Advertisement

Regulatory Approval of Botanical Products Including Herbal Drugs, Food, and Insecticides for Commercialization

  • P. Chattopadhyay
  • Vijay Veer
Chapter

Abstract

India, with its enormous topographic and climatic diversity, is home to a large number of herbs with medicinal properties. The great herbal healers of India were pioneers in the use of herbs as medicine, and the modern medical research is greatly benefitted by their findings. After post-Vedic era the traditional medicine system of India was renamed as Ayurveda. The modern Ayurvedic system is more scientific in all respects including safety, toxicity, dose accuracy, clinical evidences, efficacy, etc. Botanicals are also explored as food supplements and nutraceuticals, and now the concept of value-added specialized foods has arisen. Food supplements from plants, algae, fungi, or lichens have become widely available in the Indian market. Many countries including India regulate the use of botanicals as dietary supplements, foods, and medicines, and these should fulfill the specific requirements for consideration and regulatory clearance. Botanical insecticides are now widely accepted as attractive alternatives as compared to the synthetic chemical insecticides as they are less toxic and safer to health and environment. The chapter elaborates the regulatory process for botanical products including herbal drugs, food, and insecticides in India.

Keywords

Food Supplement Herbal Drug Synthetic Insecticide Health Supplement Complementary Alternative 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. Anonymous (2002) Problems with dietary supplements. Med Lett Drugs Ther 44:84–86Google Scholar
  2. Bhatt AD, Bhatt NS (1996) Indigenous drugs and liver disease. Ind J Gastroenterol 15:63–67Google Scholar
  3. Burton B (2003) Complementary medicines industry in crisis after recall of 1546 products. BMJ 326:1001PubMedCentralCrossRefPubMedGoogle Scholar
  4. CDSCO (2001) Guidelines for clinical trials on pharmaceutical products in India – good clinical practices. Central Drugs Standard Control Organisation, Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, New DelhiGoogle Scholar
  5. CIBRC (2015) Central Insecticides Board and Registration Committee. http://www.cibrc.nic.in. Accessed 28 Mar 2015
  6. EMEA (1999) Report from the Adhoc working group on herbal medicinal products 1997/1998 EMEA/HMPWG/25/99. European Agency for the Evaluation of Medicinal Products, London. http://www.ema.europa.eu/docs/en_GB/document_library/News_article/2009/11/WC500015693.pdf. Accessed 28 Mar 2015
  7. Ernst E (2002) Heavy metals in traditional Indian remedies. Eur J Clin Pharmacol 57:891–896CrossRefPubMedGoogle Scholar
  8. FICCI-Ernst and Young (2015) Nutraceuticals critical supplement for building Healthy India. http://plethico-fd.com/reports%5CNutraceuticals_Final_Report.pdf. Accessed 28 Mar 2015
  9. FSSAI (2015) Food Safety and Standards Authority of India. http://www.fssai.gov.in
  10. FTC (2015) Federal Trade Commission. https://www.ftc.gov. Accessed 28 Mar 2015
  11. HADSA (2015) Health Foods and Dietary Supplements Association http://www.hadsa.com
  12. Kalra EK (2003) Nutraceutical: definition & introduction. AAPS Pharmsci 5(2):Article 25. doi: 10.1208/PS/0500225
  13. Kumar GS (2007) Regulatory roadmap for herbal medicine. Business Horizons, New DelhiGoogle Scholar
  14. Lachure PS (2012) Exploration of some medicinal plants used by tribals from Digras region of District – Yavatmal Maharashtra, India. Int J Sci Res Publ 2:1–11Google Scholar
  15. Lodha R, Bagga A (2000) Traditional Indian system of medicine. Ann Acad Med Singapore 29:37–41PubMedGoogle Scholar
  16. Marcus DM, Grollman AP (2002) Botanical medicines – the need for new regulations. N Engl J Med 347:2073–2076CrossRefPubMedGoogle Scholar
  17. NIN (2015) National Institute of Nutrition, Hyderabad, India. http://www.ninindia.org. Accessed 28 Mar 2015
  18. Stein MC (2002) Are herbal products dietary supplements or drugs? An important question for public safety. Clin Pharmacol Therap 71:411–413CrossRefGoogle Scholar
  19. Straus SE (2002) Herbal medicines – what’s in the bottle? N Engl J Med 347:1997–199CrossRefPubMedGoogle Scholar
  20. US FDA (2000) Guidance for industry botanical drug products. Centre for Drug Evaluation and Research, United States Food and Drug Administration. http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070491.pdf. Accessed 28 Mar 2015
  21. US FDA (2015) United States Food and Drug Administration. http://www.fda.gov. Accessed 28 Mar 2015
  22. Verpoorte R, Mukherjee PK (eds) (2003) GMP for botanicals. Business Horizons Pharmaceutical Publishers, New DelhiGoogle Scholar
  23. WAHO (2008) Traditional medicine workshop report. Situational analysis of the level of development of traditional medicine in the ECOWAS member States. West African Health OrganizationGoogle Scholar
  24. Warude D, Patwardhan B (2005) Botanicals: quality and regulatory issues. J Sci Ind Res 64:83–92Google Scholar
  25. WHO (1999) Essential drugs in the WHO African region: situation and trend analysis. World Health Organization Regional Committee for Africa, Windhoek, Namibia. http://apps.who.int/iris/bitstream/10665/1926/1/AFR-RC49-11%20EN.pdf?ua=1. Accessed 28 Mar 2015
  26. WHO (2000) Promoting the role of traditional medicine in health systems: a strategy for the African region. WHO Regional Office for Africa, Ouagadougou, Burkina Faso. www.afro.who.int. Accessed 28 Mar 2015
  27. WHO (2004a) WHO model legal framework for the practice of TM: a bill for traditional health practitioners in the WHO African region, Tools for institutionalizing traditional medicine in health systems of countries in the WHO African region. World Health Organization Regional Office for Africa, BrazzavilleGoogle Scholar
  28. WHO (2004b) WHO model code of ethics for traditional health practitioners in the WHO African region, Tools for institutionalizing traditional medicine in health systems of countries in the WHO African region. World Health Organization Regional Office for Africa, BrazzavilleGoogle Scholar
  29. WHO (2004c) Guidelines for the registration of traditional medicines in the WHO African region. World Health Organization Regional Office for Africa, BrazzavilleGoogle Scholar
  30. WHO (2004d) Guidelines for documenting data on ethnomedical evidence, Guidelines for clinical study of traditional medicines in the WHO African region. World Health Organization Regional Office for Africa, BrazzavilleGoogle Scholar
  31. WHO (2004e) Guidelines for the regulation of herbal medicines in the south-east Asia region developed at the Regional Workshop on the Regulation of Herbal Medicine, Bangkok, 24–26 June 2003, World Health Organization, Regional Office for South-East Asia, New Delhi. http://apps.searo.who.int/PDS_DOCS/B0560.pdf?ua=1. Accessed 28 Mar 2015
  32. WHO (2005) National policy on traditional medicine and regulation of herbal medicine, Report of WHO global survey, World Health Organization, Geneva. http://whqlibdoc.who.int/publications/2005/9241593237.pdf. Accessed 28 Mar 2015
  33. WHO (2007) Guidelines on good manufacturing practices (GMP) for herbal medicines. World Health Organization, GenevaGoogle Scholar
  34. WHO (2009) Handbook of good laboratory practices (GLP) quality practices for regulated Non-clinical research and development. Special programme for research and training for tropical diseases. World Health Organization, GenevaGoogle Scholar

Copyright information

© Springer India 2016

Authors and Affiliations

  1. 1.Defence Research Laboratory(Defence Research and Development Organisation)TezpurIndia

Personalised recommendations