1) 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.

2) 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.

3) 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.

4) 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.

5) When was the Biological Diversity Act enacted and when did it come into force?

The BD Act, 2002 received the assent of the President on February 05, 2003. However, the provisions of the BD Act related to administrative matters came into force on October 01, 2003 and the provisions related to Access and Benefit Sharing came into force on July 01, 2004.

6) 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.

7) What are the key objectives of the amendments introduced to the Biological Diversity Act?

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.

8) 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.

9) Do the provisions of the BD Act contradict those of the Forest Rights Act, 2006 with respect to access and management of forest resources by the local communities?

There is no contradiction between the provisions of the two Acts regarding access/management of forest resources by the local communities as Section 7 of the BD Act clearly states that the local people and communities of the area, including growers and cultivators of biodiversity, are exempted from the provisions of the BD Act, 2002.

Further, Section 59 of the BD Act states that the provisions of this Act shall be in addition to and not in derogation of the provisions of any other law, for the time being in force, relating to forests or wildlife. This ensures legal harmony between the BD Act and other environmental / forest related legislations including the Forest Rights Act, 2006.

10) Are there specific Rules governing the implementation of the Biological Diversity Act? Have any amendments been made to these Rules?

Yes. - The Biological Diversity Rules, 2004 were notified by the Ministry of Environment, Forest and Climate Change (MoEFCC) on April 15, 2004 which came into force on July 01, 2004.

Pursuant to the amendments to the BD Act in 2023, the MoEFCC notified the Biological Diversity Rules, 2024 on October 22, 2024, thereby superseding the BD Rules, 2004. The BD Rules, 2024 came into force on December 21, 2024 upon expiry of 60 days from the date of notification in accordance with rule 1(2) of the BD Rules, 2024.

Further the BD Rules, 2024 were amended vide Biological Diversity (Amendment) Rules, 2025 which were notified on May 06, 2025 and came into force on November 01, 2025.

11) What are the functions of the National Biodiversity Authority?

The NBA is mandated to perform facilitative, regulatory, and advisory functions on matters relating to biodiversity. The mandate includes the following:

• Regulating activities referred to in Sections 3, 4, and 6 of the BD Act by granting or rejecting approvals.
• Framing regulations, in consultation with the Central Government, for access to biological resources and associated traditional knowledge (TK), and for determining the fair and equitable sharing of benefits arising from their utilisation.
• Advising the Central Government on matters relating to the conservation of biodiversity, sustainable use of its components, and fair and equitable sharing of benefits arising from the utilisation of biological resources, in accordance with the provisions of the BD Act.
• Advising the State Governments in framing rules for the management and conservation of biodiversity heritage sites (BHSs) notified by the State Government in consultation with the State Biodiversity Board (SBB)/Union Territory Biodiversity Council (UTBC), the local body, and the concerned BMC.

Taking necessary measures, on behalf of the Central Government, to oppose the grant of intellectual property rights (IPR) in any country outside India on any biological resource occurring in, found in, or brought from India including those deposited in repositories outside India or on associated TK that has been accessed illegally.

• Adjudicating upon any dispute between two or more the State Biodiversity Boards, upon a reference made to it by the Central Government, with the same powers and functions of a Civil Court (see, Section.50(clauses 4,5,6&7)
• Performing any other functions as may be necessary to carry out the provisions of the BD Act.

The general functions of the NBA are further elaborated under Rule 11 of the Biological Diversity Rules, 2024.

12) What are the institutional mechanisms for implementing the BD Act?

The BD Act is implemented through a decentralized three-tier institutional system, viz., at the national, state and local levels as mentioned below:

• At the national level, the NBA has been established to oversee all matters relating to implementation of the BD Act, BD Rules and ABS Regulations.
• At the state level, the SBBs or UTBCs in the Union territories, have been established to deal with all matters relating to implementation of the Act and the state specific Rules framed by the respective State Governments, as applicable.
• At the local level, the BMCs have been constituted at the Gram Panchayat level in the rural areas and at the Nagar Panchayat or Municipal Committee level in the urban areas.

13) What are the functions of the State Biodiversity Boards/ Union Territory Biodiversity Council?

The SBBs are mandated to perform the following functions:

• Regulate the activity of commercial utilisation of biological resources undertaken by Section 7 person (Indian individual/entity) by granting or rejecting approvals;
• Determine the fair and equitable sharing of benefits as per the regulations notified by the NBA while granting approvals;
• Advise the State Government on matters relating to the conservation of biodiversity, sustainable use of its components and fair and equitable sharing of the benefits arising out of the utilisation of biological resources or TK associated thereto, in conformity with the regulations or guidelines if any, issued by the Central Government or the NBA;
• Perform such other functions as may be necessary to carry out the provisions of this Act or as may be prescribed by the State Government in the state-specific Biological Diversity Rules.

14) What are the functions and composition of the Biodiversity Management Committee?

• The functions of a BMC include conservation, sustainable use and documentation of biological diversity, including conservation of habitats, landraces, folk varieties, cultivars, domesticated breeds of animals, living beings in water bodies, microorganisms, and chronicling of TK associated thereto relating to biological diversity as per Section 41(1A) of the Act.
• As per Section 41(1B) of the amended BD Act, the composition of the BMC shall be as prescribed by the State Government. However, the number of members of the said Committee shall not be less than seven and not exceeding eleven.
• The BMC shall issue certificates of origin of the cultivated medicinal plants being accessed in its jurisdiction, referred to under sub-section (3) of Section 7 of the Act and maintain the records of such transactions.

15) 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.

16) 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.

17) 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).

18) 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.

19) 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.

20) Who is considered as Section 3(2) person under the amended Act?

1. a person who is not a citizen of India;
2. a citizen of India, who is a non-resident as defined in clause (30) of Section 2 of the Income-tax Act, 1961;
3. a body corporate, association or organization;
   1. Not incorporated or registered in India; or
   2. Incorporated or registered in India under any law for the time being in force, which is controlled by a foreigner within the meaning of clause (27) of Section 2 of the Companies Act, 2013.

21) What is a foreign-controlled company?

A “Foreign controlled company” means any company incorporated or registered in India under any law for the time being in force, which is controlled by a foreigner within the meaning of clause (27) of Section 2 of the Companies Act, 2013.

Under Section 2(27) of the Companies Act, 2013 -“control” shall include the right to appoint majority of the directors or to control the management or policy decisions exercisable by a person or persons acting individually or in concert, directly or indirectly, including by virtue of their shareholding or management rights or shareholders agreements or voting agreements or in any other manner.

22) What constitutes ‘access’ under the BD Act?

As per Section 2(a) of the Act, “access” means collecting, procuring or possessing any biological resource occurring in or obtained from India or TK associated thereto, for the purposes of research or bio-survey or commercial utilisation.

23) Does the Biological Diversity Act in any way hinder industrial development and restrict free trade in biological resources?

No. While the BD Act promotes conservation and sustainable use of biodiversity, it also facilitates trade and commerce in relation to biodiversity. It does the balancing act between conservation and commerce, by clear stipulations like, the provision on exemption from the benefit-sharing requirement, in relation to the notified bioresources as Normally Traded as Commodities (NTACs). The recent amendments brought out measures to encourage ‘ease of doing business’ which include,

1. Encouraging the cultivation of medicinal plants by exempting the use of cultivated medicinal plants for Indians.
2. Exemption of codified traditional knowledge from the purview of the ABS mechanism to provide a favourable environment for the growth of AYUSH sectors;
3. Aligning the definition and meaning of “control” (of companies) under Amended Act with the Companies Act, 2013

24) How do the objectives of the BD Act help in the conservation of biodiversity and ecosystems?

The BD Act, 2002 plays a vital role in the conservation of biodiversity and ecosystems through its three core objectives:

1. Conservation of biological diversity: Promotes the conservation of species, ecosystems, and genetic diversity through legal measures such as notification of threatened species and biodiversity heritage sites.
2. Sustainable use of its components: Ensures that the biological resources are utilised in a manner that maintains ecological balance and prevents overexploitation.
3. Fair and equitable sharing of benefits: Ensures that users of biological resources and associated TK, share benefits on an equitable basis with the local communities, knowledge holders, and individuals. These shared benefits are then utilized by the communities for conservation and sustainable management of biological resources as well as socio-economic development of the local communities. Recent amendments have reinforced these conservation measures by exempting individuals covered under Section 7 from seeking access approvals for cultivated medicinal plants. This is intended to reduce pressure on wild populations and curb the overexploitation of natural ecosystems.
4. Altogether, these provisions create a balanced framework that promotes both sustainable use and conservation. By encouraging community participation and making provisions for socio-economic development, the Act fosters local stewardship and strengthens efforts to conserve biodiversity and ecosystems.

25) India has several practitioners of Indian systems of medicine who use various parts of herbs, shrubs, etc., for medicines and healthcare. Will such use be affected by the implementation of the BD Act?

The BD Act provides legal recognition and protection to traditional knowledge and practices associated with biological resources. It safeguards the rights of the knowledge holders and recognises them as “benefit claimers,” enabling them to receive a fair share of benefits arising from its use. Further, traditional practitioners and other such knowledge holders are provided appropriate exemptions under the Act in a supportive and enabling manner.

Section 7 of the BD (Amendment) Act, 2023 does not apply to the following:

• codified traditional knowledge;
• cultivated medicinal plants and their products; and
• local people and communities of the area, including growers and cultivators of biodiversity and to vaids, hakims and registered AYUSH practitioners only who have been practising indigenous medicines, including Indian systems of medicine as a profession for sustenance and livelihood.

However, the exemption for commercial utilization of cultivated medicinal plants shall be applicable only if a ’Certificate of Origin’ is obtained from the BMC in a manner as prescribed in Rule 19 of the BD (Amendment) Rules, 2025.

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?

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 thereto?

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 on the value derived from each parental source?

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.

51) 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.

52) Who determines the fair and equitable benefit-sharing component?

According to Section 2(g) of the Act, “fair and equitable benefit sharing” means sharing of benefits as determined by the NBA under Section 21.

Section 21 states that the NBA will determine the benefit sharing. The Authority in consultation with the local bodies impose terms and conditions while granting approvals, for securing equitable sharing of benefits.

53) Under the BD Act, upfront payment is applicable for access to biological resources of high economic value. Do seeds of cultivated crop fall under this category? If yes, which crop or types of seeds would upfront payment be applicable under the Act?

In case of biological resource having conservation value or high economic value such as red sanders, sandalwood, agarwood or any other items as decided by the Authority from time to time, and including threatened species notified under section 38 of the Act, the benefit sharing shall not be less than 5% of the proceeds of the auction or sale amount or the purchase price, as the case may be, as determined by the Authority on case to case basis, as upfront payment. This includes from both cultivated and non-cultivated biological resources

54) As per the NBA’s revised upfront payment guidelines (approved in the 46th Authority Meeting on 24 July 2018), quantity limits are defined at the species level. In this context, if multiple varieties of the same species are accessed, can they be treated as access to one species for upfront payment purposes, with the payment calculated on the total quantity accessed?

With regard to the calculation of upfront payment as concerned, the NBA will calculate each variety/lines / hybrid, etc., as a separate biological resource and the upfront will be calculated accordingly.

55) In cases where prior approval is obtained and upfront payment is made for access to a biological resource, but the biological resource is subsequently found to be unavailable at the specified location, will the NBA refund or allow adjustment of the upfront payment against a future access application?

In the event of change of location and quantity, refund or adjustment of the upfront payment will not be allowed

56) Who are the benefit claimers under the provisions of the BD Act?

The benefit claimers are individuals or groups who conserve biological resources and their by-products, creators or those who possess/holds TK associated thereto [excluding codified traditional knowledge only for Indians]. This includes individuals/groups who provide information relating to the use of such biological resources, innovations and practices. The benefit claimers are entitled to receive the benefit-sharing component arising from the use of such biological resources and associated knowledge (Section 2(aa)).

57) How does the ‘access and benefit sharing’ mechanism work?

Any person who intends to access the biological resources or TK associated thereto or both for any of the activities under Section 3, 4, & 6 shall make an application in that behalf to the concerned authority in the prescribed format. The NBA, SBB, or UTBC concerned, after scrutiny of the application and consultations with the BMC(s) concerned, may grant approval in the form of a written agreement on mutually agreed terms. The agreement consisting of terms and conditions to the users, including a benefit-sharing component payable to the NBA/SBBs/UTBCs.

The ABS amount realised from the users of biological resources and TK associated thereto on behalf of the conservers or holders of these resources and or knowledge. The NBA and SBBs/UTBCs distribute the ABS amount to beneficiaries for utilising it for the conservation or socio-economic development of the area from which these biological resources are accessed.

58) How and with whom are the monetary benefits shared?

According to Section 21 of the Act, the determination of fair and equitable benefit sharing arising out of the utilisation of accessed biological resources, their derivatives, innovations and practices associated with their use and applications and knowledge relating thereto, is done in accordance with the mutually agreed terms and conditions between the users and BMC represented by the NBA.

The monetary benefits shall be paid to the National Biodiversity Fund by the users. The NBA then distributes the benefit sharing components to the benefit claimers, which may include individuals, groups of individuals or organisations.

59) What are the modalities provided in the Act for 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.

60) How do the SBBs/UTBCs utilise the benefit sharing amount collected by them?

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.

61) 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.

62) 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.

63) What is the benefit-sharing component payable to the NBA by the applicant for accessing the biological resources for commercial utilisation?

As per regulation 4 of the BD (ABS) Regulations, 2025, the applicant shall have to pay the benefit sharing amount to the NBA as per the slabs prescribed below:

Biological resources having conservation or high economic value, including species notified under Section 38 of the Act are subject to 20% more than the benefit sharing due.

If access is made to a biological resource that has conservation value, or high economic value such as red sanders, sandalwood, agarwood, or any other item identified by the Authority, including threatened species listed under Section 38 of the Act, the ABS component shall not be less than five percent of the proceeds of the auction or sale amount, or purchase price, as the case may be. This amount will be decided by the Authority on a case-by-case basis and must be paid as an upfront payment.

64) What will be the benefit-sharing process when biological samples are collected from wild? Are there any contradictions with the Wildlife (Protection) Act, 1972?

The ABS process remains the same for all biological resources, including those collected from wild. Section 59 of the BD Act provides that the provisions of the Act are in addition to, and not in derogation of, the provisions in any other law currently in force, especially those relating to forests or wildlife.

With regard to the benefit sharing, the beneficiaries may include the State Forest Department, the SBB, BMCs or any other stakeholders, as the case may be.

65) Whether SBBs shall have the right to reject any application that is detrimental or contrary to the objectives of the BD Act, i.e., conservation and sustainable use of biological resources or equitable sharing of benefits arising out of such activity.

Yes. Under Section 7 of the Act, any Indian company can access biological resources for commercial utilisation only after giving “prior intimation” to the SBB/UTBC concerned. On being satisfied with the merits of the application, the SBB/UTBC may grant approval, subject to the terms and conditions as specified under Sections 23(b) and 24(2) of the Act.

The SBBs shall have the right to reject any application that is detrimental or contrary to the objectives of the BD Act, i.e., conservation and sustainable use of biological resources or equitable sharing of benefits arising out of such activity.

66) How does the BD Act help in checking bio-piracy/ misappropriation of biological resources?

To have a check on misappropriation of biological resources, the Act provides that access to biological resources occurring in or obtained from India, including those deposited in repositories outside India, or TK associated thereto, is subject to the approval of the NBA. Further, it is mandatory to obtain approval from the NBA before seeking any IPR based on the biological resource and associated knowledge obtained from India.

Section 18(4) empowers the NBA, on behalf of the Central Government, to take any measures to oppose the grant of IPR in any country outside India, utilizing the biological resources which are found in or brought from India, including those deposited in repositories outside India, or TK associated thereto accessed, without the approval of the NBA.

67) What is the rationale behind establishing repositories?

Section 39 provides for designating institutions as repositories for the deposition of voucher specimens of different categories of biological resources, which were accessed with the approval of the NBA under the BD Act. Repositories serve as secure and scientific storage facilities for biological samples, including seeds, tissues, and DNA, ensuring long-term conservation of biodiversity. So far, 20 institutions have been notified as repositories by the Central Government under the BD Act.

68) How does the BD Act address the concerns relating to threatened species?

Section 38 of the BD Act provides for notifying threatened species by the Central Government, in consultation with the State Governments, which are on the verge of extinction or likely to become extinct in near future and may prohibit or regulate their collection for any purpose and take appropriate steps to rehabilitate and preserve those species.

As per the recent amendments, the Central Government may delegate the power to notify the threatened species to the State Government, and in such a case, the State Government shall consult the NBA before issuing any such notification.

69) How does the BD Act address the concerns relating to the protection of biodiversity-rich areas?

Section 37 (1) of the Act provides that based on the recommendations of the SBB, the State Government may, from time to time, notify in the Official Gazette, areas of biodiversity importance as Biodiversity Heritage Sites under this Act. Further, the SBB shall consult the local body and BMC concerned before making such recommendations. The State Government, in consultation with the Central Government, may frame rules for the management and conservation of all the biodiversity heritage sites as per Section 37(2) of the Act.

70) 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 must take approval for collaborative research work with a foreign institution/Section 3(2) entity?

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.

71) Whether an Indian institute or university collaborating with another institute or university located outside India for undertaking research, with the approval of the Government of India, has to take approval from the NBA or the SBB?

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.

72) 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 NBA under the BD Act?

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.

73) Is there any prescribed application form for seeking approval of the NBA to access biological resources or associated knowledge or both by a non-Indian natural or legal person for undertaking research or for bio-survey and bio-utilization?

Yes. Both foreign individuals and entities fall under Section 3(2) of the Act. Hence, such persons have to obtain prior approval of the NBA by applying in Form-1 for access to biological resources or knowledge associated thereto for research or bio-survey and bio-utilisation as per Rule 13 of the BD Rules, 2024.

74) What should a Section 3(2) entity do when it accesses a biological resource from a trader or the wholesale market in India for commercial utilization?

If a Section 3(2) entity accesses biological resources from any place or location within India, including from a trader or the wholesale market or institute or repository in India, it is mandatory to obtain prior approval from the NBA by applying in Form-2 for accessing the biological resources for commercial utilization under Section 3 of the BD Act read with Rule 13 of the BD Rules, 2024.

75) A company (Section 7 company) seeks to access the plant species for extracting essential oil and intends to supply the oil to another company {a Section 3(2) entity} for manufacturing purposes. What is the procedure to be followed?

In the first instance, the Section 7 company must give prior intimation to the concerned SBB/UTBC, as the case may be, for accessing the biological resource for extracting essential oil for commercial utilization.

Subsequently, the Section 3(2) company has to obtain prior approval of the NBA, by filing an application in Form-2 to access the biological resource (essential oil) for commercial utilisation.

76) Are there any exemptions provided under the Act, specifically for Indians?

Yes. The amended Act provides for certain exemptions, which are as follows:

1. Access to biological resources and its associated knowledge for the purpose of conducting research or biosurvey and bio-utilization in India;
2. Access to codified traditional knowledge;
3. Access to cultivated medicinal plants and its products upon submission of a ‘certificate of origin’ obtained from the concerned BMC;
4. Local people and communities of the area for free access to use biological resources within India;
5. Growers and cultivators of biodiversity and to vaids and hakims to use biological resources;
6. Registered AYUSH practitioners who are practising indigenous medicines, including Indian systems of medicine as a profession for sustenance and livelihood;
7. Accessing the items/biological resources that are notified as “normally traded as commodities” under Section 40 of the Act; and
8. Publication of research papers or dissemination of knowledge in any seminar or workshop involving financial benefit is as per the guidelines issued by the Central Government.

77) Can you explain the provisions of Section 40 of the amended Act? Are the notified bioresources completely out of the purview of the Act?

Section 40 of the Biological Diversity Act empowers the Central Government to exempt certain biological resources or their derivatives, including agricultural wastes, as notified and cultivated medicinal plants and their products for entities covered under Section 7 from the purview of the Act, when they are “normally traded as commodities,” through a notification.

However, when the same item is used as a resource in a process or for the development of a product, or claiming an IPR, such item is not exempted, and prior approval of NBA/SBB is required under Section 3 or Section 6 or Section 7 of the Act, as may be applicable.

78) Whether commercially released crop varieties approved by the Central Variety Release Committee (CVRC), truthfully labelled, or registered under the PPV&FRA can be used for further breeding without prior approval under the ABS provisions?

Breeding activities carried out by the seed sector are considered as a research. Accordingly, Indian entities (i.e., persons covered under Section 7 of the BD Act) are not required to obtain approval from the NBA or SBBs for accessing released commercial crop varieties or PPVFR-registered materials that are already in the market, if the purpose is research or bio-survey and bio-utilization.

However, approval from the respective SBB is required when CVRC varieties are accessed for commercial utilization. The BD (ABS) Regulations, 2025, provide a simplified procedure for SBBs to grant approval for such cases. Whereas, commercial utilization of PPVRFA registered varieties are exempted under section 59A of the Act.

79) If a company multiplies seeds or vegetatively produced planting materials in India from a variety that has been developed outside India, do they need any documents/or approvals from the NBA to export the seeds or vegetatively produced planting materials again as it is their material (including possible agreements with third parties)? What steps a company needs to take with regard to the NBA?

• If the biological resources used by the company in India do not contain any Indian germplasm* (biological resource) in their development or multiplication or production or research, then it will not come within the ambit of the BD Act.
• If the biological resources handled, researched, developed, multiplied, produced, etc., contain any strain of an Indian germplasm (biological resource), then prior approval of the NBA is required under Section 3 of the Act, for the Section 3(2) entities.
• The Section 7 entities have to give prior intimation (approvals) to the concerned SBB for undertaking the above-mentioned activities.

* Indian germplasm is any genetic material that originated in Indian territory or has been introduced and/or adapted to Indian agro-ecologies where they have developed distinctive properties.

80) 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.

81) 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.

82) 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.

83) 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.

84) Whether approval is necessary for publication of results of research on any biological resources occurring in India, in a research paper or for dissemination in any workshop or seminar?

No. Section 4 exempts publication of research papers on any biological resources occurring in or obtained or accessed from India or dissemination of knowledge in any seminar or workshop involving financial benefit, provided such publication or dissemination is in conformity with the guidelines issued by the Central Government.

85) Do companies need to apply for approval to transfer of biological resources which are company-owned materials, for genotyping outside India (results to be used in the Indian breeding programme)?

The Act does not recognise a category called 'company-owned material', while dealing with biological resources. Hence the recipient/user of the biological resource needs to obtain approval of NBA under Section 3 of the Act if the biological resources contain any strain of an Indian germplasm.

86) Section 4 of the BD Act refers to 'any biological resources occurring in India', would that also include any breeding material from a (multinational) breeding company that originates from (a) Indian commercial varieties or from (b) international varieties/ germplasm?

Yes. The term “any biological resources occurring in India” includes breeding materials of Indian origin, whether from commercial or local varieties, as well as international varieties that contain Indian germplasm.

87) In which Form does a Section 3(2) entity need to file a IPR application for utilising results of the research transferred by a Section 3(2) entity?

When a Section 3(2) individual(s)/entities intends to file an IPR application utilizing results of research or biological resources transferred by another Section 3(2) entity, the applicant must seek prior approval from the NBA before the patent is granted. To comply with the requirements of the BD Act, the transferee must submit an application in Form-6 to the NBA.

Form-6 is specifically designed for applicants who wish to obtain approval for the use of biological resources or TK in relation to IPR applications, where such resources or knowledge have been transferred between individuals or entities.

88) What is the process for a seed company to transfer accessed biological resources or associated knowledge to a third party, sister company, or group member for research or commercial use?

In the event of sharing biological resources/transfer of knowledge with the sister companies involved in the same business activities located outside or inside for undertaking research, the company that applies to NBA should provide their details in the application as co-applicant(s) in Form-1. If the same research activities are undertaken by all the sister concerns using the same biological resources, the above scenario will be applicable. However, the NBA will decide on a case-by-case basis.

In the event of sharing/transfer of results of research with sister companies (with co-applicants) in or outside India for undertaking further research by the sister companies, no approval is required separately from NBA as they are all applied in Form-1.

In the event of sharing biological resources with the sister companies located in or outside India for commercial utilization, the company who applies to NBA should provide their sister companies in the application as co-applicant in Form-2.

89) Does a company need to apply for approval to send samples outside India for a genotyping study? The transferee has a stake in the resources and research/results.

If the companies in question are covered under Section 3(2) of the Act, then both the transferor and the transferee have to obtain the prior approval of the NBA for accessing the biological resources for research, including genotyping, by applying in Form-1.

If the company (transferor) sending the samples outside India is a Section 7 entity, then the receiving company (transferee) shall need to obtain the prior approval of NBA by applying in Form-1 as per Rule 13 of the BD Rules, 2024.

90) Does restructuring within a corporate group (merger, demerger) require fresh NBA approval for already accessed biological resources?

After merger or demerger in the company requires proper intimation to the NBA / SBB is required within 90 days from the completion of that event, from an authorized person of the company who obtained approval from the NBA/SBB. NBA shall decide whether this Agreement shall be amended or a fresh approval is required. The NBA’s decision in this regard shall be final.

91) 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.

92) What is the benefit-sharing obligation for transferring the results of research to a Section 3(2) entity, when such research was undertaken under a sponsored project, and no funding is available for benefit sharing?

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.

93) 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.

94) Are the biological resources notified under Section 40 of the BD Act exempt from the various provisions of the BD Act, particularly in relation to IPR?

The biological resources notified under Section 40 of the BD Act are exempted when normally traded as commodities. However, obtaining IPR for the inventions based on the use of such notified biological resources is not exempt from the provisions of the Act.

95) What are the forms applicable for IPR?

96) Under what circumstances does the NBA initiate proceedings for a contravention of the BD Act regarding IPR?

• If the applicant seeks approval from the NBA after the grant of the patent in or outside India, it shall be treated as a contravention of Section 6 of the BD (Amendment) Act, 2023.
• If a Section 3(2) (person/entity), after obtaining prior approval, access or utilise any biological resource other than those specified in the e-form application, it shall be treated as a contravention of the Act.
• If a Section 7 (person/entity) commercialises the patent without prior approval of the NBA, it will be treated as a contravention as per Section 6(1B) of the Act read with Rules 16 (3) of the BD Rules, 2024.

97) What are the prescribed forms for a Section 3(2) entity to obtain IPR approval from the National Biodiversity Authority?

A Section 3(2) person/entity needs to apply in Form- 1 for accessing the biological resources for research, and upon its approval, applications in Forms 6 and 7 are to be submitted for obtaining the IPR and its commercialization, respectively.

98) When and how to notify the NBA about the grant of a patent by Section 7 applicant(s) (India or abroad)?

As per the provisions of the BD Act, any person covered under Section 7 who has applied for IPR or a patent based on biological resources obtained from India is required to register with the NBA. Once the patent has been granted, whether the grant occurs within India or in a foreign country, this intimation must be made within 45 days from the date on which the patent is granted. The notification should be sent via email, addressed to the NBA, and must clearly include relevant details such as patent number, date of grant and the country of grant of the patent.

99) Can the NBA Issue a ‘no objection certificate’ without filing any application?

No, the NBA does not issue a ‘no objection certificate’ (NOC) under the provisions of the BD Act and the corresponding BD Rules. Instead of issuing NOCs, the NBA operates through a defined set of electronic forms (e-forms) for specific activities stipulated in the Second Schedule to the BD Rules.

100) When and who should approach the NBA for IPR-related Forms?

Any individual or entity seeking a patent or any other IPR involving biological resources or associated TK from within or outside India must approach the NBA. The applicant must submit the necessary application to the NBA before the grant of patent.

101) Whether access to biological resources, which are normally traded as commodities (NTAC), is exempted from NBA approval for IPR?

No, permission is required for the biological resources notified as NTACs if they are utilized in IPR as per Section 40.

102) 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.

103) I am based in Europe and propose to access turmeric from the market Outside India for research. Whereas the country of origin of turmeric is India, and I intend to apply for a patent in Europe and other jurisdictions. What are my obligations under the BD Act?

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.

104) 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.

105) If a person acquires biological resources or associated TK from outside India which is of foreign origin for research, commercial utilization, or for obtaining IPR in India, does the applicant need approval from the NBA?

If an applicant acquires biological resources or associated TK from outside India for purposes such as research, commercial utilization, or seeking lPR in India, they are required to submit a declaration under Form-10 to the NBA. This declaration ensures that the NBA is notified of any access to biological resources or TK of foreign origin.

106) Does a company's obtaining approval under the PPVFR Act require approval of the NBA for the activities envisaged under the BD Act?

No. As per Section 59A of the Act, the provisions of the BD Act shall not apply to a person who has been granted approval or rights under the PPVFRA, to the extent that such approvals or rights do not require similar approval under the BD Act.

107) Whether the biological resources used for standards, controls, or reference purposes (e.g., national or zonal checks) are exempted from the ABS provisions?

Yes, when Indian biological resources are used solely as standards such as national checks, zonal checks, or other commercial reference varieties, they are exempted from the ABS requirements, as these uses do not involve commercial utilisation of biological resources.

108) Do the provisions relating to ABS apply when the biological resources, such as pests, insects, pathogens, or plants, are used merely as research tools for testing innovations or for meeting the regulatory requirements?

No. The use of biological resources solely as research tools, for example, pests, insects, pathogens, or plants used in testing new seed varieties, pesticides, or biotechnology products, or for fulfilling regulatory requirements, does not attract ABS obligations because the biological resource itself is not the subject of research or commercial utilisation. Rather, it is only being used as a testing or validation tool.

109) Whether access to commercially available plant varieties used exclusively as internal check genotypes for comparative trials requires prior approval from the NBA?

No, when biological resources are used solely as research tools for internal check genotypes for comparative trials, testing purposes and fulfilling regulatory requirements (e.g., evaluating a new seed variety, pesticide, or biotech product), it won't require approval of NBA/SBBs.

110) Whether biological resources such as insects, fungi, micro-organisms, weeds, pests, and pathogens, when collected and used solely for checking the efficacy of newly developed products on them, require prior approval from the NBA?

No, when biological resources are used solely as research tools for testing purposes and fulfilling the regulatory requirements (e.g., evaluating a new seed variety, pesticide, or biotech product), it won't attract ABS obligations, as these uses do not constitute research or commercial utilisation on the biological resource itself.

111) Whether domestic approval (from NBA or SSB) is required for using international germplasm obtained under SMTAs or MTAs from institutions like USDA, IRRI, or AVRDC in compliance with the provisions of the ITPGRFA?

No. If germplasms are accessed from international institutions under the Standard Material Transfer Agreements (SMTAs) in compliance with the provisions of the ITPGRFA, then such access is exempted from the provisions of Sections 3 and 4 of the BD Act as per the MoEFCC notification no S.O. 3232(E)., dated 17.12.2014. However, such germplasm/accession belonging to the crop has to be notified by the Department of Agriculture and Cooperation, Government of India, from amongst the crops listed in Annex-1 of the ITPGRFA.

112) 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.

Disclaimer: All possible care has been taken and best efforts have been made to provide correct information in response to the likely frequently asked questions (FAQs). However, in case of any clarifications or inconsistencies on any of the responses, and for correct interpretation, the respective Legislations, Rules, Regulations, International Conventions and Protocols, etc., may be referred to. Responses to the FAQs are for general information on the various provisions of the BD Act.