This is a Multicenteric Task Force project on translational research is aimed to develop a phytopharmaceutical product from Trigonella foenum-graecum seeds (PDP-117) for preventing or delaying the development of type-2 diabetes in subjects with pre-diabetes. The project was prioritized after reviewing inter-agency projects of ICMR, DBT, DST and AYUSH. The project is approved for an initial period of 5 years and includes 4 different stages for development of Phytopharmaceutical product. The project involves Industrial partner (Emami Ltd, Kolkata) after signing a MOU right from the beginning of the project. The project comprises four different stages (stage 1- chemistry manufacturing and control (CMC), stage 2- preclinical efficacy and safety studies, stage 3- GLP regulatory toxicity studies and stage 4- clinical development) for a initial duration of 5 years enrolling 10 different centers across the country.
Currently the project is under 4th stage of drug development, which is clinical phase of product development and Conducting A Phase I, randomized, Double-Blind, Placebo-Controlled, Safety, Tolerability and Pharmacokinetic Study of Escalating Single and Multiple Doses of PDP-117 in Healthy Subjects.
Development of SDA-217 For Treatment of Sleep Disorders
This is a multicentric, translational, task force project on development of an Ayurvedic product in the area of sleep disorders. The project is approved for an initial period of 5 years and includes 4 different stages for herbal (Ayurvedic) product development from selected medicinal plants. The project involves Industrial partner (Emami Ltd, Kolkata) after signing a MOU right from the beginning of the project.
The project comprises four different stages (stage 1- chemistry manufacturing and control (CMC), stage 2- preclinical efficacy and safety studies, stage 3- GLP regulatory toxicity studies and stage 4- clinical development) for an initial duration of 5 years enrolling 9 different centers across the country.
Currently the project is under 4th stage of drug development, which is clinical phase of product development and Conducting A randomized, multi-centric, double-blind, placebo-controlled trial of SDA-217 as an add-on therapy in patients of chronic insomnia.
2. Inter-Ministerial Programmes
Inter-Ministerial Cooperation Program of CSIR, DBT and ICMR on Phytopharmaceutical Development
This is a joint program of CSIR, DBT and ICMR on development of Phytopharmaceutical drugs from medicinal plants. This inter-ministerial cooperation translational research programme was initiated after signing of a tripartite MOU between the three agencies (CSIR, DBT & ICMR) on 31st December 2018. The programme is initially aimed to develop 1-2 drug(s) under this category in a short span of time from their already identified leads.
Under this programme, eight therapeutic areas have been identified, where leads are available and can be expedited for drug development are pain management, pediatric epilepsy, osteoarthritis, gastric ulcers, neurodegenerative disorders, rheumatoid arthritis, leucoderma, cognitive dysfunction etc. Any other leads from DBT initiative of NE-mission as well as extramural funding of both DBT as well as ICMR approved by the Project Advisory Committee may also be taken up under this programme. The initial drug development activities on CMC, pre-clinical work, and others are undertaken by the CSIR institute, IIIM Jammu and the safety pharmacology and toxicological studies through approved GLP lab are coordinated and monitored by the DBT; whereas the ICMR role is in designing, planning, coordinating, monitoring and financing the clinical phase of drug development and also to provide support in preparation and submission of IND drug dossier.
Currently, out of 9 leads identified initially, 2 have been prioritized:
1. Cannabis based Phytopharmaceutical with THC: CBD in ratio of 1:1 for management of cancer pain. Under this project, CSIR lab, IIIM, Jammu has completed on obtaining narcotic license for cultivation and processing of Cannabis species, development of raw material quality specifications and extractions & purification techniques and currently working on standardization, pre-formulation development, analytical development & testing studies. Subsequently formulation development, stability studies and preclinical efficacy, safety, toxicity and pharmacology studies are under way. ICMR role on clinical development of product will began after completion of all CMC and preclinical phase of work by CSIR and DBT.
2. Boswellia based Phytopharmaceutical drug for treatment of osteoarthritis. Under this project, CSIR lab, IIIM, Jammu has developed raw material quality specifications, and completed extraction and standardization process. Pre-formulation development studies and analytical testing is under progress. Subsequently formulation development, stability studies and preclinical efficacy, safety, toxicity and pharmacology studies are also under progress. ICMR role on clinical development of product will began after completion of all CMC and preclinical phase of work by CSIR and DBT.
3. Publications
Reviews on Indian Medicinal Plants
As
part of this programme, Medicinal Plants Division of the ICMR has brought
out 27 volumes in a series of publications entitled
Reviews on Indian Medicinal Plants consolidating multidisciplinary scientific
published research work on about 6,394 medicinal plants species.
Each monograph includes regional names of each medicinal plant, its Sanskrit
synonyms as well as the Ayurvedic description (wherever available), ethnobotanical
studies, apart from the habitat and the parts used, on one hand, and the
details of botanical, pharmacognostical, chemical, pharmacological and
clinical data on the other, backed by complete references and bibliography
on each aspect of the information cited, besides the colour photographs
of important medicinal plants. The publication includes about 89,621
citations on various aspects.
☛ Serve as comprehensive, informative & reliable source of information.
☛ Provide information on new leads, help in systematic and planned evaluation of medicinal plants, including modern drug design, basic and applied research, besides exploring and exploiting hitherto untapped medicinal plants.
☛ Help in establish correlationship between efficacy of the herbal drugs (as reported/ claimed in Indigenous System of Medicine) and research data finding scientific basis of use, practice and principles/mechanism of action of herbal drugs.
☛ Provide support to issues related to Intellectual Property Rights and Patents on Indian Medicinal Plants.
☛ Serve as inventory/directory of the Indian Medicinal Plants which have undergone investigation and which could be further followed up for in depth research. The monographs may be useful to scientific bodies, regulatory authorities, policy makers, herbal industry and other institutes/organisations involved in the development, assessment and registration of such products. The work on other volumes is in progress.
☛ The 28 & 29 th volume under this series is under preparation.
Quality Standards of Indian Medicinal Plants
One of the stumbling block in the popularity and wider acceptance of Indian herbal drugs had been the inadequacy or lack of standards. This is primarily attributed to the raw material which is not of desired quality as required for reliable biological, pharmacological, chemical and clinical evaluation besides for their use in health care. It is imperative to have quality parameters laid down for the crude raw material to ensure their quality, safety and efficacy. In view of this, ICMR initiated a program for laying down quality standards of medicinal plants widely used in India.
As an outcome of ongoing programme carried out, ICMR has brought out 17 volumes of Quality Standards of Indian Medicinal Plants. It contains quality standards for 580 medicinal plants commonly used in India.
These volumes on Quality Standards of Indian Medicinal plants cover authentic botanical names, synonyms, part used, detailed macroscopic and microscopic description of the plant part used as drug, its diagnostic characters and colour photographs. Other parameters in the just released publication, includes limits of foreign matter, total ash, acid insoluble ash and ethanol extractive, water soluble extractive besides chromatographic finger print profiling. Information on important pharmacological, clinical studies, toxicity, if any, as reported in the scientific literature and prescribed in the Ayurvedic texts supported by complete references, are some of the other highlights of the monographs. The work on other volumes in the series is under progress.
The Monographs are expected to be useful for the herbal drug industry, pharmacies, practitioners of indigenous systems of medicine, academicians, researchers, health professionals and regulatory bodies.
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Phytochemical Reference Standards of Selected Indian Medicinal Plants
The programme aims at generation of Phytochemical Reference Standards (PRS), for some frequently used Indian medicinal plants. Under this programme simple procedures of isolation of PRS have been optimized by making appropriate modifications in the reported procedures. The quantification of the PRS in the total crude extract is carried out by HPLC. Special emphasis have been laid on the complete characterization of the purified PRS by recording the physical and spectral data. Extensive use of the modern spectral methods like UV-Vis, IR 1H NMR and 13C NMR spectroscopy have been done for this purpose. A herbarium sheet of each of these plants is also maintained along with the repository. The first volume of Phytochemical Reference Standards of Selected Indian Medicinal Plants containing monographs of 30 marker compounds was published which was released by the Hon.ble Union minister of Health and Family welfare Sh Ghulam Nabi Azad ji on the occasion of the inaugural ecremony of Councils centenary celebration in November 2010. The Second volume in this series containing 30 monographs has been brought in 2012. The third volume in this series containing 30 monographs has been brought out in June. 2014.The fourth volume in this series has been brought out in 2016.
Safety Reviews on Selected Indian Medicinal Plants
A new initiative to bring out the compendium of safety of Medicinal Plants with the objective to review and document the safety related scientific information on important medicinal plants which are commonly used by the industry either as single herb or as part of the polyherbal formulation continued during the year.
Under this programme information related to botanical name, common name of the plant (Ayurveda, Hindi and English), family name, parts used in the traditional medicine (i.e. Ayurveda), historical use of the plant, scientific studies related to therapeutic uses (both prechinical and clinical), safety information derived from acute, subacute and chronic toxicity studies, safety information from pharmacological studies, information on genotoxicity, reproductive studies in animals, safety information derived from clinical studies (i.e. adverse drug reactions), case reports on toxic effeds in human and herb drug-interaction both in animals and humans have been reviewed and compiled for 75 important medicinal plants.
A format has been devised after consulting experts in this area which would be the basis of these monographs. The first volume of Safety Review Monographs on Selected Indian Medicinal Plants containing 75 plants species has been published. The second volume containing another 75 plants species is under progress.
☛ The 2nd volume of this series is under prepration
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Medicinal Plants Monographs on Diseases of Public Health Importance
Inspite
of tremendous advancements in drug research, modern synthetic drugs are
still not available or adequately suitable for variety of diseases, particularly
new and reemerging infections, spread of deadly strains that are resistant
to various drugs, for which there is no cure in Allopathic system of medicine
and post global health challenge.
| In view of the above, an activity has been initiated for preparation of Monographs on select diseases of public health importance matching with the national health priorities. The monographs shall incorporate information on diseases (including etiopathogenesis) and plant drugs as given in the ancient texts (Indigenous system of Medicine) and Allopathic system of medicine on one hand and the multidisciplinary research data generated during various scientific studies on these plant remedies with focus on pharmacological, toxicological, clinical, phytochemical, pharmacognostic, on the other. The monographs shall also include complete references of the work cited and the photographs of important medicinal plants.
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The
Monographs may provide scientific basis/rationale for use of ISM drugs,
strengthen claims in respect of IPR/patents for global acceptability,
give insight in systematic and planned evaluation of plant drugs, basic
and applied research and modern drug design, leading eventually to concepts
of therapy, and therapeutic agents. The Monographs may also be used fruitfully
by practitioners of modern medicine as well as Indigenous system of Medicine.
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The
first publication in this series has been brought out on the “Perspectives
of Indian Medicinal Plants in the management of Liver disorders 2008”.
The second in this series has been on "Perspectives of Indian Medicinal Plants in the Management of Lymphatic Filariasis 2012". The third in this series is "Perspectives of Indian Medicinal Plants in the Management of Diabetes mellitus 2014".
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