Medicinal Plants Division

 

The programmes under the Division , employing multidisciplinary, multifaceted approach, through intramural and extramural programmes consolidate research efforts made in the country in the area of Medicinal plants so as to facilitate the development of safe, effective and standard drugs for various diseases where there is no satisfactory cure in Allopathic system of medicine, as well as promote, plan and coordinate, collaborative research in the area of Medicinal plants besides providing documented evidence for patents/IPR. The Quality standards on Indian Medicinal plants covering 580 plants have been developed running into 17 volumes.These publications help in developing plant drugs of adequate quality, safety and efficacy for wider acceptance. Helps in translating practically generated knowledge into direct utility for Indian Drug Industry engaged in production of plant based drugs and for the Pharmacopoeial Commisions in India & abroad for developing official quality standards on plant based drugs. Review Monographs on Indian Medicinal plants serve as comprehensive, informative & reliable source of information providing information on new leads, thus helping in systematic and planned evaluation of Medicinal plants, including drug design, basic and applied research. 21 volumes of Reviews on Indian Medicinal Plants (with botanical names starting with Piq-Pre) have been published. Phytochemical Reference Standards from Selected Indian Medicinal Plants for standardization of drugs for stakeholders engaged in establishing and maintaining quality of medicinal plants and their products have been developed. Safety Review monographs on important Medicinal Plants have been published. Medicinal plants monographs on diseases of public health importance in the management of Diabetes Mellitus,liver disorders and Lymphatic Filariasis have been published.
The Division is undertaking Task Force Projects with Translational approach involving development of Phytopharmaceuticals for some therapeutic areas.

 

1. Translational Programmes

 

Development of PDP-117 For Preventing or Delaying The Development of Type-2 Diabetes in Subjects With Pre-Diabetes

 

This is a multicentric, translational, task force project on development of a 'Phytopharmaceutical' product in the area of pre-diabetes. The project is initially approved for a total duration of 5 years and includes 4 different phases 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 first phase of the project is phytopharmaceutical development through phytochemistry, manufacturing and control (CMC). The second phase of the project includes pre-clinical pharmacological and safety studies on developed Phytopharmaceutical product. The third phase of work is to undertake GLP regulatory toxicity studies on the developed product in the laboratory animals. The fourth and clinical phase of work will evaluate clinical efficacy and safety of the product will be evaluated through well designed, multicenteric, randomized, double- blind, controlled clinical trials.

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 for a total duration of 5 years and includes 4 different phases for development of Ayurvedic product. The project involves Industrial partner (Emami Ltd, Kolkata) after signing a MOU right from the beginning of the project.

The first phase of the project is development of Ayurvedic product through chemistry, manufacturing and control (CMC). The second phase of the project includes pre-clinical pharmacological and safety studies on developed Ayurvedic product. The third phase of work is to undertake GLP regulatory toxicity studies on the developed product in the laboratory animals. The fourth and clinical phase of work will evaluate clinical efficacy and safety of the product will be evaluated through well designed, multicenteric, randomized, double-blind, controlled clinical trials.

2. Inter-Ministerial Programmes

 

Inter-Ministerial Cooperation Program of CSIR, DBT and ICMR on Phytopharmaceutical Development

 

This is a tripartite inter-ministerial cooperation translational research programme of CSIR, DBT and ICMR on development of Phytopharmaceuticals. It is initially aimed to develop drug(s) under this category in a short span of time from their already identified leads. In this reference, a MOU was signed between the three agencies (CSIR, DBT & ICMR) on 31st December 2018.

Under this programme, the initial therapeutic areas which have been identified, where leads are available and can be expedited are pain management, pediatric epilepsy, rheumatoid arthritis, gastric ulcers, neurodegenerative disorders, leucoderma, cognitive dysfunction etc. Initially 1-2 products will be brought out for their identified leads. The initial drug development activities of pre-clinical, CMC and others will be undertaken by the CSIR institute, IIIM Jammu and the safety pharmacology and toxicological studies through approved GLP lab will be coordinated and monitored by the DBT; whereas the ICMR role will be in designing, planning, coordinating, monitoring and financing the clinical phase of drug development and will also provide support in preparation and submission of IND drug dossier. 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.

3. Publications

Reviews on Indian Medicinal Plants

 

As part of this programme, Medicinal Plants Division of the ICMR has brought out 21 volumes in a series of publications entitled Reviews on Indian Medicinal Plants consolidating multidisciplinary scientific published research work on about 5,240 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 10,000
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 22nd 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.

 

☛ The 17th volume under this series has been published.

 

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.

 

☛ Data on 120 Phytochemical Reference Standards of Selected Indian Medicinal Plants has been published.

 

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

 

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.
 
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.

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".