Indo - US Symposium on Scientific
Approaches to Quality, Safety and
Efficacy Assessment of Ayurvedic &
Botanical Products
October 3-6, 2005
Venue
India Habitat Centre
Lodhi Road
New Delhi – 110003
Organised by
Regional Research Laboratory,
Canal Road, Jammu Tawi -180 001
In collaboration with
National Center for Natural Products
Research
School of Pharmacy
University of Mississippi, USA
Background
During the past decades, public interest in natural therapies has
increased dramatically, not only in the developing world but also in
industrialized countries. This has increased the international trade in
botanicals enormously and has attracted many large pharmaceutical and
consumer products companies worldwide. Until a few years ago, only
small companies had interest in the marketing of herbal medicines.
Currently, most large multinational companies are including herbal drugs
in their product portfolios. It is estimated that the European market alone
reached about US$ 7 billion in 1997. The German market corresponds to
about 50% of the European market, about US$ 3.5 billion which
represents about US$ 42.90 per capita. This market is followed by France,
US$ 1.8 billion; Italy, US$ 700 million; the United Kingdom, US$ 400
million; Spain, US$ 300 million; the Netherlands, about US$ 100 million.
Thus there is an increasing demand for herbal medicines in
developing as well as developed countries. The top ten plants used as
nutraceuticals in U.S., have sales of over $ 500 million, yet surprisingly,
these do not include a single plant of Indian origin even though there is
substantial documentation and information on plants used in Ayurveda
and Siddha.
The Indian market of medicinal plants / herbal products is of the
order of US$ 875 million (2000), and the total medicinal plant-related
trade in India is of the order of 5.5 billion US dollars and growing rapidly.
According to WHO, the international market of herbal products is
estimated to be US$ 62 billion which is poised to grow to US$ 5 trillion by
the year 2050.
However, India's share in the global export market of medicinal
plant-related trade is just 0.5%. India's export from medicinal and herbal
plants in year 2000 was only US$ 100 million only which was expected to
touch US $ 650 million annually by 2005. India, with its diversified
biodiversity and traditional knowledge base has a tremendous potential
and advantage in this emerging area.
The importance of quality control and standardization of botanical
products is of utmost concern for global acceptability. The source and
quality of raw materials, storage, post-harvest handling and
manufacturing process play a pivotal role in guaranteeing the quality and
stability of such preparations. The role of chemical and molecular markers
to standardize the potency of such products is very important. Moreover,
the levels of heavy metals, pesticide residues and mycotoxins which make
these products harmful needs to be critically evaluated before marketing.
In spite of the available pharmacopoeias and a host of information on the
phytochemical constituents of the herbs of medical importance, a huge
problem facing manufacturers in assuring the consistent quality of herbal
supplements is caused by the natural
phytochemicals that occurs in plants.
variation
of
endogenous
Thus, for maintaining quality of botanicals, it is important to follow
Good Sourcing Practices (GSP), Good Agricultural Practices (GAP) and
Good Manufacturing Practices (GMP), and to implement sensitive and
practical analytical methods for standardization and quality control.
In addition to the medicinal plant industry, there are over 8000
licensed manufacturing units of Ayurvedic medicine in India, with less
than 50 being large and leading manufacturing companies. Thus, the
majority of them operate on a small scale. A number of initiatives have
been taken by the Government of India to revamp these units and ensure
quality adherence in manufacturing. Recently the Government of India
introduced Good Manufacturing Practices (GMP) in manufacturing of
Ayurvedic medicine to ensure production of good quality medicines for the
consumers in the domestic and international market. However, the
manufacturing process has very little improved except in large
manufacturing houses who have modernized their processing plants.
The present need is therefore to subject Indian Medicinal herbs to
rigorous modern scientific testing and develop standards so as to
maintain quality for global competitiveness. A number of research centres
in the public and private sector have been engaged in this area,
individually as well as in private public partnerships (PPP) to meet the
challenges of world markets. There is a critical need to bring together
scientists, industry representatives, policy makers and regulatory
agencies to consider the challenges and opportunities of the next decade.
Objectives of the Symposium :
The symposium will focus on the current status of Indian medicinal
plants and herbal products for proper species (botanical) identification,
methods of cultivation, and introduction or domestication. It would also
deal with sustainable collection and processing methods, seeds and
product sourcing, improved chemical and agronomic traits, harvesting
and drying methods, packaging and sample forwarding methods, and
quality control and assurance for plant products for local, regional, and
international markets.
The symposium will also provide Indian herbal drug/ botanical
supplement industry and other R & D institutes involved in research on
botanicals to present their strengths and approaches in the research and
manufacture of botanical drugs/ supplements to the visiting scientists
from USA and Europe coming from various research / academic institutes,
Industry and government regulatory authorities.
Such an interaction would help all the players in the trade of
botanicals to understand consumer demands and quality parameters in
International market and develop methods of production that meet those
demands of product quality and efficacy, which either exceeds or
corresponds to international standards. This would make these industries
internationally competitive with greater share in the global market.
Expected Benefits:
The symposium would result in:
- Assessment of the status of research & manufacturing in the
Indian herbal drug sector;
- Improved compliance to quality parameters by herbal drug
manufacturers;
- Understanding trends and developments in global botanical
supplement market with a view to improve Indian exports;
- Improved quality, competitiveness and acceptability of Indian
Ayurvedic drugs in the domestic and international market; and
- Training of Indian participants on quality control measures in
plant drugs.
Participants:
A select group of scientists and managers involved in quality
compliance in herbal drug / nutraceuticals industry, researchers and
policy makers from academic, R & D, government/non-governmental
institutes and regulatory authorities will be invited to attend this
symposium - where they will be exposed to: global developments in the
field of plant-derived drugs; quality, safety and efficacy concern of the
international community; and ways and methods to improve their
manufacturing processes and techniques to assess quality of their
products using modem techniques of analysis. The maximum number of
participants in the symposium would be limited to 50.
Speakers will be eminent national and international scientists and
experts from
industry, R & D Institutions, academia, nonprofit
institutions, regulatory authorities and Centres of Excellence within India
and abroad. Participants from USA will include experts from U.S. Food
and Drug Administration, National Institutes of Health, American Herbal
Products Association and National Center for Natural Products Research,
University of Mississippi. The topics to be deliberated during the
symposium include:
Topics for symposium:
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Collection, authentication, cultivation, harvesting and post
harvesting handling and storage of medicinal plants.
Private public participation for quality production of medicinal plants.
Development of appropriate agricultural production systems for
medicinal and aromatic plants.
Quality control of plant products using traditional & contemporary
techniques.
Medicinal compound extraction, isolation and identification.
Traditional knowledge & Industrial innovations in manufacturing of
plant-based medicine.
Methods used in determining identity, purity, quality and strength
of medicinal & aromatic plants.
Isolation techniques for markers for standardization.
The search of new bioactive compounds from higher plants and
intellectual property rights.
Bioevaluation and safety of botanical preparations.
Validation of therapeutic claims of herbal drugs.
Regulatory aspects of botanicals / nutraceuticals and herbal drugs
Industry-institute partnership for improving quality compliance.
Reverse pharmacology concept for clinical evaluation of herbals.
Mode of Registration:
The symposium is being organized in collaboration with the National
Center for Natural Products Research, School of Pharmacy, University of
Mississippi, USA. The participation will be primarily on the basis of
nomination / sponsorship from USFDA, NIH and Indian R & D and
manufacturing companies and regulatory authorities. Selected experts
from India and abroad will be invited to deliver lectures in the areas listed
above.
Date & Venue :
Symposium will be held in New Delhi from 3 -6 October, 2005 at
India Habitat Center, Lodhi Road, New Delhi – 110 003 Tel. : 01124682004, 24682054, 2468222.
Registration fee :
International delegates US$ 250
Industry participants
Rs. 10,000/Academicians / Scientists
Rs. 2,000/-
Contact Persons :
Dr. G. N. Qazi, Director, Regional Research Laboratory ( CSIR), Canal
Road, Jammu Tawi-180 001; Phone : 0191-2546368, 2578923 ; Fax :
0191-2548607, 2547850 ; E mail : qazi_gn@yahoo.com
Dr. Ikhlas Khan, Assistant Director, National Center for Natural Products
Research, School of Pharmacy, University of Mississippi, University , MS
38677, Phone : (662)915-7821; Fax : (662)915-1006; E mail :
ikhan@olemiss.edu
Dr. Y. S. Bedi, Organising Secretary, Regional Research Laboratory
( CSIR), Canal Road, Jammu Tawi-180 001, Phone : 0191-2579117,
2578206 Ext. 204;
Fax : 0191-2548607, 2546030 ; E mail : ysbrrljm@rediffmail.com
“Indo – US Symposium on Scientific Approaches to Quality,
Safety and
Efficacy Assessment of Ayurvedic & Botanical Products”
Gulmohar Hall
India Habitat Centre
Lodhi Road, New Delhi- 110 003, India
3-6 October 2005
Programme
Monday, 3 October 2005
10:00 – 11:00
Registration ( Tea /Coffee)
11:00 – 11:10
Welcome Address :
Dr. G. N. Qazi, Director RRL,
Jammu
11:10 – 11:30
Introductory Remarks : Prof. Ikhlas Khan / Prof. Larry
Walker, University of MS, USA
11:30 – 11:55
Inaugural Address :
Dr. R. A. Mashelkar, Director
General CSIR, New Delhi
11:55 – 12:30
Keynote address :
Dr. Somesh Sharma,
CSO,Nicholas Piramal IndiaLtd., Mumbai
12:30 - 12:40
Remarks
Dr. Altaf Lal, Health Attache, US
Embassy, New Delhi
12:40 – 12:45
Vote of thanks :
Dr. Y. S. Bedi,RRL, Jammu
12:45 – 13: 30
Session I :
Lunch Break
Quality Assessment
Chairman: Prof. Lary Walker , Director , National Center for Natural
Products Research,
University of Mississippi, USA
13:30 – 14:10 :
Global Health
Traditional Medicine: Modern Approach for Affordable
by Prof. Bhushan Patwardhan,
14:10 – 14:50 :
Quality Standardization and Regulation of Drugs from
Indian Systems of Medicine by Dr. Surinder Kumar Sharma
14:50 – 15:30 :
Perspective by
Quality and Safety of Botanicals - Global Cooperation
Prof. Ikhlas A. Khan
15: 30 – 15:45
Tea/coffee break
15:45 – 16:25 :
LC/MS Method Development for the Analysis of Dietary
Supplements by Dr.
Steven M. Musser,
16:25 – 17:05 :
Standardization of Ayurvedic / Herbal Products and
Regulatory Relevance by .
Dr. Narendra S. Bhatt
17:05 – 17:15 :
Remarks by the Chairman
Tuesday, 4 October 2005
Session II
: Standardization
Chairperson :
Dr. Susan J. Walker, Director, Division of Dietary
Supplement Programs, ONPLDS, CFSAN, US FDA
09:00 – 09:55 :
NMITLI Effort in Drug Development : Arthritis as Case
Study by Prof. Bhushan
Patwardhan / Dr. Arvind Chopra
Note : Each Lecture restricted to 30-35 minutes followed by 5-10 minutes
question-answer / discussion
09:55 – 10:35 :
Steven Dentali
Standardization of Botanical Product Ingredients by Dr.
10:35 – 11:15 :
Therapeutics Potential for Natural Products from Ayurveda
by Dr. Narendra S. Bhatt,
11:15 – 11:30
Tea/coffee break
11:30 – 12:10 : Herbal Product Standardization - Industrial Innovations"
by Dr. Vijay Chauhan
12:10 – 12:50 : PhytomicsQCTM: A Quality Control Platform for Botanical
Drugs by Dr. Rajendra Marathe
12:50 – 13:00 :
Remarks by Chairperson
13:00 - 14:00
Lunch break
Session III
: Safety Assessment
Chairman: Prof. Mahmoud A. EISohly, Research Professor RIPS,
Professor of Pharmaceutics, The University of Mississippi,
USA
14:00 – 14:40 :
Clinical Trials on Herbal Drugs: Overview and Way
Forward by Dr.C. K. Katiyar
14:40 – 15:20 :
A SUCCESS STORY OF DESORIS: TRADITIONAL
SYSTEM AND PHARMACEUTICAL INNOVATION BY
DR. SUDERSHAN ARORA
15:20 - 15: 40
Tea/coffee break
15:40 – 16:20 :
Development of Herbs and Herbo-mineral Preparations for
global positioning by Dr. (Mrs.) Rama Mukherjee
16:20 – 17:00 :
Remarks by the Chairman & Discussion
Wednesday, 5 October 2005
Session IV : Regulatory Assessment
Chairperson:
Dr. Jeanne I. Rader, Director, Division of Research
& Applied Technology, CFSAN / FDA , USA
09:00 – 09:40 :
Regulatory Provisions & GMP for ISM Drugs - Current &
Future scope for Progress by
Mr. Ranjeet Puranik
09:40 – 10:20 :
Perspectives on Evaluating the Health Benefits of
Botanical Products: Scientific,
Regulatory, and Consumer by
Dr. Leila G Saldanha
10:20 – 11:00 :
Muthuswamy
Regulations for Indian Herbal Drugs by Dr Vasantha
11:00 – 11:20
Tea/coffee break
11:20 – 12:00 :
Regulation of Botanical Products by Dr. Susan J. Walker
12:00 – 12:00 :
Remarks by Chairperson
Note : Each Lecture restricted to 30-35 minutes followed by 5-10 minutes
question-answer
/
discussion
12: 10
13:00 – 14:00
Departure for Dabur India Ltd., Sahibabad
Lunch
14:00 – 15:00 :
Presentations on the activities of Dabur India Ltd,
Sahibabad
15:00 - 17:00 :
Visit to R&D Center : Dabur India Ltd., Sahibabad
Thursday, 6 October 2005
Session V : Indian Herbals
Chairman: Prof. R. Kumar,Honorary Professor, JNCASR,
Bangalore
I.I.Sc.,
09:00 – 09:40 :
Role of Angiogenesis in Enhancement of Wound Healing
and Chemoprevention of
Cancer by Novel Botanicals by Dr. Radha K Maheshwari
09:40 – 10:20 :
Promotion and Development of Medicinal Plants- Indian
Initiative by Mr. B.S. Sajwan
10:20 – 11:00 :
Good Collection, Cultivation and Post-harvesting Practices
of Medicinal Plants for
Quality Assurance of Botanicals by Dr. S.
Natesh
11:00 – 11:20
Tea/coffee break
11:20 – 12:00 :
Traditional Knowledge Digital Library- Sharing of
Experience by Mr. V. K. Gupta
12:00 – 12:10 :
Remarks by the Chairman
12:10 - 13:10
Wrap up Session
13:10 – 14:30
Lunch
Note : Each Lecture restricted to 30-35 minutes followed by 5-10 minutes
question-answer
/
discussion
Side Line Meetings
Monday, 3 October 2005
Venue
Windsor Hall, HOTEL LE MERIDIAN, NEW DELHI
18:30
SIGNING OF MEMORANDUM OF UNDERSTANDING BETWEEN
COUNCIL OF SCIENTIFIC &
INDUSTRIAL
RESEARCH, NEW
DELHI, INDIA AND THE UNIVERSITY OF MISSISSIPPI, USA FOR COOPERATION IN THE
field of “Development of Herbal and Botanical Products of
Global Standards”
19:30
Dinner hosted by Director General CSIR, New Delhi
Thursday, 6 October 2005
VENUE
Indian Council of Medical Research, Conference Hall
17:30
Joint Meeting of USFDA, US Industry, ICMR, CSIR, Dept. of
AYUSH, Indian Industry
Representatives
19:30
Dinner
PRESS NOTE
Indo – US Symposium on Scientific Approaches to Quality, Safety and
Efficacy Assessment of Ayurvedic & Botanical Products at RRL-Jammu
Dr R. A. Mashelkar, Director-General, Council of Scientific and Industrial Research
(CSIR), New Delhi inaugurated a four day scientific event entitled “Indo – US
Symposium on Scientific Approaches to Quality, Safety and Efficacy Assessment of
Ayurvedic & Botanical Products” being organised by Regional Research Laboratory,
Jammu in collaboration with National Center for Natural Products Research,
University of Mississippi, USA at India Habitat Centre, Delhi. A gathering of 100
researchers was present. This included eminent national and international scientists
and experts from industry, R&D Institutions, academia, nonprofit institutions,
regulatory authorities and Centres of Excellence within India and abroad.
Among the distinguished scientists were Prof. Larry A. Walker,
Director, National Center for Natural Products Research (NCNPR),
University of Mississippi, USA; Dr Somesh Sharma, Chief Scientific
Officer, Nicholas Piramal, Mumbai; Dr Ikhlas A. Khan, Director of FDA
Program, NCNPR, University of Mississippi, USA; Dr Susan J. Walker,
Director, Division of Dietary Supplement Programs, USFDA; Dr Altaf
Lal, Health Attaché, US Embassy, New Delhi; Dr S. K. Sharma,
Adviser, Department of AYUSH, Ministry of Health and Family Welfare,
Government of India, New Delhi, Dr Steven Dantali, US Botanical
Industry, USA; Prof. R. Kumar, Fellow, Indian Institute of Science,
Bangalore and Dr G. N. Qazi, Director, Regional Research Laboratory,
Jammu.
Dr R. A. Mashelkar in his Inaugural Address explained that drug discovery using
modern science is a very expensive and time-consuming process. There is a need to
develop safe and affordable drugs. Herbal drugs are widely acceptable. CSIR is
deeply involved in the development of herbal drugs in collaboration with Ayurvedic
establishments. In this context, the collaboration between India and USA will be
highly beneficial and this is the need of time for looking into requirements of
mankind globally. He was hopeful that the use of good practices, modern
technologies, Ayurvedic concept, collaborative efforts etc., would lead to
development of the products that will be available in the market.
Dr G. N. Qazi, Director, Regional Research laboratory, Jammu,
delivered the Welcome Address and introduced the audience to the
objectives of the Symposium and present scenario in the area. He also
spoke about the advantages and disadvantages of herbal drugs.
Prof. Larry A. Walker, Director, National Center for Natural Products Research
(NCNPR), University of Mississippi, USA, expressed his interest and that of his
Institute in the area of natural products chemistry and herbal drugs and hoped that
Indo-US collaboration have great potential.
Dr Ikhlas A. Khan, Director of FDA Program, NCNPR, University of Mississippi, USA
mentioned that collective efforts of India and USA by academicians, industries and
government agencies would be of great interest in the area of developing herbal
drugs.
Dr Altaf Lal, Health Attaché, US Embassy, New Delhi mentioned that the Symposium
and collaborative efforts by the two countries would be of immense importance for
both the countries. He highlighted a few success stories of the collaborative efforts.
Prof. R. Kumar¸ Fellow, Indian Institute of Science, provided
introductory remarks about the Symposium, Bangalore and he
explained the importance of herbal drugs and the concept underlying
it.
Dr G. N. Qazi presented an excellent note about CSIR’s capabilities, contributions
and Public Private Partnership in the area of herbals. He mentioned that the Indian
System of Medicine has stood the test of the time and has the potential to meet the
need of the global market. To achieve the objective, there is need to include modern
scientific approach and technologies for standardization of herbal drugs to meet the
quality, safety and therapeutics. The approach is also essential for regulatory
compliance in force from time to time and all such related issues will be discussed in
the present symposium.
Dr Somesh Sharma in his address discussed the possibilities of developing
therapeutics based on plants. He explained the advantages of using plant extracts in
terms of modern science taking arthritis as an example. He also mentioned that due
care should be paid to quality, efficacy, and safety.
During this four-day event, distinguished speakers addressed the contemporary
issues on the quality, safety, efficacy of ayurvedic and botanical products. The
lectures delivered by the experts would be highly useful to the participants from
industry, academic institutes and regulatory bodies.
An MoU between CSIR and NCNPR, University of Mississippi, USA, is expected to be
signed with the objective to develop traditional medicinal herbs for therapeutic uses
based on modern scientific knowledge by collaborative efforts. The herbal drugs/
botanicals so developed would be of such a high standard that it would meet
regulatory requirements of both the countries and beglobally competitive.
Dr Y. S. Bedi, Senior Scientist, Regional Research Laboratory, Jammu presented vote
of thanks.
Support to the symposium was extended by the Council of Scientific & Industrial
Research, New Delhi: Indian Council of Medical Research, New Delhi; Department of
Science & Technology, Government of India, New Delhi and Department of AYUSH,
Ministry of Health & Family Welfare, Government of India, New Delhi.