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The Legal Nuances of Traditional Knowledge Protection under the IPR Regime: A Critical Analysis

The protection for indigenous traditional knowledge in the Indian context is very crucial in the eye of the various infringements and challenges. In the Indian context the need to safeguard the traditional knowledge inclusive of the various traditional and indigenous practices contributing to the protection of the environment and the simultaneous protection of medicinal plants is two-fold. It involves the creation of a traditional knowledge bank that emphasizes on the use of plants in health care and identification of the medicinal plants. This includes also outlining their distributions and assessing their abundance so as to create a repository that can be beneficially accessed and protected under the IPR regime. The protection of the traditional and indigenous tribal knowledge through the various provisions of the Convention of Biodiversity (CBD) and the Nagoya protocol also aim to conserve populations of medicinal plant species in natural habitats and populations of medicinal plant species ex situ thereby building public support for the conservation of medicinal plants through communication and cooperation. The paper is an attempt to critically analyze the implementation of the available legislations and international protocols signed, the legal nuances in the direction of the protection of traditional knowledge under the Intellectual Property Rights (IPR) regime in the Indian context and the effective measures that could be enforced and practiced to make the protection fruitful besides highlighting the challenges of the lack of awareness about medicinal plants and widespread Original Research Article Vinjamuri and Bahuguna; AJARR, 16(1): 37-45, 2022; Article no.AJARR.83477 38 deforestation of areas rich in biodiversity that pose an enormous threat. It is pertinent to mention here that in particular, many medicinal plants now stand on the brink of extinction because of development in tribal areas that have historically provided most of these precious resources.


INTRODUCTION
India is a great practitioner of modern and traditional medicine, and rich source of raw materials. Medicinal plants are abound in the subcontinent, across the various regions be it the Eastern Ghats, the Western Ghats, the famed Himalayans region for its Sanjeevani Parvat.
The reserves of the natural resources including the herbal plants, remedies and their use as traditional medicine is predominantly unknown to modern science.
The effort to protect and better proliferate the traditional knowledge of the nation like many of the tropical and equatorial nations has to be robust and systematic so as to ensure the identity and intellectual property due is registered as an initiative of the state. Screening wild herbs for medicinal use and research and development efforts would benefit from involving tribal people who are often experts in local herbal remedies.
Indigenous and local communities, primarily the tribals and the rural communities in India justly cherish traditional knowledge (TK) as a part of their very cultural identity. The use, reuse on one hand and replenishing and refurbishing of the traditional knowledge be it medicinal, ornamental or beautification is an innate identity of the tribes of India who are known for their close proximity with nature.
The tribes of India and indigenous communities at large use and reuse the naturally available resources for their survival and very existence simultaneously ensuring these resources are replenished and frequently refurbished as an inherent duty and obligation. The concept and belief of 'nature-man-spirit" is directly related to the origin of many tribes as these tribes are believed to have originated from the very plants and trees which are protected as sacred grooves, hence enhancing and ensuring the protection of both biological and cultural diversity. 1 According to a report by WIPO "Maintaining the distinct knowledge systems that give rise to TK can be vital for their future well-being and sustainable development and for their intellectual and cultural vitality. For many communities, TK forms part of a holistic world-view, and is inseparable from their very way of life and their cultural values, spiritual beliefs and customary legal systems. This means that it is vital to sustain not merely the knowledge but the social and physical environment of which it forms an integral part." TK also has a strong practical component, since it is often developed in part as an intellectual response to the necessities of life: this means, more broadly, that it can be of direct and indirect benefit to society.
Protecting these resources and integrating them into modern medical practice would bring enormous benefits. Not only could we develop new drugs but we would also provide much needed job opportunities, from researchers and medical professionals to field workers and farmers in a country suffering an unemployment crisis.
The role of medicinal plants in extending the use and increasing the efficacy of existing drugs should be explored especially plants that might help in reversing resistance of some of the pharmaceutical preparations in the market.

INTERNATIONAL REGIME FOR TRADITIONAL KNOWLEDGE PROTECTION
The Convention on Biological Diversity [1] recognizes the quintessence of traditional knowledge and the inherent purpose of biological diversity at the global level which is extremely important from the perspective of indigenous people and local communities, the main feature of CBD as provided in Article 1 2.
The CBD is based on reciprocity and recognizes the biological resources to be used by other countries that do not harbour the genetic resources with consent from the countries widening the horizon for additional support from developed countries to resources existing in developing countries [2][3][4].
The convention recognizes rights of the countries through the provisions of Article 8(j) 3 Article 10(c), 4 Article 10(d) 5 , Article 15(1) 6 and Article 15 (2) 7 that proactively promote and protect the biodiversity inclusive of the indigenous tribal knowledge.
The Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits arising from their utilization to the Convention of Biological Diversity is an international agreement which aims at sharing the benefits arising from the utilization of genetic resources in a fair and equitable way.  distinguishes between tribal and indigenous peoples as follows, highlighting also the importance of self-identification 12 The importance and relevance of the plants and trees in the life of a tribe is not confined to economic viability and advantage but is ingrained in the social, cultural and traditional perspective so as to preserve the 'age old tradition of tribal people' in the specified area." International Labour Organization Convention 169 on Indigenous and Tribal Peoples is one of the key instruments relating to indigenous peoples and was adopted in 1989 being hence ratified by only 18 countries (as of January, 2007) of which 13 are in Latin America, Anthropologist Herskovits (1948) says that "culture is the manmade part of environment where human beings inculcate their ethos and adios and pass these to their future generation. In fact, tracing of 'right to environment' was done by recourse to Articles 48-A and 51-A of the Constitution of India, which are essentially postmodernist policies for eco-friendly development and citizens' participation for conservation of natural resources. When the genesis of right to environment has such complex background; solid application of convergence amidst environmental, developmental and consensual or concerted act becomes an imperative." 16 The United Nations Educational, Scientific and Cultural Organization (UNESCO) General Conference on 2 November 2001 adopted the Universal Declaration on Cultural Diversity. This was accompanied by an Action Plan, wherein the new Universal Declaration insists, amongst other things, that cultural diversity, as a source of exchange, innovation and creativity, is as 13 IFC, 2007, p.2 14 indigenous peoples have the right to own, develop, control and use the lands and territories, including the total environment of the lands, air, waters, coastal seas, sea-ice, flora and fauna and other resources which they have traditionally owned or otherwise occupied or used. This includes the right to the full recognition of their laws, traditions and customs, land tenure systems and institutions for the development and management of resources, and the right to effective measures by States to prevent any interference with, alienation of or encroachment upon these rights 15 Article 27 further notes in this regard that 'indigenous peoples' have the right to the restitution of the lands, territories and resources which they have traditionally owned or otherwise occupied or used or damage without their free and informed consent. Where this is not possible, they have the right to just and fair compensation. Unless otherwise freely agreed upon by the peoples concerned, compensation shall take the form of lands, territories and resources equal in quality, size and legal status 16 Bhat, 2009, p. 812 necessary for humankind as biodiversity is for nature.

LEGAL FRAMEWORK IN INDIA
The Survey conducted by the Ministry of Environment and Forests, Government of India, All India Ethno-biology Survey revealed that there are "more than 7,500 species of plants that are being used by 4,635 ethnic communities for human and veterinary health care across the country." The Parliament of India passed the Biological Diversity Act in the year 2002, to protect, preserve and evolve the sustainable use of natural resources with specific mention in Section 2 of the Act. 17 Traditional knowledge in the Indian context is protected primarily under the provisos of the Biological Diversity Act. The salient features of the Act are to: (a) regulate access to biological resources of the country with the purpose of securing equitable share in benefits arising out of the use of biological resources and knowledge relating to biological resources; (b) conserve and sustainable use of the biological diversity; (c) respect and protect knowledge of local communities related to biodiversity; (d) secure sharing of benefits with local people as conservers of biological resources and holders of knowledge and information relating to the use of biological resources. 18 As a Central Law the Act lays emphasis on the establishment of State Biodiversity Board under Section 22 (1)

accessed or used by third parties and an agreement should be reached on appropriate terms; they should also be fully informed about the consequences of the intended use. The agreed scope of use may be set out in contracts, licenses or agreements, which would also specify how benefits arising from the use of the TK should be shared. The principle of PIC concerning access to genetic resources is one of the cornerstones of the CBD. Given the close relationship between genetic resources and some forms of TK, this same principle is also used in a number of national laws concerning access to and use of TK. 23 The idea of an equitable balancing of interests is common to many legal systems. In IP law, this is often phrased in terms of a balancing of the interests of right holders and the general public. The fair and equitable sharing of benefits from the use of genetic resources is one of the objectives of the CBD, and the CBD also encourages equitable sharing of benefits from the use of certain forms of TK. Thus the principle of equitable benefit-sharing is found in a number of
interpreting the provisions of the indigenous peoples' role and relevance to Biodiversity protection.
"Two key demands on the IP system in particular have arisen in policy debate: first, the call for recognition of the rights of TK holders relating to their TK, and, second, concerns about the unauthorized acquisition by third parties of IP rights over TK. Two forms of IP-related protection have therefore been developed and applied: o Positive protection: giving TK holders the right to take action or seek remedies against certain forms of misuse of TK; and o Defensive protection: safeguarding against illegitimate IP rights taken out by others over TK subject matter.
Stakeholders have stressed that these two approaches should be undertaken in a complementary way. A comprehensive approach to protection in the interests of TK holders is unlikely to rely totally on one form or the other."

TRADITIONAL KNOWLEDGE AND INDIGENOUS TRIBES IN INDIA
The unique cultural identity and practices has been the trademark of the tribal world over from time immemorial with the entire tribal India having some kind of a reverence to the myriad trees and plants that are recognized to have importance in both religious and health perspectives. So far as the preservation of these is concerned, tribal people are keener to save biological resources than anything else as their biodiversity, tribal knowledge and life in India survival and life activities directly depend on them. 24 The traditional knowledge (TK) of most of tribal people is on the verge of decline and the benefits of traditional knowledge are being taken by the outsiders resulting in the tribes having meagre economic viability through these practices. social structure that create, use, preserve, and pass down TK between generations and the customary laws and protocols that govern these processes, are deeply rooted in their traditional location and community setting, and indeed may be conceived as integral to the land and environment itself. 25 TK can be characterized as "the content or substance of knowledge resulting from intellectual activity in a traditional context, and includes the know-how, skills, innovations, practice and learning that form part of traditional knowledge systems, and knowledge embodying traditional lifestyles of indigenous and local communities, or contained in codified knowledge systems passed between generations [5,6]. It is not limited to any specific technical field, and may include agricultural, environmental and medicinal knowledge, and knowledge associated with genetic resources." 26 Hoffmann (1950) mentions 71 different wild plants used by the "Mundas' as pot-herbs 26 of whose tubers, corns and roots are used as vegetables, 15 trees and shrubs where young leaves are used as pot-herbs, 10 others whose young leaves are eaten raw and of 25 wild trees and plants whose leaves are used as vegetables." The knowledge, innovations and practices of indigenous peoples and local communities are manifestations of their cultures. Protecting a peoples' culture means maintaining those conditions that allow a culture to thrive and develop further. 27 The importance of trees in the life of human is critically analyzed by ASTRA IDL Ltd., the makers of MUCOSOL, which rightly says: "A tree that lives for 50 years generates Rs Dutfield, 1999, p.514 The ancient Indians used the snake root plant (Rauwolfia serpentina) about 3000 years ago to treat several diseases from mental disorders to insomnia and snake bite. They also used the poppy juice (Papaver somniferum) to relieve pain and anxiety. 28 There are many examples wherein a single plant has multiple uses. In the case of Calotropis gigantean Dodonaea viscosa (headache, stomach pain and piles), Wrightia tinctoria (mumps ), combination plant as drugs like in case of Albizia lebbeck together with Cassia fistula and Euphorbia hirta ( urinary disorder), Capparis zeylanica with Pongamia pinnata, Cissus quandrangularis and Toddalia asiatica ( venereal disease).
In the Pattuvam (a village in Kerala) experiment, the village undertook to register all its natural resources and knowledge pertaining to these resources. The Register was accompanied by the People's Biodiversity Declaration asserting that no monopoly claims on life forms will be accepted by the people living in that area.
The judiciary in India has also been proactive in the deliverance of justice based on the principles of environmental jurisprudence as is witnessed in the case of Board of Trustee of the Port of Bombay vs. Dilipkumar R. Nandkarni (AIR 1983 SC 109) in which the Supreme Court held that right to livelihood is included within the meaning of 'life' strongly established in the case of Olga Tellis vs. Bombay Municipal Corporation (AIR 1986 SC 180).
The Supreme Court observed that life includes all meaning to a person's life including one's traditions, culture, heritage and protection of that heritage in its full measure in Ramsharan Autyanuprasi vs. Union of India (AIR 1989 SC 549) judgment.
The Honourable Supreme Court delivering the judgment in the case of Samantha v. State of A.P. [1997]8 SCC 191 observed that "Agriculture is the only source of livelihood for scheduled tribes, apart from collection and sale of minor forest produce to supplement their income. Land is their most important natural and valuable asset and imperishable endowment from which the tribals derive their sustenance social status, economic and social equality and permanent place of abode and work and living. It is a security and source of economic empowerment. Therefore, the tribes too have great emotional attachment of their lands. The land, on which they live and till, assures them equality of status and dignity of person and means to economic and social justice and is a potent weapon of economic empowerment in a social democracy".
India has been proactive in the conservation of biodiversity and it has been a pioneer in compiling the data on traditional medicines in the Traditional Knowledge Digital Library (TKDL). Varied experiments on documentation have been undertaken by the village communities, particularly in Kerala, which is one of the richest biodiversity states in India.

CHALLENGES TO TK
One of the challenges posed by the modern age is to find ways of strengthening and nurturing the roots of TK, even in times of social dislocation and change, so that the fruits of TK can be enjoyed by future generations so that traditional communities can continue to thrive and develop in ways consistent with their own values and interests [7-9]. At the same time, TK holders stress that their TK should not be used by others inappropriately, without their consent and arrangements for fair sharing of the benefits; more generally, it leads to calls for greater respect and recognition for the values, contributions and concerns of TK holders.
Researcher Vyasulu (1984) has vividly mentioned the poor state of affairs as far as the rights of tribals are concerned in their own produce. He notes that in the case of Sal seed (Shorea robusta) the tribes receive only five percent of the value of their product (per kilogram of seed, the collector received Rs.1, the contractor Rs.12, and the multinational Rs. 20). It is further noted that per every rupees spent in tribal areas for development and welfare, at least four (and possibly more) rupees worth of resources are taken out. 29 A report by WIPO gave insight into some of the traditional knowledge resources that have received global attention. WIPO's work therefore ranges from the international dimension of TK and cooperation with other international agencies, to capacity building and the pooling of practical experience in this complex area.

CONCLUSION
The safeguard if not the mere protection of traditional knowledge TK against misuse and misappropriation by miscreants who have perhaps more sensitivity to their own personal needs at the cost of the destruction and demolition of the biodiversity is very important. Also the safeguard is required for traditional knowledge TK is the breath of the indigenous and tribal communities and hence it is a cause for concern. This is reflected in the lacunae and enforceability concerns on the legal framework including the policy decisions and regulations. These policy decisions of the State globally seem to have inherent issues of practicality.
Laws exist and conventions have been signed by the world nations towards the beneficial use of traditional knowledge imbibed in the global indigenous and tribal populace and yet there are pertinent issues of the sustenance of the sustainability of these resources owing to the dynamics of social environment and the concerns of migration from the rural and tribal landscapes to urbanisation or better standard of living, precisely called historical dislocation.
Addressing these issues so as to revive the traditional practices through the stringent and fair implementation of the provisions of the CBD and the Nagoya Protocol is perhaps the way ahead to strengthen the traditional knowledge protection and this can be achieved with a resolve that truly does apprehend, approve, acknowledge and appreciate the need to safeguard TK for the benefit of future generations.
The functionality of the traditional knowledge can be effectively and efficiently enhanced through the recognition of not only the technological value (in medicine and drugs) but on extending it to the realms of cultural, intellectual and social domains which gives a holistic impetus to protect and provide for the indigenous dwellers of the tribal lands.
The initiative without any doubt requires economical viability through the protection by the various tools of intellectual property protection whose traditional qualities and frequent close linkage with the natural environment mean that TK can form the basis of a sustainable and appropriate tool for locally-based development providing a potential avenue for developing countries, particularly least-developed countries, to benefit from the knowledge economy.

DISCLAIMER
The products used for this research are commonly and predominantly use products in our area of research and country. There is absolutely no conflict of interest between the authors and producers of the products because we do not intend to use these products as an avenue for any litigation but for the advancement of knowledge. Also, the research was not funded by the producing company rather it was funded by personal efforts of the authors.

CONSENT
As per international standard or university standard, Participants' written consent has been collected and preserved by the author(s).

NOTE
The study highlights the efficacy of "traditional medicine" which is an ancient tradition, used in some parts of India. This ancient concept should be carefully evaluated in the light of modern medical science and can be utilized partially if found suitable.