Indo-US Symposium on Indian Systems of Medicine and Botanicals
Two day Indo-US Symposium on Indian Systems of Medicine and Botanicals was organized by Indian Institute of Integrative Medicine, (CSIR), Jammu in collaboration with National Center for Natural Products Research, The University of Mississippi, USA on 15-16, October, 2008 at NASC Complex, New Delhi.
The Symposium was inaugurated by Dr. Ashok Vaidya, Research Director KHS, Mumbai who delivered a Key note address on “Observational Therapeutics and Reverse Pharmacology : discovery path to novel pharmaceuticals “ and was presided over by Prof. Samir K Brahmachari, DG, CSIR. Other dignitaries who spoke on the occasion were Dr. G. N. Qazi, Vice Chancellor , Hamdard University, Prof. Ikhlas Khan, Director, FDA Center at NCNPR, Mr. Veghese Samual, Joint Secretary ( AYUSH) and Mr. Ranjit Puranik, General Secretary(ADMA).
The speakers to the symposium were from USA, Canada and India which included eminent scientists and experts from industries, R & D Institutions, academia and regulatory authorities.
Topics discussed during the symposium included sustainable supply of quality raw material to quality control, standardization and production of the finished marketable products which are clinically tested and enjoy the full confidence of consumers with respect to quality, safety and therapeutic claims. One full session was devoted to the regulatory issues on ISM / botanical products in Indian and US/ EU market.
Presentations during the symposium generated a lot of interaction specially amongst delegates from Indian ISM industry with speakers from USFDA who dealt in detail on the biomedical research on botanicals and presented regulatory update on the development of new drugs.
The symposium was attended by more than 70 delegates from India and were drawn from herbal drug / botanical industry and other R & D institutes. The event provided an excellent platform to the participants for interaction with visiting scientists & experts from USA, Canada & Malaysia to discuss the contemporary issues in the field botanicals & ISM.
The major recommendations which emerged from the two days symposium are to adopt GACP, GLP and cGMP so as to make Indian herbal drug industry products globally acceptable. For this the need for more frequent dialogue between the scientific community and regulatory bodies of the two countries was emphasized which is bound to benefit the Indian systems of medicine and products thereof. As a follow-up of this meeting an Oxford conference on Botanicals has been announced at NCNPR, the University of Mississippi from April 6-9, 2008.
The main objectives of the symposium were:
• GACP for sustainable supply of quality raw material
• Critical evaluation of status of existing Pharmacopoeias and monographs for standardization and in process controls.
• Pre clinical & clinical studies for safety and efficacy of botanical drugs.
• Normalization of Regulations for acceptability across the globe.
• Adoption of cGMP for global business of ISM / botanical products.
Moreover the symposium proved as a platform to Indian herbal drug/ botanical supplement industry and other R & D institutes involved in research on herbals / botanicals to present their strengths and approaches in the research and manufacture of ISM/ botanical drugs/ supplements and the visiting scientists from USA and Europe coming from various research / academic institutes, Industry and government regulatory authorities etc. to interact with Indian counterparts. Such an interaction helped all the players in the trade of herbal drug industry to understand consumer demands and quality parameters in International market and develop methods of production that meet those demands of product quality and efficacy, which either exceeds or corresponds to international standards.
To achieve the above objectives, the lectures were grouped in five sessions (Botanical raw materials one session); standardization, efficacy & safety assessment of botanicals of ISM & Botanical products (two session); clinical trials in botanicals (one session) and regulatory aspects of botanicals (one session) based on the five different themes viz a viz sustainable Supply of Quality Raw Material, herbal drugs for global market Problems and new initiatives, pre clinical Pharmacology and its relevance to safety and efficacy of botanical drugs., clinical studies for safety & efficacy of ISM & botanical products, normalization of Regulations for acceptability across the globe.
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Dr. Ashok Vaidya during his inaugural address stressed that observational therapeutics has been the foundation of the discipline of pharmacology, as an experimental basic science and reverse Pharmacology is a bedside to bench path for drug discovery from bioclinical screening made in Observational Therapeutics with plant-derived medicine. According to him the aforesaid approach has been adopted by CSIR- NMITLI, ICMR and several other institutes for drug discovery and development from medicinal plants. The failures and successes of the path will be illustrated by examples from phytopharmaceuticals for : (1) Malaria (2) Cancer and (3) Diabetes Mellitus. He also added that there is an amendment to the drug act awaiting approval by the parliament of India, for a new category of phytopharmaceuticals, with defined quality, safety and efficacy for specific indications. India will give a new path to the world for drug discovery by this approach. Other speakers delivered the lectures on:
- Strategies towards resource security for Botanicals
- Trans-disciplinary Strategy for developing Pharmacognostic standards
- Indian Initiatives and achievements in the pharmacopoeial standardization of ISM drugs
- Facing the Challenge
- The Role of Analytical Methods in Dietary Supplement Product Development, Quality Assurance & Regulatory Compliance
- Standardization of herbomineral preparations – a case study
- AyuGenomics : Ancient concepts – Modren pharmacogenomics
- Role of Ayurvedic Drugs Silesia oblonga in the prevention and the management of type-II Diabetes Mellitus and micro vascular complications
- Safety issues pertinent to ISM and Botanical drugs
- Explorations in the practice of plant medicine
- Radiation Countermeasure Agents from Medicinal and Aromatic Plants: Leads for Today and Tomorrow
- Ageing Associated Neurodegeneration With Reference To Senile Dementia Of Alzheimer’s Type And Parkinson’s Disease– Role Of Ayurvedic Formulations
- Therapeutic Efficacy of Polyherbal formulations in Rheumatoid Arthritis
- Approaches to Clinical Research in Indian Systems of Medicine
- Ayurvedic formulations in Cancer (as an Adjuvant) Filarial chronic Obstructive Odema
- Regulation of Ayuervedic Herbal Products in the US / EU Market-present scenario
- Challenges in Biomedical Research on Botanicals: The NIH Perspective
- Development of New Drugs: U.S. Regulatory Update
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