Transcript Ashwani

International Conclave on
Traditional Medicine (TM)
16th – 17th Nov. 2006,
New Delhi
CONSENSUS ON
REGULATORY APPROACH TO
TRADITIONAL MEDICINES
Ashwini Kumar
Ex. DCG(I)
[email protected]
Drug Regulation:
An essential measure to protect public
health by ensuring that :All medicinal/ health care products conform
to agreed standards of safety, efficacy and
quality.
Promotion and use of medicinal products is
appropriate.
Unsafe medicinal products are kept off the
market
Availability of safe and effective products is
facilitated
Drug Regulatory System:Essential Elements :
Appropriate Legislation.
Appropriate Enforcement
Infrastructure.
Appropriate Enforcement Policies
and Procedures
Progressive & effective
Drug Regulatory System
helps in :
 Building Public Trust
 Promoting Healthy Growth Of
Industry
 Providing level playing Field To
The Stake Holders
Dynamics Of Regulatory
Systems :Advances in Sciences
Public Concerns
& Technologies
Regulatory
Drugs
&
Pharmaceutical
Safety
Efficacy
Quality
Policies &
Procedures
International
Harmonization
Process
Nature of
Products
Country specific
socio-cultural and
political Scenario
TM – Consensus On
regulatory Approach
 Distinctive regulatory Approach is
required as Compared to :
 Modern Research based Drugs.
 Herbal drugs.
 Phyto Medicines.
TM – Consensus On
regulatory Approach
 Important regulatory Issues/
challenges :
 Includes Diverse Health Practices,
Approaches, knowledge base and
Beleifs.
 Mostly Plant Based Products.
 Quality Influenced By numerous factors.
 Quality Determination ( Testing) : A
Complex task
Cont’d
TM – Consensus On
regulatory Approach
 Important regulatory
Issues/challenges :
 Mostly Multi-Ingredient In Nature
 Paucity of Database on Quality
Standards, Stability, Test Protocols
 Lack Of Safety Data as Per
Contemporary pharmacovigilance norms
 Products Generally Recommended
For numerous Indications & In
Different ancient texts.
Cont’d
TM – Consensus On
regulatory Approach
 Important regulatory Issues/
challenges :
 Distinct Processing methods – How To
Establish Scientifically Verifiable
Regulatory norms ?
 Large Scale Industrial production,
Commercial Promotion, Wide Spread
Distribution & Long Term Stay On
Shelf Was Not Intended Originally
TM – Consensus On
regulatory Approach
 Some Other regulatory Issues to be
Addressed :
 Use of whole Plant material V/s
Extracts ?
 OTC V/s Prescription Drugs
 Extent Of Use of Modern
Pharmaceutical Excepients
 New TM Drugs
 Efficacy Evaluation – Benchmarks ?
TM – Consensus On
regulatory Approach
 What is Needed ?
 Sharing Of Scientific & Regulatory
Experiences/ Expertise Among
Countries Having Considerable Use OF
TM
 National Expert Committees to Address
The Regulatory Issues Specific to TM
Products
 Government Support Necessary–
Private Research Based Pharma
Industries Will Not Invest
 Self Regulation