India’s biodiversity law is undergoing a significant transformation, aimed at streamlining its regulatory framework and enhancing its effectiveness. The Biological Diversity Act, 2002 (‘BDA, 2002’) was originally enacted to promote the conservation and sustainable use of biological resources (‘BRs’), while ensuring fair and equitable benefit-sharing. However, over time, stakeholders raised concerns about the Act’s rigid compliance requirements, which were often seen as obstacles to research and commercial development.
To address these challenges, the Biological Diversity (Amendment) Act, 2023 (‘BDA’) came into effect on 1 April 2024, introducing several key reforms. These include the decriminalization of offences, a clear distinction between Indian and non-Indian entities, and relaxed conditions for Indian applicants filing patent applications. At the same time, the amendment introduced safeguards by restricting the transfer of research results and biological resources to non-Indian entities.
Building on the 2023 reforms, the Biological Diversity Rules, 2024 (‘Rules’) were notified on 22 October 2024, to operationalize and streamline the approval process. for accessing BRs. These rules outline detailed procedures for non-Indian entities seeking access for research, bio-surveys, bio-utilization, commercial use, and IP applications, along with revised fee structures and application formats.
Further strengthening the regulatory framework, the Biological Diversity Regulation, 2025 (‘Regulations’) establishes a system for upfront payments related to research activities and benefit sharing for commercial activities, transfer of research outcomes, and IP commercialization.
This article examines these recent developments, focusing on access to biological resources, intellectual property rights based on the Indian BR, and the evolving benefit-sharing mechanisms. As India continues to refine its biodiversity governance, these reforms mark a pivotal step toward balancing innovation, conservation, sustainable use of BR and national interest.
Access of biological resources ‘occurring’ in India
The legal framework governing access to biological resources in India is anchored in the definition provided under Section 2(a) of BDA. According to this provision, ‘access’ means collecting, procuring or possessing any biological resource occurring in or obtained from India or traditional knowledge associated thereto, for the purposes of research or bio-survey or commercial utilization. This definition establishes the scope of activities that fall under regulatory oversight, ensuring that any engagement with India’s biological wealth, whether for scientific inquiry or commercial gain, is subject to legal compliance.
Further clarity is provided in Section 2(c) of BDA, which defines ‘biological resources’ to include plants, animals, micro-organisms or parts of their genetic material and derivatives (excluding value-added products), with actual or potential use or value for humanity, but does not include human genetic material. This expanded definition reinforces the BDA’s intent to regulate a wide spectrum of biological resources.
Compliance requirements for non-Indian entities accessing biological resources
BDA: BDA imposes specific compliance obligations on non-Indian entities seeking access to BRs occurring in India. Under Section 3(2) of BDA, such entities must obtain prior approval from the National Biodiversity Authority (NBA) before engaging in activities such as research, commercial utilization, bio-survey, or bio-utilization.
Rules: The procedural framework for obtaining this approval is laid out in the Rules. As per Rule 13(1), Applications for access related to research, bio-survey, or bio-utilization must be submitted using Form 1, while those for commercial utilization must be submitted using Form 2. This digitized, form-based system is designed to streamline the approval process while ensuring transparency and regulatory oversight.
Regulations: The Regulations further elaborate on the benefit-sharing obligations applicable to non-Indian entities upon accessing BRs from India.
For the purpose of research /bio-survey and bio-utilization, Regulation 3 provides that if the BR has conservation value, high economic value, or is a threatened species under Section 38 of the BDA, the NBA may determine the benefit-sharing amount, including upfront payments. In certain cases, the NBA may require upfront payment for access to ‘certain BRs,’ although the term remains undefined, creating some interpretive uncertainty. For academic research, the NBA may waive upfront payments based on a case-by-case basis.
For the purpose of commercial utilization, Regulation 4 specifies that benefit-sharing is calculated as a percentage of the annual gross ex-factory sale price of the product, excluding government taxes, and is determined based on the entity’s annual turnover. Entities with turnover exceeding one crore (10 million) Rupees must file Form A, submitting an annual statement detailing BR consumption. Where the BR has conservation or high economic value, the benefit-sharing must be at least five percent of the sale or auction proceeds and may be increased by twenty percent over the standard rate, as determined by the NBA.
Compliance requirements for Indian entities accessing biological resources
BDA: In contrast to the obligations placed on non-Indian entities, the BDA provides a more facilitative framework for Indian entities accessing BRs occurring in India. Under Section 7, Indian entities are not required to obtain prior approval from the NBA or the State Biodiversity Boards (‘SBB’) for accessing BRs for research activities. However, when BRs are accessed for commercial utilization, Indian entities need to intimate the relevant SBB.
Section 7 also outlines specific exemptions. The compliance requirements do not apply to codified traditional knowledge, cultivated medicinal plants and their products, local communities including growers and cultivators of biodiversity, and practitioners of indigenous medicine such as vaids, hakims, and registered AYUSH practitioners, provided they are engaged in such practices for livelihood. In the case of cultivated medicinal plants, the exemption is conditional upon obtaining a certificate of origin from the Biodiversity Management Committee, as prescribed.
Regulations: No benefit sharing is required for Indian entities if the BR is accessed for the purpose of research /bio-survey and bio-utilization. However, for the purpose of commercial utilization, Regulation 5 provides further clarity on benefit sharing for Indian entities. First, the SBB or Board or Council are to be informed in advance via the NBA’s web portal using Form B for access to BRs for commercial utilization. The benefit-sharing amount is calculated based on the same criteria as outlined in Regulation 4, i.e., as a percentage of the annual gross ex-factory sale price, excluding government taxes, and based on the entity’s turnover.
Further, special provisions under Regulation 5 apply to high-value or conservation-sensitive BRs, such as red sanders, sandalwood, agarwood, or species listed under Section 38 of the BDA. In such cases, the benefit-sharing amount must be at least 5% of the sale, auction, or purchase price, paid upfront, and may be increased by 20% over the standard rate. However, notifications under Section 38, which would formally list such species and exempted products, have not yet been issued, creating some regulatory uncertainty.
Additionally, manufacturers using both cultivated and non-cultivated medicinal plants are not required to pay benefit-sharing for products officially exempted by the Ministry of Environment, in consultation with relevant authorities. Entities with an annual turnover exceeding ₹1 crore must also submit Form A, detailing the BRs consumed during the financial year.
Intellectual property rights based on biological resources
The compliance framework for applying for intellectual property rights (IPR) based on biological resources (BRs) accessed from India varies significantly for Indian and non-Indian entities. This applies to inventions based on research or information related to BRs accessed from India, including those stored in repositories outside the country, or associated traditional knowledge. These distinctions are clearly outlined in the BDA, the Rules, and the Regulations.
Compliance for non-Indian entities applying for intellectual property rights
BDA: As per Section 6(1), any person or entity falling under Section 3(2), which includes non-Indian individuals, companies, or organizations must obtain prior approval from the NBA before the grant of any IPR, whether in India or abroad.
Rules: Rule 16(1)(a), further mandates that such applications for approval must be submitted via the NBA’s web portal using Form 7. This includes inventions based on digital sequence information derived from Indian BRs.
Regulations: Under Regulation 8, the process and benefit-sharing obligations for IPR commercialization are detailed. If the applicant commercializes the IPR directly, the benefit-sharing obligation may be up to 1% of the annual gross ex-factory sale price, excluding government taxes, determined on a sector-specific, case-by-case basis. If traditional knowledge is involved, the benefit-sharing amount increases by 25% over the standard rate.
If the IPR is assigned or licensed to a third party, the applicant must share up to 5% of the license or assignment fee, and up to 5% of the annual royalty received, again based on sectoral norms and case-specific evaluation.
In cases where the IPR is revoked or ceases, but the applicant continues to use the BR for commercial purposes, fresh approval under Rule 13 is required, and benefit-sharing will be governed by Regulation 4.
Compliance for Indian entities applying for intellectual property rights
BDA: Unlike non-Indian entities, Indian applicants are not required to obtain prior approval from the NBA before the grant of a patent. However, as per Section 6(1A), they must register with the NBA before the patent is granted.
Rules: The registration with NBA is done via Form 8 as per Rule 16(2)(a).
BDA: Further, Section 6(1B) mandates that Indian entities must obtain prior approval from the NBA at the time of commercialization of the patent. As per Rule 16(3)(a) this approval is obtained by means of filing Form 9.
Regulations: Regulation 9 outlines the benefit-sharing obligations for Indian entities commercializing IPR. If the applicant uses the IPR for commercialization, the benefit-sharing amount may be up to 1% of the annual gross ex-factory sale price, excluding taxes, determined on a case-by-case basis. Where traditional knowledge is involved, the benefit-sharing obligation increases by 25% over the standard rate.
If the IPR is revoked or ceases, and the applicant continues to use the BR for commercial purposes, fresh approval must be obtained under Regulation 5, and benefit-sharing must be fulfilled accordingly. If the IPR is assigned or licensed to a third party, the applicant must pay up to 5% of the license or assignment fee, and up to 5% of the annual royalty, based on sectoral norms and case-specific evaluation.
Exemption under Section 40 of BDA
Section 40 of the BDA, empowers the Central Government, in consultation with the NBA, to exempt certain biological resources from the Act’s provisions if they are normally traded as commodities or the items derived from them, including agricultural wastes, as notified and cultivated medicinal plants and their products for entities covered under section 7, registered as per the regulations made or as prescribed. However, this exemption does not extend to activities related to IPR under Sections 6(1) and 6(2) of the BDA. Both Indian and foreign entities engaging in IPR-related activities must continue to comply with the relevant provisions of the BDA.
Revised penalty framework and legal status under the BDA.
BDA introduces a significant shift in the enforcement mechanism by replacing criminal sanctions with a civil penalty framework. As per Section 55 of BDA, any person or entity falling under Section 3(2) or Section 7, which includes foreign individuals, companies, and certain Indian entities, who violates or attempts to violate the provisions of Sections 3, 4, 6, or 7, or abets such violations, is now subject to monetary penalties.
The penalties begin at INR 1 lakh and may extend up to INR 50 lakh, depending on the nature and extent of the violation. In cases where the environmental or economic damage caused exceeds the maximum penalty, the fine will be proportionate to the actual harm. Furthermore, if the violation continues over time, an additional penalty of up to ₹1 crore may be imposed.
In a major departure from the original BDA 2002, the BDA also removes Section 58, which previously classified offences under the Act as cognizable and non-bailable. This effectively decriminalizes violations, shifting the focus from criminal prosecution to administrative enforcement.
Conclusion
The recent reforms represent a pivotal shift in India’s biodiversity governance, reflecting a deliberate effort to balance conservation priorities with the promotion of innovation, research, and commercial engagement. By differentiating compliance requirements for Indian and non-Indian entities, the framework supports domestic stakeholders through simplified procedures, while imposing stricter standards on foreign entities to safeguard national interests.
The introduction of digitized application processes, transparent benefit-sharing mechanisms, and sector-specific guidelines for intellectual property rights has enhanced regulatory clarity and accountability. Additionally, the legal recognition of traditional knowledge and cultivated medicinal plants, alongside tailored compliance pathways, demonstrates a commitment to respecting community practices and livelihoods.
However, as stakeholders begin to navigate this evolving legal landscape, further judicial and administrative clarity on the BDA, Rules, and Regulations would be beneficial. Clearer interpretations and consistent enforcement will help reduce ambiguity, foster compliance, and build trust among researchers, businesses, and local communities.
As India continues to refine its biodiversity laws, these reforms lay the groundwork for a more inclusive, efficient, and ethically grounded system, one that protects the country’s rich biological heritage while empowering stakeholders to engage with it responsibly.
[The authors are Executive Director and Associate, respectively, in IPR practice at Lakshmikumaran & Sridharan Attorneys, New Delhi]
References:
- Biological Diversity Act, 2002.
- Biological Diversity (Amendment) Act, 2023.
- Biological Diversity Rules, 2024.
- Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations, 2025.
- Biological Resources notified as normally traded commodities under section 40 of BD Act, 2002 Dated: 7 April 2016, in supersession of the notification number S.O.2726(E), dated the 26 October 2009, amendments, S.O. 3533 (E), dated 7 November 2017.
