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Biological Diversity Act, 2002
Biological Diversity Act, 2002
Biological Diversity Act, 2002
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Biological Diversity Act, 2002
Parliament of India
  • An Act to provide for conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of the benefits arising out of the use of biological resources, knowledge and for matters connected therewith or incidental thereto.
CitationAct No. 18 of 2003
Enacted byParliament of India
Assented to5 February 2003
Commenced1 October 2003 and 1 July 2004[1][2]
Status: In force

The Biological Diversity Act, 2002 is an Act by the Parliament of India for the preservation of biological diversity in India, and provides the mechanism for equitable sharing of benefits arising out of the use of traditional biological resources and knowledge. The Act was enacted to meet the obligations under the Convention on Biological Diversity, because India is a signatory to the treaty.

History

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The Act was enacted to meet the obligations under Convention on Biological Diversity, of which India was a part in 2002.[3][4]

Biodiversity and Biological Resource

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Biodiversity has been defined under Section 2(b) of the Act as "the variability among living organisms from all sources and the ecological complexes of which they are part, and includes diversity within species or between species and of eco-systems". The Act also defines, Biological resources as "plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value, but does not include human genetic material."[5]

National Biodiversity Authority and State Biodiversity Boards

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Main article: National Biodiversity Authority

The National Biodiversity Authority (NBA) is a statutory autonomous body, headquartered in Chennai, under the Ministry of Environment and Forests, Government of India established in 2003 to implement the provisions under the Act. State Biodiversity Boards (SBB) has been created in 28 States along with 31,574 Biological management committees (for each local body) across India.

Functions

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  • Regulation of acts prohibited under the Act
  • Advise the Government on the conservation of biodiversity
  • Advise the Government on selection of biological heritage sites
  • Take appropriate steps to oppose the grant of intellectual property rights in foreign countries, arising from the use of biological resources or associated traditional knowledge.[6]

Regulations

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A foreigner, non-resident Indian, as defined in the clause (30) of section 2 of The Income-tax Act, 1961, or a foreign company or body corporate need to take permission from the NBA before obtaining any biological resources or associated knowledge from India for research, survey, commercial utilisation.[7] Indian citizens or body corporates need to take permission from the concerned State Biodiversity Board.[8]

Result of research using biological resources from India cannot be transferred to a non-citizen or a foreign company without the permission of NBA. However, no such permission is needed for publication of the research in a journal or seminar, or in case of a collaborative research made by institutions approved by Central Government.[9] The NBA while granting such permission may make an order for benefit sharing or royalty based on utilisation of such protection.[10]

Benefit sharing

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Benefit sharing out of usage of biological resources can be done in following manner:

  • Joint ownership of intellectual property rights 2 3 4
  • Transfer of technology
  • Location of production, research development units in the area of source
  • Payment of monetary and non-monetary compensation
  • Setting up of venture capital fund for aiding the cause of benefit claimers[11]

Penalties

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If a person, violates the regulatory provisions he/she will be "punishable with imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees, fine may commensurate {be in proportion} with the damage caused, or with both."[10]

Any offence under this Act is non-bailable and is cognizable.

See also

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References

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Revisions and contributorsEdit on WikipediaRead on Wikipedia

Biological Diversity Act, 2002

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from Grokipedia
The Biological Diversity Act, 2002 is an Indian parliamentary statute enacted to conserve biological diversity, ensure sustainable use of its components, and facilitate fair and equitable sharing of benefits arising from the utilization of biological resources and associated knowledge, in fulfillment of 's commitments under the 1992 . The Act establishes the (NBA) as a statutory body headquartered in to regulate access to biological resources, particularly by foreign entities, and advises the central government on conservation matters, while state-level Biodiversity Management Committees document local and . Key provisions mandate prior approval from the NBA for obtaining biological resources for research, commercial use, or intellectual property rights, with exemptions for local communities and traditional practices, aiming to prevent biopiracy and promote benefit-sharing with indigenous groups. While the legislation has advanced documentation of people's biodiversity registers and supported conservation initiatives, it has drawn criticism for creating regulatory barriers that hinder research and industry, prompting 2023 amendments to exempt certain sectors like AYUSH and codified users, though opponents argue these changes undermine local benefit-sharing and protections.

Background and Enactment

International Obligations

The Biological Diversity Act, 2002, was enacted by to implement its obligations under the (CBD), which signed on June 5, 1992, at the United Nations Conference on Environment and Development in Rio de Janeiro and ratified on February 18, 1994, with the convention entering into force for on May 19, 1994. The CBD requires signatory states to develop national legislation promoting the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from genetic resources, thereby necessitating domestic frameworks like the Act to address these imperatives through regulatory mechanisms on access to biological resources. A core driver for the Act's alignment with the CBD was the convention's recognition of sovereign national rights over genetic resources, articulated in Article 15, which aimed to counter historical instances of biopiracy where foreign entities ed traditional knowledge-derived products without benefit sharing. This concern was exemplified by the neem patent controversy, where the United States Patent and Trademark Office granted a patent to the U.S. Department of Agriculture and W.R. Grace & Co. for a neem seed extract fungicide, despite centuries of documented use in ; the upheld a similar patent in 1994 but revoked it in 2000 following opposition from Indian organizations citing and lack of novelty, underscoring the CBD's push for and mutually agreed terms in access arrangements. Subsequent international developments, such as the on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization—adopted in 2010 and ratified by on October 1, 2012—further reinforced the CBD's access and benefit-sharing (ABS) norms, prompting amendments to align the 2002 Act with enhanced procedural requirements for prior and benefit-sharing agreements, though practical implementation has revealed persistent challenges in enforcing these globally harmonized standards amid varying national capacities.

Domestic Legislative Development

The Biological Diversity Bill, 2000, was introduced in the Lok Sabha on 15 May 2000, driven by mounting concerns over biopiracy and the unauthorized commercialization of India's biological resources and associated traditional knowledge. High-profile cases, such as the United States Patent and Trademark Office's grant of a patent on neem (Azadirachta indica) derivatives in 1990—later revoked in 2000 following Indian challenges—and a turmeric (Curcuma longa) patent in 1995, also revoked in 1997 after evidence of prior art in ancient texts, underscored vulnerabilities in protecting indigenous resources from foreign patenting without benefit sharing. These incidents, occurring amid India's post-1991 economic liberalization that encouraged foreign investment and technology transfers, fueled policy debates on balancing resource sovereignty with openness to global markets, emphasizing the need for domestic controls to prevent exploitation of biodiversity hotspots like the Western Ghats and Himalayas. Initial drafts of prioritized stringent regulations on access by non-Indian entities, reflecting a cautious approach to safeguard genetic resources and from uncompensated extraction, while allowing regulated sustainable use. After review by a , was passed by the on 2 December 2002 and the on 11 December 2002, receiving presidential assent on 5 February 2003 as Act No. 18 of 2003. The legislation aimed to assert India's sovereign rights over its biological diversity, addressing gaps in prior environmental laws that lacked specific mechanisms for access regulation and equitable benefit distribution. To operationalize the Act, the Biological Diversity Rules, 2004, were notified on 15 April 2004, providing procedural guidelines for access approvals, benefit-sharing agreements, and institutional setup, including the prompt establishment of the in 2003. This framework marked a shift toward formalized oversight, prioritizing conservation and national control in response to liberalization-era risks, though it drew critiques for potentially hindering research and industry collaborations.

Objectives and Provisions

Core Principles

The Biological Diversity Act, 2002, establishes three foundational pillars mirroring the objectives of the : the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the commercial or other utilization of biological resources and associated . These principles aim to balance resource exploitation with preservation, asserting India's sovereign rights over its biological resources to curb unauthorized foreign access that could undermine national economic interests. Central to the Act is the prevention of biopiracy through mechanisms requiring prior from authorities for accessing biological resources and mandating benefit-sharing agreements, often linked to rights derived from such resources. This framework prioritizes national and local stakeholders, particularly indigenous communities, in deriving monetary or non-monetary gains from commercialization, such as royalties from pharmaceuticals or agroproducts developed using Indian biodiversity. Provisions emphasize and joint research as forms of equitable sharing, intending to incentivize conservation by aligning economic incentives with resource stewardship. While rooted in a precautionary approach that restricts access to avert irreversible losses, the Act's principles face challenges from empirical evidence of persistent habitat degradation driven by underlying causal factors like population growth and land conversion pressures. India's population expanded from approximately 1.03 billion in to over 1.4 billion by 2023, intensifying demands for , , and fuelwood that outpace regulatory safeguards. Between and 2024, the country lost 2.31 million hectares of tree cover, representing a 7.1% decline, with contributing to broader erosion despite conservation mandates. First-principles analysis of reveals inherent trade-offs: idealized claims overlook how expanding human needs causally erode , yielding limited measurable gains in protection or integrity under the Act's framework.

Key Definitions and Scope

The Biological Diversity Act, 2002, defines biological diversity in Section 2(b) as "the variability among living organisms from all sources and the ecological complexes of which they are a part, including diversity within species, between species and of ecosystems." This definition aligns with the framework of the , emphasizing variability across terrestrial, marine, and other aquatic ecosystems. Biological resources, as per Section 2(c), encompass "plants, animals and micro-organisms or parts thereof, their genetic material and by-products (excluding value added products) with actual or potential use or value for humanity." The exclusion of value added products—such as processed goods derived post-collection—introduces interpretive ambiguity, as the threshold between by-products and items (e.g., extracts versus formulated pharmaceuticals) has sparked disputes over regulatory applicability in commercial contexts. Human genetic material falls outside this scope, as it pertains neither to , animals, nor micro-organisms, while pre-Act domesticated or cultivated crops may evade certain access restrictions if not involving novel genetic manipulation or transfer. The Act's scope regulates access to these resources and associated knowledge—encompassing or traditional practices relating to their use, including medicinal applications held by communities—primarily through Sections , 4, 6, and 7. Foreign entities, non-resident Indians, and overseas organizations require prior (NBA) approval for obtaining resources or knowledge for research, commercial utilization, bio-surveys, or bio-utilization. Indian citizens and firms face lighter requirements: no prior approval for personal or local use, but mandatory intimation to State Biodiversity Boards for commercial activities, with potential NBA escalation. Exemptions preserve customary practices, allowing local communities, growers, and traditional practitioners (e.g., vaids and hakims) free access, exchange, or sale of resources within their areas for sustenance or basic needs, without NBA or board oversight. However, restrictions apply to transfers of accessed resources or results to foreigners, intellectual property applications derived therefrom, and any R&D involving export or commercialization, necessitating approvals to prevent unapproved outflows. Benefit sharing, though not rigidly defined, mandates equitable apportionment of monetary (e.g., royalties) and non-monetary (e.g., joint ) gains from derivatives like pharmaceuticals, accruing to conservers, knowledge holders, and communities upon commercial success. This linkage to downstream value creation amplifies economic frictions, as ambiguities in tracing "associated" contributions complicate enforcement.

Institutional Framework

National Biodiversity Authority

The (NBA) was established in 2003 under Section 8 of the Biological Diversity Act, 2002, as a body corporate with perpetual succession and a common seal, headquartered in , . This autonomous operates under the Ministry of Environment, Forest and Climate Change, with authority to exercise advisory, regulatory, and recommendatory powers to implement the Act's objectives of conserving biological diversity, promoting sustainable use, and ensuring equitable benefit sharing from biological resources. Under Section 9 of the Act, the NBA comprises a Chairperson—an eminent expert in conservation, sustainable use, or benefit sharing—a Director General serving as Member-Secretary, specified ex-officio members from central ministries (such as those for environment, , and tribal affairs), and not fewer than five but not more than ten nominated members with expertise in biodiversity-related fields, with at least one-third of members being women to promote inclusive . is centralized through this expert-nominated structure, enabling enforcement of national sovereignty over biological resources and associated , distinct from state-level bodies. Section 18 delineates the NBA's core functions, including laying down guidelines for access to biological resources, advising the on policy matters related to conservation and sustainable use, granting prior approvals or imposing conditions for access and benefit-sharing (ABS) by non-Indians, body corporates, or non-profit organizations, and facilitating while restricting transfers without approval. It also manages the National Biodiversity Fund established under Section 27, into which monetary benefits such as fees, royalties, or shares from ABS approvals are deposited for conservation and community welfare initiatives. In operations, the NBA processes ABS applications through a structured procedure outlined in the Biological Diversity Rules, 2004 (as amended), prioritizing compliance with obligations by uploading approval details to the ABS Clearing-House. By 2020-21, it had granted 1,787 approvals, with cumulative figures reaching 3,539 access approvals since 2006 as of 2022, indicating active oversight of commercial and research activities involving biological resources. These approvals enforce benefit-sharing requirements, such as royalties or technology transfers, deposited into the Fund, though verifiable data on processing timelines or rejection rates remains limited in public reports, underscoring the NBA's role in regulatory gatekeeping amid India's rich biodiversity endowment.

State and Local Bodies

Under Section 22 of the Biological Diversity Act, 2002, state governments are required to establish State Biodiversity Boards (SBBs) to advise on matters relating to conservation, sustainable use, and equitable sharing of benefits from biological resources obtained within their jurisdictions. Each SBB consists of a chairperson with expertise in biodiversity conservation and members including representatives from state departments, scientific institutions, and local bodies, appointed for terms typically up to three years. SBBs perform functions such as recommending approvals for access to biological resources by Indian citizens for certain commercial purposes, in consultation with local bodies, and promoting awareness and capacity-building at the state level. Notifications for SBB formation occurred variably after the Act's enactment in 2002, with early examples like Goa's board in 2004 and progressive establishment across 28 states by the , reflecting federal discretion in implementation timelines. At the local level, Section 41 mandates that every local body—such as panchayats, municipalities, and corporations—constitute Biodiversity Management Committees (BMCs) within its area of jurisdiction to facilitate grassroots implementation. BMCs, comprising members from the local body, knowledgeable residents, and holders, are tasked with documenting biological diversity through preparation and maintenance of People's Biodiversity Registers (PBRs), advising on sustainable resource use, and regulating access in consultation with higher authorities. These registers catalog local , , and associated knowledge, serving as tools for conservation planning and benefit-sharing claims. Over 31,000 BMCs have been notified nationwide, though actual operational numbers vary by state due to mandatory formation tied to local governance structures. The Act's design incorporates by devolving advisory and documentation roles to SBBs and BMCs, enabling adaptation to regional ecological and cultural contexts in access and benefit-sharing (ABS) processes, as opposed to centralized oversight. However, causal factors such as inconsistent state-level notifications, limited funding, and inadequate training have constrained functionality, with many BMCs—particularly in rural panchayats—remaining dormant or under-resourced, leading to incomplete PBRs and minimal local enforcement of ABS. Empirical assessments indicate that while urban or supported BMCs contribute to localized conservation, broader bureaucratic fragmentation and capacity deficits result in uneven , often amplifying administrative burdens without proportional gains in on-ground outcomes. Strengthening inter-tier coordination and member expertise remains essential to realize federalism's potential over centralized inefficiencies.

Access, Benefit Sharing, and Regulations

Access to Biological Resources

Under Section 3 of the Biological Diversity Act, 2002, non-Indian entities—including foreign nationals, organizations incorporated outside , and non-resident Indians—must obtain prior approval from the (NBA) before accessing any biological resource occurring in or associated traditional knowledge for purposes such as , commercial utilization, bio-survey, or bio-utilisation. This provision, enacted to prevent biopiracy and unauthorized outflows of genetic material, establishes the NBA as the central gatekeeper for such access, requiring applications in prescribed forms with details on the resources sought and intended use. Section 4 further prohibits Indian citizens or entities from transferring accessed biological resources or knowledge to non-Indians without NBA approval, reinforcing controls on cross-border flows. Indian citizens and domestically registered entities face less stringent entry protocols but are still regulated. Section 7 requires prior intimation to the relevant State Biodiversity Board (SBB) for commercial utilization of biological resources or associated , though no formal approval is needed for basic, non-commercial conducted by Indian researchers within the country. Exemptions apply to local communities and vaids/hakims using resources for customary livelihood, domestic, or traditional practices, as well as to normally traded commodities like agricultural produce when used in unmodified form. These distinctions aim to balance domestic innovation with protection against exploitation, originally prioritizing stringent oversight for foreigners to address historical concerns over uncompensated extraction of India's hotspots. The approval mechanisms have empirically constrained timelines in and pharmaceuticals. Processes under Sections 3 and 6—particularly for rights applications based on Indian resources—have resulted in approval delays averaging 6-7 years due to bureaucratic reviews and multi-layered scrutiny, deterring investment and slowing product commercialization. Case examples include stalled herbal drug trials and seed technology validations, where NBA/SBB clearances created bottlenecks, exacerbating India's lag in bio-innovation relative to global peers despite abundant resources.

Benefit Sharing Requirements

The Biological Diversity Act, 2002 mandates fair and equitable sharing of benefits arising from the commercial utilization of biological resources accessed under the Act, with the (NBA) tasked under Section 21 with determining such shares on a case-by-case basis. These benefits may take monetary forms, such as royalties or upfront fees calculated as a of sales or revenue from derived products, or non-monetary forms including , joint ownership, capacity-building initiatives, or funding for conservation research. Collected benefits are deposited into the National Biodiversity Fund, from which up to 95% is disbursed to state biodiversity boards and local biodiversity management committees for conservation efforts and community welfare, though administrative retention by the NBA has reached 5% in practice. Government-imposed mandates for such sharing, rather than purely voluntary agreements, can incentivize users to minimize disclosed utilization or shift activities offshore, potentially reducing overall investment in resource-based innovation compared to market-driven negotiations that align provider and user interests through mutual gain. Benefit sharing amounts are negotiated between applicants and the NBA prior to approval, with disputes resolved by NBA determination or ; for instance, in one agreement involving biological resources for a commercial product, the NBA stipulated 2% of gross or as the sharing obligation. Royalties from or pharmaceutical products derived from accessed resources have been applied similarly, though empirical data indicate limited enforcement and collection, with total NBA receipts from benefit sharing remaining under ₹20 annually as of 2023 despite widespread resource use in sectors like and nutraceuticals. Actual disbursements to intended beneficiaries have been even lower, with less than 27% of accumulated funds transferred to local communities between 2008 and 2025, reflecting administrative delays and verification challenges that undermine the Act's intent to incentivize sustainable stewardship. The regime intersects with intellectual property rights under Section 6, requiring applicants for patents or similar protections based on Indian biological resources to disclose the source origin and obtain prior NBA approval, ensuring benefit sharing applies to any derived commercial value; failure to comply can invalidate IP claims. However, the Act's criteria for "fair and equitable" shares—guided by factors like resource value, utilization scale, and community contributions—lack precise quantification formulas, leading to protracted negotiations and criticisms of arbitrariness that deter research and development, as evidenced by stalled bioprospecting projects where undefined shares exceed 1-2% of projected revenues without corresponding risk adjustment. This vagueness contrasts with first-principles incentives, where clear, proportional ex-post royalties tied to verifiable profits might better preserve innovation incentives than upfront or indeterminate mandates, which impose asymmetric burdens on users while providers capture windfalls independent of conservation outcomes.

Regulatory Procedures

Applications for access to biological resources and associated knowledge under the Biological Diversity Act, 2002, require submission of Form I as prescribed in the Biological Diversity Rules, 2004, to the relevant authority. This form mandates details including the applicant's identity, or proof of nationality for non-residents, precise description of the biological resources sought, purpose of access (such as , bio-survey, or commercial utilization), quantity to be accessed, and commitments regarding benefit-sharing, , and environmental impact. Declarations of prior from local communities and non-transferability without approval are also required, with the process emphasizing verification of ecological viability before granting permission. Intellectual property-related procedures integrate with the Patents Act, 1970, mandating disclosure of the source and geographical origin of biological materials under Section 10(4)(d)(ii) during patent filings. Section 6 of the Biological Diversity Act requires prior approval from the before applying for any rights derived from Indian biological resources or , with applicants notifying the authority of subsequent IP grants or transfers. Annual reporting obligations compel users to furnish details on resource utilization, benefit-sharing outcomes, and compliance status to the designated authority, as outlined in Rule 15 of the 2004 Rules. Procedures for derivatives and value-added products, defined as items containing unrecognizable or physically inseparable portions or extracts of biological resources, necessitate prior approval if access to the underlying resources occurred post-Act enactment. Applications follow similar Form I protocols, specifying the derivative's composition and linkage to original resources, with approvals conditional on demonstrating no adverse biodiversity impacts. Approval backlogs have persisted, particularly in sectors like reliant on herbal derivatives, where processing delays stem from procedural complexities and limited administrative capacity, prompting subsequent rule updates in 2024 to streamline workflows. Non-compliance has been widespread, linked causally to enforcement gaps including inadequate , opaque application tracking, and absence of stringent timelines in the 2004 Rules, resulting in numerous ex-post regularization efforts by the Ministry of Environment. These gaps manifest in undocumented access by researchers and industries, exacerbating monitoring challenges despite mandatory declarations.

Amendments and Reforms

Biological Diversity (Amendment) Act, 2023

The Biological Diversity (Amendment) Act, 2023, received presidential assent on August 3, 2023, following its passage in the on July 25, 2023, and the on August 1, 2023. It amends the 2002 Act to streamline access to biological resources, with provisions taking effect on April 1, 2024. Key changes include exemptions from prior approval and benefit-sharing requirements for codified , as well as for AYUSH practitioners using cultivated , provided a confirms non-wild sourcing. These exemptions apply similarly to users of such resources for commercial purposes, shifting regulatory focus away from domestic traditional practices toward activities involving foreign entities or uncodified knowledge. The amendments decriminalize minor offenses under the original Act, replacing potential imprisonment with monetary penalties scaled to the violation's severity, while increasing fines for serious breaches to deter non-compliance. Government-stated rationales emphasize easing compliance burdens for Indian researchers and companies, which had previously deterred domestic by applying restrictions originally designed to counter foreign biopiracy. This causally promotes cultivation of over wild harvesting, as exemptions incentivize sustainable farming practices, potentially reducing ecological pressure on hotspots through market-driven alternatives rather than prohibitive rules. Subsequent rules under the amended Act, including the Biological Diversity Rules, 2024 (notified October 22, 2024, effective December 22, 2024), and the Access and Benefit-Sharing Regulations, 2025, introduce tiered benefit-sharing formulas. Users with annual turnover below ₹5 crore face no benefit-sharing obligations, while others pay approximately 0.2% of gross ex-factory sales, with uplifts to 0.25% or higher for resources of high conservation or economic value, or involving traditional knowledge. These rates partially align with Nagoya Protocol principles of equitable sharing but prioritize low burdens on small domestic firms to foster industry growth, reflecting a causal emphasis on incentivizing local utilization over stringent international equity mandates that could stifle endogenous economic activity.

Subsequent Rules and Updates

The Biological Diversity Rules, 2024, were notified by the Ministry of Environment, Forest and Climate Change on October 25, 2024, to implement provisions of the amended Act by streamlining access procedures and reducing administrative burdens on domestic users. These rules introduce standardized forms—such as Form I for access applications and Forms III to IX for approvals related to , commercial utilization, and —for prior intimation or approval, with quarterly review meetings mandated to enhance efficiency and address delays in original frameworks. Exempted categories, including Indian citizens and companies for non-commercial or codified use, require simplified prior intimation to State Biodiversity Boards rather than full approval, alongside monitoring via declarations and certificates of origin for cultivated (Form XI). Foreign entities face stricter requirements, including mandatory declarations (Form X) for any use of Indian biological resources, preserving regulatory oversight on cross-border access. Building on these, the Biological Diversity (Access to Biological Resources and Knowledge Associated Thereto and Fair and Equitable Benefit Sharing) Regulations, 2025, were notified by the National Biodiversity Authority on April 29, 2025, specifying benefit-sharing quanta to operationalize access and benefit-sharing (ABS) mechanisms with tiered, turnover-based obligations designed to incentivize compliance among smaller entities. Under these regulations, no benefits are required for annual turnovers up to ₹5 crore; rates escalate to 0.2% for ₹5-50 crore, 0.4% for ₹50-250 crore, and 0.6% above ₹250 crore of the gross ex-factory sale price, with higher minima (up to 20% additional) for valued or threatened resources like red sanders. Exemptions apply to cultivated medicinal plants and products blending cultivated with uncultivated components (as designated by relevant ministries), facilitating faster processing for Indian startups and AYUSH sectors by exempting low-impact or domestic innovation from sharing, while foreign users must secure prior NBA approval to maintain sovereignty over resource exploitation. Annual resource-use statements are mandated for turnovers over ₹1 crore, enabling targeted monitoring without broad disincentives to research. These updates reflect adjustments to pre-amendment rigidities, prioritizing equitable yet pragmatic enforcement through monetary and non-monetary sharing options.

Implementation and Empirical Impacts

Conservation Effectiveness

Empirical assessments of the Biological Diversity Act, 2002, reveal limited direct contributions to reversing or achieving recovery, as India's continues to face pressures from , agricultural expansion, and . Official data from the India State of Forest Report (ISFR) 2023 indicate a modest net increase in recorded forest and tree cover to 827,357 sq km (25.17% of geographical area), up from earlier assessments, primarily attributed to and plantation drives rather than restoration of natural ecosystems. However, independent monitoring by Global Forest Watch documents a loss of 2.31 million hectares of tree cover from 2001 to 2024, equivalent to 7.1% of the 2000 baseline, with significant degradation in biodiversity hotspots due to non-forest conversions. These trends suggest stability in aggregate cover masks ongoing losses in high-quality habitats, where causal drivers like and land-use shifts predominate over regulatory interventions. Biodiversity Management Committees (BMCs), mandated under the Act, have facilitated increased documentation through People's Biodiversity Registers (PBRs), with over 2.6 lakh BMCs established across states, enhancing local awareness of , , and . This has supported efforts in some regions, potentially aiding sustainable resource mapping, yet no robust studies link PBRs to measurable reductions in decline or recovery. Broader faunal and floral metrics reflect persistent erosion; for instance, monitored populations in align with global trends of sharp declines, exacerbated by human expansion since 2000, without evidence of Act-specific reversals in risks or rebounds. Causal analysis points to exogenous factors, such as a 40% increase since 2002 driving land demands, as overriding influences on trajectories. The National Biodiversity Authority's (NBA) fund management underscores implementation gaps, with disbursements remaining minimal relative to needs; for example, recent allocations total mere (e.g., ₹1.36 to select BMCs in 2025), indicating underutilization of available resources for on-ground conservation projects. This low outflow, amid reports of retained benefits not reaching local bodies effectively, limits the Act's capacity to scale ecological interventions, contrasting with scenarios where targeted, incentive-based mechanisms might yield clearer outcomes. Overall, while the Act establishes institutional frameworks, empirical metrics do not demonstrate causal efficacy in stemming losses, highlighting the dominance of demographic and developmental pressures.

Economic and Sectoral Effects

The Biological Diversity Act, 2002, imposed stringent access requirements on biological resources, particularly burdening the pharmaceutical and sectors through mandatory prior approvals from the for , commercialization, and filings. These provisions led to prolonged approval processes and elevated compliance costs, which industry stakeholders reported as deterrents to activities, potentially stifling in bioresource-derived products. Foreign entities faced additional hurdles, contributing to perceptions of regulatory barriers that limited in biodiversity-dependent industries. The 2023 amendments addressed some of these constraints by decriminalizing non-compliance for certain offenses, exempting AYUSH (Ayurveda, Yoga, Unani, Siddha, and Homeopathy) practitioners and users of codified traditional knowledge from access benefit-sharing (ABS) obligations, and streamlining procedures for Indian companies and startups. These changes aimed to reduce administrative delays and foster growth in traditional medicine and agriculture sectors, with surveys indicating perceived benefits for AYUSH operations through eased access to resources. However, actual ABS monetary collections have remained low, with annual distributions to biodiversity management committees totaling around ₹1-2 crore in recent years, reflecting limited revenue generation relative to the scale of regulated industries. Sector-specific effects show mixed outcomes: exemptions have supported domestic AYUSH formulations and agricultural value chains by lowering entry barriers, yet broader critiques from business analyses point to negligible aggregate contributions to GDP growth, as regulatory legacies continued to constrain biotech and foreign inflows. Pre-amendment compliance demands were linked to reduced incentives for , with amendments representing an attempt to reconcile these tensions from India's post-liberalization economic framework, though quantifiable boosts in exports or sectoral output directly tied to the reforms remain modest.

Controversies and Criticisms

Regulatory Burdens on Research and Industry

The Biological Diversity Act, 2002, mandates prior approval from the (NBA) for non-Indian entities seeking access to biological resources or associated knowledge for , commercial utilization, or applications, imposing a multi-layered compliance regime that includes subsequent notifications to state biodiversity boards. This framework, intended to regulate access under India's sovereign rights over resources, has generated bureaucratic delays typically spanning several months to over a year for NBA approvals, exacerbating uncertainties in time-sensitive timelines. Such protracted processes have been identified as deterrents to innovation, particularly in sectors dependent on rapid iteration and sourcing. The Act's treatment of biological resources as effectively state-controlled —vesting ultimate ownership with the government rather than clarifying rights—creates ambiguities that undermine efficient allocation and incentivize underutilization or over productive investment. Empirical assessments indicate that these regulations have inadvertently crowded out engagement in biotech R&D, with foreign investors and researchers facing heightened compliance costs and risks of retrospective benefit-sharing demands, leading to reduced inflows compared to less restrictive jurisdictions. Post-2002, the emphasis on mandatory approvals for even preliminary research has been linked to a on collaborative ventures, as firms weigh the opacity of approval criteria against potential penalties for non-compliance. Critics from industry and analyses argue that the Act normalizes growth-constraining controls framed as equitable benefit-sharing mechanisms, sidelining voluntary contractual arrangements that could align private incentives with conservation without state intermediation. This approach overlooks causal dynamics where secure property rights foster stewardship and innovation, instead favoring administrative oversight that empirically hampers sectors like pharmaceuticals and agrobiotech reliant on India's for novel compounds. The resulting disincentives have prompted calls for reforms prioritizing streamlined access to restore competitive edges lost to regulatory friction.

Debates Over Amendments and Equity

The Biological Diversity (Amendment) Act, 2023, generated polarized debates on its effects on equitable benefit sharing, with proponents emphasizing economic incentives and critics prioritizing community protections. Supporters, including firms and proponents of sectors, argued that exemptions for Indian citizens, companies, and codified uses—such as by AYUSH practitioners—remove undue regulatory hurdles, enabling faster and alignment with self-reliance policies like . These changes, they claimed, would attract foreign investment and boost exports of herbal products, as the original Act's prior approval requirements had deterred domestic without proportionally advancing conservation or sharing outcomes. By decriminalizing certain violations and streamlining filings, the amendments were positioned to foster market-led sustainable use, potentially generating broader benefits than the rigid ABS framework, which yielded limited monetary flows to the National Biodiversity Fund prior to 2023. Critics, encompassing environmental organizations and indigenous advocates, contended that the amendments dilute ABS obligations, exempting key domestic sectors from benefit-sharing mandates and thereby undermining the rights of knowledge-holders in biodiversity-rich areas. This centralization of approvals under the , at the expense of local Biodiversity Management Committees, was decried as eroding decentralized equity mechanisms and heightening biopiracy risks, particularly for uncodified , despite the Act's retention of foreign user requirements. Opponents noted that while pre-amendment benefit realizations were modest—often confined to negotiated royalties or technology transfers in isolated cases—the reforms prioritize industry gains, potentially perpetuating inequities by substituting community consent with centralized fiat and reducing transparency in fund allocation. Analyses of the trade-offs suggest that the amendments address implementation gaps in the 2002 Act, where stringent rules impeded research without ensuring robust benefit flows, but risk over-centralization without enhanced monitoring. Market-oriented could incentivize voluntary partnerships yielding technological advancements for conservation, countering zero-sum views of ABS that assume restricted access equates to greater equity; however, empirical post-2023 data remains nascent, underscoring the need for vigilant enforcement to align commercial utilization with commitments.

Enforcement Mechanisms

Penalties for Non-Compliance

The Biological Diversity Act, 2002, imposed stringent criminal penalties for key non-compliance offenses, particularly unauthorized access, transfer, or use of biological resources by specified entities under Sections 3, 4, and 6, which mandated imprisonment for a minimum of five years extendable to ten years, alongside fines up to ten rupees and additional daily fines of up to ten thousand rupees for continuing contraventions. Contraventions of Section 7, prohibiting unauthorized transfer of research results or knowledge from , or orders under Section 24(2), carried penalties of up to three years' imprisonment, fines up to five rupees, or both. The (NBA), empowered under Section 50 with civil court-like authority for inquiries and evidence collection, could initiate proceedings, but actual prosecutions for these cognizable offenses typically involved coordination with , as outlined in Section 56. The Biological Diversity (Amendment) Act, 2023, enacted on August 3, 2023, decriminalized these core violations by substituting Section 55 with provisions for civil penalties, eliminating and introducing fines up to fifty rupees for offenses under Sections 3, 4, 6, or 7, with repeat contraventions attracting up to one rupees. New Sections 55A and 55B established an adjudication process, wherein NBA-appointed officers conduct inquiries into access and benefit-sharing (ABS) evasion, false reporting, or non-disclosure, imposing penalties after hearing the violator and considering factors like offense gravity and prior compliance. This framework targets persistent issues like benefit-sharing defaults or misrepresentation in ABS agreements, with appeals lying to the NBA or . Enforcement statistics under the original Act reveal limited deterrent impact, with prosecutions and convictions remaining rare—fewer than a handful of documented cases by the early 2020s—despite widespread non-compliance in sectors like pharmaceuticals and research, largely due to NBA's resource limitations, inadequate monitoring infrastructure, and procedural complexities. The 2023 shift to monetary penalties, while easing criminal liability to encourage compliance, has yet to demonstrate improved deterrence, as mechanisms depend on enhanced NBA capacity, and early post-amendment data shows continued low case resolution rates amid ongoing challenges.

Challenges in Adjudication

The adjudication of disputes under the Biological Diversity Act, 2002, primarily involves the and State Biodiversity Boards (SBBs), whose orders on access to biological resources, benefit-sharing, and compliance can be appealed to the within 30 days of communication. For certain environmental disputes arising from NBA or SBB decisions, appeals may also lie to the , which has jurisdiction over questions related to the Act's implementation. However, the volume of litigation remains low, resulting in limited judicial precedents and inconsistent interpretations across jurisdictions, as evidenced by sparse since the Act's enactment in 2002. Vague provisions in the Act, such as undefined thresholds for "access" to biological resources and benefit-sharing entitlements, contribute to arbitrary administrative rulings by NBA and SBB officials, exacerbating uncertainty for applicants and enforcers. Enforcement gaps are pronounced in remote biodiversity hotspots, where inadequate institutional capacity, lack of local awareness, and logistical challenges hinder effective monitoring and , often leading to unaddressed violations. The Biological Diversity (Amendment) Act, 2023, decriminalized most offenses by replacing with civil penalties imposed by designated adjudicating officers—typically officials rather than independent judges—aiming to streamline processes but raising concerns over potential and reduced procedural safeguards. This shift to fines, ranging from ₹50,000 to ₹50 or 1% of annual turnover, may ease adjudication burdens but risks under-deterrence, as the absence of criminal sanctions diminishes reputational and punitive impacts, particularly for large entities with resources to absorb monetary penalties. Adjudication delays parallel those in NBA approval processes, often exceeding statutory timelines due to bureaucratic bottlenecks and resource constraints, undermining the Act's efficacy in timely . Without robust mechanisms for private enforcement, such as third-party standing for affected communities or incentives for civil suits, reliance on state-initiated actions perpetuates gaps in , as empirical patterns of non-compliance persist amid weak judicial oversight.

References

  1. https://smpb.cgstate.gov.in/sites/default/files/bioact-1.doc
  2. https://www.pib.gov.in/newsite/erelcontent.aspx?relid=67509
  3. https://www.nextias.com/blog/biological-diversity-act-2002/
  4. https://www.wipo.int/wipolex/en/text/185798
  5. https://thelaw.institute/patents/indias-biodiversity-act-key-provisions/
  6. https://www.science.org/content/article/amendments-indian-biodiversity-laws-could-open-doors-exploitation
  7. https://frontline.thehindu.com/environment/how-the-amended-biological-diversity-act-puts-profits-over-people/article67657862.ece
  8. https://india.mongabay.com/2022/09/parliamentary-panel-endorses-controversial-changes-in-biodiversity-law-overlooking-concerns/
  9. https://treaties.un.org/pages/ViewDetails.aspx?chapter=27&mtdsg_no=XXVII-8&src=TREATY
  10. https://www.cbd.int/parties
  11. https://www.nature.com/articles/nbt0505-511
  12. https://treaties.un.org/pages/ViewDetails.aspx?src=TREATY&mtdsg_no=XXVII-8-b&chapter=27
  13. https://www.ip-watch.org/2012/10/05/india-ratifies-nagoya-protocol-on-biodiversity-access-and-benefit-sharing/
  14. https://www.researchgate.net/publication/320243388_An_Inquiry_into_the_Biological_Diversity_Act_2002_in_Light_of_the_Nagoya_Protocol_on_Access_and_Benefit_Sharing
  15. https://nlsenlaw.org/legal-dimensions-of-biopiracy-famous-indian-case-studies-neem-basmati-turmeric/
  16. https://www.indiacode.nic.in/bitstream/123456789/21545/1/the_biological_diversity_act%252C_2002.pdf
  17. https://ris.org.in/sites/default/files/article5_v10n3.pdf
  18. https://wwfin.awsassets.panda.org/downloads/bd_act_status_report__final_text.pdf
  19. https://www.wipo.int/wipolex/en/legislation/details/7641
  20. https://biodiversity.tripura.gov.in/sites/default/files/2023-10/BD-Act-2002-Rules-2004.pdf
  21. http://nbaindia.org/uploaded/act/BDACT_ENG.pdf
  22. https://www.cbd.int/doc/legal/cbd-en.pdf
  23. https://abs.nls.ac.in/?page_id=219
  24. http://nbaindia.org/uploaded/docs/biological-diversityact-ii.pdf
  25. https://www.researchgate.net/publication/378139275_Root_causes_of_biodiversity_loss_with_special_reference_to_India
  26. https://www.globalforestwatch.org/dashboards/country/IND/
  27. https://www.globalforestwatch.org/dashboards/country/IND?category=forest-change
  28. https://pmc.ncbi.nlm.nih.gov/articles/PMC10513745/
  29. https://www.cbd.int/abs/infokit/revised/web/factsheet-abs-en.pdf
  30. https://www.legitquest.com/act/the-biological-diversity-act-2002-amended-upto-2023/DF02
  31. https://abs.nls.ac.in/?page_id=553
  32. https://woxsen.edu.in/woxsen-law-review/wlr-papers/traditional-medicinal-knowledge-under-biological-diversity-act-2002/
  33. https://ipwatchdog.com/2019/04/06/indias-biological-diversity-act-beware-regulatory-maze/
  34. https://nujslawreview.org/wp-content/uploads/2021/09/14.2-Swamy-Saloni.pdf
  35. https://abs.nls.ac.in/wp-content/uploads/2019/06/Training-Manual-on-Access-and-Benifit-Sharing.pdf
  36. http://nbaindia.org/uploaded/pdf/AR_English_2020-21.pdf
  37. https://www.indiacode.nic.in/handle/123456789/2046
  38. https://gh.chm-cbd.net/cooperation/tech_coop/biodiversity-development-partners/national-biodiversity-authority-india
  39. http://nbaindia.org/unep-gef/pub1/Guidance.pdf
  40. https://www.downtoearth.org.in/wildlife-biodiversity/is-india-s-biodiversity-getting-exploited-without-benefits-to-communities--84078
  41. https://ceerapub.nls.ac.in/role-powers-and-functions-of-state-biodiversity-boards-to-collect-access-and-benefit-sharing-amount-from-indian-entities/
  42. https://gsbb.goa.gov.in/
  43. https://sbbsikkim.nic.in/pdf/bmc/bmctoolkit.pdf
  44. https://jbb.jharkhand.gov.in/?page_id=2974
  45. https://www.ris.org.in/sites/default/files/Publication/RIS%2520Policy%2520Brief-65.pdf
  46. https://thelifeindia.org.in/biodiversity-management-committees-bmcs/
  47. https://ageconsearch.umn.edu/record/368174/files/Victor42122024AJAEES127594.pdf
  48. https://www.ajcb.in/journals/full_papers_july_2021/AJCB-Vol10-No1-64918_Singh-Dukariya.pdf
  49. https://uppcsmagazine.com/national-biodiversity-authority-nba-overview-functions-and-challenges/
  50. https://sbb.haryanaforest.gov.in/faqs/
  51. https://megbiodiversity.nic.in/sites/default/files/biological-act-nutshell.pdf
  52. https://www.cbd.int/doc/articles/2009/A-00676.pdf
  53. https://patentsrewind.wordpress.com/2016/12/20/national-biodiversity-act-issues-and-recommendations/
  54. https://petrieflom.law.harvard.edu/2022/09/30/proposed-amendments-would-make-foreign-investment-in-indias-biological-resources-easier/
  55. https://carnegieendowment.org/research/2017/10/modern-biotechnology-and-indias-governance-imperatives?lang=en
  56. http://nbaindia.org/uploaded/pdf/ABS_Factsheets_1.pdf
  57. https://www.downtoearth.org.in/wildlife-biodiversity/unwilling-to-share
  58. https://www.theippress.com/2022/01/24/20-years-of-the-biological-diversity-act-2002-journey-so-far-and-the-way-forward/
  59. https://envt.kerala.gov.in/wp-content/uploads/2018/07/The-Biological-Diversity-Rules-2004.pdf
  60. https://www.ipindia.gov.in/writereaddata/Portal/IPOGuidelinesManuals/1_39_1_5-tk-guidelines.pdf
  61. https://www.livemint.com/news/environment-biodiversity-regulations-ayurveda-health-wellness-start-ups-ease-of-business-11756462302129.html
  62. https://www.biospectrumindia.com/views/17/23669/decoding-the-biological-diversity-amendment-act-2023.html
  63. https://egazette.gov.in/WritereadData/2023/247815.pdf
  64. https://prepp.in/question/when-did-the-biological-diversity-amendment-act-20-68bc05e299ead7afd15a1224
  65. https://www.khuranaandkhurana.com/2023/09/08/understanding-the-biological-diversity-amendment-bill-2023/
  66. https://depenning.com/blog/biological-diversity-amendment-bill-2023/
  67. https://www.lexology.com/library/detail.aspx?g=b8ad8b9d-aa0a-4cf9-9341-9bc155724adc
  68. https://www.pib.gov.in/PressReleseDetail.aspx?PRID=1947857
  69. https://ficpi.org/blog/revised-indian-biodiversity-law-2023
  70. https://depenning.com/blog/the-national-biodiversity-authority-new-rules-and-their-implications/
  71. https://kandspartners.com/highlights-of-the-indian-biological-diversity-regulations-2025/
  72. https://www.lexorbis.com/decoding-the-new-regime-for-biodiversity-access-benefit-sharing/
  73. https://www.legalitysimplified.com/new-biological-diversity-rules-2024-key-highlights-and-implications/
  74. https://www.downtoearth.org.in/wildlife-biodiversity/access-and-benefit-sharing-new-rules-for-use-of-biodiversity-put-in-place-by-centre
  75. https://fsi.nic.in/uploads/isfr2023/isfr_book_eng-vol-1_2023.pdf
  76. https://dialogue.earth/en/forests/indias-forests-are-disappearing-but-not-on-paper/
  77. https://indo-germanbiodiversity.com/articles-details-36.html
  78. https://india.mongabay.com/2024/07/explainer-what-is-a-peoples-biodiversity-register/
  79. https://www.wwfindia.org/?27242/Staggering-73-decline-in-wildlife-populations-in-Just-50-Years
  80. https://www.pib.gov.in/PressReleseDetail.aspx?PRID=2182372
  81. https://www.insideeulifesciences.com/2022/02/04/india-to-amend-its-biodiversity-rules/
  82. https://www.mirandah.com/india-amends-the-biological-diversity-act-2002-an-overview/
  83. https://or.niscpr.res.in/index.php/JIPR/article/download/12800/4094
  84. https://pib.gov.in/PressReleseDetailm.aspx?PRID=2182001
  85. https://www.iiprd.com/prior-permission-of-nba-for-accessing-biological-resource-from-india-by-indian-public-ltd-and-foreign-entities/
  86. https://defactolawjournal.org/papers/comparative-study-of-indias-biological-diversity-act-2002-and-the-convention-on-biological-diversity-cbd-convergences-and-divergences/
  87. https://www.lexology.com/library/detail.aspx?g=1294c10e-82ad-471a-a010-371762810bd7
  88. https://www.stoneslaw.net/indias-biological-diversity-act-beware-the-regulatory-maze
  89. https://prsindia.org/billtrack/the-biological-diversity-amendment-bill-2021
  90. http://www.ili.ac.in/pdf/4sum24.pdf
  91. https://www.mondaq.com/india/diversity-equity-inclusion/1393970/challenges-and-ambiguities-in-indias-biodiversity-amendment-bill
  92. https://spicyip.com/2023/04/where-to-lean-on-the-biological-diversity-amendment-bill-2021-or-the-landmark-cases.html
  93. https://or.niscpr.res.in/index.php/JIPR/article/view/12800
  94. https://d-nb.info/136430810X/34
  95. https://www.biodiversity-science.net/EN/10.17520/biods.2023412
  96. https://nsbb.nagaland.gov.in/wp-content/uploads/2021/03/The-Biological-Diversity-Act-2002.pdf
  97. https://www.taxtmi.com/article/detailed?id=8406
  98. https://or.niscpr.res.in/index.php/JIPR/article/download/12800/4094/73106
  99. https://journals.sagepub.com/doi/pdf/10.1177/14614529251328784?download=true
  100. https://www.lexology.com/library/detail.aspx?g=7b71d404-636a-43b3-9a21-f12b43bc62e3
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