Patent and Proprietary Products of Ayurveda

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Regulatory Affairs

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Gauging irrationality in AYUSH Patent & Proprietary Formulation :

Gauging irrationality in AYUSH Patent & Proprietary Formulation Dr Anand Chaudhary Associate Professor Department of Rasa Shastra Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi -221005 E mail –anandayubhu@gmail.com

Contents :

Contents Why this title - who are stakeholders Definitions of ASU /AYUSH drugs Classical commandments Portrayal of P & P products Additional advancements Rays of radiance Global grace 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 2

Gauging :Judging Irrationality:

Gauging :Judging Irrationality What are wrongs ? Why it happened ? Who are beneficiaries ? Who are whistleblowers ? Where is way out ? 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 3

Definition :

Definition Classical - section 3 a Patent & Proprietary medicines –section 3 h External/Internal Diagnosis ,treatment ,mitigation ,prevention Formulae Authoritative text books of schedule I of D & C Act ,1940 Ingredients of formulae of authoritative text books 54 Ayurvedic Formulary of India Ayurvedic Pharmacopeia of India 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 4

Classical Connotation :

Classical Connotation Pragmatic Properties Essential Elegance Quality Safety Efficacy Time tested Recognized by regulators 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 5

Clinicians Choice :

Clinicians Choice Futuristic Freedom Modified Medicines 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 6 Design Deletion Dosage forms Disease Diseased

Portrayal of P & P Products :

Why physicians are prescribing P & P products ? Why patients are purchasing P & P products as OTC medicine ? 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 7 Portrayal of P & P Products

Rational P & P Products :

Rational P & P Products Himalayan Hilltop Realistic Reputation Reorientation Researched Reliable & Remedial 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 8

Conceptual P & P products :

Conceptual P & P products Insufficient Information Inadequate Inventory 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 9

Theoretical P & P Products :

Theoretical P & P Products 9101 ARTHROJITH CAPSULES 10 Nos Rs 25.00 9104 AYUR LIVER TONIC 100 ml Rs 26.00 9118 KESINI 100 gm Rs 54.00 9129 RHEUMA HEAL 25 gm Rs 35.00 9133 URONIL CAPSULES 30 No Rs 63.00 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 10 http://www.avpayurveda.com/ayurveda/proprietary.html

Trendsetter P & P Products :

Trendsetter P & P Products Reasons there of Public purview Physicians prescription Manufacturing melody Regulators remand Business beauty 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 11

Problematic P & P Products :

Problematic P & P Products Improper Initiative Immoral Imitation 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 12

Physicians Paradigms :

Physicians Paradigms Sr Subject Ayurveda Homeopath Total AYUSH 01 Number of Registered Practitioners 4,29,246 2,24,279 7,12,121 02 Percentage of Registered Practitioners 60.30% 31.50% 100.00% 03 Registered Practitioners per crore Population 3557 1858 5900 04 AverageAnnual Growth Rate inAYUSHdoctors during 1980-2011* 2.2% 2.4% 2.1% 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 13 http://www.indianmedicine.nic.in/writereaddata/linkimages/0516060463-3%201%20FINAL%20Section.pdf

Pharmacy Panorama :

Pharmacy Panorama Priority of private players Prominence of P & P Products Total number of Pharmacy -8896 Govt. Sector -00.40 % Non Govt. Sector -99.60 % 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 14 Approximate number of P & P Product -20,000 Approximate market share - 95 %

Commerce Connection :

Commerce Connection Solitary saga Licensed & GMP Certified Ayurveda Industry growth rate -02.90 % Approximate P & P products > 20,000 Business – Rs 10,000 Crore approx Rs 9,500 Crore of P & P products 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 15 http://www.indianmedicine.nic.in/writereaddata/linkimages/8466814124-writeup.pdf

Why so hue and cry ? :

Why so hue and cry ? Violatory Voids Fundamental Faults 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 16

Augmentative Arguments :

Augmentative Arguments Innumerable Inventions Plausible Potentiation 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 17

Additional Advancements :

By Good Governance By Industry Initiation By Consumer Care 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 18 Additional Advancements

Loyalty to Law :

Loyalty to Law 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 19

Dependable Doctrines :

Dependable Doctrines 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 20

Customer Custodian :

Customer Custodian Ingredients Influence Constituent Concern 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 21

Industry Opinion :

Industry Opinion Substantial Study Dossier Directives 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 22

Plenteous progress:

Plenteous progress WHO Report Further Features Patent and proprietary Ayurvedic medicines are sold over the counter in pharmacies. These products appear to represent a major share of branded traditional products in India . http://apps.who.int/medicinedocs/pdf/whozip57e/whozip57e.pdf Standard format Application for additional product licenses Uniform approval syst em 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 23

Consumer Care :

Consumer Care 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 24

Rays of Radiance :

By penalizing producers of irrational P & P products By promoting prominence of rational P & P products By Progressive policy planning for permissible P & P Products 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 25 Rays of Radiance

Penalty plot :

Penalty plot D & C Acts ,1940 D & C Rules ,1945 Strict Scrutiny Misbranded drugs Adulterated drugs Spurious drugs Any other new section Licensing Compliance Regular reality check Post marketing surveillance Proper punishment 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 26

Promotional Plan :

Promotional Plan Government Guideline Tradition to Trendition Draft guidelines for  CGHS Ratio of 60:40 in terms of value in classical and propriety medicines will be maintained in the CGHS procurement http://ayurbhishak.wordpress.com/2010/06/23/%E2%99%A3-centre-issues-draft-guidelines-for-procurement-of-ayurvedic-medicines-for-cghs 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 27

Research Relay :

Research Relay 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 28

Global Grace :

By enhancing export of rational P & P products By preventing export of perished P & P products By motivating international common mass 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 29 Global Grace

Intercontinental Endorsement :

Intercontinental Endorsement EU Directives THMPD Orphan drugs 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 30

Authoritative Authentication:

Authoritative Authentication Certification Verification 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 31

Assertive Assumption:

Assertive Assumption Year Export (AYUSH) Growth over previous Year (%) Export(All Items ) Growth over previous Year (%) %age Share of AYUSH Items 2006- 07 2186.96 13% 571779.29 25% 0.38% 2007- 08 2275.64 4% 655863.52 15% 0.35% 2008- 09 3036.35 33% 840755.06 28% 0.36% 2009- 10 2887.01 -5% 845533.64 1% 0.34% 2010-11 2099.00 -27% 1142648.97 35% 0.18% 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 32 http://www.indianmedicine.nic.in/writereaddata/linkimages/9753450525-9%201a.pdf

Probable Postulation:

Irrational unjustifiable P & P products must be ruled out. Genuine rational P & P product is call of day. Adaptive recommendation must be made out. 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 33 Probable Postulation

Advanced Approach :

Advanced Approach Ayurvedic Pharmacopeia Committee –APC Pharmacopeial Commission of Indian Medicine –PCIM Ayurveda Pharmacopoeia reconstituted as PCIM with aggressive growth plan Nandita Vijay, Bengaluru Wednesday, June 20, 2012, 08:00 Hrs  [IST] http://pharmabiz.com/NewsDetails.aspx?aid=69656&sid=1 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 34

Supportive Suggestions :

Supportive Suggestions Recommendations on harmonized licensing system Recommendations to permit branding of classical medicines Recommendations on new categories ASU drugs Recommendations to create a new category of ASU modern drugs based upon scientific data Any new recommendation from this seminar -----------------------------. 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 35

Causality Caution :

Causality Caution Policy Makers Regulators Industry It self Common Consumer Or Any unforeseen ? ? ? Of Foreign Origin 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 36

Conclusion :

Conclusion Branded Classical and Rational Patent & Proprietary Ayurvedic Formulations (AYUSH) are Futuristic Medicines for Holistic Health Hegemony . 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 37

Take Home Message :

Take Home Message Inspiration Imminent Insight 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 38

Acknowledgement :

Acknowledgement Dr Renuka Munshi Dr Supriya Bhalerao The Chair of Session The Learned Audience The Team Seminar 29 June ,2012 Seminar on "Herbal Products:Regulatory Aspects " ,Dept of Clinical Pharmacology ,TNMC,Mumbai 39

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