Volume. 1, July - September, 2012 - amam-ayurveda.org

Ayurveda was seized of the problem of quackery 

thousands of years ago. Many Ayurvedic texts 

had explicitly laid down the code of conduct to be 

followed by the physicians. 

Ayurvedic texts have classified physicians into 

three umbrella-like categories: Chhadmachara 

(quack), Sidhsadhita (imposter) and Pranabhisara 

(Really qualified, and savior of life). 

In ancient India, systematic study to gain knowledge 

of various aspects of disease and its treatment was the cardinal qualification 

for the physicians to-be. 

Mahrishi Charaka” narrates that a Vaidya or an ayurvedic physician must 

have four basic qualities - excellence in medical knowledge, extensive 

practical experience, dexterity and purity of body and mind. Condemning 

quackery, he opined that it is better to die than to be treated by a physician 

ignorant of the science of medicine. 

It is shocking that such a great system of medicine is today swarming with 

quacks. Whereas the western world is busy unraveling and following the 

teachings of Ayurveda. 

India has now moved forwards in advocating global usefulness of 

Ayurveda as a contemporary scenario of health care through global net 

works. 

Many foreign countries have began looking to India for understanding 

Ayurveda and incorporating it through education, research and practice to 

meet the overwhelming desire of consumers to access Complementary & 

Alternative Medicine. 

Indian Missions in U.S.A., U.K., Russia, Germany, Hungary, and South 

Africa have played an effective role in channeling the information of 

Ayurveda and opening up new opportunities for the spread of Indian 

Medicine in to foreign institutions. 

On the one hand the general public awareness is building about 

Ayurveda both in India and abroad where more and more people want 

to adopt Ayurveda. On the other hand our qualified ayurvedic doctors are 

prescribing modern medicines in their clinics and nursing homes. 

Recently, Allahabad high court ordered to conduct raids in such nursing 

homes/clinics to prohibit those persons from practicing modern system of 

medicine in their state. I appeal to all my ISM practitioners to take a pledge 

to practice a system of medicine for which we are institutionally qualified 

and are registered for. 

Let the world know us by the Pranabhisara Vaidya . 

Best Wishes!! 

Vaidya Devender Triguna 

Honored with Padma Shri and Padma Bhushan 

Volume 2, No.1, July to September’ 2012 

Contents Page 

From the Editor’s desk 2 

• Editorial Board 

• Executive Committee 

Regulatory Update 3 

• Comments on draft Notification 

• Draft Label Of Mahasudarshan 

Churna: existing & revised 

News Update 5 

• Action on ISM doctors practising 

modern medicine 

• Ayush Dept. moots setting up of 

electronic mandi for medicinal plants 

• Kerala DC raids 3 Ayurveda 

companies for violating DMR act. 

Pharamocopial Standards 8 

• Kaishora Guggulu 

• Vidanga (Fruit) 

• Danti (Root) 

Clinical Study Report 12 

• An Open Clinical Study In Menstrual 

Irregularities

From the Editor’s desk 

Dear Members, 

We wish to draw the attention of our readers to two recent developments. 

One is regarding the new labeling requirements sought by the Department 

of Ayush on ASU drugs and another is related to a news item regarding raids 

on three Ayurvedic companies in Kerala for violating Drugs and Magic 

Remedies Act. 

Recently, department of Ayush issued draft of gazette notification on 

revising labelling guidelines as per Rule 161 of D&C Act and Rules.The 

department has sought to provide the additional details to be mentioned 

on the labels of ISM medicines covering Patent or Proprietary Ayurveda, 

Siddha and Unani (ASU) medicines. 

As per the draft notification, the label would need to list all the ingredients 

with it’s official and botanical names of herbal ingredients along with parts 

used and the form of ingredient, in which, it is used in the formulation along 

with its quantity. 

We at AMAM have taken a serious objection to this move and made a 

representation on behalf of our association. 

Even if the manufacturers implement the same it may become impractical 

since the space on the label is just sufficient to comply with the current 

requirement of Rule 161 of the Drugs & Cosmetics Rules. 

While we appreciate the intent of the government to make the consumers 

more informed, there is a serious practical issue to include these details 

which the Department of Ayush needs to consider. 

As we all know, that most of the formulations in the Ayurveda texts are 

multi-ingredient. Even the Ayurvedic Formulary of India has provided that 

Analysis of Ayurvedic Formulations covered in Active Pharmaceutical 

Ingredient (API) Vol. I & II covering solids, semi solids and liquids has 

detailed the percentage of product containing up to 10 and above 20 

ingredients. 

Classical ayurvedic formulations have limited no. of manufacturers. The 

Ayurvedic industry is apprehensive on the amendment which is currently 

circulated as draft notification to seek comments. 

We are of the opinion that the move to add extra information on the label 

would become counterproductive and may not serve the purpose. 

It is possible that this move is aimed to satisfy consumers’ needs and right 

to information. Providing additional information on the label may cause 

logistical problems. Creative solutions are needed to handle this issue. A 

viable move would be to make it mandatory for manufacturers to provide all 

details on their websites and mention name of their website on the label. 

We are reproducing our letter of representation and a copy of label as an 

example else where in this news letter for your perusal and comments. 

Our second concern is about the violation of the Drugs and Magic Remedies 

Act by manufacturers of ASU drugs. 

We appeal to all our fellow members to desist from violating the DMR act 

at all costs. 

We understand making tall claims may generate some revenue but at the 

same time we do not appreciate violation of any law of the land for doing 

product promotions or giving misleading advertisements. 

Though these raids have happened in Kerala, we urge our members to look 

for local regional newspapers, especially on weekends which are flooded 

with similar tall claims made by various manufacturers. These types of tall 

claims not only violate DMR act but also bring bad name to entire ancient 

system of medicine. 

Since our sector is very small, we should not do anything which may lead 

to questions on authenticity of this age old science. Let us all work together 

for the promotion of Ayurved, Sidha and Unani system of medicines in an 

ethical way. 

Dr. Manju Rakesh 

On behalf of full editorial board 

Info Ayurveda, Volume 2, No.1, July to September’ 2012 

Members of AMAM’S 

Management Committee 

Patron 

Vaidya Brahaspati Dev Triguna 

Suresh Sharma 

Pradip Burman 

Jt. Secretary 

Ajay Sharma 

Shri Baidyanath Ayurved Bhawan, 

New Delhi 

E-mail: ajdelhi@msn.com 

President 

Arun Chauhan 

Vaidya Devender Triguna 

Tel: 011-24354141 

BACFO Pharmaceuticals (India) Ltd. 

E-mail: chauhanarun@akcgroup.com 

Dr. N.B. Brindavanam 

Vice President 

Anurag Sharma 

Shri Baidyanath Ayurved Bhawan 

Ltd., (Jhansi) 

E-mail: anurag@baidyanathayurved.com 

Dabur India Limited 

E-mail: baba@dabur.com 

M. J. Saxena 

Sanat Laboratories Ltd. 

E-mail: mjsaxena@sanatproducts.co.in 

Asad Mueed 

Hamdard (WAKF) Laboratories Members 

E-mail: amueed@hamdardindia.com Vijay Grover 

Devendra Garg 


Kamal Pharmacy, New Delhi 

E-mail: vijay@kamalpharmacy.com 

E-mail: gargd@dabur.com 

Pramod Sharma 

Ravi Prasad 

Shri Baidyanath Ayurved Bhawan 

The Himalaya Drug Co. 

Ltd. Patna 

E-mail: ravi.prasad@himalayahealthcare.com E-mail: pramodsharma54@yahoo.com 


Hon. Gen. Secretary 


Pradeep Multani 

E-mail: rakeshm@dabur.com 

Multani Pharmaceuticals Ltd. 

e-mail: chairman@multaniayurved.org 

Amit Agarwal 

Natural Remedies 

E-mail: amit@naturalremedies.com 

Treasurer 

Dr. Anantha Narayana D B, 

Tejinder Singh 


e-mail: singht@dabur.com 

Ph.D., Consultant 

Email: dba.narayana@gmail.com 

Editorial Board 

Chief Editor: 

Mr. Pradeep Multani 

Honorary General Secretary AMAM 

Chairman Multani Pharmaceutical Limited 

36-H Connaught place, New Delhi- 1 

Editor: 


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 – 2 

Mr. Ajay Sharma, President 

Shri Baidyanath Ayurved Bhawan, Naini, 

28, Ishwar Nagar East, New Delhi – 65 

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. 

2

May 7, 2012 

Dr. Bala Prasad 

Jt. Secretary 

Department of AYUSH 

Ministry of Health & Family Welfare 

Red Cross Building, New Delhi- 110 001 

Sub.: Comments on draft rules Notification F.No. K-11020/05/2011-DCC (AYUSH) dated 22nd March, 2012 [GSR 249 (E)] 

Dear Sir, 

This has reference to the draft rules Notification F.No. K-11020/05/2011-DCC (AYUSH) dated 22nd March, 2012 [GSR 249 (E)] providing the 

additional requirements of mentioning the following on the label- 

2. (ii) after the words “First Schedule of the Act” the following shall be inserted namely: 

“and in respect of Patent or Proprietary Ayurveda, Siddha or Unani drugs, the true list of all the ingredients with their official and 

botanical names (for herbal ingredients) along with part used and form of ingredient, in which, it is used in the formulation, with its quantity:; 

We wish to bring to your kind attention that even if the manufacturers implement the same it may become impractical since the space on the label 

is just sufficient to comply with the current requirement of Rule 161 of the Drugs & Cosmetics Rules. We appreciate the intent of the government 

to make the consumers more and more informed, however, we also request the Department of AYUSH to consider the practical problem of the 

Industry. Most of the formulations mentioned in the Ayurvedic texts are multi-ingredient, given below is the self-explanatory table basis analysis 

of Ayurvedic Formulary of India. 

Analysis of Ayurvedic Formulations 

covered in API Vol. I & II 

%age of product containing 

upto 10 ingredients 


%age of product containing 

upto 20 ingredients 

%age of product containing over 

20 ingredients 

Solids 60 26 14 

Semi Solids 26 33 41 

Liquids 28 32 40 

The label of Dashmularishta bottle falls short of writing the ingredients which are 62 and being a glass bottle, it is not possible to provide such 

a huge bottle in a carton. We fail to understand the necessity of this amendment asking to provide the information on the label which is already 

being provided to the Licensing Authority at the time of submission of manufacturing license application. The additional requirement regarding 

ingredients being asked for through this amendment is more of academic value to the subject expert and the consumers may not benefit from it. 

On the contrary, consumer knows common names more than botanical names. 

As you are aware the market of classical Ayurvedic products is already limited with limited number of manufacturers for these products. We have 

an apprehension that such kind of amendments may become counterproductive and may not serve the purpose. For the demonstration purpose, 

we are attaching herewith a draft label of Mahasudarshan Churna as per the existing Rule 161 and modified one. 

We, therefore, request you to abandon this draft notification. 

With regards, 

PRADEEP MULTANI 

HON. GEN. SECRETARY 

Regulatory Update 

D ear Readers, 

Recently, Department of Ayush issued guidelines on draft rules notification to provide the additional details to be mentioned on the labels of ISM medicines 

covering Patent or Proprietary Ayurveda, Siddha and Unani (ASU) drugs. 

The labeling as per the draft notification would need to list all the ingredients with official and botanical names for herbal ingredients along with parts used 

and form of ingredient, in which, it is used in the formulation along with its quantity. 

A representation was made by our association stating objection to this move. 

We are reproducing our comments made to the ministry for your perusal. Pl. read on for details and do send in your comments and feedback. 

3

DRAFT LABEL OF MAHASUDARSHAN CHURANA 

AS PER EXISTING RULE 161 

Existing Label 

• (Maha) Sudarshan Churna 

• Book Reference – Ayurveda Sar Samgraha 

• Indications – Yakrit, Pliha Vriddhi, Jvara , Visham Jvara, Jirna Jvara, 

Gulma 

• Dose – 2-4 g twice daily or as directed by the physian. 

• Ayurvedic Medicine 

• Net Weight – 100 g 

• MRP Rs……….. 

• (Inclusive of all taxes) 

• Batch No…………… 

• Mfd:…………… 

• Manufactured By – Dabur India Limited, SP – C-162, MIA Alwar, 

Rajasthan, 

• Regd Office & Consumer Cell – 

• 8/3 Asaf Ali Road, New Delhi, 110002 

• chd@dabur.com, Tel: 0120- 4181100 

• License No. ………………. 

• Storage – Store in a cool and dry place 

• Shelf Life - 2 years 

• (Maha) Sudarshan Churna - Ratio/Strength/5 gm 

Haritaki, Bibhitaka, Amalaki, Haridra, Daruharidra, Kantakari, Brihati, 

Shati, Shunthi, Marica, Pippali, Pippali Mool, Murva, Dhanvayasa, 

Katuki, Parpata, Musta, Trayamana, Hrivera, Nimba Tvak,Pushakara, 

Kutaja, Yashti, Yavani, Kutaja Beej, Bharangi, Shigru Beej, Shuddha 

Saurastri, Vaca, Tvak, Padmaka, Ushira, Shveta Chandana, Ativisha, 

Shalaparni, Prishniparni, Vidanga, Chitraka, Devadaru, Chavya, Tagara, 

Patola, Jivaka, Rishabhaka, Lavanga, Vamsha, Kamala, Kakoli, Tejapatra, 

Jatiphala, Guduci, Talis each 64.10 mg, Kiratatikta1666.66 mg. 

DRAFT LABEL OF MAHASUDARSHAN CHURANA 

AS PER MODIFIED RULE 161 

Revised Label will look like this 

• (Maha) Sudarshan Churna 

• Book Reference – Ayurveda Sar Samgraha 

• Indications – Yakrit, Pliha Vriddhi, Jvara , Visham Jvara, Jirna Jvara, 

Gulma 

• Dose – 2-4 g twice daily or as directed by the physian. 

• Ayurvedic Medicine 

• Net Weight – 100 g 

• MRP Rs……….. 

• (Inclusive of all taxes) 

• Batch No…………… 

• Mfd:…………… 

• Manufactured By – Dabur India Limited, SP – C-162, MIA Alwar, 

Rajasthan, 

• Regd Office & Consumer Cell – 

• 8/3 Asaf Ali Road, New Delhi, 110002 

• chd@dabur.com, Tel: 0120- 4181100 

• License No. ………………. 

• Storage – Store in a cool and dry place 

• Shelf Life - 2 years 

• (Maha) Sudarshan Churna - Ratio/Strength/5 gm 

Haritaki (Terminalia chebula) – Fruit Pericarp - Powder, Bibhitaka 

(Terminalia bellirica) – Fruit Pericarp - Powder, Amalaki (Emblica 

officinalis) – Fruit Pericarp - Powder, Haridra (Curcuma longa) – Dried 

Rhizome - Powder, Daruharidra (Berberis aristata) – Stem - Powder, 

Kantakari (Solanum xanthocarpum) – Plant - Powder, Brihati (Solanum 

indicum) – Plant - Powder, Shati (Hedichium spicatum) – Dried Rhizome 

- Powder, Shunthi (Gingiber officinale) – Dried Rhizome - Powder, 

Marica (Piper nigrum) – Dried Fruit - Powder, Pippali, (Piper longum) 


– Dried fruit – Powder, Pippali Mool (Piper longum) – Root - Powder, 

Murva (Maersdenia tenacissima) – Root - Powder, 

Dhanvayasa (Fagonia cretica) – Plant - Powder, Katuki (Picrorhiza 

kurroa) – Dried rhizome/root - Powder, Parpata (Fumeria parviflora) 

– Plant - Powder, Musta (Cyperus rotundus) – Dried Rhizome - Plant, 

Trayamana(Gentiana korroo) – Plant - Powder, Hrivera (Coleus 

vettiveroides) – Root - Powder, Nimba Tvak (Azadirachta indica) 

Stem bark – Powder,Pushakara (Inula racemosa) – Root - Powder, 

Kutaja (Holarrhena antidysenterica) – Stem Bark - Powder, Yashti 

(Glycyrrhiza glabra) – Root - Powder, Yavani (Trachyspermum ammi) 

– Seed - Powder, Kutaja Beej (Holarrhena antidysenterica) – Seed - 

Powder , Bharangi (Clerodendrum serratum) – Plant - Powder, Shigru 

Beej (Moringa pterygosperma) – Seed - Powder , Shuddha Saurastri, 

Vaca (Acorus calamus) – Rhizome - Powder, Tvak (Cinnamomum 

zeylanicum) – Stem Bark - Powder, Padmaka (Prunus cerasoides) _ 

Heart wood - Powder, Ushira (vetiveria zizanioides) – Root - Powder , 

Shveta Chandana (Santalum album) – Heart wood - Powder, Ativisha 

(Acotinum heterophyllum) – Rhizome - Powder, Shalaparni (Desmodium 

gangeticum) – Plant - Powder, Prishniparni (Uraria picta) – Plant - Powder, 

Vidanga (Embelia ribes) - Fruit - Powder, Chitraka (Plumbago zeylanica) 

– Root - Powder, Devadaru (Cedrus deodara) – Heart wood - Popwder, 

Chavya (Piper chava) – Fruit - Powder, Tagara ((Valeriana wallichii) – 

Root – Powder , Patola (Trichosanthes dioica) – Leaf - Powder, Jivaka 

(microstylis muscifera) – Root Tuber – Powder, Rishabhaka (Microstylis 

walichii) – Root Tuber - Powder, Lavanga (Sizigium aromaticum) – 

Flower bud - Powder, Vamsha (Bambusa bambos) – Siliceous concretion- 

Powder , Kamala (Nelumbo nucifera) – Flower - Powder, Kakoli (Lilium 

polyphyllum) – Root Tuber - Powder, Tejapatra (Cinnamomom tamala) 

- Leaf, Jatiphala (Myrstica fragrans) – Seed - Powder, Guduci (Tinospora 

cordifolia) – Stem - Powder, Talis (Abies webbiana) – Leaf - Powder each 

64.10 mg, Kiratatikta (Swertia chirata) – Plant – Powder 1666.66 mg. 

Laugh! 

It’s the best Medicine 

Cookies in Heaven? 

An elderly man lay dying in his bed. In death's agony, he suddenly 

smelled the aroma of his favorite chocolate chip cookies wafting 

up the stairs. He gathered his remaining strength, and lifted himself 

from the bed. Leaning against the wall, he slowly made his way out 

of the bedroom, and with even greater effort forced himself down 

the stairs, gripping the railing with both hands, he crawled down the 

stairs. 

With labored breath, he leaned against the door-frame, gazing into 

the kitchen. Were it not for death's agony, he would have thought 

himself already in heaven: there, spread out upon waxed paper on the 

kitchen table were literally hundreds of his favorite chocolate chip 

cookies. Was it heaven? Or was it one final act of heroic love from 

his devoted wife, seeing to it that he left this world a happy man? 

Mustering one great final effort, he threw himself toward the table, 

landing on his knees in a rumpled posture. His parched lips parted: 

the wondrous taste of the cookie was already in his mouth, seemingly 

bringing him back to life. 

The aged and withered hand trembled on its way to a cookie at the 

edge of the table, when it was suddenly smacked with a spatula by 

his wife. 

"Stay out of those," she said, "they're for the funeral." 

4


News Update 

Allahabad HC directs state CMOs, DMs 

to take action on ISM doctors practising 

In a significant order, the Allahabad High Court last week 

directed the Chief Medical Officers (CMOs) and the District 

Magistrates (DMs) to initiate prosecution against those ISM 

practitioners who administer modern medicine to their patients 

by prescribing drugs and carrying out surgeries in their nursing 

homes. 

The Court also ordered to conduct raids in such nursing homes 

and prohibit those persons from practising modern system of 

medicine. The judgement said besides initiating prosecution, an 

FIR should be lodged and those clinics/nursing homes should 

be sealed. There were reports in the media that large number 

of unauthorized, unqualified and unregistered persons and 

physicians in homoeopathy, Unani, Ayurveda and Siddha are 

practising modern system in several places in the state. 

In the judgement it is noted that there was allegation that the 

quacks were practising modern medicine in connivance with the 

chief medical officers and their staff. 

In his judgement on the contempt application filed by one Rajesh 

Kumar Srivastava, Justice Sunil Ambwani also directed the chief 

secretary and the principal health secretary to comply with the 

earlier orders passed by the Court prohibiting those persons, 

who are unqualified and unregistered, from practising modern 

medicine. The court reminded the state’s chief bureaucrats of its 

earlier orders and directed them to submit a compliance report in 

the court by July 13, 2012. 

modern medicine Peethaambaran Kunnathoor, Chennai 

Tuesday, May 29, 2012, 08:00 Hrs [IST] 

In February 2010, in a similar case, the High Court of Madras in 

an order restrained the ISM practitioners from practising allopathic 

system. Passing the order, Justice K K Sasidharan had held that 

police could take action against those who practise modern system 

without qualification. Following this order, the state police had 

started widespread crack down on ISM practitioners for practising 

allopathy. 

Desperate over the police action the traditional physicians approached 

the High Court and on July 30, Justice FM Ibrahim Kalifulla ruled that 

the registered practitioners in Siddha, Ayurveda, Homoeopathy and 

Unani were eligible to practice surgery, obstetrics and gynaecology, 

anaesthesiology, ENT, ophthalmology, etc. and said penal action 

against such practitioners should be dropped immediately. The court 

took note of section 17 (3) B of the Indian Medicine Central Council 

Act, 1970 to issue the order. 

After the order came out, the state government wrote to the state 

police that the institutionally qualified and registered practitioners of 

Ayurveda, Siddha and Unani could practise their respective systems 

with modern scientific medicines including surgery, gynaecology & 

obstetrics, anaesthesiology, ENT, ophthalmology, etc. based on their 

training and teaching in the course. This was based on section 17 (3) 

B of the Indian Medicine Central Council Act, 1970. 

Later the Tamil Nadu branch of the Indian Medical Association 

(IMA) appealed against the verdict before the High Court and the 

case is still pending with the court. 

Courtesy: PHARMABIZ.com 

5

Ayush Dept moots setting up of 

electronic mandi for medicinal plants 

The Department of Ayush has directed all the stakeholders from 

the Ayurveda, Siddha, and Unani (ASU) fraternity to share their 

comments and suggestions on ways to establish an electronic 

herbal mandi project for the medicinal plants. Through this 

project, the government wants to bridge the existing gap between 

medicinal plant growers and the ASU drug manufacturers, so as to 

help in better facilitation of sale and purchase of medicinal plants 

based on the prevalent market conditions. 

This ambitious project aims at providing a level playing ground 

for the medicinal plant growers to get right market price for their 

products without any undue influences. The idea to launch this 

project was announced by the Dr Balaprasad, CEO of NMPM and 

the joint secretary of Department of Ayush while discussing the 

potential ways of exploring newer methods to develop cultivation 

of medicinal plants. 

He informed that the Department has ensured to make provisions 

for the same in the 12th five year plan. At present, though this 

project is at a very nascent stage, the industry has expressed 

their support for this initiative and feels that it is high time for 

the Government to finally to take a pro-active stance on their long 

standing demand for electronic mandi. 

According to Dr Nagesh, member of technical committee, 

Ayurvedic Drug Manufacturers Association (ADMA), “Having 

an electronic mandi for the purchase and sale of medicinal plants 

will provide an ideal platform for both the manufacturers and the 

producers of these plants to do business directly. This will not 

only help the farmers to get just and deserved price value for their 


Suja Nair Shirodkar, Mumbai 

Monday, May 07, 2012, 08:00 Hrs [IST] 

products but will also provide as an impetus for them to continue 

producing this plants based on the demands of the manufacturers. 

Most importantly it will ensure timely delivery of quality products 

to the drug manufacturers.” 

Over the years, ADMA had been insisting to the Government, 

through repeated representations, to implement this scheme for the 

benefit of the industry. The Association feels that such initiative 

is essential to ensure that there is prolonged cultivation of these 

medicinal plants for meeting the demands of the industry. 

The Association informed that they will soon be taking initiative 

to get all the stakeholders to give their suggestions and views on 

this topic. The final suggestion will be sent to the Department 

after substantial deliberations and meetings with the industry 

members and farmers to get their detailed perspective on the 

affordability and feasibility of the technology that can be adopted 

for the electronic mandi. 

At present there are 52 listed of medicinal plants that are 

generally grown in the state of Maharashtra which are used for 

manufacturing of ASU drugs. The industry feels that through the 

implementation of this project there will be a substantial increase 

in the production of medical plants in the country 


6

Kerala DC raids 3 big Ayurveda cos for 

violating Magic Remedies Act, may lose 

Acting tough against ayurvedic companies giving misleading 

advertisements without complying to the set norms, the Kerala 

Drug Control Department in its ongoing raid against such drug 

syndicates has netted ‘big sharks’ from 13 districts in the state 

on Thursday, May 10. 

The team of enforcement officials from various districts 

conducted operations in the depots of wholesalers and 

manufacturing premises in different places and the total value 

of the seized products is Rs.5,211,770. The manufacturing 

companies who were found violating the provisions of the 

Drugs & Magic Remedies Objectionable Act are Dhathri 

Ayurveda Pvt Ltd, Kochi, Cochin Ayurvedic Centre 

(Indulekha), Kochi and Sreedhareeyam Ayurvedic Medicines 

Pvt Ltd, Koothattukulam, said C S Satheeshkumar, Drugs 

Controller, Kerala. 

The confiscated products, which are popular in Kerala and in 

the national level, were produced before the CJM courts in 

respective areas and the process of filing of prosecution cases 

are on, he added. 

According to him, the big sharks whose licences are soon to be 

lost are Dhatri, Indulekha and Sreedhareeyam. The enforcement 

officials have conducted inspections at the manufacturing 

premises of Indulekha in Thalasseri and Kannur and of Dhatri 

in Moovattupuzha and Ernakulam. Steps are on to cancel their 

licences as per the law, said the DC. 

He said the department was getting a host of complaints 

from different quarters about the misleading advertisements/ 

statements given by several ayurvedic companies highlighting 

their products which were sold at exorbitant prices. There 

was discussion in the state assembly also about the unethical 


licences 

Peethaambaran Kunnathoor, Chennai 

Monday, May 14, 2012, 08:00 Hrs [IST] 

practices of these companies by violating all provisions of the Drugs 

& Magical Remedies Objectionable Act, Satheesh told Pharmabiz. 

The law enforcing officers have initiated action into the misleading 

advertisements of products are Indulekha Bringha Complete Hair 

Care Oil, Dhathri Fair Skin Cream and Sreedhareeyam Smartlean. 

These products were marketed in all the states in the country and 

abroad. 

Leaflets/labels of the drugs with false/misleading statements such as 

“Controlling hair loss is not the solution to prevent thin hair, instead 

new hair generation has to be aided, which Indulekha Bringa does 

scientifically well”, “ Slimming and fitness...Smart way to deal 

obesity..Dissolve excess fat, Scientifically proven...”, and “Cools the 

scalp and gives relief from stress and strain”, have been seized from 

the depots and the companies’ go-downs. 

Out of the total value of the seized products, Rs.5,211,770, Dhathri 

products come around Rs.480,370, Indulekha Rs.4,606,300 and 

Sreedhareeyam Rs.125,100. 

The products confiscated and licences are to be lost are Indulekha 

Bringha Complete Hair Care Oil, Indulekha Skin Care Oil, Dhathri 

Hair Cream,Dhathri Hair Care Capsules, Dhathri Diavita Plus 

Capsules, Dhathri Fair Skin Cream, Dhathri Hair Care Herbal Oil 

and Sreedhariyam Smart Lean. 

The raids were conducted in the wholesale depots of these 

companies in Thiruvananthapuram, Kollam, Alappuzha, Kottayam, 

Pathanmthitta, Ernakulam, Thrissur, Palakkadu, Malappuram, 

Kozhikodu, Wynadu, Kannur and Kasargodu. 


7

KAISHORA GUGGULU 

(AFI, PART I, PAGE 57) 

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izf{kI; rks;jk”kkS f=Qyk¥p ;Fkksäifjek.kke~AA97AA 

}kf=a”kfPNé:gkiykfu ns;kfu ;RusuA 

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f=Qtkpw.kkZ)Ziya f=dVks”pw.kZ ‘kM{kifjek.keAA100AA 

d`fefjiqpw.kkZ)Ziya d’kZa d’kZa f=o`gUR;ks%A 

ve`rk;k% iyesda lfiZ”p iyk’Vda f{kisneye~AA101AA 

mi;qT; pkuqikua ;w’ka {khja lqxkfU/klfyy¥pA 

bPNkgkjfogkjh Hks’kteqi;qT; loZdkyfeneAA102AA 

ruqjksf/k okr”kksf.kresdteFk }U}ta fpjksRFk¥pA 

eUnkfXu¥p foxU/ka izesgfiMdk¥p uk”k;R;k”kqAA103AA 

lrra fu’ksO;ek.k% dkyo”kk}fUr loZxnku~A 

vfHkHkw; tjknks’ka djksfr dS”kksjda :ie~AA104AA 

izO;sda f=QykizLFkks tye= ‘kMk

polygonal in shape and filled with plenty of starch grains, simple, ovoid, 

or irregularly ovoid-elliptical, occasionally compound of 2-4 components, 

several secretory cells, found scattered in the cortex, pericyclic fibres 

lignified with wide lumen and pointed ends, associated with a large 

number of crystal fibres containing a single prism in each chamber, 

vascular zone composed of 10-12 or more wedge-shaped strips of xylem, 

externally surrounded by semi-circular strips of phloem, alternating, with 

wide medullary rays, phloem consists of sieve tube, companion cells and 

phloem parenchyma of polygonal or tangentially elongated cells, some 

of them contain cryste1s of calcium oxalate, cambium composed of one 

to two layers of tangentially elongated cells in each vascular bundle, 

xylem consists of vessels, tracheids, parenchyma and fibres, in primary 

xylem, vessels comparatively narrow devoid of tyloses, secondary xylem 

elements thick-walled, lignified, vessels cylindrical in shape bearing 

bordered pits on their walls some large vessels possess several tyloses and 

often contain transverse septa, meduallry rays 15-20 or more cells wide 

containing rounded,hemispherical, oblong, ovoid, with faintly marked 

concentric striations and central hilumappearing like a point, starch grains 

of 5.5-11.20 μ in diameter and 6-11.28 μ in length,pith composed of large, 

thin-walled cells mostly containing starch grains. 

IDENTITY, PURITY AND STRENGTH 

For dried drug:– 

Foreign matter - Not more than 2 per cent 

Total ash - Not more than 16 per cent, 

Acid-insoluble ash - Not more than 3 per cent, 


Alcohol-soluble extractive - Not less than 3 per cent, 

Water-soluble extractive - Not less than 11 per cent, 

For fresh drug:– 

Foreign matter - Nil 

Moisture content - 75 per cent 

CONSTITUENTS - Terpenoids and alkaloids. 

PROPERTIES AND ACTION 

Rasa: Tikta, Kashaya 

Guna: Laghu 

Virya: Ushna 

Vipaka: Madhura 

Karma: Tridoshashamaka, Samgrahi, Balya, Dipana, Rasayana, 

Raktashodhaka, 

Jvaraghna 

IMPORTANT FORMULATIONS - Amritarishta, Amritottara Kvatha 

Churna, Guduci Taila, Guduchyadi Churna, Guduchyadi Sattva, 

Chinnodbhavadi Kvatha Churna 

THERAPEUTIC USES - Kushtha, Vatarakta, Jvara, Kamala, Pandu, 

Prameha 

DOSE - 3-6 g of the drug in powder form. 

20-30 g of the drug for decoction. 

VIDANGA (Fruit) 

(API Part - I,Volume 1, Page 123) 


Vidanga consists of dried mature fruits of Embelia ribes Burm. F. (Fam. 

Myrsinaceae), large scandent shrub with long slender, flexible branches, 

distributed throughout hilly parts of India upto 1600 m, 

SYNONYMS 

Sanskrit: Jantughna, Krimighna, Vella, Krimihara, Krimiripu 

Assamese: Vidang 

Bengali: Vidang 

Gujrati: Vavding, Vavading, Vayavadang 

Hindi: Vayavidanga, Bhabhiranga, Baberang 

Kannada: Vayuvilanga, Vayuvidanga 

Kashmiri: Babading 

Malayalam: Vizhalari, Vizalari 

Marathi: Vavading, Vavding 

Oriya: Bidanga, Vidanga 

Punjabi: Babrung, Vavaring 

Tamil: Vayuvilangam, Vayuvidangam 

Telugu : Vayuvidangalu 

Urdu : Baobarang, Babrang 

DESCRIPTION 

a) Macroscopic 

Fruit brownish-black, globular 2-4 mm in diameter, warty surface with 

a beak like projection at apex, often short, thin pedicel and persistant 

calyx with usual1y 3 or 5 sepals present, pericarp brittle enclosing a 

single seed covered by a thin membrane, entire seed, reddish and covered 

with yellowish spots (chitra tandula), odour slightly aromatic, taste, 

astringent. 

b) Microscopic 

Transverse section of fruit shows epicarp consisting of single row of 

tabular cells of epidermis, usually obliterated, in surface view cells 

rounded with wrinkled cuticle, mesocarp consists of a number of layers 

of reddish-brown coloured cells and numerous fibrovascular bundles and 

rarely a few prismatic crystals of calcium oxalate, inner part of mesocarp 

and endodennis composed of stone cells, endodermis consisting of single 

layered, thick-walled, large, palisade-like stone cells, seed coat composed 

of 2-3 layered reddish-brown coloured cells, endosperm cells irregular in 

shape, thick-walled, containing fixed oil and proteinous masses, embryo 

small when present otherwise most of the seeds sterile. 

Powder-Reddish, under microscope shows reddish parenchyma and stone 

cells. 


Identification:- 

(I) Shake 1 g of the powdered seeds with 20ml of Solvent Ether for five 

minutes and filter. To a portion of the filtrate add 5 per cent v/v solution of 

Sodium Hydroxide; a deep violet colour is developed in the aqueous layer. 

To the other portion add 2 drops of Dilute Ammonia solution; a bluish 

violet precipitate is obtained. 

(II) Boil 5 g of the powdered seeds: with 25 ml alcohol and filter. Divide the 

deep red coloured filtrate into two portions. To one portion, add solution 

of lead Acetate, a dirty green precipitate is produced. To the other portion 

add solution of ferric chloride a reddish-brown precipitate is produced. 


Foreign matter - Not more than 2 per cent, 

Total Ash - Not more than 6 per cent, 

Acid-insoluble ash - Not more than 1.5 per cent, 

Alcohol-soluble extractive - Not less than 10 per cent, 


Assay:-Contains not less than 2 per cent w/w of embelin (limits 1.85 to 

2.15) when assayed as follows:- 

Weigh accurately about 10 g of powder (40 mesh) and transfer to a 500 ml 

glass stoppered flask Shake occasionally for thirty minutes with 150 ml 

9

of Solvent Ether. Pack the whole mass in a percolator, allow to macerate 

for thirty minutes and extract with Solvent Ether till the ethereal solution 

ceases to give a pink colour with a drop of Dilute Ammonia Solution. Distil 

off the Ether, treat the residue with small quantity of light Petroleum (b.p. 

40° C to 60° C) cool in ice, filter through a Buchner funnel under suction 

and reject the filtrate. Wash the residue with further small quantities of 

cooled Ether (b. p. 40° C to 60° C). Transfer the residue to a tared beaker 

with sufficient quantity of Solvent Ether, remove the Light Petroleum and 

dry the residue of embelin to constant weight at 80°. The melting range of 

the residue is 142° C to 144° C. 

CONSTITUENTS - Benzoquinones, alkaloid (Christembine), tannin and 

essential oil 


Rasa: Katu, Tikta 

Guna: Ruksha, Laghu, Tikshna 

Virya: Ushna 

Vipaka: Katu 

Karma: Kriminashna, Dipana, Anulomana, Vatakaphapaha 

IMPORTANT FORMULATIONS- Vidangarishta, Vidanga Lauha, 

Vidangadi Lauha 

THERAPEUTIC USES- Krimiroga, Adhmana, Shula, Udararoga 

DOSE- 5-10 g of the drug in powder form. 

DANTI (Root) 

(API Part - I, Volume -III, Page 41) 

Danti consists of dried root of Baliospermum montanum Muell.-Arg. 

(Fam.Euphorbiaceae); a leafy undershrub, distributed in outer range 

of Himalayas from Kashmir to Assam and in moist deciduous forests 

elsewhere in India. 

SYNONYMS 

Sanskrit : Danti 

Assamese : Danti 

Bengali : Danti 

English: Wild Croton 

Gujrati: Danti 

Hindi: Danti 

Kannada : Kadu Haralu 

Malayalam : Neervalam, Dantti 

Marathi : Danti 

Oriya : Danti 

Punjabi : Danti 

Tamil : Danti 

Telugu : Konda Amudamu 

Urdu: Danti 


DESCRIPTION 

a) Macroscopic 

Root pieces almost cylindrical, straight or ribbed with secondary and 

tertiary roots, 0.2-1 cm thick and upto 10 cm or more in length, tapering 

at one end, tough, externally brown; surface, rough due to longitudinal 

striations, transverse cracks and scars of rootlets; internally creamcoloured; 

transversely smoothened root shows thin, brown bark and 

yellowish-white central core; taste, bitter. 

b) Microscopic 

Shows 5-18 layered cork, consisting of brown coloured, suberised or 

lignified brickshaped cells, a few cells containing tannin and red colouring 

matter; secondary cortex consists of 2-7 layers of oval to elliptical, 

tangentially elongated cells, a few cortical fibres are also present in this 

region; secondary phloem consists of usual elements, traversed by uni 

to biseriate phloem rays; secondary xylem consists of usual elements; 

vessels and tracheids, bordered pits, a few having reticulate thickening; 

fibres slightly thick-walled, narrow lumen and blunt tips; xylem rays 1 or 

2 cells wide; rosette crystals of calcium oxalate and starch grains, present 

only in secondary cortex and phloem; starch grains solitary and in groups, 

simple, round to oval measuring 6-17 μ in dia. 

Powder - Brown; shows fragments of cork more or less rectangular, thickwalled 

in surface view; rosette crystals of calcium oxalate; numerous 

phloem fibres with narrow lumen and blunt tips, border pitted- and 

reticulate vessels, tracheid and tannin cells, round to oval simple starch 

grains measuring 6-17 μ in diameter, and in groups occasionally. 


Foreign matter - Not more than 2 per cent, 

Total Ash - Not more than 10 per cent, 


Alcohol-soluble extractive - Not less than 1.5 per cent, 


T.L.C. 

T.L.C. of the alcoholic extract on Silica gel ‘G’ plate using Toluene: 

Ethylacetate (9:1) shows under U.V. (366 nm) a fluorescent zone at Rf 

0.65 (blue). On exposure to Iodine vapour two spots appear at Rf 0.51 

and 0.65 (both yellow). On spraying with 50% Methanolic-Sulphuric acid 

reagent and heating the plate for ten minutes at 110°C two spots appear at 

Rf 0.51 and 0.65 (both grey). 

CONSTITUENTS - β - Sitosterol and Triterpenoids, Resinous 

Glycosides, Phorbol Esters. 


Rasa: Katu 

Guna: Tikshna, Sara, Laghu 

Virya: Ushna 

Vipaka: Katu 

Karma: Kaphahara, Raktadoshahara, Vidahara, Dipana, Rocaka, 

Shodhaka, Vikasi, Vrana 

IMPORTANT FORMULATIONS 

Dantyadyarishta, Punarnava Mandura, Abhayarishta, Kankayana Gutika, 

Dantiharitaki, Kalyanaka Kshara, Kaishora Guggulu 

THERAPEUTIC USES 

Tvak dosha, Daha, Shotha, Udararoga, Sularoga, Krimi, Arsha, Ashmari, 

Kandu, Kushtha, Vrana, Pliha Vriddhi, Gulma, Kamala 

DOSE - 1-3 g of the drug in powder form 

10

Pharmocopial Standards For Kaishora Guggulu 

1. Guggulu API- (Shuddha) Commiphora wightii Exd. 768 g 

2. Haritaki API Terminalia chebula P. 256 g 

3. Bibhitaka API Terminalia bellirica P. 256 g 

4. Amalaki API Phyllanthus emblica 

(Emblica officinalis) 

P. 256 g 

5. Chinnaruha (Guduci API) Tinospora cordifolia St. 1.54 kg 

6. Jala API for decoction Water 12.29 l 

reduced to 6.14 1 

7. Haritaki API Terminalia chebula P. 8 g 

8. Bibhitaka API Terminalia bellirica P. 8 g 

9. Amalaki API Phyllanthus emblica P. 8 g 

10. Shunthi API Zingiber officinale Rz. 24 g 

11. Marica API Piper nigrum Fr. 24 g 

12. Pippali API Piper longum Fr. 24 g 

13. Krimiripu (Vidanga API) Embelia ribes Fr. 24 g 

14. Trivrit API Operculina turpethum Rt. 12 g 

15. Danti API Baliospermum 

montanum Rt. 

12 g 

16. Amrita (Guduci API) Tinospora cordifolia St. 48 g 

17. Ghrita (Goghrita API) Clarified butter from 384 g 

cow’s milk 

Method of preparation: 

Take all ingredients of pharmacopoeial quality. 

Wash, dry and powder the ingredients number 7 to 16 of the formulation 

compostion to a fine powder separately and pass through sieve number 

85. 

Soak the coarse powder of ingredients 2 to 5 in potable water in the 

specified ratio for 1 hr, boil it till the volume is reduced to half of its 

original volume. Cool the kashaya and filter through a muslin cloth. 

Boil Shuddha-Guggulu in the above kashaya in an iron vessel and 

concentrate, add fine powders of remaining drugs with continuous stirring. 

Add Ghrita to the above mixture to form a semisolid mass for preparation 

of vati. 

Expel the mass through vati machine fitted with suitable die and cut vatis 

of desirable weight. 

Dry the rolled vatis in a tray-dryer at a temperature not exceeding 60 

degree. Pack it in tightly closed glass containers to protect from light and 

moisture. 

Description: 

Spherical pills, dark brown in color with pleasant odour, taste astringent 

and sweetish. 

Identification: 

Microscopy: 

Take about 5 g of the sample, powder it and add n-hexane (20 ml), stir 

for 10 min thoroughly over a water-bath; pour out hexane. Repeat the 

process thrice adding fresh quantities of hexane; discard hexane. Wash the 

sediment in hot water thoroughly. Take a few mg of the washed material, 

stain with iodine solution and mount in 50 per cent glycerin. Clarify a few 

mg with chloral hydrate and mount in 50 per cent glycerin. 

Observe the following characters in different mounts. 

Groups of parenchymatous epidermal cells having beaded walls, several 


KAISHORA GUGGULU (VATI) 

(API, PART - II, VOLUME –I, PAGE 94) 

DEFINITION:Kaishora Guggulu is a vati preparation made with the ingredients in the Formulation composition given below with Guggulu as the 

basic ingredient. 

Formulation Composition: 

showing a thin cross wall, crisscross layer of sclerenchymatous fibres 

(Haritaki); short, unicellular, thick walled trichomes with sharp tips and 

bulbous bases and fragments of polyhedral epidermis showing cicatrices 

(Bibhitaka); thin walled cells of epidermal tissue with paracytic stomata 

and containing silica crystals, brachysclereids with pitted wide lumen, 

parenchymatous tissue with large irregular thick walled cells showing 

corner thickenings (Amalaki); groups of parenchymatous cells, densely 

packed with starch grains, isolated starch grains, simple, oval to rod 

shaped, measuring 15 to 70 μ in length, hilum eccentric, lamellae distinct, 

yellow coloured oleo-resin cells, non-lignified, septate fibres some of them 

bearing marks of adjacent cells pressing against them, 30 to 50 μ broad 

(Shunthi); fragments of inner epidermis in surface view with group of 

stone cells, interspersed amidst parenchyma (Marica); spindle shaped or 

elongated stone cells showing narrow boundary and broad lumen isolated 

or in groups of 2 to 8 (Pippali); groups of polygonal, non lignified, thick 

walled brown coloured cells of testa in surface view, palisade like thick 

walled cells of testa in transverse view measuring 55 to 80 μ in length 

and 15 to 30 μ in width, thick walled polygonal cells filled with yellowish 

brown content of mesocarp cells almost square in shape, measuring 

25 to 45 μ in dia (Vidanga); cortical parenchymatous cells containing 

rosette crystals of calcium oxalate, broken, thick rod-like cellulosic fibres, 

fragments of typically honeycomb like pitted vessels, resin canals lined 

with epithelium (Trivrita); cork cells in surface and transverse view 

several with tannin or red colouring matter (Danti); parenchymatous cells 

filled with starch grains, starch grains abundant, single and compound, 

ovoid, elliptical, hilum, mostly irregular in shape, measuring 5 to 10 μ in 

dia, fragments of bordered pitted vessels (Guduci). 

Thin layer chromatography: 

Extract 5 g of powdered vatis (vatti powder) in 75 ml of n- hexane under 

reflux on a water-bath for 30 min. Filter and concentrate the extract to 10 

ml and carry out the thin layer chrmotography. Apply 10 μl of n-hexane 

extract on TLC plate and develop the plate to a distance of 8 cm using 

n-hexane : ethyl acetate (8.5 : 1.5) as mobile phase. After development, 

allow the plate to dry in air and examine under ultraviolet light (366 nm). 

It shows major spots at Rf 0.10, 0.17 (both blue), 0.25 (fluorescent blue) 

and 0.46 (blue). 

Physico-chemical parameters: 

Loss on drying: Not more than 13.0 per cent 

Total ash: Not more than 9.0 per cent 

Acid-insoluble ash: Not more than 2.0 per cent 

Alcohol-soluble extractive: Not less than 40.0 per cent 

Water-soluble extractive: Not less than 34.0 per cent 

pH (1% aqueous solution): 4.0 to 4.5 

Other requirements: 

Microbial Limits 

Aflatoxins 

Storage: Store in a cool place in tightly closed containers, protected from 

light and moisture. 

Therapeutic uses: Mandagni (Dyspepsia); Vibandha (constipation); 

Vatashonita (Gout); Pramehapidka (Diabetic carbuncle); Vrana (Ulcer); 

Kasa (cough); Kushtha 

(diseases of skin); Gulma (abdominal lump); Svayathu (oedema); Pandu 

(anaemia);Meha (excessive flow of urine); Jaradosha (geriatric disorder). 

Dose: 3 g daily in divided doses. 

Anupana: Mudga Yusha, Milk, Sugandhijala. 

11

An Open Clinical Study To Evaluate Efficacy Of WHS/2004/1 

(DRF/AY/4007) In Menstrual Irregularities 

INVESTIGATORS: 

Dr.Harpreet, Department of Stri Rog & Prasui, Shri Dhanwantary 

Ayurvedic Hospital, Sector 46, Chandigarh 

Dr. R. K. Shukla, Shalakya Department, Shri Dhanwantary Ayurvedic 

Hospital, Sector 46, Chandigarh 

STUDY CENTRE: Shri Dhanwantary Ayurvedic Hospital, Sector 46, 

Chandigarh 

DURATION OF THE STUDY: August 2004 to January 2005 

1. INTRODUCTION: 

Woman healthcare around the world is changing rapidly. In US 

approximately 40% of adult females have menstrual pain, and about 10% 

are incapacitated for 1-3 days each month. The present clinical study was 

designed to assess efficacy of the trial medicament in primary menstrual 

irregularities. Menstrual Irregularities include various abnormalities 

of periods and menstruation. Menstrual Irregularities is also defined as 

painful menstrual cramps. Primary menstrual irregularities is the pain, 

often incapacitating, that accompanies periods only when secondary 

menstrual irregularities, due to underlying pathology, is excluded. 

Types of menstrual irregularities: Amenorrhoea, Dysmenorrhoea, 

Heavy Periods, Vaginal Bleeding 

Symptoms related to menstrual irregularities: Menstrual Pain, 

Vaginal Symptoms, Vaginal Bleeding, Vaginal Odour, Vaginal discharge, 

Uterus Symptoms, Vulva Symptoms, Ovary Symptoms, Fallopian-tubesymptom, 

Menstrual Symptoms and Female Sexual Symptoms Menstrual 

irregularities are a considerable nuisance for women because it leads to an 

unpredictable menstrual flow. It is most likely to occur at the extremes of 

reproductive life. At the menopause unopposed estrogen production leads 

to persistent proliferative endometrium and occasionally hyperplasic 

change may be associated with extremely heavy bleeding at irregular 

intervals. 

Treatment: 

Periodic use of estrogens is most common. Synthetic preparations are 

also made available. However, increasing risk of cancer breast and cervix 

restricts usage of hormonal therapy. Keeping this in mind the present 

formulation has been designed which may be of potential use in primary 

menstrual irregularities and irregularities of menstrual cycle. Owing to 

the advantages of phyto-estrogens and safety of the herbal medicines 

the proposed drug is studied for its efficacy on regularizing the irregular 

menstrual cycles as well. 

Ayurvedic Perspective: 

Ayurveda described Artava as the eighth Dhatu for females and also 

as a Upadhatu of Rasa dhatu. Susruta delineated eight types of Artava 

doshas, Artava vriddhi (menorrhagia), Artava kshaya (oligomenorrhea), 

Rakta Pradara (DUB) and other related conditions. About 20 types of 

Yoni Vyapats (gynecological conditions) are described and being quoted 

by Caraka (C.S.Ci.30) and Susruta (S.S.Ut.39). The treatment of these 

disorders was mainly aimed at controlling Vata, which is main factor 

responsible for causation. Therefore, the pharmacotherapy also consists 

of herbs, which alleviate Vata e.g. Ashoka, Triphala, Hingu, Trivrit etc. 

2. INGREDIENTS OF WOMEN HEALTH SYRUP: 

Women Health Syrup formulation [WHS/2004/1 (DRF/AY/4007)] 

contains herbs such as Ashoka, Ghrit Kumari, Daruharidra, Chandan, 


Trivirit, Mangraila, Ajwain, Sunthi, Triphala, Mustak, Safed jeera, Vasaka, 

Pippali, Neelkamal, Hingu, Amarashti, and Dhatkipushpa. 

3. MATERIAL AND METHODS: 

3.1. Study Design: Open and Prospective clinical study. 

3.2. Dosage: WHS/2004/01 was administered at a dose of 10 ml 

twice daily for 120 days 

3.3. Inclusion & Exclusion criteria: 

Patients, willing to participate and sign informed consent form, aged 

between 14-45 years, diagnosed cases of menstrual irregularities, 

complaining of non-specific problems like body aches, abdominal pain, 

backache, nausea, vomiting, physical discomfort and other problems 

related to menstruation, diagnosed cases of dysfunctional uterine bleeding 

- only polymenorrhea and oligomenorrhea were included in the study. 

Patients having organic causes of menstrual abnormalities like uterine 

myeloma, pelvic inflammatory disease, adenomyosis, polyps, fibroids, 

endometriosis etc, patients participating in any other clinical study, nursing 

or pregnant and lactating women, patients having systemic disorders like 

thyroid dysfunction or pituitary disease or coagulation disorders, chronic 

infection like respiratory, cardiac problems, diabetes, renal dysfunction 

& HIV, taking medicines like analgesics, sedatives, muscle relaxants, 

tranquilizers or anti-spasmodic within 48 hrs of expected menstrual 

period, when efficacy evaluations are scheduled, participating in new 

drug evaluation in proceeding three months, moderate or severe mental 

retardation were kept as exclusion for the study. 

4. OBSERVATION & RESULTS: 

In total 44 females suffering from menstrual irregularities between the age 

group of 14-45 years participated in the study. 

Out of 44 females (mean age 28.65 yrs + 10.13), 42 had completed total 

duration of the study i.e. 120 days. In the study 24-32 days of cycle was 

considered to be regular while, period of menstrual flow was considered 

to be normal if it was 4-6 days. 

Among the subjects with increased duration of cycles (n=26), 12 showed 

normal bleeding pattern, 7 with increased and 7 with decreased bleeding 

days. Similarly, out of 5 subjects with decreased duration of cycles, 3 

have shown normal bleeding pattern while 2 had decreased bleeding 

days. It is interesting to find that 11 subjects out of 42 have fallen under 

the normal cycle duration. But, 8 of them were reported with decreased 

bleeding days, 1 with increased bleeding days while remaining 2 with 

increased flow 

4.1. Effect of the trial drug on irregular duration of cycles 

4.1.1. Effect of trial drug on increased duration of cycles (n=26): 

In subjects reporting with increased duration of cycles (n=26), mean 

duration was 46.15 (+ 18.9) days at baseline. After intervention with the 

trial drug, 22 out of 26 (84.62%) have achieved normal duration of cycles 

by the end of third cycle with a mean duration of 30.45 (+ 4.04) days. 

Mean change was 15.7 days i.e., 34% reduction in duration of cycle with 

P

Table 1: Pattern of Improvement in the subjects with increased duration 

of cycles 

Duration Baseline Cycle 

1 

(>32 days) 

Increased 

cycles 

Mean 46.15 

(n=26) 

35.03 

(n=26) 

Cycle 2 Cycle 

3 

35.65 

(n=26) 

30.45 

(n=22) 

± 18.9 ± 9.72 ± 7.82 ± 4.04 

Mean 

Change 


% 

reduction 

15.7 34.01 

4.1.2. Effect of WHS on decreased duration of cycles (n=5): 

In subjects reporting with decreased duration of cycles (n=5), mean 

duration was 17.80 (+ 03.97) days at baseline. After intervention 

with the trial drug, all the subjects (100%) have achieved near normal 

duration of cycles by the end of fourth cycle with a mean duration of 

23.60 (+ 07.16) days. Mean change was 05.80 days i.e., 32.58% increase 

in duration of cycle with P32 days) 

Increased 

cycles 

Mean 17.80 

(n=5) 

22.60 

(n=5) 

Cycle 

2 

23.00 

(n=5) 

Cycle 

3 

22.20 

(n=5) 

Cycle 

4 

23.60 

(n=5) 

SD ±3.97 ±3.43 ±2.73 ±4.49 ±7.16 

4.2. Effect of trial drug on irregular bleeding days 

Mean 

Change 

% 

reduction 

5.8 32.58 

4.2.1. Effect on increased bleeding days (n=11): 

After the intervention with the trial drug none of the subjects shown 

normal bleeding days by the 3rd cycle. Only 4 subjects (36.67%) have 

shown normal bleeding days pattern during the 4th cycle. The mean 

number of days of improvement was 0.97 days i.e., a percentage reduction 

of 14.43% with P>0.05 

Table 3: Effect of trial drug in subjects with increased bleeding days 

Duration Baseline Cycle 

1 

(>32 days) 

Increased 

cycles 

Mean 03.75 

(n=8) 

04.25 

(n=8) 

Cycle 

2 

04.25 

(n=8) 

Cycle 

3 

04.13 

(n=8) 

Cycle 

4 

04.20 

(n=5) 

SD ± 0.7 ± 1.4 ± 1.3 ± 0.9 ± 0.8 

Mean 

Change 

% 

reduction 

0.45 12.00% 

4.2.2. Effect on decreased bleeding days (n=8): 

After the intervention with the trial drug all the subjects have shown 

normal bleeding days by the 3rd cycle (4.2 days + 0.90). The mean number 

of increase in bleeding days was 0.45 days i.e., a percentage increase of 

12.00% with P>0.05. 

Table 4: Effect of trial drug in subjects with decreased bleeding days 

Duration Baseline Cycle 1 Cycle 

2 

( > 3 2 

days) 

Increased 

cycles 

Mean 17.80 

(n=5) 

22.60 

(n=5) 

23.00 

(n=5) 

Cycle 

3 

22.20 

(n=5) 

Cycle 

4 

23.60 

(n=5) 

SD ±3.97 ±3.43 ±2.73 ±4.49 ±7.16 

Mean 

Change 

% 

reduction 

5.8 32.58 

4.2.3. Effect of Trial drug on number of pads (increased duration of 

cycles): (n=26) 

The reduction in number of pads in case of subjects having increased 

duration of cycles was 21.4 at baseline against 19.4 at the end of 4th 

cycle. 

Table 5: Efficacy of WHS on no. of pads in increased duration of cycles 

Baseline 

(n=26) 

cycle 1 

(n=26) 

Cycle 2 

(n=26) 

Cycle 3 

(n=22) 

No. of pads 21.4 24.42 26.5 23.4 19.4 

Cycle 4 (n=5) 

4.2.4. Effect of trial drug on number of pads (decreased duration of 

cycle): (n=5) 

There was an increase in number of pads in case of subjects having 

decreased duration of cycles viz., 16.3 at baseline against 21.4 at the end 

of 4th cycle. 

Table 6: Efficacy of WHS on no. of pads in decreased duration of cycles 

No. of 

pads 

Baseline 

(n=5) 

cycle 1 

(n=5) 

Cycle 2 

(n=5) 

Cycle 3 

(n=5) 

Cycle 

4 

(n=5) 

Cycle 5 

(n=5) 

16.3 21.1 19.8 23.1 21.4 28.75 

4.2.5. Effect of trial drug on menstrual flow (increased duration of 

Cycle): (n=26) 

Among 26 subjects in the increased duration of cycle, there were 9 with 

heavy flow and 8 with scanty flow. Remaining 9 subjects presented with 

moderate (normal) flow. In the heavy flow category only one subject was 

left with heavy bleeding by 3rd cycle. Among the scanty flow category 2 

were left with scanty flow by 3rd cycle. 

Table 7: Efficacy of WHS on amount of flow in increased duration of 

cycles 

Flow Baseline cycle 1 Cycle 2 Cycle 3 Cycle 4 

Heavy 9 7 2 2 

Moderate 9 14 19 19 5 

Scanty 8 5 5 2 

4.2.6. Effect of trial drug on menstrual flow (decreased duration of 

Cycle): (n=5) 

In case of decreased duration of cycles, 2 had heavy flow and 3 had 

moderate (normal) flow. By 4th cycle all the subjects have fallen under 

the moderate flow category. 

Table 8: Efficacy of WHS on amount of flow in decreased duration of 

cycles 

Flow Baseline cycle 1 Cycle 2 Cycle 3 Cycle 4 Cycle 5 

Heavy 2 1 1 1 0 0 

Moderate 3 4 4 4 5 2 

Scanty 0 0 0 0 0 0 

13

4.2.7. Effect of trial drug on normal cycle duration & bleeding days 

with heavy flow (n=8): 

Among the subjects with heavy flow (under normal duration of cycle and 

bleeding days), only one subject showed improvement by the 3rd cycle 

(P>0.05). 

Table 9: Efficacy of trial drug in amount of flow 

N=8 Baseline Cycle 1 Cycle 2 Cycle 3 Cycle 4 

H 4 3 3 3 2 

M 4 5 5 5 6 

S 0 0 0 0 0 

4.2.8. Efficacy of trial drug on number of pads (normal duration of 

cycles (n=8): 

Subjects with moderate flow have been documented using a range of 18 to 

35 pads per cycle. All the subjects were having almost normal pads usage 

at the baseline (mean = 30.3) and at the end of the study (mean= 19.67). 

Table 10: Effect of trial drug on number of pads 

No. of 

pads 

Cycles 

Baseline Cycle 1 Cycle 2 Cycle 3 Cycle 4 

30.3 23.25 25.44 21.63 19.67 

No Adverse Drug Reactions were reported / documented with any of the 

subjects with the trial drug. No patient is withdrawn from the study due to 

reactions related to study drug or due to any other adverse event. 

5. SUMMARISED STUDY AND CONCLUSION: 

• 44 female subjects suffering from menstrual irregularities with 

the mean age of 23 years (+ 4.04) have been administered with 

WHS/2004/02 (DRF/AY/4007) orally at a dose of 10 ml twice daily 

for 120 days. 

• 22 out of 26 (84.62%) with increased duration of cycles showed 

mean reduction of 15.7 days from baseline. The cycle duration was 

reduced from 46.15 days to 30.45 days (P

World Ayurveda Congress and Arogya Expo 

A Newsletter By 

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UPCOMING EVENTS 

Date: 27-DEC-12 to 30-DEC-12 

5th World Ayurveda Congress will be held at Bhopal in December 2012. 

It will be organized by Vijnana bharati and Government of Madhya 

Pradesh. Vijnana Bharati or VIBHA is a national movement dedicated 

to the integrated development of Bharat through the intervention of 

science, engineering, and technology. The largest gathering of its kind 

for exploring new frontiers in the field of medicine, the World Ayurveda 

Congresses started in the year 2002 at Kochi, Kerala. WAC attracts people 

from all disciplines to present their research works related to Ayurveda and 

allied sciences. It takes keen interest in trade Improvement, acceptance of 

Ayurveda as a medical system, registration of Ayurvedic practitioners and 

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