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Introduction
The National Biodiversity Authority (NBA) has issued a notification on February 04, 2026 to clarify the obligation to submit a Declaration in Form-10 by any person intending to use any biological resource or associated traditional knowledge, obtained from a foreign country in India. This article provides an overview of the new requirement and its implications for businesses and research institutions.
What is Form-10?
Form-10 is a statutory declaration to be submitted through the NBA’s official web portal. It is required whenever a person including individual, company, institution, or research body intends to use any biological resource or associated traditional knowledge obtained from a foreign country, for one or more of the following three defined purposes:
|
Research |
Commercial Utilization |
Intellectual Property Rights |
|
Scientific or academic study involving foreign biological material or traditional knowledge |
Using biological resources in products, services, or any profit-generating activity |
Applying for or obtaining patents or any other form of IPR based on foreign resources |
The declaration mechanism enables the NBA to monitor and regulate the use of foreign biological resources within India, and to ensure compliance with the Biological Diversity (Amendment) Act, 2023. The declaration is required only in respect of activities that occur on or after 21 December 2024.
Who is Affected?
The Rule casts a wide net. Any “person” defined broadly under Indian law to include individuals, research institutions, universities, companies, start-ups, and multinational entities, who intends to use foreign biological resources or traditional knowledge in India falls within the scope of Rule 18(1).
Sectors particularly affected include:
- Pharmaceutical and biotech companies conducting research on foreign plant or animal extracts
- Agricultural firms working with foreign germplasm
- Academic institutions collaborating on international biodiversity research
- Any organisation seeking Indian patents built on foreign biological material
Significance of the Notification
Form-10 is India’s implementation of the Nagoya Protocol on Access and Benefit-Sharing, ensuring that the use of foreign genetic resources in India is transparent, regulated, and traceable. This update reflects the NBA’s intent to actively enforce Rule 18 as a monitoring and regulatory tool, not merely a procedural formality.
Conclusion
Organizations working with foreign biological resources in India must take proactive steps to ensure compliance with the Form-10 declaration requirement. Failure to comply could result in regulatory consequences. Businesses are advised to review their operations, identify activities falling within the scope of Rule 18(1), and submit the necessary declarations through the NBA’s official portal in a timely manner.
Our Coverage on LinkedIn: https://www.linkedin.com/feed/update/urn:li:activity:7442095543583109120
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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