Model Answer
0 min readIntroduction
Traditional knowledge of medicine in India, accumulated over millennia, represents a significant cultural and economic resource. However, this knowledge has been vulnerable to ‘biopiracy’ – the patenting of traditional knowledge by entities outside the country without due recognition or benefit-sharing. The issue gained prominence with instances like the patenting of turmeric and neem, prompting the Indian government to proactively safeguard its TMK. Recognizing the need for a robust system, India has implemented a series of legislative and institutional measures to prevent the misappropriation of its traditional medicinal practices and ensure equitable benefit-sharing.
Historical Context & The Problem of Biopiracy
Historically, India’s rich biodiversity and traditional medicinal systems like Ayurveda, Unani, and Siddha have been sources of valuable knowledge. However, the lack of a formal documentation system and the complexities of international patent laws made this knowledge susceptible to exploitation. The patenting of turmeric (wound-healing properties) by the University of Mississippi in 1995 and neem (insecticidal properties) by US corporations in the late 1990s were landmark cases that highlighted the vulnerability of Indian TMK.
Legal Framework
The Biological Diversity Act, 2002
This Act is the cornerstone of India’s TMK protection. It aims to conserve biological diversity, sustainable use of its components, and fair and equitable sharing of benefits arising from its utilization. Key provisions include:
- Regulation of access to biological resources: Requires prior approval from the National Biodiversity Authority (NBA) for accessing biological resources and associated knowledge.
- Establishment of People’s Biodiversity Registers (PBRs): Local-level documentation of biological resources and associated knowledge.
- Benefit-sharing mechanisms: Ensures that benefits derived from the utilization of biological resources and associated knowledge are shared with local communities.
The Patents (Amendment) Act, 2005
This amendment to the Patents Act, 1970, introduced Section 3(j), which explicitly prohibits the granting of patents for inventions based on traditional knowledge or aggregation or duplication of known properties of traditionally used substances. This provision is crucial in preventing the patenting of TMK as ‘new’ inventions.
Protection of Plant Varieties and Farmers’ Rights Act, 2001
While primarily focused on plant varieties, this Act also indirectly protects TMK related to plant-based medicines by recognizing the rights of farmers and traditional plant breeders.
Institutional Mechanisms
National Biodiversity Authority (NBA)
Established under the Biological Diversity Act, 2002, the NBA is a statutory body responsible for implementing the Act and regulating access to biological resources and associated knowledge. It plays a key role in scrutinizing patent applications and opposing those that are based on TMK.
Traditional Knowledge Digital Library (TKDL)
Launched in 2001, the TKDL is a collaborative project between the Council of Scientific and Industrial Research (CSIR) and the Department of AYUSH. It contains digitized information on traditional medicinal formulations in multiple languages, making it accessible to patent offices worldwide. The TKDL acts as a ‘prior art’ database, preventing the granting of patents for TMK by demonstrating its existing knowledge. As of 2023, the TKDL contains over 580,000 formulations.
AYUSH Grid
Launched in 2018, AYUSH Grid is a comprehensive IT platform for promoting and facilitating the AYUSH systems of medicine. It aims to standardize and digitize data related to AYUSH practices, including traditional knowledge, and make it accessible to stakeholders.
Challenges and Future Prospects
Despite these measures, challenges remain. These include:
- Lack of awareness: Limited awareness among local communities about their rights and the mechanisms for protecting TMK.
- Documentation gaps: Incomplete documentation of TMK, particularly in remote areas.
- Enforcement issues: Difficulties in enforcing the provisions of the Biological Diversity Act and the Patents Act in international jurisdictions.
- Defensive patenting: The need for continued defensive patenting efforts to prevent the misappropriation of TMK.
Future prospects involve strengthening PBRs, enhancing the TKDL’s coverage, promoting international cooperation on TMK protection, and fostering greater awareness among stakeholders. The integration of Artificial Intelligence (AI) and Machine Learning (ML) in the TKDL can further enhance its efficiency and accuracy.
Conclusion
The Government of India has taken significant steps to protect its traditional knowledge of medicine from biopiracy through a combination of legislation, institutional mechanisms, and digital initiatives. While challenges persist, the ongoing efforts to strengthen these measures and promote awareness are crucial for safeguarding this invaluable cultural and economic resource. Continued vigilance, international collaboration, and technological advancements will be essential to ensure the equitable and sustainable utilization of India’s traditional medicinal heritage.
Answer Length
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