August 19, 2025 10:39 am
As a party to the CBD, India enacted the Biological Diversity Act, 2002, which serves as a comprehensive legal framework to protect biological resources and regulate their use.
Objectives of the Act
- Conservation of biological diversity
- Sustainable use of biological diversity
- Fair & equitable sharing of benefits arising from the use of biological resources and associated traditional knowledge

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Definition of Biological Resources
- Biological resources include plants, animals, micro-organisms, and their genetic material.
- Excludes human genetic material.

Regulatory Authorities Under the Act
The Act provides for the establishment of three regulatory bodies:
- National Biodiversity Authority (NBA) – Advises the Central Government on implementing the Act and selecting biodiversity heritage sites.
- State Biodiversity Board (SBB) – Advises State Governments on implementing the objectives of the National Biological Diversity Act, 2002.
- Biodiversity Management Committee (BMC) – Constituted at the local level to promote conservation, sustainable use, and documentation of biological diversity.
Both the National Biodiversity Authority (NBA) and State Biodiversity Boards (SBBs) are mandated to consult BMCs before making any decisions on the use of biological resources and traditional knowledge.
Biological Diversity (Amendment) Act, 2023 – Major Amendments and Analysis
The Ministry of Environment, Forest and Climate Change (MoEF&CC) observed that the 2002 Act imposed heavy compliance burdens on AYUSH practitioners, seed industries, researchers, and the biotech sector. The 2023 Amendment aims to:
- Ease regulatory compliance
- Encourage investment in India’s biotechnology and pharmaceutical sectors
Key Amendments
- Exemption for AYUSH Medical Practitioners
- AYUSH medical practitioners are exempt from informing State Biodiversity Boards before accessing biological resources.
- Criticism: This exemption leaves large sections of biological resource users outside the Act’s regulatory framework, raising concerns about unchecked biopiracy.
- Exemption of ‘Codified Traditional Knowledge’ from Benefit Sharing Provisions
- The amendment excludes Codified Traditional Knowledge (CTK) from the definition of benefit claimers.
- CTK Definition: Traditional knowledge recorded in Ayurvedic books recognized under the Drugs and Cosmetics Act, 1940.
- Criticism: Since AYUSH companies can claim their products are based on codified knowledge, many indigenous and local traditional knowledge holders might not receive benefits, undermining fair and equitable sharing.
- Clarification of Regulatory Jurisdiction (NBA vs. SBBs)
- Indian entities are regulated under State Biodiversity Boards (SBBs).
- Foreign companies fall under the jurisdiction of the National Biodiversity Authority (NBA).
- This clarifies regulatory mandates and prevents conflicts in decision-making.
- Decriminalization of Certain Offences
- The Amendment Act decriminalizes violations under the Biological Diversity Act, 2002, replacing them with monetary penalties.
- Fines for violations have been increased, ensuring that compliance remains effective despite decriminalization.
- Criticism: While reducing criminal liability improves the ease of doing business, it might weaken deterrence against biopiracy.
Conference of the Parties (CoP) and Major Developments at CoP 16 (Cali, 2024)
Each Conference of the Parties (CoP) reviews the progress and sets new commitments for biodiversity conservation. The most recent CoP 16 in Cali (2024) introduced landmark decisions, including:
1. Operationalization of the Cali Fund
- Establishment of a multilateral mechanism to equitably share benefits from digital sequence information on genetic resources (DSI).
- A historic decision impacting developing nations that contribute significantly to global genetic resources.
2. Advancements in Synthetic Biology
- Recognized as a new dimension of modern biotechnology.
- Defined as:A field that integrates science, technology, and engineering to design and modify genetic materials and biological systems.
- CoP 16 introduced an Action Plan focusing on:
- Capacity-building
- Technology transfer
- Knowledge-sharing among developing countries
3. Addressing Invasive Alien Species (IAS)
- Strengthening cross-border trade regulations to prevent IAS spread.
- Developing global databases and surveillance mechanisms.
- Encouraging e-commerce platforms to regulate the sale and transfer of IAS.
4. Ecologically or Biologically Significant Marine Areas (EBSAs)
- Enhancement of marine conservation efforts through the EBSA framework (established in 2010).
- Strengthening international commitments to protect ocean biodiversity.
5. Global Action Plan on Biodiversity and Health
- Approved a holistic ‘One Health’ approach.
- Aims to:
- Curb zoonotic disease emergence.
- Prevent non-communicable diseases.
- Promote sustainable ecosystems to benefit biodiversity and human health.
Conclusion
The Biological Diversity Act, 2002, and its 2023 Amendments, along with international commitments under CBD, play a pivotal role in shaping India’s biodiversity governance.
However, certain provisions in the 2023 Amendment, such as exemptions for AYUSH practitioners and codified traditional knowledge, raise concerns about equitable benefit sharing. Continuous oversight and enforcement will be crucial to safeguarding the interests of traditional knowledge holders, local communities, and biodiversity conservation efforts, while simultaneously ensuring ease of doing business in India’s bio-economy.

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