भारत सरकार | GOVERNMENT OF INDIA
inner page banner

FAQ's

1. What is meant by "biological resources"?

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.

2. What is the concept and purpose of “access and benefit sharing”?

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.

3. Why was the Biological Diversity Act, 2002 enacted?

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

4. Has India’s status as a signatory to the CBD helped the tribal people and local communities safeguard their TK and derive benefits from its utilisation?

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.

5. What is the United Nations Convention on Biological Diversity (CBD)?

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.

6. How does CBD recognise the biological resources at the country level?

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.

7. What are ‘value added products’ and their applicability?

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.

8. Is any exemption available from paying the benefit sharing amount to the NBA/ SBB?

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.

9. Whether I need to take approval to share or transfer my research results to a Section 3(2) entity?

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.

10. Do Indian researchers require approval for obtaining biological resources for research purposes?

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.

11. Does the collection fees paid to the BMCs, a part of the benefit-sharing component?

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.

12. What is the benefit-sharing obligation for using the results of research for commercial utilization?

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.

13. Why was the Biological Diversity Act, 2002 enacted despite the existence of earlier legislations like the Indian Forest Act (1927), Wildlife (Protection) Act (1972), and Forest (Conservation) Act (1980)?

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.

14. Whether approval of the NBA is required for accessing commercially available varieties/hybrid seeds from the market solely for the purpose of investigating potential infringement of my proprietary line/variety/hybrid?

No, when biological resources are used solely for testing of infringement of commercially available biological resources (hybrid/variety), it will not attract the provisions of the BD Act.

15. Do the non-Indian scientists/researchers/students visiting herbaria/ museum/universities for comparing the species with the holotype/ herbaria/other samples available with these institutions; including BSI/ZSI/universities, require prior approval of the N

No. Scientists, researchers, and students are not required to obtain prior approval from the NBA for comparing holotype or herbarium samples within institutions such as herbaria, museums, universities, BSI, or ZSI. However, prior approval from the NBA is mandatory for taking such materials outside India.

16. Whether permission of the NBA is required for IPR if a biological resource is procured from the market or a trader?

Yes, permission from the NBA is required even if a biological resource is procured/ accessed from the market or a trader.

17. Who has the authority to classify a material as a biological resource, derivative, or value-added product under the BD Act?

The responsibility for determining whether a material qualifies as a value-added product, biological resource, or derivative lies with the NBA. The NBA reviews each application on a “case-by-case basis”, considering the nature of the resource, how it aligns with the definitions provided under the Act and Rules.

18. Is a transferee free to use the obtained results of research from the transferor?

  • No. If the transferee {Section 3(2) entity} wants to utilise the obtained results of research for further research, they need to register with the NBA in Form-4.
  • Similarly, for further commercial utilisation of the results of the research, prior approval of the NBA has to be obtained in Form-5. For obtaining any IPR within or outside India, prior approval from the NBA is required in Form-6 as per Rule 15 of the BD Rules,2024.
  • In the case of accessing biological resources along with the obtained results of research for further research, prior approval from the NBA is required in the application in Form -1.

19. What are the activities regulated under the BD Act after coming into force of the BD (Amendment) Act, 2023?

S.noActivitySection 7 personSection 3(2) person
1ResearchNo approval is requiredPrior approval from the NBA is mandatory
2Bio-survey and Bio-utilizationNo approval is requiredPrior approval from the NBA is mandatory
3Commercial utilizationPrior intimation (Approval) from the SBB/UTBC is required. [State/UT from whose jurisdiction the bioresources are to be accessed]Prior approval from the NBA is mandatory
4For obtaining any IPRPrior registration with NBA is mandatoryPrior approval from the NBA is mandatory
5Commercialization of any IPRPrior approval from the NBA is mandatoryPrior approval from the NBA is mandatory
6Sharing or transferring the results of research to Section 3(2) person for monetary consideration or otherwisePrior approval from the NBA is mandatoryPrior approval from the NBA is mandatory
7Using the results of research obtained through transfer for further research by the transferee {Section 3(2) entity}Not applicablePrior registration with NBA is mandatory
8Using the results of research obtained through transfer for commercial utilization by the transferee {Section 3(2) entity}Not applicablePrior approval from the NBA is mandatory
9Using the results of research for obtaining IPR by the transferee {Section 3(2) entity}Not applicablePrior approval from the NBA is mandatory
10Conducting non-commercial research or research for emergency purposes outside India by Indian researcher or institutionPrior approval from the NBA is mandatoryNot applicable
11Utilization of biological resource or TK associated thereto obtained from any foreign country for research or for commercial purpose or for obtaining IPR in IndiaDeclaration to NBA is mandatoryDeclaration to NBA is mandatory
12Deposition of micro-organisms by Indian researchers/scientist in the repositories of other country for claim of discovery of novel species for publication in journalsPrior intimation to NBA is mandatoryNA
The relevant application forms and fees are provided in the BD Rules, 2024

20. What is the benefit-sharing obligation for undertaking research by Section 3(2) applicants?

If a Section 3(2) applicant accesses certain biological resources, including digital sequence information or knowledge associated thereto, for research, the applicant has to pay the upfront payment as determined by the NBA. However, this upfront payment is not applicable in cases where the research is undertaken for academic purposes.

FAQ Disclaimer

Version of FAQ: 

Date of FAQ: