India's new 2025 biodiversity rules: decoding access, benefit sharing & dsi

In a significant move to align with global biodiversity standards, the National Biodiversity Authority (NBA) has notified the Biological Diversity (Access and Benefit Sharing) Regulation 2025. These new rules, issued under the foundational Biological Diversity Act, 2002, replace the previous 2014 guidelines. The update is a direct response to evolving international agreements, particularly the Kunming-Montreal Global Biodiversity Framework and decisions made at CBD COP16 (2024), aiming to create a more equitable and transparent system for sharing the benefits derived from India’s vast biological wealth.

The core objective is to regulate how benefits—both monetary and non-monetary—from the commercial use of India’s biological resources and associated traditional knowledge are shared fairly with the local communities who conserve them. This framework is crucial for balancing economic development with conservation ethics.

Fun Fact: India is one of the 17 mega-biodiverse countries in the world, hosting around 8% of the world’s recorded species, making its genetic resources incredibly valuable for pharmaceutical, agricultural, and cosmetic industries globally.

India’s Legal Framework on Access and Benefit Sharing (ABS)

Access and Benefit Sharing (ABS) is a principle enshrined in the Convention on Biological Diversity (CBD), an international treaty to which India is a signatory. It operates on the premise that those who access and use genetic resources (like corporations or researchers) must share the resulting benefits with the countries and communities that provide and conserve them. The Nagoya Protocol (2010) provides the detailed international framework for implementing ABS.

India’s Biological Diversity (BD) Act, 2002 is the domestic legislation that gives effect to the CBD. It has a broader scope than the Nagoya Protocol, covering all biological resources, not just genetic ones. To implement this, India established a unique three-tier system:

1. National Biodiversity Authority (NBA): The apex body at the central level, responsible for regulating access for foreign entities and all matters related to IPR and transfer of research results.
2. State Biodiversity Boards (SBBs): Functional at the state level, they deal with access requests from Indian citizens and entities for commercial purposes.
3. Biodiversity Management Committees (BMCs): Established at the local body level, their primary role is to document local biodiversity and traditional knowledge in People’s Biodiversity Registers (PBRs) and ensure benefit sharing reaches the grassroots.

Mnemonic for Implementation Tiers: To remember the three-tier structure (NBA, SBB, BMC), think: “Nature’s Sanctity Balances Modern Commerce.”

Key Highlights of the 2025 Regulations

The 2025 regulations introduce several critical updates to modernize the ABS regime, with the most groundbreaking being the inclusion of Digital Sequence Information (DSI).

1. Inclusion of Digital Sequence Information (DSI): For the first time, the rules explicitly bring DSI under the ABS framework. DSI refers to the digital data derived from genetic resources, such as DNA, RNA, and protein sequences. As biotechnology allows companies to develop products using only this data without needing the physical resource, this inclusion, following the global consensus at COP16 in 2024, closes a major loophole and ensures benefits are shared from this new form of bio-prospecting.

2. Prior Informed Consent (PIC): Any person or company intending to access biological resources or associated knowledge must provide prior intimation and receive approval from the NBA. This ensures that access is regulated and transparent from the outset. An exemption exists for accessing cultivated medicinal plants, a move aimed at supporting the AYUSH industry.

3. Structured Quantum of Benefit Sharing: The rules introduce clear, tiered slabs for benefit sharing based on the annual turnover of the user, making compliance more predictable.

4. High-Value Biological Resources: For resources with high economic and conservation value, such as red sanders or agarwood, the benefit sharing is set at a minimum of 5% of the auction or sale price and can exceed 20% for commercial use, reflecting their immense value.

Illustrative Analogy: Think of ABS like a royalty system for nature. If a company writes a bestselling book (a new drug) based on a story idea from a small village (a traditional medicinal plant), the ABS framework ensures the village gets a fair share of the book’s profits.

Critical Policy Appraisal

The new regulations, building on the 2023 amendments to the BD Act, attempt to streamline processes while strengthening the benefit-sharing mechanism. However, they face both praise and criticism.

Fun Fact: The famous ‘Jeevani’ drug case involving the Kani tribe of Kerala is a landmark example of ABS in action. The Tropical Botanic Garden and Research Institute (TBGRI) shared 50% of the license fee and royalty obtained from the drug’s sale with the tribe, a model that has been studied globally.

Analytical Lens: UPSC Focus (Mains & Prelims)

Conceptual Basis

The legal and historical backbone of this topic rests on:

• International Convention: Convention on Biological Diversity (CBD, 1992) and its Nagoya Protocol on Access and Benefit Sharing (2010).
• National Legislation: The Biological Diversity Act, 2002 and the subsequent Biological Diversity (Amendment) Act, 2023.

UPSC Integration: Connecting the Dots

• GS-II (Polity & Governance): Federalism (division of power between NBA, SBBs, BMCs), functioning of statutory bodies, rights of tribal and local communities (Schedule V & VI areas), and the process of law-making.
• GS-III (Economy & Environment): Intellectual Property Rights (IPR), bio-economy, impact on the pharmaceutical and AYUSH industries, sustainable development, biodiversity conservation, and the role of technology (DSI).
• GS-IV (Ethics): Environmental ethics, equity, and the moral responsibility of corporations and governments towards indigenous communities and the conservation of natural resources.

Future Impact & Policy Relevance

The inclusion of DSI is the most forward-looking aspect of these regulations. As genomics and synthetic biology advance, the value chain will increasingly “dematerialize,” making DSI the new frontier for bio-prospecting. The long-term challenge for India will be to build the technological and regulatory capacity to track the use of its DSI globally. Successfully implementing this framework will be key to positioning India as a leader in the global bio-economy while ensuring that the benefits of its immense biodiversity flow back to the communities who are its primary custodians.

UPSC Prelims Practice Question (MCQ)

Question: Which of the following bodies are established under the Biological Diversity Act, 2002 to implement the Access and Benefit Sharing (ABS) mechanism in India?

1. National Biodiversity Authority (NBA)
2. State Biodiversity Boards (SBBs)
3. Biodiversity Management Committees (BMCs)
4. Genetic Engineering Appraisal Committee (GEAC)

Select the correct answer using the code given below: (a) 1 and 2 only (b) 1, 2, and 3 only (c) 1, 3, and 4 only (d) All of the above

Answer: (b) 1, 2, and 3 only Explanation: The Biological Diversity Act, 2002 establishes a three-tier structure for implementation: the National Biodiversity Authority (NBA) at the national level, State Biodiversity Boards (SBBs) at the state level, and Biodiversity Management Committees (BMCs) at the local level. The Genetic Engineering Appraisal Committee (GEAC) is a statutory body constituted under the Environment (Protection) Act, 1986, and it deals with the appraisal of proposals related to the release of genetically engineered organisms and products.

UPSC Mains Practice Question

Question: The recent amendments to India’s biodiversity framework, particularly the inclusion of Digital Sequence Information (DSI), represent a double-edged sword. Critically analyze this statement in the context of balancing ease of doing business with the principles of equity and community rights enshrined in the Convention on Biological Diversity. (15 Marks, 250 Words)

Mind Map Outline (Revision Structure)

• India’s Biological Diversity & ABS Framework (2025 Regulations)
  • Core Legal & International Framework
    • International Treaties
      • Convention on Biological Diversity (CBD, 1992)
      • Nagoya Protocol on ABS (2010)
      • Kunming-Montreal Global Biodiversity Framework
    • Domestic Legislation
      • Biological Diversity Act, 2002
      • Biological Diversity (Amendment) Act, 2023
  • Key Provisions of the 2025 Regulations
    • Digital Sequence Information (DSI)
      • Definition: Digital data from genetic resources.
      • Significance: Closes loophole of non-physical resource use.
    • Prior Informed Consent (PIC)
      • Mandatory approval for access.
      • Exemption: Cultivated medicinal plants.
    • Benefit Sharing Mechanism
      • Tiered slabs based on company turnover (0.1% - 0.5%).
      • Special provision for High-Value Resources (5-20%+).
      • Sharing of benefits from research transfer and IPR commercialization.
  • Implementation Machinery (Three-Tier System)
    • National Biodiversity Authority (NBA): Apex body, regulates foreign access, IPR.
    • State Biodiversity Boards (SBBs): Regulates domestic commercial access.
    • Biodiversity Management Committees (BMCs): Local level, documents knowledge (PBRs), ensures grassroots benefit sharing.
  • Critical Policy Appraisal
    • Challenges/Criticisms
      • Weak institutional capacity (SBBs/BMCs).
      • Ambiguity between academic vs. commercial research.
      • Complexity of transboundary resources.
      • Potential dilution of equity for “ease of business.”
    • Opportunities/Way Forward
      • Empowering local communities through customary law.
      • Using technology to digitize PBRs.
      • Developing multilateral benefit-sharing for DSI.
      • Creating a predictable investment climate.
  • UPSC Focus Areas
    • Inter-Topic Linkages
      • GS-II: Federalism, Statutory Bodies, Tribal Rights.
      • GS-III: IPR, Bio-economy, Environment, S&T.
      • GS-IV: Environmental Ethics, Equity.
    • Practice Questions
      • Prelims: Focus on statutory bodies, key definitions (DSI, PIC).
      • Mains: Analysis of policy balance, implementation challenges, and future implications.