Ayurvedic Drug Manufacturers’AssociationUnit No. 227, T.V. Industrial Estate, 248/A, S.K. Ahire Marg, Worli,Mumbai - 400 030

Tel: 91 - 22 -24984405, 24984423. Fax: 91- 22 – 24983658 Email: admaindia@vsnl.net

0612/ADMA/224 21st June 2012

ToAll Members of ADMA

Dear Sirs,

We are pleased to forward herewith a communication received from Department of ClinicalPharmacology with regard to seminar on "Herbal Products: Regulatory Aspects" to be held on29th & 30th June 2012 along with seminar brochure and Pre -final programme details for yourinform and participation.

Thanking you,

Yours faithfully,

O.P. PoojariSecretary General---------------------------------------------------------------------------------------

From: Dept of Clinical Pharmacology, TNMCSent: Tuesday, June 19, 2012 6:04 PMTo: admaindia@gmail.comCc: Dr. Renuka Munshi; Dr. Supriya Bhalerao; Dr. Samidha KalekarSubject: Re: Seminar on "Herbal Products: Regulatory Aspects"

Dear Sir/Madam,

You may be aware that the Dept. of AYUSH, Government of India has drafted guidelines onGood Clinical Practices for clinical trials on Ayurveda, Siddha, Unani (ASU) medicines. Oncethese guidelines are finalised & notified in public, the Ayurvedic industry and the potentialinvestigators will need to gear up to conduct clinical trials in accordance with these guidelines.In view of this we have organised a Seminar entitled “Herbal Products: RegulatoryAspects” on 29th & 30th June 2012, in which along with various aspects related to regulatoryrequirements for evaluating the safety, efficacy and quality of herbal products, a specialsession on “AYUSH GCP” has been planned.

During this session, we have planned brainstorming discussions on these guidelines fromethical, academic and regulatory angles. Dr. DC Katoch, Joint Advisor (Ayurveda) who has amajor role in drafting the GCP guidelines, has accepted our invitation to discuss thegovernment’s perspectives behind these efforts.

The program copy of the said seminar is attached herewith for your perusal. This seminar, webelieve will also help in better understanding of the current regulations applicable in ourcountry as well as the regulations regarding launching a Herbal Product in the SAARC, USA andEU markets).

We expect participation from both academia, ndustry and organizations who are activelyinvolved in research & marketing of herbal products.

We request you to kindly circulate the enclosed brochure to your members/associates ofyour Organization who are actively involved in research on herbal products to participate inthe Seminar.

Looking forward to active participation from your organization,

With warm regards,

Sincerely yours,

Dr. Renuka Munshi Dr. Supriya BhaleraoConvenor Co-Convenor

Seminar on “Herbal Products: Regulatory Aspects”

Registration Fees*

Category Before After st st31 May 2012 31 May 2012

#Students Rs. 1,500/- Rs. 3,000/-

Faculty/Professionals Rs. 3,000/- Rs. 5,000/-

Industry Delegates Rs. 5,000/- Rs. 7,000/-

Seminar on‘Herbal Products: Regulatory Aspects’29th & 30th June 2012Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital

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Pre-final ProgramDay 1: 29th June 2012

Timing Topic Speaker Chairpersons8.30 am to9.30 am Registration9.30 am to10.30 am Inaugural function Guest of Honor: Dr PV AppajiDirector, Pharmexcil, HyderabadKeynote address:“Stewarding futureregulation through AYUSHPharmacopeia”

Dr Ramesh BabuDirector General, CCRAS, New Delhi10.30 am to11.00 am Tea Break11.00 am to2.00 pm Session I: Regulations to launch a Herbal Product

(Traditional Medicine/Food/Health supplement/raw material)Gauging irrationally inAYUSH P & P Formulation

Indian & SAARC markets

USAEuropean Union

Dr. AnandChaudhury,Associate Professor,Dept. of Rasa Shastra,Faculty of AyurvedaInstitute of MedicalSciences, BanarasHindu University,VaranasiDr. Vijay Chauhan,Vice President ( R & D,Herbals) at NicholasPiramal India Limited,MumbaiDr. Sunil BhaskaranMD, Indus Biotech,PuneDr. SS GandhiDirector, GuficBiosciences, Mumbai

Shri Mahesh Zagade,Commissioner, FDA,MaharashtraDr. KR Kohli,Director , MaharashtraState AyurvedaDirectorate

2.00 pm to2.30 pm Lunch

Seminar on‘Herbal Products: Regulatory Aspects’29th & 30th June 2012Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital

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Day 1: 29th June 2012 (Contd)2.30 pm to5.30 pm Session II: Quality & Safety requirements

Newer “vistas” inupgrading GMP inHerbo-mineralformulations

Regulatoryrequirements for safetydata documentation(example – TGA, Australia)Safety assessment/generation of History ofsafe use data for herbalproducts

How to strengthenregulatory submissionby additionaltoxicological assessment

Dr. SS SavrikarProfessor and Head, Dept.of Rasashastra, RA PodarAyurvedic College,MumbaiDr. Amit Agarwal,Director,Natural Remedies Pvt.Ltd., BangaloreDr. Adip RoyResearch ScientistSafety & EnvironmentalAssurance CentreUnilever R&D, BangaloreDr. CK KatiyarHead, Health CareResearchDabur R&D CentreDabur India LtdGhaziabad (UP)

Dr. UM Thatte,Professor & Head,Dept of ClinicalPharmacology,GSMC & KEMHospital,MumbaiDr. MK Raina,Herbal Consultant,Mumbai

5.30 pm to6.00 pm Tea & Snacks

Seminar on‘Herbal Products: Regulatory Aspects’29th & 30th June 2012Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital

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Day 2: 30th June 2012

Timing Topic Speaker Chairpersons9.00 am to10.30 am Session III: Efficacy Requirements

Regulatoryrequirements forhuman studies of Foodsupplements withbotanicals

Claim substantiation:regulatoryrequirements forTraditionalmedicine/foodsupplements

Dr. Arun BhattPresident ,ClininventResearch, MumbaiFSSAI NomineeFood Safety And StandardsAuthority of IndiaMinistry of Health & FamilyWelfare, New Delhi

Dr. BhushanPatwardhanVice-Chancellor atSymbiosis InternationalUniversity, PuneMr. ChandrakantBhanushaliSecretary , ADMA,Mumbai

10.30 am to11.00 am Tea Break11.00 am to11.45 am Regulatoryrequirementsregarding Quality ofHerbal Products

Dr. GN QaziVice Chancellor, JamiaHamdard, New Delhi Dr. Narendra Bhatt,Ayurvedic Consultant,Research & IndustryMumbaiDr. NN RegeProfessor & Head,Dept of Pharmacology,GSMC & KEM Hospital,Mumbai11.45 am to2.00 pm Session IV: AYUSH GCP: Need for guidelinesGovernment perspective

Ethical perspectiveIndustry’s perspective

Dr. Dinesh KatochJoint Advisor (Ayurveda),Dept. of AYUSH, New DelhiDr. Vasantha MuthuswamySenior Deputy DirectorGeneral (Retd.), ICMR, NewDelhiDr. Nagesh SanduDirector, Sandu Brothers PvtLtd, Mumbai

Dr. AB VaidyaDirector, MedicalResearch Centre-KHS,MumbaiDr. NA KshirsagarNational Chair inClinical Pharmacology,ICMR,Dean, ESI-PGIMSR MGMHospital, Mumbai

Seminar on‘Herbal Products: Regulatory Aspects’29th & 30th June 2012Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital

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Day 2: 30th June 2012 (Contd)

Timing Topic Speaker Chairpersons/Moderator2.00 pm to3.00 pm Lunch3.00 pm to4.00 pm IPR issues related to

herbal products(Branding, Trademarks,Copyrights and patents)Dr. DB Anantha NarayanaEx-Director, RegulatoryAffairs-South AsiaUnilever Research India,Bangalore

Dr. SD Kholkutte,Director. NIRRH,Mumbai4.00 pm to5.00 pm Panel discussion Panelists:Representatives from StateFDA, AYUSH, Industry, ADMA,ICMR, Academics & Selectfaculty

Moderator: Mr.Ranjit PuranikCEO, ShriDhootpapeshwar Ltd,Mumbai5.00 pm to5.30 pm Valedictory function