Context:

On April 29, 2025, the Central Government notified the Biological Diversity (Access to Biological Resources and Knowledge Associated thereto and Fair and Equitable Sharing of Benefits) Regulation, 2025, replacing the 2014 guidelines. Issued by the National Biodiversity Authority (NBA), it governs benefit-sharing from the use of biological resources, including digital sequence information (DSI).

Key Provisions of the 2025 Regulation

1. Turnover-Based Benefit Sharing Structure:
The regulation introduces a graded slab based on annual turnover:

·         Up to ₹5 crore: Exempt from benefit-sharing.

·         ₹5 crore – ₹50 crore: 0.2% of annual gross ex-factory sale price (excluding taxes).

·         ₹50 crore – ₹250 crore: 0.4%.

·         Above ₹250 crore: 0.6%.

All users with turnover over ₹1 crore must submit annual statements on the biological resources used.

2. Exemptions for Cultivated Medicinal Plants:

• The new framework exempts cultivated medicinal plants from benefit-sharing, aligning with the Biological Diversity (Amendment) Act, 2023, which supports cultivation and eases regulations for Ayurveda, Siddha, and Unani practitioners.
• For products with both cultivated and uncultivated plants, exemption applies only if recognized by MoEFCC, in consultation with the Ministry of AYUSH.

3. High-Value and Threatened Resources:
Special provisions apply to:

·         Red sanders

·         Sandalwood

·         Agarwood

·         Species listed under Section 38 of the Biological Diversity Act, 2002.

For these, benefit-sharing is no less than 5% of sale/auction proceeds and may exceed 20% in cases of commercial exploitation.

4. Benefit Sharing for Researchers and IPR Applicants:
Mandatory for:

·         Researchers using biological resources or traditional knowledge.

·         Entities filing for IPRs based on Indian biological material.

5. Benefit Distribution Mechanism:

·         10–15% of benefits retained by NBA for administration and monitoring.

·         Remaining shared with local communities that conserve biodiversity and possess traditional knowledge.

Implications for Industry

Major herbal and traditional medicine companies will be affected:

• Dabur India: ₹1,28,864 crore (2024)
• Patanjali Ayurved: ₹31,961.62 crore
• Baidyanath: ₹713 crore

These firms fall under the top slab but may receive exemptions depending on product composition and government classification.

Alignment with Global Frameworks

The global focus on ABS and DSI peaked at COP16 of the Convention on Biological Diversity (Cali, Colombia, 2024), where a multilateral benefit-sharing mechanism for DSI was adopted. It mandates pharmaceutical, agriculture, biotech, and cosmetics industries to share benefits with biodiversity-conserving communities holding traditional knowledge.

Conclusion

The 2025 Regulation redefines benefit-sharing in India, balancing biodiversity-based industrial growth, traditional knowledge protection, and community rights. With DSI now clearly included, the law marks progress, but continuous monitoring and inclusive dialogue remain essential for resolving exemption ambiguities and ensuring compliance.