New Biodiversity Regulation Enhances Benefit Sharing in India

The National Biodiversity Authority of India has introduced new regulations to manage 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 ensure fair compensation for the use of biological resources, including digital sequence information.

Key Features of the Regulation

The regulation outlines a structured approach to benefit sharing based on the annual turnover of users. It categorises users into different slabs. Those with an annual turnover of up to Rs 5 crore are exempt from sharing benefits. Users with a turnover between Rs 5 crore and Rs 50 crore must share 0.2 per cent of their annual gross ex-factory sale price. Higher turnover categories face increased sharing requirements, with 0.4 per cent for Rs 50-250 crore and 0.6 per cent for above Rs 250 crore.

Impact on Major Industries

Significant industries that utilise biological resources include traditional medicine manufacturers. Companies such as Patanjali, Baidyanath, and Dabur India fall into the top category based on their annual turnovers. However, the regulation exempts users of cultivated medicinal plants, creating ambiguity about the extent of benefits to be shared by these companies.

Relation to Previous Legislation

This regulation aligns with the Biological Diversity (Amendment) Act 2023, which replaced the Biological Diversity Act of 2002. The amendment promotes the cultivation of medicinal plants and eases the approval process for practitioners of Indian medicine. This regulatory landscape aims to balance the interests of biodiversity conservation and the economic benefits derived from biological resources.

Benefit Sharing for High-Value Resources

For biological resources with conservation or economic value, the regulation mandates a minimum benefit sharing of five per cent from sales. This includes valuable resources like red sanders and sandalwood. In cases of commercial use, the sharing could exceed 20 per cent, reflecting the high demand and value of these resources.

Digital Sequence Information Inclusion

The 2025 regulation expands the scope of benefit sharing to include digital sequence information, which was not covered in the previous guidelines. This inclusion is vital as digital information can represent biodiversity without requiring physical samples. It addresses contemporary issues in biodiversity management and intellectual property rights.

Global Context and Multilateral Mechanisms

The regulation is part of a broader global discussion on access and benefit sharing, particularly concerning digital sequence information. During COP16 of the Convention on Biological Diversity, a multilateral mechanism was established to ensure users share benefits with communities that have historically protected biodiversity. This international framework complements India’s regulatory efforts.

Administrative Aspects

The regulation stipulates that users with an annual turnover exceeding Rs 1 crore must submit a statement detailing the biological resources used. Additionally, 10-15 per cent of the total collected benefits will be retained by the National Biodiversity Authority for administrative purposes.

Questions for UPSC:

1. Critically analyse the implications of the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulation 2025 on traditional medicine practices in India.
2. What are the key differences between the Biological Diversity Act of 2002 and the Biological Diversity (Amendment) Act 2023? Explain with examples.
3. What is digital sequence information? How does it impact biodiversity conservation and benefit sharing?
4. Comment on the significance of multilateral mechanisms in addressing global biodiversity challenges and the sharing of benefits derived from biological resources.

Answer Hints:

1. Critically analyse the implications of the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulation 2025 on traditional medicine practices in India.

1. Regulation introduces structured benefit sharing based on annual turnover, impacting financial dynamics of traditional medicine practitioners.
2. Exemption for users of cultivated medicinal plants may lead to ambiguity in benefit-sharing obligations for major companies.
3. Traditional medicine manufacturers like Patanjali and Dabur may face new compliance requirements, influencing their operational costs.
4. Potential for increased funding towards biodiversity conservation initiatives from shared benefits, enhancing sustainable practices.
5. May encourage ethical sourcing and recognition of indigenous knowledge in traditional medicine practices.

2. What are the key differences between the Biological Diversity Act of 2002 and the Biological Diversity (Amendment) Act 2023? Explain with examples.

1. The 2002 Act focused on access and benefit sharing without provisions for digital sequence information, while the 2023 Amendment includes it.
2. Amendment promotes the cultivation of medicinal plants, easing approval processes for practitioners, unlike the restrictive 2002 Act.
3. 2023 Amendment exempts cultivated plants from benefit sharing; 2002 did not have such exemptions, impacting traditional practices.
4. New regulation allows for higher percentages of benefit sharing for high-value resources, reflecting market dynamics absent in the 2002 Act.
5. 2023 Amendment aligns with global biodiversity goals, enhancing India’s participation in international discussions on biodiversity.

3. What is digital sequence information? How does it impact biodiversity conservation and benefit sharing?

1. Digital sequence information (DSI) refers to genetic data stored digitally, representing biological material without physical samples.
2. Inclusion of DSI in regulations facilitates access to genetic resources while ensuring ethical benefit sharing with source communities.
3. DSI can aid in biodiversity conservation by enabling research and innovation without depleting physical resources.
4. It raises challenges in intellectual property rights, necessitating clear guidelines for sharing benefits derived from DSI.
5. Global discussions on DSI highlight the need for equitable sharing mechanisms, influencing national regulations like India’s 2025 Regulation.

4. Comment on the significance of multilateral mechanisms in addressing global biodiversity challenges and the sharing of benefits derived from biological resources.

1. Multilateral mechanisms facilitate international cooperation in biodiversity conservation, addressing challenges that transcend national borders.
2. They ensure equitable sharing of benefits among countries and communities that contribute to biodiversity, promoting fairness.
3. Such frameworks encourage sustainable practices by holding users accountable for their impact on global biodiversity.
4. They create a platform for sharing knowledge and best practices, enhancing collective efforts in biodiversity management.
5. Multilateral agreements, like those established during COP16, reinforce commitments to sustainable development goals globally.