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Ashwini Kumar Ex. DCG(I) ashwini_k46@yahoo.co

I nternational C onclave on T raditional M edicine (TM) 16 th – 17 th Nov. 2006, New Delhi CONSENSUS ON REGULATORY APPROACH TO TRADITIONAL MEDICINES. Ashwini Kumar Ex. DCG(I) ashwini_k46@yahoo.co.in. Drug Regulation: An essential measure to protect public health by ensuring that :-.

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Ashwini Kumar Ex. DCG(I) ashwini_k46@yahoo.co

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  1. International Conclave on Traditional Medicine (TM) 16th – 17th Nov. 2006, New Delhi CONSENSUS ON REGULATORY APPROACH TO TRADITIONAL MEDICINES Ashwini Kumar Ex. DCG(I) ashwini_k46@yahoo.co.in

  2. 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

  3. Drug Regulatory System:- Essential Elements: • Appropriate Legislation. • Appropriate Enforcement Infrastructure. • Appropriate Enforcement Policies and Procedures

  4. Progressive & effective Drug Regulatory System helps in : • Building Public Trust • Promoting Healthy Growth Of Industry • Providing level playing Field To The Stake Holders

  5. Dynamics Of Regulatory Systems :- Advances in Sciences & Technologies Public Concerns Regulatory Policies & Procedures Safety Efficacy Quality Drugs & Pharmaceutical International Harmonization Process Nature of Products Country specific socio-cultural and political Scenario

  6. TM – Consensus On regulatory Approach • Distinctive regulatory Approach is required as Compared to : • Modern Research based Drugs. • Herbal drugs. • Phyto Medicines.

  7. 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

  8. 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

  9. 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

  10. 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 ?

  11. 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

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