STATUS REPORT

Development of Herbo-Mineral formulation

(HMF) for Chronic Pancreatitis (CP)

Clinic to Concept

(Positivism)

Sponsored by:

Uttarakhand Council of Science & Technology

Ministry of Science & Technology,

Government of Uttarakhand

Pricipal Investigator:

Vaidya Balendu Prakash VCP Cancer Research Foundation,

Mandir Marg, Turner Road, Clement town,

Dehradun 248002, Uttarakhand, INDIA

Telephone: 0135 2640792, 2640405, Mobile: 9837028544 Email: balenduprakash@gmail.com

Website: www.ayurvedapancreatitisclinic.com

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Vaidya Balendu Prakash met Hon’ble Chief minister of Uttrakhand on

September 4, 2014 with a document entitled “Mission Noble Prize” focusing

on his innovation in the treatment Chronic pancreatitis by using his self

prepared mineral complex. Hon’ble CM took note of his work and

forwarded the said document to DG, UCOST with a note to “take it urgent”.

Accordingly, a four members inspection group* headed by Dr Rajendra

Dobhal, DG, UCOST visited the premises of Vaidya Balendu Prakash 4th

September 2014 to take ready stock of the claim of Vd Balendu Prakash

regarding the treatment of CP patients. The inspection committee viewed

case files of few CP patients and also met with some patients of CP who

were undergoing treatment at his centre. Committee also visited

manufacturing site and took detailed note of the process of manufacturing of

HMF used in the treatment of CP. After deliberate discussion, committee

concluded;

that HMF prepared by Vaidya Balendu Prakash has proven curing potential

for CP, a fatal progressive inflammatory disease of Pancreas;

that HMF deserve worth promotion for CP, however, it need to examine for

characterization, pharmacology as well as toxicology potential followed by

clinical trials;

that the process of patent filing for the proven HMF for CP shoule be

initiated at the earliest;

that a detailed project proposal for financial assistance should be submitted

by Vaidya Balendu Prakash to UCOST;

that the said project proposal will be sent to few independent experts of the

field to seek their views and suggestions

that UCOST will identify resource institutes in Uttrakhand or other parts of

India to carry ut scientific analysis.

Dr. B P Purohit (Joint Director), Dr D P Uniyal (Senior Scientific Officer),

Dr. Kailash Bhardwaj (Junior Scientific Officer)

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Remarks from the experts:

1) Chronic Pancreatitis (CP) is a global uprising disease. It is also fatal in nature.

Surprisingly, it has highest incidence from India, especially in the southern states. In the

above background, the subject of the project is quite important and interesting. I have

personally interacted with few beneficiaries of the treatment this coupled with stated

objectives, justify the merit of the proposal. Though the project is not on the the line of

new drug development, however, the development path chosen in this project is

scientific, novel, economic and time saving. Best part is, that prima facie clinical efficacy

has already been established basis documented clinical practice and the project has been

submitted to establish its scientific basis with minimum or no chance of failure.

Rasa-Shastra has been one of the most glorified chapters of Ayurveda. These days it is

much talked but least practiced. Proposed global ban on Mercury is staring at the face

of Ayurveda posing threat to Rasa-Shastra. Project like this may actually bring forth

the importance of subject and save this crucial specialty. This is why the proposed

project assumes more importance and significance. Any scientific development which

could establish the therapeutic efficacy of any Rasa preparation for a fatal and

unanswered disease will give a big boost to sustainability and revival of Rasa-

Shastra.

Usually development of new drug takes nearly 15 years with a hopping budget of approx.

USD 1.8 billion. I am wondering that creation of projected drug master file basis safety

and clinical studies could be accomplished in only 7 years and with a budget of mere Rs

5,07,90000 (Five crores Seven lakh ninety thousands only). Being a scholar of Ayurveda

and modern pharmacology I would be very much interested to see that this path making

route of innovation succeeds. I must congratulate Vaidya Balendu Prakash, Uttarakhand

Council for Science and Technology, and State Government of Uttarakhand for taking

such a bold step.

- CK Katiyar, MD (Ay), Ph D (Pharmacology), BHU, Varanasi Member, National Academy of Science India,CEO Technical Emami Ltd, Kolkata,Former, Director,Herbal Drug Research, Ranbaxy Research Labs, Gurgaon,Former Vice President and Head R&D, Dabur India Ltd,Member Governing Body and Executive Council, All India Institute of Ayurveda, Department of AYUSH, Government of India, New Delhi (November 7, 2014)

2) I found the project genuine for the cause from all angles of evaluation. I

examined it on basis of literature, research, pharmaceutics, administration and

finance and have reasons to believe that this is a flawless project. I am of opinion

that this project may be a mile stone path breaking research to establish safety and

efficacy of HMF of Ayurveda

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- Anand Kumar Chaudhary, M D (Ayurveda), Ph.D.

Professor & Head, Department of Rasa – Shastra Ayurvedic Pharmaceutics),

Faculty of Ayurveda, Institute of Medical Sciences & Superintendent, Ayurvedic

Pharmacy, Banaras Hindu University, Varanasi – 221005, (November 11, 2014)

3) I am very happy with the meticulous planning and quality of the project – that

will meet international standards. It will also prove tf this will not only prevent /

treat Chronic Pancreatitis but also has the potential to prevent Cancers. If proven to

be effective, it will be a landmark contribution to world medicine and shall put

Uttarakhand firmly on the map of innovation in showing the benefit of traditional

Indian medicines – complying with standards of modern medicine.

- Dr Purvish M Parikh, MD, DNB, FICP, Ph.D, ECMO, CPI, MBA

- Member Board of Studies, Maharashtra University of Health Sciences, Director of

Precision Oncology and Research, Asian Institute of Oncology. Emeritus Editor –

Indian Journal of Medical Sciences (November 15, 2014)

4) Chronic Pancreatitis is a serious condition of which the causes is not

fully understood, the management is difficult, largely symptomatic and remains a

major challenge. In India this is of major concern because of high incidence and the high

cost of the treatment. In absence of effective drugs, the novel drug development or

new strategy for treatment should be considered an unmet need.

The Herbo- mineral formulation(HMF) prepared with the the concept of RASA-

SHASTRA of Ayurveda has shown significant promise in the clinical practice. I

understand the HMF is a complex formulation of Cu, Hg and S. The herbal decoration is

made with juices of herbs fruits and fruits.

The formulation now must be scientifically validated in well drafted clinical study in

adequate number of subject and with modern scientific parameters. The preparation need

to be fully standardized and the data for stability, impurity etc need to be generated.

Detailed regulatory toxicology data should be generated. Dose calculation should be done

in different set up- say children, adults. Iteration studies should also be done

The project in general is well drafted. It should be done in Phase wise manner. The total

budget for the entire project of this nature is modest but need to be detailed. I

strongly recommend the Government to sup[port the project and would also recommend

that there should be two committees a. for refining and fine tuning the project proposal;

b .for regular monitoring the project and suggest go no go decision in between. I consider

this project of great relevance and wish it great success.

- Dr.Y.K.Gupta,M.D.,FAMS,FNASc,FIPS,FIAN,FST,FIACS,FAEB

Professor and Head, Department of Pharmacology, Former President, Society of

Toxicology I( India ), Former President,Indian Pharmacological society, National

Scientific Co-ordinator, Pharmacovigilance Program of India, Editor, Indian

Journal of Physiology and harmacology( Pharmacology), All India Institute of

Medical Sciences, New Delhi-110029, India (November 15, 2014)

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Filing of Patent:

A patent application form was submitted to competent authorities on 4th

October, 2014 through attorney. Afterwards a Provisional Patent

Specification no 3373/DEL/2014 dated 20/11/2014 has been filed with

patent office in Delhi.

A draft project proposal was prepared to carry the drug development

program as joint venture of V C P cancer Researcg Foundation and UCOST

Dehrdaaun. The proposal was sent to few acclaimed experts on the subject.

Following that, A three hours long program “path of Innovation” was held

on November 23, 2014 at ANM Ghosh Auditorium, ONGC Campus,

Dehradun in the presence of the followings:

1. Shri Harish Rawat; Hon’ble Chief Minister of Uttrakhand

2. Ms Sunita Narain, Padamshri and Chief Editor of Down to Earth

scinec magazine.

3. Smt Manorma Sharma, Hon’ble MP, Rajya sabha

4. Shri M A Baby, Member Politburo, CPM, India, former MP Rajya

sabha, Former Mp Rajya Sabha and MLA Keral state of

legistagive assemble of keral

5. Shri Salim Iqbal Sherwani, Formet union Minister of health and

Family welfare and foreign external affairs

6. Dr. Y K Gupta, Prof & Head, Department of Pharmacology,

AIIMS, New Delhi

7. Dr G S Toteja, Director, Desert Medical Centre (ICMR), Jodhpur,

Rajasthan

8. Dr. C K Katiyar, CEO (Technical – Health Care), Emami Group of

Companies, Kolkata

9. Dr S K Sharma, Former Advisor Ayurveda, Department of

AYUSH, Ministry of Health & Family Welfare, Government of

India, New Delhi

10. Dr Rajendra Dobhal, DG, UCOST, Dehradun

11. Vaidya Balendu Prakash, Padamshri, Founder Director, VCP

Cancer Research Foundation, Dehradun

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Besides, large number of scientist, physicians from Ayurveda and modern

medicines, researchers, faculty, students, eminent people and media

participated in nearly three hours long proceedings of the event. Many

beneficiary patients of CP who were successfully treated in the past by VBP,

also came from different parts of the country. These were presented to guest,

people and media to share their experiences.

DG UCOST made opening remarks on the subject. Later, Vaidya Balendu

Prakash made a presentation of the project. All experts and policy makers

whole heartedly supported the project proposal. Following that Hon’ble CM

announced the project of great importance for humanity, science, State and

Country and extended full support of his government to the project proposal.

January 3rd 2015, a meeting was held at DG office, UCOST where it was

decided that a minimum amount of grant could be released to purchase raw

material and consumables along with three months fellowship for two men

power to initiate the work on the project.

January 8th 2015, a grant of Rs. 2,77,000/ (Rs. Two lacs Seventy Seven

Thousand only) was sanctioned vide order no UCS&T/R&D/MED-01/2014-

15/8768. A bank cheque no 034899 dated 08/01/2015 drawn on Union Bank

of India for Rs 2,50,000 (Rs Two lacs Fifty Thousand only) was released in

favour of VCP Cancer Research Foundation.

January 10th 2015, a separate bank account was opened with Canara Bank,

Turner Road, Clement Town Branch to carry forward the project.

Procurement of raw material:

S. No Date Item Quantity Amount Sources 1. 2. 3. 4. 5. 6. 7. 8. 9.

08-01-2015

10-01-2015

Copper wires (Used) Light Diesel Oil Hingul Amlasaar Gandhak Til oil Butter milk Cows urine Triphala Kulathi daal

15 kg 400 litre

100 kg 45 litre

100 litre 100 litre

8 kg 8 kg

7’500.00 22,668.00

Local vendor Local vendor

Delhi Delhi

Local vendor Local vendor Local vendor Local vendor Local vendor

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……14th January, 2015

HMF is a complex compound of processed Cu*, Hg* and S*. Under its

preparation, known amount of processed Hg and processed S are ground in

dry condition in a hand operating mortar and pestle to obtain a black powder

called “KAJJALI” to this powder known amount of processed Cu is added

and ground in herbal decoction (Lemon, Luffa echinata and Clitoria

ternatea) in stone mortar. The compound is ground for several hours in a

motor operated wet grinder till the particles become fine ranging from 0.046

micron to 5 micron. The mixture is dried in sun and packed in covered clay

pots (indigenously designed Nalika Damroo Yantra) and subjected to

continuous heating at the temperature range between 400c to 600 c for 24 to

120 hours. The fired compound is taken out of the clay pot on cooling. The

above process of grinding and heating is termed as one cycle. Such a cycle is

repeated sixty times after adding and grinding same amount of sulfur with

aforesaid liquid. A black powder with unknown chemistry is obtained and

used for treatment of the patients of CP. A total 16 kg of HMF will be

required to undertake proposed study**.

*Processed Cu: Copper thin sheets are procured and subjected to Light Diesel Oil

(LDO) Furnace until all sheets turn red hot which are then dipped into sesame

seed oil. The process of making Cu sheets red hot and pouring into liquids are

repeated seven times by using sesame seed oil, Buttermilk, Cow’s urine,

Decoction of Triphala and Kulath Daal. Later, the sheets are washed and dried

under sun.

*Processed Hg: Mercury is extracted from Hingul (Mercurous sulfide) using

traditional method (Kanduk Yantra). Later Hg is ground with copper sheets in

lemon juice and evaporated (Urdhvapatan) using Shivling-shaped Urdhvapatan

Yantra. The evaporated Hg so obtained is further ground with Cu in lemon juice

and evaporated same way. This process is repeated seven times and hg so

obtained is called Tamroth Parad (TP). That is further ground with seven plant

origin substances (Arka Khseer, Snuhi Ksheer, Dhatoora Patra Swaras, Kaner

Mool Twak Kwath, Opium water, Ghughunchi Kwatha, Kalihari Kwath) and

seven times and evaporated in the same fashion. This Hg is termed as Vishoth

Parad (VT) or processed Hg and is used in the preparation of HMF.

*Processed S: Sulphur (Amlasar Gandhak) is first melted in an iron vessel with

Ghee and then poured into the decoction of Triphla. When cooled, it is filtered

and dried under sun. It is known as Shodhit or processed sulfur.