IPR
Topic 85 BD Act
Topic 85 — Biological Diversity Act 2002 (with 2023 Amendment)
India is one of the world's 17 megadiverse countries, hosting approximately 8% of all recorded global biodiversity. To protect this remarkable biological wealth and prevent biopiracy — the unauthorised exploitation of biological resources and traditional knowledge — India enacted the Biological Diversity Act 2002 (BD Act) on 5 February 2003. The Act implements India's obligations under the Convention on Biological Diversity (CBD) 1992 and the Nagoya Protocol on Access and Benefit Sharing 2010. It establishes a three-tier institutional structure: National Biodiversity Authority (NBA) at Chennai; State Biodiversity Boards (SBBs); and District-level Biodiversity Management Committees (BMCs). The Act's framework — requiring NBA approval before accessing biological resources, sharing benefits with local communities, and disclosing biological resource use in patent applications — has shaped Indian IP law substantially. The Biological Diversity (Amendment) Act 2023 (Act 10 of 2023; effective 1 April 2024) significantly streamlined compliance for domestic companies, exempted AYUSH practitioners and codified traditional knowledge users from benefit-sharing requirements, and decriminalised offences. This topic walks through the entire framework — original Act, 2023 amendments, and operational implications.
1. The Concept and Background
A. India's Biodiversity Wealth
8% GLOBAL biodiversity share | 17 MEGADIVERSE countries | 4 HOTSPOTS global biodiversity |
- India hosts ~8% of recorded global biodiversity.
- 17 of world's megadiverse countries.
- 4 global biodiversity hotspots (Western Ghats, Eastern Himalayas, Indo-Burma, Sundaland).
- Centre of origin for crops like rice, mango, banana, cotton.
- Rich traditional knowledge — Ayurveda, Unani, Siddha medicine.
✅ Why protect biological resources? India's biological resources face multiple threats: · Foreign pharmaceutical companies seeking traditional knowledge. · "Biopiracy" — unauthorised exploitation of Indian biological resources abroad. · Genetic resource access for commercial purposes without compensation to source communities. · Loss of traditional knowledge through documentation gaps. · Patent claims on Indian traditional medicines and plants (Neem, Turmeric, Basmati). The BD Act 2002 addresses these through: · Sovereignty assertion over biological resources. · Access regulation requiring NBA approval. · Benefit-sharing requirement. · Patent disclosure requirements. · Three-tier institutional framework. This is critical infrastructure protecting India's biological heritage. |
2. International Foundation
Treaty | Year | Significance |
|---|---|---|
Convention on Biological Diversity (CBD) | 1992 (Rio) | National sovereignty over biological resources; foundation of BD Act. |
Cartagena Protocol on Biosafety | 2000 | Living modified organisms; safe handling. |
Nagoya Protocol on Access and Benefit Sharing | 2010 | International framework for ABS; specific guidelines. |
Bonn Guidelines | 2002 | Voluntary guidelines for ABS; basis for many national laws. |
WIPO Treaty on Genetic Resources and TK | May 2024 | New global treaty on traditional knowledge. |
A. CBD's Three Objectives
CBD 1992 establishes three foundational objectives:
- Conservation of biological diversity.
- Sustainable use of components.
- Fair and equitable sharing of benefits arising from use of genetic resources.
3. Statutory Architecture — BD Act 2002
Chapter | Sections | Subject |
|---|---|---|
I | 1-2 | Preliminary; definitions. |
II | 3-9 | National Biodiversity Authority (NBA). |
III | 10-17 | Conservation, sustainable use, biological diversity heritage. |
IV | 18-26 | NBA powers; access regulation; transfer of research. |
V | 27-35 | State Biodiversity Boards (SBBs); Biodiversity Management Committees (BMCs). |
VI | 36-40 | Conservation, sustainable use; National Biodiversity Strategy and Action Plan. |
VII | 41-46 | Funds (NBA Fund; State Biodiversity Funds; Local BMC Funds). |
VIII | 47-50 | Audit, accounts, returns, finances. |
IX | 51-66 | Penalties (note: 2023 amendment decriminalised many). |
X | 67-71 | Miscellaneous; rules; tribunals. |
4. Section 2 — Key Definitions
A. "Biological Resources" — Section 2(c)
‘Biological resources [Section 2(c) — post-2023 amendment]’ — means plants, animals and micro-organisms or parts thereof, their genetic material and derivatives (excluding value added products), with actual or potential use or value for humanity, but does not include human genetic material. |
B. "Benefit Claimers" — Section 2(aa)
‘Benefit Claimers [Section 2(aa) — post-2023 amendment]’ — means the conservers of biological resources, their by-products, creators or holders of traditional knowledge associated thereto (excluding codified traditional knowledge only for Indians) and information relating to the use of such biological resources, innovations and practices. |
C. "Biological Diversity" — Section 2(b)
‘Biological Diversity [Section 2(b)]’ — means the variability among living organisms from all sources and the ecological complexes of which they are part and includes diversity within species or between species and of ecosystems. |
D. "Traditional Knowledge" Reference
The 2023 amendment introduced "codified traditional knowledge" exemption for Indians:
- Codified TK = TK documented in ancient texts (Vedic, Ayurvedic literature).
- AYUSH practitioners exempted from benefit sharing.
- Domestic users of codified TK exempted.
- Foreign users of codified TK still require benefit sharing.
5. The Three-Tier Institutional Structure
NBA NATIONAL Chennai | SBB STATE each state | BMC DISTRICT panchayat-level |
A. National Biodiversity Authority (NBA)
NBA established at Chennai under Section 8:
- Apex authority for biological diversity matters.
- Headquarters at Chennai, Tamil Nadu.
- Multi-member structure with Chairperson + members.
- Approves access by foreign and non-resident persons.
- Approves benefit-sharing arrangements.
- Approves intellectual property applications based on Indian biological resources.
B. State Biodiversity Boards (SBBs)
SBBs established in each state under Section 22:
- Coordinate biodiversity matters at state level.
- Address access by Indian citizens and entities.
- Maintain state-level biodiversity data.
- Coordinate with BMCs at district level.
C. Biodiversity Management Committees (BMCs)
BMCs established at panchayat level under Section 41:
- Local-level biodiversity management.
- Maintain People's Biodiversity Registers (PBRs).
- Approve local-level access for research.
- Document local biological resources and traditional knowledge.
- Distribute benefit-sharing funds to local communities.
6. Access Regulation Framework
A. Section 3 — Foreign Access Restrictions (Pre-2023)
Section 3 — Pre-2023 (general framework) "No person referred to in sub-section (2) shall, without previous approval of the National Biodiversity Authority, obtain any biological resource occurring in India or knowledge associated thereto for research or for commercial utilisation or for bio-survey and bio-utilisation." |
B. Pre-2023 Categories of Restricted Persons
- Foreign citizens and entities.
- Non-resident Indians (NRIs).
- Body corporate, association, or organisation not registered in India.
- Body corporate registered in India but with non-Indian participation in capital or management.
C. 2023 Amendment Streamlining
The 2023 amendment streamlined compliance for:
- Indian companies with foreign participation — partial relief.
- AYUSH practitioners — exemption from NBA approval and benefit sharing.
- Codified TK users (for Indians) — exemption.
- Research and bio-survey activities — process simplification.
7. Patent and IPR Disclosure Requirements
A. Section 6 — Pre-Grant Approval
Section 6(1) — Pre-2023 "No person shall apply for any intellectual property right, by whatever name called, in or outside India for any invention based on any research or information on a biological resource obtained from India without obtaining the previous approval of the National Biodiversity Authority before making such application." |
B. 2023 Amendment — Streamlined IPR Approval
The 2023 amendment refined IPR approval:
- Pre-grant approval still required for IP applications based on Indian biological resources.
- Section 6 retained but procedurally streamlined.
- Section 7 requires post-grant disclosure for Indian biological resources from repositories outside India.
- Section 7(1B) — post-grant compliance for ex-situ collections.
- Coordination with PPV&FR Authority for plant varieties.
8. Benefit Sharing
A. Section 21 — Determination of Benefit Sharing
- NBA determines proportion of benefit sharing for foreign access.
- SBBs determine for Indian access.
- Funds flow to benefit claimers (local communities).
- Goes to NBA Fund / State Biodiversity Fund / BMC Fund.
B. Forms of Benefit Sharing
- Monetary benefits — royalties, license fees.
- Technology transfer.
- Joint research and development.
- Capacity building for local communities.
- Conservation activity funding.
C. 2023 Amendment Exemptions
✅ AYUSH and Codified TK exemptions The 2023 amendment exempted from benefit-sharing requirements: · AYUSH practitioners — Ayurveda, Yoga, Naturopathy, Unani, Siddha, Homeopathy. · Domestic users of codified traditional knowledge. · "Codified traditional knowledge" not explicitly defined — creates interpretation ambiguity. Reason for exemption: · Industry argued mandatory NBA approval delayed traditional medicine industry growth. · Codified TK already in public domain (ancient texts). · Indian users should not pay for using Indian heritage. Criticism: · "Codified TK" lacks clear definition — wide interpretation possible. · Could undermine local community benefit sharing. · May contradict CBD/Nagoya principles. · Concerns about indigenous knowledge holders being marginalised. |
9. Biological Diversity (Amendment) Act 2023
A. Background
The 2023 Amendment (Act 10 of 2023) was significant reform:
- Bill introduced 16 December 2021 in Lok Sabha.
- Public consultation: 1,217 comments received.
- Joint Parliamentary Committee report August 2022.
- Lok Sabha passage: 25 July 2023.
- Rajya Sabha passage: 1 August 2023.
- Effective: 1 April 2024.
B. Major Changes
Area | Pre-2023 | Post-2023 |
|---|---|---|
AYUSH practitioners | NBA approval required | EXEMPTED from NBA approval and benefit sharing. |
Codified TK users | NBA approval required | EXEMPTED for Indians. |
Indian companies with foreign participation | Treated as foreign | Streamlined treatment. |
Research/bio-survey activities | Strict approval | Some exemptions. |
Penalties | Criminal sanctions (imprisonment) | DECRIMINALISED — civil penalties up to ₹1 crore. |
Adjudicating Officer | Not specified | Government official appointed. |
Repeat offenders | Variable | Up to ₹1 crore penalty. |
Ease of business | Restrictive | Streamlined. |
C. Decriminalisation
1L MIN PENALTY civil penalty | 50L MAX PENALTY standard | 1Cr REPEAT offenders |
D. Critical Reception
- Industry welcomed streamlined compliance.
- Indigenous community advocates expressed concerns.
- AYUSH industry significantly benefited.
- Conservation advocates worried about benefit-sharing dilution.
- "Codified TK" definitional ambiguity criticised.
10. Coordination with Other IP Laws
A. Coordination with PPV&FR Act
BD Act and PPV&FR Act coordinate:
- PPV&FR application requires biological resource disclosure.
- NBA prior approval for IP applications including PPV&FR.
- Benefit sharing coordinated through Gene Fund + Biodiversity Funds.
B. Coordination with Patents Act
BD Act applies to all IP applications:
- Pre-grant NBA approval for patents based on Indian biological resources.
- Patent Office requires NBA approval certificate.
- Geographic and biological information disclosure under Patents Act Section 10(4).
11. Practical Considerations
✅ For researchers and IP applicants — twelve points Identify biological resources from India in research/products. For foreign access, file Section 3 application with NBA. For Indian citizens (post-2023), assess if codified TK exemption applies. For AYUSH practitioners (post-2023), confirm exemption applies. For IP applications, obtain pre-grant NBA approval (Section 6). Document biological resource origin and traditional knowledge use. Plan for benefit-sharing arrangements (where applicable). Coordinate with PPV&FR Authority for plant varieties. Maintain compliance records for audit and inspection. For ex-situ collections (post-2023), Section 7(1B) compliance. For violations (post-2023), civil penalties up to ₹1 crore (₹50 lakh standard). Monitor evolving NBA guidance on codified TK definition. |
🎯 EXAM POINTERS — TOPIC 85
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