CSIR has earned the distinction of developing 11 out of the 16 new drugs developed in India. It has developed cost-effective and innovative processes for around 25 generic drugs, standardization of over 50 herbal drugs and devised new diagnostic tools. The production of over 25 drugs/drug intermediates, technologies for which have been developed and successfully commercialized, is valued at around Rs. 600 million annually. Several of these drugs are exported and save net foreign exchange through export substitution. Some noteworthy accomplishments in the area of herbal drug research are listed below:
I. Products commercialized
- Bacopa monniera standardized extract developed, manufactured and marketed under trade name ‘Promind’ by Lumen Marketing Company, Chennai.
- A polyherbal standardized drug for asthma ‘Asmon’ commercialized by Herbochem Remedies India Limited, Kolkata.
- Spermicidal saponins of Sapindus mulkrossi developed as ‘Consap’ is to be marketed by Hindustan Latex Ltd.
- ‘Shallaki’, an anti-inflammatory drug for the treatment of rheumatoid arthritis and osteoarthritis produced from Boswellia serrata, is marketed by Gufic (P) Ltd., Mumbai.
- ‘Livzon’, a multi-herbal formulation with hepatoprotective property, marketed by M/s Hind Chemicals Ltd., Kanpur.
- ‘Imminex’, a multi-herbal formulation with immunomodulatory property, marketed by M/s Hind Chemicals Ltd., Kanpur.
- Technology for the development of an eco-friendly cosmetic from multiple natural colours fortified with natural aromas has been transferred to M/s Ayur Herbal (Pvt) Ltd.
II. Products available for commercialization
- A saccharifying amylase in pure form is identified in the aqueous extract of Tinospora cordifolia stem. With a huge potential for use in the pharmaceutical industry it has been patented by IICB.
- NMITLI-HA-002, a multi-herbal formulation as hepatoprotective against alcoholic cirrhosis and viral cirrhosis is under multi-centric trials.
- VIJAYASAR, a single plant based anti-diabetic drug under multi-centric clinical trials sponsored by ICMR.
- End-to-end technology on Hypericum perforatum, a mild anti-depressant, passed on to M/s Nicolas Piramal Ltd., Mumbai.
III. Diagnostic kits/probes
- RJ-NE-299E a plant-based adjuvant for use in anti-hepatitis vaccine replacing the usual Al(OH)3 is in advanced stage of development with DST, Bharat Biotech having extended financial support for this.
IV. Products under development
- A unique plant-based therapeutic agent that specifically targets cancer cells, ignoring normal cells, for chronic myelogenous leukemia, which constitutes 80% of blood cancers, has been developed by IICB.
- Two strong candidate anti-cancer drugs being developed out of more than 20 short-listed plant extracts/fractions by RRL Jammu.
- 97 M, an iridoid glycoside mixture from Vitex species being developed as a hepatoprotective for alcoholic cirrhosis.
V. Technology available for commercialization
- Production of phytopharmaceuticals – colchicine, colchiside, silymarin, boswellic acid, diosgenin, 16-DPA, berberis hydrochloride and rutin.
- End-to-end technology of standardized extract of Tinospora cordifolia.
VI. Traditional Knowledge Digital Library
The rich traditional knowledge of India lying in common knowledge of our people, having been passed on from generation to generation by word of mouth was largely not documented. Though part of this knowledge is available in ancient classic medical and other literature, it is inaccessible to the common man and rarely understood in the context of its original notion. Documentation of such knowledge, available in public domain, on various traditional systems of medicine has become imperative to safeguard the sovereignty of this knowledge and to protect it from being misappropriated in the form of patents on non-original innovations, which has been a matter of national concern.
India fought successfully for the revocation of turmeric and basmati patents granted by United States Patent and Trademark Office (USPTO) and neem patent granted by European Patent Office (EPO). As a sequel to this, in 1999, the Department of AYUSH constituted an inter-disciplinary task force, for creating a traditional knowledge digital library (TKDL). The project TKDL was initiated in the year 2001.
TKDL provides information on traditional knowledge existing in our country, in languages and format understandable by patent examiners at International Patent Offices (IPOs), so as to prevent the grant of wrong patents. TKDL thus acts as a bridge between the traditional knowledge information existing in local languages and the patent examiners at IPOs.
TKDL is a collaborative project between CSIR and Department of AYUSH, Ministry of Health and Family Welfare, and is being implemented by CSIR. An inter-disciplinary team of traditional medicine experts, patent examiners, IT experts, scientists and technical officers are involved in the creation of TKDL for ISM.
Project TKDL involves documentation of the traditional knowledge available in public domain in the form of existing literature related to Ayurveda, Unani, Siddha and Yoga, in digitalized format in five international languages, namely English, German, French, Japanese and Spanish. Traditional knowledge resource classification (TKRC) is an innovative structured classification system for the purpose of systematic arrangement, dissemination and retrieval, evolved for about 25,000 subgroups in relation to medicinal plants, minerals, animal resources, effects and diseases, method of preparations and mode of administration. This was an improvement over the few subgroups that were available in the earlier version of the International Patent Classification (IPC). Thus, TKRC developed by TKDL led to the creation of World Intellectual Property Organization-Traditional Knowledge (WIPO-TK) task force constituting participation of patent offices from the United States, EU, Japan, China and India to consider linking TKRC with IPC. This resulted in the inclusion of a new group with 207 subgroups covering different categories of plants in the IPC.
Thus TKDL gives legitimacy to the existing traditional knowledge and enables protection of such information from getting patented by the fly-by-night inventors acquiring patents on India’s traditional knowledge. It also breaks the format and language barrier making it accessible to patent examiners at International Patent offices for the purpose of carrying out search and examination.
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