The Biological Diversity (Amendment) Act, 2023, which came into force on April 1, 2024, introduced notable alterations to the Biological Diversity Act, 2002. In furtherance to it, on October 25, 2024, the Ministry of Environment, Forest and Climate Change notified the Biological Diversity Rules, 2024, which will supersede the Biological Diversity Rules, 2004. These amended Rules, effective from December 24, 2024, aim to strengthen the monitoring and regulation of the use of biological resources and associated traditional knowledge while promoting research and development in traditional medicine and medicinal plant cultivation.

Some of the major revisions made in the Rules are:

– Changes related to the National Biodiversity Authority (‘Authority’):

• Term of office of the Chairperson: The amended Rules clarify that the term of the chairperson is three years from the date of publication of appointment.
• Pay and allowances of the Chairperson: The fixed monthly salary of Rs. 26,000 for the Chairperson has been replaced with a pay equivalent to that of a Secretary to the Government of India.
• Filling of vacancies of non-official Members: Under the amended Rules, non-official members have to give a month’s notice to the Central Government, under intimation to the Chairperson, in case they wish to resign. The 2004 Rules did not provide for such notice period.
• Member-Secretary: Member-Secretary is a full time Secretary of the Authority, or of the State Biodiversity Board or of the Union territory Biodiversity Council. The Member-Secretary is now a member of the Authority, appointed by the Central Government. The terms and conditions of the appointment is also determined by the Central Government. Previously, the Secretary was not considered a member of the Authority and was appointed by the Authority. The Member-Secretary’s pay is now set to be equivalent to that of a Joint Secretary to the Government of India.
• Meetings of Authority: In addition to four annual meetings, a special meeting can be called by the Chairman upon a written request from minimum six members of the Authority or upon a direction of the Central Government. Previously five members were required. The required quorum for Authority meetings has increased from five to seven. The amended Rules also provide for emergency meetings to address urgent matters.
• General functions of Authority: The Authority now has broader responsibilities, including:
  • administering the National Biodiversity Fund;
  • deciding the format and contents of the mutually agreed terms of the various agreements executed between the parties embodying the approvals of the Authority;
  • specifying the electronic and manual formats of the People’s Biodiversity Register and laying down the procedure for documentation biodiversity-related information;
  • providing legal advice and clarifications to the State Biodiversity Boards or Union territory Biodiversity Councils;
  • offering guidance and technical support to the Biodiversity Management Committees (BMC) for validation and maintenance of Biodiversity Registers;
  • creating awareness and organising training and capacity building programmes for all stakeholders, including the line departments and academic, scientific and research institutions, to meet the objectives of the Act;
  • adjudicating disputes of State Biodiversity Boards and Union territory Biodiversity Councils referred by the Central Government;
  • setting model guidelines for adjudicating disputes of BMS by the State Biodiversity Boards or Union territory Biodiversity Councils;
  • developing procedures for seeking exemption under Section 7(1) of the Act on production of a certificate of origin of cultivated medicinal plants;
  • suggesting guidelines for framing rules by the State Government or Union territory Administration for conservation and management of the areas of biodiversity importance notified as biodiversity heritage sites;
  • formulating model guidelines for collection of fee by the BMC for accessing biological resources from their jurisdiction;
  • facilitating the BMC for providing prior informed consent by the local communities for access to biological resources and the associated traditional knowledge;
  • developing an online information technology portal for the discharge of its various functions under the Act in a transparent and accountable manner;

– Application Filing: Notably, the 2023 amendment of the Act expanded the scope of approval required from the Authority, essentially making prior approval from the Authority a mandatory requirement before the grant of Intellectual Property Rights (IPR) only for those applicants who fall under the purview of Section 3(2) of the Act i.e. non-citizens, non-resident citizens, body corporate not registered in India, and body corporate registered in India which is controlled by a foreigner. Indian nationals and Indian-controlled body corporates, after the amendment of the Act, are required to register with the Authority before the grant of IPR and are only required to obtain approval when the IPR so obtained is to be commercialized. The amended Rules ensure the implementation of the Biological Diversity (Amendment) Act, 2023

Individuals and organizations seeking access to biological resources and associated traditional knowledge, seeking approval for sharing or transferring results of research relating to biological resources and associated traditional knowledge, seeking approval before the grant of IPR for inventions related to biological resources and associated traditional knowledge, seeking registration before obtaining IPR for inventions related to biological resources and associated traditional knowledge, seeking approval for commercialization of IPR related to biological resources and associated traditional knowledge, etc. are now required to apply through the web portal of the Authority, accompanied with a specified fee paid in the form of electronic transfer or digital payment to the National Biodiversity Fund. Previously the fee was required to be paid in the form of a cheque or demand draft drawn in favour of the Authority. The amended Rules also require the Authority to publicise all the approvals granted or rejected on its website and also ensure that such information is shared with other agencies if required.

– Inclusion of Digital Sequence Information: The amendment has brought digital sequence information on biological resources within the ambit of the Rules. Now, when an invention is based on research or information including digital sequence information on biological resource which is accessed from India, including those deposited in repositories outside India, or associated traditional knowledge associated, prior approval of the Authority or registration with the Authority, as the case may be, will be needed.

– Consideration of Emergency Situations (e.g., Epidemics and Pandemics): The amended Rules grant the Chairperson of the Authority additional powers to act on behalf of the Authority in granting expedited approvals under Sections 3, 4, and 6 of the Act, particularly in the event of imminent emergencies that threaten human, animal, or plant health. After grating these approvals, the Chairperson is required to present them before the next meeting of the Authority for approval. The amended Rules also provide that the Authority may process the applications for access to biological resources and associated traditional knowledge expeditiously without consultation with the BMC in cases of present or imminent emergencies situation

The amended Rules also outline a procedure for conducting non-commercial research or research for emergency purposes to address certain present or imminent emergencies outside India by Indian researcher or institution.

– Timeline for grant of approvals: The amended Rules require the Authority to take a decision on granting or denying approval:

• For access to biological resources and associated traditional knowledge within a period of ninety days from the receipt of the application, after consultation with the BMC either directly or through State Biodiversity Board or Union territory Biodiversity Council. Previously the time period was six months and consultation with the local bodies was required. With the amended Rules, it is up to the BMC to consult with the concerned community, individual or entity to whom the bio-resource belongs to, before conveying its views to the Authority. The amended rules additionally provide that if the applicant fails to provide the requisite information sought by the Authority within thirty days from the date it was sought, the application will be closed. Similarly, if the applicant does not sign the agreement of the grant of the approval within a period of sixty days from the date of communication of the draft agreement by the Authority, the application will be deemed closed. If the application is deemed closed when the applicant fails to sign the agreement within the prescribed time, the applicant has an option to revive the application by paying half the fee specified for fresh application within a period of ninety days.
• For sharing or transferring results of research relating to biological resources and associated traditional knowledge within a period of ninety days from the receipt of the application. The 2004 Rules also prescribed the same time period; however, the amended Rules prescribe time restraints on the applicant for providing the requisite information and signing the agreement of the grant (same as mentioned for applicants seeking access to biological resources and the same recourse for revival of the application is available).
• Before grant of IPR, registration before obtaining IPR and commercialization of IPR within a period of one hundred and eighty days from the date of receiving the application or from the date the requisite information is received, whichever is later. Previously the time period was three months from due appraisal of the application and after collecting additional information, if any. The amended rules additionally provide that if the applicant seeking prior approval before grant of IPR fails to provide the requisite information sought by the Authority within ninety days from the date it was sought, the application will be closed. If the applicant (seeking approval before grant or seeking registration or approval for commercialization) does not sign the agreement of the grant of the approval within a period of ninety days from the date of communication of the draft agreement by the Authority, the application will be deemed closed. If the application is deemed closed when the applicant fails to sign the agreement within the prescribed time, the applicant has an option to revive the application by paying half the fee specified for fresh application within a period of ninety days. The applicant is also required to intimate the Authority within forty-five days from the date of the grant of the IPR related to the application, failing which the competent authority may take appropriate action.

– Procedure for obtaining a certificate of origin for cultivated medicinal plants: Under the amended Rules, a person referred in Section 7 seeking an exemption to access cultivated medicinal plants under Section 7(2) of the Act is required to submit a self-declaration to obtain a certificate of origin from the concerned BMC. The fee of the application is to be paid by the applicant to the Local Biodiversity Fund. The timeline for the issuance of the certificate of origin is fifteen days. If the certificate is not issued by BMC within fifteen days, the applicant may approach the State Biodiversity Board, which is mandated to resolve the issue within seven days. If a dispute arises between the applicant, BMC, or State Biodiversity Board, the matter will be referred to the Authority, whose decision will be final.

– National Biodiversity Fund: The amended Rules provide that the benefit sharing, that is to be earmarked for the Authority, State Biodiversity Boards or Union Territory Biodiversity Council, may range from minimum of ten percent to maximum of fifteen percent, as the case may be, and rest may be transferred to benefit claimers or for other uses when benefit claimers are not identified.

– The 2023 amendment of the Act dispensed with the punishment of imprisonment and limited the punishment to fine of up to fifty lakh rupees. Additionally, an adjudicating officer, not below the rank of Joint Secretary to the Government of India or a Secretary to the State Government, has been given the power to impose an additional penalty of up to one crore rupees in certain cases. The amended Rules establish the manner of inquiry by the Adjudicating Officer. The Rules also provide the list of factors to be considered by the Adjudicating Officer for determining the quantum of penalty. First, the amount of unfair gain or advantage, if measurable, obtained from violating the provisions of the Act will be considered. The penalty for violations under section 55 of the Act will not be less than one lakh rupees and may extend to fifty lakh rupees. If the damage caused exceeds the penalty amount, the penalty will be adjusted to align with the extent of the damage, which includes harm to the environment, biological resources, and products derived from them due to the violation. In cases of failure to comply or continued violations, an additional penalty of up to one crore rupees may be imposed, on top of the initial penalty. The Adjudicating Officer may also consider other factors that are relevant to the conservation of biodiversity and environmental protection. Additionally, the penalty imposed by the Adjudicating Officer will be in addition to any liability for relief or compensation under section 55 of the Act or section 17 of the National Green Tribunal Act, 2010. Any person aggrieved by the order of the Adjudicating Officer may prefer an appeal to the National Green Tribunal.

The amended Rules require the penalty amount realised under the Rules to be deposited in the National Biodiversity Fund and the penalty amount relating to offences under Section 7 of the Act to be deposited in the Biodiversity Fund of the concerned State Biodiversity Board or the Union territory Biodiversity Council.

The Biological Diversity Rules, 2024, represent a significant step forward in strengthening the framework for the conservation and sustainable use of biological resources in India. By refining the operational guidelines for the National Biodiversity Authority and other associated bodies, these amendments aim to streamline processes, enhance transparency, and ensure better compliance with the provisions of the Biological Diversity Act, 2002. The inclusion of digital sequence information and expedited procedures for emergency situations further underscores the dynamic approach adopted to address contemporary challenges. As these rules come into effect, they are expected to foster greater accountability, promote research and innovation, and contribute to the overall goal of biodiversity conservation and sustainable development.