Decoding the New Regime for Biodiversity Access Benefit Sharing

With the approval of the Central Government, the National Biodiversity Authority (NBA) has notified new Regulations on April 29, 2025, to regulate various aspects of benefit sharing for access to biological resources (BR) or associated knowledge (AK). These regulations are built on the Biological Diversity Act of 2002 as amended in 2023 (‘BD Act’) and the newly introduced Biological Diversity Rules, 2024 (‘BD Rules’). The new Regulation of 2025 replaces the old Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014.

The new Regulations basically reshape the manner in which financial obligations of the users of genetic resources are to be determined for each of the activities [namely, research or commercial utilisation or transfer of results of research or intellectual property rights (IPR)] for which biological resources are obtained and also how these benefits are to be shared. The new Regulations came into effect on April 30, 2025.

For a comprehensive understanding, the new Regulations are to be read with the BD Act/ Rules. Foreign citizens, NRIs or a foreign entity or a foreign-controlled entity registered in India are classified as Section 3(2) person or user of biological resources (BR). On the other hand, Indian citizens or an entity registered in India are referred to as a Section 7 person or user of BR. Thus, only companies under foreign control fall under Section 3(2) and Indian-controlled companies are exempted from Section 3(2).

A summary of relevant clauses under the new Regulations in respect of Access & Benefit Sharing (ABS) for various activities is listed as under:

(^#Form B is prescribed in the new Regulation)

ABS for DSI: There is no explicit mention of ‘digital sequence information’ (DSI) in the BD Amendment Act 2023 and the old ABS Guidelines 2014. However, BD Rules 2024 clearly provide that NBA approval will be required for the commercialisation of IPR for any invention based on DSI accessed from India. Further, the new Regulation of 2025 explicitly includes DSI within the ambit of ‘biological resource’ for the purpose of ABS obligations, and users of DSI will now be liable to pay the benefit sharing amount for each of the prescribed activities.

Another significant change is in the computation of the ABS amount for different activities. In particular, the old Guidelines of 2014 contained two modes for the calculation of ABS amount for commercial utilisation – resource value basis (percentage of the purchase price of BR) and/or product value basis (graded percentages of the annual gross ex-factory sale of the product). However, the new Regulation primarily adopts product value formulae and modifies them as ‘graded percentages of the annual gross ex-factory sale of the product based on the annual turnover of the person or entity’. The new Regulation also removes the distinction between trader and manufacturer applicants for ABS obligations/ calculations.

The benefit sharing by a user applicant may be in monetary and/ or non-monetary modes. 8 options for monetary ABS (including upfront payment) and 14 options for non-monetary ABS have been indicated in Form F of the new Regulations. Either one or more options may be applied in accordance with mutually agreed terms between the applicant and the NBA. In the event of a contribution to a non-monetary benefit as mutually agreed, the monetary benefit sharing obligation may be reduced by the NBA. It may also be noted that the amount of benefit sharing shall remain the same whether the product contains one or more biological resources. Regulations 3, 4, 5, 7, 8 and 9 basically provide an exhaustive framework of monetary benefit sharing for various purposes/ activities, and these are outlined as under:

ABS for specified activities under the new Regulation

1. For research or bio-survey and bio-utilisation under section 3 of the BD Act

Foreign entities (Section 3(2) person) shall apply for prior approval of the NBA for access in Form-1. If BR/DSI/AK has conservation value or high economic value, it is accessed for research or for bio-survey and bio-utilisation, the benefit sharing, including the upfront payment, may be determined by the NBA. These valued BR include red sanders, sandalwood, agarwood or any other items as decided by NBA and threatened species notified under Section 38 of the BD Act. If other BR/DSI/AK is accessed for research or for bio-survey and bio-utilisation, NBA may also require upfront payment on a case-by-case basis. However, if BR/DSI/AK is accessed for conducting academic research, the NBA may waive the benefit sharing, including the upfront payment.

2. For commercial utilisation

Foreign entities (Section 3(2) person) shall apply for prior approval of the NBA for access in Form 2. If BR/DSI/AK is accessed for commercial utilisation, the applicant shall have to pay the benefit sharing amount as per Table 1 below:

Table 1: Benefit Sharing Linked to Turnover

Indian entities (Section 7 person) shall give prior intimation to the State Biodiversity Board or Biodiversity Council for access in Form B. If BR/DSI/AK is accessed for commercial utilisation, the applicant shall have to pay the benefit sharing amount as per Table 1 above.

Mandatory reporting: Any person/ entity (foreign or Indian) with an annual turnover of less than 5 crore will not have to share benefits. However, any person/ entity (foreign or Indian) with an annual turnover of more than 1 crore shall submit an annual statement containing information on BR consumed in the Financial Year in Form A of the Regulations.

Higher ABS for valued BR: If BR has a conservation value or high economic value and is accessed for commercial utilisation by any person/ entity (foreign or Indian), the benefit sharing component shall be 20% more than the amount due as per Table 1. In such cases, however, the benefit sharing as an upfront payment shall not be less than 5% of the proceeds of the auction or sale amount or the purchase price. The valued BR includes red sanders, sandalwood, agarwood or any other items as decided by NBA and threatened species notified under Section 38 of the BD Act.

Exemption for cultivated medicinal plants: The new Regulation exempts Indian entities (Section 7 person) in the case of access to cultivated medicinal plants as notified under Section 40 of the BD Act [see Notification dated 07.04.2016 and amendments dated 07.11.2017]. The applicant claiming such exemption shall apply in Form-11 to obtain a certificate of origin. Moreover, for Indian entities (Section 7 person) manufacturing products containing both cultivated and non-cultivated medicinal plants, the benefit-sharing payment shall not be payable for the products as notified by the Central Government. These exemptions are aligned with the Biological Diversity (Amendment) Act, 2023, which seeks to reduce the pressure on wild medicinal plants by encouraging the cultivation of medicinal plants.

3. For sharing or transferring results of research relating to BR/ATK

Any person/ entity (transferor) intending to share or transfer any result of the research to a Section 3(2) person or foreign entities (transferee) shall apply for prior approval of the NBA in Form-3 for commercial purposes or otherwise. The transferor shall pay such monetary benefit or share non-monetary benefit, as agreed between him and the NBA. On such a transfer, the transferor shall pay to the NBA up to 5% of the monetary consideration, if any, received by him.

Section 3(2) person or foreign entities (transferee) intending to use the results of research for commercial utilisation shall apply for prior approval of NBA in Form-5. The transferee shall pay the benefit sharing amount as per Table 1 above.

4. For the commercialisation of IPR

• Foreign entities (Section 3(2) person) intending to use the results of research for obtaining IPR shall apply for prior approval of NBA in Form-6.
• Foreign entities (Section 3(2) person) applying for an IPR (in or outside India) for any invention based on any research or information on BR/DSI/ATK, which is accessed from India, shall apply for prior approval of NBA in Form-7 before the grant of IPR.
• Indian entities (Section 7 person) applying for an IPR (in or outside India) for any invention based on any research or information on BR/DSI/ATK which is accessed from India shall register with NBA before the grant and shall intimate NBA within 45 days of the grant of IPR. At the time of commercialisation of IPR, such applicant shall apply for prior approval of NBA in Form-9.

In each case above, where the applicant himself uses the IPR for commercialisation, the monetary benefit sharing shall be in the range of up to 1% of the annual gross ex-factory sale minus government taxes. If the applicant assigns or licenses to a third party for commercialisation, the applicant shall pay up to 5% of the license or assignee fee received and up to 5% of the royalty amount received annually from the assignee or licensee. All rates/ amounts will be based on a sectoral approach, on a case-by-case basis. Moreover, if the traditional knowledge (TK) is involved in the invention, the benefit sharing obligation shall be 25% higher than the benefit sharing due.

Special consideration may be given to cases where access to BR/DSI/AK is for technologies/ innovations/ products that are developed, leading to IPR for controlling epidemics, mitigating environmental pollution affecting human, animal or plant health, or for food security or conservation of biodiversity. In such cases, the benefit sharing may be at a lower percentage in the range.

Lastly, regulation 10 is also a new addition, which provides that any Indian researcher or scientist who has discovered a novel microbial strain from India and intends to deposit the same in the repositories outside India for publication in journals for claiming novelty, shall give prior intimation to the NBA in Form E of Regulations. Section 3(2) person (foreign entities) can access microorganisms deposited with the repository by obtaining the necessary approvals from the NBA.

In sum, the new Regulations streamline and update the existing regime of ABS in light of recent changes in the BD Act/ Rules, and they would enable BR users to refine their business planning. The procedure and calculus of ABS depend on a multifactorial matrix including the legal status of the user (Indian or foreign) and its financials (turnover and product sales), nature of the sector and technology, potential commercial use of the proposed activity, ecological impact, usage of any valued BR, etc. As the Regulations have just been released, their practical implementation will be crystallised more in the coming days.

Authors: Manisha Singh (Partner) & Neha Ruhela (Associate Partner)