Appendix 1
Database precedents
There are a number of useful database projects already underway in India. Each can provide useful starts for this proposal although none provide all the material needed. The projects include the following.
Pragya has conducted comprehensive ground surveys of the medicinal plants in the high-altitude Himalayan region. There is detailed botanical and ecological information on these plants. There is more information on the usage (including propogation, cultivation and harvesting NOT formulations and dosage) but only for endangered plant species at the present. There is no information on the chemical composition and active principles as yet.
Pragya understand that Indian traditional plant medicine knowledge is about more than Ayurveda and Unani. Whereas all other major information systems concentrate on the most widely used codified and mainstream systems above. They have not, yet, taken into account the local tribal medicine traditions or other less widely used traditional medicine systems.
Botanical Survey of India (Government of India)
This is an inventory of the flora of the country, including information on endangered species. There are three strands to the database, one of which is medicinal plants. The database so far includes 38 plants from A-H. The information given includes plant names, traditional use, modern use, distribution, ecology and cultivation, chemical contents and adulterants.
Traditional Knowledge Digital Library (TKDL - Government of India)
Three government departments collaborated on this project. The aim is to stop biopiracy by making information available for international patenting purposes, preventing the granting of wrong patents based on Indian traditional knowledge. The TKDL includes 53000 Ayurvedic formulations and 41000 Unani formulations (concentrating on 2 mainstream systems of traditional medicine so far). The TKDL also aims to disseminate information about Indian traditional knowledge on medicines and accelerate modern research on Ayurveda, leading to acceptability at an international level
Foundation for Revitalisation of Local Health Traditions (FRHLT)
This is an organisation based in the Western Ghats in the southwest of India.. They have set up a large editorial group including international luminaries, linked to a number of databases. The main goal is to serve the needs of students and teachers of Indian systems of medicine, medical practitioners, researchers, community enterprises, community health NGOs and pharmaceutical companies.
Medicinal Plants Master Database A comprehensive database on medicinal plants of India has been built up over 8 years. Currently, incorporates over 7,500 botanical names which are linked to more than 140,500 vernacular names in 13 different languages like Tamil, Kannada, Malayalam, Hindi, Sanskrit, etc. Each such correlation can be traced back to a published reference. This database also incorporates more than 10,000 authentic digital images of plants duly linked to their botanical names. An important feature of this database is a fully-referenced distribution database which provides information on geographical distribution of nearly 6,000 plant species. The database is linked to referenced information on the plant materia-medica of traditional systems of medicine as well as to pharmacognosy and pharmacology of the plant entities.
Pharmacognosy database on Indian medicinal plants. A computerised database called Labguru has been created for storing and retrieving referenced literature on pharmacognosy and pharmacology of medicinal plants. Labguru is a stand-alone database with an easy-to-use interface, linked to the master database. This database is a valuable literature source for researchers and industry alike. Data compilation is from published sources such as texts and on-line databases.
AYUSH database. FRLHT has been documenting and developing traditional knowledge databases on the materia medica of Indian systems of medicine for over 10 years. Medicinal plant databases have been initiated on Ayurveda, Siddha, Unani system and Homoeopathy. The current FRLHT databases have screened a limited number of the known medical texts written across the period 1500 BC to 1900 AD and therefore much work yet remains to be done.
Appendix 2
Pragya
Aim
To shape and enable holistic, sustainable development with focus on vulnerable and neglected communities and ecosystems.
Achievements
Mapping and Threat Assessment of Herbal Wealth. Recognizing the need for scientific data gathering and documentation in order to ensure appropriate conservation planning and action, Pragya began for the first time to map the herbal wealth of the Himalayan cold deserts. Comprehensive vegetative mapping was carried out with intensive community collaboration and expert advice from traditional healers (amchis/vaids). The activity also involved networking and liaison with the local administration as well as with several research institutes. Regional CAMPs (Community Conservation Assessment and Management Plan workshops) helped validate ground survey findings, establish the status of habitats and species, and develop the conservation management strategies.
Achievements Aim
Pragya have set up certification systems (working with the Government) to ensure correct identifiation of species being cultivated for sale.
Future plans
Pragya will produce a comprehensive report of the findings of the mapping exercise, as well as various print publications, including a Red Data Book, a user-friendly e-herbarium of medicinal & aromatic plants of the target region with detailed bioprofiles of each species.
o Domestication of and development of agronomic practices for indigenous medicinal and aromatic plants.
o Production of seeds and other propagating materials of select genotypes of domesticated medicinal and aromatic plants.
o Screening and analysis of medicinal and aromatic plants to determine the chemical constituents and their active principles.
o Quality assurance, grading and standardisation of plant extracts towards addressing issues of adulteration and informal markets.
o Development of appropriate rural technologies for management of plant material, including storage, testing and processing.
o Documenting research results and disseminating information on conservation and cultivation of medicinal & aromatic plants.
Appendix 3
National Institute of Pharmaceutical Education and Research
TO FOLLOW
Appendix 4
Marketing and long-term sustainability
A major outcome of Project Fair Deal will be a new market for assured remedies from indigenous traditions manufactured to international standards of quality and supported by information that could satisfy a modern discerning enquirer. Standards of sourcing and manufacture would assure that only cultivated raw materials from approved suppliers would be used: the initiative would benefit local communities working to meet these standards rather than the large number of opportunists that usually undermine this industry.
Subject to further discussions with the Bhumi Vardaan Foundation and further to the report commissioned by the Whitley Fund for Nature, further marketing research and development would roll out these achievements in the form of international marketing plans, initially identifying parts of the world with significant Indian communities, negotiating franchises and licensing arrangements in each region and constructing the relevant business plans. It may be that all these marketing plans remain in the non-profit sector but a range of business models will be considered depending on the nature of support available for this stage.
The project will also depend on a strong ‘fairtrade’-type agreement (Fairtrade itself is not currently applied here) that protects the interests of the hill farmers, for example in the Pragya cooperatives. Pragya have conducted seminars and workshops that bring together members of these cooperatives and the final buyers, including herbal majors and large traders. Many of the Himalayan farmers work in designated forest reserves where a permit is needed to harvest. However, because of the inaccessibility of these areas this is hard to monitor and control. Illegally harvested plants do make there way onto the markets. Even some of the larger manufacturers buy their raw materials from these uncertified sources. Opening up the market for a particular product will therefore encourage exploitative sourcing and profiteering unless the products are clearly kite-marked or branded. Ideally products selected in Project Fair Deal would be marketed with a Bhumi Vardaan brand as meeting “internationally recognised quality standards for medicines” and sourced only from approved suppliers. Such agreements are not widespread in India.
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Appendix 5
Organic growers
TO FOLLOW
Appendix 6
TO FOLLOW
Appendix 7
In order for Project Fair Deal to be sustainable, and to protect the reputation of all those involved, it is essential that product quality is assured to international standards. The herbal market is blighted by poor quality and there have been particular problems associated with traditional products from India. There have been high profile cases of products adulterated with different materials, other plants and heavy metals like lead and arsenic. Independent inspection of manufacturing is not only a basic requirement for the production of pharmaceuticals but is also required for herbal medicines in Europe and Australia. The term used for manufacturing procedures which comply with independent verification of quality is Good Manufacturing Practice (GMP). In the production of medicines GMP requirements are very rigorous, assuring quality within very narrow boundaries, and with procedures for monitoring adverse consumer reports and other safety data. In practice only a manufacturer genuinely certified as applying such GMP will be able to sustain the reputation of its products on the international stage, the reputation of any supporter and indeed of the Prince of Wales himself.
Complying with GMP is very expensive and the increased costs are passed on in the price of the products. In an unregulated market GMP manufacturers therefore face a significant disadvantage, confounded by the fact that most consumers buy on price rather than quality. However the real price of poor quality can be very high. It only needs one case of a potentially dangerous product to doom the prospects of the company on the international market, especially if healthcare practitioners are involved.
The issue is confused further by there being GMPs for food products as well as medicines. Food GMPs are lower standards that apply to kitchen inspections and are primarily geared to assure minimum hygiene standards and otherwise that a product is fit for human consumption. Nevertheless these are standards that the majority of herbal products in the USA have still not even met (although new FDA regulations will ensure this by 2010). In looking for potential manufacturing partners one needs to be alert to claims of GMP status. Some claims are actually meaningless hype, the majority of others on inspection turn out to be food GMPs.
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