New Rules for Biological Resource Benefit Sharing
The National Biodiversity Authority (NBA) of India has introduced new regulations for the sharing of benefits derived from biological resources. The Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulation 2025 was approved by the Central Government and notified on April 29, 2025. This regulation aims to enhance the management of biological resources and replaces the previous guidelines established in 2014.
Prior Informed Consent (PIC)
The new rules mandate that any individual or industry seeking access to biological resources must provide prior notification to the NBA. This requirement does not apply to cultivated medicinal plants as stipulated under the Biodiversity Act of 2002.
Quantum of Benefit Sharing
The regulations specify benefit-sharing slabs based on the annual turnover of the user. Users with an annual turnover exceeding ₹1 crore must submit a statement detailing the resources utilised each year. For high-value biological resources, the minimum benefit share is set at 5% of the proceeds from sales, which can increase to over 20% for commercial applications.
Commercialization of Intellectual Property Rights
Applicants seeking to commercialise intellectual property must provide monetary or non-monetary benefits to the NBA. This ensures that the benefits from biological resources are equitably shared.
Access and Benefit Sharing (ABS) Framework
ABS refers to the mechanisms governing the access to genetic resources and the sharing of benefits derived from their use. This framework is guided by the Convention on Biological Diversity (CBD), including the Bonn Guidelines and the Nagoya Protocol established in 2010.
Digital Sequence Information Inclusion
The 2025 regulation includes provisions for Digital Sequence Information, which was not covered under the 2014 guidelines. This addition reflects the evolving nature of biodiversity management and recognises the importance of genetic data in conservation and research.
Categories of Users
The regulations categorise users based on their annual turnover. Those with turnovers up to ₹5 crore are exempt from sharing benefits. Users with turnovers between ₹5 crore and ₹50 crore must share 0.2% of their gross ex-factory sale price, while those with turnovers between ₹50 crore and ₹250 crore must share 0.4%, and over ₹250 crore must share 0.6%.
Exemptions and Controversies
The regulation exempts users of cultivated medicinal plants, aligning with the Biological Diversity (Amendment) Act 2023. This amendment promotes the cultivation of medicinal plants and alleviates the burden of approvals for practitioners of traditional medicine.
Global Context and Multilateral Mechanisms
The issue of access and benefit sharing is a global concern. During the CBD COP16 in Cali, Colombia, a multilateral mechanism for sharing benefits from DSI was established. This mechanism encourages users from various industries, including pharmaceuticals and agriculture, to share benefits with communities that have preserved biodiversity.
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