The Biological Diversity Act, 2002 (the “Act”) primarily regulated the sustainable use of biological resources of India, and the equitable sharing of benefits arising out of the use of biological resources. The Act also aimed at conserving and using biological diversity sustainably, and obligated foreign nationals and organizations to obtain prior approval of National Biodiversity Authority (“NBA”) for the use of biological resources.

The Indian Parliament has amended the Act, through the Biological Diversity (Amendment) Act, 2023 (the “amended Act“). The amended Act came into force on 3^rd August 2023. The amended Act streamlines inter alia the patent filing process for inventions which utilize Indian biological resources, and promotes the use of indigenous medicine. In addition, the amended Act protects commercial interest of local communities by sharing benefits of biodiversity commerce with locals and decriminalises biodiversity-related offences. Some of the significant amendments to the Act, include the following:

1. The amended Act clearly lists out the category of persons who do not require prior approval from the NBA to seek Intellectual Property Rights (“IPR”) protection. Nevertheless, such applicants are required to register themselves with the NBA before the grant of IPR. Certain foreign entities (i.e., non-citizens, non-resident citizens, organizations not registered in India, organisations registered in India with no Indian shareholder, etc.) will nevertheless be required to obtain approval from NBA before filing applications for IPRs.
2. Parties are required to intimate the concerned State Biodiversity Boards and seek prior approval from the NBA before the commercialization of their IPRs which involve biological resources. Parties can access biological resources and the related know-how for commercial utilization, only after obtaining approval from the NBA
3. The amended Act has revised the penalty for contravention of the provisions of the Act,with the minimum penalty being INR One Lakh (i.e., around USD 1,200) and up to a maximum of INR Fifty Lakhs (i.e., USD 60,000). However, the penalty may be adjusted to commensurate with the damage caused. Additional penalties, may be imposed, for failure to comply, or for continued contravention. The amendment has omitted imprisonment, thereby decriminalizing contravention of the requirements stipulated in the Act. The amended Act also provides for the appointment of Adjudicating Officers, for holding investigation against errant parties/acts, and for determining the quantum of penalties on a case-to-case basis.