On December 16, 2021, the Biological Diversity (Amendment) Bill, 2021 (“the Bill”) to further amend the Indian Biological Diversity Act, 2002 (“the Act”), was introduced in the Lok Sabha, the lower house of the Indian Parliament.
The Bill seeks to:
- encourage cultivation of medicinal plants;
- encourage the Indian system of medicine;
- facilitate fast-tracking of research, patent application process and transfer of research results while utilising the biological resources available in India without compromising the objectives of the United Nation’s Convention on Biological Diversity and its Nagoya Protocol;
- remove provision of imprisonment;
- encourage more foreign investments in the chain of biological resources, including research, patent and commercial utilisation, without compromising national interests.
The Bill appears to offer considerable reliefs over some of the existing burdensome provisions. Some key amendments suggested by the Bill are as follows:
- The definition of ‘biological resources’ (“BR”) has been amended to replace the term “by products” with “derivatives”. “Derivative” has further been defined as a naturally occurring biochemical compound or metabolism of biological resources, even if it does not contain functional units of heredity. The scope of actual or potential use or value of a BR has been stated to be “for humanity”.
- Bio utilisation has been excluded from the purview of the Act. Bio survey has been retained and redefined to extend the scope to survey or collection of any taxa and variety in addition to genes, components and extracts of biological resource.
- The concept of ‘Foreign Controlled Company’ has been introduced for ‘Section 3(2) entities’ to mean a foreign company under the Indian Companies Act, namely, a company or body corporate incorporated outside India. This replaces the previous phrase, “any non-Indian participation in its share capital or management” in Section 3(2), thus excluding organizations incorporated in India but having foreign participation.
- Applications for Intellectual Property Rights (IPR): Prior approval from the National Biodiversity Authority (NBA) before the grant of IPRs is done away with for Indian entities. It is now replaced with a simpler process of registration. Approval would be needed at the time of commercialization. For foreign companies, approval from NBA prior to grant of IPRs continues to be mandatory.
- For the purposes of IPR protection, the scope of biological resource has been expanded to mean not only those accessed from India, but also including those deposited in repositories outside India.
- Prior intimation to NBA for the purpose of bio-survey is no longer needed by Indian entities. It is still required for commercialization. Registered traditional medicine practitioners exempted from the purview of permissions under the Act.
- New provision to allow NBA or any other designated authority to monitor and regulate access and utilisation of biological resources obtained from a foreign country to meet India’s international obligations.
- Definition of Biological Resources normally traded as commodities (NTAC) under Section 40 has been slightly expanded to include agricultural wastes and medicinal plants. However for research, commercialization or bio-survey or where applications for IPRs have been filed based on such Biological Resources NTAC, approvals are required now.
- The harsh penal provision of possible imprisonment for contraventions under the Act, has been removed. However, amounts of financial penalty have been enhanced to be commensurate with the damage caused. There is substantial increase of the amounts for repeated offenses.