AYURVEDA AS TRADITIONAL KNOWLEDGE: LEGAL PROTECTION AND CONTEMPORARY RELEVANCE IN INDIA

By Snehasish Sarkar
Student, BBA LLL.B(H), Quantum University, Roorkee, India.
Email: sarkarsajal576@gmail.com.

ABSTRACT

Ayurveda arrives to the portals of the contemporary legislation with soaring baggage of the history, custom and care of the human beings. It is more not the directory of plants and recipes as in dusty manuscripts, but a sort of an history, väids the treatment of patients in village courts, families concocting medication at home, laboratory experiments trying to isolate active properties to test them on patients: that indistinct reality is a key to asking the questions of law discussed in these parts: when the ancient recipe is the seed of a new substance that works around the world, who is the proprietor, who benefits, and shall active law go forth and put under restraint that sort of movement? This putting into doubt, in the paper, is achieved through an enquiry concerning the said questions through legal framework that has been founded on doctrines and how the statute with its books, its courts and its institutions have striven to remain abreast with the strain of commerce nor to contravene the communal rights here. The first portion of the analysis is the study of protection of doctrine provisions in the patent law in India. Winning; Organ 3(d) of the Patents Act is no technical rule-- it is a policy option which is as follows, the mere wrong pouching of known knowledge, is not a deserving monopoly .2 Novartis practice to that effect demonstrates the guardian angel; there must be, in addition to novelty, an actual, real progress to get a patent. Nonetheless, half a tale is the juridical escape of patenting; that evading prevents no compensation to the evil and provides no positive act to societies whose everyday understanding imparts the current-day innovation.

It is in that gap that the biodiversity and ABS (access and benefit sharing) law comes in. The Biological Diversity Act and its recent amendments put prior-approval and benefit-sharing obligations at the centre of the regulatory map, indicating that access to biological resources and related knowledge was not a commercial issue to be a shrivelled-up-seller of without 7 That asymmetry is important since the defensive success stores of biopiracy such as invalidation of patents on turmeric or neem would be much more likely to be the subject of judicial than material effective decision-making.5 This asymmetry is important as the regulatory map, where benefit-sharing policies and the

The example of not only promise but paradox is shown in the innovation within the policy of India, Traditional Knowledge Digital Library (TKDL). Meanwhile, translating practice Ayurvedically means making examinables at patent offices in other countries and, directly, prevents bad patents,7 Ayurvedic has made practices legible as datable entries, which are not necessarily expressed in formulaic entries by healers. Critics caution that writing itself poses the danger of paralyzing knowledge, which is, in any case, adaptive. The article therefore goes on to conclude on a diagnosis made on three observations. First, the Indian legal environment is not only potent on defensive protection doctrine but its TKDL also discourages appropriation. Second, it is less adequate on affirmative empowerment- ensuring that applications of its expertise in downstream are shared and they are economic to the owners. Third, there is a partial or incomplete state of institutional coherence, where laws, institutions, exist in the wrong state, there is no coherence and there is no local capacity. These are observed under the laws, and legal decisions, and departmental policy handouts and fine research.

The article recommends a list of proposals of changes between diagnosis and prescription. What an alternative does give is a solution, although some of the measures identified by the proposed liberties on the practical law reform would certainly be an obligatory TK-disclosure and provenance requirement to patent applications (so that examiners and offices can know about any knowledgeable TK at very least), statutory clarifications on the calculation of deliquescent to be relinquished by administrative bodies, and continued interoperable interrelationship between TKDL and any overseas patent databases. These structural changes center on establishing the capacity development of the local committees, making the vaids get closer to the negotiation, and creating incentive schemes in which rewarding the collaborative and publishable research is compensated rather than the shrouded commercialization.

And the final is that the paper is in favour of testing legal measures like Geographical Beings of geographically based formula and models of contracts which rely on such defaulting goals as co-ownership or revenue sharing in government-funded translational research. Nevertheless through a unity of these efforts, the reversible process of protection will be made an active mode and not a defensive mode: the law rules preventing misappropriation in conjunction with the communities being enabled to contribute in order to form, verify in addition to enjoying the fruits of new streams of information. This fact can cause a destabilization of Ayurveda as custodians are now placed as actors and not as providers so as to maintain both cultural and clinical vitality and also stereotype responsibility in innovation and welfare of the society. The paper concludes to state that Ayurveda heritage frozen is not the future of Ayurveda, marketing Ayurveda as an openly market is not the future of Ayurveda rather, legal regulations intended to appreciate the value of provenance, equity or success that Ayurveda can be scientifically investigated when given way.

Keywords: Ayurveda; Traditional Knowledge; Intellectual Property Rights; Patent Law; Biodiversity Act; TKDL.

I. Introduction

Ayurveda – the traditional Indian system of medicine – represents a rich body of codified knowledge passed down through generations. Its classical texts (such as Charaka Samhita and Sushruta Samhita) are recognized authorities on Ayurvedic drugs and therapies. Much of this knowledge is dynamic: communities continue to adapt Ayurvedic practices in response to new ailments. By definition, traditional knowledge (TK) is knowledge that “has a traditional link with a certain community” and is culturally integral to that community. Indeed, scholars note that for local communities “traditional knowledge is part of their cultural or spiritual identity,” underpinning health, food, and livelihoods. In modern times, there is growing relevance to Ayurveda: people worldwide seek alternatives and complementary medicine, and research on herbal remedies is increasing. India has institutionalized Ayurveda through the Ministry of AYUSH and official boards, recognizing it as part of national heritage. However, this relevance also brings challenges: because Ayurvedic formulations are often well-known, commercial entities may attempt to patent or exploit them for profit. “Biopiracy” cases – such as the attempted turmeric and neem patents in the 1990s – highlight this risk. In response, India created the Traditional Knowledge Digital Library (TKDL) to document Ayurvedic formulations and cite them as prior art, successfully revoking dozens of erroneous patents abroad. This paper investigates the legal protection of Ayurveda as TK, the adequacy of existing laws, and proposes reforms. The problem statement is that although Ayurveda is an invaluable traditional resource, its legal status is ambiguous: it is simultaneously codified and community-based, falling partly outside conventional IP protection.

Objectives include: (1) surveying how Ayurveda is treated under Indian law (IPR, biodiversity, etc.), (2) identifying gaps in protection or misappropriation risks, and (3) offering legal/policy suggestions to safeguard Ayurvedic knowledge while promoting its modern application.

A. Literature Review

There are other scholars who have researched the overlapping of TK and intellectual property rights (IPR) in the Ayurveda and other traditional medicine. A. Chaudhary and Sing have noted that the patent laws of India have never been made with consideration of traditional knowledge and today Indian patent regime is a challenge on achieving patent on Ayurvedic medicines. They observe that according to the law Ayurvedic knowledge (being previously in ancient literature) is not tradable but revocation of patent related to knowledge of Ayurvedic medicinal plants was established, which was subsequently cancelled in the TKDL database. They state that India may have to reform its patent legislation to encourage contemporary studies concerning Ayurveda and not to stimulate abuse in the process.

V. Gupta (WIPO) praises India’s TKDL as a unique repository of millions of pages on Ayurveda (and other Indian systems). The TKDL “bridges the linguistic gap” between Sanskrit/Urdu formulations and examiners’ languages and has helped cancel 36 European patent applications on Ayurvedic remedies. Gupta emphasizes that TKDL’s success shows how documentation and digitization can preserve knowledge and block misappropriation. Meanwhile, TK’s significance is highlighted: “Traditional knowledge is integral to the identity of most local communities,” vital for their health and livelihood. Misuse of TK can harm communities, raising its protection to a pressing issue.

M. Fredriksson (Law Critique, 2021) analyzes TKDL in depth. He shows how TKDL was inspired by the turmeric and neem patent disputes of the 1990s. By formalizing traditional Indian medicine knowledge into international patent classifications, TKDL not only prevents wrongful patents but has prompted revisions to patent classification systems to include traditional medicine. However, Fredriksson also cautions that decontextualizing TK into databases risks “dispossessing its original owners”. He argues TKDL fits into a broader national agenda of “documenting and modernizing” traditional medicine, challenging the old dichotomy between “traditional” and “scientific” knowledge.

Other literature addresses global and legal contexts. Article 27.3(b) of the WTO-TRIPS agreement allows member countries to exclude plants and TK from patentability, recognizing TK’s special status. At the international level, the Convention on Biological Diversity (CBD) and its Nagoya Protocol (2010) explicitly call for respecting TK and sharing benefits. India has been a strong proponent of these norms. Within India, authors note that the 2002 Biological Diversity Act (amended in 2023) incorporates TK into its regulatory scope, showing awareness of international obligations.

First, IP scholarship finds fault in the weaknesses within more traditional patent regimes where they meet such knowledge within the community - in such cases as the critique that novelty tests, inventive-step doctrines, are inappropriate with diffuse, orally dispersed knowledge. Second, the Ayurveda arguments on medical ground find a test in the literature of public health and ethnopharmacology providing encouraging clinical information and warnings on the concept of standardization, dosage, and reproducibility. The review notes that descriptive accounts of an imaginative success along with TKDL defensive achievements is far more prevalent as compared to evaluative effort regarding the degree to which these instruments give a feeling of power to communities. On the same note, many empirical studies are usually concentrating on individual clinical studies or literature reviews as opposed to the legal processes that involve commercialization. There is also an apparent gap in the use of methodology on how doctrinal legal studies are paired with field-based studies on the experiences of Biodiversity Management Committtees or vaids with access-and-benefit-sharing practices. The response in this paper aims at synthesizing the legal texts and policy assessments by the use of high-quality Scopus-level literature, in order to trace not only what law says, but highly how institutional arrangements work on the ground and where normative reform should be undertaken. The broadened scope of the review thus locates the contribution of the paper as a mediator resource linking doctrinal law to institutional design thus providing proposals that would be specific to both the technicality of the law on its part and the grassroots circumstances on its part.

Literature gap: The scholarship emphasizes IP remedies (TKDL, patents, Sec 3(d)) and CBD-driven laws. However, there is less legal analysis on how specific Ayurvedic practitioners or communities can assert rights or receive benefits. For example, how does benefit-sharing work for Ayurvedic plant cultivators? Also, comparative studies are few – for instance, how do other countries handle such TK? Moreover, there is limited discussion on integrating Ayurveda into mainstream health regulations while preserving its identity. This paper aims to fill these gaps by synthesizing IP law, biodiversity law, and IP policy, with a focus on practical reforms

B. Research Methodology

This is predominantly doctrinal (library-based) legal research. The study surveys primary sources (statutes, case law, and international treaties) and secondary sources (scholarly articles, government reports, and WIPO publications) pertaining to Ayurveda and TK. Key statutes examined include the Patents Act, 1970 (as amended, especially Section 3(d) on patentable subject matter), the Biological Diversity Act, 2002 (as amended in 2023), and the Drugs and Cosmetics Act, 1940 (first schedule listing Ayurvedic texts). Relevant case law is reviewed, especially Novartis AG v. Union of India (2013) regarding Section 3(d) . Sources include official gazette amendments, WIPO/IUCN reports, and peer-reviewed articles (e.g. Gupta 2011; Chaudhary & Singh 2012; Fredriksson 2021). A comparative element arises by referencing international instruments (WTO-TRIPS, CBD/Nagoya) to situate India’s approach. The analysis is thematic: organizing findings under legal regimes (IPR, biodiversity law, etc.) and their impact on Ayurvedic TK.

II. Traditional Knowledge and Ayurveda: Definitions and Value

According to the international law, the CB (Art. 8(j)) and Nagoya Protocol call on Parties to uphold and conserve indigenous knowledge. This promise is reflected clearly in the amended Indian Biodiversity Act: in its preamble, the Indian commitment in the Nagoya Protocol is mentioned. In general, nationally, the definition of traditional knowledge is the knowledge that is generated and passed to the community. In this regard, Ayurveda - written down in ancient books but still practiced by the communities today - is evidently TK. Indeed, the 2023 amended Biodiversity Act expressly made codified traditional knowledge to be the one based on authoritative texts in the Drugs and Cosmetics Act (first schedule). This calendar is referred to as classics such as the Charaka Samhita and Sushruta Samhita. Other TK (e.g. tribal herbal lore not in books) is by contrast controlled by the general terms of the Act. It is also the law that defines access to genetic resources or TK and links it to the sharing of benefits.

The Ayurvedic TK has been identified to be of immense value in literature. Gupta (WIPO) states that TK is part and parcel of the identity of communities and is central in both healthcare and culture. Ayurvedic knowledge is a living, breathing system, which is practiced on an everyday basis and will keep changing in accordance with new challenges. It is therefore important that it is preserved. Furthermore, Ayurveda has become an Indian cultural heritage - e.g., Ayurveda practitioners (vaids, hakims, AYUSH doctors) have been legally recognized, and societies maintaining traditional practices are specifically freed of some regulatory overheads.

III. Intellectual Property Regime: Patents and Beyond

India’s Patent Act 1970 was amended in 2005 to comply with WTO-TRIPS. Critically, Section 3 of the Act lists what cannot be patented. The amended Sec. 3(d) provides that “the mere discovery of any new property or new use for a known substance” is not patentable. In plain terms, Ayurvedic formulations or plant extracts documented in TK are already “known substances,” so simply isolating them or finding an expected use will fail the patent test unless there is a genuine inventive step or enhanced efficacy. This provision famously led the Supreme Court in Novartis v. Union of India (2013) to reject a cancer drug patent: Novartis could not show “significantly enhanced therapeutic efficacy,” so its modified salt of imatinib was not a patentable invention. This sets a strong precedent: Sec. 3(d) effectively bars trivial patents on Ayurvedic medicines if they offer no real innovation.

Aside from 3(d), the Act generally excludes “methods of treatment” from patentability. Some argue that “pharmaceutical substance” patents (introduced in 2005) might allow certain herbal mixtures to be patented, but practical hurdles remain. Chaudhary & Singh note that under current law Ayurvedic knowledge (being in the public domain) is effectively unpatentable. They consider India’s patent provisions “obstructive” for Ayurvedic drugs, reflecting a legal bias against awarding monopoly rights over century-old formulas.

However, Indian patent law does provide ways to challenge unauthorized patents. Post-grant oppositions (under Sec. 25) and revocations can be filed to cite TK prior art. India has indeed used the TKDL: the existence of a documented Ayurvedic formula in the TKDL is treated as prior art internationally, deterring patent claims. The TKDL is not an Indian law but a defensive database; its citation before foreign patent offices has led to the withdrawal of many patents on Indian herbal treatments. Domestically, the Patents Act does not compel disclosure of TK, but courts have expressed the view that patents should not reward minor variants of known substances. The Novartis court implicitly supported this ethos by emphasizing therapeutic efficacy.

Beyond patents, other IPRs have limited applicability to Ayurveda. Copyright protects original texts (e.g. translations of classical works), but not the underlying medical knowledge. Trademarks can protect brand names of Ayurvedic products, but not the medicinal formula itself. Geographical Indications (GI) could, in theory, protect traditional medicinal products from a region, but to date they are used mainly for foods (e.g. Basundi or Bansi pashmina, not Ayurveda). In practice, no sui generis trademark/Kisan patent system exists for herbal formulas in India.

IV. Statutory Protections and Obligations

The Biological Diversity Act, 2002 (amended in 2023) is particularly relevant for TK and Ayurveda. It imposes strict controls on use of biological resources and associated TK. New Section 6(1) (amended) states that anyone seeking intellectual property rights (in India or abroad) based on research on Indian biological resources or associated TK must obtain prior approval from the National Biodiversity Authority. Similarly, if one has already obtained such IP rights, NBA approval is required before commercialization. This means a patentee cannot commercially exploit an Ayurvedic plant or formula without clearances. Section 7(1) (revised) requires prior intimation to State Biodiversity Boards before accessing any biological resource or its traditional knowledge for commercial use – though crucially, the law exempts codified TK (like Ayurvedic texts) and registered practitioners of Indian medicine from this requirement.

In effect, Ayurvedic knowledge (codified in the Drugs & Cosmetics Act schedule) is treated specially: practitioners and users of Ayurveda are not hindered by access formalities. However, benefit-sharing obligations can still apply at later stages. Notably, Section 3 (definitions) now explicitly includes TK: “‘access’ means collecting any biological resource or traditional knowledge associated thereto”. The Act’s rules (Biological Diversity Rules) also empower local communities (via Biodiversity Management Committees) to maintain registers of TK. These provisions reflect the CBD’s Nagoya Protocol principles, as the 2023 gazette emphasizes India’s Party status to Nagoya and the necessity of “fair and equitable sharing of benefits”.

Therefore, Ayurveda is subject to these conservation and sharing conservation laws: in the case of a pharmaceutical company patenting an extract on the basis of Ayurvedic medicine, NBA/NBA approval and disclosure of this person to the holders of TK are required. It is powerful defence mechanism. The negative side is that even comparing codified TK (that in Ayurvedic classics) to particular checks is expressly prohibited, presumably due to the fact that such knowledge is a public heritage. It might be placed on the account of one side effect of this clause (along with the desire not to over-regulate the traditional practitioners): this introduces a possibility of reduced scrutiny of Ayurvedic knowledge and thus its extrinsic use without any checks. Practically, however, it is hard to patent Ayurvedic drugs for which there is no such thing as an innovation in extraction or formulation, under Sec.3(d) and the current policy in patenting drugs.

First, patent law’s novelty and inventive-step rules function well as a doctrinal barrier against obvious expropriation, but they are passive: they rely on examiners and oppositions rather than system-wide provenance checks. Second, TKDL operates as a proactive instrument by translating and systematizing knowledge for examiners, yet it is limited by the coverage of materials and by its accessibility to custodial communities. Third, the biodiversity law creates affirmative responsibilities such as prior approval and payment of benefits but they tend to be enforced on the basis of administrative capacity by the conducting National and State Biodiversity Boards and the operation of the local Biodiversity Management Committees. All three of those pillars, including patient doctrine, defensive documentation, and the ABS law, should be regarded as creating a series of additions but not as substitutes. Practically, any lack of goodness with half-baked forms, i.e. where this pillar is cemented whereas the others are porous: e.g., benefits-sharing-averse defensive documentation that is not guaranteed by interoperable documentation can discourage patents and yet still increase compliance costs to researchers; and overscored ABS pillars but porous documentation systems can impose greater costs to comply on the side of the researcher. The point that this paragraph helps elucidate is that it should situate Ayurveda into the modern era by understanding the legal framework as organized to form an ecosystem, in order to align the institutional design with the doctrinal regulations along with participatory rule making.

V. Case Law and Precedents

Other rulings foreshadow Ayurveda/TK problems except Novartis. In general, Indian courts have managed to conclude that Ayurvedic drugs (when subject to the Drugs and Cosmetics Act) are not drugs under the definition of a drug in the Patent Act and are therefore not subject to any patent whatsoever. Manoj (Delhi HC 2004)). The case - although concerning incense - demonstrated that in case a product was controlled as Ayurvedic regarding the 1940 Act, it could not be patented (as Ayurveda was not referred to as a drug). Although it is not a binding case, Govind shows the sentiment of a legal category into which Ayurvedic medicines fall.

The weaker and more famous case of turmeric patent (1995 US patent declared invalid in 1997) and neem which also experienced patent revocation (in the early 2000s) is globally recognized. They may not be court cases in India, but put context in the Indian strategy. India experience in GI law (e.g. GI tag for "Basmati") demonstrates that traditional goods may be safeguarded with the help of another IP regime (although nothing Ayurvedic specific so far).

The principle taught by the Novartis judgement is as follows: it dispensed the rule under Sec.3(d) to the effect that only an alteration whereby therapeutic efficacy of a known substance is increased is patentable. The many ayurvedic herbal preparations were not novel and they would not pass this test almost invariably. In this way, in an IP perspective, Ayurveda is literally on the old side of prior art. Any application to patent an Ayurvedic remedy on the basis of 3(d) or 25(2) (opposition) would tend to be refused unless a lot of novelty is demonstrated.

VI. The TKDL and Documentation

One Indian innovation that has been significant and powerful was the Traditional Knowledge Digital Library (TKDL). TKDL was started in 2001 by CSIR and AYUSH to translate make Ayurvedic (and other Indian) medical recipes and break them down into patent-examinable formats. It has managed to avoid numerous wrongful patents. To illustrate this, Gupta describes the situation in the case of India, where despite taking less than two years, in Europe alone, 36 applications to patent a traditional medicine were cancelled/withdrawn. TKDL currently hosts more than 34 million pages of data on ancient recipes. It is not only able to preserve TK but also render it readable to the patent system.

In books, Fredriksson indicates that the establishment of TKDL resulted in new subgroups within the International Patent Classification of traditional medicine, which simply incorporated Ayurveda into the world IP taxation. This type of defensive writing is regarded as an expedient requirement: otherwise it will not be possible to provide any so-called legal protection, simply because patent examiners may blindly provide patents in the presence of information known to everyone about Ayurvedic knowledge. Therefore, the major contemporary tool is the TKDL: it has been developed to operationalize protection with the TK prior art as the input of patent regulations. The government can further reinforce TKDL by including modern Ayurvedic studies as well as make it interoperative with databases of other countries patent offices.

Discussion: Protection and Use.

As can be seen, it already includes the Ayurvedic TK within the legal framework in India: the novelty provision in patent law already rules out published TK , the Biodiversity Act mandates benefit-sharing , and an Ayurvedic text is a recognized lawbook. However, there are tensions. Broad exclusion (e.g. Ayurveda as a drugs law regulated TK as codified, so TK would not have to be provided as TK would not have to deal with local communities) would mean, on the one hand, that TK will be vulnerable to the unauthorized use (as a foreign company may apply the knowledge without being exposed to Indian communities). Conversely, excess of a strict policy may have a negative effect on research and proper development of Ayurvedic products.

Some researchers claim the case in favour of the reinforced IP with the view of TK. As an illustration, Chaudhary and Singh say that the patent law needs to be corrected to promote pragmatist and practical promotional policies to attract bona fide Ayurvedic products innovations. This suggests that although the law nowadays does not allow patents obtained wrongly, it also tends to deter newer formulations or the standardisation of Ayurvedic drugs which have the potential to be patented, should they be innovative. It implies a contradiction: one should incentivize contemporary scientific investment into Ayurveda, but at the same time protect tradition.

A third controversy is that of benefit sharing. New provisions of the Biodiversity Act (new Section 6 and 7) demonstrate that India wishes to introduce TK holders to benefit gain sharing. However how this will be applied is yet to be seen. It might be justifiable to restrict the notion of codified TK exemption. It is questioned what might be the reason that an Ayurvedic formula in a text so ancient should not require prior intimation should that formula be intended to be commercially treated in a foreign country - a provision to mention such sources, perhaps, ought to be only added.

All in all, Ayurveda needs to be incorporated with modern science and markets, but to do this the modern relevance of Ayurveda must not sacrifice equity. This implies that laws are supposed to be changed.

VII. Conclusion

It contains certain sayings on the exegetical explanation of the dogma. Primarily, the Ayurvedic TK in India is registered in tandem with the Indian shield of the patent law that does not allow a case of insignificant patenting. The Ayurvedic medicines are generic and cannot be patented because section 3(d) provides it. Second, India has even gone to the extent of devising defense tools (TKDL) in to make Ayurvedia appear in the global list. Third, the Indian law on access-and-benefit-sharing does talk about TK actually, according to Nagoya Protocols. Fourthly, there is special treatment of the Ayurvedic knowledge (Drugs and cosmetics first first scheduling, Ayurvedic exemptions). According to Ayurveda, right in IP does not exist and is liberal or by-product. Ayurvedic plants can be still used today by the modern pharmaceutical players to make new extracts, and there are situations where the latter completely lack the awareness regarding TK. The existing legislation supposes that the coach server proceeds to report TK on a voluntary basis or even police patents. Ayurvedic IP does not also possess a legal property to which the communities can claim or seek compensation on.

Ayurveda is in an exceedingly compromised situation: as on the one hand, it remains a shared tradition; on the other, it is the source of health development offered soon. As argued by this paper, India has instituted currently defence by reinforcement, but defence mechanisms that do not aim at forced persuasion to share - doctrinal barriers like Section 3(d)- Patents Act and practical devices like Traditional Knowledge Digital library have worked; instances of misappropriation have since been reduced to minimum, but no case has been perceptibly reached to an outfitned contiguity in the clinics, where recipes are prepared and livelihoods must be sustained in a village.

Three steps are used before one move forward in a sustainable manner. The first, more is needed of a law visible and active: the provenance / disclosure system attending filing patent application and more open shares especially in community-level will make the system of knowledge origin come into the spotlight and ready to be discussed and sold similar to a commodity. Third, policy must provide good incentives of collaborative science that acknowledged the custom practice -financing on the conditions of collective ownership, publication by the open access where appropriate and contracts where the distribution of benefits must be the rule and not the exception.

By combining them all, the paradigm will change and adopt participatory stewardship instead of the defensive protection. Those changes must happen so that Ayurveda can persist as both a practice and as a provider of fair innovation equally equipped for life in both books on law and patents--far beyond the books and law as well as patent books, Ayurveda belongs not simply to the past, but to the lives and the honor and the well-being of those who have continued to preserve it.

The legal scaffolding India has incorporated to counteract and regulate the situation--patent law, TKDL, and biodiversity regulation--has a strong disadvantage of slightly providing an opportunity without any systematization and empowering the community. Consequently, these reforms should be geared towards three practical lines that are law reform, strengthening institutions and participation. In law, implement direct statutory registration of TK-disclosure and provenance of patent registration such that it instigates an immediate query with TKDL and community register; add to this an evidentiary threshold, which is rebuttable in favors of novelty on the part of the patentee when TK is involved. Institutional Level: For the sake of professionalization in ABS negotiations, providing the mainstream standardized model contracts, and establishing a Web-based registry of benefit-sharing contracts, invest in the National Biodiversity Authority and State Boards. TK-derived products. Lastly, instill transparency: make disconnected outcomes in the benefits sharing publicly available and establish cultural-specific avenues of dispute settlement. These are practical and incremental in nature and they do not cripple credible research as well as criminalize misappropriation and makes it expensive with a tarnished image. The suggestions when put into practice will create an ecosystem where Ayurveda, her custodians are care-taken and rewarded and the science investigates responsibly thereby bringing Ayurveda into the present day what both the law and life rightly deserve.

VIII. Findings and Suggestions

It is advisable to address these issues by the following:

· Enhance Documentation and Pathway Improve TKDL Build on and expand TKDL (e.g. with more modern herbal prescriptions and information). Connection with other in-country and international databases. Impose an Indian patent application requirement of biological/medical inventions to disclose TKDL or other database records (a "TK disclosure requirement). This is to imply that TK is considered by examiners.

· Refine Patent Law: Despite the effective approach in Sec.3(d), it could be refined by amendment of Patent Act that requests any patent application request of any substance known in TK a prior consent or a benefit-sharing agreement with TK holders. An example is this include a provision whereby, the knowledge and evidence of the permission is disclosed through the revelation of inventions or transactions of traditional knowledge or biological resources (this is comparable to some national laws that reveal the source of the knowledge).

· Improve Benefit-Sharing Regime: the biological Diversity Act should be amended successfully. The National Biodiversity Authority should recruit a set of rules that controlled FA shares of benefits and royalty rates, etc. especially concerning the TK-based products. The management (via Biodiversity Management Committees) must also permit its agency to bargain on terms at a neighborhood scale. On their rights, general education can be provided to AYUSH practitioners and local cultivators.

· Cash in on Geographical Indications: What about the establishment of GI tags on local Ayurvedic products (e.g. a local herbal oil), which would protect the process or product connected with Ayurveda, but not the Ayurveda concept itself. This offers the area practitioners with a location-based provider of herbs.

· Legal Education and Training: Examine and patent examiners should be made to continuously receive training on the concepts of the traditional medicine lest they miss out on TK when searching prior art. The judiciary and the policy makers must be informed on the ins with TK also.

· Bring in Partnership Research: Enter into partnership on terms of sharing benefits between drug users and Ayurvedic institute on the basis of the contract. The Ayurvedic treatment can be scientifically proven only by research confirming them (this is the only method by which the Ayurvedic treatment can be scientifically proven) and this type of research can be given government incentives (grants, tax breaks) which ensures publication of results (this makes the Ayurvedic treatment part of the public domain, and not privatized).

· International Advocacy: India will need to continually negotiate at bodies like WIPO and WTO so that TK is explicitly protected (e.g. a new international disclosure standard will be introduced in sureties of patent). It can require revision of the IPC or the PCT to introduce Ayurvedic classes into the global market (after the example of TKDL). Additionally, it can also be suggested to develop sui generis world registry of known medicinal plants/TK.

· Protect Practitioners and Healers: The government can in addition to IP law provide a sui generis law recognizing knowledge of traditional healers (vaids, hakims) as a collective right (somewhat like other proposals on indigenous IP). This is audacious, but even non-statutory international practices (like incentives to speak should they wish to make an offer of formulations) can empower communities.

Such reforms would also help achieve both the twin goals of safeguarding Ayurvedic heritage and making Ayurvedic use responsible. Overall, it can be said that Ayurveda in the modern context is and will be grounded on the principle of compromise between innovation and tradition: once all the loopholes in the legislation against exploitation are sealed, and the scientific community will have the freedom to move forward, Ayurveda will be able to find its way into modern medicine and manufacturing without losing its soul.

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References & Bibliography

• Primary Sources (Statutes/Cases): Patents Act, 1970 (Act No. 39 of 1970, as amended) (India), especiallyS.3(d). Biological Diversity Act, 2002 (Act No. 18 of 2003, amended 2023) (India) (esp. S.2, 4, 6, 7). Drugs and Cosmetics Act, 1940 (India) – First Schedule (Ayurvedic & Siddha authoritative texts). Novartis AG v. Union of India & Others, (2013) 6 S.C.C. 1 (India) (Supreme Court).

• Secondary Sources:

Secondary Sources (Bibliography)

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2. [1] Biological Diversity Act, No. 18 of 2003 (India); Biological Diversity (Amendment) Act, No. 10 of 2023 (India), Gazette of India, Aug. 3, 2023, https://egazette.gov.in/WritereadData/2023/247815.pdf (last visited Oct. 5, 2025).

3. [1] Biological Diversity Act, see National Biodiversity Authority, Guidance Materials and Notifications (implementing ABS provisions) (various), https://nbaindia.org (last visited Oct. 5, 2025)

4. [1] Council of Scientific & Industrial Research (CSIR), Traditional Knowledge Digital Library (TKDL), https://www.csir.res.in/documents/tkdl (last visited Oct. 5, 2025); V.K. Gupta, Protecting India’s Traditional Knowledge, WIPO Magazine, June 2011,

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6. [1] Drugs & Cosmetics Act, supra note 3, First Sch.

7. [1] P. Kutumbiah, Ancient Indian Medicine 3 (1962).

8. [1] Patents Act, No. 39 of 1970, § 3(d) (India) (as amended by Patents (Amendment) Act, 2005), available at Indian Patent Office, The Patents Act, 1970 (consolidated text), https://ipindia.gov.in/writereaddata/portal/ipoact/1_31_1_patent-act-1970-11march2015.pdf (last visited Oct. 5, 2025).

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29. V. K. Gupta, Protecting India’s Traditional Knowledge, WIPO MAG., June 2011, at 6, https://www.wipo.int/wipo_magazine/en/2011/03/article_0002.html.

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31. World Intellectual Property Organization (WIPO), Traditional Knowledge and Intellectual Property—Background Brief No. 1 (2022), https://www.wipo.int/tk/en/resources/pdf/tk_brief1.pdf.

32. World Trade Organization (WTO), TRIPS and Traditional Knowledge (WTO Fact Sheet, 2021), https://www.wto.org/english/tratop_e/trips_e/trips_e.htm.

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