The Central Government has appointed 1st April, 2024 as the date on which the Biological Diversity (Amendment) Act, 2023 (“Amendment Act”) shall come into force [Please refer to the attachment “Enforcement of Biological Diversity (Amendment) Act, 2023” for the notification”. The Amendment Act aims at:
- reducing the pressure on wild medicinal plants by encouraging cultivation of medicinal plants;
- encouraging Indian system of medicine;
- facilitating fast-tracking of research, patent application process, transfer of research results while utilizing the biological resources available in India without compromising the objectives of United Nation Convention on Biological Diversity and its Nagoya Protocol;
- decriminalizing certain provisions;
- bringing more foreign investments in the chain of biological resources, including research, patent, and commercial utilization, without compromising the national interest.
The details of the amendments are as follows:
1. Section 3-
i. In sub- section (2) clause (c) sub-clause (ii):
In the Principal Act, a body corporate, association, or organization was described as an incorporated or registered in India under any law for the time being in force which has any non-Indian participation in its share capital or management.
Now, after the amendment, a body corporate, association, or organization is described as an incorporated or registered in India under any law for the time being in force, which is controlled by a foreigner within the meaning of clause (27) of section 2 of the Companies Act, 2013.
2. Section 4
The Principal Act provided that in order to transfer the results of any research relating to any biological resources occurring in, or obtained from, India for monetary consideration or otherwise, the person cannot transfer the results without prior approval of the National Biodiversity Board to any person who is not a citizen of India or citizen of India who is non-resident as defined in clause (30) of section 2 of the Income-tax Act, 1961 or a body corporate or organization which is not registered or incorporated in India or which has any non-Indian participation in its share capital or management.
Now, after the amendment, the results of research on any biological resource or traditional knowledge etc. for monetary consideration, any person or entity cannot share or transfer to any person or body corporate referred to in sub-section (2) of section 3, without the prior written approval of the National Biodiversity Authority, except the codified traditional knowledge which is only available for Indians. The Amendment Act also provides that if the results of research are used for commercial utilization or for obtaining any intellectual property rights, within or outside India and if the results of the research are used for further research then, prior approval of the National Biodiversity Authority has to be obtained.
3. Section 5
i. In sub- section (1):
In the Principal Act the provisions- Sec. 3 and Sec. 4 did not apply to collaborative search projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries.
Now, the Amendment Act, provides that only Sec. 3 will not be applicable to collaborative search projects involving transfer or exchange of biological resources or traditional knowledge associated thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries.
4. Section 6-
i. In sub-section (1):
The Principal Act provided that an application by a person for intellectual property rights cannot be made without approval of National Biodiversity Authority whether made in whatever name, in or outside India for any invention based on any research or information on a biological resource obtained from India, the aspect of traditional knowledge was not covered by the Principal Act.
In the Principal Act, if a person applied for patent, permission of the National Biodiversity Authority was to be obtained after the patent was accepted but before sealing by the Patent Authority.
Now, the Amendment Act, provides that an application for intellectual property rights by any person or entity covered under Sec. 3(2) cannot be made without approval of National Biodiversity Authority whether made in whatever name, in or outside India for any invention based on any research or information on a biological resource or traditional Knowledge associated thereto obtained from India.
The Amendment Act also provides that any person covered under Sec. 7 applying for intellectual property rights, in or outside India, for any invention based on any research or information on a biological resource which is accessed from India or traditional knowledge associated thereto are required to register with National Biodiversity Authority before grant of such intellectual property rights.
It is also provided after the amendment that any person who has obtained intellectual right is required to obtain approval of National Biodiversity Authority at time of commercialization.
5. Section 7-
The Principal Act provisioned that no person who is a citizen of India or a body corporate, association or organization which is registered in India, to obtain any biological resource for commercial utilization, or bio-survey and bio-utilization for commercial utilization except after giving prior intimation to the State Biodiversity Board. This does not apply to local people and communities of the area, including growers and cultivators of biodiversity, and vaids and hakims, who have been practicing indigenous medicine.
Now, after the amendment, no person other than the person covered under sub-section (2) of section 3, shall access any biological resource and its associated knowledge for commercial utilization, without giving prior intimation to the concerned State Biodiversity Board. This provision is not applicable to codified traditional knowledge cultivated medicinal plants and its products, local people and communities of the area, including growers and cultivators of biodiversity and to vaids, hakims and registered AYUSH practitioners only who have been practicing indigenous medicines, which includes Indian systems of medicine as profession. The exception for cultivated medicinal plant will be available only if a Certificate of origin is obtained from Biodiversity Management Committee in such manner as may be prescribed.
6. Section 19 –
i. In sub- section (2):
The Principal Act provided that any person intending to apply for patent or other form of Intellectual property protection in India or outside were required to make an application in such form and manner prescribed by National Biodiversity Authority.
Now, after the amendment, any person under section 3(2) intending to apply for patent or other form of Intellectual property protection in India or outside were required to make an application in such form, manner and on payment of such fee as may be prescribed by National Biodiversity Authority. The amendment also provided that any person referred to in sub-section (1A) of section 6 making the application to get registered with National Biodiversity Authority. Also the persons referred to in sub-section (1B) of section 6 are required to obtain prior approval from the National Biodiversity Authority at the time of commercialization.
7. Section 20-
i. In sub- section (2):
The Principal Act provided that any person intending to transfer any biological resource or knowledge associated thereto to make application in such form and manner as prescribed to National Biodiversity Authority.
Now, the amendment Act, substituted the words “any biological resource or knowledge associated thereto” with the words “the results of research”.
8. Section 55-
The Principal Act provided separate penalties for Sec. 3, Sec. 4, Sec. 6 and Sec. 7, the penalties were- Imprisonment for a term which may extend to five years, or with fine which may extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees and Imprisonment for a term which may extend to three years, or with fine which may extend to five lakh rupees, or with both.
Now, after the amendment, the penalties for Sec. 3, Sec. 4, Sec. 6 and Sec. 7 are fine not less than one lakh rupees, which may extend to fifty lakh rupees. On the failure or contravention continues, an additional penalty may be imposed, which shall not exceed one crore rupees.
Source: Ministry of Environment, Forest and Climate Change
