Evidence-based Ayurveda

Defining a New Scientific Path

C. P. Khare, C. P. Khare

• Editore: Routledge
• Anno: 2019
• ISBN:
  9781000707137
• Edizione: 1
• Argomento: Medizin
• Categoria: Alternativ- & Komplementärmedizin

This groundbreaking work calls for the overhaul of traditional Ayurveda and its transformation into a progressive, evidence-based practice.

This book begins by looking back at the research of the last three centuries, Indian medicinal plants, and Ayurveda in a twenty-first-century context. The first part of this book explores the limitations of contemporary Ayurvedic pharmacognosy and pharmacology, discussing the challenges the practice faces from research and clinical trials. It makes a compelling argument for the necessity of change. The second part of the book defines and elaborates upon a new, scientific path, taking the reader from identification of the herb through all stages of drug development.

An essential tool for herbal drug development, this text is designed for knowledgeable students, practitioners, and scholars of Ayurveda, pharmacy, and herbal medicine.

Part I

The legacy and logical steps for a new therapeutic regimen

1 The need for liberal regulations for promoting evidence-based Ayurveda

• Why Ayurvedic Medicine and Herbal Medicine are treated as two rival systems with different legal regulations?
• Why all Indian medicinal Plants are not Ayurvedic Plants?
• Why the research of the last three centuries is not a part of Ayurveda?

The Drugs and Cosmetics Act, 1940

(Editor’s note: First, we will quote certain clauses of The Drugs and Cosmetics Act, 1940 (23 of 1940) (as amended up to the 31 December 2016) and The Drugs And Cosmetics Rules, 1945 (as amended up to the 31st December 2016), which need to be reviewed for an all-round growth of the 5,000-year-old traditional medicinal systems of India.)

The Drugs and Cosmetics Act Chapter, 3(a): Drug [Ayurvedic, Siddha or Unani] includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books (of Ayurvedic, Siddha and Unani Tibb systems of medicine) specified in the First Schedule.

3(h): patent or proprietary medicine means –

• (i) in relation to Ayurvedic, Siddha or Unani Tibb systems of medicine all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb systems of medicine specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a);
• (ii) in relation to any other systems of medicine, a drug which is a remedy or prescription presented in a form ready for internal or external administration of human beings or animals and which is not included in the edition of the Indian Pharmacopoeia for the time being or any other Pharmacopoeia authorized in this behalf by the Central Government after consultation with the Drugs Technical Advisory Board constituted under section 5.

THE FIRST SCHEDULE [See section 3(a)]¹

A. Ayurvedic Books:² contain 54 (actually 59) authoritative books. (For analysis, see chapter 3.)

(1. Subs. by Act 13 of 1964, s. 31, for the Sch. The First Schedule came into force with effect from 1–2–1969.)

Drugs and Cosmetics Rules, 1945

PART X A: 122 DAC. Permission to conduct clinical trial: (1) The Licensing Authority as defined in clause (b) of Rule 21, on being satisfied that the data submitted along with the application in support of the proposed clinical trial is adequate in all respects, issue permission for conduct of clinical trial, subject to the following conditions, namely:

• (a) Clinical trial shall be conducted in compliance with the approved protocols, requirements of Schedule Y annexed to these rules, Good Clinical Practice Guidelines for conduct of clinical trials in India and other applicable regulations;
• (b) Approval of the Ethics Committee shall be obtained before initiation of the study;
• (c) Clinical trial shall be registered at Clinical Trials Registry of India before enrolling the first patient for the study;
• (d) Annual status report of each clinical trial, as to whether it is ongoing, completed or terminated, shall be submitted to the Licensing Authority and in case of termination of any clinical trial the detailed reasons for the same shall be communicated to the said Licensing Authority;
• (e) Any report of serious adverse event occurring during clinical trial to the subject, after due analysis, shall be forwarded within ten days of its occurrence as per Appendix XI and in compliance with the procedures prescribed in Schedule Y.

(Editor’s Note: See The Controversy on PART X A: 122 DAC and ADVISORY from AYUSH on April 2, 2019, at the end of salient features of Drugs and Cosmetics Rules, 1945, chapter 2.)

Part XVI: 158(B) Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs.

• I (A) Ayurveda, Siddha Unani Medicines under section 3(a): Ayurveda, Siddha or Unani drugs includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb system of medicine, as specified in the First Schedule;
• (B) Patent or Proprietary medicine under section 3(h):
  • (i) In relation to Ayurvedic, Siddha and Unani Tibb system of medicine of all formulations containing only such ingredients mentioned in the formulae described in the authoritative books of Ayurveda, Siddha or Unani Tibb system of medicines specified in the First Schedule, but does not include a medicine which is administered by parenteral route and also a formulation included in the authoritative books as specified in clause (a); (iv) Aushadh Ghana (Medicinal plant extracts – dry/wet) obtained from plant mentioned in books of First Schedule of the Act include Aqueous or hydro-alcoholic extracts.
• II (A) For issue of licence to the medicine with respect to Ayurvedic, Siddha and Unani, the conditions relating to safety study and the experience or evidence of effectiveness shall be such as specified.
• Guidelines for issue of license with respect to Ayurveda, Siddha or Unani drugs (Drugs and Cosmetics Rules 1945. See CCRAS Guidelines):
  • 1 Category: Ayurveda, Siddha and Unani drugs, given in 158. B as referred in 3(a).
  • 2 Ingredients: As per texts. (54 Authoritative books)
  • 3 Indication(s): As per texts. (54 Authoritative books)
  • 4 Requirement of non-clinical Safety data: Not required
  • 5 Published Literature: Required
  • 6 Requirement of non-clinical Efficacy data: Not required
  • 1 Category: Any change in dosage form of Ayurveda Siddha and Unani drugs as described in section 3(a) of the Drugs and Cosmetics Act, 1940.
  • 2 Ingredients: As per text
  • 3 Indication(s): As per texts
  • 4 Requirement of non-clinical Safety data: Not required
  • 5 Published Literature: Required
  • 6 Requirement of non-clinical Efficacy data: Not required
  • 1 Category: Ayurveda, Siddha and Unani drugs referred in 3(a) to be used for new indication.
  • 2 Ingredients: As per text
  • 3 Indication(s): New*.
  • 4 Requirement of non-clinical Safety data: Not required
  • 5 Published Literature: If required
  • 6 Requirement of non-clinical Efficacy data: Required
• II (B) For issue of license with respect to Patent or Proprietary medicine. The condition relating to Safety studies and experience or evidence of effectiveness shall be specified as follows:
  • 1 Category: Patent or Proprietary medicine containing crude drugs
  • 2 Ingredients: As per text
  • 3 Indication(s): Textual Rationale
  • 4 Requirement of non-clinical safety data: Not required
  • 5 Published Literature: Of ingredients
  • 6 The requirement of non-clinical efficacy data: Pilot study as per relevant protocol for ASU drugs
• For the issue of license with respect to medicine Aushadh Ghana, extract of medicinal plant (dry or wet):
  • Category: Crude drug/Aqueous extract(s)/hydro-alcoholic extracts/dry/wet
  • Ingredient(s): As per text
  • Indication: Textual Rationale
  • Requirement of non-clinical Safety data: Not Required
  • Published Literature Not Required
  • Requirement of non-clinical Efficacy data: Not Required
  • Category: Aqueous extract dry/wet
  • Ingredient(s): As per text
  • Indication: New indications*
  • Requirement of non-clinical Safety data: Not Required
  • Published Literature: Not Required
  • Requirement of non-clinical Efficacy data: Required
  • Category: Hydro-Alcohol extract dry/wet
  • Ingredient(s): As specified
  • Indication: As per text
  • Requirement of non-clinical Safety data: Not Required
  • Published Literature If Required
  • Requirement of non-clinical Efficacy data: Not Required
  • Category: Hydro-Alcoholic extract dry/wet
  • Ingredient(s): As specified
  • Indication: New indications*
  • Requirement of non-clinical Safety data: Required
  • Published Literature: If Required
  • Requirement of non-clinical Efficacy data: Required
  • Category: Other than Hydro/Hydro-Alcoholic extracts containing other solvents
  • Ingredient(s): As specified
  • Indication: As specified/claimed
  • Requirement of non-clinical Safety data: Required for oral preparations. Single dose toxicity, Repeated systematic toxicity (long term toxicity studies in rats), Reproductive and Developmental toxicity, Genotoxicity, Carcinogenicity, metal/mineral toxicity (in cases of mineral/metal ingredients).
  • Published Literature: If Required
  • Requirement of non-clinical Efficacy data: Required

The standard protocol will also include the concept of Anupan, Prakriti and Tridosha etc. published by Central Research Councils Ayurveda, Siddha, Unani and other Government/Research Bodies.

* New indication means which is other than mentioned in 1st schedule books of Drugs and Cosmetics Act 1940.

ADVISORY from AYUSH on April 2, 2019

Subject: Scientific Studies and publication of Research Papers on AYUSH drugs and treatments by non-AYUSH researchers/scientists.

Whereas it is reported that research papers and scientific studies on AYUSH (Ayurveda, Yoga, Naturopathy, Unani, Siddha and Homoeopathy systems) drugs and treatments have been published by non-AYUSH scientists/researchers with unfounded statements & conclusions to damage the credibility and sanctity of the whole system and qualified AYUSH experts were not involved/consulted in these studies and research publications.

Whereas AYUSH systems are officially recognized an integral part of the country’s healthcare delivery network and are promoted and mainstreamed through various policies, strategies, and schemes of Government of India including the National Health Policy-2017, National Health Mission and National AYUSH Mission. Principles, concepts, and approaches of AYUSH systems and their drug-based interventions are not at all comparable to the prevalent modern medical system. Whereas for scientific development of AYUSH systems, Central Government has inter alia established five Research Councils (viz. Central Council for Research in Ayurvedic Scie...