Prior to Convention on biological diversity (CBD), bio-resources were considered to be heritage of mankind and were shared freely among nations. India being a signatory to CDB, enacted the Biological Diversity Act, 2002 (hereinafter the Act) with the objective of conservation of Biological Diversity, sustainable use of its components and fair and equitable sharing of benefits arising out of the use of its biological resources, knowledge and for matters connected therewith or incidental thereto. For the effective implementation of the Act, National Biodiversity Authority (NBA) and State Biodiversity Board (SBB) were established, for regulating activities relating to access to biological resources and for fair and equitable benefit sharing. However, NBA is bound by the directions of the Central Government in exercise of its functions and duties under the Act (section 48).
The provisions of the Act have different restrictions and exemptions, depending on the person/entity involved or the activity envisaged with respect to bio-resources. Foreign nationals, non-resident Indians or body corporates as mentioned under section 3(2) of the Act, are required to obtain prior approval of NBA for obtaining any biological resource occurring in India or knowledge associated thereto for research or for commercial utilization or for bio-survey and bio-utilization. Provided under section 5, collaborative research projects are exempted from prior-approval of NBA. In case of obtaining intellectual property rights other than plant variety rights, in or outside India, for any invention based on any research or information on a biological resource obtained from India, has to obtain prior permission of NBA in the prescribed manner. Further, under section 7 of the Act, Indian nationals or a body corporate, association or organisation which is registered in India, shall not obtain any biological resource for commercial utilization, or bio-survey and bio-utilization for commercial utilization, except after giving prior intimation to the concerned State Biodiversity Board in the prescribed manner. Provided that the provisions of this section, shall not apply to the local peoples and communities of that area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practising indigenous medicine.
Due to lack of awareness about the provisions of the Act and clarity on related notification under the Act, a large number of cases have been brought into the notice of NBA, where individuals, universities, companies and Government institutions, un-intentionally, have undertaken above mentioned activities without the requisite prior approval of NBA. In order to address such issue and to give an opportunity to various stakeholders to comply with the said provisions of the Act, the Central Government in exercise of its powers under section 48, on September 10, 2018, issued an Office Memorandum (O.M.) directing the National Biodiversity Authority (NBA) to hear all those cases in which the approval was required to be obtained but was not obtained, with retrospective effect, by the persons/entities, within a period of 100 days from the date of issue of said O.M. In response to such notification, over 450 applications were received from various stakeholders.
For spreading awareness about the provisions of the Act and in response to requests from some stakeholder group seeking extension of above 100 days window, the Ministry on March 18, 2019, issued an O.M.1, granting extension of another 60 days from the date of issue of this O.M. to comply with the provisions of the Act, for activities requiring NBA approval, with retrospective effect. Hence, the persons/entities may apply and obtain NBA approval for the activities undertaken under Section 3, Section 4 or Section 6 of the Act on or before May 17, 2019. We strongly recommend availing this opportunity to get the NBA approval for inventions involving use of Indian bio-resources so that the patent applications, pending with the Indian Patent Office because of NBA approval, may be granted without undue delay.
1 Office Memorandum D.O.No. C-12025/8115-CS-III dated 18 March 2019, MoEF, Govt. of India
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