भारत सरकार | GOVERNMENT OF INDIA

FAQs

101. Whether access to biological resources, which are normally traded as commodities (NTAC), is exempted from NBA approval for IPR?

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

102. Should the name of the applicant and the biological resources mentioned in IPR applications (Forms 6-9) be the same as in the patent application?

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.

103. I am based in Europe and propose to access turmeric from the market Outside India for research. Whereas the country of origin of turmeric is India, and I intend to apply for a patent in Europe and other jurisdictions. What are my obligations under the BD

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.

104. Whether permission of the NBA is required for IPR if a biological resource is procured from the market or a trader?

Yes, permission from the NBA is required even if a biological resource is procured/ accessed from the market or a trader.

105. If a person acquires biological resources or associated TK from outside India which is of foreign origin for research, commercial utilization, or for obtaining IPR in India, does the applicant need approval from the NBA?

If an applicant acquires biological resources or associated TK from outside India for purposes such as research, commercial utilization, or seeking lPR in India, they are required to submit a declaration under Form-10 to the NBA. This declaration ensures that the NBA is notified of any access to biological resources or TK of foreign origin.

106. Does a company's obtaining approval under the PPVFR Act require approval of the NBA for the activities envisaged under the BD Act?

No. As per Section 59A of the Act, the provisions of the BD Act shall not apply to a person who has been granted approval or rights under the PPVFRA, to the extent that such approvals or rights do not require similar approval under the BD Act.

107. Whether the biological resources used for standards, controls, or reference purposes (e.g., national or zonal checks) are exempted from the ABS provisions?

Yes, when Indian biological resources are used solely as standards such as national checks, zonal checks, or other commercial reference varieties, they are exempted from the ABS requirements, as these uses do not involve commercial utilisation of biological resources.

108. Do the provisions relating to ABS apply when the biological resources, such as pests, insects, pathogens, or plants, are used merely as research tools for testing innovations or for meeting the regulatory requirements?

No. The use of biological resources solely as research tools, for example, pests, insects, pathogens, or plants used in testing new seed varieties, pesticides, or biotechnology products, or for fulfilling regulatory requirements, does not attract ABS obligations because the biological resource itself is not the subject of research or commercial utilisation. Rather, it is only being used as a testing or validation tool.

109. Whether access to commercially available plant varieties used exclusively as internal check genotypes for comparative trials requires prior approval from the NBA?

No, when biological resources are used solely as research tools for internal check genotypes for comparative trials, testing purposes and fulfilling regulatory requirements (e.g., evaluating a new seed variety, pesticide, or biotech product), it won't require approval of NBA/SBBs.

110. Whether biological resources such as insects, fungi, micro-organisms, weeds, pests, and pathogens, when collected and used solely for checking the efficacy of newly developed products on them, require prior approval from the NBA?

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.

111. Whether domestic approval (from NBA or SSB) is required for using international germplasm obtained under SMTAs or MTAs from institutions like USDA, IRRI, or AVRDC in compliance with the provisions of the ITPGRFA?

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.

112. Who prepares the biodiversity strategies and action plans for our Country/State(s)?

As per Section 36 of the BD Act, 2002, the Central Government (Ministry of Environment, Forest and Climate Change) shall develop national plans for the conservation, promotion and sustainable use of biological resources. The State Government shall develop state plans for the conservation, promotion and sustainable use of the biological diversity in conformity with the national strategies, plans and programmes, as per Section 36B of the amended BD Act.

In October, 2024, India’s updated national biodiversity strategy and action plan was prepared in alignment with the Kunming-Montreal Global Biodiversity Framework. India released the same in the side event of the COP-16 meeting at Cali, Colombia.