India is one of the world’s 17 mega-diverse countries, hosting nearly 8% of all recorded species on the planet despite covering only 2.5% of its land area. Yet this extraordinary biological wealth has historically been vulnerable to exploitation – foreign entities accessing genetic resources, filing patents on traditional knowledge, and sharing little to nothing with the communities that preserved these resources for generations. The Biological Diversity Act, 2002 (BDA) was enacted precisely to correct this imbalance. It creates a legal framework for conserving India’s biological resources, ensuring their sustainable use, and guaranteeing that the benefits flowing from them are shared fairly with local communities and the nation at large. More recently, the Biological Diversity (Amendment) Act, 2023 has updated several provisions to better balance conservation with ease of doing business. This post walks through the key provisions that every law student needs to understand.

Table of Contents

Background and objectives of the Act

The BDA was passed by Parliament in 2002 and came into force on 1st October 2003. It was India’s domestic response to the Convention on Biological Diversity (CBD), signed at Rio de Janeiro in 1992, which recognized the sovereign rights of nations over their biological resources. The Act has three core objectives: conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of benefits arising from the use of biological resources and traditional knowledge. These three pillars run through every provision of the Act and provide the framework against which any access, transfer, or commercialization of biological resources must be assessed.

Key definitions under the Act

Understanding the BDA requires clarity on its foundational definitions, which are set out in Section 2 of the Act.

Biological diversity

Section 2(b) defines biodiversity as the variability among living organisms from all sources and the ecological complexes they are part of, including diversity within species, between species, and of ecosystems. This broad definition ensures the Act’s coverage is not limited to commercially valuable species alone.

Biological resources

Biological resources are defined as plants, animals, and microorganisms – or parts thereof – their genetic material, and by-products with actual or potential use or value. Critically, the definition excludes human genetic material. It also excludes value-added products, defined under Section 2(p) as products containing portions or extracts of plants and animals in unrecognizable and physically inseparable form – a distinction that has generated significant litigation over what qualifies as a biological resource versus a processed product.

Access

Following the 2023 amendment, access is defined as collecting, procuring, or possessing any biological resource occurring in or obtained from India, or traditional knowledge associated with it, for the purposes of research or commercial utilization. This definition anchors the regulatory structure for who needs approval and from which authority.

The three-tier regulatory structure

The BDA establishes a three-tier institutional framework to regulate access to biological resources across different levels of governance. Each tier has a distinct role in granting approvals, regulating commercial use, and involving local communities.

National Biodiversity Authority (NBA)

The National Biodiversity Authority is the apex regulatory body established under Section 8 of the Act. It was constituted in 2003 by the Central Government and is headquartered in Chennai. The NBA is a statutory, autonomous body that performs facilitative, regulatory, and advisory functions. Its composition includes a Chairperson, three ex officio members representing the Ministries of Tribal Affairs and Environment, seven ex officio members from other Central Government ministries, and five non-official members who are specialists in biodiversity-related fields.

The NBA’s core functions include advising the Central Government on biodiversity conservation, issuing guidelines for access and benefit sharing, granting approvals for access to biological resources by foreign entities, and taking measures to oppose intellectual property rights granted outside India on biological resources or associated knowledge illegally obtained from India.

State Biodiversity Boards (SBBs)

State Biodiversity Boards are established by State Governments under Section 22 of the Act. Every state (excluding Union Territories, where the NBA acts directly) must constitute an SBB. Their primary function is to regulate commercial utilization of biological resources by Indian citizens at the state level, and to advise the State Government on conservation and equitable benefit sharing. Under the 2023 amendment, SBBs have been further empowered to collect Access and Benefit Sharing (ABS) fees from Indian entities accessing resources commercially.

Biodiversity Management Committees (BMCs)

At the grassroots level, Biodiversity Management Committees are constituted by every local body under Section 41 of the Act. Their role is to promote conservation, sustainable use, and documentation of biological diversity in their area. One of their most significant responsibilities is preparing the People’s Biodiversity Register (PBR) – a community-level documentation of locally available biological resources, their medicinal or cultural use, and associated traditional knowledge. BMCs must be consulted by the NBA and SBBs when making decisions relating to the use of biological resources or associated knowledge within their jurisdiction.

Provisions on access to biological resources

The Act draws a clear line between foreign access and domestic access, creating different compliance obligations for each.

Access by foreign entities – Section 3

Under Section 3, no foreign national, non-resident Indian, or foreign-controlled body corporate can obtain any biological resource occurring in India, or knowledge associated thereto, for research or commercial utilization without the prior approval of the NBA. This is the most stringent tier of access control and reflects India’s concern about biopiracy. The NBA reviews such applications and may impose conditions, including benefit-sharing requirements, before granting approval. Following the 2023 amendment, Indian-controlled companies – even those with some foreign investment – are no longer treated as “foreign” entities under Section 3(2)(c)(ii), significantly easing compliance for domestic businesses.

Access by Indian entities – Section 7

Indian citizens and organizations registered in India seeking biological resources for commercial utilization or bio-survey are not required to obtain NBA approval at the access stage. Instead, they must give prior intimation to the concerned State Biodiversity Board. However, exemptions apply: local communities, farmers, cultivators, vaids, hakims, and registered AYUSH practitioners using resources for their profession are exempted from even this intimation requirement. Where cultivated medicinal plants are involved, a Certificate of Origin from the Biodiversity Management Committee is required to claim this exemption.

Transfer of research results – Section 4

Section 4 restricts the transfer of research results derived from Indian biological resources to foreign entities. Such transfer – whether for money or otherwise – requires the prior written approval of the NBA. An important exception exists: publication of research in journals or dissemination at seminars does not require NBA approval, provided it follows Central Government guidelines. However, if research results are used for commercial utilization or for obtaining IPR, NBA approval becomes mandatory even for Indian entities.

Intellectual property rights and biodiversity

One of the most patent-law-relevant provisions of the BDA is Section 6, which governs the grant of intellectual property rights (IPR) involving Indian biological resources. The original Act required all applicants – Indian or foreign – to obtain prior NBA approval before filing for any patent or other IPR based on research involving Indian biological resources. The 2023 amendment made a significant distinction here.

Under the amended Section 6, Indian entities covered under Section 7 now only need to register with the NBA before the grant of IPR – not obtain prior approval. This substantially shortens the timeline for Indian patent applicants. However, prior NBA approval is mandatory before the commercialization of any IPR so obtained. Foreign entities and foreign-controlled companies, on the other hand, continue to require NBA’s prior approval before even filing for IPR. The provision ensures that traditional knowledge embedded in Indian biological resources is not appropriated without accountability, regardless of who the applicant is.

Benefit sharing mechanisms

Equitable benefit sharing is the heart of the BDA. When the NBA or SBBs grant approval for access or commercial utilization of biological resources, they impose benefit-sharing conditions as part of the approval. Benefits can be shared through joint ownership of IPR, payment of royalties, technology transfer, joint research and development, or direct payment to local communities. The quantum of royalties for pharmaceutical companies using bioresources is typically set at 3% to 5% of extracted bioresources or 0.01% to 0.05% of annual gross ex-factory sales.

Monetary benefits collected are deposited into the National Biodiversity Fund at the central level or equivalent State Biodiversity Funds, which are then directed towards conservation efforts and local community development. Under the 2023 amendment, the NBA now negotiates on behalf of local communities for the terms of benefit sharing, replacing the earlier model of direct community involvement in negotiations – a change that has drawn criticism from conservation advocates who argue it reduces community agency.

Biodiversity heritage sites and threatened species

The Act empowers State Governments, in consultation with local self-government bodies, to notify areas of significant biodiversity importance as Biodiversity Heritage Sites. These are areas with unique, well-known, or culturally significant biodiversity. Separately, the Central Government in consultation with the NBA can notify threatened species and prohibit or regulate their collection, rehabilitation, and conservation. It can also designate institutions as repositories for specific categories of biological resources – functioning as custodians of genetic material and associated data.

Penalties and enforcement

Originally, violations of the BDA’s core provisions – unauthorized access, transfer without approval, or obtaining IPR without compliance – were punishable with imprisonment up to five years and fines up to โ‚น10 lakh. The 2023 amendment completely decriminalized these offences, removing the possibility of imprisonment. In its place, violations now attract monetary fines ranging from โ‚น1 lakh to โ‚น50 lakh. For continuing or aggravated violations, an adjudicating officer (not below the rank of Joint Secretary to the Government of India) can impose an additional penalty of up to โ‚น1 crore. The rationale offered by the government was to reduce compliance anxiety and encourage voluntary disclosure – though critics argue that removing criminal liability weakens deterrence against biopiracy.

Offences under the Act are cognizable and non-bailable, and any person aggrieved by an order of the NBA or SBB can file an appeal to the High Court within 30 days of receiving the order.

The 2023 amendment in context

The Biological Diversity (Amendment) Act, 2023 came into force on 1st April 2024. Its stated goals were to reduce regulatory burdens on Indian businesses, promote the AYUSH sector, encourage cultivation of medicinal plants over wild harvesting, and fast-track patent processes. However, it has also attracted sustained criticism – particularly for reducing the direct role of local communities in benefit-sharing negotiations and for the risk that decriminalization may weaken enforcement. The landmark Divya Pharmacy v. Uttarakhand Biodiversity Board (2018) case, where the Uttarakhand High Court held that even Indian companies must comply with ABS obligations, remains a critical precedent in understanding how seriously courts view the Act’s equitable-sharing mandate – irrespective of the nationality of the user.

What do you think? Given that the 2023 amendment removes criminal liability for biodiversity violations and reduces community involvement in benefit-sharing negotiations, does it adequately protect India’s biological heritage – or does it tilt the balance too far in favour of commercial interests? And with India committing to international frameworks like the Nagoya Protocol and the Global Biodiversity Framework, how should domestic law evolve to hold both conservation and innovation as equally non-negotiable goals?

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References
  1. https://www.nextias.com/blog/biological-diversity-act-2002/
  2. https://indiankanoon.org/doc/548841/
  3. https://egazette.gov.in/WriteReadData/2023/247815.pdf
  4. https://www.indiacode.nic.in/bitstream/123456789/21545/1/the_biological_diversity_act,_2002.pdf
  5. https://en.wikipedia.org/wiki/Biological_Diversity_Act,_2002
  6. https://lawforeverything.com/biological-diversity-act-2002/
  7. https://www.drishtiias.com/to-the-points/paper3/biological-diversity-act-2002
  8. http://nbaindia.org/uploaded/docs/biological-diversityact-ii.pdf
  9. https://byjus.com/free-ias-prep/biological-diversity-act-2002/
  10. https://www.lexology.com/library/detail.aspx?g=fabfb5fd-598b-455f-9f9b-2f7dd4dbb498
  11. https://lexplosion.in/the-biological-diversity-amendment-act-2023-to-be-effective-from-1st-april-2024/
  12. https://www.lexology.com/library/detail.aspx?g=b8ad8b9d-aa0a-4cf9-9341-9bc155724adc
  13. https://ceerapub.nls.ac.in/note-on-biological-diversity-amendment-act-2023/
  14. https://india.mongabay.com/2023/07/biological-diversity-bill-which-facilitates-commercial-use-of-traditional-resources-passed-in-lok-sabha/
  15. https://depenning.com/blog/the-national-biodiversity-authority-new-rules-and-their-implications/

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Patents

1 Fundamentals of Patenting

  1. Historical Background of Patents
  2. Types of Patents
  3. World Patent
  4. Procedure for Filing a Patent in India
  5. Filing Patent Application in Other Countries

2 Terms and Definitions

  1. Inventions
  2. Inventive Steps
  3. Capable of Industrial Application
  4. New Invention
  5. Pharmaceutical Substance

3 Rights in Patents

  1. Scope of Patent Protection
  2. Limitation on Patent Rights
  3. Acts Not Considered as Infringement
  4. Compulsory License
  5. Revocation of Patent

4 Administration of Patents

  1. Patent Office
  2. Powers of the Controller General
  3. Register of Patent
  4. Patent Agents
  5. Training of Patent Agents and Examiners
  6. Modernization of Patent Offices
  7. Introducing Patent Education in Science Colleges

5 Procedure for Obtaining A Patent in India

  1. Stages Involved in Grant of a Patent
  2. Type of Patent Applications
  3. Format for Making Application
  4. Appropriate Office
  5. Prescribed Fee
  6. Person Entitled to File
  7. Procedure of Filing Application
  8. Patent of Addition

6 International Patent Search, Documentation and Analytics

  1. Structure of Patent Document
  2. Bibliographic Information Contained in Patent Documents INID Codes
  3. Kind Codes for Patent Documents
  4. International Patent Classification
  5. Types of Searches
  6. Sources of Patent Information
  7. How to Conduct Patent Search
  8. Understanding an International Search Report

7 Patent Specification and Claims

  1. Provisional and Complete Specification
  2. Categories of Invention
  3. Process of Drafting a Patent Specification
  4. Description Requirements of a Patent Specification in Different Jurisdictions
  5. Examples illustrating Various Components of a Patent Specification
  6. Essential Features of Description of an Invention
  7. Filing of a Patent Application at Patent Office

8 Commercialisation of Patents

  1. Objectives of Commercialisation of Patents Organisations
  2. Patent Commercialisation vs Product Marketing
  3. PatentlTechnology Valuations and Pricing
  4. Identifying Potential Licensees
  5. Formulating a Patent Licensing Strategy
  6. Licensing of Patented Know How to Clients in Developed Countries

9 Infringement of Patent

  1. Infringement: Its Meaning
  2. Exceptions to Infringement
  3. Types of Infringement
  4. Determination of Infringement
  5. Jurisdiction of Suit for Infringement
  6. Time for Filing the Suit

10 Filing Opposition- Pre/Post Grant Issues

  1. Pre-Grant Opposition
  2. Post-Grant Opposition
  3. Grounds of Opposition
  4. Procedure for Pre-Grant Opposition
  5. Procedure for Post-Grant Opposition

11 Grounds of Defence

  1. Defences
  2. Revocation Grounds
  3. Gillette Defence
  4. Relief or Remedy
  5. Declaration as to Non-Infringement

12 Intellectual Property Appellate Board (IPAB)

  1. Introduction
  2. Amendments in the Patents Act
  3. Objective of IPAB
  4. Location of IPAB and its Benches
  5. Salient features of the IPAB
  6. Qualifications of the Chairman and Vice-Chairman
  7. Qualifications of the Technical Member Patents
  8. Transfer of Cases
  9. Operationalisation of IPAB for Patents

13 Patent Co-operation Treaty and International Patent Filing Strategies

  1. Introduction
  2. Need for Protecting Inventions Abroad
  3. Using PCT Route for Filing Patent Applications
  4. General Procedure of PCT Filing
  5. Strategies followed by Applicants for PCT Filings
  6. Benefits of Using PCT System

14 Technology Transfer

  1. Introduction
  2. Technology Transfer Activities
  3. Dynamic Relationship between IPR Activity, Technology Transfer, and Commercialisation
  4. Partnerships in Technology Transfer and Development
  5. Methods of Technology Transfer
  6. Major Technology Transfer Organisations in India and Abroad
  7. Government Control on Technology Transfer
  8. Reasons for Failure of a Technology
  9. Future Scenario of Technology Transfer
  10. Practical Examples of Technology Transfer

15 Patents and Indian Biodiversity Act

  1. Convention on Biological Diversity 1992 (CBD)
  2. CBD and Biodiversity Act of India 2002
  3. Provisions in BDA
  4. Sourcing Biological Material and Associated Knowledge from India
  5. Patents Act and Protection of Bio-Resources
  6. Application Format for Access to Biological Resources and Associated Traditional Knowledge
  7. Benefit Sharing and Other Provisions