The National Biodiversity Authority has notified the new Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulation, 2025.
Key Highlights of the Biological Diversity Regulation, 2025
- These rules govern how benefits from the use of biological resources, physical or digital, must be shared.
- Inclusion of Digital Sequence Information (DSI): DSI is now officially covered under benefit-sharing rules.
- Recognizes that genetic information can be used without accessing physical material.
- Turnover-Based Benefit Sharing Slabs: No benefit sharing for turnover up to Rs 5 crore.
- Exemption for Cultivated Medicinal Plants: Users of cultivated plants are exempt from sharing benefits.
- It is in line with the Biological Diversity (Amendment) Act, 2023.
- No Sharing for Approved Mixed-Source Products: If a product has both cultivated and wild plants, benefit sharing is not required if it is listed by MoEFCC and Ministry of AYUSH.
- Higher Benefit Sharing for High-Value Species: Minimum 5% of sale or auction proceeds for species like:
- Red sanders
- Sandalwood
- Agarwood
- Mandatory Sharing by Researchers and IPR Applicants: Researchers and patent/IP seekers must comply with ABS rules.
- Distribution of Benefits: 10–15% retained by the National Biodiversity Authority (NBA) and remainder shared with local communities and knowledge holders.
What the Regulation Covers
- Applies to: Biological resources, digital sequence information (DSI), and associated traditional knowledge.
- Replaces: The 2014 Guidelines, which did not include digital sequence information.
| Benefit Sharing Based on Annual Turnover |
| Annual Turnover |
Benefit Sharing Rate |
| Up to Rs 5 crore |
Exempt from benefit sharing |
| Rs 5 crore – Rs 50 crore |
0.2% of gross ex-factory sale price |
| Rs 50 crore – Rs 250 crore |
0.4% of gross ex-factory sale price |
| Above Rs 250 crore |
0.6% of gross ex-factory sale price |
| Reporting Requirement: All users with turnover above Rs 1 crore must submit an annual statement on resource usage. |
Need for the Biological Diversity (ABS) Regulation
- Access to Natural Resources: These rules ensure fair access to natural resources and traditional knowledge.
- India is a mega diverse country, which possesses 7-8% of the world’s biodiversity.
- Ensure Fair and Equitable Benefit Sharing: These rules ensure local communities and knowledge holders are fairly compensated for their contributions.
- Promote Conservation and Sustainable Use: By linking economic benefits to biodiversity, the rules encourage conservation.
- Align with International Commitments: India is a signatory to the Convention on Biological Diversity (CBD) and Nagoya Protocol.
- The new regulation aligns national law with international agreements, especially on DSI.
- Balance Commercial Use with Biodiversity Protection: The rules aim to strike a balance between allowing industries to innovate and protecting natural resources.
Digital Sequence Information (DSI)
- Digital Sequence Information (DSI) refers to the digital form of genetic data derived from biological resources. This includes information about:
- DNA, RNA, or protein sequences
- Genetic maps
- Genomic data stored in databases
- It allows researchers and companies to study and utilize genetic information without needing physical samples.
- DSI is now included in the Rules as it can substitute for physical genetic material.
- A global multilateral mechanism for DSI benefit sharing was introduced during COP16 of the Convention on Biological Diversity, held in Cali, Colombia (2024).
- Users in sectors like pharmaceuticals, cosmetics, agriculture, and biotech must share benefits under this mechanism.
Access and Benefit Sharing (ABS)
- Access and Benefit Sharing (ABS) is a framework established under the Convention on Biological Diversity (CBD) and further elaborated by the Nagoya Protocol.
- It governs how genetic resources and associated traditional knowledge are accessed, and how the benefits derived from their use are shared in a fair and equitable manner.
- ABS ensures that biodiversity-rich countries and communities are fairly compensated when their resources are used in industries like pharmaceuticals, agriculture, and biotechnology.
Key Components of ABS
- Access: Obtaining genetic resources (e.g., plants, animals, microbes) or traditional knowledge from a country or indigenous community..
- Benefit Sharing: Ensures that the country or community providing the resource receives fair compensation.
Significance of ABS
- Prevents biopiracy (unauthorized commercial use of genetic resources).
- Promotes equitable partnerships between researchers, companies, and indigenous communities.
- Encourages conservation and sustainable use of biodiversity by rewarding providers.
|
National Biodiversity Authority (NBA)
- The National Biodiversity Authority (NBA) is a statutory body established under the Biological Diversity Act, 2002.
- It was formed in 2003 and is headquartered in Chennai.
Key Functions
- Acts as a facilitative, regulatory, and advisory body to the Government of India.
- Focuses on:
- Conservation of biological diversity,
- Sustainable use of its components,
- Fair and equitable sharing of benefits arising from the use of biological resources.
- Under the Biological Diversity Act (2002) and Biodiversity Rules (2004), two additional bodies complement the NBA:
- State Biodiversity Boards (SBBs) – at the State level.
- Biodiversity Management Committees (BMCs) – at the local/village level.
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