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 variation of endogenous phytochemicals that occurs in plants.

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:

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. : 011- 24682004, 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 Lunch Break

Session I : Quality Assessment

Chairman: Prof. Lary Walker , Director , National Center for Natural Products Research, University of Mississippi, USA

13:30 – 14:10 : Traditional Medicine: Modern Approach for Affordable Global Health by P rof. Bhushan Patwardhan,

14:10 – 14:50 : Quality Standardization and Regulation of Drugs from Indian Systems of Medicine by D r. Surinder Kumar Sharma

14:50 – 15:30 : Quality and Safety of Botanicals - Global Cooperation Perspective by

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 : Standardization of Botanical Product Ingredients by Dr. Steven Dentali

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 : PhytomicsQC TM : 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 : Regulations for Indian Herbal Drugs by Dr Vasantha Muthuswamy

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:: Departure for Dabur India Ltd., Sahibabad

13:00 – 14:00 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, I.I.Sc., Bangalore

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 M r. 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, H otel 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 co-operation 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.