भारत सरकार | GOVERNMENT OF INDIA
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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 is "digital sequence information"?

Digital Sequence Information (DSI) refers to data of genetic information from biological resources, including DNA, RNA, and protein sequences, and other related molecular data.

8. In the case of a Section 7 company accessing genetic material from multiple states to develop multi-parent hybrids, what is the recommended approach for distributing ABS payments — should these be allocated equally among the contributing states or based o

If the applicant is covered under Section 7 of the Act and the applicant intends to access the biological resources from more than one state, prior intimation to all such State Biodiversity Boards shall be given by the applicant for obtaining approval as required under Section 7 of the Act.

To facilitate the process, an online single window system is being developed by the NBA for facilitating the filing of ABS applications with SBB.

The total amount of the accrued benefits shall be shared with the Boards or Councils concerned, proportionately, on a case-by-case basis as per Regulation 11 of the ABS Regulations 2025.

9. Can molecular marker assisted breeding/selection be considered as ‘conventional breeding’ (as this is mentioned under commercial utilization).

Molecular marker-aided breeding/selection cannot be considered as conventional breeding. Conventional breeding generally refers to traditional methods such as selection, hybridization, and back-crossing based on observable traits. In contrast, molecular marker-based selection involves the use of molecular tools and genetic markers to identify and select desirable traits at the DNA level, and therefore falls outside the scope of conventional breeding.

10. Who prepares the biodiversity strategies and action plans for our Country/State(s)?

As per Section 36 of the BD Act, 2002, the Central Government (Ministry of Environment, Forest and Climate Change) shall develop national plans for the conservation, promotion and sustainable use of biological resources. The State Government shall develop state plans for the conservation, promotion and sustainable use of the biological diversity in conformity with the national strategies, plans and programmes, as per Section 36B of the amended BD Act.

In October, 2024, India’s updated national biodiversity strategy and action plan was prepared in alignment with the Kunming-Montreal Global Biodiversity Framework. India released the same in the side event of the COP-16 meeting at Cali, Colombia.

11. Does access to derivatives require approval under the Act?

Yes, as defined under Section 2(c) of the Act, biological resources include ‘derivatives’. Section 2(fa) defines “derivative” as a naturally occurring biochemical compound or metabolism of biological resources, even if it does not contain functional units of heredity. Therefore, access to derivatives for undertaking the activities in the Act requires prior approval.

12. What are the modalities provided in the Act for utilising the benefit sharing amount received by the NBA?

utilising the benefit-sharing amount received by the NBA?
As per Section 27(2) of the Act, the benefit sharing amount realized by the NBA shall be utilised for the following purposes:

  1. channelling benefits to the benefit claimers;
  2. conservation, promotion and sustainable use of biological resources;
  3. Socio-economic development of areas from where such biological resources or TK associated thereto have been accessed in consultation with the BMC. When it is not possible to identify the 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; and
  4. For any other activities to meet the purposes of the Act.

13. What is the benefit-sharing obligation for transferring the results of research to a Section 3(2) entity?

The applicant shall be liable to pay up to 5.0% of the monetary benefit received from the transferee, as a benefit-sharing amount, as determined by the NBA on a case-by-case basis.

14. Has there been any amendments to the Biological Diversity Act?

Yes, the BD Act, 2002 has been amended twice as given below:

  1. A new provision Section 52A, was inserted with an enactment of National Green Tribunal Act, 2010 which came into force on October 18, 2010. The appellate jurisdiction under the relevant provisions of the Act has been transferred from the High Court to the National Green Tribunal.
  2. The Biological Diversity (Amendment) Act, 2023 (No. 10 of 2023) published in the Gazette of India, Ext., Pt. II, S.1, vide notification no. CG-DL-E-03082023-247815 dated August 03, 2023. Subsequently, the first corrigendum was issued on 09-08-2023 and second corrigendum was issued on 29-02-2024.

15. How does one apply for NBA approval to access biological resources and knowledge associated thereto, including Traditional and contemporary knowledge? How should one apply for approval from the NBA to access biological resources and knowledge associated t

The application forms for getting specific permissions are available on the ABS e-filing portal. After receiving the application complete in all aspects, the NBA will examine and verify the information. If the application is found in order, the Competent Authority shall grant necessary approval.

16. Whether the provisions of the BD Act affect research and collaborative research projects between Indian research institutions with foreign institutions? Are there any guidelines for undertaking collaborative research projects? Whether an Indian institute

No. Section 5 exempts transfer or exchange of biological resources or TK associated thereto between institutions under collaborative research projects from obtaining approval for the purpose of research provided that such research projects conform to the policy guidelines issued by the Central Government from time to time. The principal investigator of the Indian institution is required to furnish the following to the NBA;

  1. Information in a proforma for giving intimation to the NBA;
  2. Approval of the concerned Ministry/Department of the State or the Central Government for the collaborative research project in the prescribed format; and
  3. Copy of the MoU executed between the concerned institutions.

17. Should the name of the applicant and the biological resources mentioned in IPR applications (Forms 6-9) be the same as in the patent application?

Yes, the name of the applicant and the biological resources mentioned in the IPR-related forms (Forms 6-9) must be consistent with the details provided in the corresponding patent applications. This alignment ensures that the NBA can check the information between the patent application and the IPR forms. Discrepancies in the applicant's name or the biological resources listed may result in delays or complications during the approval process. Therefore, to maintain transparency, compliance, and consistency, the details provided in both the patent application and the NBA forms should be identical.

18. What is “codified traditional knowledge” and whether it is exempted from the purview of the Act?

Section 2(ea) of the Act defines “codified traditional knowledge” as the knowledge derived from authoritative books specified in the First Schedule to the Drugs and Cosmetics Act, 1940. Access to such codified traditional knowledge is exempted for Section 7 persons (individual/entity).

19. In case of hybrids developed using both Indian and non-Indian biological resources, how should ABS liability be calculated?

ln the event of developing hybrids combination of both lndian and non-lndian biological resources, the ABS will be calculated proportionate use of lndian biological resources, on a case-by-case basis. However, the scientific proof of onus lies with the applicant.

20. Is it necessary to seek NBA’s approval for video graphing and camera trapping to record the behaviour of animals?

No. The activity of “video graphing” and “camera trapping” does not fall within the scope of Sections 3, 4, 6 or 20 of the Act and therefore no approval is required from the NBA.

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