysis of bhasma preparations have

been reported. Before coming to any definite conclusion about it’s
utility for routine analysis it is important to generate sufficient amount
of data to ascertain whether it can be effectively employed as an
parameter for the quality control purpose of Bhasmas or other similar
metal and miner based preparations.
 Chromatographic Analysis

As mentioned earlier different chromatographic analysis like TLC, Gas

chromatography, H.P.L.C. and H.P.T.L.C. are to be carried out for
evolving suitable reproducible chromatographic pattern (Finger
printing). This will be very useful for identifying and maintaining
quality of the products.

Biological Standardization

Very little work has been done so far regarding biological

standardization of Ayurvedic formulations. But, this is a very
important aspect. Chemical standardization of Ayurvedic formulations,
especially compound formulations, is not an easy task. Numbers of
limitations are there. Along with physico-chemical and
chromatographic parameters if some biological standardization can be
done then the problem may be overcome to a great extent. The recently
developed cell culture based high through put screening system can be
considered for this purpose.

B. PROCESS STANDARDIZATION

Perusal of the available literature and Ayurvedic texts reveals that many a
time for the preparation of a single formulation numbers of methods have
been described. At present it is not clear, in majority of the cases, which would
be the ideal one to be employed. Studies undertaken by earlier workers show
that the same formulation prepared by different methods vary considerably in
their composition. Sodhana (purification) is one of the processes mentioned in
Ayurvedic literature and used for various raw materials like guggulu,
Vatsanav, etc. Various methods of sodhana using different materials like
gomutra, godugdha, triphala-kwath, etc for the purification of the Guggulu
has been mentioned in the literature. Guggulu is used in various types of
ailments. It may be possible that guggulu purified by different methods may
have different therapeutic indication. Study shows that the same guggulu
purified by different methods vary in their chemical composition. So if the
raw materials and manufacturing process is not standardized, the
standardization of finished products will be meaningless. Hence, the process
standardization of Ayurvedic formulations is also very important and this will
also be carried out in the Centre.

Future requirements:

Among the above-mentioned areas moderate progress has been achieved in

drug standardization based on limited number of parameters. There is an
urgent need to undertake Standardization of ISM drugs employing a battery
of parameters encompassing all the above aspects including chemical finger
printing, biological standardization etc. Process standardization remains
completely neglected area not many efforts are forthcoming in this vital but
difficult area of research. Studies to prove efficacy are there but are not
adequate and studies to provide proof of safety have not undertaken in the
requisite number. Thus efforts are required to be made to full-fill the above
lacunae.

Aims and Objects

Considering the need as referred above the objective of this project
is to set up an Advanced Research Center which will function as a
major institute in the area of Drug research pertaining to drugs
used in Indian System of Medicine.

Organization

For carrying out systematic study according to the project design

and methodology the following divisions are necessary:

1. Pharmacognosy division
2. Pharmaceutical Chemistry Division
3. Pharmacology & Microbiology Division
4. Pharmacy Division
5. Technical Services
6. Essential Services
Pharmacy Division

This division will manufacture Ayurvedic formulations, as per

textual references, which will be used for evolving suitable
parameters for their quality control. This is also essential for
process standardization. In case of consultancy projects related
to formulation development the scaling up from the laboratory
scale to pilot plant scale can also be carried out in this division.

Infrastructural Facilities
I Buildings - Space requirement (Square Mtr.)

a. Director’s office Directors Room – 50

PA to Director - 20
Visitors lounge - 20
Committee Room - 50
140

b.
Central administration and accounts - 100
Central Store - 100
Records and Central Computer room - 50
Joint Directors Room - 50
Toilets and bathroom - 50
Total 490 sq. m.
c. Pharmacognosy Division

Office - 50
Laboratory - 150
Tissue Culture - 50
 Authentic Drug Museum & Herbarium - 100
Total 350 sq.m.

d. Pharmaceutical Chemistry Division

Office - 50
Laboratory - 250
Instrumentation - 200
Total 500 Sq.m.
e. Pharmacology & Microbiology Division

Office - 50
Pharmacology Laboratory - 200
Microbiology Laboratory - 50
Animal House - 300
Total 600 sq. m.

f. Pharmacy Division
Office - 50
Laboratory - 100
Pilot plants - 200
Stores - 50
Total 400 sq.m

g. Technical Services

Library - 200
Documentation & Publication- 100
Drawing & Photography - 50
Computer - 100
Engineering - 50
 Total 500 sq.m.

h. Essential Services

Administration - 100
Accounts - 100
Total 200 sq.m.

i. Others

Central Stores - 100

Conference/Seminar hall- 200
Auditorium - 500
Guest house - 200
Garage for vehicles - 100
Total 1100 sq.m.

Total space requirement - 4140 sq. m.

II. Instrument & equipments -

The list of Instrument and equipments has been mentioned in
Annexure.

Out put

When the Centre will start functioning in a full-fledged manner

it will be a pioneer institute which will undertake in-depth study
regarding standardization, quality control efficacy and safety
aspects of ISM drugs (including Ayurvedic drugs). The Centre
will have many fold activities.
1. To plan and conduct in-depth work related to standardization
and quality control aspects of Ayurvedic drugs. The data
generated will be very useful for evolving their
Pharmacopoeial standards.

2. The centre would generate in-depth data providing proof for

the safety and efficacy of the drugs used in the Indian
Systems of Medicine.

3. The Centre will accept consultancy projects related to

standardization and quality control aspects of Ayurvedic
drugs and income can be generated from this.

4. To offer information related to standardization and quality

control aspects of Ayurvedic drugs on consultancy basis.

5. To offer training related to standardization and quality control

aspects of Ayurvedic drugs.

6. The Centre may have Ph.D. Scholars working on various

aspects of standardization and quality control of Ayurvedic
drugs.

7. Availability of data on safety, efficacy and internationally

acceptable standards for ISM drugs will help in increasing
the state and country’s share in the international trade in
medicinal plant based preparations.

8. It will also help in the scientific utilization of the medicinal

plant wealth of the state, besides helping the medicinal
plant based industry in the state especially considering
 that a large quantity of drugs are wasted as weeds that
accompany cash and food crops.

Financial Requirements

Non-recurring expenses (in lakhs)

I
1. Instruments, equipments : 150
2. Furniture etc. : 50
3. Books, journals, magazines, etc (initial) : 30
4. Vehicles : 20
II. Cost of building (excluding land cost) : 550

Total 800
Recurring expenses (in Lakhs):

Salary (Annexure ) :
120
Stationary, Electricity, Telephone, Water, etc.
: 10
Maintenance, Security, etc. (On contract)
: 10
Books, journals, etc. : 10
Materials and supplies : 20
Repairing, yearly servicing of equipments/instruments etc.
: 10
Miscellaneous : 10 lakhs

Total : 190
lakhs
GRAND TOTAL 990 Lakhs