Intellectual Property Rights - Law and Practice · Biological Diversity

Regulation of Access to Biological Resources and Knowledge

Updated 11 October 2026 · Fact-checked

Under the Biological Diversity Act, 2002, the persons referred to in section 3(2) (non-citizens, non-resident Indians, and bodies not registered or incorporated in India or with non-Indian participation) need prior National Biodiversity Authority (NBA) approval to access Indian biological resources, transfer research results, or seek IPR based on them. Other persons mainly give prior intimation to the State Biodiversity Board for commercial use, with listed exemptions.

Understand Regulation of Access to Biological Resources and Knowledge

India holds biological resources and knowledge that others may want for research or products. The Act controls access so that the country, and the communities who conserved these resources, share in the benefits. Think of it as a gate with different levels of control.

The strictest level applies to the persons referred to in sub-section (2) of section 3. Section 4 lists the categories: non-citizens, non-resident Indian citizens, and bodies corporate or organisations not registered or incorporated in India or with non-Indian participation in share capital or management. Sections 6, 19 and 20 refer to the same group. This guide calls them section 3(2) persons. They must apply to the NBA under section 19 before obtaining biological resources or associated knowledge for research, commercial use, or bio-survey and bio-utilisation. The NBA may approve on terms, including royalty and benefit sharing, or reject for recorded reasons. It cannot reject without giving a hearing. Under the proviso to section 19(3A), it may also, by order and for recorded reasons, prohibit or restrict an activity that is detrimental to conservation and sustainable use of biodiversity, or to fair and equitable sharing of benefits, again after a hearing. It must publish every approval or rejection.

Research results have their own gate. Section 4 bars transfer of results of research on Indian biological resources to such persons without previous NBA approval. Section 20 adds the application route and covers results held in repositories outside India and associated traditional knowledge. Publishing research papers or sharing knowledge at a seminar or workshop is not a transfer, if it follows Central Government guidelines.

IPR has a third gate. Under section 6, a section 3(2) person applying for an IPR, in or outside India, for an invention based on research or information on a biological resource accessed from India or associated traditional knowledge must get NBA approval before the IPR is granted. Section 6(1A) and (1B) apply to a person covered by section 7 who applies for or holds an IPR for an invention based on research or information on a biological resource accessed from India (including one deposited in a repository outside India) or associated traditional knowledge. That person must register with the NBA before grant, and take NBA approval at commercialisation. Not every Indian company must register. The duty arises only when the IPR is based on such a resource or knowledge. The NBA may impose a benefit sharing fee, royalty or conditions.

The lightest level applies to persons covered by section 7, that is, persons other than section 3(2) persons. They give prior intimation to the State Biodiversity Board before accessing a biological resource and associated knowledge for commercial utilisation. Codified traditional knowledge, cultivated medicinal plants and their products, local people and communities including growers and cultivators, and vaids, hakims and registered AYUSH practitioners practising indigenous medicine for livelihood are exempt. For cultivated medicinal plants, the exemption needs a certificate of origin from the Biodiversity Management Committee.

Key rules to remember

Section 19(1): access approval: Section 3(2) person + access for research / commercial use / bio-survey and bio-utilisation / transfer of results → apply to NBA; NBA may approve with terms (including royalty) or reject for recorded reasons, after a hearing. Under the proviso to section 19(3A) it may also prohibit or restrict a detrimental activity, for recorded reasons and after a hearing.
Section 4: transfer of research results: Transfer of results to section 3(2) persons → previous NBA approval; Publication of papers or sharing at seminars or workshops is not a transfer if it follows Central Government guidelines.
Section 20: transfer application: Application to NBA in prescribed form and fee; NBA grants (with benefit sharing) or rejects; details placed in public domain; Covers results on resources found in or brought from India, including those in repositories abroad, and associated traditional knowledge.
Section 6(1): IPR by section 3(2) persons: Prior NBA approval before grant of IPR; Applies to IPR in or outside India for inventions based on research or information on resources accessed from India or associated traditional knowledge.
Section 6(1A) and (1B): IPR by section 7 persons: Section 7 person + IPR for an invention based on research or information on a biological resource accessed from India (including repositories abroad) or associated traditional knowledge → register with NBA before grant; prior NBA approval at commercialisation; The duty depends on the invention being based on such a resource or knowledge. It is not a general duty of every Indian company. Do not mix it with the prior approval required of section 3(2) persons.
Section 7: prior intimation: Non-section 3(2) person + commercial utilisation → prior intimation to State Biodiversity Board; Subject to listed exemptions; cultivated medicinal plants need a BMC certificate of origin.
Section 21(2): modes of benefit sharing: Joint IPR ownership; technology transfer; location of units; scientist and community involvement; venture capital fund; monetary and non-monetary benefits; Money may go to the National Biodiversity Fund, or directly to a benefit claimer where access came from an identified individual, group or organisation.
Section 6(3): plant variety exclusion: Section 6 does not apply to applications under plant variety protection law; The authority granting such a right endorses a copy to the NBA.

How to solve Regulation of Access to Biological Resources and Knowledge questions

Case questions ask whether approval is needed, from whom, and what follows. Work through the facts in a fixed order.

1Identify the person: citizen resident in India, non-resident Indian, non-citizen, or body corporate with non-Indian share capital or management. This decides whether section 3(2) applies.
2Identify the activity: access for research or commercial use, bio-survey, transfer of research results, or an IPR application.
3Match the activity and person to the provision: section 19 for access, sections 4 and 20 for transfer, section 6 for IPR, section 7 for Indian commercial users.
4Check exemptions: codified traditional knowledge, cultivated medicinal plants with a certificate of origin, local communities, growers and cultivators, vaids, hakims and registered AYUSH practitioners, research publication, plant variety law applications.
5State the authority and the stage: NBA or State Biodiversity Board, and whether before access, before grant of IPR, or at commercialisation.
6Add the consequences: the NBA may impose conditions, royalty or benefit sharing under section 21, must hear the applicant before rejection, and publishes its decisions.
7Conclude clearly and advise on compliance: what to file, with whom and when.

Quickest way: Person, activity, authority

When to use it: Use this for short case questions where you need a fast, well-structured answer.

Write 'Person:' and classify as section 3(2) or section 7.
Write 'Activity:' as access, research transfer or IPR.
Write 'Gate:' as NBA approval, NBA registration, or State Board intimation.
Add one line on exemptions and one on benefit sharing.
Close with a one-sentence conclusion.

Common mistakes in Regulation of Access to Biological Resources and Knowledge

Saying every user needs NBA approval.
Students remember the NBA as the main authority and ignore the two-tier design.
Fix: Only section 3(2) persons need NBA approval for access. Other persons give prior intimation to the State Biodiversity Board for commercial use.
Treating all IPR applicants alike, or saying every Indian company must register with the NBA.
Section 6(1), (1A) and (1B) look similar, and the condition that the invention is based on a resource accessed from India is forgotten.
Fix: Section 3(2) persons: prior approval before grant. Section 7 persons: registration before grant and approval at commercialisation, but only where the invention is based on research or information on a biological resource accessed from India, or associated traditional knowledge.
Treating publication of research papers as a restricted transfer.
The word transfer is read broadly.
Fix: The Explanation to section 4 excludes publication and dissemination at seminars or workshops that follow Central Government guidelines.
Exempting cultivated medicinal plants without conditions.
Students remember the exemption but forget its proviso.
Fix: The exemption for cultivated medicinal plants is available only with a certificate of origin from the Biodiversity Management Committee.
Claiming that the NBA can reject an application without hearing the applicant.
Students focus on the NBA's power and skip the safeguard.
Fix: State that rejection needs recorded reasons and an opportunity of being heard.
Applying section 6 to plant variety applications.
Both deal with biological material and IP.
Fix: Section 6(3) excludes applications under plant variety protection law; the granting authority endorses a copy of the grant to the NBA.

Worked examples

Example 1

Helix Labs Inc., a company incorporated in the USA, wants to collect a medicinal plant from Kerala for commercial research. Advise on the approval needed under the Biological Diversity Act, 2002.

Show the solution

Person: Helix Labs is not incorporated in India, so it is a section 3(2) person.
Activity: obtaining a biological resource occurring in India for research and commercial utilisation. Section 19(1) applies.
Gate: it must apply to the NBA in the prescribed form with the prescribed fee.
Outcome: the NBA may make enquiries, and consult an expert committee if needed, then grant approval with terms and conditions including royalty, or reject for recorded reasons after a hearing. Under the proviso to section 19(3A), if it finds the activity detrimental or contrary to conservation and sustainable use, or to fair and equitable benefit sharing, it may by order, for recorded reasons and after a hearing, prohibit or restrict it.
Benefit sharing: the NBA determines it under sections 19(3A) and 21, for example through monetary benefits or technology transfer.
Transparency: the NBA places its decision in the public domain.

Answer: Helix Labs needs prior NBA approval under section 19 before accessing the plant. The NBA may approve with benefit sharing conditions, reject after giving a hearing, or prohibit or restrict the activity for recorded reasons if it is detrimental to conservation and sustainable use.

Example 2

Dr. Meera Nair, an Indian citizen resident in India, filed for a patent on a formulation based on an herb obtained from a tribal community in Odisha. Another firm, Verde Biotech Pvt. Ltd., wholly owned by Indian citizens, wants to buy the herb commercially. State the requirements.

Show the solution

Dr. Nair is a resident Indian citizen, so she is not a section 3(2) person. She is covered by section 7.
Her invention is based on an herb accessed from India, with associated knowledge from a tribal community. So sections 6(1A) and 6(1B) apply to her. Without this link, they would not.
Section 6(1A): she must register with the NBA before the patent is granted.
Section 6(1B): once she holds the patent, she must get prior NBA approval at commercialisation.
The NBA may impose a benefit sharing fee, royalty or conditions under section 6(2).
Verde Biotech is incorporated in India with no non-Indian participation, so it is not a section 3(2) person and section 7 applies. For commercial utilisation it must give prior intimation to the State Biodiversity Board.
Check exemptions: if the herb is a cultivated medicinal plant, the exemption applies only with a BMC certificate of origin. Local communities and growers are themselves exempt.

Answer: Dr. Nair must register with the NBA before grant and obtain NBA approval at commercialisation, because her patent is based on a biological resource accessed from India. Verde Biotech must give prior intimation to the State Biodiversity Board unless an exemption applies.

Exam tips

Begin every answer by classifying the person as section 3(2) or section 7. Marks follow from this.
Quote section numbers only for the ones you are sure of: 4, 6, 7, 19, 20, 21. For the restricted group, write 'persons referred to in sub-section (2) of section 3' and list the categories given in section 4.
Cover provision, application to facts, conclusion, then compliance steps such as forms, fees and timing.
Remember the stage of approval: before access, before grant of IPR, or at commercialisation.
For exemptions, list the categories exactly and mention the BMC certificate condition for cultivated medicinal plants.

Practice questions from Biological Diversity

Regulation of Access to Biological Resources and Knowledge: frequently asked questions

Who needs prior NBA approval under the Biological Diversity Act, 2002?

Persons referred to in sub-section (2) of section 3 need it. Section 4 lists them as non-citizens, non-resident Indian citizens, and bodies corporate or organisations not registered or incorporated in India or with non-Indian participation in share capital or management. They need it for access, transfer of research results and IPR based on Indian biological resources.

Is publishing a research paper a transfer of research results?

No. The Explanation to section 4 says publication of research papers or dissemination in a seminar or workshop is not a transfer. It must follow guidelines issued by the Central Government.

Do Indian companies need any permission to use biological resources commercially?

They must give prior intimation to the concerned State Biodiversity Board under section 7 before accessing a biological resource and associated knowledge for commercial utilisation, unless an exemption applies. If they apply for an IPR on an invention based on research or information on a biological resource accessed from India, or associated traditional knowledge, they must also register with the NBA before grant and obtain its approval at commercialisation under section 6.

Who is exempt from the prior intimation requirement?

Exempt are codified traditional knowledge, cultivated medicinal plants and their products, local people and communities including growers and cultivators, and vaids, hakims and registered AYUSH practitioners who practise indigenous medicine for livelihood. Cultivated medicinal plants need a certificate of origin from the Biodiversity Management Committee.

How does benefit sharing work after NBA approval?

Under section 21, the NBA ensures fair and equitable sharing on mutually agreed terms. It may use joint IPR ownership, technology transfer, venture capital funds, monetary compensation and other modes. Money may go to the National Biodiversity Fund or directly to the benefit claimer.