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NEWS AND FILLER  
Year : 2010  |  Volume : 1  |  Issue : 4  |  Page : 279-281
Science meet report: Safety and risk assessment approaches for materials of herbal origin


Hindustan Unilever Limited, Bangalore, India

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Date of Web Publication16-Feb-2011
 

How to cite this article:
Narayana DA. Science meet report: Safety and risk assessment approaches for materials of herbal origin. Int J Ayurveda Res 2010;1:279-81

How to cite this URL:
Narayana DA. Science meet report: Safety and risk assessment approaches for materials of herbal origin. Int J Ayurveda Res [serial online] 2010 [cited 2014 Oct 24];1:279-81. Available from: http://www.ijaronline.com/text.asp?2010/1/4/279/76796
Unilever R and D

September 3, 2010, Bangalore


A one-day symposium on, 'Safety and Risk Assessment Approaches for Materials of Herbal Origin,' was organized by Unilever R and D [Figure 1], in association with the Indian Drug Manufacturers Association (IDMA) and Ayurvedic Drug manufacturers Association (ADMA) at the Unilever R and D Center, in Bangalore, on September 3, 2010
Figure 1: Symposium on 'safety and risk assessment approaches for materials of herbal origin'

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About 120 delegates from the Academia, Government agencies, and the Industry participated in this symposium. Dr. Vilas Sinkar, VP, R and D, and Site Leader (Bangalore) welcomed the delegates and gave a brief overview of Unilever, its R and D Centers, and Safety and Environmental Assurance Centre (SEAC). He talked about the increased use of herbal materials (including Ayurveda and Traditional Chinese Medicine), which necessitates the development of appropriate science-based risk assessment approaches.

Dr. Julia Fentem, Head of the Safety Environment Assurance Center, Unilever, in her introductory presentation, highlighted the growing interest in herbal materials ('naturals') for consumers, globally, to improve the health and well-being, and the increasing application of herbal materials beyond medicinal products to personal care, foods, and dietary supplements.

Emphasizing the need to understand and apply the most up-to-date scientific knowledge and approaches to ensure the safety of these products for consumers globally, Dr. Fentem set up the context of the symposium:

  • To share our expertise and insights on assessing the safety of herbal materials
  • To identify key gaps in our scientific knowledge and future research needs


The inaugural address was delivered by Dr. SK Sharma, Adviser Ayurveda, Department of AYUSH (Government of India), on 'Regulatory Status and Recent Development of Herbals'. He gave an overview of the existing regulations on herbals, in the context of medical applications. He also talked about the upcoming regulations and Government of India's initiatives on education and research in Ayurveda. He clarified the ample history of usage known in Traditional knowledge for naturals, and summarized the regulatory initiatives taken by the government. The highlights of these were, permitting the use of excipients to extend the shelf-life of herbals, mandating marking of the shelf-life for Ayurvedic products, creating of new categories, namely, Ayurvedic supplements, Ayurvedic cosmetics, Ayurvedic extracts, permitting the use of solvent-based extracts in Ayurveda, provided the necessary additional safety data and published scientific literature was provided for such extracts, publication of more than eight volumes of pharmacopoeial compendium for raw herbs and two volumes for recipes, and so on. He also said that there was a need to have greater interaction between traditional medicine experts and current safety assessors.

The keynote address was delivered by Dr. Vasantha Muthuswamy, Senior Deputy Director General (Retd.), Indian Council of Medical Research (ICMR); on 'Challenges in Herbal Materials'. Giving a brief history of traditional medicines, Dr. Vasantha talked about the increasing herbal market globally. She brought out specific limitations and risks associated with herbal materials and the need for quality standards and enforcement of regulations for herbal materials. Giving case studies on the use of traditional herbs for disease conditions (Berberine for Alzheimer's disease and Bacopa for epilepsy) she emphasized the need to use modern methods for assessing the efficacy and safety of herbals and using ICMR guidelines for Clinicals.

The technical sessions started with a presentation from Dr. Ram Manohar, Director, Research, Arya Vaidya Pharmacy on the 'Principles and Insights from Ayurveda on Safety of Herbals'. He brought out the key principles of the safety and risk assessment ingrained within Ayurveda and cited Ayurvedic literature that indicated the existence of a risk-based framework. The evolution of the medical system also indicated the existence of a long-term, evaluation process, running into 5 - 10 years, before widespread application of a therapy. He also talked on the safety needs of herbal remedies, and the approaches for generating long-term epidemiological data on traditional system-based remedies in the current context, rather than following traditional toxicology approaches.

Dr. CK Katiyar, VP - Health Care Research, Dabur R and D, gave a talk on the 'Modern Challenges for Safety Assessment of Ayurvedic Materials'. Dr. Katiyar discussed the factors responsible for safety concerns in herbal materials (e.g., use of toxic substances, heavy metal contamination, poor quality, batch variations, etc.) and the challenges in safety evaluation of herbals (geographical and seasonal variations, processing variations, etc.). He also talked about the modern safety evaluation methods, regulations (Drug and Cosmetics Act), and guidelines (e.g., WHO, AYUSH) for the safety evaluation of herbals and using new approaches like nematode models, for assessing safety.

Dr. Poonam Kakkar, Head - Herbals Research at the Indian Institute of Toxicology Research presented a review on the 'Toxicological Assessment of Herbal Materials: Current Status and Progress in India'. Dr. Kakkar discussed factors of safety concern, such as, inherent toxic constituents, purity of preparation, contamination, compromised quality, and toxicological evaluations. She presented the science and technology map in India on this aspect. On toxicological evaluations of herbal materials, she also emphasized that need to address the 'intended use' for determining toxicological end points. Discussing the future approaches, Dr. Kakkar stressed the importance of predictive toxicology (building relevant databases), in silico modeling (QSAR) and 'omics' technologies in the safety assessment of herbal materials.

The final talk was delivered by Dr. Bobbie Bradford, Product Toxicologist, SEAC, who presented the Unilever's strategy for the safety assessment of herbals. Through illustrative case studies, she highlighted the History of the Safe Use approach for herbal materials, which was refined using modern mathematical approaches and advanced analytical chemistry tools, the extent of exposure, nature and format in which used, the route of administration, and the extent of application and contact time. Gaps, if any, on any toxicological end points were addressed using the traditional toxicological tools. The Unilever presentation generated good discussion and the approach was appreciated as a balanced one, while addressing all relevant consumer risks.

The symposium ended with a panel discussion chaired by Prof. YK Gupta and moderated ably by: Dr. DBA Narayana.

The Panel discussions involved an open-house discussion on several outcomes of the discussions that occurred throughout the day in the symposium, as recorded by the reporters, and the following position statements were agreed upon:

  • The history of use of herbal materials, recognized in the traditional medical systems is a great scientific asset for Safety and Risk Assessment. This should constitute an appropriate evidence of safety in the risk assessment of herbal materials
  • There is a need to improve the documentation of the history of use of herbal materials
  • It is essential to establish the History of Safe Use with reference to the part of the plant, processing, format, dose, and route of administration
  • It is also critical to develop the relevant quality profiles, fingerprints, and specifications for all herbal materials that have a safe history of use
  • Currently, there is no common, globally determined acceptable level of heavy metals, as contaminants (including US FDA).
  • Large manufacturers are moving away from raw herbs to extracts, wherein, heavy metal levels could get concentrated


Approaches

  • Common global acceptable levels
  • Rigorous scientific evaluation and harmonization, to avoid barriers to trade
  • Develop technologies that can selectively remove or reduce levels of heavy metals in extracts, without altering the composition of the extracts
  • There is a need to develop a robust safety assessment process for Herbal extracts prepared using organic solvents as a medium, which appropriately considers any Health Outcomes Survey (HOS) data and guides additional safety data to be generated
  • Great care is to be exercised while reviewing published scientific literature / data related to Safety of Herbals. A guideline needs to be developed that can help in identifying the relevant information for safety from published literature (e.g., not to extend information of a chemical component to a total herb)
  • There is a need for focused education and training to enhance human resource for toxicology and safety evaluation sciences (including regulatory toxicologists) in India
  • Academic Institutions and National Laboratories need to evaluate the initiation of specific courses to encourage safety professionals and regulatory toxicologists
  • In the absence of a structured pharmacovigilance program for herbals, there is a need to create greater awareness
  • Pilot projects that document the safety aspects experienced by patients / consumers when they use herbals, and a system to evaluate such data, need to be initiated in the country. Such a project has the potential to generate large 'Phase-IV human use data' in a true market situation


The additional points that came up repeatedly for discussions were:

  • Need to generate more data on traditional medicine and their efficacy and safety, through Pharmacovigilance and Pharmacoepidemiology
  • Need for generating data on the effects of Herbals and their bio-availability, efficacy / safety, and interactions, if any, with other medicines taken concurrently by consumers
  • Evolving a balanced safety and risk assessment approach and building on existing approaches being practiced, for example, Unilever's History of Safe Use approach, wherever relevant
  • It was recommended that a core group be formed to draw out a comprehensive strategy and propose the next steps


Adip Roy (adip.roy@Unilever.com) and Rajendra Dobriyal (Rajendra.dobriyal@Unilever.com)

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Correspondence Address:
D.B A Narayana
Hindustan Unilever Limited, Bangalore
India
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DOI: 10.4103/0974-7788.76796

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