The Biological Diversity Act, 2002 (BDA 2002), was enacted with the objective of conservation and sustainable use of biological resources. Over the years, several concerns were raised by stakeholders with respect to the stringency of compliance imposed by BDA 2002.  To address these concerns, the Biological Diversity (Amendment) Act, 2023 (BDA, 2023) came into force on April 01, 2024, with key features including: (i) decriminalization of offences under the Act; (ii) logical categorization of Indian and non-Indian entities; (iii) ease of restrictions imposed by the NBA on Patent Applications filed by Indian entities;(iv) restricting the transfer of research results or biological resources to non-Indian entities.

The non-Indian entities (covered under Section 3(2) of BDA, 2023), will require prior approval from NBA to access biological resources occurring in India for research, commercial utilization, bio-survey and bio-utilization. On the other hand, the Indian entities (covered under Section 7 of BDA, 2023), will not require prior approval from NBA or State Biodiversity Boards (SBB) to access biological resources occurring in India for research. However, Indian entities need to intimate SBB for accessing any biological resource for commercial utilization.  

Similarly, the compliance is different for Indian and non-Indian entities while applying for Intellectual property rights based on biological resources accessed from India. As per Section 6(1) of the BDA, 2023 the non-Indian entities are required to get approval from NBA before the grant of the patents for any invention based on biological resource which is accessed from India. The Indian entities, on the contrary, are not required to get approval from NBA before the grant of the patents. However, the Indian entities are required to register with the NBA before grant of such Patents as per Section 6(1A) of BDA, 2023. Having said that, as per Section 6(1B) of BDA, 2023, the Indian entities are required to obtain prior approval of the NBA at the time of commercialization of patents.

The processes for obtaining approval from the NBA by Indian as well as the non-Indian entities would further be streamlined with the coming into effect of the Biological Diversity Rules, 2024 after December 21, 2024 (Rules, 2024). Rules 2024, furnish detailed procedures for obtaining approvals from the NBA by non-Indian entities for accessing biological resources for the purpose of research, bio-survey, bio-utilization, commercial utilization or for applying for Intellectual property rights based on Indian biological resources. Further, Rules 2024 provide the revised fees and forms in the First and Second schedules, respectively. Together, the BDA, 2023, and the Rules 2024, provide an orchestration for management of India’s biological resources with due consideration to the interests of stakeholders as well as the local communities.

[The author is a Executive Director in IPR practice at Lakshmikumaran & Sridharan Attorneys]