Home India Ministry of Environment, Forest and Climate Change Regulatory reforms under Biological Diversity (Amendment) Ac...
Date: 2026-04-01 Category: Press Release State: Union Government Country: India

Regulatory reforms under Biological Diversity (Amendment) Act, 2023 lead to surge in IPR filings

Issued by Ministry of Environment, Forest and Climate Change · Not Applicable

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Executive Summary & Key Takeaways

**Executive Summary** The Biological Diversity (Amendment) Act, 2023, has led to a significant surge in Intellectual Property Rights (IPR) applications and the issuance of Certificates of Registration (CoR) by the National Biodiversity Authority (NBA). By streamlining procedures and mandating prior registration for biological resources originating in India, the Act aims to balance scientific innovation with conservation and fair benefit sharing. Data from April 2024 to March 2026 indicates a steady upward trend in filings across multiple science-based sectors. **Key Points / Main Content** **Regulatory Mandates and Procedures** * **Mandatory Registration:** Applicants covered under Section 7 of the Act must obtain a Certificate of Registration (CoR) from the NBA before seeking IPR, such as patents, for biological resources originating in India. * **Registration-Based System:** The amended framework has shifted toward a streamlined, registration-based system with clearly defined approval pathways to enhance transparency and accountability. * **Legislative Alignment:** The reforms ensure that the utilization of biological resources remains aligned with national legislation and the principles of fair and equitable benefit sharing. **Performance and Sectoral Adoption** * **Growth in Filings:** IPR applications increased from 857 (April 2024 – March 2025) to 1,077 (April 2025 – March 2026). * **Issuance Efficiency:** The NBA issued 792 CoRs in the 2024–2025 period and 885 CoRs in the 2025–2026 period, reflecting the timely disposal of applications. * **Broad Industrial Application:** The regulatory mechanism has been adopted across various sectors, including biotechnology, pharmaceuticals, chemicals, food sciences, biochemistry, agrochemicals, and biomedical engineering. **Strategic Objectives** * **Responsible Innovation:** The Act seeks to foster an ecosystem that balances scientific advancement with conservation priorities. * **Ease of Business:** The simplified approval mechanisms are designed to facilitate ease of doing research and business while maintaining a robust regulatory ambit for individuals and entities. **Impact Analysis** **National Biodiversity Authority (NBA)** **Impact** The NBA is overseeing a growing volume of applications and has moved toward a more streamlined, timely disposal process for IPR-related filings. **Action Required** The authority must continue to process and issue CoRs for applications found to be in order to maintain the upward trend in compliance and disposal. **Applicants (Researchers and Industrial Entities)** **Impact** Entities across sectors such as pharmaceuticals and biotechnology now face a clearer but mandatory pathway for securing IPR linked to biological resources. **Action Required** Applicants falling under Section 7 must obtain a CoR from the NBA prior to seeking any form of IPR, including patents, for Indian biological resources. **Biodiversity and Traditional Knowledge Stakeholders** **Impact** These groups are protected by a framework that ensures the utilization of resources is linked to conservation and the principles of fair and equitable benefit sharing. **Action Required** The document implies that the regulatory framework (via the NBA) acts on their behalf; no specific direct action for these stakeholders is mentioned other than their inclusion in the benefit-sharing ecosystem.

Key Entities Referenced

Biological Diversity (Amendment) Act, 2023: The primary legislation that reformed the regulatory framework for access to biological resources and associated traditional knowledge in India, leading to increased IPR filings. National Biodiversity Authority (NBA): The statutory body responsible for overseeing the registration-based system and issuing Certificates of Registration (CoR) for intellectual property applications involving biological resources. Section 7 of the Biological Diversity Act: The specific legal provision mandating that certain applicants obtain a Certificate of Registration from the NBA prior to seeking Intellectual Property Rights.
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Ministry of Environment, Forest and Climate Change Regulatory reforms under Biological Diversity (Amendment) Act, 2023 lead to surge in IPR filings Posted On: 01 APR 2026 8:50AM by PIB Delhi A significant increase in Intellectual Property Rights (IPR) applications linked to India’s biological resources has been recorded by the National Biodiversity Authority (NBA), reflecting the growing convergence of biodiversity, research, innovation and industrial development. This upward trend is a direct outcome of the Biological Diversity (Amendment) Act, 2023, which has strengthened and clarified the regulatory framework governing access to biological resources and associated traditional knowledge. Under the amended provisions, applicants covered under Section 7 of the Act are required to obtain a Certificate of Registration (CoR) from the NBA prior to seeking IPR, including patents, based on biological resources originating in India. This mandate has enhanced compliance, transparency and accountability within the IPR ecosystem, while ensuring that the utilisation of biological resources is aligned with national legislation and the principles of conservation and fair and equitable benefit sharing. The amended framework has also streamlined procedures and introduced clearly defined approval pathways, resulting in a decisive shift towards a registration-based system. During the period from April 2024 to March 2025, around 857 IPR applications were received and 792 CoRs were issued for applications found to be in order. In the subsequent period, from April 2025 to March 2026, the office received 1,077 IPR applications and issued 885 CoRs, demonstrating an upward trend in filings and continued efforts towards the timely disposal of IPR-related NBA applications. These applications were received across a wide spectrum of sectors, including biotechnology, pharmaceuticals, chemicals, food sciences, biochemistry, agrochemicals, polymer technology, microbiology, biomedical engineering, textiles and other science-based industries. This reflects the broad- based adoption and growing relevance of the streamlined regulatory mechanism across knowledge-driven sectors. By mandating prior registration for IPR linked to biological resources and simplifying approval mechanisms, the Biological Diversity (Amendment) Act, 2023 is fostering a responsible innovation ecosystem – one that balances scientific advancement with conservation priorities and ensures fair and equitable benefit sharing with stakeholders. It has facilitated ease of doing research and business, while ensuring that individuals and entities accessing biological resources are brought within a robust and transparent regulatory ambit. ***** VM/GS (Release ID: 2247439) Visitor Counter : 816 Read this release in: Urdu , ही , Bengali , Punjabi , Gujarati

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