FAQ's

• 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.

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.

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

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.

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.
 

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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

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.

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.

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.