Abstract

In India, the industrial sector that specializes in the invention, production, and marketing of neotraditional therapeutic specialties has been rapidly growing for two decades. In addition to standard pharmaceutical laboratory knowledge, it heavily mobilizes local medical knowledge. This article follows the trajectory of a new formulation called Jeevani, originating in the mining of both the classical Ayurveda texts and the tribal healing practices in the Indian state of Kerala. We investigate the strong coupling established by the reformulation regime between the invention of complex polyherbal therapeutic preparations with local forms of appropriation, namely Indian patents and benefit-sharing agreements.

One day in October 2012, we entered the premises of the Jawaharlal Nehru Tropical Botanic Garden and Research Institute (JNTBGRI) in Kerala. We came to meet with senior researchers and other staff members of the institute in an attempt to better understand how this state academic institute had participated in the invention of a product called Jeevani, an antifatigue and rejuvenating preparation sold by an Ayurvedic firm, Arya Vaidya Pharmacy (AVP). This drug is an intriguing therapeutic entity. It is registered as an Ayurvedic proprietary medicine, which means that it is marketed under a name registered as a trademark. This form of intellectual property is based on the recognition that this drug is not a formulation mentioned in the classical medical texts, but a modified preparation stemming from Ayurveda. Jeevani is actually manufactured as a polyherbal whose invention was rooted in the mining both of the classical Ayurveda texts and of tribal healing practices in the Indian state of Kerala.

But how can one design an innovative yet traditional therapeutic preparation out of medical texts that barely mention one of the main ingredients, the plant locally called arogyapacha? This question is critical for understanding Jeevani’s trajectory as its invention mobilized not only Western pharmaceutical knowledge and Ayurveda but also the knowledge concerning arogyapacha that the members of the Kani tribe in Kerala had accumulated over time.1 Jeevani thus seems to superpose several lives: the life of a typical drug, standardized and marketed following the norms of modern industrial pharmacy, but promoting tradition; the life of a material composition of plants worked out by botanists claiming lineage in Ayurveda, an assemblage of multiple parts supporting a discourse of efficacy focusing on the synergies and interactions between ingredients; and the life of an invention based on the collection and later appropriation of tribal knowledge whose recognition and compensation was first a private issue only to become a matter of public controversy after a few years. Is Jeevani, then, the symbol of another stage in the biomedicalization of Ayurveda? Is it a case of biotechnology oriented biopiracy? What is a traditional association of a few ingredients whose combination has an equivalent neither in established Ayurvedic texts nor in recorded or claimed tribal knowledge? How could such a hybrid entity become a commercial product whose propriety and therefore the mechanisms for distributing the profits accruing from its sales, involved three highly heterogeneous groups of actors?

Such questions regarding the contemporary transformation of traditional medical knowledge in India often receive answers focusing on binary epistemologies opposing medical systems.2 Binary epistemologies have, however, the great disadvantage of simplifying things far too much. Placing too much emphasis on the purity, coherence, and incompatibility of medical systems does not only result in the impossibility of intermediates but also produces a caricature of medical, especially clinical, practices, supposedly unified and stable in time. When binary epistemologies keep open the possibility of bridging worlds, it is only in the form of a mere juxtaposition with little creative power. Ayurveda is also commonly approached as a single coherent tradition of medicine characterized predominately by the doctrines, clinical practitioners, and medical infrastructure that supports it. But it is not a homogenous entity, as in the case of Kerala, with its diverse practices following the gurukula system with improvisations in Charaka Samhita, Susrutha Samhita, Ashtanga hridaya, or Ashtanga Samhita; this lineage-based system was considered a major component of uniquely variant regional practices, thus a corpus of fragmented, regionally and socially specified forms of medicinal knowledge.

Looking for a more dialectical or relational vision of the medical knowledge deemed traditional, we use Jeevani as an entry point into what we consider as a more general transformation of Ayurveda. In today’s India, the pharmaceutical production based on local medical traditions, which started in the early twentieth century, is experiencing unprecedented developments (Banerjee 2009; Bode 2008; Langford 2004; Madhavan 2009; Pordié 2015; Pordié and Gaudillière 2014a, 2014b; Sujatha 2011; Sujatha and Abraham 2012).3 An industrialized world of Ayurveda is currently reinventing remedies and in doing so, it is borrowing from various sources of knowledge, which cannot be reduced to the tense dialog with biomedicine but seek to integrate various forms of local knowledge. This is pertinent in the context of hierarchy of legitimacy (Mishra, Nambiar, and Madhavan 2018) within the pluralism debate in India to argue that much of the policy response on different systems of medical and therapeutic knowledge in India follows a tripartite schema with biomedicine at the top of the hierarchy, followed by professionalised/codified systems of medicine like Ayurveda and the ‘residual’ category, often known as folk medicine/LHTs/indigenous healing that fall outside the purview of the state (Hardiman and Mukharji 2010).

The emergence of a world of pharmacy within Ayurveda is a radical change, which may qualify as a third wave of alternative modernization.4 What we might call the present reformulation regime of Ayurveda is thus characterized by the emergence of a sector specializing in the production, invention, and marketing of polyherbal therapeutic specialties building on strong continuities, both conceptual and material, with India’s traditional medicines.5 As such, the reformulation regime carries radical changes in nature and scale of the practices associated with these forms of medicine. Reformulation is not only a change in the ‘formulas’; it also is a process of industrialization whose main actors are no longer vaidyas, local collectors and merchants, or household members but Ayurvedic drug–producing companies, academic settings specializing in the research and development of medicinal plants and governmental institutions supporting the expansion of the corresponding market. The reformulation regime thus entails critical economic, technological, and regulatory aspects regarding these new products and their uses among which the creation of property rights plays an essential role.

Intellectual property rules are not simply legal tools formalizing the rights pertaining to the production and commercialization of inventions, they are important mediating instruments, linking actors participating in the invention of products and the construction of markets, making boundaries between them, defining whose knowledge is valuable and who holds rights to it. Within this framework, issues of traditional-knowledge appropriation are the source of deeply engulfed tensions since claims for benefit sharing rely on past, often barely documented, processes addressed as state-of-the-art questions in the dominating and global patent system of intellectual property rights. It is shown elsewhere how the regime of reformulation and the rise of industrial Ayurveda have been associated with a strong critique of patents and the invention of new tools such as the Traditional Knowledge Digital Library intended to hinder the patenting of traditional Ayurvedic recipes, at least at the international level (Gaudillière 2014). Following the trajectory of Jeevani helps focus on a different aspect of the same debates: the strong coupling of the invention of new therapeutic polyherbal preparations and local rather than global forms of appropriation. This coupling was indispensable in turning traditional knowledge into intellectual property items—in this case Indian patents and benefit-sharing agreements—and constructing new markets. Recognizing that such mediation was important does not imply that creating intellectual property rights simply smooths the fundamental tensions pertaining to the reformulation regime and its forms of valuation. As we shall see, the latter resurfaced in due course, around issues of scaling up, mass production, and commercialization.

1 Inventing Jeevani, or the Redefinition of Ethnobotanical Practices in the Era of Ayurvedic Reformulation

Jeevani activates the body’s natural defences. It activates antibody synthesis, and delays hypersensitivity reactions. It increases the number of polymorphonuclear granulocytes and peritoneal macrophages. It activates the cellular immune system. It exhibits hepato-protective and cholorectic activities. It has adaptogenic properties as evidenced by anti–peptic ulcer and anti-fatigue effects. (Arya Vaidya Pharmacy Jeevani brochure, 2010)

Jeevani is a polyherbal preparation sold by Arya Vaidya Pharmacy (AVP), a company based in North Kerala. It is made of four plants: Trichopus zeylanicus, Withania somnifera, Piper longum, and Evolvulus alsinoides. It is advertised as a restorative, immune-enhancing, antistress and antifatigue medication. Although its sales have never reached the sort of high figures associated with major Ayurvedic industrial formulations, Jeevani has become popular because of its double origins in Ayurveda and in the traditional medical knowledge of the Kani tribal people who live in the forests of South Kerala. Although three of the ingredients in the composition of Jeevani are well-known Ayurveda plants, the first, Trichopus zeylanicus (or arogyapacha in Malayalam, “the green that gives strength”), was not part of this tradition, at least not until the invention of the new formulation.

The story of Jeevani is indeed closely linked with the work of the scientists working at the JNTBGRI in Kerala. In the late 1980s, these botanists were involved in a general survey of tribal knowledge of forests plants that focused on plants used as food and/or healing agents, the All India Coordinated Project on Ethnobiology (AICRPE) (Pushpangadan and Pradeep, 2008). At JNTBGRI, the survey was organized around three levels of documentation: an assessment of the ecological situation and biodiversity of the area, the local uses of plants, and a social and economic evaluation of the communities’ statuses. The reference procedure in the survey was to contact the local administration, meet the community leaders, get their agreement to present the project to the entire tribe and—if things were agreed on verbally—pursue the survey, trying to link specific plants with their mode of manipulation and use, and binding this knowledge with putative carriers identified either as individuals, families, or communities (S. Rajasekharan, JNTBGRI, pers. comm., June 2012). The first survey lasted until 1992, but the JNTBGRI researchers learned about arogyapacha from their Kani guides at an early stage, in 1987.

As the story goes, within the first few days of their stay, the ethnobotanists realized that the Kanis accompanying them were far from feeling as tired and fatigued as they themselves were, and they noticed that on the way, their guides regularly chewed some red fruits. On further (and pressing) inquiries, they were told that the fruits in question, from the plant called arogyapacha, were known among Kanis for their antifatigue properties. The JNTBGRI scientists then collected samples, which were later identified as exemplars of what botanists consider a local subspecies of Trichopus zeylanicus. Arogyapacha qualifies as a local subspecies in its botanical identification, making this a telling example of what Projit Bihari Mukharji (2014) considers retro-botanizing. He has pointed out that identification of botanical designations of plants used in the local health traditions and even in Ayurvedic texts is a process fraught with its own politics and history. Having left the forest, arogyapacha was now given an experimental existence. The coordinator of the AICRPE, Palpu Pashpangadan, a biologist trained in biochemistry, plant breeding, and ethnobotany, was very interested in the new plant and pushed for it to be closely studied at his home institution, the Indian Institute for Integrative Medicine in Jammu/Srinagar. In 1991, he became director of the JNTBGRI, where he reinforced the laboratory infrastructure and established pharmacology and phytochemistry divisions as well as animal-testing facilities.

The first scientific paper on arogyapacha was published in 1988 in Ancient Science of Life, an Ayurvedic research journal edited with the support of the AVP. The aim was not to grant the plant new botanical or pharmacological properties, but to argue for a specific Ayurvedic identity, taking into account its description as well as its anti-fatigue and rejuvenating potency. The botanists then joined Ayurvedic practitioners from the Kerala Research Center in Ayurveda (Poojapura, near Trivandrum) to consider that the plant had already been described in one important text in Ayurveda, written by Sushruta:6

From a critical survey of the ancient Ayurvedic classics, the authors have come across with [sic] some descriptions of a plant which match strikingly with “Arogyapacha.” Sushruta also described one “Varahi”—which he described as “Kandha sambhava”—rhizomatous, “Ekapatra” single leaves arising from a stem and “Anjana samaprabha”—shining like he [sic] grey-black stone. . . . Sushruta also described the plant that with [sic] its railing stem where the raised leaves appears—“Krishnasarpa swarupena”—like a black cobra with its raised hood. Sushruta ascribed [a] great rejuvenating property to the divine “Varahi” which is very true to [sic] “Arogyapacha.” Sushruta has also described the habitat of this plant as a shade loving herb found in the banks of rivers and natural pounds is also true [sic] to this plant. These descriptions . . . suggests [sic] that the divine “Varahi” . . . may be about “Arogyapacha” . . . (Pushpangadan et al., 1988: 15).

Giving arogyapacha an Ayurvedic name and place in the classical texts was however not enough to grant it value in Ayurvedic system of medicine, which had already experienced two waves of modernization since the late nineteenth century, as mentioned above. The JNTBGRI scientists thus considered that the plant and its antifatigue properties ought to be inserted into the framework provided by contemporary Ayurvedic pharmacopoeia, with its emphasis on the relations between the three basic humors constituting the Ayurvedic body, the materiality of the drug, and its differentiated effects in the patient’s body. Mixing paradigms, the team’s first publication thus provided a standard but highly simplified summary of an evaluation process, which borrowed from Ayurvedic pharmacology textbooks in many ways but left out all its complexities, for instance the fact that two among the most important attributes of remedies—vipaka and prabhava—are not physical properties that are accessible by manipulating or testing plants through the senses (or through any type of pharmaceutical equipment) but are inferential qualities, the results of a type of clinical experience that did not separate medicine and pharmacy.

In addition to the routine modern chemical and pharmacological evaluation, the drug “Arogyapacha” will also be subjected to evaluation from the point of view of Ayurvedic pharmacy and pharmacology (Dravya Guna Rasa Shastra) and the conceptual foundations [sic] of Ayurveda (the Panchabhoota concept, constitutional types based on Tridosha theory, etc.). The plant will have to be examined for its properties called Rasa (the “Shadrasas”; the six tastes), Guna (the attributes of qualities which are eight in numbers), “Veerya” (potency), “Vipaka” (the taste that comes out after the materials digested) and “Prabhav” (the specific action) and then evaluate its relation as well as is [sic] reaction to the constitutional types (the “Vata,” “Pitta” and “Kapha” balance in the body) of the body taken into account for correcting the vitiated “Doshas” (Pushpangadan et al. 1988: 16).

Linking arogyapacha and Ayurveda not only meant taking the plant away from oral, indigenous, tribal knowledge to bring it into the realm of a written, scholarly, institutionalized Indian system of medicine, it also implied changing its economic status. As discussed below, once associated with as classical an Ayurvedic source as Sushruta’s text, arogyapacha could become an ingredient in formulations legally registered as Ayurvedic proprietary medicine even though T. zeylanicus had never been mentioned in the numerous lists of botanical names given as equivalent to the plants used in classical Ayurveda (shastric) preparations.7

In resonance with this perspective, the main target of work at the JNTBGRI soon became the creation of a new formulation including arogyapacha as main ingredient. Such a choice distinguishes the JNTBGRI scientists’ approach from that of any bioprospecting project since: (1) plants are not considered in isolation but as part of a combination, that is, as a polyherbal, even if the clinical principles grounding the classical formulations are complex and sometimes not part of formalized Ayurvedic teaching; and (2) isolating active ingredients and linking therapeutic potency with purified chemicals is not the goal. The JNTBGRI scientists thus made little effort in the direction of searching the (active) ingredients of arogyapacha and no attempt to isolate and purify them (Varughese George, Amity Institute, pers. comm., January 2012).

As we were told by Ayurvedic drug manufacturers, the separation of entire fractions through chromatography, which is current practice in the Ayurvedic industry, is actually less employed as an indicator of the therapeutic potency of the active ingredients than as an instrument to control the quality of the raw materials by comparing plant-bundle testing with the reference chromatographic profiles (locally) established for the most important plants purchased on the medicinal plant market (Sheela Karalam, Oushadhi [Pharmaceutical Corporation (IM) Kerala Ltd.], pers. comm., March 2013).

Even if active ingredients were not targeted, the choice of using polyherbals was nonetheless linked to forms of biological rationalization. The use of entire extracts of individual plants as well as the reliance on combinations of several plants were justified by the idea of synergy as a common denominator for (1) the putative positive interactions among the ingredients contained in one plant, and (2) the complementary effects of plants with different medicinal properties (Palpu Pushpangadan, Amity Institute, pers. comm., June 2012). The first is common to many pharmaceutical traditions, Western and non-Western; the second originates in the very specific practice of Ayurvedic formulation.

Being true to the Ayurvedic formulation was, however, far from obvious given that even though arogyapacha had been included in the family of rejuvenating plants, the JNTBGRI scientists were starting from an isolated plant rather than a classic shastric formula. Which ingredients were to be selected to build a composition that would enhance and diversify its action profile? Kani knowledge did not help to solve this problem because the locals used T. zeylanicus in isolation. One possibility for the formulation could have been to collaborate with a trained vaidya. This was done eventually but at a later stage in the development process, when issues of clinical evaluation surfaced. The initial solution was simply to build on the resource of limited but real in-house knowledge of translations between Ayurveda and biomedicine.

To design the formulation, I used my double training in Ayurveda and modern pharmacology. We wanted a formulation from the beginning for two reasons. The first one was a problem of raw material. Trichopus zeylanicus is an endemic and endangered species and its supply was limited even if following the preclinical trials, we decided to use the leaves rather than the fruits to spare its reproductive capacity. The second reason is that formulating creates synergies between the components. These synergies can either enhance the anti-fatigue potency—that was the reason why we included Piper longum—or confer new properties to the preparation (S. Rajasekharan, JNTBGRI, pers. comm., January 2012).

In contrast to classical formulations, which may include dozens of components, the JNTBGRI researchers restricted their number to three or four plants. The main reason for this limitation seems to have been less the pragmatics of working on what would be a good formulation out of a hybrid experimental-testing combination and examination of the classical texts (on this basis, thirty to thirty-five candidate plants were initially selected) than the speculation that the new combination would have to be validated and marketed at the international level. In contrast to commercialization in India, entry into the European and US markets, even as food supplements, would be all the more difficult as the number of ingredients grew and would be almost impossible to be accepted with more than four or five (Palpu Pushpangadan, Amity Institute, pers. comm., 25 January 2012). Adding Piper longum to many tested formulations thus originated in its status of “enhancer.” The main driver in the reformulation was however a reinterpretation of the properties of plants used in the broader Ayurvedic Rasayana category of rejuvenating plants (now including arogyapacha) with a specific interest in ashwaganda (Withania somnifera), an ingredient associated with immunomodulating, rejuvenating, and/or psychoactive effects.

The procedure for selecting formulations at the JNTBGRI thus borrowed from heterogeneous forms of knowledge. However, it bore strong analogies with pharmaceutical screening. The newly established pharmacology division at the botanical garden systematically prepared combinations of three to four ingredients out of the thirty to thirty-five selected plants, and these were tested in the same animal assay that had been used to demonstrate and publicize the antifatigue potency of arogyapacha through laboratory experimentation (Palpu Pushpangadan, Amity Institute, pers. comm., 25 January 2012). Presented in a 1989 article in Ancient Science of Life, the protocol borrowed directly from industrial pharmacy procedures. JNTBGRI scientists thus ran a swimming-endurance test with mice, looking at the amount of time mice fed with arogyapacha or complete extracts (water or alcoholic) could swim compared to mice in control groups (Sharma et al. 1989).

In this herbalized version of Ayurveda, the formulations are taken away from the clinical context of their use, which authorizes variations in the content as well as in the proportions of the ingredients. They are taken as stable composition of individualized plants, which show specific combinations of properties and indications. If the formulation becomes a unique (standardized) entity permitting synergies, it can—for all practical purposes—be constructed and evaluated as a mere juxtaposition of ingredients, each bringing a peculiar type of action or potency. Hence, (1) the possibility of formulating entirely new combinations in which the elements are all part of Ayurveda but have not previously been put together, and (2) the need to test them in a systematic manner since existing Ayurvedic knowledge is not considered to result in specific predictions of the overall result.

This practice of reformulation was not restricted to the development of antifatigue and rejuvenating formulas but expanded into a search for other uses of arogyapacha. Enlarging the palette of pharmacological tests, JNTBGRI researchers developed at least two other formulations to the preclinical stage: one is a simplification of Jeevani (without Evolvulus alsinoides) with diabetes as main indication; the second is an anticancer preparation combining T. zeylanicus and a second plant collected during the Kani survey, amrithapala (Janakia arayalpathra), which the tribe allegedly uses to treat peptic ulcers and skin tumours. Like arogyapacha, amrithapala was given an Ayurvedic identity although in a weaker manner, as the reference did not originate in the classical shastric texts but in a 1906 compendium of medicinal plants, one of the first to argue for the autonomy of Ayurvedic pharmacology. These weak roots in the formal tradition were somehow compensated by the fact that the Kani themselves link amrithapala to the Ramayana’s characters Hanuman and Laxmanan (Pushpangadan et al. 1990: 213).

2 Appropriating and Producing Jeevani: Benefit Sharing, Patents, and the Construction of Polyherbal Markets

Jeevani thus stands as a striking example of how community-based knowledge, preserved and developed by generations through local interactions, observations, and experimentation, has been harnessed for an utterly different, formalized, and professionalized body of knowledge to elaborate a new herbal preparation. The practices involved in this reformulation did not take shape in a vacuum but in a context of market-oriented innovation. We will now turn to the construction of the polyherbals market and—more specifically—the various appropriation mechanisms involved in reformulation.

Market construction is not only a problem of legally recognized property rights. It obviously requires constant and nonchaotic interventions of institutions to generate and stabilize the demand for new Ayurvedic products. Being members of the first full-fledged ethnopharmacological initiative in India, JNTBGRI scientists engaged in efforts to demonstrate the commercial potential of their tradition-based innovation approach. Long before the stabilization of the Jeevani formulation, the JNTBGRI had positioned various ethnobotanical projects as attempts to develop products (Gaudillière 2015). This method of tradition-based drug discovery received a major fillip in the later research agendas of public institutes in India (Patwardhan and Raghunath 2009).

Soon after its invention, Jeevani acquired some visibility in the public sphere. This visibility was not only that of an innovative neotraditional preparation, produced and promoted by a major Ayurvedic firm. More significantly, it was the public presence of a formulation embodying all the contradictions associated with the valorization of traditional medical knowledge. In 2000, the World Intellectual Property Organization (WIPO) established an intergovernmental group whose purpose was, following the Convention of Biological Diversity (CBD) mandate, to consider issues of biopiracy and traditional knowledge, and more specifically, to elaborate proposals for mechanisms that would allow for the compatibility of the international patent regime and the recognition of community rights over traditional knowledge. In 2005, when the WIPO committee succeeded in publishing its first programmatic document on the topic, the story of Jeevani appeared as a celebrated example of how sui generis mechanisms—specific benefit-sharing agreements—rather than amendments in the patent laws could solve this conundrum (WIPO 2005).

Jeevani was actually presented as one among the first cases of a contract between so-called bioprospectors and local communities. It triggered discussions in both the local and the international media, but not on the same issues. While international trade and property-rights institutions highlighted the value of Jeevani as an experiment in establishing a sound boundary between innovation and the recognition of oral, informal, ancient knowledge, discussions in the regional Kerala public sphere insisted on the negative consequences of commercialization and on the tensions between the various ownership rights created around Jeevani, stressing the latter’s impact on both the local institutions and the life of heterogeneous sections of the Kani community.

2.1 Property Rights and Benefit Sharing

The first step in the appropriation of Kani knowledge was a verbal contract between the JNTBGRI team and a number of Kanis, defining not intellectual property rights per se, but how the sharing of benefits would be organized if product development would follow a successful trajectory. It should be recalled that this proposal was made before any institutional framework for defining property rights on community resources and traditional knowledge had been devised in national or international forums.

The informal arrangement in the Kani case was built on the belief that a system of intellectual property protection covering the use, dissemination, and commercialization of traditional knowledge is above all a tool in local economic development, a means for providing rewards, personal control, and commercial opportunity for knowledge holders, rather than defensive mechanisms against biopiracy as understood today. The oral contract on Jeevani in fact focused on the economic implications for the community (both in-kind and cash), considering the appropriated knowledge as an information commodity. This is evident from both the expired as well as the newly proposed contracts as mentioned in Table 1.

JNTBGRI scientists were thus prepared to share their benefits with the community. To transfer the monetary benefits, they formed the Kerala Kani Samudaya Kshema Trust (KKSKT) with the majority of community members. In September 1997, the amount of Rs 519,000 (USD 13,000), due because the informal agreement had started before the creation of the trust, was transferred to the KKSKT bank account. This amount included Rs 500,000 (USD 12,500) originating in the 50–50 sharing of the license fee paid by AVP, the rest being the first installment of royalties. The trust had the power to decide on the ways of utilizing the accrued interests but not the capital provided by the license fee and the royalty installment. Up to 2003, an additional sum of USD 2,500 was obtained as royalty from the sales of the drug. With the help of funds from this trust, the Kanis were able to start a school and a hospital and also a storeroom for arogyapacha, and a vehicle for timber transportation—given their new visibility—was also engaged in projects sponsored by the World Bank.

Cultivation of the plants required initial training but offered the Kani tribe members possibilities of daily earnings—at least during the specific season when the leaves are available. The AVP purchased leaves at Rs 150 per kg. As the species is endemic, biopiracy in the form of exploitation of T. zeylanicus from other areas seemed to be difficult, and the Kanis could benefit from a de facto monopoly on the resource and continue to get revenues for their exclusive supply of raw materials. A kilogram of these leaves fetches about Rs 150 (USD 3) in the market and there can be two harvests in a year, each harvest yielding about 200 kilograms. The Kanis could therefore expect to make about Rs 60,000 (approximately USD 1,000) every year, which, for a community of 21,251 people (2011 Census of India), is small but not negligible.

On the other hand, the Kanis had to face several hurdles. One of these was the initial suggestion that the proceeds should be transferred to the Kerala tribal development department, which the Kanis were vehemently opposed to and the problem was ultimately solved by the KKSKT. Another sore issue has been the Kanis’ difficult negotiations with the Forest Department regarding the uses of nontimber forest products. Some recognition of rights had therefore been granted. This does not mean, however, that the agreement, claiming financial parity between the JNTBGRI and the community, did not generate strong asymmetries and inequalities.

2.2 Patents and Power Inequalities

In India, the Drugs and Cosmetics Act of 1940 and the Drugs and Cosmetics Rules of 1945 regulate traditional medicines. They define the rules for import, manufacture, distribution and sale of both drugs and cosmetics. In 1959, the government of India recognized the Indian systems of medicine and amended the Drugs and Cosmetics Act to include drugs that are derived from traditional bodies of medical knowledge such as Ayurveda, Unani, and Siddha, stating that no products derived from traditional systems may be manufactured without a license from the State Drug Control Authorities. Patent and proprietary medicines derived from the traditional systems must contain ingredients that are mentioned in the recognized texts of the different Indian systems of medicine as specified in the Drugs and Cosmetics Act.8 In 1993, an expert committee appointed by the Indian government developed guidelines for the safety and efficacy of herbal medicines, which were intended for incorporation into the Drugs and Cosmetics Act and rules. It was proposed that no new herbal medicines other than those authorized by the licensing authorities be allowed to be manufactured or marketed, except for those mentioned in—and manufactured in compliance with—the formulae given in the authentic books for Ayurveda, Siddha, and Unani herbal medicines (the so-called classical drugs). The requirements as per the Drugs and Cosmetics Act are summarized in Table 2. The JNTBGRI scientists followed these rules.

For instance, to qualify for proprietary ownership, toxicological, phytochemical, and pharmacological studies as well as ethnographic documentation of T. zeylanicus were produced at the JNTBGRI. As mentioned in the previous section, the ethnopharmacological screening of arogyapacha revealed multiple activities: antifatigue (Tharakan, Dhanasekaran, and Manyam 2005), antitumor, anti–gastric ulcer, antiallergic (Saudagar, Sambathkumar, and Bachhav 2013), antioxidant (Chacko et al., 2002), adaptogenic (Singh et al. 2005), aphrodisiac (Subramoniam et al. 1997), immune modulatory (Pushpangadan et al. 1995), hepatoprotective (Subramoniam et al. 1998), and cardioprotective (Velavan, Selavrani, and Adhitan 2009). Once the drug had been registered as Ayurvedic proprietary medicine, drug regulators decided that it could be produced under the swastahitha (health promoting) group of drugs.

The second step to appropriation was patenting. In 1996, the JNTBGRI filed a patent application for the process of manufacturing an herbal sports medicine, the first to be based on arogyapacha. The application describes the invention as “a novel, safe herbal sports medicine, having anti-fatigue, anti-stress and stamina boosting properties.” The application text included claims related to the preparation process of an herbal drug composed of arogyapacha and three other plants in the form of granules. It did not specifically mention the tribal knowledge of the plant. On the contrary, it recorded that “the therapeutic effect of this plant has been established by detailed pharmacological studies” and added a direct reference to Ayurveda: “the physical appearance and characters of this plant matches well with the description of ‘Varahi’ described in Susrutha Samitha” (Gupta 2004). This key patent covering the process of Jeevani production was filed in India in 1996, at a time when the country did not have pharmaceutical product patents, and protection of the process was limited to seven years from the date of application. In the following years, four other patents emanated from the research work on T. zeylanicus that various teams led by the then JNTBGRI Director Palpu Pushpangadan conducted at the Regional Research Laboratory, Jammu, and the JNTBGRI.

Patent registration is a lengthy, highly formal and expensive task. As an effect of its mere existence, the appropriation of Jeevani through patenting generated a novel and fundamental type of inequality between the Kani people and the JNTBGRI scientists. The latter did not consider this asymmetry problematic: they perceived the process as a rather straightforward registration of the division of tasks involved in the development of a new formulation with ancient knowledge on the one hand and innovation on the other hand. Since patents recognize invention—in this case the reformulation work achieved at the JNTBGRI—it seemed all the more logical that it remained separated from the benefit-sharing procedure, acknowledging what had been done within the framework of the ethnobotanical survey. As an effect of this “boundary-work” (Gieryn 1983), the Kani community did not become part of any official ownership emerging from the knowledge of T. zeylanicus. Actually, none of the patent applications from the JNTBGRI acknowledges or mentions the Kani contribution. This separation has since become a major point of contention in international discussions regarding the recognition of rights on traditional knowledge, with local community advocates pleading for a disclosure clause to be made mandatory in patent laws. It should however be noted that, although such reform would give increased visibility to the bioprospected communities and help trace the uses and transformation of traditional knowledge, it would not alter the fundamental hierarchy between benefit-sharing agreements and patents, a hierarchy rooted both in the pharmaceutical innovation culture, and in the part played by monopoly of use in the construction of drug markets.

JNTBGRI patent applications also radicalized the differences—both ontological and economical—between the two registers of traditional knowledge involved in the making of Jeevani. In India, Ayurveda is a medical system recognized as such by the state and the medical institutions. This official status does not, however, translate straightforwardly into the political economy of reformulation. Indeed, a paradoxical situation resides in the juxtaposition of two registers of state intervention. On the one hand, with the establishment of the Traditional Knowledge Digital Library in 2000, its digitalization of classical (shastric) formulations and its systematic practice of opposing patents on them, the Indian state has issued an important tool for keeping classical Ayurveda as a common good. On the other hand, as in the case of Jeevani, reformulation is associated with filing and obtaining patents on combinations bearing a direct relationship to the same shastric corpus. Through its patent office, the Indian State thus acts in favor of proprietary valorization of the “common good” it seeks to defend. The paradox is well acknowledged and in most instances accounted for in terms of innovation, as the patents granted on Ayurvedic proprietary medicine are viewed as fostering invention because they protect changes in the formulation and because they protect unprecedented combinations. As the case of Jeevani shows, the crux of the matter is that these reformulations may depend to a very large extent on classical Ayurveda and/or other forms of nonbiomedical knowledge.

A second important dimension to the appropriation of Ayurveda-derived knowledge is its national status. Due to their institutionalization in the postwar era, Ayurveda and the other Indian systems of medicine have become ipso facto national resources. In spite of occasional communal claims, the corpuses of reference textbooks are not associated with specific communities but have been made “Indian,” that is, nationalized. There is therefore no official need to share benefits and biopiracy has no meaning when it comes to Ayurveda, unless appropriation operates at the international level. Hence the opposition practices of the Traditional Knowledge Digital Library, which has thus been entrusted as protector of both the national common good and the national freedom of appropriation (Gaudillière 2014).

JNTBGRI’s successful patent filing on T. zeylanicus formulations ultimately led to a sort of influx in patent applications on tribal knowledge obtained from the Kanis but concerning other plants, for instance, a medicine used for generations by the Kanis to treat disorders, which have been equated with diabetes and certain allergies. The medicine was derived from the roots of a small-sized tree, Humboldtia decurrens (known locally as neeru vatti or chembravalli in Malayalam) and three institutions were involved in the 1997 joint application: the Regional Research Laboratory of the Council for Scientific and Industrial Research at Thiruvananthapuram; the Sree Chitra Tirunal Institute for Medical Sciences and Technology also located in Thiruvananthapuram; and KIRTADS (Kerala Institute for Research Training and Development Studies of Scheduled Castes and Scheduled Tribes).

Due to the high costs of patenting outside India, patents on reformulations including T. zeylanicus are national patents, leaving the possibility of making claims on Trichopus-based products abroad. In 1999, NutriScience Innovations, LLC, a New York–based herbal medicine company, applied to the US Patent and Trademark Office (USPTO) for registration of a trademark on Jeevani. When this came to the attention of the botanical garden officials, a dispute broke out and brought considerable media attention. While the case was never officially resolved, NutriScience abandoned its trademark application in 2001. However, Great Earth, another New York–based supplement and vitamin company, registered a trademark for Jeevani in the United States in 2000. Great Earth then marketed an energy drink called Jeevani Jolt 1000 that included the same ingredients as those in the original Jeevani, though it is unclear how Great Earth acquired arogyapacha. These products did not infringe on any intellectual property rights since the JNTBGRI had never filed a trademark application for Jeevani with the USPTO. As a result of Great Earth’s promotion, Jeevani became widely known in North America, and many other companies have since released products claiming to be Jeevani or made of Jeevani (WIPO 2010). This clearly shows how, just as in the case with classical pharmaceuticals, the creation of exchange value for new Ayurvedic polyherbals is not limited to the appropriation of knowledge through intellectual property rights but extended to the whole process of commercialization.

2.3 Market Construction but Failed Commercialization

The company that entered into negotiations with JNTBGRI scientists, AVP, is a traditional Ayurvedic firm (of Ashtavaidya family tradition)9 from Kerala, but based in Coimbatore, Tamil Nadu, has a pan India network of doctors with six hundred sales and distribution outlets across country. It produces nearly five hundred products, majorly authentic classical formulations, and has also recently entered the domain of patent and proprietary medicines. In the 1980s and 1990s, it emerged as one of the major firms in the field of Ayurvedic manufacturing, promoting integrative research with an associated foundation hosting a hospital and the establishment of a scholarly journal, Ancient Science of Life (published in English). AVP is one of the leading research firms in the private Ayurvedic industry. It possesses a chemistry laboratory and a manufacturing laboratory, and organizes controlled clinical trials. AVP produces about four hundred therapeutic formulations in two GMP (Good Manufacturing Practices)-certified production facilities in Kerala. It was the first company in South India to obtain GMP certification for production standards in Ayurveda. Jeevani was one of its earliest commercialization attempts of proprietary products with the establishment of a large capacity production line and mass promotion. This herbal medicine received a surprisingly positive echo on the market. Officials at the AVP revealed that the bulk of their exports to Southeast Asian and Western countries consist of Jeevani and it contributed to the rapid growth of AVP at the turn of the century.

AVP marketed Jeevani for seven years but commercialization was plagued with major issues of raw-material availability. In 2005, the company stopped producing the formulation. Even if it can no longer be ordered, Jeevani is still promoted on the AVP website. This makes sense on two levels: the value of Jeevani as a symbol of AVP involvement in innovative reformulations on the one hand and, on the other, the fact that the company produced another formulation, Punarjeevani, targeting the same indications and using the same composition as Jeevani but excluding its key ingredient, T. zeylanicus. How should this substitution and commercialization failure be interpreted? The final stage in the trajectory of Jeevani—its disappearance from the Ayurvedic market—shows how an informal benefit-sharing understanding was not able to ease, much less resolve, the tensions between the multiple stakeholders involved in the late stages of reformulation, namely the shift from pilot to mass production and the transformation of anticipated use value into effective exchange value.

First, it is important to note that while the Kani informants had used the plant fruits for vitality and energy, the JNTBGRI scientists experimented with—and patented the use of—the leaves even while claiming a continuity of purposes with tribal practices. The research was concentrated on leaves because the berries could not be sustainably harvested, their use increasing the possibility of extinction of the plant. As a consequence, the major source of income from the benefit-sharing scheme discussed above was the supply of T. zeylanicus leaves for drug manufacturing. After pilot-level in situ (within the natural habitat) cultivation begun in 1997 and involving fifty households, who garnered a significant addition to their income in the process, more families started cultivation during the second season of the year and uprooted the plant in this second harvest (Martin 1998). The planting material was collected from the forest and the opportunity cost of family labor was the only expenditure incurred by the tribes. The price offered by AVP was comparatively meagre for the first purchase (Rs 25 per kg of fresh leaves), but the tribes were able to bargain for a better price after the second harvest (securing Rs75 per kg). Due to the lucrative nature of Trichopus leaf sales, the tribes also began to collect whole plants from the natural habitat and, ultimately, the Forest Department proscribed cultivation, fearing extinction of the species. AVP attempted to cultivate plants with the tribal population, offering to provide the initial investment, but the Forest Department rejected the entire proposal.

The JNTBGRI scientists tried to solve the problem of supply, first by experimenting ex situ (outside the natural habitat) cultivation under a simplified version of the forest ecosystem, and later by inventing a propagation technique through tissue culture seedlings. The former was a failure due to the fact that T. zeylanicus grown under artificial conditions did not preserve its therapeutic potency (S. Rajasekharan, JNTBGRI, pers. comm., March 2013). The latter was only partially successful (Krishna and Pascual 2004). But growth of the plants was deemed too slow to ensure the supply of the anticipated big market (Payyappallimana 2000). The first contract had not envisioned these conservation and cultivation problems, and these had not been included in the main text of the first agreement between AVP and the JNTBGRI. This is not exceptional. It has been pointed out that in most access and benefit-sharing arrangements, sustainability is not viewed as part of the main objective and is overlooked in the negotiations stage. The situation was nonetheless quite serious. Toward the end of the patent-protection period, AVP was able to produce only two thousand bottles per month when the capacity of its production line was of thirty thousand bottles per day. AVP was then prepared to pay the cultivators a much higher amount for the raw materials as demand for Jeevani remained very substantial.

Second, the problem of supply was not only material but also institutional as well. Conflicting institutional interests had made the tribal community—and the supply of leaves—even more vulnerable. Various governmental institutions thus tried to push their own agenda in an ethnic community’s name. Although it had contributed no material or financial resources to the research effort, the Forest Department demanded a share of the license fee and royalties on the grounds that the plant material collected was endemic to the forest. The JNTBGRI was forced to renegotiate the terms of its agreement with AVP to include the forest administration, all of which cut back the profit share due to the Kanis even further (Reddy 2006).

Finally, coming up with a proper definition of the community proved an arduous task. The JNTBGRI scientists’ early informants were the first to receive benefits in the community’s name. The scientists’ intention had been to help the community manage the new resources through their own institution rather than being placed under state tutelage. The trust fund model had been envisioned as more democratic and accountable to the Kani people. But many members of the community claimed to be left outside the benefits the trust provided. The main problem was, however, created by the sharing mechanism itself because it lumped together the indigenous and the local in the definition of the community. The JNTBGRI failed to recognize that the traditional political systems among the Kanis had been eroded and replaced by administratively relevant nontribal local communities (Reddy 2006). Thus, when the JNTBGRI interacted primarily with the Kanis from one panchayat area, those who lived in the other two panchayats were offended by what they saw as the JNTBGRI’s cultural insensitivity, bias and exclusion policy. Several village-level leaders then boycotted the meetings organized by the JNTBGRI to administer the agreement, arguing that the trust was neither representative nor participatory. These tensions further endangered the commercialization of Jeevani.

3 Conclusion

Following the trajectory of Jeevani thus highlights the critical role intellectual property rights play in the rise of industrial Ayurveda and of its regime of reformulation. Jeevani’s invention shows the strong coupling between the invention of new therapeutic polyherbal preparations and local rather than global processes of appropriation. This coupling was indispensable in bringing together the two forms of traditional knowledge involved in Jeevani’s invention and turning them into intellectual property items, in this case Indian patents and benefit-sharing agreements, and constructing new markets on that basis. These items not only worked as institutional, economical, and moral arrangements but also performed important epistemic functions as they eased the tensions and putative incompatibilities between the three registers of knowledge involved—that is, Kani’s vision and uses of arogyapacha, Ayurvedic reference texts, and TBGRI’s experiments—while providing a decisive hierarchy between them and between each party’s allocation of benefits. Recognizing that such mediation was important does not imply that creating intellectual property rights simply solves the contradictions inherent to the reformulation regime, the practices of invention, and the modes of valuation it entails. As we have seen, some of these contradictions resurfaced in due course when scaling up and mass production of Jeevani turned issues of access to arogyapacha, its collection, and its cultivation into a major challenge.

In 2005, the World Intellectual Property Organization issued a booklet on issues of traditional knowledge protection. The document included a short story of Jeevani, summarizing its development and ending with the creation of a trust-fund to share the benefits arising from the commercialization of the TK[traditional-knowledge]-based drug (WIPO 2005: 7). Our reconstruction of Jeevani’s trajectory could be considered a classical story of local complexities and irretrievable local contradictions. What WIPO’s booklet does not say is that the tensions, hierarchy, and compromises between benefit sharing and patent, between traditional knowledge and pharmaceutical development, Jeevani reveals, have been so central to WIPO-led negotiations of an international agreement on the protection and valuation of traditional knowledge that its international committee has been oscillating between strategies aiming at a reform of the patent system and plans for the establishment of ad hoc and community-based property rights for more than ten years now.

Acknowledgments

We are grateful to the valuable input and suggestions of two anonymous reviewers. This research was supported by European Research Council Advanced Grant 340510.

Notes

1

The Kani tribe is based mainly in the forests of the Agasthyamala hills of the Western Ghats in the Thiruvananthapuram district of Kerala, India. The traditional occupation of the Kanis includes handicrafts, such as basket making, mat making, and cane works, and the seasonal collection of minor forest produce, such as honey and beeswax. The Kanis today live in several tribal hamlets, each consisting of approximately twenty families spread around the forest areas of Thiruvananthapuram; they constitute slightly less than 2 percent of the district population.

2

For critical use and discussion of the system’s approach in the case of Ayurveda and its different modes of modernization, see Arnold 1993; Attewell 2007; Berger 2013; Leslie 1977, 1992; Mukharji 2011, 2016; and Zimmermann 1989.

4

Alternative modernization is a widespread notion with multiple meanings in anthropology and history. In the context of this paper, borrowing from the collective work of the Indian Subaltern Collective, it refers to processes of transformation claimed to be both echoing and opposing Western modernity. See, for instance, Partha Chatterjee’s (1993) discussion of Indian nationalist thought.

5

Labeling the recent emergence of reformulation as the third wave of modernization in Ayurveda builds on the historical and sociological literature that distinguishes a first phase of transformation, circa 1900, that focused on issues of certification and professionalization and a second phase of institutionalization after independence associated with the opening of medical schools, hospitals, and local care facilities, thus creating a parallel but distinct medical system. See Attewell 2007; Berger 2013; Banerjee 2009; Sujatha 2011; and Sujatha and Abraham 2012.

6

The question of which texts should count as references to define classical Ayurveda is critical, and the choice of Sushruta as significant corpus might be contested. Our understanding is that it was the only one providing the ethnobotanists with a suitable plant description.

7

By placing arogyapacha in the category of Varahi (the family of Dioscoreaceae), this plant becomes a part of Ayurvedic Pharmacopeia of India (part 1, volume IV, item no. 63) and hence legitimately included in the proprietary Ayurvedic medicine preparations (as mentioned in the Drugs and Cosmetic Act of 1941) with necessary evidences. As one reviewer of this paper rightly pointed to, this process of renaming, matching existing textual description, and combining with other (legitimate) plants may be thought of as a process of “ayurvedicalization” of the knowledge produced and shared by the Kani people since it is aimed at the inscription of arogyapacha in the administrative superstructure of state Ayurveda.

8

As one of the reviewers rightly points out, the botanical identity of plants mentioned in the corpus of the text is controversial. For a detailed read on the problems of linking ayurveda’s polynominal naming system to modern botanical names, see Payyappallimana 2008.

9

AVP’s founder, Arya Vaidyan P.V. Rama Varier, was trained as a physician under Vaidyaratnam P.S. Varier, the founder of Arya Vaidya Sala Kottakkal. He was part of Arya Vaidya Sala Kottakkal for more than a decade; this is where he was trained in making medicines before he established the Arya Vaidya Pharmacy. The role of Arya Vaidya Sala in the history of revitalization of Ayurveda and in initiating an organized mass medicine production is well documented (Panikkar 1992; Cleetus 2007).

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Le discours des remèdes au pays des épices: Enquête sur la médecine Hindoue
(The Discourse of Remedies in the Land of Spices: An Investigation of Hindu Medicine).
Paris
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Payot
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