The Biological Diversity Act, 2002, was amended in 2023, and in view of the amendments, the Biological Diversity Rules 2024 were notified on October 22, 2024, having effect from December 22, 2024. After the notification of new Rules, the revision in the Biological Diversity Regulations 2014 was awaited, and now the Biological Diversity Regulations, 2025 have been notified on April 29, 2025.
The Regulations can be accessed here:
https://egazette.gov.in/(S(w1bod3yh4liyh0pyocnmwn4x))/ViewPDF.aspx
The BD Regulations 2025 broadly provide the guidelines for benefit sharing for the following:
- For accessing biological resources, including digital sequence information or knowledge associated thereto, for research, bio-survey, and bio-utilisation by a Foreign Entity.
- For access to biological resources or associated knowledge for commercial utilisation by a Foreign Entity.
- For access to biological resources or associated knowledge for commercial utilisation by an Indian Entity.
- To share or transfer results of research relating to biological resources or traditional knowledge associated therewith.
- For the commercialisation of intellectual property rights by a Foreign Entity.
- For the commercialisation of intellectual property rights by an Indian Entity.
One of the significant regulations is providing clarity on the criteria for determining benefit sharing, viz:
- The benefit sharing may be in monetary and or non-monetary modes.
- Determination of benefit sharing would be sector-specific and based on considerations such as the nature and quantity of biological resources used and their sustainability, ecological impact, nature of technology applied, potential commercial use of the proposed activity, etc.
- Special consideration may be given, like a lower percentage of benefit sharing, where access to biological resources is for technologies, innovations or products that are developed, leading to intellectual property rights for controlling epidemics, mitigating environmental pollution affecting human, animal or plant health, or for food security or conservation of biodiversity.
- The amount of benefit sharing shall remain the same whether the product contains one or more biological resources.
The benefit sharing has been kept significantly higher for biological resources having conservation value or high economic value, such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, as compared to other biological resources.
We expect the BD Regulations, 2025, to provide the necessary guidance on the benefit sharing in view of the amendment in the BD Act and the new BD Rules.
The PDF of Regulations can be accessed here: Biological Diversity Regulations 2025