FAQ's

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.

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.

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.

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.

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.

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.

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.

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.

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.

• 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.
   

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_{* 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}

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.

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

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.

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.

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.

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.

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

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

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.

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.