भारत सरकार | GOVERNMENT OF INDIA
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FAQs

26. Whether exemption is applicable for access to the biological resources associated with codified traditional knowledge?

No. Access to biological resources that are associated with codified traditional knowledge is not exempted.

27. 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.

28. Whether Indian biological resources accessed from outside India would attract the provisions of the Act?

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.

29. 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.

30. 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
31. Does the BD Act provide for any exemptions?

The Act provides for the following exemptions:

  1. Access by Section 7 entities for research / bio-survey / bio-utilization: Access to biological resources or knowledge associated thereto by a Section 7 entity for undertaking research or bio-survey and bio-utilisation in India is exempted from seeking approval of SBB/NBA under the Act.
  2. Value-added products: Access to value-added products, which may contain portions or extracts of plants and animals in unrecognisable and physically inseparable form {Sec. 2(p)}.
  3. Codified traditional knowledge and cultivated medicinal plants: Codified traditional knowledge, cultivated medicinal plants and their products, local people and communities of the area, including growers and cultivators of biodiversity and vaids, hakims and registered AYUSH practitioners only, who have been practising indigenous medicines, including Indian systems of medicine as profession for sustenance and livelihood are exempted under Section 7 of the Act.
  4. Conventional breeding: Accessing biological resources for conventional breeding or traditional practices in use in any agriculture, horticulture, poultry, dairy farming, animal husbandry or beekeeping, in India {Section 2(f)}.
  5. Academic dissemination: Publication of research papers or dissemination of knowledge, in any seminar or workshop involving financial benefit, if such publication is in conformity with the guidelines issued by the Central Government from time to time (first proviso clause to Section 4).
  6. Collaborative research: Transfer or exchange of biological resources or TK under collaborative research projects between Government-sponsored institutions and such institutions in other countries are exempted subject to conformity to the policy guidelines issued by the Central Government (Section 5).
  7. Normally traded as commodities: Biological resources when normally traded as commodities or to the items derived from them, including agricultural wastes, as notified and cultivated medicinal plants and their products for entities covered under Section 7, registered as per the regulations made or as may be prescribed, notified by the Central Government (Section 40).
  8. Crops under ITPGRFA: Accessing the crops from amongst the crops listed at Annex-I of the International Treaty on Plant Genetic Resources for Food and Agriculture (ITPGRFA), as notified by the Department of Agriculture and Cooperation, Ministry of Agriculture, Government of India from time to time, is exempted from the provisions of Sections 3 and 4 of the Act, for the purpose of utilization and conservation for research, breeding and training for food and agriculture.
  9. Approvals under the PPVFRA: Any person who has been given any approval or granted any right under any law relating to protection of plant varieties enacted by the Parliament to the extent that such approvals or rights given under that Act does not require similar approval under the BD Act (Section 59-A).
32. Whether the consent of the local community (ies) is required for granting approvals by the NBA or SBBs/UTBCs on the applications for accessing biological resources?

Yes. Upon receipt of an application for access to biological resources, the NBA forwards the application to the concerned SBB(s) for obtaining the consent or otherwise of the relevant BMC(s) through a consultative process in the area from where the biological resources are obtained/accessed. The BMC is responsible for facilitating the task of obtaining prior informed consent from the concerned local communities or individual benefit claimants, if any. A similar procedure is followed by the SBBs in the respect of applications submitted by the applicants other than those covered under Section 3(2) of the Act.

33. Whether accessing a variety imported or developed without using Indian Biological resource by a section 3(2) company require prior approval from the NBA?

No approval is required. However, any person who intends to use the biological resource(s) and or traditional knowledge associated thereto obtained from any foreign country for research or commercial purpose or for obtaining intellectual property rights in India, shall submit a declaration in Form-10 to the NBA as specified under Rule 18 of the BD Rules, 2024 read with Section 36A of the BD Act.

34. Is there any mechanism to monitor the biological resources being brought to India for research purposes?

Yes. As per Rule 18 of the BD Rules, 2024, an entity who uses the biological resources of foreign origin for the purpose of undertaking research or commercial utilisation or obtaining IPR in India, it shall have to submit a declaration in Form-10 to the NBA.

35. Does a company covered under Section 3(2) imports varieties or develops varieties independently using foreign biological resources require prior NBA approval?

No approval is required. However, any person who intends to use the biological resource(s) and or TK associated thereto obtained from any foreign country for research or commercial purposes or for obtaining IPR in India, shall submit a declaration in Form-10 to the NBA as specified under Rule 18 of the BD Rules, 2024.

36. Is prior permission required for conducting biodiversity surveys?

Yes, bio-survey and bio-utilization are regulated activities under the provisions of the BD Act. Hence, prior approval from the NBA is mandatory for individuals/ entities who fall under Section 3(2) of the BD Act.

37. Does an Indian need approval to report a new species or genus?

Reporting a new species or genus is not a regulated activity under the provisions of the BD Act. However, prior intimation shall be provided to the designated repository in India.

38. 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.

39. Is accessing soil/water samples for microbial analysis regulated under the BD Act?

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.

40. 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.

41. I am based in Germany and plan to access the DNA sequence of a microorganism from a German microbial repository. The DNA sequence of microorganism was deposited by an Indian scientist in the past. What are my obligations under the BD Act?

Prior approval of the NBA is required before accessing the DNA sequence from a foreign microbial repository for undertaking research. You must apply in Form-1, as accessing the biological resources occurring in or obtained from India or digital sequence information on biological resources which are accessed from India, including those deposited in repositories outside India, is regulated under the provisions of the BD Act.

42. What constitutes an approval under this Act? How will I be informed about the approval of my application by the NBA to access a biological resource?

Approval shall be granted in the form of an agreement executed between the applicants and the NBA. The agreement shall contain the benefit sharing component, terms and conditions subject to which the applicant shall access the biological resources for research/commercial utilization/bio-survey and bio-utilization/IPR.

43. Can NBA approvals be granted in a phased or umbrella manner for long-term breeding programmes?

NBA approval for research is maximum five years and timeline will be extended on request from the applicant, on a case to case basis. However, in case of adding new biological resources into the ongoing research, may be considered after following due process such as PIC and MAT

44. Whether submission of voucher specimens required for every access request under the ABS framework, or should it be limited to unique, wild, or non-widely available biological resources?

The Authority may exempt the deposition of voucher specimen in the repository on a case by case basis, considering the nature of biological resources, abundance, source of access, etc.

45. Under what circumstances the approval granted by the NBA be revoked?

The NBA may/shall revoke an approval if the applicant violates the provisions of the BD Act or provides false information or misleading information, or fails to comply with the terms and conditions specified in the agreement entered into with the NBA.

46. Will I get an Internationally Recognised Certificate of Compliance (IRCC) if I sign an agreement with the NBA?

Yes, as part of the agreement signing process with the NBA, the applicant is required to sign the IRCC consent form, wherein he/she may indicate specific information, if any, to be treated as confidential. Based on this declaration, the NBA will update the relevant details on the Access and Benefit Sharing-Clearing House (ABS-CH) website, an official platform under the CBD and will publish only the non-confidential information. If the applicant has provided a valid email address, a copy of the certificate will be sent to them directly from the ABS-CH portal upon publication.

The IRCC serves as evidence that biological resources have been accessed lawfully and in compliance with the provider country’s regulatory framework, thereby facilitating transparency and fair and equitable sharing of benefits at the international level.

47. Whether SBBs/UTBCs are empowered to regulate the access and determine the benefit sharing component for Section 7 persons?

Yes, as per Section 23 (b) and (ba) of the Act, the SBBs/UTBCs are empowered to regulate activity of access to biological resources or its associated TK by Section 7 person entities for commercial utilisation by granting or rejecting approval. While granting approval, SBB/UTBCs shall determine the benefit sharing component payable by the applicant as per the provisions of the BD (ABS) Regulations, 2025 issued by the NBA.

48. 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.

49. 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.

50. 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.
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