|Year : 2023 | Volume
| Issue : 1 | Page : 91-93
General guidelines for safety/toxicity evaluation of Ayurvedic formulations: Book review
Bidhan Mahajon, Mukesh B Chincholikar, Ashish Kumar Tripathi
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, New Delhi, India
|Date of Submission||02-Aug-2022|
|Date of Acceptance||16-Aug-2022|
|Date of Web Publication||30-Dec-2022|
Dr. Ashish Kumar Tripathi
Central Council for Research in Ayurvedic Sciences (CCRAS), Ministry of Ayush, Government of India, New Delhi
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Mahajon B, Chincholikar MB, Tripathi AK. General guidelines for safety/toxicity evaluation of Ayurvedic formulations: Book review. J Drug Res Ayurvedic Sci 2023;8:91-3
|How to cite this URL:|
Mahajon B, Chincholikar MB, Tripathi AK. General guidelines for safety/toxicity evaluation of Ayurvedic formulations: Book review. J Drug Res Ayurvedic Sci [serial online] 2023 [cited 2023 Sep 23];8:91-3. Available from: http://www.jdrasccras.com/text.asp?2023/8/1/91/366290
| Introduction|| |
The fundamental facets of holistic systems such as Ayurveda need adequate positioning while designing clinical trials to examine the safety and efficacy. The challenges concerning the quality, safety, dosage forms and delivery system, diverse basic concepts and complex approaches in the study design, diagnostic and therapeutic procedures, outcomes of clinical efficacy, and drug interactions also pose certain limitations in research. There is a need for a system medicine approach to validate the therapies with the integration of fundamental principles of Ayurveda and biomedicine without losing the vital fundamentals of both systems. Such an approach with well-designed research plans could facilitate generating tangible evidence.,
Factors such as the place, soil, season, and time for collecting the drugs from natural sources also play a vital role in the quality, strength, and purity of drugs. With the incredible growth in the use of traditional natural products worldwide, safety and efficacy, as well as the quality control of Ayurveda medicines, have become a key concern for both health authorities and the public in general., The development of a drug is a stepwise process concerning evaluating both preclinical and clinical efficacy and safety information. Preclinical evaluation of drug safety usually consists of standard animal toxicology studies. Animal toxicity studies are carried out to assess the potential undesirable pharmacodynamic effects of drugs on physiological functions concerning exposure within the therapeutic range. However, Ayurveda medicines are prescribed considering various aspects, viz., age, dose, dosage form, Anupana (vehicle), etc., which play a pivotal role in their therapeutic potential. Moreover, it is essential to state that some drugs are used after proper purification and processing. Therefore, safety/toxicity studies of such medicines may only be conducted by adopting similar Ayurvedic procedures. Therefore, there is an urgent need for a fundamentally different approach for toxicological studies that need to be adopted for Ayurveda drugs. Notwithstanding the subsistence of several guidelines such as General Methodologies and Research Evaluation Traditional Medicines; OECD Guidelines; GCP Guidelines for ASU Medicines, etc., there is a need to evolve a comprehensive guideline to address system-specific issues for conducting safety/toxicity studies of Ayurveda medicines. The present publication, “General Guidelines for Safety/Toxicity Evaluation of Ayurvedic Formulations,” is intended to serve as a comprehensive ready reference for researchers engaged in Research and Drug Development in Ayurveda systems.
| Content of the Book|| |
The whole compendium is presented in five chapters along with references, other suggestive readings, and a glossary of technical terms used in the chapters, along with four annexure comprising 158 (B) Guidelines for the Issue of License Concerning 24 Ayurveda, Siddha or Unani Drugs; Guidelines on the Regulation of Scientific Experiments on Animals; Committee for the Purpose of Control and Supervision of Experiments on Animals (CPCSEA) Guidelines for Laboratory Animal Facility 2005, and the List of Experts Involved in the Development of Guidelines and Consultative Process [Table 1].
| Salient Features of the Book|| |
Eight steps of general research guidelines and methodologies for drug development at a glance have been well presented. Research criteria for evaluating the safety/toxicity of ASU drugs are also described in this book. The details of single-dose toxicity studies (acute toxicity), repeated-dose oral toxicity studies, female fertility studies, teratogenicity studies, and perinatal studies are well explained. The book also deals with fine points of special toxicity tests such as genotoxicity and carcinogenicity tests, as well as local toxicity tests for topical preparations.
The eminent experts from the Central Council for Research in Ayurvedic Sciences (CCRAS) and other reputed institutions such as the National Institute of Pharmaceutical Education and Research (NIPER), All India Institute of Medical Sciences (AIIMS), CSIR-Central Drug Research Institute, and the National Institute of Nutrition (NIN) were solemnly involved in the development of guidelines and consultative process described in this book.
Despite the availability of different national and international guidelines, there is also a need for a single comprehensive guideline to conduct research in the Ayush sector. This is one of the unique salient features of this publication to stand as a directive on research practices for various components of Ayurveda research sectors for uniform adoption across all stakeholders, such as research councils, academic institutes, and funding agencies engaged in Ayurveda research.
| Way Forward|| |
The book deals with comprehensive and concise guidelines focusing on drug development ensuring standards and quality assurance of the product for ready reference of various stakeholders. The guidelines described in the book encompassed research practices generally to be adopted and followed by researchers in the field of the Ayush system, such as research organizations, academic institutions, and researchers seeking a grant from different funding agencies for research on the Ayush system. The book will help the researchers while designing and formulating the proposals and planning academic/industrial research in the field of Ayush systems.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
| References|| |
Nath R, Mahajon B, Sengupta A, Chattopadhyay A Importance of Nidana (Ayurvedic diagnosis) for treating an anonymous disease in Ayurveda: A case study. J Ayu Herb Med 2016; 2:3-5.
Srikanth N Ayurveda: The knowledge source for systems medicine. J Drug Res Ayurvedic Sci 2021;6:1-2.
Srikanth N, Mahajon B, Chincholikar M, Narayanan R, Venigalla S, Ahmad A . Basis for use of substitutes for medicinal flora and harmonization of rational use: A critical appraisal based on “Kitab al-Abdal”: A classical compendium of unani medicine. J Drug Res Ayurvedic Sci 2020;5:121-31.
Chincholikar M, Mahajon B, Tripathi AK Ayurveda-based seasonal collection practices for selected medicinal plants: A scientific appraisal—Book review. J Drug Res Ayurvedic Sci 2021;6:195-6.
Chincholikar M, Mahajon B Pathyapathyavinishchaya—An Ayurveda treatise on wholesome diet and lifestyle. J Res Ayurvedic Sci 2021;5:201-5.