FAQ's

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.

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.

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).

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.

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.

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.

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.
    

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.