India(Mumbai)

United Kingdom(London)

Switzerland(Geneva)

Directors 1. Dr. A. J. Baxi2. Dr. Tapankumar Vaidya3. 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).

MLX 283: March 2002MLX 283: March 2002. . European European Commission’s Proposals For A Directive Commission’s Proposals For A Directive On Traditional Herbal Medicinal On Traditional Herbal Medicinal ProductsProducts

MLX 318: January 2005-Consultation MLX 318: January 2005-Consultation On Proposed Herbal Medicines On Proposed Herbal Medicines Advisory Committee Advisory Committee

MLX 325: June 2005-Implementation of MLX 325: June 2005-Implementation of THMPDTHMPD

THMPDTHMPD Making of the Making of the

“Menace”“Menace”

ConsultationsConsultations RIA- Impacts assessed partially hiding RIA- Impacts assessed partially hiding

many facts and projecting the harmful many facts and projecting the harmful ones with lesser gravity.ones with lesser gravity.

Completely ignorant about the Completely ignorant about the principles and practice of the systems principles and practice of the systems covered (Eg.Ayurveda, TCM)covered (Eg.Ayurveda, TCM)

IAF had to fight a long battle to get into IAF had to fight a long battle to get into consultations, out valid points ignored!consultations, out valid points ignored!

• 1968 – UK Medicinal Act 1968.1968 – UK Medicinal Act 1968.• Pharmaceutical Directive – PD (Directive Pharmaceutical Directive – PD (Directive 2001/83/EC)2001/83/EC)• Section 12 – Exemptions for herbalists in Section 12 – Exemptions for herbalists in UK.UK.• Safety and quality issues of usage of Sec Safety and quality issues of usage of Sec 12.12.• Proposal for a regulatory scheme for Proposal for a regulatory scheme for Herbal Medicines.Herbal Medicines.

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

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

“Fast track”! Registration forHerbal medicines• which can be sold without the intervention of

a practitioner(OTC)• Permitted indications• Oral use or topical applicationIf 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

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

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

Scope of the DirectiveScope of the Directive : :

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

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

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

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

• Diplomatic approach – Bilateral Task Diplomatic approach – Bilateral Task Forces CommitteeForces 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 Joint effort from Ayurveda Industry to mobilise protectmobilise protect activities.activities.

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