0612/ADMA/224 21st June To All Members of ADMA. Dear Sirs,

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1 Ayurvedic Drug Manufacturers Association Unit No. 227, T.V. Industrial Estate, 248/A, S.K. Ahire Marg, Worli, Tel: , Fax: admaindia@vsnl.net 0612/ADMA/224 21st June 2012 To All Members of ADMA Dear Sirs, We are pleased to forward herewith a communication received from Department of Clinical Pharmacology with regard to seminar on "Herbal Products: Regulatory Aspects" to be held on 29th & 30th June 2012 along with seminar brochure and Pre -final programme details for your inform and participation. Thanking you, Yours faithfully, O.P. Poojari Secretary General From: Dept of Clinical Pharmacology, TNMC Sent: Tuesday, June 19, :04 PM To: admaindia@gmail.com Cc: Dr. Renuka Munshi; Dr. Supriya Bhalerao; Dr. Samidha Kalekar Subject: 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 on Good Clinical Practices for clinical trials on Ayurveda, Siddha, Unani (ASU) medicines. Once these guidelines are finalised & notified in public, the Ayurvedic industry and the potential investigators 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: Regulatory Aspects on 29 th & 30 th June 2012, in which along with various aspects related to regulatory requirements for evaluating the safety, efficacy and quality of herbal products, a special session on AYUSH GCP has been planned. During this session, we have planned brainstorming discussions on these guidelines from ethical, academic and regulatory angles. Dr. DC Katoch, Joint Advisor (Ayurveda) who has a major role in drafting the GCP guidelines, has accepted our invitation to discuss the government s perspectives behind these efforts.

2 The program copy of the said seminar is attached herewith for your perusal. This seminar, we believe will also help in better understanding of the current regulations applicable in our country as well as the regulations regarding launching a Herbal Product in the SAARC, USA and EU markets). We expect participation from both academia, ndustry and organizations who are actively involved in research & marketing of herbal products. We request you to kindly circulate the enclosed brochure to your members/associates of your Organization who are actively involved in research on herbal products to participate in the Seminar. Looking forward to active participation from your organization, With warm regards, Sincerely yours, Dr. Renuka Munshi Convenor Dr. Supriya Bhalerao Co-Convenor Seminar on Herbal Products: Regulatory Aspects

4 Registration Fees* Category Before 31st May 2012 After 31st 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/-

5 Day 1: 29 th June 2012 Seminar on Herbal Products: Regulatory Aspects 29 th & 30 th June 2012 Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital Pre-final Program Timing Topic Speaker Chairpersons 8.30 am to 9.30 am 9.30 am to am am to am am to 2.00 pm Inaugural function Keynote address: Stewarding future regulation through AYUSH Pharmacopeia Gauging irrationally in AYUSH P & P Formulation Indian & SAARC markets USA Registration Guest of Honor: Dr PV Appaji Director, Pharmexcil, Hyderabad Dr Ramesh Babu Director General, CCRAS, New Delhi Tea Break Session I: Regulations to launch a Herbal Product (Traditional Medicine/Food/Health supplement/raw material) Dr. Anand Chaudhury, Associate Professor, Dept. of Rasa Shastra, Faculty of Ayurveda Institute of Medical Sciences, Banaras Hindu University, Varanasi Dr. Vijay Chauhan, Vice President ( R & D, Herbals) at Nicholas Piramal India Limited, Dr. Sunil Bhaskaran MD, Indus Biotech, Pune Shri Mahesh Zagade, Commissioner, FDA, Maharashtra Dr. KR Kohli, Director, Maharashtra State Ayurveda Directorate 2.00 pm to 2.30 pm European Union Dr. SS Gandhi Director, Gufic Biosciences, Lunch 1

6 Seminar on Herbal Products: Regulatory Aspects 29 th & 30 th June 2012 Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital Day 1: 29 th June 2012 (Contd) 2.30 pm to 5.30 pm Newer vistas in upgrading GMP in Herbo-mineral formulations Session II: Quality & Safety requirements Dr. SS Savrikar Professor and Head, Dept. of Rasashastra, RA Podar Ayurvedic College, 5.30 pm to 6.00 pm Regulatory requirements for safety data documentation (example TGA, Australia) Safety assessment /generation of History of safe use data for herbal products How to strengthen regulatory submission by additional toxicological assessment Dr. Amit Agarwal, Director, Natural Remedies Pvt. Ltd., Bangalore Dr. Adip Roy Research Scientist Safety & Environmental Assurance Centre Unilever R&D, Bangalore Dr. CK Katiyar Head, Health Care Research Dabur R&D Centre Dabur India Ltd Ghaziabad (UP) Tea & Snacks Dr. UM Thatte, Professor & Head, Dept of Clinical Pharmacology, GSMC & KEM Hospital, Dr. MK Raina, Herbal Consultant, 2

7 Seminar on Herbal Products: Regulatory Aspects 29 th & 30 th June 2012 Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital Day 2: 30 th June 2012 Timing Topic Speaker Chairpersons 9.00 am to am Regulatory requirements for human studies of Food supplements with botanicals Session III: Efficacy Requirements Dr. Arun Bhatt President,Clininvent Research, Dr. Bhushan Patwardhan Vice-Chancellor at Symbiosis International University, Pune am to am Claim substantiation: regulatory requirements for Traditional medicine/food supplements FSSAI Nominee Food Safety And Standards Authority of India Ministry of Health & Family Welfare, New Delhi Tea Break Mr. Chandrakant Bhanushali Secretary, ADMA, am to am Regulatory requirements regarding Quality of Herbal Products Dr. GN Qazi Vice Chancellor, Jamia Hamdard, New Delhi Dr. Narendra Bhatt, Ayurvedic Consultant, Research & Industry am to 2.00 pm Government perspective Ethical perspective Industry s perspective Dr. NN Rege Professor & Head, Dept of Pharmacology, GSMC & KEM Hospital, Session IV: AYUSH GCP: Need for guidelines Dr. Dinesh Katoch Joint Advisor (Ayurveda), Dept. of AYUSH, New Delhi Dr. Vasantha Muthuswamy Senior Deputy Director General (Retd.), ICMR, New Delhi Dr. Nagesh Sandu Director, Sandu Brothers Pvt Ltd, Dr. AB Vaidya Director, Medical Research Centre-KHS, Dr. NA Kshirsagar National Chair in Clinical Pharmacology, ICMR, Dean, ESI-PGIMSR MGM Hospital, 3

8 Day 2: 30 th June 2012 (Contd) Seminar on Herbal Products: Regulatory Aspects 29 th & 30 th June 2012 Venue: TN Medical College Auditorium, BYL Nair Ch. Hospital Timing Topic Speaker Chairpersons/ Moderator 2.00 pm to Lunch 3.00 pm 3.00 pm to 4.00 pm 4.00 pm to 5.00 pm IPR issues related to herbal products (Branding, Trademarks, Copyrights and patents) Panel discussion Dr. DB Anantha Narayana Ex-Director, Regulatory Affairs-South Asia Unilever Research India, Bangalore Panelists: Representatives from State FDA, AYUSH, Industry, ADMA, ICMR, Academics & Select faculty Dr. SD Kholkutte, Director. NIRRH, Moderator: Mr. Ranjit Puranik CEO, Shri Dhootpapeshwar Ltd, 5.00 pm to 5.30 pm Valedictory function 4

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