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International Ayurveda Foundation. International Ayurveda Foundation. India (Mumbai). United Kingdom (London). Switzerland (Geneva). Directors Dr. A. J. Baxi Dr. Tapankumar Vaidya Dr. Hemalatha Potti. Directors Dr. Vishal Gulati, Mr. Mark Rosenberg (Germany)

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International Ayurveda Foundation

India

(Mumbai)

United Kingdom

(London)

Switzerland

(Geneva)

  • Directors

  • Dr. A. J. Baxi

  • Dr. Tapankumar Vaidya

  • Dr. Hemalatha Potti

  • Directors

  • Dr. Vishal Gulati,

  • Mr. Mark Rosenberg

  • (Germany)

  • Mr. Surendra Kumar (UK)

  • Dr. S.N. Gupta (India)

  • Ms. Saroj Patel (Geneva)

  • Ms. Shakuntla Shukla (UK).

Directors

Dr. C. K. Patel


Shri. Praful Patel

General Secretary

International Ayurveda Foundation


Traditional Herbal

Medicinal Product Directive

A new challenge for Global Ayurveda Trade

Presentation by

Dr. Vidhi Bapna, MD(Ayu)

On behalf of International Ayurveda Foundation


Thmpd making of the menace
THMPD Making of the “Menace”

  • 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 325: June 2005-Implementation of THMPD


Consultations
Consultations

  • 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)

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


THMPD

Background

  • 1968 – UK Medicinal Act 1968.

  • Pharmaceutical Directive – PD (Directive 2001/83/EC)

  • Section 12 – Exemptions for herbalists in UK.

  • Safety and quality issues of usage of Sec 12.

  • Proposal for a regulatory scheme for Herbal Medicines.


THMPD

Traditional Herbal

Medicinal Product Directive

  • Amendment to the Pharmaceutical Directive.

  • “Fast Track” registration scheme for “Traditional

  • Herbal Medicines”.

  • Efficacy data to be replaced by data on Traditional use.

  • Stringent dossier requirement for safety and quality

  • demo, in the lines of synthetic medicines .

  • Euro centric, against non-European traditions.


Route for a Herbal Medicine

to European Union.

  • Marketing Authorization as a Medicinal Product as

  • per PD.

  • Positive list by Committee for Herbal Medicine

  • Products – direct entry.

  • Traditional Use Registration as per THMPD.

  • Only Viable option is to getting into the positive list.


Traditional Use Registration (TUR)

“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


THMPD

Ambit

  • Purely Herbal Medicines.

  • For sale OTC.

  • Only oral and topical use.

  • History of 15/30 years use in EU.

  • Most current Ayurveda products OUT !!!


Impact on Ayurveda

Scope of the Directive :

  • Only “Herbal Products”, other non-herbal biological

  • and non-biological active ingredients not covered.

  • Combinations of otherwise legal ingredients (Like

  • honey, milk, ghee, other animal products etc.) not

  • allowed for TUR.

  • Chyavanaprasham, most lehas, all ghrithas,

  • asavarishtas, gutikas, internally used oils like

  • Dhanwantharam (101), all rasa preprations etc. which

  • use other than herbal ingredients in a regulatory vacuum.


Impact on Ayurveda

  • Only those herbal drugs having “indications appropriate

  • for traditional herbal medicine products that are

  • designed to be used without the intervention of a medical

  • practitioner for diagnosis, treatment or monitoring

  • purpose.”

  • All drugs for the use of Ayurveda practitioners for

  • treatment of many diseases – OUT !!!.


Impact on Ayurveda

  • The applicant needs to present Bibliographic review of

  • safety data, together with an expert report. There is

  • a provision for the authorities to ask for “more data” to

  • prove safety.

  • Who and how a safety data can be provided when the

  • system itself is not defined or recognised in EU ?

  • Who is qualified in EU to be called as an expert in case of

  • Ayurveda medicine to give this report ???

  • Can Western Herbalists rationally do it when they do not

  • know or understand the system ?


Impact on Ayurveda

  • Furnish all the quality requirements applicable to licensed

  • medicines in EU.

  • GMP requirements for manufacturers, importers.

  • Licensing for the manufacturers, importers and

  • distributors compulsory.

  • Cost prohibitive to most Ayurveda companies, may be

  • none of the Indian companies qualify !!!


Impact on Ayurveda

  • 15 years rule.

  • Most discriminative rule against non-European traditions.

  • All new drugs out !!

  • Old ones without proof of TU will go out !!


What needs to be done

  • Diplomatic approach – Bilateral Task Forces Committee

  • – EP – GOI.

  • SAARC – WHO Initiatives.

  • Legal Challenge & WTO – IPR violations.

  • Joint effort from Ayurveda Industry to mobilise protect

  • activities.


What needs to be done

  • 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!!



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