This is the 6th post in Environmental Law, Unit III — Legal Framework for Environment Protection (the previous post covered the Environment (Protection) Act, 1986). This post covers the Biological Diversity Act, 2002.
India is one of the world's biodiversity-rich nations, home to enormous genetic and biological wealth — medicinal plants, crop varieties, microorganisms — that foreign companies and researchers had, for decades, accessed and commercialised (patenting derivatives of neem, turmeric, and basmati rice being the most cited examples) without any benefit flowing back to India or to the local communities whose traditional knowledge often pointed the way to the resource's value. India's ratification of the Convention on Biological Diversity (CBD), 1992 (adopted at the Rio Earth Summit) committed it to conserve biodiversity, ensure sustainable use, and secure fair and equitable sharing of benefits from its biological resources — obligations Parliament implemented through this Act.
The Biological Diversity Act, 2002 creates a three-tier regulatory structure, unusual among the statutes in this unit:
The three-tier structure, national to local: National Biodiversity Authority (Section 8, Chennai) — regulates foreign access, approves IPR applications based on Indian biological resources → State Biodiversity Boards (Section 22, one per State) — regulate Indian citizens'/entities' commercial access, advise the State Government → Biodiversity Management Committees (Section 41, every panchayat/municipality) — maintain People's Biodiversity Registers, the grassroots documentation layer.
| Who | What they need | From whom |
|---|---|---|
| Foreign nationals/entities, NRIs, and body corporates with non-Indian participation (Section 3) | Prior approval before obtaining any Indian biological resource for research or commercial use, or before applying for IPR based on it | National Biodiversity Authority |
| Indian citizens/entities (Section 7) | Prior intimation (not approval) before obtaining a biological resource for commercial utilisation (research is exempt) | State Biodiversity Board |
| Anyone seeking an IPR based on Indian biological resources/associated traditional knowledge (Section 6) | Previous approval before the IPR is actually granted (application can be filed first, approval needed before grant) | National Biodiversity Authority |
Section 21 requires the National Biodiversity Authority, while granting any approval under the Act, to ensure equitable sharing of benefits arising from the use of biological resources or associated knowledge — benefits which may take the form of monetary compensation, joint research ventures, technology transfer, association of Indian scientists/local communities in research, or setting up venture-capital funds. This benefit-sharing mandate implements India's obligations under the Nagoya Protocol on Access and Benefit-Sharing (2010), an international supplementary agreement to the CBD.
Illustrative application — the "biopiracy" problem the Act targets
Point of law: A foreign company seeking to obtain and commercially exploit an Indian medicinal plant's extract — particularly where its therapeutic use is already known through Indian traditional knowledge — must first obtain the National Biodiversity Authority's approval under Section 3, and any resulting patent application must independently secure Section 6 approval before grant, with benefit-sharing terms fixed under Section 21. Accessing the resource and filing for a patent without either approval is the paradigm case of unauthorised access this Act was designed to prevent — the very pattern documented in the neem, turmeric, and basmati controversies that preceded the Act.
Divya Pharmacy v. Union of India (Uttarakhand High Court, 2018) confirms that this benefit-sharing duty is not limited to foreign entities. Divya Pharmacy, an Indian company, argued that Section 7's "intimation" requirement for Indian entities meant no benefit-sharing was owed. The Court rejected this, holding that Indian companies extracting and commercially using biological resources are equally liable to share benefits with the local communities that conserved those resources — the protection the Act gives to indigenous and local communities applies "equally from outside as well as from within." For exam purposes: Section 7's lighter "intimation, not approval" requirement for Indian entities does not mean Indian companies are exempt from benefit-sharing — Divya Pharmacy is the authority that closes that argument.
The 2023 Amendment made several significant changes:
A foreign pharmaceutical company wants to research a compound derived from a plant native to the Western Ghats, based on leads from local traditional healers' knowledge, and eventually patent the resulting formulation. Under Section 3, the company must first obtain the National Biodiversity Authority's approval before accessing the plant for research; if it proceeds to seek a patent, Section 6 requires separate NBA approval before the patent can actually be granted; and under Section 21, the NBA will fix benefit-sharing terms — which could include royalty payments or research collaboration — before finalising its approval, ensuring the source community and India as a whole receive a share of any resulting commercial value.