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3. Strengthen pharmacopoeial standards: Despite extensive documentation of
medicinal plants, there is a strong need for creating internationally acceptable
pharmacopoeias for herbal medications, as well as eco-system specific, regional
pharmacopoeias for various bio-geographic regions of India.
4. Increase quality and quantity of clinical trials & certification: Promotion of
traditional medicine goes hand-in-hand with increase in the quality of rigorous, yet
sensitively designed clinical trials to support or refute traditional medical claims of
efficacy. Also, lack of information on toxicological data/safety studies makes it
difficult to evaluate the risk profile of traditional medications. There is a need for
greater institutional enabling of such evaluations and trials. These should be
accompanied by a world-class certification process, which will assist the achievement
of internationally acceptable standards for good manufacturing, laboratory, clinical,
agricultural and collection practices. The pre-clinical and clinical efficacy validation
and standardization of ten best THS products for global market should be supported
as a flagship project. Similarly technological upgradation of the manufacturing units
involved in manufacture of these successful products to international standards must
be carried out.
5. Digitise traditional knowledge: The work underway for creating a comprehensive
Traditional Knowledge Digital Library (TKDL) should be diversified and expanded.
A major program should be established for digitization of India&'s medical manuscripts
(located both within India & abroad) and for making this digital library accessible to
teaching and research institutions in India. To modernise data-mining from the vast
corpus of traditional medical literature, an all-India coordinated,"Traditional
Knowledge Informatics program" should be constructed to create a comprehensive
list of available plant material-medica (2,000 species), their products (40,000
formulations) and clinical applications (5,000 conditions).
6. Create suitable framework of intellectual property rights: Emphasis should be put
on creating suitable Intellectual Property Rights framework in the country for
protection of the sources of traditional medical knowledge. At the same time
sufficient incentives should be created for commercialization of traditional
medications. Steps should be taken for the use and incorporation of TKDL, with all
pertinent sources of information, into the minimum search documentation lists of
International Search Authorities and other patent offices while processing patent
applications.
Lack of clarity regarding the 'ownership' issue for traditional knowledge
must be addressed in the TKDL. This is especially pressing since underprivileged
communities are commonly the primary sources of such knowledge. The need is to
create IPR systems that ensure that such knowledge remains in the public domain and
is "protected" for the communities of origin through mechanisms such as GIs.
An approach to the commercial dissemination of traditional medications will be to
allow companies to access TKDL upon payment of adequate user fees and subject to
the condition that invention arising out of the TKDL would require royalty sharing.
Both user fees and royalty must be shared between government and the communities
identified as the sources of the knowledge, and innovative modalities will need to be
found to administer such distribution. The revenue generated by the government from
commercialization of TKDL and other commercially synergistic initiatives should be
used to create a 'Traditional Knowledge Development Fund' and its proceeds should
be used for conservation, evidence-based analysis and research on traditional
knowledge and for the benefit of communities that have contributed to the creation of
traditional knowledge.
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