FAQs

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.

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.

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.

• 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}

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.

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. 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. If the transferee {Section 3(2) entity} wants to utilise the obtained results of research for further research, they need to register with the NBA in Form-4.
• Similarly, for further commercial utilisation of the results of the research, prior approval of the NBA has to be obtained in Form-5. For obtaining any IPR within or outside India, prior approval from the NBA is required in Form-6 as per Rule 15 of the BD Rules,2024.
• In the case of accessing biological resources along with the obtained results of research for further research, prior approval from the NBA is required in the application in Form -1.

No. Section 4 exempts publication of research papers on any biological resources occurring in or obtained or accessed from India or dissemination of knowledge in any seminar or workshop involving financial benefit, provided such publication or dissemination is in conformity with the guidelines issued by the Central Government.

The Act does not recognise a category called 'company-owned material', while dealing with biological resources. Hence the recipient/user of the biological resource needs to obtain approval of NBA under Section 3 of the Act if the biological resources contain any strain of an Indian germplasm.

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.

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.

In the event of sharing biological resources/transfer of knowledge with the sister companies involved in the same business activities located outside or inside for undertaking research, the company that applies to NBA should provide their details in the application as co-applicant(s) in Form-1. If the same research activities are undertaken by all the sister concerns using the same biological resources, the above scenario will be applicable. However, the NBA will decide on a case-by-case basis.

In the event of sharing/transfer of results of research with sister companies (with co-applicants) in or outside India for undertaking further research by the sister companies, no approval is required separately from NBA as they are all applied in Form-1.

In the event of sharing biological resources with the sister companies located in or outside India for commercial utilization, the company who applies to NBA should provide their sister companies in the application as co-applicant in Form-2.

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.

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.

The applicant shall be liable to pay up to 5.0% of the monetary benefit received from the transferee, as a benefit-sharing amount, as determined by the NBA on a case-by-case basis.

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.

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 biological resources notified under Section 40 of the BD Act are exempted when normally traded as commodities. However, obtaining IPR for the inventions based on the use of such notified biological resources is not exempt from the provisions of the Act.

• If the applicant seeks approval from the NBA after the grant of the patent in or outside India, it shall be treated as a contravention of Section 6 of the BD (Amendment) Act, 2023.
• If a Section 3(2) (person/entity), after obtaining prior approval, access or utilise any biological resource other than those specified in the e-form application, it shall be treated as a contravention of the Act.
• If a Section 7 (person/entity) commercialises the patent without prior approval of the NBA, it will be treated as a contravention as per Section 6(1B) of the Act read with Rules 16 (3) of the BD Rules, 2024.

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.

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.

No, the NBA does not issue a ‘no objection certificate’ (NOC) under the provisions of the BD Act and the corresponding BD Rules. Instead of issuing NOCs, the NBA operates through a defined set of electronic forms (e-forms) for specific activities stipulated in the Second Schedule to the BD Rules.

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.