ishing You Happy New Year - amam-ayurveda.org

Volume. 1 No.7 Jan - March. 2011
President’s Message
Index
Contents
Page
From the Editor’s desk 2
• Editorial Board
• Executive Committee
Regulatory Updates 3
• Supplementary Guidelines for
Manufacturing of Rasaushadhies
ishing You
Happy New Year
• Patenting of Indian Traditional
Knowledge
• Submission of the record of raw
material consumption
Industry Event 9
• QCI Seminar on the “Quality Mark For
Ayush Products” - a presentation by
Bureau Veritas Certification
Pharamocopial Standards 12
From:
President
&
All Other Executive Committee Members
• Vasavleha
• Vasa
• Pippali
• Sarkra
• Goghrita
• Pharamocopial Standards
For Vasavleha

From the Editor’s desk
Dear Readers,
Department of Ayush issued guidelines for manufacturing of
Rasaushadhies or Rasamarunthukal and Kushtajat (Herbo-mineralmetallic
compounds) of ASU medicines. These guidelines provide
general and minimum technical requirement for quality assurance
and control in manufacturing Rasaushadhies or Rasamarunthukal
and Kushtajat.
The guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya
Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of metals and
minerals origin) Druti Parpam, Karpu, and Kushta etc used in ASU
systems of medicine.
The GMP guidelines for Rasaushadhi or Rasamarunthukal and
Kushtajat are required to establish the authenticity of raw drug,
minerals and metals, in-process validation and quality control
parameters to ensure that these formulations are processed and
prepared in accordance with classical texts and for which safety
measures are complied. Only those manufacturing units which have
GMP for ASU drugs and supplementary certificate for Rasaushadhies
or Rasamarunthukal and Kushtajat formulations shall be allowed to
manufacture the same.
As per the supplementary guidelines, the manufacturing area of
Bhasma and Kupipakawa and Rasaushadhi preparations made from
metals and minerals should be completely segregated from the
production area used for preparation of plants and animal byproduct
based formulation to avoid cross-contamination. The guideline
specifies the minimum area that the manufacturers have to use for
each and every stages of manufacturing the medicines.
As per the guidelines, the manufacturers have to keep a Shodhan
Register for ready reference, providing even minute details.
For quality control, the guidelines specify that the specifications for
finished Rasaushadhi are primarily intended to define the quality
rather than to establish full characterization, and should focus on
those characteristics found to be useful in ensuring the quality.
Consistent quality for Rasaushadhi can only be assured if the starting
material-metals and minerals are used of pharmacopoeial standards.
The manufacturers must ensure in-house standards for the uniform
quality of product.
Quality testing shall be carried out as per official Pharmacopoeia or
Schedule books for texts.
The Particle size of the product should also be tested by adopting
microscope fitted with micrometer or particle size analyzer or
any other appropriate techniques. Required physio-chemical
characterization of the product should be undertaken by appropriate
analytical equipment. The Standard Manufacturing Process of the
product should be evolved/follow up. The disintegration time of pillsvati
and tablets should also be recorded.
You will find inside this issue the detailed guidelines for manufacturing
of Rasaushadhies as guided by the Dept. of Ayush for your ready
reference & implementation at your respective units.
Let us all extend our support to Department of Ayush for its
implementation. Besides this the current issue also contains our
regular features like “Pharmocopial standards of an ayurvedic product
and other regulatory updates. Hope you will find them useful too.
We wish our readers a very a Happy New Year!
Dr. Manju Rakesh
On behalf of full editorial board
Disclaimer: Articles in the newsletter are written by independent individuals. News Clips of Upcoming
Events, Govt. Notifications, Schemes have been taken from different sources. Their opinions do not
necessarily reflect those of Info Ayurveda. They are put here for interest and reference only. None of the
contributors, sponsors, administrators, or anyone else connected with Info Ayurveda in any way whatsoever
shall be responsible for the appearance of any inaccurate information or for your use of the information
contained in the newsletter.
Editorial Board:
Chief Editor:
Mr. Pradeep Multani, Honorary General Secretary AMAM
Chairman Multani Pharmaceutical Limited
36-H Connaught place, New Delhi- 1
Editor:
Dr. Manju Rakesh
Dabur India Limited, Plot No. 22, Site IV,
Sahibabad - 201010, Ghaziabad (U.P.)
Mr. Anurag Sharma, Executive Director
Shri Baidyanath Ayurved Bhawan Pvt. Ltd. (Jhansi)
B- 6/5, Safdarjung Enclave, New Delhi
Mr. Asad Mueed, Director
Hamdard (WAKF) Laboratories, Asaf Ali Road,
New Delhi – 110 002
Mr. Ajay Sharma, President
Shri Baidyanath Ayurved Bhawan, Naini,
28, Ishwar Nagar East, New Delhi – 110065
Executive Committee
Patron
Vaidya Brahaspati Dev Triguna
Ashok Chand Burman
Suresh Sharma
Pradip Burman
President
Vaidya Devender Triguna
Tel: 011-24354141
Vice President
Anurag Sharma
Shri Baidyanath Ayurved Bhawan Ltd.,
(Jhansi)
e-mail: anurag@baidyanathayurved.com
Asad Mueed
Hamdard (WAKF) Laboratories
e-mail: amueed@hamdardindia.com
Devendra Garg
Dabur India Limited
e-mail: gargd@dabur.com
Ravi Prasad
The Himalaya Drug Co.
e-mail: ravi.prasad@himalayahealthcare.com
Hon. Gen. Secretary
Pradeep Multani
Multani Pharmaceuticals Ltd.
e-mail: chairman@multaniayurved.org
Jt. Secretary
Ajay Sharma
Shri Baidyanath Ayurved Bhawan,
New Delhi
e-mail: ajdelhi@msn.com
Dr. C.K. Katiyar
Dabur India Limited
e-mail: chandra.katiyar@dabur.com
Arun Chauhan
BACFO Pharmaceuticals (India) Ltd.
e-mail: chauhanarun@akcgroup.com
Rajiv Bansal
Divya Pharmacy
e-mail: rajivbansal20@gmail.com
Members
Vijay Grover
Kamal Pharmacy, New Delhi
e-mail: vijay@kamalpharmacy.com
Pramod Sharma
Shri Baidyanath Ayurved Bhawan Ltd. Patna
e-mail: pramodsharma54@yahoo.com
Dilip Bhujbal
Dabur India Limited
e-mail: bhujbald@dabur,com
Dr. Manju Rakesh
Dabur India Limited
e-mail: rakeshm@dabur.com
Amit Agarwal
Natural Remedies
e-mail: amit@naturalremedies.com
A. V. Anoop
Cholayil Pharmaceuticals
e-mail: av_anoop@satyam.net.in
M. J. Saxena
Sanat Laboratories Ltd.
e-mail: mjsaxena@sanatproducts.co.in
Treasurer
Tejinder Singh
Dabur India Limited
(M) 98112 05266
e-mail: singht@dabur.com
Executive Secretary
Jagdish Prasad
(M) 0 96543 50711, 0 96543 50712
A Publication of:
Association of Manufacturers of Ayurvedic Medicines
Regd. Office: 22, Site –IV, Sahibabad,
Ghaziabad - 201010 (UP), Tel: 0120 4378400,
Fax: 0120 4376909
Correspondence Address: H-36, Connaught Place,
New Delhi-110001, Tel: 011-23350062,
Fax: 011-23350063
E-mail : amamindia@gmail.com
website: www.amam-ayurveda.org
www.amam-ayurveda.org 2

Regulatory Update
Dear Members,
The department of Ayush has issued a notification on supplementary guidelines for manufacturing of Rasaushadhies or Rasamarunthukal and Kushtajat (Herbomineral-metallic
compounds) of Ayurveda, Siddha and Unani (ASU) medicines in the country. The supplementary guidelines are to provide general and minimum
technical requirement for quality assurance and control in manufacturing Rasaushadhies or Rasamarunthukal and Kushtajat.
These guidelines deal with Bhasmas, Sindura, Pishti, Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa (of metals and minerals origin)
Druti Parpam, Karpu, and Kushta etc used in ASU systems of medicine.
Given below is a copy of notification on the same for your ready reference please.
“Supplementary guidelines for manufacturing
of Rasaushadhies or Rasamarunthukal and
Kushtajat (Herbo-mineral-metallic compounds)
of Ayurveda, Siddha and Unani medicines”
These guidelines are intended to complement those provided above and
should be read in conjunction with the parent guidelines. The supplementary
guidelines are to provide general and minimum technical requirements
for quality assurance and control in manufacturing Rasaushadhis or
Rasamarunthukal and Kustjat (Herbo-mineral-metallic formulations).
These supplementary guidelines deal with Bhasmas, Sindura, Pishti,
Kajjali, Khalviya Ras, Kupipakwa, Rasayan, Parpati, Potali Rasa, Satwa
(of Metals and Minerals origin) Druti Parpam, Karpu, and Kushta etc.
used in Ayurvedic, Siddha and Unani Systems of medicine.
The supplementary GMP guidelines for Rasaushadhi or Rasamarunthukal
and Kustajat are needed to establish the authenticity of raw drug, minerals
and metals, in-process validation and quality control parameters to ensure
that these formulations are processed and prepared in accordance with
classical texts and for which safety measures are complied. Only those
manufacturing units which have Good Manufacturing Practices for ASU
drugs and supplementary certificate for Rasaushadhies or Rasamarunthukal
and Kustajat formulations shall be allowed to manufacture the
same. Supplementary Good Manufacturing Practices certificate for
Rasaushadhies shall be issued by the State Licensing Authority only
after thorough inspection by an expert team including Rasashstra experts
nominated by the Department of AYUSH.
2. Manufacturing Process Areas.-
For the manufacture of Bhasma and Kupipakawa and Rasaushadhi
preparations made from metals and minerals the following specific areas
shall be provided, which should be completely segregated from the
production area used for preparation of plants and animal byproduct based
formulation to avoid cross contamination. The following exclusive areas
are required for Rasaushadhies or Rasamarunthukal and Kustajat:-
2.2 (a) Bhatti or Heating Devise Section for Bhasma and Rasaushadhies:-
100 Sq. feet for heating, burning, putta and any heat related work
with proper ventilation, exhaust and chimney. This could be tin shed
also.
(b) Grinding, Drying and Processing Section for Bhasma and
Rasaushadhies:- 100 Sq. feet (Manual or Mechanical, oven etc.).
Drying may be done in a space which is covered by glass or other
transparent material to allow entry of sunrays on the material to keep
for the purpose. If drying is being done in oven the temperature of the
same may be selected specific temperature.
(c) Rashaushadi Related Store:- 100 Sq. feet.
The size and dimensions of each Bhatti Section would be so designed
to suit the batch size or quantity of materials to be processed, keeping in
mind the processing is done as per the conditions of Drug and Cosmetics
Act mentioned under Schedule I official books.
In addition to the fuels prescribed in the schedule books namely coal, fire
wood, cow dung cakes etc., use of other heating devices e.g. electrical
heating, oil or gas fired furnaces and others may be employed so as to
provide the required temperature as per the nature of material and object of
heating. Depending on the formulation being manufactured, manufacturers
may adopt aerobic or anaerobic process. Properly baked andclean earthen
pots of other crucibles and glass containers or appropriate design shall be
used.
The manufacturing area should be designed with special attention to
process the products that generate toxic fumes like SO2, arsenic and
mercury vapor, etc. When heating and boiling of the materials is necessary,
suitable ventilation and air exhaust flow mechanism should be provided
to prevent accumulation of unintended fumes and vapors. Such areas may
be provided with properly designed chimneys or ducts fitted with exhaust
system and suitable scrubbing system to remove fumes and smoke, so that
safety of personnel and environment is taken care of.
Since processing of Rasaushadhis may introduce heavy metal contamination
and cross contamination etc., therefore, cleaning of equipment is
particularly important after every process by using appropriate cleaning
agent which should not react with material of equipment and must be free
from unwanted properties e.g. corrosiveness.
2.3 Records shall be maintained specially for temperatures attained
during the entire process of Bhasmikaran, while employing different
kinds of classical puta, furnaces using oil, gas or electricity. Appropriate
temperature measuring instrument should be employed such as pyrometer
and, pyrograph for manual reading or recording by heat sensors, connected
to computer as the case may be.
In order to handle large quantities, appropriate technology like use of
hand operated extruders for makingchakrikas or pellets may be adopted.
However, such equipments made of aluminium or its alloys should not
be used.
Access to manufacturing areas shall be restricted to minimum number of
authorized personal only.
3. Quality Control.-
A. In Process Quality Control:-
The registers as indicated below should exclusively be maintained for
ready reference:-
(a) Shodhan Register with following details:-
1. Sl. No.
2. Batch No. and Size
3. Date, time and duration
4. Name of the Raw-material with Quality reference and quantity
5. Quantity of Shodhana Dravya
6. Book Reference followed
7. Methodology
www.amam-ayurveda.org 3

(b) Bhavana and Putta Register with following details:-
1. Sl. No.
2. Batch No.
3. Date, time
4. Name of the material and quantity of starting materials
5. Quantity of Nirvapya Dravya
6. Quantity of Bhavana Dravya
7. Date and Time of Starting and completion of Bhavana or Mardana
and duration
8. Type and Number of Puttas
9. Time and Date of completion Puttas
10. Colour and texture of the product or standards
11. In process tests followed (Bhasma Pariksha and any other tests)
12. In case heating at a particular temperature is required, record of
attainment of that temperature.
(c) Grinding Record Register:- (Finished Product/Intermediate
procedure)
1. Sl. No.
2. Batch No.
3. Date and time
4. Name of the material and quantity
5. Name of the equipment (SS/granite)
6. Duration of grinding
7. Repeat the grinding if required (Number of repetition)
(d) Packing details:-
1 Name of Rasaushadhi
2 Type of Dosage Form (eg. Powder, pill, tablet etc.)
3 Weight of Rasaushadhi in each unit
B. Product Quality Control:-
The specifications for finished Rasaushadhi are primarily intended to
define the quality rather than to establish full characterization, and should
focus on those characteristics found to be useful in ensuring the quality.
Consistent quality for Rasaushdhi can only be assured if the starting
material-metals and minerals are used of pharmacopoeial standards. In
some cases more detailed information may be needed on aspects of their
process. The manufacture will ensure in-house standards for the uniform
quality of product.
Quality testing will be carried out as per official Pharmacopoeia or Schedule
books for texts namely, colour, taste, varitaratwa, Rekhapurnatwa,
Laghutva, Nirdhumatwa, Dntagre Kachakacha, Niruttha, Apunarbhava
and Nischandratwa.
The Particle size of the product should be tested by adopting microscope
fitted with micrometer or particle size analyzer or any appropriate other
techniques. Required physio-chemical characterization of the product
should be undertaken by appropriate analytical equipment. The Standard
Manufacturing Process of the product should be evolved/follow up. The
disintegration time of pills-vati and tablets should also be recorded.
4. Product recalls.- Literature inserted inside the product package should
indicate the name address of the manufacturing unit or email or telephone
number for reporting of any adverse drug reaction by physicians or
patients. On receipt of such Adverse Drug Reaction report, it will be the
responsibility of the manufacturer to ensure the recall the product from
the market.
Standard operating procedures (SOP) should be included for storage of
recalled Rasaushadhies in a secure segregated area, complying with the
requirements specified for storage, till their final disposal.
5. Medical examination of the employees.- Employees engaged in
manufacturing should be medically examined periodically at least once
a year for any adverse effect of the drug during manufacturing process
for which necessary investigations may be carried out for ensuring that
there is no effect of material on the vital organs of the employees. Annual
examination reports of the employees shall be made available to statutory
inspectors during Good Manufacturing Practices inspections.
6. Self-Inspection.- The release of Rasaushadhis should be under the
control of a person who has been trained in the specific features of the
processing and quality assurance of Rasaushadhis. Personnel dealing with
the production and quality assurance of Rasaushadhis manufacturing section
should have an adequate training in the specific subject of Rasaushadhis
manufacturing. He will be at least a degree holder in Ayuryeda/Siddha/
Unani medicine or B. Pharma degree holder in Ayurveda/ Siddha/Unani
medicine.
Laugh!
It’s the best Medicine
Men and Women on planet earth die from various places throughout the world at a particular moment
in time and go to God’s abode to be judged.
The God welcomes this new batch and tries his experimental new judgement trick and says,” I want all
you humans to form two queues.
One line is for the men who dominated their women, and the other one for the men who were dominated
by their women. Also, I want all the women to go away from here so that no man and woman can talk
and I can talk to men alone.”
When the women were gone, the Almighty returns and there are two lines. The line for the men who
were dominated by their women is a hundred miles long, and in the line of men who dominated their
women there is only one solitary man.
The God about to open his third eye of anger, thunders, “You men should be ashamed of yourselves. I
created you in my image, and you were all whipped by your mates. Look at the only one of my sons who
stood up and made me proud. Learn from him!”
“Come and tell all them henpecked, my brave son, how did you manage to be the only one in this line”
God asked.
The nervous man replies, “I don’t know sir, but my wife told me to stand here, until this is over.”
www.amam-ayurveda.org 4

7. Dosage form of Rasaushadhi.- The Rasaushadhies may be made into
an acceptable dosage forms such as, churna, vati, guti, tablet, capsule or
Capsule etc. after adding suitable permissible fillers or binding agents
as permissible under the Ayurvedic Pharmacopoeia of India or Indian
Pharmacopoeia as updated from time to time. In such cases the label must
indicate the quantity of Ayurveda, Siddha and Unani medicine in one
Tablet or Pill or Capsule in addition to the filler. The crystalline product
may be grinded before packing in the individual dispensing size”. All the
Rasaushadhi or Rasamaruthukal or Kushtajat shall be packed in a dosage
form which is ready for use for the consumer. Grinding and weighting of
individual dose of potentially poisonous products will not be permissible
in patient consumer pack. This arrangement may reduce the Adverse
Drug Reaction of Rasaushadhi which takes place due to dose variation.
However for hospital bulk pack, it will not be applicable and label will
clearly indicate the “Hospital pack”.
8. Area Specifications/requirement for an applicant companies only to have GMP of Rasaushadhies or Rasamarunthukal and Kushtajat
(Herbomineral/metallic compounds) of Ayurveda, Siddha and Unani medicines:-
S.
No.
Category of Medicine / Manugacturing area
Minimum Manufacturing
space required (1500 sq. ft.)
Machinery equipment recommended
1. Pisti/Grinding area for Bhasma, Pishti, Kushtajat. 100 sq. ft. Kharal/Mechanized/motorized Kharal, end runner/ball-Mill Siaves/
Shifter.
2. Powdering area for raw drugs of plants origin giving
in Rasaushadhies (Herbometalio formulations)
200 sq. ft. Grinder/Distintegrator/Pulvarisar/powder mixer/ sieves/Shiftar.
3. Pills/Vati/Gutika Matrica and tablets/Habb making
area
4. Kupi pakva / Ksara/ Parpati/Lavana Bhasma Satva
/ Sindura Karpu / Uppu / Param/ qushta / Jawhar
5. Receiving and storing raw material 200 sq. ft.
6. Quality Control Section 150 sq. ft.
7. Quarantine / Observation 50 sq.ft.
8. Finished goods store 150 sq. ft.
9. Rejected goods store 50 sq. ft.
10. Bhatti-putta area 200 sq. ft.
11. Ara for water and washing etc. 50 sq. ft.
12. Office 100 sq. ft.
Total
1500 sq. ft.
100 sq. ft. Ball Mill Mass Mixer / Powder mixer, Granulator drier, tablet
compressing machine, pill/vati cutting machine, stainless steel trays /
container for storage and sugar coating, polishing pan in case of sugar
coted tablets, mechanized chatoo, (for mixing of guggulu) where
required.
150 sq. ft. Bhatti, Karahi/stainless Steel Vassels/ Patila Flask/ Multani Matti
/ Plaster of Paris, Copper Rod, Earthen container, Gaj Put Bhatti,
Muffle furnace (electrically Operated) End / Edge Runner, Exhaust
Fan, Wooden, S.S. Spatula.
Note: The above requirements of machinery, equipments, space are made subject to the modification at the discretion of the Licensing Authority; if he is of the opinion that having regard to the
nature and extent of the manufacturing operations it is necessary to relax or alter them in the circumstances in a particular case ( he may do so after recording reasons in writing)
An c i e n t Wi s d o m
Hav i n g t au g h t t h e Ve d a s , t h e t e ac h e r s ay s : “Sp e a k t h e t ru t h. Do y o u r d u t y.
Ne g l e c t n o t t h e s c r i p t u r e s. Gi v e y o u r b e s t t o y o u r t e ac h e r. Do n o t c u t o f f t h e
l i n e o f p r o g e n y. Sw e r v e n o t f r o m t h e t ru t h. Sw e r v e n o t f r o m t h e g o o d. Pr o t e c t
y o u r s p i r i t ua l p r o g r e s s a l w a y s . Gi v e y o u r b e s t in l e a r n i n g a n d t e ac h i n g. Ne v e r
fa i l in r e s p e c t t o t h e s a g e s. Se e t h e divine in y o u r m o t h e r, fat h e r , Te ac h e r, a n d
g u e s t. Ne v e r d o w h a t is w r o n g . Ho n o r t h o s e w h o a r e w o r t h y o f h o n o r. Gi v e w i th
fa i t h . Gi v e w i th l o v e . Gi v e w i th j o y . If y o u a r e in d o u b t a b o u t t h e r i g h t c o n d u c t,
f o l l o w t h e e x a m p l e o f t h e s a g e s, w h o k n o w w h a t is b e s t f o r s p i r i t ua l g r o w t h .
Th i s is t h e i n s t ru c t i o n o f t h e Ve d a s ; t h i s is t h e s e c r e t; t h i s is t h e message.
- Taittiriya Upa n i s h a d
www.amam-ayurveda.org 5

Indian cos see red over
laldant manjan patent
ARINDAM
Ayurvedic Body Slams Colgate For patenting Indian Traditional Knowledge
Sagar Malviya & Maulik Vyas
MUMBAI
Lal dant manjan may make many Indian
remember the old Dabur commercial
featuring a schoolbay named Raju and
his Masterji, Bur Lal dant manjan, or red herbal
dentifrice, is now patented in the US by Colgate
Palmolive, and Indian ayurvedic companies have
sought government intervention to cancel it.
The Association of Manufacturers of Ayurvedic
Medicines (AMAM), which represents 200
companies, including Dabur, Himmalaya, Hamdard
and Baidyanath, has accused the American personal
care giant of patenting an Indian traditional
knowledge in the US, India and elsewhere.
It has urged the patent authority, the health ministry
as well as the industrial ministry to take immediate
measures to stop patenting of this traditional product
and “initiate action not only in the US but also in
other countries where Colgate Palmolive might
have applied for the patent”.
Colgate received patent for red herbal dentifrice in
the United States in June this year on the basis of an
application dated 2005, filed in India.
The company did not respond to an email query.
“Colgate has used its clout to obtain patent in the
drawal the US. But the Indian government should
seek with drawal the US patent and cancel the
Indian application too as the product is a traditional
herbal medicine discovered in India, “said Pradeep
Multani, general secretary ot the association.
The controller General of Patents, which grants
patents in India, has yet to decide on Colgate’s
application. “In the US, getting patents is far more
simple compared to India, “said Abhishek Khare,
partner at Khare Legal Chambers.
In India, a patent is granted post-grant objections,”
said Mr Khare.
In fact, the US and the European Union have
conclled patents on tunneric and neem following
opposition form India. In 1995, the US granted a
patent for turmeric to two non-resident Indians
associated with the University of Mississipi Medical
Centre, Jackson, USA. New Delhi based Council
for Agriculture Reserch challenged the patent on
the ground that it lacked novelty and the US Patent
Office up-held the objection and cancelled the
patent.
Similarly, the European Patent Office awarded a
patent for Neem to the United States Department of
Agriculture and chemical multinational WR Grace
in 1995. This parent was withdrawn in 2005 due to
severe opposition from various parties in India.
In its patent application for lal dant manjan,
Colgete included several medicinal plants such as
piper nigrum, piper longum, camphor, tomar seed,
tenninalla chebula, clove, cinnamon, vajradanti
among other herbs in the patent.
Amam has challenged this in its letter to the
Indian health ministry, the Controller General ot
Patents and the Department of Industrial Policy
& Promotion, which is responsible for policies on
intellectual property rights, patents and trademarks.
“Several companies like Dabur and Baidyanath
have been marketing this product since decades in
India, “it said in the letter.
Dabur India, which has been selling Dabur Lal Dant
Manjan since 1970, declined to comment, but some
people close to the company said it is exploring
legal actions against Colgate.
Colgate Palmolive, which controls half the oral
care segment worth Rs. 2,800 crore in India, is
synonymous with toothpaste in India. Of late, it has
been gradually pushing more affordable products
such as toothpowder to penetrate into rural areas
and reach out to a larger sonsumer base.
While the oral care category is growing be around
8-10%, the toothpowder segment worth Rs. 500
crore offers huge potential as rural India, which
houses 70% of Indian population, joins the India
growth Penetration of modern oral care products is
very low and many people in rural India still clean
their teeth and many people in rural India still clean
their teeth with traditional products like twige of the
neem tree, salt, ash and other herbal items.
That’s precisely the opportunity that Colgate seeks
to tap in a market where it still share the top spot
with rival Dabur, both having 30% share in the
hinterland. “If Colgate manages to get the patent,
it will have an added advantage to expand in this
category,” said Anand Raghuraman, partner and
director at Boston Consulting Group.
Courtsey: Economic Times
Dated: 20/10/2010; Wednesday
www.amam-ayurveda.org 6

Dear Members,
Regulatory Update
You must be aware & must have read in the newspapers that M/s. Colgate Palmolive filed an Indian patent application for a tooth cleaning powder (see news
clipping on the previous page). They have patented tooth cleaning powder in the hope that it would take the multibillion dollar Indian oral hygiene market by
storm. We, the Indian manufacturers strongly feel that this claim is bogus because the medicinal plants like clove oil, camphor, tomar seeds, vajradanti, pippali,
kali mirch, haritaki etc. have been used for the dental cleaning & gum hygiene since ages.
We on behalf of AMAM are demanding that the Indian Government should take a legal action. We have requested Department of AYUSH to take immediate steps
to stop patenting of this traditional knowledge and product in India and initiate the opposition not only in US but also in other countries wherever M/s. Colgate
Palmolive might have applied for patent.
Department of AYUSH should take all possible corrective steps in this regard immediately including withdrawal of their patent application.
We are hereby reproducing a copy our representation & request made to the Department of AYUSH.
The Hon’ble Secretary September 10, 2010
Department of AYUSH
Ministry of Health & Family Welfare
Red Cross Building
New Delhi 110 001
Sub.: Patenting of Indian Traditional Knowledge by multinational company viz., ‘Red herbal dentifrice’ by M/s. Colgate
Palmolive
Dear Madame,
We wish to inform you that recently M/s. Colgate Palmolive have been granted a US Patent No. 7,736,629 titled ‘Red Herbal Dentifrice’ on
June 15, 2010 with Mr. Shridhara Kamath, Mumbai and Mr. Ramesh Nair, Pune as Inventors.
As you are aware Red Tooth powder is a household item in the Indian rural masses and is manufactured by several Ayurvedic companies.
The product essentially contains gairic powder and herbal ingredients.
M/s. Colgate Palmolive filed an Indian patent application no. 3081/DEL/2005 on 18th November, 2005 which has been used as priority date
for US patent application. They have included several medicinal plants like Piper nigrum, Piper longum, Camphor, Tomar seed, Terminalia
chebula, Clove, Cinnamon, Vajradanti, etc. in the patent. All these herbs have been traditionally used for their benefits on the gums and
teeth in India and have been documented in Ayurvedic literature.
For your reference we are attaching herewith the photocopies from Ayurvedic text books where the composition, which is subject matter of
the patent, has already been mentioned. Besides several Indian companies like Dabur and Baidyanath have been marketing this product
for decades in India.
We urgently request the Department of AYUSH to please take immediate steps to stop patenting of this traditional knowledge and product
in India and initiate the opposition not only in US but also in other countries wherever M/s. Colgate Palmolive might have applied for
patent.
In addition to that Department of AYUSH may also consider to send strong letter to M/s. Colgate Palmolive to take all possible corrective
steps in this regard immediately including withdrawal of their patent application.
We hope Department of AYUSH would take necessary steps without any delay.
With regards,
PRADEEP MULTANI
HON. GEN. SECRETARY
Encl.: a/a.
CC: The Controller General of Patents
Government of India
Central Building, 101, M. K. Road, Mumbai – 400 020.
CC: The Joint Secretary
Department of Industrial Policy & Promotion
Ministry of Commerce and Industry
Government of India, Udyog Bhavan, New Delhi-110 011
www.amam-ayurveda.org 7

Dear Members,
We have received a letter from Department of AYUSH (National Medicinal Plants Board), Government of India, Ministry of Health & Family Welfare, Chanderlok
Building, 36-Janpath, New Delhi-110 001 on the submission of the record of raw material consumption by licensed manufacturing unit.
The same is reprinted for your information.
COPY OF LETTER
Dated 19th August, 2010
F. No. A. 11019/29/2009-MPB
Government of India
Ministry of Health & Family Welfare
Department of AYUSH
(National Medicinal Plants Board)
To,
1. All Drug Licensing Authorities,
All regulators of ASU Drugs, All States
(As per list enclosed)
2. ASU Associations
(As per list enclosed)
Chanderlok Building
36-Jannpath, New Delhi – 110 001
Fax: 011-23319356, Telefax: 011-23315637
E-mail: info-nmpb22nic.in
Dated: October 13, 2010
Subject:
Record of raw material consumption of the licensed ASU Drug Manufacturers licensed in your States – Reg.
Sir,
It is continuation to earlier communication sent to you vide D.O. letter no. 11019/29/2008-NMPB dated 26th May 2009 from Sh. B.S. Sajwan,
Chief Executive Officer, regarding the subject above.
2. It is however, informed that despite several reminders sent to the licensed manufacturers located in you state, the record of raw material consumption
for the financial year ending March 31st 2009 and now March 31st 2010 has been received from only a very few ASU Drug manufacturers, putting
the department in a very difficult situation.
3. It is once again requested to immediately direct rthe ASU Drug manufacturers to submit their returns for both financial year to the NMPB’s authorized
agency either through courier or via email as below:
NMPB Help Desk
C/o Datamation Consultants Pvt. Ltd.
Plot#3$3 Hasanpur, I.P. Extension, Delhi – 110 092 (India), Email: infonmpb@gmail.com
4. The ASU Drug Manufacturer also has the option to log online through the NMPB website link. We request you to popularize these response mechanisms
actively through various communication channels so that we receive hundred percent response from all registered ASU Drug Manufacturer in
compliance with the law.
5. In this regard, you are again requested to refer notification vide 9th July, 2008, Department of AYUSH, Ministry of Health & Family Welfare, No.
G.S.R. 512 (E). As per para (2) of notification, each licensed manufacturing unit of Ayurveda or Siddha or Unani drug shall keep a record of raw
material used by each licensed manufacturing unit of Ayurveda, siddha or Unani drugs as the case may be in the performa given in Schedule TA in
respect of all raw materials utilized by that unit in the manufacture of Ayurveda or Siddha or Unani drugs in the preceding financial year to the State
Drug Licensing Authority of Ayurveda, Siddha and Unani drugs and to the National Medicinal Plants Board or any agency nominated by the National
Medicinal Plants Board for the purpose.
6. The State Drug Licensing Authorities are requested to direct the ASU (Ayurveda, Siddha and Unani) Drug Manufacturing’s Units to maintain record
of information regarding raw material consumed by them and furnish as per Performa prescribed under said notification. It may be impressed upon
the manufacturing units that one of the conditions for renewal of their manufacturing license is to furnish this information on a yearly basis.
7. All Association of Drug manufacturers of ASU (Ayurveda, Siddha and Unani) drugs are also requested for similar action for required compliance on
the part of manufacturers’. As per the notification, the Information is to be submitted latest by 30th June of the succeeding financial year to the
State Drug Licensing Authorities.
8. The manufacturing units may also be informed that the information furnished by them shall be confidential and will be used only for official
purposes.
It is again requested that necessary action on your part be taken immediately for procurement / providing of information from ASU drug manufacturers
by the prescribed date and forwarded as suggested under para – 3-4 above. In case of failure on the part of manufacturing units to provide required
information under Drugs & Cosmetic Act 1942, it may be considered not to grant them new licenses or extend the existing license to them.
Yours Faithfully
(Parhlad Rai)
Director
Copy to:
1. Datamation Consultants Pvt. Ltd., Plot No. 3 & 4, Hasanpur, I.P. Extension, New Delhi – 110 092 (Fax: 2224 0086)
www.amam-ayurveda.org 8

Industry Event - QCI Seminar
In continuation to our efforts to keep you apprised of the developments in and around the AYUSH Industry, we are once again sharing the ways to get the quality
mark certification for your Ayush products from yet another certifying body named BVCI.
To help make available common Ayush Products in the market with a quality seal AYUSH Dept., Ministry of Health , Govt. of India in collaboration with Quality Council
of India, has launched Certification Scheme for AYUSH Products .
In a Seminar organized by AMAM, a couple of months ago, Mr. Sarbjeet Mukherjee of BVCI made a crisp presentation about the certification process from their own
perspective. His presentation has enumerated respective organizational strengths and also provided an insight into the cost structure for certification.
Considering its importance for our fellow members we are reproducing the presentation made by him during the seminar to refresh our knowledge.
For further queries you may contact:
Mr. Sarbajeet Mukherjee
General Manager – India North Region, Bureau Veritas, H-85, Sector 63, Noida 201307, U.P. India.
Office:+91 120 450 7600 Fax: +91 120 450 7650, Direct:+91 120 450 7602 Mobile:+91 9818794077
Mail: samukherjee@in.bureauveritas.com Internet: www.bureauveritas.co.in
Bureau Veritas Certification
WHY BUREAU VERITAS CERTIFICATION
1
Sarbajeet Mukherjee
1.
2.
3.
4.
5.
6.
7.
8.
The Bureau Veritas Certification Brand
Accreditations
Our Learning Culture
Locations
Auditor Base
Quality Of Our Auditors
International Certification Centre
Qci’s (Quality Council Of India) Grading
2
The Bureau Veritas Certification Brand
Bureau Veritas Certification’s brand is very strong worldwide
• We are world leaders with 12% of the worldwide market share and
over 1,00,000 certifications.
• In India we have over 5000 certifications and the ‘who’s who’ of
Indian industry is certified by Bureau Veritas Certification.
• In fact of the top 50 ‘value-creation’ companies in India (in terms
of market capitalization) 34 have been certified by Bureau Veritas
Certification.
• While it is difficult to estimate market share in India we have
about 14% market share in India in terms of no. of certifications.
However this is often a misnomer and what is more reliable
indicator is the number of ‘person-days’ of audit delivered.
• We deliver about 23,000 person-days of audits annually
3
Bureau Veritas Certification’s Accreditations
Amongst all the Certification Bodies, Bureau Veritas Certification has
the largest number of accreditations worldwide.
• We have as much as 35 accreditations. This is an indication of
our strong capabilities and commitment to the certification
process.
• We submit that this is the single most important indication in
judging the quality of a certification body.
4
•
Bureau Veritas Certification’s ‘Learning
Culture’
Value-adding audits:
Bureau Veritas Certification have an inbred culture of stimulating
the intellect and that is why when we say that our audits are ‘valueadding’,
it is not just a cliché, but also something that can be felt
and experienced.
Bureau Veritas Certification’s Locations
In India we have offices in 39 locations.
• These offices are in all the large metros and in most of the State
capitals. Thus we are in a position to provide local auditors in most
locations.
• This not only leads to lesser traveling cost but also makes it
convenient for our customers, in getting service.
• All our reporting is done on electronic media and this makes our
operations more efficient and speedy.
5 6
www.amam-ayurveda.org 9

Bureau Veritas Certification’s auditor Base
We have 120 auditors on our rolls.
• This is the largest number that any Certification Body
has in India.
• As a result we carry out most of our audits through our
own auditors..
• While we also employ outsourced auditors, our
Exclusive auditors perform 90% of our audits. We
submit that using our own auditors leads to much better
control and improves the quality of the certification
process
7
Quality Of Our Auditors
• Most of India’s best and respected organizations have
been certified by Bureau Veritas Certification.This
puts Bureau Veritas Certification India Pvt Ltd in a
leadership role, and as the leading brand it enables us
to attract the best talent from the industry. Conversely
because we are the strongest brand, the best talent is
also attracted to Bureau Veritas Certification. Since
certification is an intellectual activity, the quality of our
auditors gives us the cutting edge over competition.
8
International Certification Centre
Bureau Veritas Certification in India is an International
Certification Centre serving 39 countries in the Bureau
Veritas group.
• This means that we can independently review files and
take independent decisions in granting certifications
against ISO 9001/ ISO 14001/ ISO22001/ ISO 27001
under UKAS/ANAB/NABCB.
• To you as a a customer this means faster issuance of
certificates and also a recognition of our technical
capabilities and competence(s) and Integrity..
9
Food Safety Audits In India
• We are one of the three accredited certification bodies
for FSMS(Food Safety Management Systems) – ISO
22000 by NABCB(National Accredited Body for
Certification Bodies)
• We have done audits for Coca Cola for their Quality
Management Systems(QMS) & also TCCMS(The Coca
Cola Management Systems) and also Environmental
management Systems(EMS)
• We have done QMS & FSMS Audits for Pepsi in
India
• Our Auditors have also done audits for Nestle Water
America in US for the Nestle Standard as also FSMS
(ISO 22000) Standards
10
Audits By Bureau Veritas In Food Safety
• We have been working with Wall Mart in the entire globe
offering audits for their Health Safety,Environment and food
related standards and in the process of doing the same in India
• We have worked with Carrefour in Malaysia & Singapore
providing inspection, testing, external audits, GMP(Good
Management Practices) & FSMS training and audits.
• We are in the process of tying up with the Hotel Trade unions
for launching a supplier food safety scheme for their suppliers
for better results in the Food Safety Management System in
the hotels.
• We have certification schemes in India certifying for ISO
22000, HACCP, FAMI-QS, BRC, IFS & training for FSMS as
a host of certified products for whom we have local resources
available.
11
Quality Council Of India’s (Qci) Gradingleading
Certification Body (Cb) In India
Since the last two years Quality Council of India (QCI) conducts
a independent survey to decide which is the finest CB in India.
• In the last two years QCI have graded Bureau Veritas
Certification as the finest Certification Body in India. Next
two slides present results of First survey. Please note that
Bureau Veritas Certification India P Ltd was then known as
“BVQI India). The name was changed subsequently on 20th
September 2006 to Bureau Veritas Certification India Pvt
Ltd. We draw your attention to the scores on a scale of Five.
We are toppers in both the categories.
• In a subsequent survey conducted by QCI in 2007, we have
retained our top position.
12
Ayush Certification
• Certification Process
• Audit Type
• Determination of Evaluation Time
• Cost Structure
Certification Process
• Send Application to interested clients
• Give commercial Proposal
• Perform Stage 1/ Stage 2 audits
• Certificate Decision
• Issue certificate to client
• Perform surveillance at six monthly intervals (5 Nos)
• Do Recertification
13 14
10

Organization
Send AYUSH Application
Area Office
Receive & Review
Complete Application Form
Area Office
Audit type
The Ayush Certification is awarded at two levels
Ayush Standard Mark
• Single Stage audit (stage 1) and surveillance audits
Ayush Premium Mark
• Two stage audit (stage 1 & Stage 2) and surveillance audits
Send back
to team
leader for
Modification
No
Applicagtion
Form Complete with
all information
requested.
Review of
Application for
Completeness
Yes
Yes
Yes
Forward Application to
Mumbai Office
Area Office
Perform Contract Review And Send it
to area office for making proposal
Mumbai Office
Issue proposal to Client as per Contract Review
Area Office
Receive contract & Schedule 1st stage / stage 2 on site audit
Stage 2 not applicable
for standard Product
Area Office
1st Stage
Audit Satisfactory
OK
Schedule 2nd Stage Audit
Area Office
No
Follow up
Audit onsite
Prepare & review Audit Report & Forward to POV
Team Leader
Review and Power
of Veto Check
POV /
Mumbai Office
To be POV
Check by
Technical
Manager in
case POV is
part of team.
No
Reject
Determination of evaluation time
Evaluation time, is based on
• The complexity of operations,
• The number of employees
• The number of products offered for certification
Cost Structure
• Example 1
• Manpower strength- 50 persons
• Type of Certification- Ayush Standard Mark
• No of Product to be certified- 2
COST DETAILS (for 3 year Period)
Registration Cost
NIL
Stage 1 audit Rs 42000
Cost of Issuing Certificate Rs 20000
Each Surveillance Audit Rs 42000 (There will be 5
surveillance )
Cost of Testing Samples Charged at Actual
Traveling & Living Cost Charged at Actual
Service Tax
Charged at Actual
Cost Structure
Example 1
Manpower strength- 50 persons
Type of Certification- Ayush Premium Mark
No of Product to be certified- 2
16
17
COST DETAILS (for 3 year Period)
Registration Cost
NIL
Stage 1 audit Rs 12000
Stage 2 Audit Rs 42000
Cost of Issuing Certificate Rs 20000
Each Surveillance Audit Rs 42000 (There will be 5 surveillance )
Cost of Testing Samples Charged at Actual
Traveling & Living Cost Charged at Actual
Service Tax
Charged at Actual
18
NO
Satisfactory
YES
Notify Mumbai Office for Authorisation &
Issue of Certificate
POV
Final Authorisation & Issue of Certificate to Client
TM/DTM/ATM Mumbai Office
POV - Power of Veto authorized person after adequate training on the subject
TM - Technical Manager
DTM - Deputy Technical Manager
ATM - Assistant Technical Manager
15
www.amam-ayurveda.org 11
19

Pharmocopial Standards For Ayurvedic Formulations
and Raw Material
Vasavleha (AFI, Part I, 3:26)
okldLojlizLFks flrke”ViyksfUerke~A
lfiZ”kks f}iya nÙok fiIiyhf}iya rFkkAA82AA
ipsYysgRoek;krs ‘khrs e/kq iyk”Vde~A
nÙokorkj;s}S|ks ek=;k ysg mÙke%AA83AA
fugfUr jkt;{ek.ka dkla Üokla lqnk:.ke~A
ikÜoZ’kwy´p âPNwya jäfiÙkToja rFkk AA84AA
¼HkS’kT;jRukoyh] jkt;{ekf/kdkj( 82&84½
1. Vass Svarasa (Vasa) (Lf.) 768 g
2. Sita 384 g
3. Sarpi (Goghrita) 96 g
4. Pippali (Fr.) 96 g
5. Madhu 384 g
Dose: 6 to 12 g
Anupana: Milk, Water
Important Therapeutic Uses:
Kasa (Cough), Shvasa (Dyspnoea/Asthma), Jvara (Fever), Raktapitta
(Bleeding disorder), Rajayakshma (Tuberculosis), Parshava shula
(Intercostal neuralgia and pleurodynia), Hritshula (Angina pectoris)
Main Ingredients of Vasavleha
VASA (Leaf)
SYNONYMS
Sanskrit : Vrisha, Atarusha, Vasaka
Assamese : Titabahak, Bahak, Vachaka
Bengali : Baksa, Vasaka
English : Vasaka
Gujrati : Aduso, Ardusi, Adulso
Hindi : Aduss, Arusa
Kannada : Adsale, Adusoge, Atarusha, Adsole, Adasale
Kashmiri : Vasa
Malayalam : Attalatakam, Atalotakam
Marathi : Vasa, Adulsa
Oriya : Basanga
Punjabi : Bhekar, Vansa, Arusa
Tamil : Vasambu, Adathodai
Telugu : Addasaramu
Urdu : Adusa, Basa
DESCRIPTION
a) Macroscopic
Leaves, 10-30 cm long and 3-10 cm broad, lanceolate to ovate-lanceolate,
slightly acuminate, base tapering, petiolate, petioles 2-8 cm long,
exstipulite, glabrescent, 8-10 pairs of lateral vein bearing few hairs, dried
leaves dull brown above, light greyish brown below, odour, characteristic,
taste, bitter.
b) Microscopic
Transverse section of leaf shows, dorsiventral surface with 2 layers of
palisade cells, in surface view, epidermal cells sinuous with anomocytic
stomata on both surfaces,
more numerous on the lower, clothing trichomes few, 1-3, rarely upto 5
celled, thinwalled, uniseriate, upto 500 μ and glandular trichomes with
nicellular stalk and 4 celled head measuring, 25-36 μ in diameter in
surface view, cystoliths in mesophyll layers, elongated and cigar shaped,
acicular and prismatic forms of calcium oxalate crystals present in
mesophyll , palisade ratio, 5-6, 5-8.5, stomatal index, 10.8-14.2-18.1 for
lower surface.
IDENTITY, PURITY AND STRENGTH
Foreign matter: Not more than 2 per cent,
Total Ash: Not more than 21 per cent,
Acid-insoluble ash: Not more than 1 per cent,
Alcohol-soluble extractive: Not less than 3 per cent,
Water-soluble extractive: Not less than 22 per cent,
CONSTITUENTS - Alkaloids and essential oil
Vasa consists of fresh, dried, mature leaves of Adhatoda vasica Nees
(Fam. Acanthaceae), a sub-herbaceous bush, found throughout the year in
plains and sub- Himalayan tracts in India, ascending upto 1200m, flowers
during February-March and also at the end of rainy season, leaves stripped
off from older stems and dried in drying sheds.
PROPERTIES AND ACTION
Rasa: Tikta, Kashaya
Guna: Laghu
Veerya: Shita
Vipaka: Katu
Karma: Kaphapittahara, Raktasamgrahika, Kasaghna, Hridya
IMPORTANT FORMULATIONS –
Vasakasava, Vasavaleha
www.amam-ayurveda.org 12

THERAPEUTIC USES –
Kasa, Shwasa, Kshaya, Raktapitta, Prameha, Kamala, Kushta
DOSE - 10-20 ml of the juice of fresh leaves /par10-20 g of the dried drug
for decoction.
PIPPALI (Fruit)
cells and colourless, inner layer composed of tangentially elongated cells,
having reddish-brown content; most of endocarp filled with starch grains,
round to oval measuring 3 to 8 μ in dia.
Powder - Deep moss green, shows fragments of parenchyma, oval
to elongated stone cells, oil globules and round to oval, starch grains,
measuring 3 to 8 μ in dia.
IDENTITY, PURITY AND STRENGTH
Foreign matter: Not more than 2 per cent,
Total Ash: Not more than 7 per cent,
Acid-insoluble ash: Not more than 0.5 per cent,
Alcohol-soluble extractive: Not less than 5 per cent,
Water-soluble extractive: Not less than 7 per cent,
T.L.C.
T. L. C. of alcoholic extract of the drug on Silica gel ‘G’ plate using
Toluene: Ethylacetate (90: 10) as mobile phase. Under U.V. (366 nm) six
fluorescent zones are visible at Rf. 0.15, 0.26, 0.34, 0.39, 0.50 and 0.80. On
exposure to Iodine vapour seven spots appear at Rf. 0.04, 0.15, 0.26, 0.34,
0.39, 0.50 and 0.93 (all yellow). On spraying with Vanillin-Sulphuric acid
reagent and heating the plate at 105°C for ten minutes five spots appear at
Rf. 0.04, 0.22, 0.35, 0.43 and 0.82. On spraying with Dragendorff reagent
three spots appear at Rf. 0.15, 0.26 and 0.34 (all orange).
Pippali consists of the dried, immature, catkin-like fruits with bracts of
Piper longum Linn. (Fam. Piperaceae), a slender, aromatic climber with
perennial woody roots, occurring in hotter parts of India from central
Himalayas to Assam upto lower hills of West Bengal and ever green
forests of Western ghats as wild, and also cultivated in North East and
many parts of the South..
SYNONYMS
Sanskrit : Kana, Magadhi, Magadha, Krishna, Saundi
Assamese : Pippali
Bengali : Pipul
English : Long Pepper
Gujrati : Lindi Peeper, Pipali
Hindi :
Pipar
Kannada : Hippali
Kashmiri : --
Malayalam : Pippali
Marathi : Pimpali, Lendi Pimpali
Oriya :
Pipali, Pippali
Punjabi : Magh, Magh Pipali
Tamil :
Arisi Tippali, Thippili
Telugu :
Pippalu
Urdu :
Filfil Daraz
CONSTITUENTS - Essential Oil and Alkaloids
PROPERTIES AND ACTION
Rasa : Katu, Tikta, Madhura
Guna : Snigdha, Laghu
Veerya : Anushna
Vipaka : Madhura
Karma : Vatahara, Kaphahara, Deepana, Rucya, Rasayana, Hridya,
Vrishya, Tridoshahara, Recana
IMPORTANT FORMULATIONS –
Gudapippali, Amritarishta, Ayaskriti, Ashvagandhadyarishta,
Kumaryasava, Candanasava, Chyavanapr¡asha Avaleha,Shiva Gutika,
Kaishora Guggulu
THERAPEUTIC USES –
Shwasa, Kasa, Pliha Roga, Gulma, Jvara, Prameha, Arsha, Kshaya, Udara
Roga, Hikka, Trishna, Krimi, Kushta, Sula, Amavata, Amadosha
DOSE - 1-3 gm
SARKARA (Sugar)
DESCRIPTION
a) Macroscopic
Fruit greenish-black to black, cylindrical, 2.5 to 5 cm long and 0.4 to 1
cm thick,
consisting of minute sessile fruits, arranged around an axis; surface rough
and composite;
broken surface shows a central axis and 6 to 12 fruitlets arranged around an
axis; taste, pungent producing numbness on the tongue; odour, aromatic.
b) Microscopic
Catkin shows 6 to 12 fruits, arranged in circle on a central axis, each having
an outer epidermal layer of irregular cells filled with deep brown content
and covered externally with a thick cuticle; mesocarp consists of larger
cells, usually collapsed, irregular in shape and thin-walled; a number of
stone cells in singles or in groups present; endocarp and seed coat fused
to form a deep zone, outer layer of this zone composed of thin-walled
Sharkara is a powder prepared from sugar cane juice by open pan
process.
SYNONYMS – Matsynidika, Sita, Sikata, Sitopala, Sukla, Subhra
www.amam-ayurveda.org 13

REGIONAL LANGUAGE NAMES:
Ass:
Chini
Ben:
Chini
Eng:
Sugar
Guj:
Shakkar
Hin:
Chini
Kan:
Sakkare
Mal.:
Panchasara
MAR.:
Sakhara
Ori:
Chini
Pun:
Chini
Tam:
Sarkkarai
Tel:
Panchadhara, Chekkera
Urd.:
Sakkara
DESCRIPTION
A brown to yellowish powder with sweet taste. When a representative
sample is spread in a thin layer, it should be free from dirt, filth, iron
filings and similar foreign matter.
IDENTITIY PURITY STRENGTH
Moisture content: Not more than 1.5 per cent by wt.
Acid –Insoluble Ash: Not more than 0.7 per cent by wt.
Sucrose:
Not more than 93 per cent by wt.
Sulphur dioxide: Absent
Calcium Oxide: Not more than 100 (mg/100g)
Heavy Metal: Complies with API
Microbial Limit: Complies with API
Pesticide residue: Complies with API
Storage:
Should be stored in air tight container
PROPERTIES AND ACTION
Rasa:
Madhura
Guna:
Snigdha
Virya:
Shita
Vipaka;
Madhura
Karma:
Chakshushya, Dhatuvardhaka,
Hridya, Pittahara, Vatahara, Vishya
IMPORTANT FORMULATIONS
Chyawanprasha, Vasavleha, Kankaryavleha
THERAPEUTIC USES:
Arsha (Piles), Aruchi (tastelessness), Bhrama (Vertigo), Chardi (emesis),
Daha (burning sensation), Daurbalya (weakness), Jvara (fever),
Krimi (helminthiasis/worm infestation), Kshata (wound), Madataya
(alcoholism), Moha (delusion), Murccha (syncope), Raktapitta (bleeding
disorder) Raktasruti (hemorrhage), Raktavikara ( disorders of blood),
Shrama (fatigue/lethargy), Trishna (Thirst), Vatarakta (Gout), Visavikara
( disorder due to poison)
DOSE: 5 to 30 g
GOGHRITA
Goghrita consists of clarified butter derived from cow’s milk to which no
coloring matter or preservative is added and contains not less than 76.0
per cent of milk fat by weight.
SYNONYMS: Aajya, Havishya, Sarpi, Ghrita
REGIONAL LANGUAGE NAMES:
Ass:
Ghee
Ben:
Gava ghee, Gava ghrita
Eng:
Clarified butter
Guj:
Ghee
Hin:
Gaya Ghee
Kan.:
Tuppa
Mal.:
Pasu Ney, Pasu nei
Mar:
Toop
Ori.:
Gai Ghia
Pun.:
Ghee
Tam.:
Nei
Tel.:
Neyyi, Nei
Urd.:
Gaya ka ghee
DESCRIPTION:
Goghrita is an oily liquid or a semi solid with granular texture: at room
temperature, colur white to yellow, odour rich and characteristic, taste
pleasant, It is required to be free from animal fats, wax, mineral oil,
vegetable oils and fats.
IDENTITY PURITY STRENGTH
Specific gravity at 25 deg.: 1.01995
Reichert Meissel Value: 24-28
Moisture: Not more than 0.5 per cent
Saponification value: Not more than 225
Iodine value: Not more than35
Unsaponifiable matter: Not more than1.5 PER CENT
Carotene: Not less than 2000 IU
Microbial limits – Complies with API
Heavy Metals - Complies with API
PROPERTIES AND ACTION:
Rasa: Madhura
Guna: Guru, Snigdha, Mridu
Virya: Shita
Vipaka: Madhura
Karma: Agnidipan, Anabhisyandi, Ayushya, Balya, Chaksushya,
Dipana, Hridya, Kantiprada, Medya, Ojaovardhak, Rasayana,
Ruchya, Sleshmavardhana, Snehana, Sukravardhaka,
Tejobalakara, Tvachya, Vatapittaprashmana, Vayasthapana,
Vishahara, Vishya
IMPORTANT FORMULATIONS
Brahmi ghrita, Triphala ghrita, Ashoka ghrita, Eladi ghrita, Changeri
ghrita, Amrita ghrita
THERAPEUTIC USES:
Agnidagdha (fire burns), Amlapitta (Hyperacidity), Apasmara (Epilepsy),
Aruchi (tastelessness), Grahni (malabsorption syndrome), Jirnajwara
(chronic fever), Karna shula ( otalgia), Kshatksheena (debility due to chest
injury), Mada (intoxication), Murccha (syncope), Sirashula (headache),
Smritinasha (loss of memory), Sosha (cachexia), Unmada ( mania/
psychosis), Vishamjvara (intermittent fever), Visarpa (Erysipelas), Visha
vikara (disorder due to poison), Yonisula (pain in female genital tract)
Dose: 5 to 20 ml
www.amam-ayurveda.org 14

Pharmocopial Standards For Vasavleha
Vasavleha
(AFI, Part-I; 3:26)
Definition:
Vasavleha is a semisolid avaleha preparation made with the ingredients in
the Formulation composition given below.
Formulation composition:
1. Vasaka (Vasa API) svarasa Adhatoda vasica Lf. (Fresh) 768 g
2. Sita (Sarkara API) Sugar candy 384 g
3. Sarpi (Goghrita API) Clarified butter from cow’s milk 96 g
4. Pippali API Piper longum Fr. 96 g
5. Madhu API Honey 384 g
Method of preparation:
Take all ingredients of pharmacopoeial quality.
Take fresh leaves of Vasa, wash with water. Chop the leaves to about 2.5
cm, grind into a paste and prepare vasa svarasa through puta paka vidhi.
Clean, dry, grind Pippali into fine powder and pass through sieve no. 85.
Add powdered Sharkara to Vasa svarasa, heat mildly and filter through
muslin cloth, after complete dissolution of Śarkara. Stir continuously
while heating on mild fire.
Concentrate the above mixture by continuous stirring on low fire.
Add Gh¨ta and Pippalī to the above mixture and mix well. Continue
heating till the preparation reaches the required consistency confirmed by
the formation of a soft ball that does not disperse in water and cool to
room temperature. Add honey and again mix well by continuous agitation
with stirrer to make a homogeneous mixture.
Pack it in tightly closed containers to protect from light and moisture.
Description:
Dark brown coloured, semi solid, malleable, sticky preparation with odour
of ghee; taste bitter and pungent.
Identification:
Microscopy:
Take about 5 g of sample dissolve in sufficient quantity of n-hexane for
removal of ghee.
Repeat the procedure with two further increments of solvent pouring
out solvent each time, wash the sediment with warm water, followed by
cold water repeatedly till a clear sediment is obtained. Take a few mg of
the sediment, mount in 50 per cent glycerine and observe the following
characters. Simple starch grains with concentric hilum, abundant polygonal
perisperm cells packed with starch grains (Pippalī); multicellular,
uniseriate, warty covering trichomes, sessile glandular trichomes with
quadricellular head, fragments of lower epidermis showing the presence
of diacytic stomata, cigar-shaped crystoliths (Vasa).
Thin layer chromatography:
Extract 5 g of avaleha with 100 ml of methanol under reflux on a waterbath
for 30 min.
Filter, concentrate to 25 ml and carry out the thin layer chromatography.
Apply 10 μl of the extract on TLC plate and develop the plate to a distance
of 8 cm using ethyl acetate : methanol : ammonia (8 : 2 : 0.2) as mobile
phase. After development, allow the plate to dry in air and examine under
ultraviolet light. It shows major spots at Rf 0.34 (vasicine), 0.74, 0.96
(piperine) under ultraviolet light (254 nm) and at Rf 0.77 (fluorescent
blue), 0.89 (blue), 0.96 (fluorescent blue – piperine) under ultraviolet light
(366 nm). Derivatise the plate with modified Dragendorff’s reagent and
observe under visible light. It shows two orange coloured spots at Rf 0.34
and 0.96.
Physico-chemical parameters:
Loss on drying: Not more than 12.16 per cent,
Total Ash: Not more than 2.5 per cent,
Acid-insoluble ash: Not more than 0.15 per cent,
Alcohol-soluble extractive: Not less than 20 per cent,
Water-soluble extractive: Not less than 60 per cent,
Total sugar: 83 to 88 per cent,
Reducing sugars: 44 to 45 per cent,
Non-reducing sugars: 38 to 43 per cent,
pH (10% aqueous solution): 4.35 to 4.9,
The formulation contains not less than 0.2 per cent of vasicine and not less
than 0.2 per cent of piperine when assayed by the following methods.
Estimation of vasicine:
Dissolve 2 mg of vasicine in 25 ml of methanol in a volumetric flask.
From this stock solution pipette out aliquots of 2 to 6 ml and make up
the volume to 5 ml in volumetric flasks with methanol. Apply 10 ml of
each standard solution (corresponding to 320 to 960 ng of vasicine) on
TLC plate. Develop the plate to a distance of 8 cm using ethyl acetate:
methanol: ammonia (8 : 2 : 0.2) as mobile phase.
After development, dry the plate and scan in TLC scanner at a wavelength
of 298 nm.
Note the peak area under the curve for a peak corresponding to vasicine
and prepare the calibration curve by plotting peak area vs amount of
vasicine.
Extract accurately weighed about 5 g of Vasavaleha in methanol (25 ml
x 5). Filter the extract, pool, concentrate and adjust the volume to 25 ml.
Apply 10 ml of test solution on TLC plate and develop, dry and scan the
plate as described in the preceeding paragraph for calibration curve of
vasicine. Calculate the amount of vasicine in the test solution from the
calibration curve of vasicine.
Estimation of piperine:
Dissolve 5 mg of piperine in 100 ml of methanol. From this stock
solution, pipette out 0.8 to 4.8 ml aliquots into 10 ml volumetric flasks
and make up the volume with methanol to prepare standard solutions of
4 to 24 μg / ml. Apply 10 ml of each standard solution (corresponding
to 40 to 240 ng) on TLC plate and develop the plate to a distance of 8
cm using dichloromethane: ethyl acetate (7.5: 1) as mobile phase. After
development, dry the plate and scan in TLC scanner at a wavelength of
337 nm. Note the peak area under the curve for a peak corresponding to
piperine and prepare the calibration curve by plotting peak area vs amount
of piperine.
Extract accurately weighed about 5 g of Vasavaleha with ethyl acetate (25
ml x 5). Filter the extract, pool, concentrate and adjust the volume to 25
ml in a volumetric flask. Apply 10 ml of test solution on TLC plate and
develop, dry and scan the plate as described in the preceding paragraph for
calibration curve of piperine. Calculate the amount of piperine in the test
solution from the calibration curve of piperine.
Other requirements:
Microbial limits: With in specified limits
Aflatoxins: With in specified limits
Storage: Store in a cool place in tightly closed containers, protected from
light and moisture.
Therapeutic uses: Kasa (cough); Shvasa (Dyspnoea); Jvara (Fever);
Raktapitta (Bleeding disorders); Rajayakshma (Tuberculosis);
Parshvashula (intercostal neuralgia and pleurodynia); Hritshula (Angina
pectoris).
Dose: 12 g daily in divided doses.
Anupana: Milk, Water.
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