The Biological Diversity Act, 2002: Complete Note on Conservation, Access, Benefit Sharing, Institutions, Biopiracy and the 2023 Amendment

India is one of the world's megadiverse countries, and its biological resources and the traditional knowledge associated with them are valuable to industry, especially in pharmaceuticals, cosmetics, agriculture and traditional medicine. The Biological Diversity Act, 2002 gives effect to the Convention on Biological Diversity in India. It regulates access to biological resources and associated knowledge, ensures fair and equitable sharing of benefits with the communities that conserve them, and creates a three-tier institutional structure from the National Biodiversity Authority to village Biodiversity Management Committees. The Biological Diversity (Amendment) Act, 2023, in force from 1 April 2024, eased compliance for Indian users and traditional medicine, and decriminalised offences. This note covers the Act as it now stands.

1. Objectives and International Background

1.1 Objectives of the Act

The Act's objectives mirror the three objectives of the CBD: conservation of biological diversity, sustainable use of its components, and fair and equitable sharing of the benefits arising out of the use of biological resources and knowledge. The preamble also refers to India's sovereign rights over its biological resources.

1.2 Conservation of biological diversity

Conservation under the Act is achieved through the duties of the Central Government to develop national strategies and plans and to integrate conservation into sectoral policies (Section 36), the declaration of biodiversity heritage sites (Section 37), notification of threatened species (Section 38), designation of repositories (Section 39), and the powers of State Biodiversity Boards to restrict activities that threaten biodiversity (Section 24).

1.3 Sustainable use of biological resources

Sustainable use means the use of components of biological diversity in such manner and at such rate that does not lead to the long-term decline of the biological diversity, thereby maintaining its potential to meet the needs and aspirations of present and future generations. The Act promotes it by regulating commercial utilisation, by the State Boards' power to restrict harmful activities, and by the management role of local Biodiversity Management Committees.

1.4 Fair and equitable benefit sharing

Fair and equitable benefit sharing means sharing of benefits as determined by the National Biodiversity Authority under Section 21. Its purpose is to ensure that those who conserve biodiversity and hold traditional knowledge, often poor rural and tribal communities, share in the value that others derive from it.

1.5 Convention on Biological Diversity and Indian law

India ratified the CBD in 1994. Article 15 of the CBD recognises the sovereign rights of States over their natural resources and the authority of national governments to determine access to genetic resources, subject to prior informed consent and mutually agreed terms, with fair and equitable sharing of benefits. Article 8(j) requires respect for the knowledge, innovations and practices of indigenous and local communities. The Act was enacted under Article 253 of the Constitution to implement these obligations.

1.6 Nagoya Protocol and Indian biodiversity law

The Nagoya Protocol on Access and Benefit Sharing (2010, in force 2014), which India ratified, requires provider countries to establish clear access rules and user countries to ensure compliance, including through internationally recognised certificates of compliance. India implements it through the approvals of the National Biodiversity Authority, which are notified as certificates of compliance, the Guidelines on Access to Biological Resources and Associated Knowledge and Benefit Sharing Regulations, 2014, and their successor, the Biological Diversity (Access and Benefit Sharing) Regulations, 2025.

2. Key Definitions

2.1 Biological resources

Biological resources (Section 2(c), as amended in 2023) means plants, animals, micro-organisms or parts thereof, their genetic material and derivatives (excluding value-added products), with actual or potential use or value, but does not include human genetic material. The 2023 amendment replaced 'by-products' with 'derivatives', meaning naturally occurring biochemical compounds or metabolites of biological resources, even if they do not contain functional units of heredity. Value-added products are products which may contain portions or extracts of plants and animals in unrecognisable and physically inseparable form, and are outside the regulatory net.

2.2 Traditional knowledge

The Act protects knowledge associated with biological resources, including traditional knowledge held by local people and communities. The 2023 amendment introduced the concept of codified traditional knowledge, meaning knowledge recorded in authoritative texts of traditional systems such as Ayurveda, Siddha, Unani and Sowa-Rigpa, and exempted its use from certain obligations, while uncodified traditional knowledge held by communities remains protected. Documentation in People's Biodiversity Registers and the Traditional Knowledge Digital Library supports its protection.

2.3 Benefit claimers

Benefit claimers (Section 2(a)) means the conservers of biological resources and their derivatives, and the creators and holders of knowledge and information relating to the use of such resources, innovations and practices associated with such use and application. They are the persons in whose favour benefits are to be shared.

3. Regulation of Access

3.1 Access to biological resources: the three-tier approach

The Act treats users differently according to who they are:

1. Foreign persons and entities (Section 3): a person who is not a citizen of India, a non-resident citizen, or a body corporate that is a foreign-controlled company (as defined in the Companies Act, 2013), must obtain the prior approval of the National Biodiversity Authority before obtaining any biological resource occurring in India or associated knowledge for research, commercial utilisation, or bio-survey and bio-utilisation.
2. Transfer of research results (Section 4): no person shall transfer the results of research relating to biological resources obtained from India to a foreign person or entity without the NBA's prior approval.
3. Indian persons and entities (Section 7): Indian citizens and Indian-controlled companies need only give prior intimation to the State Biodiversity Board before obtaining biological resources for commercial utilisation. The 2023 amendment exempts local people and communities, growers and cultivators, registered AYUSH practitioners, and persons using codified traditional knowledge or cultivated medicinal plants, from this requirement, subject to conditions.

Collaborative research projects involving foreign institutions that are approved by the Central Government under its guidelines are exempt from Sections 3 and 4 (Section 5).

3.2 Prior approval of the National Biodiversity Authority

The NBA considers applications for access, transfer of research results, IPR and third-party transfer. It may approve them subject to terms and conditions, including benefit sharing, or reject them, after consulting the concerned local bodies and benefit claimers where appropriate (Section 19). Approvals are published and serve as the internationally recognised certificate of compliance under the Nagoya Protocol.

3.3 Intellectual property rights and biodiversity: Section 6

Section 6 prevents the appropriation of Indian biological resources and knowledge through patents and other IPRs without benefit sharing. As amended in 2023: a foreign person or entity must obtain the NBA's approval before the grant of an IPR (not before filing, as earlier) based on research on biological resources or knowledge obtained from India; and an Indian person or entity must register with the NBA before the grant of the IPR. The NBA may impose benefit-sharing fees or royalties. The Patents Act, 1970 reinforces this: an applicant must disclose the source and geographical origin of biological material used in the invention (Section 10(4)(ii)(D)), and non-disclosure or wrongful disclosure, or anticipation by traditional knowledge, is a ground of opposition and revocation (Sections 25 and 64).

4. Access and Benefit Sharing

4.1 Benefit-sharing mechanisms: Section 21

When granting approval, the NBA determines benefit sharing on mutually agreed terms between the applicant, the local bodies concerned and the benefit claimers. Benefits may take any of the following forms:

• grant of joint ownership of intellectual property rights to the NBA or to identified benefit claimers;
• transfer of technology;
• location of production, research and development units in areas that facilitate better living standards of benefit claimers;
• association of Indian scientists, benefit claimers and local people with research and development;
• setting up of venture capital funds for aiding benefit claimers; and
• payment of monetary compensation and non-monetary benefits to benefit claimers as the NBA deems fit.

Where the benefit claimers are identifiable, monetary benefits may be paid directly to them; otherwise they are deposited in the National Biodiversity Fund (Section 27) or the State Biodiversity Fund, and used for conservation and for the benefit of the communities from whose areas the resources were accessed.

4.2 The 2025 ABS Regulations

The Biological Diversity (Access and Benefit Sharing) Regulations, 2025, which replace the 2014 guidelines, fix benefit sharing for commercial utilisation on a turnover-based scale: users with annual turnover up to Rs 5 crore are exempt, while those above pay a percentage, of the order of 0.2 to 0.6 per cent of the annual gross ex-factory sale price of products, depending on turnover. High-value resources such as red sanders and sandalwood attract a minimum of five per cent of the transaction amount. The Regulations also bring digital sequence information derived from biological resources within their scope, and exempt cultivated medicinal plants.

5. The Institutional Structure

5.1 National Biodiversity Authority

The National Biodiversity Authority (NBA) (Section 8), established in 2003 with its headquarters at Chennai, is a statutory body with a Chairperson, ex officio members from the concerned ministries, and non-official experts. Its functions (Section 18) are to regulate activities under Sections 3, 4 and 6 by approvals, advise the Central Government on conservation and sustainable use, advise State Governments on biodiversity heritage sites, and take measures to oppose the grant of IPRs abroad on biological resources or knowledge obtained from India in contravention of the Act.

5.2 State Biodiversity Boards

Each State has a State Biodiversity Board (SBB) (Section 22), which advises the State Government, regulates commercial utilisation by Indian persons through prior intimation, and performs other functions. Under Section 24, the SBB may restrict or prohibit a proposed activity if it is detrimental or contrary to the objectives of conservation, sustainable use or benefit sharing. In Union territories, the NBA performs the functions of a State Board.

5.3 Biodiversity Management Committees

Every local body (panchayat or municipality) must constitute a Biodiversity Management Committee (BMC) within its area (Section 41), to promote conservation, sustainable use and documentation of biological diversity, including preservation of habitats, conservation of land races, folk varieties and cultivars, domesticated stocks and breeds of animals and micro-organisms, and chronicling of knowledge. The NBA and SBBs must consult the BMCs when taking decisions on the use of biological resources in their areas. BMCs may levy collection fees on persons accessing biological resources for commercial purposes from their area.

5.4 People's Biodiversity Registers

The principal function of a BMC is to prepare a People's Biodiversity Register (PBR) in consultation with local people, documenting the availability and knowledge of local biological resources, their medicinal or other uses, and the associated traditional knowledge. PBRs serve as evidence of prior art against wrongful patents, as the basis for identifying benefit claimers, and as a tool for local conservation planning. The NGT, in Chandra Bhal Singh v. Union of India (2016 onwards), monitored and directed the constitution of BMCs and preparation of PBRs across the country.

6. Conservation Tools

6.1 Biodiversity heritage sites

The State Government may, in consultation with local bodies, notify areas of biodiversity importance as biodiversity heritage sites (Section 37). They are well-defined areas that are unique, ecologically fragile ecosystems with rich biodiversity, such as sacred groves and areas with rare species or wild relatives of domesticated species. The designation is meant to strengthen conservation by local communities without imposing restrictions on their prevailing practices. Nallur Tamarind Grove in Karnataka (2007) was the first biodiversity heritage site; others include the Glory of Allapalli in Maharashtra and the Arittapatti hills in Tamil Nadu.

6.2 Threatened species

The State Government, in consultation with the Central Government, may notify species that are on the verge of extinction or likely to become extinct in the near future as threatened species, and prohibit or regulate their collection and take steps to rehabilitate and preserve them (Section 38).

6.3 Exempted biological resources

Under Section 40, the Central Government may, in consultation with the NBA, declare that the Act shall not apply to any items, including biological resources normally traded as commodities. The Ministry has notified lists of such items, so that ordinary trade in agricultural and other commodities is not burdened. The exemption does not apply where the resources are used for research or for obtaining IPRs.

6.4 Cultivated medicinal plants and traditional Indian medicine

The Indian traditional medicine industry, which relies on medicinal plants, argued that the original Act burdened it with approvals and benefit-sharing demands even for cultivated plants and knowledge recorded in classical texts. The 2023 amendment responded by exempting cultivated medicinal plants from the Act's requirements (subject to conditions and certification of cultivated origin), exempting users of codified traditional knowledge and registered AYUSH practitioners from prior intimation, and promoting cultivation of medicinal plants to reduce pressure on wild resources. Critics note that it can be difficult to distinguish cultivated from wild-collected material, and that exemptions may reduce benefits to communities whose knowledge underlies the codified texts.

7. Biopiracy

Biopiracy is the appropriation of biological resources or traditional knowledge, usually through patents or commercial exploitation, without the consent of the provider country or communities and without sharing benefits. The Act was partly a response to high-profile cases: patents in the United States on the wound-healing properties of turmeric (revoked in 1997) and the basmati rice patent (largely narrowed), and a European patent on a neem-based fungicide (revoked in 2000). India built the Traditional Knowledge Digital Library to supply patent offices with prior art in their own languages.

The Act has been invoked domestically as well. In the Bt brinjal matter (2011 to 2012), the National Biodiversity Authority decided to proceed against a seed company and its collaborators for using local brinjal varieties in developing genetically modified brinjal without the approvals required by the Act, the first major biopiracy action under it. By contrast, the Kani tribe of Kerala, whose knowledge of the plant arogyapacha led to the herbal drug Jeevani, received a share of licence fees and royalties through a trust in the 1990s, an early model of benefit sharing.

8. Offences and Penalties: The 2023 Changes

As originally enacted, contravention of Sections 3, 4 or 6 was punishable with imprisonment up to five years, or fine up to ten lakh rupees (or higher where damage exceeded that amount), or both. The 2023 amendment decriminalised the Act: contraventions now attract monetary penalties of not less than one lakh rupees, extendable to fifty lakh rupees, and where the contravention continues, an additional penalty that may extend to one crore rupees, imposed by an adjudicating officer of the rank of Joint Secretary to the Government of India or Secretary to the State Government, with an appeal to the National Green Tribunal.

9. The Act Before and After the 2023 Amendment

10. Biodiversity Conservation versus Commercial Use

The Act embodies a bargain: biodiversity may be used commercially, but only if the users obtain approval and share benefits with those who conserved it. The 2023 amendment shifted the balance towards ease of doing business, arguing that the earlier regime deterred research and investment and was widely ignored. Critics argue that the changes weaken the rights of communities: exemptions for codified knowledge and cultivated plants reduce the scope of benefit sharing, the removal of imprisonment reduces deterrence, and the consultation of BMCs remains weak in practice. The proper balance is the one the CBD envisaged: commercial use that funds conservation and rewards conservers, rather than use that depletes resources or appropriates knowledge without return.

11. Related Topics and Provisions