Traditional Medicinal Knowledge System of Tridosha in Ayurveda
The role played by Traditional Medicinal Knowledge (TMK) such as, Ayurveda in personalized and preventive healthcare has its foundations in the Humoral Doctrine of Tri-dosha:- Vata, Pitha and Kapha. This encompasses the manifestation of Panchamahabhutas within the human body thereby exhibiting unique bodily characteristics. Advanced pharmacogenomics hasscientifically been correlated to the traditionally known genetic attributes of Tri-dosha and human body Prakriti.
Simultaneously the advancement of ethnopharmacology has enabled the extraction of plant-derived chemical compounds and bioactive constituents in drug discovery leading to commercial manufacturing of modern medicine that are a part of global market economy and founded on the western ideals of IPR and monopolistic trade tendencies. This has led to the bypassing of Access and Benefit Sharing (ABS) of the Convention on Biological Diversity (CBD) resulting in rampant misappropriation and bioprospecting of TMK through obtaining of IP rights without prior approval. This has challenged the very subsistence and survival of indigenous and local communities thereby raising a strong necessity for a cooperative model of TMK sharing over the prevailing knowledge commercialization, private rights and monopolistic-
capitalistic approaches.
The objectives of the research paper is to discuss and understand the scientific validation of Tri-doshas, to critically analyze the protection of TMK through IPR, local customary laws & traditions and current national and international policy perspectives. Further, the research explores historical roots of modern western medicine to TMK and also analyses several cases where objections have successfully been raised by TKDL at the global patent offices against the grant of patent to prior art dealing with TMK of India. A detailed case study of the success story of the ‘Kani Model’ of Access and Benefit Sharing has been made to emphasize on cooperative knowledge sharing.
The treatment of diseases originally started as a sacred and spiritual belief and therefore involved a mix of prayers, practices and herbal mixtures thereby forming the basis of traditional medicine knowledge system among the indigenous and local communities in India and at the global level. India has seen the evolution, documentation and practicing of traditional
medicinal knowledge such as Ayurveda and yoga as a viable tool of wellness management. Ayurveda is one of the traditional medicinal knowledge system that is widely practiced in India. The evolution of modern medicine too has had its roots in the traditional
medicine system until the Renaissance and Industrial
Revolution enabled the gradual advancement of
technology, understanding of pathology and pharmaceuticalization procedures in a competitive
globalized market as we see today.
Notably, there have also been colonial implications in the intercontinental exchange of medicinal plant species and traditional medicinal knowledge at the global level.
Therefore, the progress achieved in modern medicine have evolved out of the empirical knowledge from traditional medicinal system such as Ayurveda and Siddha from India. Ancient civilizations such as China, Egypt, Greece, Mesopotamia, etc. too have roots in traditional medicinal knowledge. Having said that a large chunk of the global population still use medicines that are based on traditional medicinal knowledge systems.
The 1980s saw the role played by biotechnology in the discovery of plant derived pharmaceutical drugs there by causing greater interest among the scientists and physicians towards ethnopharmacology and traditional medicinal knowledge that were historically and customarily protected and carry forwarded by the indigenous and local communities.
The protection of traditional knowledge by deeming it as intellectual property first took shape at the 1992 Rio Summit.
wherein the Convention on Biological Diversity was
adopted to ensure access and benefit sharing under the perspective of ‘semi-commons’ and prevent bioprospecting of traditional knowledge by third parties.
The prospects of Semi-Commons enable the greater benefit of traditional knowledge to its holders and the public through cooperative sharing of knowledge and resources.
Evolution of Traditional Knowledge and Intellectual Property
The historical foundations behind the intellectual
property can be traced back to the industrialization era with constant upgradations inorder to suit such nations that were leaders in technology and advanced scientific research post the Industrial Revolution (IR).
The First and the Second World Wars proved to the
world nations that vital scientific knowledge and
cutting edge technological expertise were crucial for
the nations to sustain as global and regional superpowers.
The disintegration of the USSR was just the beginning of USA‘s emergence as a monopolistic power with the backing of the European Union. The ‘global north’ there after ensured that the global south unitedly marched behind it practically in all aspects, particularly in trade relationship. This enabled them to have an extra edge over the other nations or societies in ensuring that the legal ledgers played an
advantageous role for the ‘global north’ over the
‘global south’ in terms of knowledge acquisition
under the garb of Liberalization, Privatization and Globalization (LPG).
While there existed an
established ‘selfless culture’ of traditional knowledge on the principles of cooperation and togetherness in the countries of the global south, the global north bound the entire world with competition and commercialization through the Trade Related Aspects
of Intellectual Property
Rights (TRIPS) under the
World Trade Organization (WTO) to bring about a
commonality among the world nations and assert that intellectual property is a trade related asset inspite of the diversity prevailing in the intellectual property regimes of the “global south‘ that had originally suited their culture, tradition, and indigenous communities.
The concern that the indigenous people and their
communities are mainly in the developing and under developed countries of the global south have demanded equal protection for traditional knowledge.
As a result in the year 2000, the Inter-governmental Committee on Intellectual Property and Genetic Resources, Traditional Knowledge and Folklore
(IGC) was established by the World Intellectual Property Organisation (WIPO) so as to develop a global legal instrument that would render effective protection for traditional knowledge, genetic resources and traditional cultural expression / folklore. The liveliness and richness associated with traditional knowledge is that it has phenomenally been developed, sustained and passed on from one
generation to another in a community. The authorship
or inventor of any traditional knowledge is mostly unknown and the dynamic nature of traditional knowledge makes its protection difficult using the TRIPS or other legal instrument available.
Intellectual Property and
Traditional Medicinal
Knowledge in India
A large number of population depend on traditional medicine while several of the modern vaccines and drugs are based on natural resources and associated traditional medicinal knowledge. In India the importance of traditional medicinal knowledge with regards to the indigenous communities also comes with social, cultural and scientific values. As a result it has invited recognition, respect, preservation and protection from undue commercialisation and
scientific interest towards traditional medicinal
knowledge. TMK are mostly derived from plant and animal varieties and hence fall under genetic resources which are not human creations but occur naturally in the nature and therefore cannot be directly protected as intellectual property. Intellectual Property refers to creation of the mind, such as
inventions; literary and artistic works; designs; and
symbols, names and images used in commerce.
Intellectual Property is protected in law by patents,
copyright and trademarks which enable people to earn recognition or financial benefit from what they invent or create. This means that the individual creator or inventor holds the rights over his/her intellectual property – Intellectual Property Rights/IPR.
The World Health Organization (WHO) defines traditional medicine as the sum total of the knowledge, skills and practices based on the theories, beliefs and experiences indigenous to different cultures, whether explicable or not, used in the maintenance of health, as well as in the prevention, diagnosis, improvement or treatment of physical and mental illness wherein ‘traditional’ means the knowledge that is created in a manner that reflects community traditions that have been created preserved and transmitted from generations and held collectively. Though the indigenous community may
innovate, the fact which deems their innovation is
based on the community‘s collective heritage that it
has held. WIPO, through its Intergovernmental Committee on Intellectual Property and Genetic
Resources, Traditional Knowledge and Folklore,
seeks to develop international legal instrument that would provide effective protection of Traditional Cultural Expressions, Folklore and TK – including traditional medicinal knowledge. Though, there are a multitudinal definitions that cover various areas of traditional knowledge, a holistic definition for traditional medicinal knowledge with all its features and aspects concerning indigenous rationale, sustainability and customary self-regulations is required so as to understand the indigenous and local communities in its truest essense. Therefore, a contextual definition for Traditional Medicinal Knowledge is:-
“Traditional Medicinal Knowledge is associated
with indigenous communities that are unique and derived through observations from the nature, surrounding environment and then transmitted, originally orally, from one generation to another
throughout the world.”
Traditional Medicinal Knowledge with its spirit
of local - collective ownership characterizes the consciousness of spiritual belief, diverse culture, dynamic wisdom, collective heritage, sacred values, time tested sustainable practices that are ancestrally inherited within the indigenous & local communities and their social world. This time proven nature of Traditional Medicinal Knowledge system is such that it precisely provides the indigenous and local communities with the required knowledge, wisdom, practices and purpose of their existence by simultaneously enabling the communities to live in harmony with the ecosystem and uncompromisingly adapt themselves to ecological changes. Such holistic
interconnectedness between community level activities of humans and various components of mother nature over a prolonged period of time with a scope to adapt
to change is what distinguishes Traditional Medicinal Knowledge from that of modern western medicine.
Role of Panchamahabhuta and Tri-dosha in Ayurveda
Traditional Medicinal Knowledge Systems
(TMKS) such as, Ayurveda, uses combinations of physiological exercises, massages, meditation, diet
modification, medicines derived from indigenous
plants, animal products and minerals for the treatment
of ailments. The fundamental aspect of the healing and treatment in TMKS is based on the theoretical understandings of the Panchamahabhutas and the Tri-doshas. According to Charaka, the famous physician from ancient India, it is the doctrine of tri-doshas that dominates the theory and practice of traditional
medicinal knowledge systems such as Ayurveda and are not just theoretical concepts but real substances.
The five eternal and base components of nature or the Panchamahabhutas are Prithvi (Earth), Apa (Water),
Agni (Fire), Vayu (Wind) and Aakasha (Ether). All the living and non-living beings including the human body are created from the permutations and combinations of different variables or the components of Panchamahabhutas Thereby making every
individual as a unique entity in relation to the external
environment from the preview of Ayurveda.
This is to precisely say that human body is a ‘miniature form of nature’ wherein the similar components of the
nature are present in our body. The following description of the properties of Panchamahabhutas with regards to our body is important:-
(i) Prithvi or earth is the basic gross element which
gives the sense of smell and is characterized with
mass, density, opacity and inertia.
(ii) Apa or water is the element of aqua or liquids and possesses the characters of fluidity, coldness, viscosity etc
(iii) Agni or fire is the thermal element and is related to digestion. Agni also represents the manifestation of anger, passion and courage in the human body.
(iv) Vayu or air is the basic gaseous element and
possesses the characteristics of lightness.
(v) Akasha or Ether is related to space and enables sound and hearing. They form the pores, cavities and channels in the human body. Panchamahabhutas control various activities of our body through the Tri-doshas or body humours which are the three vital energies of our body namely Vata (wind), Pitta (bile) and Kapha (phlegm).
Further, each of the doshas are composed of two of
the Panchamahabhutas and perform anatomical
activities as:-
1. Vata has the primary elements of Vayu (air) and
Akasha (ether) with the functional control over
movement and communication.
2. Pitta has the elements of Agni (fire) and Apa(water) to functionally oversee digestion, metabolism and transformation.
3. Kapha has the elements of Apa (water) and Prithvi (earth) to functionally provide cohesiveness, body structure and lubrication.
Each person contain the unique blend of these doshas. So the core and foundational aspect of health and disease as per the principles of Ayurveda is centred in the uniqueness of an individual. However most of them have one of it as a dominating doshas which form the true nature of the body or the prakriti. The Tri-doshas are present in varying proportions in the human body and tend to form specific body signatures according to the dominant dosha of our body to form distinct prakriti or the nature of the body. Just like the Panchabhutas create atmospheric, climatic and physical changes in the surrounding nature, they also affect our bodily wellbeing through different proportions and combinations in the form of doshas. M. S. Valiathan
in his book, ―The Legacy of Charaka writes ―While the homology between the structural materials within the body and outside, in the physical world, is the theme of the pancabhuta doctrine, the functional equilibrium inside the body is explained by tridosa.
Therefore, the role played by the Tri-doshas in our body and mind are crucial for its survival, metabolism, endurance, health, and disease prevention apart from determining of physical and mental characteristics of our body. The ratio of vata, pitta and kapha influence the human body in its individual features, mental and emotional character and traits as well as our unique strengths and vulnerabilities. Every dosha has a quality and bodily manifestations of its own. Any deficiency or excessive quantity of the tri-doshas is said to unsettle a condition of health disorders and disturbances.
Ayurveda also prescribes several lifestyle oriented
remedies and adaptations to ensure the equilibrium of
the doshas. Ayurveda not only stresses on the physical nature of the body but also on the psychological aspect of the individual and a holistic
approach towards diet and lifestyle inorder to maintain health and prevent disease.
It is also important to understand the specific
dosha properties and the detailed results of their
balance and imbalances in the human body.
The following shloka from the Susruta Samhita
describes as to what ‘health’ is according to Ayurveda, a traditional medicinal knowledge system:-
“Samadosha Samagnischa Samadhatumalakriyaha
Prasannatamenindriyamanaha SwasthyaItyabhidheeyate”
It means When the doshas are in balance (samadosha); when the different forms of agni are in balance (samagni); when the processes are associated with the creation of dhatus and mala are in balance and working seamlessly; when the atma (soul); the sense organs (jnanendriya and karmendriya) and the mind (manaha) are in a state of happiness and harmony (prasanna); this (iti) is called (abhidhiyate) health (swasthya).
The vaidyas or the traditional healer understands the particular prakriti that the human body is predominantly associated with for diagnosis of ailments. The treatment is given in accordance with the imbalance of dosha in a person. TMKS provide the
scope and relevance towards personalized medicine and prevention system through the better understanding of the body type or prakriti thereby making Ayurveda a universal concept of traditional medicinal system that can be associated with the concepts of science.
Personalised preventive medicine is of greater
advantage in the case of Ayurveda wherein other non-traditional systems of medicine have the scope of only personalized medicine.
The prakriti signature is
unique from one person to the other and this has been
validated and evidenced by modern science.
Scientific Validation of Tri-doshas
The article titled, “DNA methylation analysis of
phenotype specific stratified Indian population”
published in the Journal of Translational Medicine
has elaborately reported that the respective doshas of vata, pitta and kapha were experimentally correlated with their known characteristics of motion (vata), higher metabolism (pitta) and structural attributes (kapha). The experimental research method involved had been the sampling of whole blood DNA samples of individuals whose ayurvedic prakriti specimens of vata, pitta and kapha was earlier known. The samples were subjected to methylated DNA immuno-precipitation (MeDIP) and microarray analysis. After data analysis, prakriti specific signatures were validated through bisulfite DNA 'sequencing'. The research also concluded that the differential DNA methylation signatures of all three doshas showed the genetic basis of traditional human classification system, in accordance with Ayurveda, that provides the scope for personalized medicine.
Another study determined the genetic basis of doshas, in varying proportions of dominance, which were as described in the Charaka Samhita by performing SNP (single nucleotide polymorphism) analysis of the three prakritis. The results were also independently confirmed by ‘AyuSoft’ which is a software developed on the basis of classical ayurvedic literature.The scientific and genetic basis for body‘s
prakriti have been distinguished and differentiated with individuals of pitta-prakriti having faster metabolism and those of kapha-prakriti having slower metabolism thereby enabling drug discovery,pharmacogenomics and personalized medicine.
A better understanding of dosha theory as abided in
Traditional Medicinal Knowledge system such as
Ayurveda from the perspective of genetic and
biotechnological research have opened the scope for
pharmacogenomics which is but the study of genetic
response with regards to variations and responses to a drug thereby utilizing the genetic information in
preventing an adverse reaction. Simultaneously,
genomic research have shown correlations between genetic patterns and doshas thereby impacting physiological and psychological applications. The Prakriti of human body has genetic connotation
that are totally based on the dosha cluster thereby
making every individual as a unique entity in terms
of physical, physiological and psychological characteristics
Specific dosha properties and its result in the human body
VATA
Constitution
Involved in breathing and eye movement
Motor functioning
Cell functioning
Easily excited, alert without thinking much before constant action
Thin, light and flexible body
BALANCED
Personal creativity &
accomplishment
Courage
UNBALANCED
Fear, worry, and anxiety
Problems with motor
functioning,nimbleness, and dexterity
Fear of loneliness
Boredom
PITTA
Constitution
Involved in body metabolism
Involved in appetite, food digestion and absorption,transformation and transportation for assimilation of nutrition into the body and dispelling of waste products
Cell functioning
Neurotransmission and neuropeptides in intelligence
Vitality
Learning and understanding theories and concepts
Seldom gains or loses weight nor has weight fluctuations
Disciplined leaders
Intelligence and understanding
UNBALANCED
Anger, hatred, and jealousy
Perfectionism
Judgemental and critical
Problems with inflammation leading to chronic disorders and heart diseases
KAPHA
Constitution
Involved in body structure and the stability of the structure
Involved in water metabolism and fluid distribution throughout the body
Lubricates cells, tissues, joints and organs
Cell functioning Chubby shape
Retention of
knowledge for memory
BALANCED
Expression of love and compassion
Faith and devotion
Melodious voice and speech patterns
Longevity in life
Feelings of calmness
Forgiveness and benevolence
UNBALANCED
Addictions and unhealthy attachments to things, substances and people
Calculating greed and ruthlessness
Disorders involving the congestion of fluids trapped in various places within the body.
Slow digestion and weight gain
Cravings for sweet and salty food
Idleness and long periods of sleeping
TMK and IPR: Cases of Modern Medicines
Derived from Traditional Medicine
The therapeutic use of traditional medicinal plants for the treatment of human diseases has been in practice in many of the cultures and societies across the globe. This has also, over the period of time, led to the development of various independent and organised medicinal systems in accordance with the geographic availability of various species of medicinal plants until they were finally institutionalized from the modern perspective.
A large population of the developing countries depend on Traditional Medicinal Knowledge as it is an available and affordable source of treatment for various ailments.
With the aid of modern sciences and technological
tools it has become possible to extract active drug compounds from the medicinal plants and this has become possible because the medicinal plants are naturally capable of amalgamating thousands of such individual bioactive constituents from the soil and environment that are rooted to it. Plant derived chemical compounds have thereby enabled the manufacturing of modern medicine and it has been scientifically correlated that the diagnosis based on
traditional medicinal plant and that of chemical
compounds derived from the active compounds of the plant happen through similar process and mechanism.
Therefore, traditional plant based medicines are as
effective as the modern - conventional medicines while Traditional Medicinal Knowledge continue to be the foundational base for the development of modern drugs as they are the best source for obtaining a variety of drugs.
Since the plant derived drugs continue to be an inevitable source of new drug discoveries and opportunities they are also the simultaneous interjecting points of global platform for pharmaceutical market economy, determining factor for the stability of pharmaceutical markets worldwide, intellectual property rights and bio-prospecting of Traditional Medicinal Knowledge, habitat degradation and sustainable exploitation of natural resources, tropical forest-biodiversity conservation and rights of indigenous & local communities.
The Materia Medica of Ayurveda contain 8000
known medicinal recipes made of herbs, metals,
minerals, animal products and their ash in right
proportions and a systemic therapy. Further, the detailed study of ethnopharmacology and traditional medicine have led to several natural products, drug discoveries and several pharmaceutical companies have altered their strategies accordingly to differing uidelines of standardization, manufacture and quality control. Importantly, the process of reverse engineering towards traditional knowledge driven drug development by adopting reverse pharmacology path with much faster and cheaper cost with the help of modern technologies have found scope too.
In this regard, Traditional Medicinal Knowledge
involves the medicinal use of plants and herbs that
form the integral part of genetic resources and are
therefore not the original creation of the human
intellect and hence does not qualify for protection as
an intellectual property. Moreover, the Traditional
Medicinal Knowledge have been guarded, preserved
and held as collective heritage by the indigenous and local communities as a part of their cultural traditions that have been continuing for several generations.
Such time-proven knowledge have also been a source of subsistence and survival for the indigenous and local communities and therefore any intention to commercialise Traditional Medicinal Knowledge should happen in accordance with the Access and Benefit Sharing (ABS) mechanism of the Convention on Biological Diversity (CBD). Instances of patents granted to plant based genetic resources involving Traditional Medicinal Knowledge such as, turmeric and neem had invited criticism thereby resulting in subsequent revoking of the patents that were awarded to them. Prevention of misuse and misappropriation of Traditional Medicinal Knowledge is therefore crucial. Inspite of this the global attraction garnered
by Traditional Medicinal Knowledge has been
immense due to the growing side-effects of allopathic medicines and therefore, the systems of traditional medicinal knowledge has become subject to biopiracy and patenting.
The development of the Traditional Knowledge Digital Library (TKDL) by Council of Scientific and Industrial Research (CSIR) to prevent the misappropriation of traditional medicinal knowledge from awarding of patent at the International Patent Offices by scientifically classifying India‘s Traditional Medicinal Knowledge systems such as Ayurveda, Siddha, Unani and Yoga into a multi-language searchable database is therefore important in this regard.
While this is the case, patents for products, formulation, compositions and processes for
traditional ayurvedic medicine, medicinal plants and herbal based formulations have well been granted to several Indian and foreign entities.
Roots of Modern Western Medicine in TMK
The roots of western medicine too is founded on
the basis of traditional humour based medicine that are similar to those of the Tri-doshas and had plant based herbal medicines as its medicinal materials.
Before the 20th century, European Medicine depended on the indigenous medicine system wherein the components of drugs were availed from natural products such as plants and their parts that were available from the mediterranean region and with the Middle East, Asia, and the Americas contributing knowledge and materials in the medieval and early modern periods and therefore a large number of Traditional European Pharmaceutical writings that can be located to the mediterranean region that were compiled by the physicians of Greece, Rome, Byzantine and medieval Islamic with the earliest dating back to 500 BC uptill the 19th century AD that reveal the earliest tradition and imprints of
Western - European Ethnopharmacology by providingplant, animal and mineral based medicinal
informations and therapeutic formulations that cured diseases from time to time.1As multi-disciplinary studies on pharmacology from the historical perspective reveal European herbal medicines were used for the treatment of rheumatic disorders in the 16th and 17th century.
Instances of medicinal plant species introduced from other continents during European colonization show the importance accorded to Traditional Medicinal Knowledge.
Inspite of having such a tradition in the history of
European medicine which forms the foundation of
modern western medicine, the effectiveness of TMK
and herbal medicine is termed as unscientific and
therefore brushed off as invalid and ineffective.
Importantly we have already discussed the widespread urge and exhaustive efforts by pharmaceutical companies to discover new drugs and
develop modern allopathic medicines from Traditional Medicinal Knowledge by obtaining Intellectual Property Rights that emphasise on knowledge commercialization and bioprospecting.
The role played by renaissance and industrial
revolution with regards to advancing science and
technology played a role in altering the history of
pharmacy and medical chemistry thereby causing the gradual diminishing of traditional medicinal use and rise of pharmaceutical companies with economical
motives. The change of attitude from traditional
medicine towards medical science in Europe was seen in 19th century and to study the ancient sciences was considered waste as against scientific experimentation.
In 20th century the scientific discovery of life saving antibiotics like Penicillin further declined the study of traditional medicine.
Success Stories of ‘Access and Benefit Sharing’ and Protection of TMK Amidst past instances of unauthorized use and
misappropriation of traditional medicinal knowledge by third parties, there are also success story models
that have taken prior consent from the indigenous and local communities who are the holders of Traditional
Medicinal Knowledge by sharing the benefits of access and commercialisation by patenting chemical compounds that are derived from plant based
Traditional Medicinal Knowledge.
From Arogyapacha plant to ‘Jeevani’: The Traditional Medicinal Knowledge of the Kani Tribe
The indigenous Kani tribe inhibit the wind-ward side
of Agasthyamalai hills in the tropical forests of
Western Ghats in the state of Kerala.The Plathi who are the tribal physicians of the Kani tribe ‘customarily’ hold the exclusive Traditional Medicinal Knowledge belonging to the community and they alone have the right to transfer and disseminate their Traditional Medicinal Knowledge which includes the use of wild plants as medicines. It was in December 1987 that an ethnobotanical expedition team from the All India Coordinated Research Project on Ethnobiology (AICRPE) led by Dr. Palpu Pushpangadan who was then the director of the Jawaharlal Nehru Tropical Botanical Garden and
Research Institute (JNTBGRI) in Kerala noticed the ‘untiring’ Kani guides while the expedition team particular traditional knowledge has enabled the
Kani tribals to survive for generations altogether in
travelling large distances in search of food and other
forest resources. After constant persuasion the Kani guides finally led the expedition team and identified the plants that are locally known as Arogyapacha and scientifically as Trichopus zeylanicus Travancoricus.
Though Trichopus zeylanicus is also found in Sri Lanka and Thailand, only the Indian sub-specie is found to possess medicinal properties.
Dr. Palpu Pushpangadan and his team of scientists
took the Arogyapacha plant to JNTBGRI so as to study it scientifically and to look into the possibility of commercializing. After undergoing over an eight
year research constituting several chemical and
pharmacological tests it was discovered that the fruit and the leaves of the plant exhibited properties of
antistress, immune stimulating, stamina boosting, fatigue relieving, controlling tumor growth, activating body‘s natural defenses and cellular immune system. This followed the isolation of twelve active chemical compounds from the Arogyapacha plant that was responsible for the effects that the team had experienced during their expedition.
While the Kanitribals traditionally practiced eating the berry fruits of the Arogyapacha plant to directly obtain these compounds and the benefits associated with them, the JNTBGRI team discovered that crushing of the Arogyapacha plant leaves was the most effective way to obtain the twelve compounds. The JNTBGRI team, through a standard research and development program
successfully conducted clinical trials and scientifically demonstrated the critical medicinal benefits of the Arogyapacha plant. The JNTBGRI team had in 1994
decided to file process patent application with the IP office in India for the manufacturing of polyherbal sports medicine named ‘Jeevani’ based on the isolated chemical compounds from the Arogyapacha plant for
protection and effective commercialisation of the
accessed traditional medicinal knowledge for which the benefit incurred was intended to be shared with the Kani community. Notably ‘Jeevani’ was a
standardized medicinal formulation obtained as an
end product of the research and development using
the Arogyapacha plant, its isolated chemical compounds and other herbal plants. The intellectual property protection for ‘Jeevani’ was crucial for preventing third party misuse and misappropriation and for the sharing of benefits by JNTBGRI with the indigenous and local communities as per the benefit sharing agreement signed with the Kani people, which is in accordance with the Access and Benefit Sharing
(ABS) mechanism of the United Nations Convention
on Biological Diversity (CBD).
The product technology licensing for the effective
commercialisation of ‘Jeevani’ was granted to Arya Vaidya Pharmacy Ltd of Coimbatore for primary
commercial manufacturing of ‘Jeevani’ in 1995. The initial licensing agreement between JNTBGRI and Arya Vaidya Pharmacy Ltd Was for a period of seven years and a license fee of $ 50,000 USD. However large scale commercial cultivation of Arogyapachaplant at the land inhibited by the Kani people, which belonged to the Indian Forest Department, caused
environmental concerns pertaining to land and forest degradation, and therefore necessitated prior approval and significant challenges. It is here that JNTBGRI pointed out the usage of only the leaf part of the Arogyapacha plant need to be harvested without actually destroying the plant as a whole. It was only after JNTBGRI gave assurances to the Forest Department and ‘Integrated Tribal Development
Program’ of the Directorate for Tribal Welfare, Govt. of Kerala, that it would pay Kani people for the seeds as well as the leaf-harvests which in turn would fetch a stable source of income for the Kani cultivators, that the cultivation of Arogyapacha plant was permitted by the Forest Department. This followed the training and skilling of selected Kani cultivators in cultivation and harvesting that enabled JNTBGRI to supply Arogyapacha plant leaves to the Arya Vaidya Pharmacy Ltd. The formation of Kerala KaniSamudaya Kshema Trust in 1997 with people of the
Kani tribe as its members has the objective to promote welfare and development activities amongst the members of the Kani community. In March 1999, the first royalty payment of US $ 12,500 was received in
accordance with the benefit sharing agreement that
have been simultaneously used for various welfare
projects of the Kani people. Further in 2006, JNTBGRI formed a Business Management Committee with the Kani people in setting minimum conditions for Access and Benefit Sharing (ABS) such as extending license and royalty benefits.
The role played by traditional medicinal knowledge in customarily protecting and preserving the medicinal secrets of Arogyapacha plant within the indigenous Kani tribe is notable. The access to the traditional medicinal properties of Arogyapacha
plant by JNTBGRI, the subsequent commercial
development and licensing of ‘Jeevani’ sports drug,
the ultimate benefit sharing and financial impact on
the lives of Kani people is but a unique global model
that signifies the pivotal importance and the need for the recognition of traditional medicinal knowledge holders and their intellectual property towards ‘cooperative’ R&D induced drug discovery in the modern times. Kani model is also a epitome of an idea of semi-commons that calls for the rights of indigenous and local communities.
Protection of Traditional Medicinal Knowledge
The WIPO postulates the preservation of the indigenous community as the best possible way for
the protection of Traditional Medicinal Knowledge as
they are linked to the subsistence of the community just as seen in the case of the Kani tribe. By protecting the indigenous and local communities in accordance with their customary laws, practices and protocols enables them to pass on from one generation to another as a part of their traditional obligatory duties. Customary laws and protocols are the traditional rules abided by the indigenous communities so as to enable the elderly members to govern their community. This has been seen as important because the customary laws define as to how the resources and knowledge of the community are shared, utilized and inherited within the community so as to prevent inappropriate and
unauthorized use by those outside the community.
Apart from the customary laws, there are several
international instruments that provide Intellectual
Property Protection of Traditional Medicinal Knowledge. The Convention on Biological Diversity, 1992 recognizes the value of TK of the indigenous and local communities. The CBD in Article 8 (j) requires the party countries to ―respect, preserve and maintain knowledge, innovations and practices of indigenous and local communities embodying traditional lifestyles relevant for the conservation and
sustainable use of biological diversity; promote their wider application with the approval and involvement
of the holders of such knowledge, innovations and practices; and encourage equitable sharing of benefits arising from the utilization of such knowledge, innovations and practices.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization, 2010, objectivizes ―the fair and equitable sharing of the
benefits arising from the utilization of genetic resources, including by appropriate access to genetic resources and by appropriate transfer of relevant technologies, taking into account all rights over those resources and technologies, and by appropriate funding, thereby contributing to the conservation of biological diversity and the sustainable use of its components.
In India, The Biological Diversity Act, 2002,
mandates an individual or a body to obtain approval
from the National Biodiversity Authority to access biological resources or Traditional Knowledge
associated with it for the purposes of research, bio-
survey, bio-utilization or commercial utilization, to
make any application for obtaining any IPR and
transfer of any results of research pertaining to
genetic resources. However, the act has proven to be too stringent in enabling the securing of patents so as
to enable the sharing of knowledge and benefit to the traditional knowledge holders.
Conclusion
The role played by indigenous and local communities in the preservation, protection and proliferation of traditional knowledge including traditional medicinal systems through the respective customary and cooperative mechanism as an effective tool for wellness management is well evident. However the growing concern of biopiracy, bioprospecting and misappropriation of Traditional Medicinal Knowledge on one side and inappropriate claims over the genetic resources through the various instruments of intellectual property rights by third parties without prior approval has already posed as a challenge to the subsistence and survival of the indigenous and local communities. The advent of biotechnology and related disciplines such as, Ethnopharmacology and Pharmacogenomics has
scientifically validated traditional medicinals concepts such as the humoural theories into factual entities thereby attracting greater interest of the modern medicine and pharmaceuticals to look into the expertise of wellness management and health related solution held by traditional medicinal systems.
Particularly the validation of Tri-dosha as the foundational entity of Ayurveda has been attractive enough for pharmaceutical companies to commercialize herbal medicines and drugs that are derived from plant/animal sources. However, the traditional medicinal systems are also deep rooted as cultural entities that hold multitudinal character and immense value among the practitioners of such systems.
This has importantly been a definite outcome of inter-generational interaction of the indigenous communities over a greater period of time resulting in the carving of substantial necessities and economic needs on traditional lines.
The evolving of an alternative global economic regime post the second-world war and the disintegration of the USSR on the lines of liberalization, privatisation and globalization with emphasis on intellectual property rights has increased the scope for knowledge as a private entity through commercialisation which is in contradictory with the perception of knowledge as a common entity for the benefit of the social constituents.
This is irrespective of the fact that Traditional Medicinal Knowledge has historically been a cooperative phenomenon at the global stage. The ‘Kani Model’ of access and benefit sharing provides a greater scope for furthering the true nature of indigenous and local
communities with regards to the protection of traditional medicinal knowledge on the lines of cooperative knowledge sharing and equitable benefit mechanism that can be made possible through a sui generis instrument.
With this the scope of intellectual property as a semi-commons finds greater emphasis wherein every stakeholder is benefitted through cooperative knowledge sharing.
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