India is home to roughly 8% of the world’s biodiversity – a staggering wealth of plants, animals, microorganisms, and the centuries-old traditional knowledge communities have built around them. But accessing this wealth is not a free-for-all. The Biological Diversity Act, 2002 (BDA) puts in place a structured, approval-based system to ensure that anyone who wants to access India’s biological resources and associated traditional knowledge does so legally, transparently, and with a fair share of benefits going back to the country and its communities. If you’re studying patents or biodiversity law, understanding the application process under this framework is non-negotiable.
Table of Contents
- Why an application process exists in the first place
- Who needs to apply?
- The four application forms under the ABS framework
- Form 1 – direct access to biological resources and/or associated traditional knowledge
- Form 2 – transfer of research results
- Form 3 – intellectual property rights applications
- Form 4 – third party transfer
- What goes into an application: required documentation
- The role of benefit sharing: monetary and non-monetary
- The approval process: step by step
- People’s Biodiversity Registers and traditional knowledge protection
- Consequences of non-compliance
- India’s ABS framework in a global context
Why an application process exists in the first place
India’s biological resources have historically been accessed – and exploited – without adequate compensation to the country or the communities that stewarded them. The BDA was enacted to fix this. It establishes a tiered regulatory structure: the National Biodiversity Authority (NBA) at the central level, State Biodiversity Boards (SBBs) at the state level, and Biodiversity Management Committees (BMCs) at the local level. Together, these bodies regulate who can access biological resources, for what purpose, and on what terms.
The application process is the entry point into this system. Before anyone covered under the Act can access biological resources or associated traditional knowledge – whether for research, commercial use, or bio-survey – they must go through a formal approval process. This ensures that prior informed consent (PIC) is obtained, mutually agreed terms (MATs) are established, and benefit sharing is built into the agreement from the start.
Who needs to apply?
Not everyone accessing biological resources in India needs NBA approval. The Act draws a clear distinction based on the identity of the applicant and the purpose of access.
Under Section 3 of the BDA, the following categories must obtain prior approval from the NBA before accessing any biological resource or associated knowledge for research, commercial utilization, or bio-survey and bio-utilization: foreign nationals, non-resident Indians (NRIs), and any body corporate, association, or organization that is not incorporated in India or is incorporated in India but has non-Indian participation in its share capital or management.
Indian citizens and entities (without foreign involvement) accessing biological resources for commercial use must give prior intimation to the concerned SBB under Section 7 of the Act, rather than seeking full NBA approval. However, this distinction shifted somewhat with the Biological Diversity (Amendment) Act, 2023, which broadened exemptions and revised the classification of entities. Local communities, vaids, hakims, and registered AYUSH practitioners who practise Indigenous medicine for sustenance and livelihood are exempt from these requirements altogether.
The four application forms under the ABS framework
The Access and Benefit Sharing (ABS) framework under the BDA operates through four distinct application forms, each corresponding to a specific category of activity involving biological resources.
Form 1 – direct access to biological resources and/or associated traditional knowledge
This is the primary form. It is used when a person or entity wants to directly access biological resources occurring in India, or knowledge associated with them, for research or commercial utilization. Whether the purpose is academic research, bio-survey, or commercial exploitation, Form 1 is where the process begins. On being satisfied with the application, the NBA enters into a benefit sharing agreement with the applicant, and this agreement itself constitutes the grant of approval.
Form 2 – transfer of research results
This form applies when results of research involving biological resources obtained from India are to be transferred to a foreign person or entity. Under Section 4 of the BDA, no one can share or transfer such results without prior written approval from the NBA. Form 2 governs this process and ensures that even the downstream use of research outputs doesn’t bypass the benefit-sharing framework.
Form 3 – intellectual property rights applications
Under Section 6 of the BDA, any person seeking to apply for an intellectual property right – anywhere in the world – based on research or information derived from biological resources accessed from India must obtain prior NBA approval before the grant of such rights. Form 3 is the application for this approval. This is especially relevant for patent filings where the invention involves biological material or traditional knowledge of Indian origin. One notable exception: applications under the Protection of Plant Varieties and Farmers’ Rights Act (PVPFRA) do not require prior NBA approval – the burden there shifts to the PVPFRA authority to notify the NBA.
Form 4 – third party transfer
Once biological resources or associated traditional knowledge have been accessed through Form 1, they cannot simply be passed on to another party without further authorisation. Form 4 governs the transfer of such resources or knowledge to third parties by individuals or entities who originally obtained access. This prevents any circumvention of the framework through downstream transfers.
What goes into an application: required documentation
An application under the ABS framework is not a simple one-page form. It requires comprehensive documentation that gives the NBA enough information to evaluate the request fully.
A complete application typically includes the following:
Detailed project proposal: This outlines the purpose of access, the methodology to be used, and the expected outcomes of the research or commercial activity. The NBA needs to know what is being done with the resources and why.
Specifics of biological resources: The application must identify the resources being accessed with precision – scientific names, quantities required, and the geographical locations from which collection is intended. Vague descriptions are not acceptable.
Details of associated traditional knowledge: If the application involves traditional knowledge, the applicant must disclose the source and nature of that knowledge. This is particularly sensitive because traditional knowledge is community-owned and its misappropriation has been a major global concern.
Proposed benefit sharing arrangements: This is central to the entire process. The applicant must propose how benefits – monetary or non-monetary – will be shared with the benefit claimers. Under the ABS Guidelines (2019), benefit sharing for commercial utilization is typically calculated as a percentage of the purchase price or the ex-factory sale price of the product. For research access, the mode and quantum of benefit sharing are negotiated and fixed in the benefit sharing agreement itself.
Declarations: Applicants and, where applicable, their supervisors or institutional heads must submit declarations confirming that biological resources will not be commercially utilized or subjected to IPR claims without separate NBA approval. Any outcomes of the research must also be shared with the NBA.
The role of benefit sharing: monetary and non-monetary
Benefit sharing is the heart of the ABS framework. It is not an afterthought – it is a condition of access. The ABS Regulations provide two main options for computing monetary benefit sharing in commercial contexts. Under Option I, benefit sharing is fixed in the range of 3% to 5% of the purchase price of the biological resource. Under Option II, it is up to 0.5% of the annual gross ex-factory sale price (minus government taxes), with a sliding scale based on annual turnover. Companies with turnover below ₹1 crore pay a flat lumpsum of ₹500.
Non-monetary benefits are equally recognized. These include technology transfer, capacity building, collaborative research opportunities, joint ownership of intellectual property rights, and infrastructure development for conservation. The benefit claimers – that is, local communities, conservers of biodiversity, and holders of traditional knowledge – receive a significant share. As per the funding framework, 95% of benefits deposited with the NBA flow to the concerned BMCs and benefit claimers directly.
The approval process: step by step
Since the Biological Diversity Rules, 2024 came into force (effective December 22, 2024), the entire application process has been moved online. All forms are submitted through the NBA’s web portal, and all payments go to the National Biodiversity Fund online. The new Rules also introduced faster timelines for disposing of applications, simplified forms with dropdown menus, and differential fees based on whether the applicant is an individual or an entity.
The approval process follows a defined sequence. Once an application is submitted, the NBA evaluates it based on environmental impact, intended use, and proposed benefit-sharing terms. The NBA consults with the concerned BMCs – whose territorial jurisdiction covers the areas from which resources will be accessed – before reaching a decision. The NBA may grant approval with conditions, or reject the application. If approved, the applicant enters into a formal benefit sharing agreement. This agreement is what operationalizes the approval.
The NBA Chairperson also has the power to expedite approvals in emergencies such as epidemics or pandemics – a practically important provision given how biological resources and associated knowledge are often central to rapid drug or treatment development.
People’s Biodiversity Registers and traditional knowledge protection
A critical supporting mechanism in the ABS framework is the People’s Biodiversity Register (PBR). Under Rule 22(6) of the Biological Diversity Rules, every local body (through its BMC) is required to prepare a PBR – a legal document recording the biological resources occurring within its jurisdiction and the traditional knowledge associated with them. The PBR acts as an inventory and serves as evidence of the prior existence of traditional knowledge, which is vital in preventing biopiracy and wrongful patent claims.
When an applicant seeks access to traditional knowledge through Form 1, the NBA and SBB are required to consult the BMC under whose jurisdiction that knowledge exists. The BMC’s role is consultative – it advises the NBA or SBB – but its input directly shapes the terms of access and benefit sharing. This ensures that local communities have a voice in decisions about their own knowledge, even if the final approval authority rests with the NBA or SBB.
Consequences of non-compliance
Accessing biological resources or traditional knowledge without the required approval is not a minor procedural lapse. Under the original BDA, it was a criminal offence punishable with imprisonment of up to five years. The Amendment Act, 2023 decriminalized these offences but replaced them with significant civil penalties – ranging from ₹1 lakh to ₹50 lakh, with additional penalties of up to ₹1 crore for continuing contraventions. An adjudicating officer of at least the rank of Joint Secretary (central government) or Secretary (state government) conducts the inquiry and determines the penalty.
For patent applicants specifically, the consequences extend further. If a patent is granted based on biological resources obtained from India without prior NBA approval, the NBA – acting on behalf of the Central Government – has the power under Section 18(4) of the BDA to oppose the grant of such intellectual property rights in any country worldwide.
India’s ABS framework in a global context
India’s ABS mechanism is part of its commitment to the Nagoya Protocol on Access and Benefit Sharing, an international agreement under the Convention on Biological Diversity (CBD). The Nagoya Protocol requires countries to ensure that benefits from the use of genetic resources and associated traditional knowledge are shared fairly and equitably with the country of origin. Section 21 and Rule 20 of the BD Rules directly correspond to Articles 5 and 12 of the Nagoya Protocol, making India’s domestic law a concrete implementation of its international obligations.
What do you think? India’s ABS framework tries to balance facilitating legitimate research and innovation with protecting the rights of local communities over their biological resources and traditional knowledge – do you think the current system strikes the right balance, or does the complexity of the approval process risk discouraging research? And given that traditional knowledge is community-owned but the NBA acts as the central approving authority, how effectively do you think local communities can assert their interests in the ABS process?
References
- https://www.indiacode.nic.in/bitstream/123456789/2046/4/a2003-18.pdf
- http://www.nbaindia.org/
- https://prsindia.org/billtrack/the-biological-diversity-amendment-bill-2021
- http://nbaindia.org/content/26/59/1/forms.html
- https://abs.nls.ac.in/?page_id=219
- https://asbb.gov.in/pdf/access/draft-guidline-abs.pdf
- https://www.lexology.com/library/detail.aspx?g=9bfabf95-af22-45eb-9b4b-4e6c45d69270
- https://abs.nls.ac.in/?page_id=553
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