Biodiversity Authority Sets Out Fresh Regulations and Consequences for Wildlife Conservation
India's New Biological Diversity Regulations Expand Access and Benefit Sharing Obligations
India has taken a significant step in the conservation and sustainable use of its biodiversity with the 2023 Amendment to the Biological Diversity Act and the 2025 Biological Diversity (Access and Benefit Sharing) Regulations. These new regulations broaden the scope of the Act to include Digital Sequence Information (DSI) under the definition of genetic resources, thereby imposing Access and Benefit Sharing (ABS) obligations on industries that utilize DSI[1].
The new regulations have far-reaching implications for industries such as pharmaceuticals, cosmetics, and biotechnology. These companies must now comply with a series of new requirements, including mandatory reporting and benefit-sharing provisions[1]. Entities with an annual turnover exceeding ₹1 crore must submit annual statements detailing their use of biological resources, including DSI. The ABS payments are scaled based on turnover, with rates ranging from 0.2% to 0.6%[1].
The expanded scope of biodiversity regulation means that even genetic information accessed digitally, such as genome sequence data used in drug development or cosmetic formulations, is subject to benefit-sharing rules[1]. This has implications for R&D models that rely on digital databases worldwide, requiring companies to track and report such usage for India-origin resources[1].
The regulations also shift the focus towards user-side monitoring, enhancing enforcement of ABS compliance in industrial sectors[3]. State Biodiversity Boards (SBBs) and Biodiversity Management Committees (BMCs) are established at the state and local levels, respectively, to implement the Act and Rules, and to document local biodiversity and advise on biodiversity-related matters[2].
The National Biodiversity Authority (NBA) is a statutory body under the Ministry of Environment, Forests, and Climate Change, Government of India, responsible for overseeing the implementation of the Act and Regulations[2]. The new regulations require online application via the NBA portal, with digital form submissions and fee payment[4].
The Biological Diversity (Amendment) Act, 2023, aims for technology-inclusive, industry-responsive, and community-conscious governance[5]. The Act was India's response to the Convention on Biological Diversity (CBD) of 1992 and later, the Nagoya Protocol on Access and Benefit Sharing (ABS) of 2010[6]. The new regulations, including the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulations, 2025, modernize India's biodiversity system[7].
The regulations outline benefit-sharing obligations for high-value or threatened species like red sanders, agarwood, and sandalwood[8]. The Divya Pharmacy case (2018) and the Monsanto-Mahyco case (BT Brinjal Controversy) have established that native entities are subject to ABS obligations, regardless of nationality, and that genetically modified organisms and DSI derived from them are within the ABS regulatory perimeter[4][9].
Companies must identify their user category (Indian vs foreign, academic vs commercial) and follow the ABS slabs outlined in the 2025 Regulations[4]. The regulations serve as a practical guide to define compliance procedures, set out benefit-sharing formulas, and introduce sector-specific clarifications[10]. The new rules operationalize the 2023 Amendment Act by introducing updated procedures, fees, and digitized systems[11].
Overall, these regulatory changes have increased the regulatory burden on pharmaceutical, cosmetic, and biotech industries in India, particularly in tracking and sharing benefits arising from the use of genetic resources and DSI. Companies must now implement thorough compliance mechanisms to adhere to reporting and payment requirements under the new ABS framework. No detailed sectoral impact assessments are yet available, but the tighter ABS compliance is likely to affect cost structures and operational practices related to bioprospecting, R&D, and product commercialization in these industries[1][3].
References: 1. The Wire 2. Ministry of Environment, Forests and Climate Change 3. Indian Journal of Medical Ethics 4. The Hindu 5. The Economic Times 6. Ministry of Environment, Forests and Climate Change 7. The Hindu 8. The Times of India 9. The Wire 10. Financial Express 11. Indian Journal of Medical Ethics
- The firm's approach to environmental-science must now include compliance with India's new biological diversity regulations, as it relates to Digital Sequence Information (DSI) under the definition of genetic resources.
- The protection of India's climate-change efforts is strengthened by the expanded scope of access and benefit sharing obligations, as they apply to industries such as pharmaceuticals, cosmetics, and biotechnology.
- Innovation in science and technology sectors may be impacted by the requirement for support of user-side monitoring to enforce access and benefit sharing compliance in industries.
- The rights of indigenous communities are recognized in the new regulations, as they are entitled to fair and equitable sharing of benefits arising from the use of biological resources and associated knowledge.
- Support for environmental-science and self-development is crucial in this era of increased impact of climate-change, as it relates to the investment in businesses that prioritize sustainable practices and ethical sourcing.
- Living a lifestyle that prioritizes sustainability and ethical consumption means supporting businesses that comply with access and benefit sharing regulations, like India's new biodiversity regulations.
- The finance industry has a role to play in the trend of investing in businesses that adhere to the new environmental regulations, as it may affect the business's cost structures and operational practices related to bioprospecting, R&D, and product commercialization.
- Data-and-cloud-computing companies must address the challenge of tracking and reporting usage of genetic resources and DSI for India-origin resources, due to the new regulations' focus on R&D models that rely on digital databases.
- Stay updated on general-news to understand the impact of these regulatory changes on various industries and the implications for various sectors, including casino-and-gambling and sports.
- Education-and-self-development in the field of environmental-science is essential for understanding the new regulations and their implications for industries and the environment.
- Advocacy and support for businesses that prioritize environmental sustainability and adhere to regulations like India's new biodiversity regulations can have a positive impact on the overall protection of the environment and climate-change efforts.
