Transcript Dr. P M Murali

“POLYHERBALS” as drugs - will they be available to the
common man soon on prescription? Are the present
regulatory environment conducive?
Dr. P. M. Murali
What are Polyherbal formulations?
Simple definition - a mixture of phytochemicals from
more than one plant or plant parts
They do not contain any animal parts or metals
Irrespective of the number of ingredients they are
considered as “one entity” for treating a disease
Formulated for present day needs and clinically validated
for the chosen indication
Present regulations – is it conducive to the
development of this category to be dispensed as
drugs?
No
POLYHERBALS
Proof through
the Rational
drug design Constraints
• MOA of each and
every ingredient
• Looking for Synergy
• Elimination studies
• Bioactive principles
• Targets
• Serious issues with
designing animal
studies
Why people want herbal medicines?
Attrition of present day
drugs developed through
Rational design
Efficacy
Toxicity
Draw back of the present regulations for
bringing out cheaper drugs
Very high costs commensurate new
drugs low
Long time lines
Regulatory
requirements
Are there “alternative”drug designs?
“...organisms function in an integrated
manner ...But biologists have
historically studied them part by part
and celebrated the modern ability to
study them molecule by
molecule...Systems Biology is a new
science of the future that seeks to
understand the integration of the
pieces to form biological systems...”
Prof. David Baltimore
System Biology approach
"The reductionist approach has successfully
identified most of the components and many of the
interactions but, unfortunately, offers no convincing
concepts or methods to understand how system
properties emerge...the pluralism of causes and
effects in biological networks is better addressed by
observing, through quantitative measures, multiple
components simultaneously and by rigorous data
integration with mathematical models" Science
Drug Discovery Today, Jan 2007
Key benefits of the present regulatory system for plant drugs
Quality
Documentation
and audit trails
Minimizing
batch variations
Safety
Absence of
toxicity
Specific
biomarkers
within
acceptable limits
Efficacy
Alleviation of
symptoms in a
given time
frame
Prognosis levels
against a gold
standard
Having controls
equivalent to
CMC during
scale-up
Side effects vs.
efficacy
What new considerations that needs to be taken
into account to develop this area rapidly
Regulations on Polyherbals to be designed based on
treating them as “Entities” with a bouquet of ‘attributes’
to treat the chosen ‘clinical state’
‘Attributes’ of an Entity cannot be viewed in ‘isolation’ –
hence one-to-one correlation for activity establishment
should not be the bottleneck in its development
Explore ways of providing affordable medicines
through pragmatic approaches
Improved
pharmaco
vigilance
Effective
implementation
of CMC controls
To recognize
structured clinical
trial and post
marketing data
Carry out limited
Phase 2 for drug –
herb interaction
and a Phase 3 for
faster approval
Summary
Improved
CMC,
Pharmaco
vigilance
Recognize
POLY
HERBALS as
one entity
Pragmatic
regulatory
approaches
using System
biology
approaches
Clinical trials
and Phase 4
data to be
recognized
and carry
out the
most
necessary
approaches
“Snakes can only grow by bursting their
skin. Moulting has to be painful process,
and should it fail the snake would die.
Mankind also grows by now and then
bursting its outgrown skin of antiquated
ideas, thinking and institutions”.
Albert Szent-Gyorgyi
NYT , March 29th, 1978
Thank You
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Dr. P. M. Murali
Member - Governing Board
Dalmia Centre for Research and Development
Coimbatore- 641010
India
Telephone: +91- 422-2607987
Fax:+91- 422-2607688
E. Mail: [email protected]