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Overview
In India, the Biological Diversity Act, 2002, a law governing utilization of biological resources and access benefit sharing has been in existence for a long time, but its awareness is still not prevalent. The familiarity of this law has been mainly due to the need for obtaining permission for applying for Intellectual Property Rights viz. patents. The requirement of obtaining approval even before carrying out the research for accessing biological resources from India by entities like Indian public limited companies having any non-Indian holding its share is yet not very well-known among the Indian Industry, as well as foreign researchers and corporate resulting in inadvertent violation of provisions of the law.
India is one of the world’s ‘mega diversity’ countries that accounts for 7-8% of all recorded species, including over 45,000 species of plants and 91,000 species of animals. It is ranked ninth in the world in terms of higher plant species, which makes it a rich reserve for obtaining biological resources for carrying out research to contribute to human well-being. In order to safeguard its biological and natural resources India has enacted numerous laws and along with them drafted its own national biodiversity plan and enacted the “Biological Diversity Act” in 2002 after becoming a party to the United Nations Convention on Biological Diversity signed in 1992. The Biological Diversity Act, 2002 regulates the utilization of biological resources for various purposes. As per definition, any plants or their parts, animals or their parts, or microorganisms, or by-products are considered as a biological resource.
Penalties
Those who contravene or attempt to contravene section 3, as per Biological Diversity Act, 2002 will be punished with imprisonment for a term which may extend to five years, or with a fine or with both. The fine can extend to ten lakh rupees and where the damage caused exceeds ten lakh rupees the fine would be commensurate with the damage caused,
Those who contravenes or attempts to contravene section 7 would be punished with imprisonment for a term extending to three years, or with a fine extending to five lakh rupees, or with both.
Types of Prior Approval, Permission or Intimation Required
1. Requirement of Obtaining a Prior Approval by Foreign Entities and Indian Entities Having Foreign Participation (in Shares or Management)
Indian public limited companies whose even a single share is held by a foreigner, or any Indian company whose management includes any non-resident Indian or foreigner needs to obtain a permit from the NBA before obtaining the biological resources for initiating research or in case of commercial utilization of biological resource from India. Similarly, foreign researchers or foreign enterprises need to obtain prior NBA permission before accessing Indian biological resources. A non-compliance would otherwise render such entities in contravention of the Act, which can result in a grave penalty. It is also imperative to understand other provisions of this Act requiring the prior intimation to the State Biodiversity Board (SBB) for obtaining biological resources for commercial utilization by Indian or foreign entities.
2. Prior Intimation to the State Biodiversity Board to Obtain any Biological Resource for Commercial Utilization
Any entity whether Indian person, Indian private limited or public limited company, or any foreign person or foreign company needs to give a prior intimation to the respective State Biodiversity Board (SBB) for obtaining biological resources from its territory for commercial utilization. This requirement however is not applicable to cultivators of the bioresources themselves or practitioners of indigenous medicines like voids and hakims.
3. Application for Prior Permission for Research or Commercial Utilization
The application to the NBA for seeking prior permission to carry out research is to be made in the prescribed form along with the requisite documents and official fee of INR. 10,000/-. Similarly, the intimation or application to the State Biodiversity Board (SBB) for commercial utilization is required to be made in the form as prescribed by the concerned SBB from whose territory the biological resource is required to be obtained.
Timelines and Express Approval for Carrying out Research for COVID-19
Usually, the approval by the NBA takes a long period up to few months or even more than a year which can impede obtaining the biological resource and initiate research. However, Guidelines on Access to Biological Resources and Benefits Sharing Regulations, provide that special consideration may be given to cases where technologies/products are developed for controlling epidemics/diseases and for mitigating environmental pollution affecting human/ animal/plant health.
In view of the recent pandemic of COVID-19, research activities are underway throughout the world in the chase for finding the vaccine, diagnostic kits, immunological and other products. To facilitate such public limited companies in India and foreign entities who would be in need to obtain biological resources for India to carry out research against fighting COVID-19, the NBA has afforded the opportunity to fast-track the application filed by such entities.
As per the notification dated 3rd April 2020, the NBA has issued a notification that “In order to Fastrack the process of obtaining approval for conducting research on biological resources occurring in India or knowledge associated thereto, as mandated under Section 3 of the Biological Diversity Act 2002, for the person/entity falling under Section 3(2) of the said Act it has been decided to process the applications received by NBA, complete in all respects, within 5(five) working days”
Therefore, it is essential that applications must be complete in all respect and such applications will be taken on the fast track and the approval will be given with 5 working days so that whatever medicine or vaccination is required to cure COVID-19 is manufactured as soon as possible and that there is no delay.
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Frequently Asked Questions
1. What does the Biodiversity Act, 2002 cover?
The Biodiversity Act, 2002 provides a legal framework for the conservation, sustainable use of biological resources in the country, issues related to access to genetic resources and associated knowledge, and fair and equitable sharing of benefits arising from the utilization of biological resources to the country and its people.
2. What is the role of National Biodiversity Authority?
The National Biodiversity Authority is tasked to regulate the use of India’s biological resources; facilitate/ enable conservation action and provide advice to Central and State Governments on issues of conservation, sustainable use, and access and benefit-sharing.
3. Do Indian researchers/ individuals/ entity require approval for obtaining biological resource for research purposes?
No, approval is not required for research carried out by Indians in India. However, in case the results of the research are used for commercial purposes or are to be shared with a foreign institutions, or when a foreign individual/ entity wants to access, or when Intellectual Property Protection is sought then prior approval/ intimation is required.
4. Who are exempted?
Following are exempted:
- Local people and communities of the area for free access to use biological resources within India.
- Growers and cultivators of biodiversity and to Vaids and Hakims to use biological resources.
- Exemption through notification of normally traded commodities from the purview of the Act only when used as a commodity.
- Exemption for collaborative research through government-sponsored or government-approved institutions subject to overall policy guidelines and approval of the Central Government and conforms to the central government guidelines.
5. How does the approval process for IPR work under the Biological Diversity Act?
Biodiversity Act, 2002 provides that prior approval of NBA is necessary before applying for any kind of IPRs in India and outside based on any research or information on a biological resource obtained from India. However, in the case of patents, the permission of the NBA may be obtained after the application is made but before sealing of the patent.
The patent applicant should disclose the source and geographical origin of the biological material when used in an invention. Further, non-disclosure or wrongful disclosure of the source of biological material and any associated knowledge will result in opposition to the grant of patent or revocation of the patent.