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The National Biodiversity Authority has released a new set of rules to manage sharing of benefits generated through the use of 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.
The rules will now guide the sharing of benefits for the use of biological resources, including digital sequence information or knowledge associated with it.
The Regulation has set slabs based on the annual turnover of the person or the industry accessing the resource. While users who have an annual turnover of up to Rs 5 crore do not have to share benefits, those with a turnover between Rs 5 crore and Rs 50 crore have to share 0.2 per cent of the annual gross ex-factory sale price of the product (excluding government taxes).
The remaining two slabs indicate that 0.4 per cent and 0.6 per cent of the turnover between Rs 50-250 crore and above Rs 250 crore respectively would need to be shared. All users who have an annual turnover of over 1 crore need to share a statement with information on the resources used per year.
In India, the major users of biological resources include traditional medicine manufacturers. The regulation would put companies such as Patanjali with an annual turnover of Rs 31,961.62 crore; Baidyanath with annual turnover of Rs 713 crore, and Dabur India with an annual turnover of Rs 128,864 crore in 2024, in the top category.
However, the extent of benefits they would need to share is not clear as the Regulation exempts users of cultivated medicinal plants. This is in line with the controversial Biological Diversity (Amendment) Act 2023, which had replaced the Biological Diversity Act of 2002.
The new Act promoted cultivation of medicinal plants and freed the practitioners of Indian systems of medicine from the need to take approvals for access or share benefits. The bill was introduced in Parliament on December 16, 2021, by Bhupender Yadav, Union minister for environment, forest and climate change.
The 2025 notification indicates that in case a product contains both cultivated and uncultivated plants, benefits would not need to be shared on products identified by the Union Ministry of environment, forest and climate change, in consultation with the Ministry of Ayurveda, Unani, Siddha and Homeopathy or AYUSH.
In case of biological resources that have high conservation or economic value, the benefit sharing shall not be less than five per cent of the proceeds of the auction or sale amount or the purchase price. These resources include red sanders, sandalwood, agarwood and threatened species notified under Section 38 of the Biodiversity Act 2002. The benefit sharing component could go up to more than 20 per cent in case of commercial use.
The Regulation replaces The Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014. The latter did not include digital sequence information in the ambit of genetic resources. This addition is crucial, considering they can be used instead of a physical form of biodiversity.
The Regulation also puts in place, the requirements for benefit sharing by researchers and for those who want to apply for intellectual property rights. The document also outlines how benefits would be shared with the claimants. Of the total collected, around 10-15 per cent would be retained by the National Biodiversity Authority.
The issue of access and benefit sharing, especially on the use of digital sequence information, is being discussed globally too.
To ensure that users share benefits with communities that have protected the biodiversity and hold the knowledge of its use, a multilateral mechanism for sharing benefits accrued from the use of digital sequence information was put in place during COP16 of the Convention on Biological Diversity in Cali, Colombia, last year. Users of biodiversity such as pharmaceuticals, cosmetics, agriculture, and the biotechnology industry were asked to share benefits under this mechanism.