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DOI: 10.4172/2161-1009.1000311
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Analytical Biochemistry
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ISSN: 2161-1009

Short Communication OMICS International

Traditional Medicine Based Drug Development

Pathirage Kamal Perera*
Department of Ayurveda Pharmacology and Pharmaceutics, Institute of Indigenous Medicine, University of Colombo, Sri Lanka

Abstract
Currently few of traditional medicines have been developed by blending basic sciences and technologies up to
the clinical usage. In future standard traditional medicine based botanical therapeutics will be important in biomedicine
developments due to economic background in most parts of the world. Today there are many basic experimental
research have being doing for plant based materials. But very limited data can be founded for evidence based use
of those experimented plant materials in clinical setup. Therefore this is the high time for develop effective evidence
based traditional medicine system in the world. This can be done by evaluating traditional medicine remedies for
their pharmacodynamics, pharmacokinetics, stability, shelf life and toxicity par with current standards. Challenge of
reproducibility and consistency of herbal remedies can be achieved by developing standard assay markers and chemi-
informatic approaches. Further conventional concepts of clinical research design methods may not be adequate when
evaluating and conducting clinical trials for traditional medicine. Therefore needs to identifying traditional medicine
concepts and develop research strategies for achieve full benefits of these medicine systems. Further there is need to
develop and validate a range of parameters applicable to modern and traditional medicines in the light of basic sciences
like biochemistry and molecular biology.

Keywords: Traditional medicine; Bio medicine; Modern medicine

Introduction
Currently traditional medicine (TM) is used in primary health care
systems in most countries parallel to conventional medicine. Therefore
TM should be subjected to rigorous research for their efficacy and safety
for better health care. At present there is a high necessity for evidence
based clinical drug development with changing of global economic
scene. When developing novel drugs using TM candidates it is essential
to consider novel standard parameters whenever possible. Quality
control of TM is also prerequisite of standard clinical trials. When
following evidence based clinical herbal product development cycle
it is necessary to follow current standard quality controlling methods
viz Good Laboratory Practice (GLP); Good Manufacturing Practice
(GMP; Good Clinical Practice (GCP); Chemistry, Manufacturing and Figure 1: Evidence based clinical herbal product development cycle (GLP:
Controls (CMC) or Pharmaceutical Quality (Figure 1) [1]. World Good Laboratory Practice; GMP: Good Manufacturing Practice; GCP: Good
Health Organization (WHO), 2004 has published guidelines for safety Clinical Practice; CMC: Chemistry, Manufacturing and Controls/Pharmaceutical
Quality).
issues in herbal product development (Table 1). According to this
categorization it is required to be addressed safety and toxicity before
clinical usage of TM. ICH's mission is to achieve greater harmonization to ensure that safe,
effective, and high quality medicines are developed and registered
Clinical Trials for TM in the most resource-efficient manner [4]. Still most of countries are
far behind with guidelines and standardization of TM products for
Unique characteristics of TM products are that they are multi
affiliated of ICH. It is much important to achieve global standards
component mixtures and they have used in humans in sometimes
in harmonization organizations for remarkable expanded import
thousands of years [2]. These two exclusive features sometimes lead
market for traditional medical products. To achieve these international
to biased decisions in clinical practice in TM. Therefore even it is
standards should be assisted by the organizations like World Health
undergone in excessive clinical practice it is utmost important to
validate those TM for better development of health care systems. Some
international organizations and national authorities have published
*Corresponding author: Pathirage Kamal Perera, Department of Ayurveda
statements for supporting clinical trials of TM for develop those drugs Pharmacology and Pharmaceutics, Institute of Indigenous Medicine,
in ethical manner [3]. The International Conference on Harmonization University of Colombo, Sri Lanka, Tel: 009411269238; 0094716419072;
(ICH) [4] document makes recommendations on information that E-mail: [email protected]
should be included in a core clinical study report of an individual Received:  December 27, 2016; Accepted: March 02, 2017; Published March
study of any therapeutic, prophylactic, or diagnostic agent conducted 06, 2017
in human subjects.  The International Conference on Harmonization Citation: Perera PK (2017) Traditional Medicine Based Drug Development.
of Technical Requirements for Registration of Pharmaceuticals for Biochem Anal Biochem 6: 311. doi: 10.4172/2161-1009.1000311
Human Use (ICH) is unique in bringing together the regulatory Copyright: © 2017 Perera PK. This is an open-access article distributed under
authorities and pharmaceutical industry of Europe, Japan and the the terms of the Creative Commons Attribution License, which permits unrestricted
use, distribution, and reproduction in any medium, provided the original author and
USA to discuss scientific and technical aspects of drug registration. source are credited.

Biochem Anal Biochem, an open access journal

ISSN: 2161-1009 Volume 6 • Issue 1 • 1000311
Citation: Perera PK (2017) Traditional Medicine Based Drug Development. Biochem Anal Biochem 6: 311. doi: 10.4172/2161-1009.1000311

Page 2 of 3

Category 1: Indigenous herbal medicines

These can be used freely by the local community or region, and no safety data would be
required. However, if the medicines in this category are introduced into the market or moved beyond the local community or region, their safety has to be reviewed by
the established national drug control agency. If the medicines belong to safety category 1, safety data are not needed. If the medicines belong to safety category 2, they
have to meet the usual requirements for safety of herbal medicines. Medicines belonging to safety category 3, i.e. ‘herbal medicines of uncertain safety’, will be identical
to that of any new substance.
Category 2: Herbal medicines in systems
The medicines in this category have been used for a long time and have been officially
documented. Review of the safety category is necessary. If the medicines are in safety categories 1 or 2, safety data would not be needed. If the medicines belong to
safety category 3, they have to meet the requirements for safety of ‘herbal medicines of uncertain safety’.
Category 3: Modified herbal medicines
The medicines in this category can be modified in any way including dose, dosage form,
mode of administration, herbal medicinal ingredients, methods of preparation, or medical
indications based on categories 1 and 2. The medicines have to meet the requirements of
safety of herbal medicines or requirements for the safety of ‘herbal medicines of uncertain
safety’, depending on the modification.
Category 4: Imported/exported products with a herbal medicine base
Exported products shall require safety data, which have to meet the requirements for safety
of herbal medicines or requirements for safety of ‘herbal medicines of uncertain safety’, depending on the safety requirement of the importing/recipient countries.
Source: Guidelines for the Regulation of Herbal Medicines in the South-East Asia Region, Based on Developed at the Regional Workshop on the Regulation of Herbal
Medicines, Bangkok, 24-26 June 2003, World Health Organization (WHO), 2004
Table 1: Guidelines for the regulation of herbal medicines.

Ethical requirement Definition

Research leadership must include bilateral representation based on mutual respect between equal partners with community advice.
Collaborative partnership It includes a responsibility to invest in the scientific training and capacity-building for ongoing research in a host country where such
resources are not well developed.
Knowledge gained from the research should have the potential to lead to new generalizable knowledge or improvements in health.
Social value
Partners should specify in advance to whom benefits will accrue and in what way.
Research should be designed to produce beneficial and generalizable knowledge. This includes designing research so that it can be
Scientific validity
feasibly implemented in the settings where it will be conducted.
Fair subject selection Subjects should be selected on the basis of scientific importance, not based on convenience, vulnerability or bias.
The potential benefits of individual participation should outweigh the risks of participation. Benefits to the community or population
Favorable risk–benefit ratio
being studied should also be optimized. Compelling societal benefit can justify risks to individuals in certain circumstances.
To maintain the integrity of the research, bodies not tied to the investigators must agree that the risks and potential benefits of the
Independent review
research are justified.
Investigators must obtain valid permission for study participation from subjects in a manner that is sensitive to the cultural context in
Informed consent
which the study is conducted.
Researchers should have a plan for how the research results will be disseminated; ensuring participants know their right to withdraw,
Respect for subjects
and monitoring the research for relevant adverse events.
Table 2: A comprehensive framework for research ethics.

S. No Operational guidance: information needed to support clinical trials of herbal products (OG – CTHP)
Conventional modern allopathic medicinal drugs containing a chemically-defined pharmaceutical ingredient, herbal products are, almost always, mixtures of
1. partially or wholly uncharacterized constituents; and that being a mixture provides putative therapeutic advantages of one constituent enhancing the efficacy of one
or more others in an additive or synergistic fashion, or of one constituent minimizing the side-effects of others.
2. OG – CTHP has asserted that assessing their efficacy does not require attempts to purify herbal medicines down to single constituents or chemical entities.
Phase 1 studies in healthy volunteers are generally unnecessary for most herbal medicines if their substantial prior human use conveys reasonable confidence that
3.
these regimens can safely be administered to small numbers of carefully monitored clinical participants in phase 2 trials.
Crucial stipulation of the CTHP is that, notwithstanding historical evidence of safety, in both phase 2 clinical trials with small numbers of participants and large
4. phase 3 trials (which include several hundred to several thousand), safety of participants should be assured by a comprehensive literature review as well as by
specified protocol provisions.
Table 3: Operational guidance: Information needed to support clinical trials of herbal products (OG – CTHP).

Organization for developing countries and governments also should Most of time when conducting TM clinical research has to adapt some
implement these tasks in their strategic planning. methodologies according to relevancy of the context. According to
WHO Operational Guidance, Information Needed to Support Clinical
Ethical Framework for TM Trials of Herbal Products (OG-CTHP) (Table 3) [3], Phase 1 studies
in healthy volunteers are generally unnecessary for most herbal
In general research on TM should be followed by the same ethical
medicines if their substantial prior human use conveys reasonable
requirements as all research related to human participants. An
confidence that these regimens can safely be administered to small
ethical framework previously outlined by Emanuel et al. and revised numbers of carefully monitored clinical participants in phase 2 trials.
for international research offers a useful starting point for thinking Crucial stipulation of the OG-CTHP is that, notwithstanding historical
about the ethics of TM research. This framework includes eight evidence of safety, in both phase 2 clinical trials with small numbers
ethical requirements for clinical research (Table 2) [5,6]. These ethical of participants and large phase 3 trials, safety of participants should
requirements are universal and comprehensive but must be adapted be assured by a comprehensive literature review as well as by specified
to the particular social context in which the research is implemented. protocol provisions.

Biochem Anal Biochem, an open access journal

ISSN: 2161-1009 Volume 6 • Issue 1 • 1000311
Citation: Perera PK (2017) Traditional Medicine Based Drug Development. Biochem Anal Biochem 6: 311. doi: 10.4172/2161-1009.1000311

Page 3 of 3

Conclusion 2. Che CT, Wang ZJ, Chow MS, Lam CW (2013) Herb-herb combination for
therapeutic enhancement and advancement: theory, practice and future
To develop safe and quality drug based on TM is a current needed. perspectives. Molecule 18: 5125-5141.

For that purposes integrated of basic sciences, modern medicine and 3. UNICEF/UNDP/World Bank/WHO (2005) Operational guidance: Information
TM is essential and it is the golden triangle for novel evidence based need to support clinical trials of herbal products. WHO Special Programme for
Research and Training in Tropical Diseases. TDR/GEN/Guidance/ 05.1.WHO
drug development n future.
4. ICH (2010) Organisation changes.
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1. Perera PK (2014) Evidence based drug development in the light of basic ethical analysis. Bull World Health Organ 66: 594–599.
sciences and modern medical technologies for traditional medicine. Recent
6. Emanuel EJ, Wendler D, Killen J, Grady C (2004) What makes clinical research
Advances on the role of basic sciences in Ayurvedic Medicine. Int J Ayurveda
in developing countries ethical? The benchmarks of ethical research. J Infect
Res 1: 41-46. Dis 189: 930-937.

Biochem Anal Biochem, an open access journal

ISSN: 2161-1009 Volume 6 • Issue 1 • 1000311