FAQ's

As per Section 2(c) of the BD Act, the biological resources include plants, animals, micro-organisms or parts of 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.

ABS mechanism has been evolved under the CBD and Nagoya Protocol to ensure that the users of biological resources share a portion of their gains/profits with the conservers of these resources which serves as an incentive for them to continue their efforts in conserving, preserving and maintaining the biological diversity and TK associated thereto. This works on the principle of equity which contributes to the conservation and sustainable use of the components of biological resources.

In compliance with our obligations under CBD, the Biological Diversity Act was enacted with the core objectives to conserve the biological resources, ensure sustainable use of its components, and promote the fair and equitable sharing of benefits arising from the utilisation of such biological resources and or associated knowledge

Yes. As a signatory to the CBD, India has enacted BD Act, 2002, to conserve biological resources and associated TK of the tribal people and local communities. The BD Act mandates the establishment of BMCs, at the local level, which documents biological diversity and associated TK through the preparation of People’s Biodiversity Registers (PBRs).

The Act also regulates access to biological resources and associated TK. Access for research or commercial utilisation requires prior informed consent (PIC) of the concerned communities, obtained through the relevant BMCs as provided under Section 41 of the Act. Furthermore, the Act ensures fair and equitable sharing of benefits arising out of the use of biological resources and associated TK with the concerned tribal/ local communities or the original knowledge holders. These provisions empower local communities and help safeguard their TK.

The variety of life and lifeforms referred to as “biodiversity” is the source of support, sustenance and succour to all the lifeforms, including humans, on earth. Rapid loss of biological diversity and its unfair commercial application, owing to a host of reasons - unplanned development, over exploitation, unscientific use and commercial application, piracy from host nation and communities of people etc., all over the world, became a matter of grave concern of humanity. To arrest such a trend and to take measures for its conservation, its sustainable and fair use, a new international legal arrangement was crafted. CBD is the outcome of such a deliberation and the first major international legal arrangement, under the United Nations. Ratified by 196 Countries, it promotes the conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of benefits arising from the utilisation of genetic resources. The Convention was opened for signature on 5 June 1992 at the United Nations Conference on Environment and Development (the Rio “Earth Summit”). It remained open for signature until 4 June 1993, by which time it had received 168 signatures. The Convention entered into force on 29 December 1993, which was 90 days after the 30th ratification.

The CBD reaffirms the sovereign rights of the Parties (i.e., member countries) over their biological resources. It encourages countries to facilitate appropriate access to genetic resources by other Parties, subject to their national legislations.

While encouraging access to genetic resources by other Parties, the CBD makes it clear that such access is subject to prior informed consent (PIC) and mutually agreed terms (MAT), as determined by the provider country (country providing the genetic resource(s) and associated traditional knowledge).

Additionally, the CBD promotes the fair and equitable sharing of benefits arising from the utilization of genetic resources, including benefits derived from associated traditional knowledge (TK), innovations, and practices of indigenous and local communities. CBD provides the legal framework for the member countries to evolve their own legislations, with institutions of enforcement for achieving its goals that would include, regulation of access, determination of the terms for benefit sharing, and ensuring fairness and equity in sharing of benefits arising from the commercial application of biodiversity.

Yes, as per the BD (Amendment) Act, 2023, access to biological resources which are occurring in or obtained from India, including those deposited in repositories outside India would attract the provisions of the Act.

As per Section 32(2) of the Act, the benefit sharing amount collected by the SBBs/UTBCs shall be utilised for the following purposes:

1. the management and conservation of heritage sites;
2. channeling benefits to the benefit claimers;
3. compensating or rehabilitating any category of the people economically affected by notification under sub-section (1) of Section 37;
4. conservation, promotion and sustainable use of biological resources;
5. socio-economic development of areas from where such biological resources or TK associated thereto have been accessed in consultation with the BMC or the local body concerned. When it is not possible to identify the specific area from where the biological resources or TK associated thereto have been accessed, the fund shall be utilised for socio-economic development of the area where such biological resources occur;
6. making grants or loans to the BMCs; and
7. for any other activities to meet the purposes of the Act.
    

As per Regulation 7 of the BD (ABS) Regulations, 2025, where no budgetary allocation has been made specifically for the benefit sharing under a sponsored research project, the sponsoring organisation shall be required to provide an undertaking. This undertaking must state that, in the event the results of research are utilised for commercialisation, the resultant benefits shall be shared with the NBA. Further, any Indian person awaiting sponsorship for such projects is obligated to keep the sponsoring entity informed of this requirement.

The key objectives of the amendments introduced to the Act are as follows:

1. To simplify compliance procedures, enhance ease of doing business, and ensure quicker, more efficient approvals through streamlined regulatory mechanisms.
2. To give effect to the certain provisions of the Nagoya Protocol on Access and Benefit Sharing.
3. To encourage the Indian Systems of Medicine by providing certain exemptions for the AYUSH sector.
4. Exempting Section 7 entities from payment of Access and Benefit Sharing (ABS) amount for the utilisation of cultivated medicinal plants.
5. To facilitate fast-tracking of research and transfer of research results for research.
6. To streamline and rationalise provisions relating to intellectual property rights.
7. To enhance and clarify the role of State Biodiversity Boards.
8. To provide clarity regarding the amounts that may be credited to and utilised from the National Biodiversity Fund and the State Biodiversity Funds.
9. To strengthen biodiversity management committees (BMCs) and empower State Governments with the discretion to constitute BMCs at intermediate and district local body levels.
10. To regulate and monitor the utilisation of biological resources and associated knowledge of foreign entities within the territory of India.
11. To clarify provisions relating to exemptions for biological resources normally traded as commodities.
12. To decriminalise certain offences by replacing imprisonment with penalties.
13. To introduce provisions for the appointment of an Adjudicating Officer for determining penalties.

Yes. Accessing soil or water samples with the intent to analyse microorganisms are regulated under the BD Act. Prior approval of the NBA must be obtained as per Section 3 & 6 of the Act.

No. The collaborative research projects that fulfil the conditions laid down in the policy guidelines notified by the Central Government are exempted from the approval for undertaking research under Section 5 of the BD Act.

However, a proforma, along with the approval of the Government, in the format prescribed by the NBA, has to be submitted to the NBA by the Indian institution before the exchange or transfer of biological resources. While transferring the results of the research to the institute outside India, approval from the NBA has to be obtained by the Indian collaborator.

Prior approval of the NBA is mandatory before accessing the biological resource for the purpose of research or obtaining IPR. He must apply in Form-1 for research and Form-7 for obtaining IPR, as the biological resources occurring in or obtained from India are regulated under the BD Act. The application forms are available on the ABS e-filing portal.

Section 2(p) of the Act defines “value added products” as products which may contain portions or extracts of plants and animals in unrecognizable and physically inseparable form. Access to value added products is exempted from the purview of the BD Act only if the products meet the criteria given in Section 2(p) of the Act.

Yes. If an entity has an annual turnover of less than Rupees Five crore, it is not obligated to pay the benefit sharing amount. However, such an entity has to comply with the following procedures:

1. The entity has to file an application with the NBA and complete the approval process.
2. If the annual turnover is above rupees one crore, the applicant has to submit an annual statement containing information regarding the biological resource utilized in the financial year in Form-A, within three months of finalisation of annual income tax or corporate tax return respect to that financial year.
3. For the entities covered under Section 7, manufacturing products containing both cultivated and non-cultivated medicinal plants, the benefit-sharing payment may not be payable in respect of the products, if notified by the MoEFCC, in consultation with the Authority and Ministry of Ayush, from time to time.

Yes. Section 4 of the BD Act mandates that the share or transfer of results of research by any person to a Section 3(2) person shall be with the prior approval of the NBA.

No, the Indian researchers are exempted from obtaining approval of SBB/NBA for accessing the biological resources including DSI or associated knowledge thereto, for undertaking research or bio-survey and bio-utilisation in India.

No. The collection fees to be paid to the BMC are in addition to the benefit-sharing component payable to the NBA/SBB.

The BMC is empowered under Section 41(3) of the BD Act to levy charges by way of collection fees from any person for accessing or collecting any biological resource for commercial purposes from areas falling within its territorial jurisdiction.

The collection fee, referred to as “access fee”, is, a nominal amount statutorily required to be paid to the BMC directly. BMC, as the overseer and protector, at the local level, of both the resource and the realisation of the right of the “benefit claimer”, besides being the custodian of the Biodiversity Register, is entitled to collect the fee, to meet part of its administrative expenses. As such, this statutory entitlement cannot in any way be considered as part of the benefit-sharing amount nor as a toll fee.

Any person covered under section 3(2) of the Act, who intends to use the results of research relating to biological resources or traditional knowledge associated thereto, for commercial utilisation, shall pay the benefit-sharing amount to the Authority as provided under sub-regulation (1) of regulation 4. The quantum of the benefit-sharing obligation shall be determined based on the annual turnover of the entity concerned as per the slab structure.

The Indian Forest Act 1927, Wildlife (Protection) Act, 1972 and the Forest (Conservation) Act, 1980 substantially address matters relating to the conservation of forests, protection of species and habitats, regulation of forest land diversion and sustainable use in forestry and wildlife sectors. However, these legislations do not cover regulating access to the biological resources, preventing biopiracy, ensuring benefit sharing with local communities arising out of use of biological resources and associated traditional knowledge. The Biological Diversity Act, 2002 covers all these aspects and thus fills a critical gap aligning domestic law with India’s obligations under the CBD.