| Element | Detail |
|---|---|
| Full Name | Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (ABS) to the Convention on Biological Diversity |
| Short Name | Nagoya Protocol on ABS | Nagoya Protocol |
| Type | Supplementary agreement to the CBD (not standalone treaty) |
| Parent Convention | Convention on Biological Diversity (CBD), 1992 |
| Secretariat | CBD Secretariat, Montreal, Canada |
| Depositary | Secretary-General of the United Nations |
| Aim | Implement the third objective of CBD — fair and equitable benefit sharing from genetic resources |
| Term | Meaning | Exam Relevance |
|---|---|---|
| ABS | Access and Benefit Sharing — regulated access to genetic resources with fair benefit return | Central concept of protocol |
| Genetic Resources (GR) | Plants, animals, microorganisms with actual or potential value — genetic material with functional units of heredity | Scope of protocol |
| PIC | Prior Informed Consent — consent of the provider country before accessing resources | Mandatory under Art 6 |
| MAT | Mutually Agreed Terms — negotiated agreement on how benefits will be shared | Mandatory under Art 5 |
| IRCC | Internationally Recognised Certificate of Compliance — electronic proof of legal access via ABS Clearing-House | India = 60% global IRCCs |
| Biopiracy | Unauthorized commercial exploitation of genetic resources / TK without PIC or MAT | Neem, Turmeric, Basmati cases |
| TK | Traditional Knowledge — indigenous community knowledge about biological resources | Art 7, 8(j) CBD |
| DSI | Digital Sequence Information — genetic data stored digitally; major emerging loophole in ABS | COP-16 Cali Fund (2024) |
India is one of the world's 17 mega-diverse countries, hosting 7–8% of recorded global species on just 2.4% of Earth's land area. India has 4 biodiversity hotspots: Western Ghats & Sri Lanka, Himalaya, Indo-Burma, and Sundaland.
UPSC often tests the relationship between Nagoya Protocol and CBD: Nagoya Protocol is a supplementary agreement to CBD — not a protocol under UNFCCC. The Cartagena Protocol (biosafety/LMOs) is the other CBD protocol. Know both.
COP-10 (2010, Nagoya): Nagoya Protocol + Aichi Targets adopted. COP-15 (2022, Montreal): Kunming-Montreal GBF adopted. COP-16 (2024, Cali): Cali Fund for DSI + India's NBSAP 2024–30 launched. Next: COP-17 (Yerevan, Armenia).
India ratified the Nagoya Protocol in 2012 but the Protocol entered into global force in 2014 (after 50th ratification). These are different dates. UPSC may give 2012 as the entry into force date — that is WRONG.
| Article | Subject | Key Provision |
|---|---|---|
| Art 3 | Scope | Applies to genetic resources under CBD scope + TK associated with GRs |
| Art 5 | Fair & Equitable Benefit-Sharing | Benefits shared on MAT; monetary + non-monetary; directed toward conservation |
| Art 6 | Access to Genetic Resources | Parties must establish clear PIC procedures, legal certainty & transparency |
| Art 7 | Access to Traditional Knowledge | Requires PIC from indigenous communities holding TK; applies even where TK not codified |
| Art 9 | Conservation & Sustainable Use | Benefits from ABS shall support conservation & sustainable use |
| Art 12 | TK & Community Protocols | Respects community protocols & customary laws of indigenous peoples |
| Art 17 | Monitoring & IRCC | Establishes IRCC system via ABS Clearing-House; checkpoints for compliance |
| Art 18 | Compliance & Non-Compliance | Parties must create penalties/remedies for ABS violations by users |
| Art 23 | Capacity Building | Developed countries assist developing countries in implementing ABS |
| Art 29 | Monitoring & Reporting | Parties must submit National Reports on ABS implementation (basis for India's NR1) |
| Step | Action | Instrument |
|---|---|---|
| 1 | User applies to access genetic resource/TK | Application to NBA (in India) |
| 2 | Provider gives Prior Informed Consent (PIC) | PIC from community / national authority |
| 3 | Parties negotiate Mutually Agreed Terms (MAT) | MAT contract specifying benefit-sharing modalities |
| 4 | National authority grants access permit | NBA approval / SBB approval |
| 5 | NBA uploads to ABS Clearing-House | Generates IRCC — serves as digital legal passport |
| 6 | Benefits flow back (monetary or non-monetary) | To BMC / local community / NBA fund |
An IRCC is an electronic permit generated through the ABS Clearing-House that proves genetic resources were accessed with PIC and MAT. It tracks resources from research through commercialisation, preventing biopiracy. India has issued 3,556 IRCCs = 60%+ of the global total of ~5,800.
UPSC often asks: "Which article of the Nagoya Protocol mandates monitoring and reporting?" Answer: Article 29. India's NR1 was submitted under Article 29. The IRCC system is under Article 17. PIC is under Article 6. Benefit-sharing is under Article 5.
| Tier | Body | Level | Key Functions | Legal Basis |
|---|---|---|---|---|
| Tier 1 | National Biodiversity Authority (NBA) | National — HQ Chennai | Regulates access by foreign entities & for IPR; grants Section 3(2) approvals; issues IRCCs; advises GoI; manages ABS fund | Section 8, BD Act 2002 |
| Tier 2 | State Biodiversity Boards (SBBs) / UT Biodiversity Councils (UTBCs) | State / UT level | Regulates commercial use by Indian entities (Section 7); advises state govts; monitors local biodiversity | Section 22, BD Act 2002 |
| Tier 3 | Biodiversity Management Committees (BMCs) | Local body level | Prepares People's Biodiversity Register (PBR); conserves local biodiversity; levies collection fees; advises SBB/NBA on ABS | Section 41, BD Act 2002 |
India has established over 2.76 lakh BMCs across the country. The NBA is headquartered at Ticel Bio Park, Taramani, Chennai. NBA was established in 2003 under the BD Act, 2002.
| Instrument | Year | Key Changes |
|---|---|---|
| Biological Diversity Act | 2002 | Established NBA, SBBs, BMCs; made PIC mandatory for foreign entities; required ABS for research, bio-survey, commercial use, IPR; India enacted this before Nagoya Protocol |
| BD Rules | 2004 | Operationalised the Act; prescribed PBR preparation; set procedures for NBA/SBB approvals |
| ABS Guidelines | 2014 | Issued by NBA after Nagoya Protocol entered into force; detailed benefit-sharing modalities; empowered SBBs |
| BD Amendment Act | 2023 | Streamlined compliance; exempted AYUSH practitioners & codified TK from ABS; decriminalised offences (fines vs imprisonment); included DSI; simplified IPR process; empowered SBBs under Section 7 |
| BD Rules | 2024 | Updated rules aligned with 2023 Amendment; Rule 18 requires declarations for foreign biological resource use |
| ABS Regulations | 2025 (Apr 29) | Fixed timelines for ABS approvals; ABS fee thresholds: 0% for turnover ≤ ₹5 cr; 0.2% for ₹5–50 cr; allows upfront NBA payments; covers DSI explicitly |
A PBR is prepared by each BMC in consultation with local communities. It documents:
PBRs serve as prior art evidence, preventing biopiracy by documenting TK before it can be misappropriated. They are also consulted by NBA/SBB before granting ABS approvals.
BMCs advise the NBA/SBB before approval — they do NOT grant ABS approvals themselves. Approval authority: NBA (for Section 3/4/6 entities) and SBBs (for Section 7 Indian entities). BMCs only document and advise.
| Approving Body | Section | Entities Covered | No. of Approvals |
|---|---|---|---|
| NBA | Section 3(2) | Foreign individuals/companies; research, bio-survey, commercial use, IPR, transfer of research results | 5,913 |
| SBBs / UTBCs | Section 7 | Indian companies & entities for commercial utilisation of biological resources | 6,917 |
| Total ABS Approvals | 12,830 | ||
| Rank | Country | IRCCs Issued |
|---|---|---|
| 🥇 1 | India | 3,556 (60%+ of global total) |
| 🥈 2 | France | 964 |
| 🥉 3 | Spain | 320 |
| 4 | Argentina | 257 |
| 5 | Panama | 156 |
| 6 | Kenya | 144 |
| Global Total | ~5,800–6,311 | |
| Countries registered on ABS Clearing-House | 142 | |
| Countries that have issued IRCCs | Only 34 (out of 142) | |
| Parameter | Detail |
|---|---|
| Submitted by | MoEFCC in collaboration with NBA |
| Submitted to | CBD Secretariat (ABS Clearing-House) |
| Submission Date | 27 February 2026 |
| Reporting Period | 1 November 2017 – 31 December 2025 |
| Legal Basis | Article 29 of Nagoya Protocol (Monitoring & Reporting) |
| Previous Report | Interim National Report — November 2017 |
| NBSAP Target | Contributes to Target 13 of updated NBSAP 2024–30 |
| Case Studies | 12 case studies of successful ABS implementation included |
| Foreign Declarations | 41 declarations (Form 10) under Rule 18 / Section 36A for foreign biological resource use |
Under ABS Regulations 2025: No ABS fee for annual turnover ≤ ₹5 crore. 0.2% of annual gross ex-factory price for turnover ₹5–50 crore. Higher slabs apply above ₹50 crore. Upfront payments to NBA now permitted.
Case: University of Mississippi Medical Center was granted US Patent #5,401,504 for use of turmeric in wound healing (1995). India's Response: India's CSIR challenged the patent citing centuries of prior art documented in Sanskrit texts. Outcome: US Patent and Trademark Office (USPTO) revoked the patent in 1997. First successful biopiracy challenge by India.
Case: US company W.R. Grace & co-applicants held European Patent #436257 on neem-based fungicide. India's Response: Green MEP Linda Chalker + India challenged; CSIR/IFOAM filed opposition citing India's age-old use. Outcome: European Patent Office (EPO) revoked the neem patent in 2005. Established that traditional knowledge in public use cannot be patented.
Case: American company RiceTec Inc. obtained US Patent with 20 claims covering basmati rice varieties and their breeding methods (1997). India's Response: Government of India challenged the patent; extensive negotiations. Outcome: RiceTec withdrew 15 of 20 claims in 2002. Partial victory; showed limits of international patent challenges without binding ABS law.
Case: Uttarakhand Biodiversity Board (UBB) issued notice to Divya Pharmacy (commercial arm of Baba Ramdev's Patanjali Yogpeeth) in 2016 for using Uttarakhand's biological resources in Ayurveda products without intimating the SBB or paying ABS fees. Divya Pharmacy challenged this as unconstitutional. Holding: Uttarakhand High Court (2018) upheld SBB's power to demand ABS fees. Fair and Equitable Benefit Sharing (FEBS) obligations apply to ALL entities — domestic OR foreign — commercially exploiting biological resources. Landmark precedent affirming India's ABS framework for Indian companies.
Case Study from NR1: One of the 12 NR1 case studies involves Sun Pharmaceutical Industries Ltd accessing the medicinal plant Cocculus hirsutus from India. This case demonstrates a successful ABS agreement — PIC obtained from local communities, MAT negotiated, IRCC issued, and benefits shared back. Often cited as a model commercial ABS implementation.
| Parameter | Detail |
|---|---|
| Established | 2001 (CSIR + Ministry of AYUSH) |
| Purpose | Prevent biopiracy by making India's TK available to international patent examiners as prior art |
| Content | 5+ lakh formulations from Ayurveda, Siddha, Unani, Yoga, Sowa Rigpa transcribed from Sanskrit, Urdu, Arabic, Persian, Tamil |
| Languages | 5 languages: English, German, French, Spanish, Japanese |
| Access | Available to 16 patent offices globally |
| Patents Blocked | 265+ patent applications withdrawn/amended/rejected based on TKDL evidence (as of 2022) |
| Classification | TKRC (Traditional Knowledge Resource Classification) — India's system adopted by WIPO in 2003 |
Chronological order: Turmeric Patent challenged → revoked 1997; Basmati fight → 2002 (RiceTec withdrew 15/20 claims); Neem Patent → EPO revoked 2005; Divya Pharmacy → Uttarakhand HC ruling 2018. UPSC loves chronological arrangement questions.
| Parameter | Data |
|---|---|
| Adopted | 29 October 2010, Nagoya, Japan (COP-10 of CBD) |
| Opened for Signature | 2 February 2011 |
| Entered into Force | 12 October 2014 (after 50th ratification) |
| Parties | 141–142 (including EU and 140 UN member states) |
| Notable Non-Parties | USA (also not a CBD party), Australia (CBD party but not Nagoya) |
| Signatories | 92 |
| Countries issuing IRCCs | Only 34 out of 142 parties (India leads far ahead) |
| Governing Body | COP/MOP (Conference of Parties serving as Meeting of Parties to Nagoya) |
| Decision | Detail |
|---|---|
| Cali Fund | Multilateral benefit-sharing fund for Digital Sequence Information (DSI) established; pharma, biotech, cosmetics, nutraceuticals companies to contribute % of revenue; 50% to indigenous peoples & local communities |
| DSI Decision | Adopted modalities for multilateral mechanism on DSI; does NOT replace Nagoya Protocol but addresses its DSI gap; effective November 2024 |
| Article 8(j) | New subsidiary body on indigenous peoples & local communities established; Afro-descendant communities recognised |
| Cali Fund Launch | Officially launched at resumed COP-16 session (Rome, February 2025) |
| India's NBSAP | India presented updated NBSAP 2024–30 at COP-16, aligned with Kunming-Montreal GBF's 23 targets |
| Next COP | COP-17 — Yerevan, Armenia |
In May 2024, a WIPO Diplomatic Conference concluded the International Treaty on Intellectual Property, Genetic Resources and Associated Traditional Knowledge (GRATK). It mandates disclosure of genetic resource origin in patent applications — a landmark IP-biodiversity convergence.
COP-16 Cali Fund was the first global mechanism to address DSI benefit-sharing. Three CBD Protocols exist: (1) Cartagena Protocol (biosafety/LMOs); (2) Nagoya Protocol (ABS); (3) Nagoya-Kuala Lumpur Supplementary Protocol (liability & redress under Cartagena). Do not confuse them.
| Linked Concept | Connection to Nagoya/ABS | Exam Angle |
|---|---|---|
| CBD (1992) | Parent convention; Nagoya Protocol implements CBD's 3rd pillar | Always link Nagoya to CBD; 196 CBD parties |
| Kunming-Montreal GBF | Target 13 of KM-GBF directly addresses ABS; NR1 contributes to this target | KM-GBF adopted COP-15 (2022, Montreal); 23 targets for 2030 |
| India's NBSAP 2024–30 | India's updated NBSAP presented at COP-16; Target 13 links to NR1 reporting | NBSAP = National Biodiversity Strategy & Action Plan; updated 2024 |
| Aichi Targets | Predecessor to KM-GBF; Aichi Target 16 specifically covered ABS protocols | COP-10 (2010, Nagoya): both Nagoya Protocol AND Aichi Targets adopted |
| Cartagena Protocol | Second CBD protocol; covers biosafety of LMOs (not ABS) | Do not confuse Cartagena (LMOs/biosafety) with Nagoya (ABS) |
| TKDL | Defensive protection of TK from biopiracy — complements Nagoya's positive benefit-sharing | CSIR + AYUSH; 5+ lakh formulations; 16 patent offices |
| People's Biodiversity Register | BMC-prepared document; serves as prior art + ABS consultation evidence | Mandatory under BD Rules 2004; protects local knowledge |
| DSI & Cali Fund | COP-16 addressed DSI gap in Nagoya Protocol; India's BD Amendment 2023 included DSI | DSI = genetic sequence data; Cali Fund = global DSI benefit-sharing |
| Geographical Indications (GI) | GI Act 1999 protects place-specific traditional products (Darjeeling tea, Basmati) — complements Nagoya's TK protection | Basmati GI protection is distinct from ABS benefit-sharing |
| Protection of Plant Varieties Act, 2001 | Protects plant breeders' rights; farmers' rights provision complements ABS | PPV&FR Act — farmers can save, use, and share seeds |
| WIPO GRATK Treaty 2024 | Mandates disclosure of GR origin in patent applications; strengthens anti-biopiracy architecture | Concluded May 2024; convergence of IP and biodiversity law |
| Hotspot | States/Region | Key Feature |
|---|---|---|
| Western Ghats & Sri Lanka | Kerala, Karnataka, TN, Maharashtra, Goa | High endemism; 5,000+ flowering plants; Agasthyamalai, Nilgiris |
| Himalaya (Eastern Himalaya) | NE India, Sikkim, Bhutan, Nepal | Rich orchid & rhododendron diversity; medicinal plant hub |
| Indo-Burma | NE India (Assam, Meghalaya, Manipur, Mizoram, Nagaland, Arunachal) | High freshwater biodiversity; one of world's richest biomes |
| Sundaland | Nicobar Islands (India's portion) | Maritime biodiversity; coral reefs; island endemic species |
India = 17 Mega-diverse countries · 7–8% of world species · 2.4% of land · 45,968 plant taxa · 91,364 animal species · 4 biodiversity hotspots · 1 of 196 CBD parties · ratified Nagoya 2012
India submitted its First National Report (NR1) on the Nagoya Protocol to the CBD Secretariat on 27 February 2026. Prepared by MoEFCC + NBA under Article 29 of the Protocol, covering November 2017 – December 2025. Key numbers: 12,830 ABS approvals; ₹216.31 crore mobilised; ₹139.69 crore disbursed to communities; 3,556 IRCCs (60%+ global total); 2.76 lakh BMCs; 3,724 workshops training 2,56,393 persons.
MoEFCC released key insights from NR1, including 12 case studies of successful ABS implementation. One case involves Sun Pharmaceutical Industries Ltd accessing Cocculus hirsutus. Report highlighted that Biodiversity Management Committees (BMCs) functionality remains inconsistent — questions linger about equitable grassroots distribution. NR1 is available on the ABS Clearing-House of CBD (absch.cbd.int).
ABS Regulations 2025 notified by NBA on 29 April 2025. Third pillar of India's reformed ABS legal framework alongside BD Amendment Act 2023 and BD Rules 2024. Key change: ABS fee structure set — 0% for turnover ≤ ₹5 crore; 0.2% for ₹5–50 crore; timelines fixed for approvals; upfront payments to NBA now allowed. The 2025 Regulations allow exemption of Indian entities from ABS for products containing cultivated medicinal plants.
CBD COP-16 held in Cali, Colombia (Oct–Nov 2024). Landmark outcomes: (1) Cali Fund established for Digital Sequence Information (DSI) benefit-sharing — commercial users (pharma, biotech, cosmetics) to contribute % of revenue; 50% earmarked for indigenous peoples; (2) New Article 8(j) subsidiary body for indigenous peoples; (3) India presented NBSAP 2024–30 aligned with KM-GBF; (4) COP-17 to be held in Yerevan, Armenia.
India emerged as global leader in IRCC issuance: 3,556 IRCCs out of global total of ~6,311 (over 56–60%). India far ahead of France (964), Spain (320), Argentina (257), Panama (156), Kenya (144). Of 142 Nagoya Protocol parties, only 34 have issued IRCCs. India's performance attributed to its robust digital ABS Clearing-House and decentralised institutional structure.
BD Rules 2024 notified, replacing 2004 Rules. Key addition: Rule 18 — NBA must receive declarations in Form 10 from entities utilising foreign biological resources under Section 36A of BD Act. During NR1 period, 41 such declarations were received, enabling monitoring of India's use of foreign bioresources.
For Prelims 2026: Know that NR1 = 27 Feb 2026; COP-16 Cali = 2024; ABS Regulations = Apr 2025; BD Rules = 2024; BD Amendment Act = 2023. The Cali Fund addresses DSI — this is a brand-new mechanism created at COP-16.
| Statement | ✅/❌ | Reason / Correct Fact |
|---|---|---|
| The Nagoya Protocol is a protocol under the UNFCCC. | ❌ | It is a supplementary agreement under CBD, not UNFCCC. UNFCCC covers climate — Paris Agreement, Kyoto Protocol. |
| India ratified the Nagoya Protocol in 2014. | ❌ | India ratified in 2012; the Protocol entered into global force in 2014. |
| The Nagoya Protocol was adopted at COP-10 of CBD at Nagoya, Japan, in 2010. | ✅ | Correct. COP-10 (CBD), Nagoya city, Aichi Prefecture, Japan, 29 October 2010. |
| The NBA grants ABS approvals to both Indian and foreign entities under Section 7 of the BD Act. | ❌ | Section 7 applies to Indian entities, regulated by SBBs. Section 3(2) applies to foreign entities — regulated by NBA. |
| India has submitted its first National Report on the Nagoya Protocol in 2026. | ✅ | NR1 submitted 27 February 2026 by MoEFCC + NBA to CBD Secretariat. |
| BMCs have the power to grant ABS approvals to access biological resources. | ❌ | BMCs only document and advise. Approval authority rests with NBA (national) and SBBs (state). |
| The Cartagena Protocol deals with access and benefit sharing of genetic resources. | ❌ | Cartagena Protocol = biosafety of Living Modified Organisms (LMOs). ABS is Nagoya Protocol. |
| India accounts for over 60% of all IRCCs issued globally under the Nagoya Protocol. | ✅ | 3,556 out of ~5,800–6,311 global IRCCs = 56–60%+ — India is the undisputed leader. |
| The Aichi Biodiversity Targets were adopted at COP-15 of CBD. | ❌ | Aichi Targets adopted at COP-10 (2010, Nagoya). COP-15 (2022, Montreal) adopted the Kunming-Montreal GBF. |
| Prior Informed Consent (PIC) under Nagoya Protocol must be obtained from the user country. | ❌ | PIC must be obtained from the provider country — the country from whose territory resources are accessed. The user seeks PIC; the provider gives it. |
India ratified the Nagoya Protocol in 2012. The Protocol entered into global force in 2014. Trap: "India ratified Nagoya Protocol in 2014" — FALSE. India was ahead of the global entry into force.
COP-10 (2010, Nagoya): Nagoya Protocol + Aichi Targets. COP-15 (2022, Montreal, Canada): Kunming-Montreal GBF. COP-16 (2024, Cali, Colombia): Cali Fund + India NBSAP. UPSC tests all three. Never mix them up.
Both are CBD protocols but cover different subjects. Cartagena = LMO biosafety/transboundary movement. Nagoya = ABS/genetic resources. A third protocol — Nagoya-Kuala Lumpur Supplementary Protocol — deals with liability and redress under Cartagena (not ABS).
Foreign entities & IPR applications → NBA (Section 3, 4, 6). Indian commercial entities → SBBs (Section 7). BMCs → only advise and document. Mixing these jurisdictions is the most common error in Prelims questions on BD Act.
CBD has 196 parties. Nagoya Protocol has only 141–142 parties. Not all CBD parties are Nagoya parties. USA is not a party to either. Australia is a CBD party but not a Nagoya party. Always quote the correct number.
Nagoya Protocol appeared in UPSC Prelims 2014, 2016, 2017, 2019. Common formats: (1) Match-the-following: Protocol → Convention/Year/Purpose; (2) Statement-based T/F: "Consider the following statements about the Nagoya Protocol..."; (3) Which of the following is/are correct? Focus on: adopted year, entry into force, parent convention, India's ratification, PIC/MAT/IRCC mechanism, biopiracy cases.
| Item | Date/Number |
|---|---|
| CBD adopted | 22 May 1992, Rio Earth Summit |
| CBD in force | 29 December 1993 |
| India joins CBD | 1994 |
| BD Act, India | 2002 |
| Nagoya Protocol adopted | 29 October 2010 (COP-10, Nagoya) |
| Nagoya: opened for signature | 2 February 2011 |
| India ratified Nagoya | 2012 |
| Nagoya: global entry into force | 12 October 2014 |
| BD Amendment Act | 2023 (LS: 25 Jul; RS: 1 Aug) |
| BD Rules | 2024 |
| ABS Regulations | 29 April 2025 |
| COP-16 CBD | Cali, Colombia, Oct–Nov 2024 |
| Cali Fund launched | February 2025 (Rome, resumed COP-16) |
| India NR1 submitted | 27 February 2026 |
| India IRCCs issued | 3,556 (60%+ of global total) |
| Total ABS approvals (NR1) | 12,830 (5,913 NBA + 6,917 SBBs) |
| Benefits mobilised | ₹216.31 crore |
| Benefits disbursed | ₹139.69 crore to communities |
| BMCs in India | Over 2.76 lakh |
| Nagoya Protocol parties | 141–142 |
| CBD parties | 196 |
| COP-17 next | Yerevan, Armenia |