Regulating Access to India’s Biological Resources: Insights from the Biodiversity Act

India is home to nearly 7-8% of all recorded species on Earth, despite covering only 2% of the world’s land area. This extraordinary richness – spanning medicinal plants, wild crops, microorganisms, and millennia of traditional knowledge about their use – has long attracted the attention of foreign researchers and corporations. But access without accountability has a name: biopiracy. India’s legislative response to this threat, the Biological Diversity Act, 2002, builds a regulatory wall around the country’s biological resources – specifying exactly who can access them, for what purpose, and on what terms.

Why India needed a law on biological resources 🔗

The problem became impossible to ignore in the 1990s. In 1995, the US Patent and Trademark Office (USPTO) granted a patent to researchers at the University of Mississippi Medical Center for using turmeric in wound healing – a practice already documented in ancient Sanskrit texts and known to every Indian household for centuries. Around the same time, the European Patent Office granted a patent to the US corporation W.R. Grace for a neem oil-based antifungal formulation, again based on knowledge that had been part of Indian agricultural tradition for generations.

In the turmeric case, India’s Council of Scientific and Industrial Research (CSIR) challenged the patent by submitting 32 references from Sanskrit, Urdu, and Hindi literature as evidence of prior art. The USPTO revoked the patent in 1997, acknowledging that the use of turmeric for wound healing was established traditional knowledge. The neem patent took considerably longer to overturn – the EPO finally revoked it in 2000 after a prolonged legal fight involving Indian government agencies and international NGOs. These battles exposed a fundamental gap: India had no domestic legal framework to prevent such exploitation before it happened. The Biological Diversity Act, 2002 was Parliament’s answer to that gap.

The three-tier regulatory structure 🔗

The Act creates a three-tier institutional structure to regulate access at different levels:

At the national level sits the National Biodiversity Authority (NBA), headquartered in Chennai, established under Section 8 of the Act. It is the apex body that handles all access requests from foreign entities, oversees intellectual property matters involving biological resources, and issues benefit-sharing guidelines. Below it, State Biodiversity Boards (SBBs) operate at the state level, primarily regulating commercial access by Indian nationals. At the grassroots, Biodiversity Management Committees (BMCs) function within local bodies, and their main task is to prepare People’s Biodiversity Registers (PBRs) – local records documenting available biological resources and associated traditional knowledge. As of recent years, the NBA has facilitated the establishment of around 2,77,688 BMCs across the country.

Who needs approval, and for what? 🔗

The Act draws a clear distinction between foreign entities and Indian nationals, and this distinction is central to understanding how access is regulated.

Foreign entities and non-resident Indians 🔗

Under Section 3 of the Act, any foreigner, non-resident Indian, or foreign company must obtain prior approval from the NBA before accessing any biological resource occurring in India, or any knowledge associated with it, for three categories of activity: research, commercial utilisation, and bio-survey or bio-utilisation. The approval is not automatic – it comes with conditions, including negotiated terms for equitable benefit sharing. The results of any research conducted on Indian biological resources also cannot be transferred to a foreign entity without prior written approval from the NBA.

Indian nationals and companies 🔗

Indian citizens and Indian-registered companies occupy a different position. Indian researchers do not need prior approval or even prior intimation to the SBB for conducting research within India. However, if the research results are to be used for commercial purposes, prior intimation to the concerned State Biodiversity Board is required under Section 7. For commercial utilisation of biological resources, the access is subject to the SBB’s oversight, not the NBA’s – unless the activity crosses into intellectual property rights territory.

Exemptions under the Act 🔗

The Act carves out specific exemptions. It does not apply to biological resources that are normally traded as commodities, so long as those resources are used purely as commodities and for no other purpose. Traditional uses of biological resources by local communities and practitioners of Indian systems of medicine are also exempt, as are collaborative research projects between Indian and foreign institutions that have received Central Government approval. Codified traditional knowledge – knowledge documented in classical texts of Ayurveda, Siddha, Unani, and Yoga – is explicitly excluded from benefit-sharing obligations for practitioners who use it as part of their profession.

Section 6: the IPR gateway 🔗

One of the most significant provisions in the Act from a patents perspective is Section 6. It requires that any person applying for intellectual property rights – whether in India or abroad – for an invention based on research or information on a biological resource obtained from India must obtain prior approval from the NBA before filing the application. This applies even if the biological resource was accessed from a repository outside India, provided it was originally sourced from India.

The 2023 amendment modified this slightly for Indian nationals: they now only need to register with the NBA before the patent is granted (rather than seek prior approval before filing), which speeds up the application process. However, signing an access and benefit-sharing agreement with the NBA remains necessary for the commercial utilisation of any IPR derived from Indian biological resources. For foreign entities and organisations with foreign shareholding or control, prior NBA approval before filing the application remains mandatory.

The NBA is also empowered to take measures to oppose the grant of intellectual property rights in any foreign country for any biological resource or traditional knowledge illegally accessed from India – a direct legislative response to cases like the turmeric and neem patents.

Equitable benefit sharing: the core obligation 🔗

The Act’s purpose is not simply to block access, but to ensure that when India’s biological resources are used commercially, the communities that have conserved them receive a fair share of the resulting benefits. The mechanism for this is Access and Benefit Sharing (ABS).

The Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulation, 2025, notified by the NBA in April 2025, provides the current operational framework. Benefits can be monetary or non-monetary – royalties, joint ownership of IPRs, technology transfer, or association of Indian scientists in research and development. The 2025 Regulations introduce turnover-based slabs for benefit sharing: companies with annual turnover up to ₹5 crore are exempt; those between ₹5-50 crore must share 0.2% of the annual gross ex-factory sale price; between ₹50-250 crore, the rate is 0.4%; and above ₹250 crore, 0.6%. For high-value species such as red sanders, sandalwood, and agarwood, or threatened species notified under Section 38 of the Act, benefit sharing cannot be less than 5% of the sale or auction price and can go considerably higher. Of the total benefits collected, 10-15% is retained by the NBA and the remainder is distributed to local communities and knowledge holders.

The 2025 Regulations also extend ABS obligations to Digital Sequence Information (DSI) – digitised genetic data derived from biological resources – recognising that researchers can now study and commercially exploit genetic information without needing a physical sample. This brings India in line with commitments made at the 16th Conference of Parties to the Convention on Biological Diversity (COP16), held in Cali, Colombia in 2024, which finalised a multilateral mechanism for DSI benefit sharing.

The Traditional Knowledge Digital Library: documentation as defence 🔗

Alongside the legislative framework, India built an institutional tool specifically to prevent biopiracy at the patent examination stage: the Traditional Knowledge Digital Library (TKDL). Established in 2001, it is a searchable, multilingual database that documents traditional knowledge from Ayurveda, Siddha, Unani, and Yoga in five international languages – English, French, German, Japanese, and Spanish. The TKDL gives patent examiners at offices including the USPTO, EPO, and JPO direct access to prior art drawn from India’s classical texts, making it far harder for applicants to claim novelty for inventions rooted in traditional practices. CSIR estimated in 2005 that around 2,000 patents were being granted annually worldwide that incorrectly covered Indian systems of medicine – the TKDL was a direct response to that scale of misappropriation.

The 2023 Amendment: streamlining access and the debate it sparked 🔗

The Biological Diversity (Amendment) Act, 2023 made significant changes to the original framework, primarily aimed at reducing compliance burdens and attracting investment in AYUSH industries, biopharmaceuticals, and research. Key changes include: replacing imprisonment with monetary penalties for most violations (fines ranging from ₹1 lakh to ₹50 lakh); exempting practitioners of codified traditional knowledge and AYUSH from ABS obligations; simplifying procedures for startups, MSMEs, and Indian entities; and streamlining the IPR approval process for Indian nationals. The amendment also clarified the definition of “foreign-controlled company” by aligning it with the Companies Act, 2013 – meaning companies with foreign control as defined under that Act still need full NBA approval before accessing resources.

However, the amendments drew significant criticism. Environmental advocates and legal experts warned that decriminalising violations, expanding exemptions, and reducing oversight could dilute the original Act’s ability to prevent commercial exploitation of India’s biodiversity without adequate benefit sharing – particularly since most Ayurvedic and herbal products now classified as using “codified traditional knowledge” have their roots in community-held knowledge. The concern is that the balance between facilitating business and protecting the communities whose knowledge underpins these industries may have shifted too far in one direction.

Penalties for non-compliance 🔗

Under the unamended Act, violations were cognizable and non-bailable offences, punishable with imprisonment of up to five years or a fine of up to ₹10 lakhs, or both. The 2023 Amendment replaced imprisonment with higher monetary penalties for most violations. Any grievances related to benefit-sharing determinations or orders by the NBA or an SBB are now adjudicated by the National Green Tribunal (NGT), which replaced the High Court as the first appellate forum.

What do you think? The Biological Diversity Act tries to balance two goals that can pull in opposite directions: making India’s biological resources accessible enough to drive research and economic growth, while ensuring the communities that have conserved those resources for generations receive a fair share of any resulting benefits. Do the 2023 amendments strike the right balance, or do they trade away too much of the original Act’s protective intent? And given that biopiracy can now happen through digital sequence information without anyone physically taking a sample out of the country, is the current regulatory framework equipped to handle the next generation of access disputes?

References

1. https://vajiramandravi.com/current-affairs/biodiversity-act-2002/
2. https://www.indiacode.nic.in/bitstream/123456789/2046/4/a2003-18.pdf
3. https://www.mondaq.com/india/patent/586384/traditional-knowledge-and-patent-issues-an-overview-of-turmeric-basmati-neem-cases
4. https://www.iiprd.com/patenting-of-traditional-knowledge-in-light-of-the-turmeric-case/
5. https://www.nextias.com/blog/biological-diversity-act-2002/
6. https://megbiodiversity.nic.in/sites/default/files/faq-biodiversity-act.pdf
7. https://www.drishtiias.com/to-the-points/paper3/biological-diversity-act-2002
8. https://corporate.cyrilamarchandblogs.com/2024/04/navigating-change-unravelling-the-biological-diversity-amendment-act-2023/
9. https://www.downtoearth.org.in/wildlife-biodiversity/access-and-benefit-sharing-new-rules-for-use-of-biodiversity-put-in-place-by-centre
10. https://www.drishtiias.com/daily-updates/daily-news-analysis/biological-diversity-access-and-benefit-sharing-regulation-2025
11. https://chambers.com/articles/safeguarding-traditional-knowledge-under-indian-patent-law-can-legal-frameworks-keep-pace
12. https://ficpi.org/blog/revised-indian-biodiversity-law-2023
13. https://www.science.org/content/article/amendments-indian-biodiversity-laws-could-open-doors-exploitation