2. India (Mumbai) United Kingdom (London) Switzerland (Geneva) Directors 1.Dr. A. J. Baxi 2.Dr. Tapankumar Vaidya 3.Dr. Hemalatha Potti Directors Dr. C. K. Patel Directors 1.Dr. Vishal Gulati, 2.Mr. Mark Rosenberg (Germany) 1.Mr. Surendra Kumar (UK) 2.Dr. S.N. Gupta (India) 3.Ms. Saroj Patel (Geneva) 4.Ms. Shakuntla Shukla (UK).

5. MLX 283: March 2002. European Commission’s Proposals For A Directive On Traditional Herbal Medicinal Products MLX 283: March 2002. European Commission’s Proposals For A Directive On Traditional Herbal Medicinal Products MLX 318: January 2005-Consultation On Proposed Herbal Medicines Advisory Committee MLX 318: January 2005-Consultation On Proposed Herbal Medicines Advisory Committee MLX 325: June 2005-Implementation of THMPD MLX 325: June 2005-Implementation of THMPD MLX 283: March 2002. European Commission’s Proposals For A Directive On Traditional Herbal Medicinal Products MLX 283: March 2002. European Commission’s Proposals For A Directive On Traditional Herbal Medicinal Products MLX 318: January 2005-Consultation On Proposed Herbal Medicines Advisory Committee MLX 318: January 2005-Consultation On Proposed Herbal Medicines Advisory Committee MLX 325: June 2005-Implementation of THMPD MLX 325: June 2005-Implementation of THMPD THMPD Making of the “Menace”

6. Consultations RIA- Impacts assessed partially hiding many facts and projecting the harmful ones with lesser gravity. RIA- Impacts assessed partially hiding many facts and projecting the harmful ones with lesser gravity. Completely ignorant about the principles and practice of the systems covered (Eg.Ayurveda, TCM) Completely ignorant about the principles and practice of the systems covered (Eg.Ayurveda, TCM) IAF had to fight a long battle to get into consultations, out valid points ignored! IAF had to fight a long battle to get into consultations, out valid points ignored! RIA- Impacts assessed partially hiding many facts and projecting the harmful ones with lesser gravity. RIA- Impacts assessed partially hiding many facts and projecting the harmful ones with lesser gravity. Completely ignorant about the principles and practice of the systems covered (Eg.Ayurveda, TCM) Completely ignorant about the principles and practice of the systems covered (Eg.Ayurveda, TCM) IAF had to fight a long battle to get into consultations, out valid points ignored! IAF had to fight a long battle to get into consultations, out valid points ignored!

7. 1 1968 – UK Medicinal Act 1968. P Pharmaceutical Directive – PD (Directive 2001/83/EC) S Section 12 – Exemptions for herbalists in UK. afety and quality issues of usage of Sec 12. P Proposal for a regulatory scheme for Herbal Medicines.

8. A Amendment to the Pharmaceutical Directive. “ “Fast Track” registration scheme for “Traditional Herbal Medicines”. E Efficacy data to be replaced by data on Traditional use. S Stringent dossier requirement for safety and quality demo, in the lines of synthetic medicines. E Euro centric, against non-European traditions.

9. M Marketing Authorization as a Medicinal Product as per PD. P Positive list by Committee for Herbal Medicine Products – direct entry. T Traditional Use Registration as per THMPD. O Only Viable option is to getting into the positive list.

10. “Fast track”! Registration for Herbal medicines which can be sold without the intervention of a practitioner(OTC) Permitted indications Oral use or topical application If it can provide required data for quality (GACP, GMP) traditional use history for a total of 30 yrs 15 years should be within the EU boundaries

11. P Purely Herbal Medicines. F For sale OTC. O Only oral and topical use. H History of 15/30 years use in EU. Most current Ayurveda products OUT !!!

12. Only “Herbal Products”, other non-herbal biological Only “Herbal Products”, other non-herbal biological and non-biological active ingredients not covered. and non-biological active ingredients not covered. Combinations of otherwise legal ingredients (Like Combinations of otherwise legal ingredients (Like honey, milk, ghee, other animal products etc.) not honey, milk, ghee, other animal products etc.) not allowed for TUR. allowed for TUR. Chyavanaprasham, most lehas, all ghrithas, Chyavanaprasham, most lehas, all ghrithas, asavarishtas, gutikas, internally used oils like asavarishtas, gutikas, internally used oils like Dhanwantharam (101), all rasa preprations etc. which Dhanwantharam (101), all rasa preprations etc. which use other than herbal ingredients in a regulatory vacuum. use other than herbal ingredients in a regulatory vacuum. Only “Herbal Products”, other non-herbal biological Only “Herbal Products”, other non-herbal biological and non-biological active ingredients not covered. and non-biological active ingredients not covered. Combinations of otherwise legal ingredients (Like Combinations of otherwise legal ingredients (Like honey, milk, ghee, other animal products etc.) not honey, milk, ghee, other animal products etc.) not allowed for TUR. allowed for TUR. Chyavanaprasham, most lehas, all ghrithas, Chyavanaprasham, most lehas, all ghrithas, asavarishtas, gutikas, internally used oils like asavarishtas, gutikas, internally used oils like Dhanwantharam (101), all rasa preprations etc. which Dhanwantharam (101), all rasa preprations etc. which use other than herbal ingredients in a regulatory vacuum. use other than herbal ingredients in a regulatory vacuum. Scope of the Directive :

13. Only those herbal drugs having “indications appropriate Only those herbal drugs having “indications appropriate for traditional herbal medicine products that are for traditional herbal medicine products that are designed to be used without the intervention of a medical designed to be used without the intervention of a medical practitioner for diagnosis, treatment or monitoring practitioner for diagnosis, treatment or monitoring purpose.” purpose.” All drugs for the use of Ayurveda practitioners for All drugs for the use of Ayurveda practitioners for treatment of many diseases – OUT !!!. treatment of many diseases – OUT !!!. Only those herbal drugs having “indications appropriate Only those herbal drugs having “indications appropriate for traditional herbal medicine products that are for traditional herbal medicine products that are designed to be used without the intervention of a medical designed to be used without the intervention of a medical practitioner for diagnosis, treatment or monitoring practitioner for diagnosis, treatment or monitoring purpose.” purpose.” All drugs for the use of Ayurveda practitioners for All drugs for the use of Ayurveda practitioners for treatment of many diseases – OUT !!!. treatment of many diseases – OUT !!!.

14. The applicant needs to present Bibliographic review of The applicant needs to present Bibliographic review of safety data, together with an expert report. There is safety data, together with an expert report. There is a provision for the authorities to ask for “more data” to a provision for the authorities to ask for “more data” to prove safety. prove safety. Who and how a safety data can be provided when the Who and how a safety data can be provided when the system itself is not defined or recognised in EU ? system itself is not defined or recognised in EU ? Who is qualified in EU to be called as an expert in case of Who is qualified in EU to be called as an expert in case of Ayurveda medicine to give this report ??? Ayurveda medicine to give this report ??? Can Western Herbalists rationally do it when they do not Can Western Herbalists rationally do it when they do not know or understand the system ? know or understand the system ? The applicant needs to present Bibliographic review of The applicant needs to present Bibliographic review of safety data, together with an expert report. There is safety data, together with an expert report. There is a provision for the authorities to ask for “more data” to a provision for the authorities to ask for “more data” to prove safety. prove safety. Who and how a safety data can be provided when the Who and how a safety data can be provided when the system itself is not defined or recognised in EU ? system itself is not defined or recognised in EU ? Who is qualified in EU to be called as an expert in case of Who is qualified in EU to be called as an expert in case of Ayurveda medicine to give this report ??? Ayurveda medicine to give this report ??? Can Western Herbalists rationally do it when they do not Can Western Herbalists rationally do it when they do not know or understand the system ? know or understand the system ?

15. Furnish all the quality requirements applicable to licensed Furnish all the quality requirements applicable to licensed medicines in EU. medicines in EU. GMP requirements for manufacturers, importers. GMP requirements for manufacturers, importers. Licensing for the manufacturers, importers and Licensing for the manufacturers, importers and distributors compulsory. distributors compulsory. Cost prohibitive to most Ayurveda companies, may be Cost prohibitive to most Ayurveda companies, may be none of the Indian companies qualify !!! none of the Indian companies qualify !!! Furnish all the quality requirements applicable to licensed Furnish all the quality requirements applicable to licensed medicines in EU. medicines in EU. GMP requirements for manufacturers, importers. GMP requirements for manufacturers, importers. Licensing for the manufacturers, importers and Licensing for the manufacturers, importers and distributors compulsory. distributors compulsory. Cost prohibitive to most Ayurveda companies, may be Cost prohibitive to most Ayurveda companies, may be none of the Indian companies qualify !!! none of the Indian companies qualify !!!

16. 15 years rule. 15 years rule. Most discriminative rule against non- European traditions. Most discriminative rule against non- European traditions. All new drugs out !! All new drugs out !! Old ones without proof of TU will go out !! Old ones without proof of TU will go out !! 15 years rule. 15 years rule. Most discriminative rule against non- European traditions. Most discriminative rule against non- European traditions. All new drugs out !! All new drugs out !! Old ones without proof of TU will go out !! Old ones without proof of TU will go out !!

17. Diplomatic approach – Bilateral Task Forces Committee Diplomatic approach – Bilateral Task Forces Committee – EP – GOI. – EP – GOI. SAARC – WHO Initiatives. SAARC – WHO Initiatives. Legal Challenge & WTO – IPR violations. Legal Challenge & WTO – IPR violations. Joint effort from Ayurveda Industry to mobilise protect Joint effort from Ayurveda Industry to mobilise protect activities. activities. Diplomatic approach – Bilateral Task Forces Committee Diplomatic approach – Bilateral Task Forces Committee – EP – GOI. – EP – GOI. SAARC – WHO Initiatives. SAARC – WHO Initiatives. Legal Challenge & WTO – IPR violations. Legal Challenge & WTO – IPR violations. Joint effort from Ayurveda Industry to mobilise protect Joint effort from Ayurveda Industry to mobilise protect activities. activities.

18. Second battle against the British and European Union authorities for self esteem and for guarding our culture and heritage.. “Jaagte Raho India!!” The last nail in the coffin may be stroked in anytime!!