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GUIDELINES SERIES-I

GENERAL GUIDELINES FOR
DRUG DEVELOPMENT OF
AYURVEDIC FORMULATIONS

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES

Ministry o f AYUSH, Government o f India

New Delhi

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GENERAL GUIDELINES FOR DRUG
DEVELOPMENT OF AYURVEDIC
FORMULATIONS

Volume – 1

CENTRAL COUNCIL FOR RESEARCH IN AYURVEDIC SCIENCES
Ministry of AYUSH, Govt, of India
New Delhi

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© Central Council for Research in Ayurvedic Sciences

Ministry of AYUSH, Government of India, New Delhi – 110058

First Edition – 2018

Publisher: Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Government of

India, New Delhi, J. L. N. B. C. A. H. Anusandhan Bhavan, 61-65, Institutional Area, Opp. D-Block,

Janakpuri, New Delhi – 110 058, E-mail: dg-ccras@nic.in, Website : www.ccras.nic.in

Disclaimer: All possible efforts have been made to ensure the correctness of the contents. However

Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, shall not be accountable

for any inadvertent error in the content. Corrective measures shall be taken up once such errors are

brought to notice.

ISBN : 978-93-83864-23-2

Other Related Guidelines:
Volume – I I : General Guidelines for Safety/Toxicity Evaluation of Ayurvedic Formulations
Volume – IE : General Guidelines for Clinical Evaluation of Ayurvedic Interventions

Printed a t : JK Offset Graphics Pvt. Ltd., New Delhi-110020

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Prologue

Research & Development in the field of AYUSH system in different areas such as drug
development including quality assurance, pre-clinical safety evaluation and clinical research
are being conducted at different levels such as Research Council under AYUSH, Academic
institutions (both AYUSH and non AYUSH institutes such as Medical Colleges, Universities
etc.), other Research organization such as ICMR, CSIR etc. Further, research support is also
being extended through grant under EMR vide Ministry of AYUSH, DST, DBT, ICMR etc.
in the area of traditional medicine.

Lot of research is being conducted at different levels as above in the field of AYUSH
adopting different guidelines, methods and protocols and ending up research outcomes with
low or poor translational value. Only few of them have led to clinical trial and marketing
level. This may be attributed to lack of awareness regarding AYUSH strategies for R&D and
provisions of Drug & Cosmetic Act related to AYUSH.

In spite of availability of several guidelines such as GCP guidelines for ASU drugs, ICMR
guidelines for biomedical research for human participants, GCP guidelines published by
CDSCO Ministry of Health and Family Welfare, WHO guidelines for traditional medical
research etc., there is no single comprehensive directive to conduct research in AYUSH
sector is available.

This might be one among the major reasons that has led to R&D in AYUSH sector with
diverse approaches with low translational value.

In the light of this preamble, it becomes imperative to develop directives on research
practices for various components of AYUSH research sectors for uniform adoption across all
stakeholders such as research councils, academic institutes, funding agencies engaged in
AYUSH research.

Considering this, efforts have been made by CCRAS and developed three comprehensive and
concise Guidelines and directives focusing on drug development (Standardization and quality
assurance), safety and toxicity and clinical evaluation for ready reference of stack holders.
These directive and Guidelines encompassed with research practices generally to be adopted
and followed by researchers in the field of AYUSH system such as Research organizations,
academic institutions and Researchers seeking grant from EMR/IMR schemes of different
agencies funding for research on AYUSH system, would certainly help the researchers while
designing and formulating the proposals and also planning academic industrial research in the
field of AYUSH systems. The users may refer other two documents for having an overall
idea concerning drug development and R & D in this field.

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Background

Quest for healthy and long life are perhaps as old as human existence and efforts are
unremitting to address the challenges and triumph over the bottlenecks across this journey.
Ayurveda -the science of life, evolved as a comprehensive system of healthcare
systematically through scientific experimentations of high order backed by sound and
reproducible evidence base and stood the test of the time. Several strategies and road maps
are being drawn to carry forward merits of this science so as to meet the current day health
needs and mainstream its core strengths alongside through research & development in this
country and across the globe. The fundamental aspects of holistic systems needs adequate
positioning while designing clinical trials to examine the safety and efficacy of Ayurveda
approaches. Furthermore, the other challenges and issues related to quality and safety viz.
dosage forms/delivery system, diverse concepts and complex approaches in trial design,
diagnosis and therapy, outcomes of clinical efficacy and drug interactions also pose certain
limitations in research. A systems approach may be adopted to validate the therapies and
approaches with integration of principles of Ayurveda and bio-medicine without losing the
vital fundamentals of both systems. Such an approach with well designed research plans
could possibly facilitate to generate tangible evidence.

Ayurveda and Siddha drugs are mainly based on the plants and plant products besides
animal products metal/minerals and products of marine origin. About 90% products of
Ayurveda are purely herbal. These plant drugs have different chemical constituents which
may vary in same species of plant due to influence of climatic condition under which they
grow, nature and properties of soil and fertilizer, geographical distribution, age of the plant,
altitude and period of harvesting and storage conditions. Hence to control the quality of raw
plant material with reference to chemical constituents is a tedious and difficult job. Due to
these reason plant drugs differ from that of the conventional drugs and some innovative
methods are in practices for the quality assessment of herbal drugs. It also includes a
composite study of Ayurveda and Siddha dosage forms like chumas, bhasma, kwatha, taila,
tablets and ointments etc.

Plant products and their derivatives constitute about 50% of modem drugs. There has
been a quest to develop new drugs /formulation despite of being a costly and low success rate
process. In recent years the research have focused on drug discovery from herbal medicines
or botanical source by gaining leads from traditional literatures, folklore claims, database etc.
As Traditional Systems have long history of herbal usage in management of disease, the
success rate of their development as therapeutic approach is comparatively higher than that of
the synthetic counterpart. Examples of plant products and derivatives used by the
artemesinin,
pharmaceutical
camptothecin, podophyllotoxin, etc. (Patwardhan, et. al. 2004)

include paclitaxel, vincristine, vinblastine,

industry

Although Drug Development has been driven by various technology platforms which
are also helpful in development of therapeutic agents from herbals medicines, drug
development remains a lengthy process with lot of investment and low success rate.
Normally, it takes about 10-15 years for a new synthesized compound to become a

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marketable therapeutic agent and cost in 2006 was approximately €1 billion (Barden &
Weaver, 2010). About half of all drugs fail in the late stages of clinical trials. Sometimes
soon after their approval some new drugs have to be withdrawn from the market due to
severe side effects and clinical risks that were not detected in Phase III trials. For example
rofecoxib (vioxx), which was launched in 1999, was withdrawn in 2004 due to an increased
risk of heart attack in users.

Following modem approach drug development is a costly and time consuming process,
whereas the approach leased on the time-tested traditional medicine following a reverse
pharmacology is cost-effective and less time consuming.

New approaches to improve and accelerate the joint drug discovery and development
process are expected to take place mainly from innovation in drug target elucidation and lead
structure discovery. Powerful new technologies such as automated separation techniques like
flash chromatography, high-throughput screening are revolutionizing drug discovery.
Traditional knowledge will serve as a powerful search engine for the drug discovery process
(Bhushan, et. al., 2004). The objective of this book is to provide a protocol for Drug
development to the industries, academic institutions and researchers and other stakeholders.

Despite existence of several guidelines such as quality control of Ayurveda, Siddha
and Unani Drugs, Quality control methods for medicinal plant materials,(WHO, 1998),
Quality control methods for herbal materials, WHO 2011, Laboratory Manual for the
Analysis of Ayurveda and Siddha formulations, (CCRAS, 2009), Quality Control Manual for
Ayurvedic, Siddha & Unani Medicine, (PLIM, 2008), Protocol for Testing of ASU
Medicines, (PLIM, 2007), ASU Pharmacopoeias etc. there is a need to evolve a
comprehensive guideline to address system specific issues for drug development of ASU
drugs. The present document would certainly serve as a ready reference for researchers
engaged in Research and Drug development in ASU systems.

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