Advertisement

Safety Aspects of Ayurvedic Drugs

  • K. K. Pant
  • C. K. Katiyar
  • Arun Gupta
Chapter

Abstract

Ayurvedic medicines are usually considered safe by consumers especially because of their traditional usage. However, in the current global regulatory scenario, safety of Ayurvedic medicines needs to be established. The concerns of heavy metals in Ayurvedic products raised by few international published papers have further questioned the safety of Ayurvedic products. But it needs to be addressed, whether mere presence of certain heavy metals in Ayurvedic products is reason enough to believe that these products are not safe. The presence of heavy metals in some Ayurvedic products, especially the products where few metals might be used as one of the ingredients, needs to be addressed separately, considering the fact that these metals are used only after being processed by Ayurvedic methods of detoxification. However, the issue of presence of metals as contaminants definitely is a safety concern. It is advisable that finished multi-ingredients Ayurvedic product should undergo the relevant toxicity studies, and then the same may be subjected to clinical research to establish their safety. There is also a need to strengthen pharmacovigilance system for Ayurvedic products to find out rare side effects. Though there is a need to develop optimum scientifically validated methods of safety evaluation of Ayurvedic products, yet the prolonged history of usage of traditional medicinal products cannot be ignored.

Keywords

Heavy Metal Toxicity Study Safety Evaluation Herbal Product Ayurvedic Medicine 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

References

  1. 1.
    Malik V (2010) Drugs & Cosmetics Act, 1940 and Rules 1945. In: Law relating to Drugs & Cosmetics. Eastern Book Company, LucknowGoogle Scholar
  2. 2.
    WHO Research guidelines for evaluating the safety and efficacy of herbal medicines (1993) World Health Organization, GenevaGoogle Scholar
  3. 3.
    Saper RB, Kales SN, Paquin J, Burns MJ, Eisenberg DM, Davis RB, Phillips RS (2004) Heavy metal content of Ayurvedic herbal medicine products. JAMA 292:2868–2873PubMedCrossRefGoogle Scholar
  4. 4.
    GSR 663(E) (2010) Gazette notification of Government of IndiaGoogle Scholar
  5. 5.
    WHO report of the 44th World Health Assembly (1991) World Health Organization, GenevaGoogle Scholar
  6. 6.
    WHO report of 31st World Health Assembly (1978) World Health Organization, GenevaGoogle Scholar
  7. 7.
    WHO report of the 40th World Health Assembly (1987) World Health Organization, GenevaGoogle Scholar
  8. 8.
    WHO report of the 42nd World Health Assembly (1989) World Health Organization, GenevaGoogle Scholar
  9. 9.
    The International Conference on Primary Health Care (1978) Alma-Ata, USSRGoogle Scholar
  10. 10.
    The Ayurvedic Pharmacopoeia of India. Part I; Volumes I–VII. Government of India, Ministry of Health and Family Welfare, Department of Ayurveda Yoga & Naturopathy Unani Sidha and Homeopathy (AYUSH), New DelhiGoogle Scholar
  11. 11.
    The Ayurvedic Pharmacopoeia of India (formulations). Part-II; Volumes I–III. Government of India, Ministry of Health and Family Welfare, Department of Ayurveda Yoga & Naturopathy Unani Sidha and Homeopathy (AYUSH), New DelhiGoogle Scholar
  12. 12.
    Indian Systems of Medicine and Homeopathy in India (1999) Planning and evaluation cell, Department of ISM & H, Ministry of Health & Family Welfare, Government of India, New DelhiGoogle Scholar
  13. 13.
    Bhaishajaya Ratnavali (1961) Ed. Rajeshwar Dutt Shastri. Chowkhamba Sanskrit Sansthan, VaranasiGoogle Scholar
  14. 14.
    Ethical Guidelines for Biomedical Research on Human Subjects (2006) Indian Council of Medical Research, New DelhiGoogle Scholar
  15. 15.
    OECD (2001) Guidelines for testing of chemicals: Test No. 425. Acute oral toxicityGoogle Scholar
  16. 16.
    OECD (2009) Guidelines for the testing of chemicals, section 4: health effects, Test No. 412: Subacute inhalation toxicity: 28-day studyGoogle Scholar
  17. 17.
    OECD (2009) Guidelines for the testing of chemicals, section 4: health effects, Test No. 413: Subchronic inhalation toxicity: 90-day studyGoogle Scholar
  18. 18.
    OECD (2008) OECD guideline for the testing of chemicals test guideline 452: Chronic toxicity studiesGoogle Scholar
  19. 19.
    OECD (2008) OECD guideline for the testing of chemicals test guideline 451: Carcinogenicity studiesGoogle Scholar
  20. 20.
    OECD (1983) Test guideline 415. One-generation reproduction toxicity study. In: OECD guidelines for the testing of chemicals. Organisation for Economic Cooperation and Development, ParisGoogle Scholar
  21. 21.
    OECD (2001) Test guideline 416. Two-generation reproduction toxicity study. In: OECD guidelines for the testing of chemicals. Organisation for Economic Cooperation and Development, ParisGoogle Scholar
  22. 22.
    Järup L (2003) Hazards of heavy metal contamination. Br Med Bull 68:167–182PubMedCrossRefGoogle Scholar
  23. 23.
    WHO Guidelines for assessing quality of herbal medicines with reference to contaminants and residues (2007) World Health Organization, GenevaGoogle Scholar
  24. 24.
    Data on Dabur R&D Files, Dabur India limited, Sahibabad, Ghaziabad, IndiaGoogle Scholar
  25. 25.
    Savarikar SS, Safety of Ayurvedic Drugs (2011) Ayurvedic perspective in relation to current drug safety design. International conference on recent advances in safety and efficacy of Ayurvedic formulation: 33–44Google Scholar
  26. 26.
    Sharma DC, Jha J, Sharma P (2001) Evaluation of safety and efficacy of a gold containing Ayurvedic drug. Indian J Exp Biol 39:892–896PubMedGoogle Scholar
  27. 27.
    Gupta SK, Kaleekal T, Joshi S (2000) Misuse of corticosteroids in some of the drugs dispenses as preparations from alternative systems of medicine in India. Pharmacoepidemiol Drug Saf 9(7):599–602PubMedCrossRefGoogle Scholar
  28. 28.
    Gogtay NJ, Bhatt HA, Dalvi SS, Kshirsagar NA (2002) The use and safety of non-allopathic Indian medicines. Drug Saf 25(14):1005–1019PubMedCrossRefGoogle Scholar
  29. 29.
    Sarmukaddam S, Chopra A, Tillu G (2010) Efficacy and safety of Ayurvedic medicines: recommending equivalence trial design and proposing safety index. Int J Ayurveda Res 1(3):175–180PubMedCrossRefGoogle Scholar
  30. 30.
    Saper RB, Phillips RS, Sehgal A, Khouri N, Davis RB, Paquin J, Thuppil V, Kales SN (2008) Lead, Mercury, and Arsenic in US- and Indian-Manufactured Ayurvedic medicines sold via the internet. JAMA 300(8):915–923PubMedCrossRefGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg 2012

Authors and Affiliations

  1. 1.Department of PharmacologyC.S.M. Medical UniversityLucknowIndia
  2. 2.Dabur R&D CentreDabur India LimitedSahibabadIndia

Personalised recommendations