Journal of Drug Research in Ayurvedic Sciences

Register      Login

VOLUME 3 , ISSUE 4 ( October-December, 2018 ) > List of Articles

REVIEW ARTICLE

Safety Concerns on Ayurvedic Herbomineral Formulations—Myth or Reality?

Shreshtha Kaushik, Rohit Singh, Pradeep Kumar Prajapati

Keywords : Metals, Multicentric studies, Safety, Toxicity,Herbomineral formulations

Citation Information : Kaushik S, Singh R, Prajapati PK. Safety Concerns on Ayurvedic Herbomineral Formulations—Myth or Reality?. J Drug Res Ayurvedic Sci 2018; 3 (4):234-241.

DOI: 10.5005/jdras-10059-0055

License: CC BY-NC 4.0

Published Online: 00-12-2018

Copyright Statement:  Copyright © 2018; Jaypee Brothers Medical Publishers (P) Ltd.


Abstract

Background: Ayurveda, systematically evolved science of the universe, focuses on preventing, preserving health, and curing diseases in a comprehensive way. This heritage is survived through the ages and Ministry of Ayurvedic, Yoga and Naturopathy, Unani, Siddha and Homeopathy (AYUSH) took a number of initiatives to showcase its usefulness at global levels. Exclusive and extensive use of various metals and minerals in therapeutics is an integral part in Ayurveda. But, safety and toxicity concerns in the past couple of decades opened debates in conventional community, which attempted to malign the glory of Ayurveda. Aim: The aim of this study is to review classical concepts and published researches on metallic formulations and generate evidences inferring the effectiveness and safety of Ayurveda interventions in different pathologies. Results: Classical Ayurveda texts are filled with comprehensive information pertaining to drug collection, storage and preservation methods, standards of raw materials, standard operative procedures for different dosage forms, quality control aspects for finished products, shelf life, posology, safety, adverse drug reactions (ADRs) on inappropriate use of medicines and their management, concurrent diet advices, etc., to avoid possible ill effects. It infers that the seers were well studied about good collection practices (GCPs), good storage practices (GSPs), good manufacturing processes (GMPs), therapeutic use of such formulations, good dispensing practices (GDPs), good agricultural and collection practices (GACPs), etc., and took maximum care in the management of diseases. To substantiate classical concepts, a good number of studies on herbomineral and metallic formulations have been conducted that have proven their safety and efficacy. Conclusion: It can be said that rational use of Ayurvedic formulations is well established before the period of Charaka Samhita, more than 5,000 BC. All the safety and efficacy concerns raised in the recent past are possibly some part of conspiracy that needs to be addressed systematically.


PDF Share
  1. Pliangbangchang S. Foreword in Traditional Herbal Remedies for Primary Health Care, WHO, Regional Office for South East Asia, New Delhi; 2010.
  2. Newman DJ, Cragg GM, Snader KM. Natural products as sources of new drugs over the period 1981–2002. J Nat Prod 2003;66(7):1022-1037, 10.1021/np030096l.
  3. Agnivesha, Charaka Samhita, Ayurveda Dipika Commentary by Chakrapanidutta, Sutra 1/68, Chaukhambha Surbharati Prakashan, Varanasi, Reprint 2000.
  4. https://www.indiatoday.in/mail-today/story/who-will-certify-yoga-and-ayurveda-323576-2016-05-15, last accessed on 16.10.2018 at 17.05.
  5. https://www.bmj.com/content/350/bmj.h2879, last accessed on 17.10.2018 at 10.35.
  6. Mathur R, Velpandian T. Medicinal plant-based health products: Where is the medicinal constituent? Indian J Pharmacol 2009;41(4):205-206, doi: 10.4103/0253-7613.56063.
  7. Kar A. Ayurveda: where we are? Curr Sci 2007;92(2):159.
  8. Valiathan MS, Thatte U. Ayurveda: the time to experiment. Int J Ayurveda Res 2010;1(1):3, doi: 10.4103/0974-7788.59935.
  9. Saper RB, Phillips RS, Sehgal A, et al. Lead, Mercury, and Arsenic in US and Indian Manufactured Ayurvedic Medicines Sold via the Internet. JAMA 2008;300:915-923, doi: 10.1001/jama.300.8.915.
  10. Hore P, Ahmed M, Ehrlich J, et al. Lead Poisoning in Pregnant Women Who Used Ayurvedic Medications from India - New York City, 2011–2012, Centre for Disease Control and Prevention (Morbidity and Mortality Weekly Report), 61(33) August 24, 2012.
  11. Douros A, Bronder E, Andersohn F, et al. Drug-induced liver injury: results from the hospital-based Berlin Case-Control Surveillance Study. Br J Clin Pharmacol 2014;79(6):988-999.
  12. Devarbhavi H. Ayurvedic and herbal medicine-induced liver injury: It is time to wake up and take notice. Indian J Gastroenterol 2018;37(1):5-7, doi: 10.1007/s12664-018-0820-6.
  13. Dalal KK, Holdbrook T, Peikin SR. Ayurvedic drug induced liver injury. World J Hepatol 2017;9(31):1205-1209, doi: 10.4254/wjh.v9.i31.1205.
  14. Beniwal P, Gaur N, Singh SK, et al. How harmful can herbal remedies be? A case of severe acute tubule-interstitial nephritis. Indian J Nephrol 2017;27:459-461.
  15. https://en.wikipedia.org/wiki/Minamata_Convention_on_Mercury, last accessed on 31.05.2019 at 11.50.
  16. Chaudhari SY, Nariya MB, Galib R, et al. Acute and subchronic toxicity study of Tamra Bhasma (incinerated copper) prepared with and without Amritikarana. J Ayurveda Integr Med 2016;7(1):23-29, doi: 10.1016/j.jaim.2015.11.001.
  17. Rasa vagbhata, Rasa Ratna Samuchaya, Vigyanbodhini Commentary by Dattatreya Anant Kulkarni, Chaukhambha Orientalia, Varanasi, Reprint 2017.
  18. Agnivesha, Charaka Samhita, Ayurveda Dipika Commentary by Chakrapanidutta, Chikitsa 1-iii/15-23, Chaukhambha Surbharati Prakashan, Varanasi, Reprint 2000.
  19. Agnivesha, Charaka Samhita, Ayurveda Dipika Commentary by Chakrapanidutta, Chikitsa 12/21-2, Chaukhambha Surbharati Prakashan, Varanasi, Reprint 2000.
  20. Agnivesha, Charaka Samhita, Ayurveda Dipika Commentary by Chakrapanidutta, Chikitsa 5/57, Chaukhambha Surbharati Prakashan, Varanasi, Reprint 2000.
  21. Harishastri P, ed. (9th ed.), Ashtanga Hridayam of Vagbhata, Kalpa siddhi Sthana; chapter 6, verse 12. Chowkhambha Orientalia; Varanasi: 2005.
  22. Agnivesha, Charaka Samhita, Ayurveda Dipika Commentary by Chakrapanidutta, Chikitsa 30/293, Chaukhambha Surbharati Prakashan, Varanasi, Reprint 2000.
  23. Mehta S, Gogtay NJ. From the pen to the patient: Minimizing medication errors. J Postgrad Med 2005;51:3-4.
  24. Srinivasan S. A network for the rational and ethical use of drugs. Indian J Med Ethics 2004;1(1):13-14, doi: https://doi.org/10.20529/IJME.2004.005.
  25. World Health Organization. Rational Use of Medicines. Available at http://www.who.int/medicines/areas/rational_use/en/index.html, last accessed on 17.10.2018 at 11.53.
  26. https://www.ncbi.nlm.nih.gov/pubmed/21617554, last accessed on 01.06.2019 at 14.23
  27. Wanjari MM, Mishra S, Dey YN, et al. Antidiabetic activity of Chandraprabha vati – A classical Ayurvedic formulation. J Ayurveda Integr Med 2016;7(3):144-150, doi: 10.1016/j.jaim.2016.08.010.
  28. Bulbul J, Obayed U, Rahaman MA, et al. Effect of Garbha cintamani rasa - An ayurvedic formulation on lipid profile, liver function and kidney function parameters of rat plasma after chronic administration. Eur J Sci Res 2009;32:25-32.
  29. Kumar G, Srivastava A, Sharma SK, et al. Safety evaluation of an ayurvedic medicine, Arogyavardhini vati on brain, liver and kidney in rats. J Ethnopharmacol 2012;140:151-160, doi: 10.1016/j.jep.2012.01.004.
  30. Saba K, Rajnala N, Veeraiah P Energetics of Excitatory and Inhibitory Neurotransmission in Aluminum Chloride Model of Alzheimer's Disease: Reversal of Behavioral and Metabolic Deficits by Rasa Sindoor. Front Mol Neurosci 2017;10:323, doi: 10.3389/fnmol.2017.00323.
  31. Dwivedi V, Anandan EM, Mony RS, et al. In vivo effects of traditional ayurvedic formulations in Drosophila melanogaster model relate with therapeutic applications. PLoS One 2012;7:e37113, doi: 10.1371/journal.pone.0037113.
  32. Sinyorita S, Ghosh CK, Chakrabarti A, et al. Effect of Ayurvedic mercury preparation Makaradhwaja on geriatric canine – A preliminary study. Indian J Exp Biol 2011;49:537.
  33. Kumar G, Srivastava A, Sharma SK, et al. Efficacy & safety evaluation of Ayurvedic treatment (Ashwagandha powder & Sidh Makardhwaj) in rheumatoid arthritis patients: a pilot prospective study. Indian J Med Res 2015;141(1):100-106.
  34. Inder D, Kumar P. Sedative-hypnotic Effect of Ash of Silver in Mice: A Reverse Pharmacological Study. J Tradit Complement Med 2014:4:268-271, doi: 10.4103/2225-4110.129198.
  35. Inder D, Rehan HS, Bajaj VK, et al. Analgesic activity and safety of ash of silver used in Indian system of medicine in mice: A reverse pharmacological study. Indian J Pharmacol 2012;44:46-50, doi: 10.4103/0253-7613.91866.
  36. Mashru M, Galib R, Shukla VJ, et al. Effect of Sameera Pannaga Rasa (arsenomercurial formulation) in the management of Tamaka Shwasa (bronchial asthma) - Randomized double blind clinical study. Ayu 2013;34(4):346-351, doi: 10.4103/0974-8520.127692.
  37. Jhelum P, Wahul AB, Kamle A, et al. Sameerpannag Ras Mixture (SRM) improved neurobehavioral deficits following acute ischemic stroke by attenuating neuro-inflammatory response. J Ethnopharmacol 2016;197:147-156. doi: 10.1016/j.jep.2016.07.059.
  38. Rao VN, Suresh P, Dixit S, et al. Effect of Yashada bhasma in streptozotocin induced diabetes. Anc Sci Life 1997;17: 114-116.
  39. Vardhini NV, Sathya TN, Balakrishna MP Assessment of genotoxic potential of herbomineral preparations – bhasmas. Curr Sci 2010;99(8):1096-1100.
  40. Savalgi PB, Patgiri BJ, Thakkar JH, et al. Evaluation of subchronic genotoxic potential of Swarna Makshika Bhasma. Ayu 2012;33(3):418-422, doi: 10.4103/0974-8520.108858.
  41. Jagtap CY, Chaudhari SY, Thakkar JH, et al. Assessment of Genotoxic Potential of Hridayarnava Rasa (Herbo-Mineralo-Metallic Ayurvedic Formulation) Using Chromosomal Aberration and Sperm Abnormality Assays. Toxicol Int 2014;21:242-247, doi: 10.4103/0971-6580.155331.
  42. Chaudhari SY, Jagtap C, Thakkar JH, et al. Assessment of genotoxic potential of Tamra Bhasma (incinerated copper). Int J Green Pharm 2015;9:175-179.
  43. https://www.ncbi.nlm.nih.gov/pubmed/29366690, last accessed on 01.06.2019 at 14.36
  44. Klaassen CD. Heavy Metals and Heavy-M, et al Antagonists in Pharmacological basis of therapeutics. In: Brunton LL, ed. 11th ed., New York: McGraw-Hill Medical Publishing Division, 2006, p.1760.
  45. Singh SK, Chaudhary AK, Rai DK, et al. Preparation and characterization of a mercury based Indian traditional drug – Rasa sindoor. Indian J Trad Know 2009;8(3):346-351.
  46. Liu J, Shi J-Z, Yu L-M, et al. Mercury in Traditional Medicines: Is Cinnabar Toxicologically Similar to Common Mercurials? Exp Bio Med 2008;233:810-817, doi: 10.3181/0712- MR-336.
  47. Zhou X, Wang L, Sun X, et al. Cinnabar is not converted into methylmercury by human intestinal bacteria. J Ethnopharmacol 2011;135(1):110-115.
  48. Baghel MS. Proposed ban on mercury may hit Ayurveda adversely. Ayu 2013;34(1):2-3, doi: 10.4103/0974-8520.115431.
  49. Agnivesha, Charaka Samhita, Ayurveda Dipika Commentary by Chakrapanidutta, Chikitsa 30/284, Chaukhambha Surbharati Prakashan, Varanasi, Reprint 2000.
  50. Sonnedecker Gienn. Evolution of Pharmacy (Chapter 2 in Remington's Pharmaceutical Sciences, Pennsylvania), 1980.
PDF Share