FAQ's

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.

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.

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.

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.

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.

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.

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.

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)).