Traditional Medicines Global Scenario

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Traditional Medicines Global Scenario Muhammed A. Qayyum PTPMA Role of DRAP in Development of Traditional Medicine Industry in Pakistan Islamabad Feb 13, 2013

Absence of understanding does not warrant absence of existence Abu Ali al-husayn ibn Abd Allah ibn Sina (980-1037)

To administer medicine to diseases which have already developed and thereby suppress bodily chaos which has already occurred is comparable to the behavior of those who would begin to dig a well after they had grown thirsty, or those who would begin to cast weapons after they have engaged in battle. Would these actions not be too late? Harvard Magazine, Mar Apr 2002 circa 400 B.C.

Recognition of the value of traditional medicine needs to be accompanied by strong political, legal and financial support Draft Regional Strategy for Traditional Medicine in the Western Pacific Fifty Second Session, Brunei Darusslam 10-14 September 2001

potential of the herbal and natural products industry in providing competitive advantage to Malaysia towards the attainment of a developed country status by year 2020 Minister of Rural Development, Dato' Azmi Khalid Kuala Lumpur, 10 April 2003 Malaysia

Population Using TM / CAM Population in developing countries using TM for PHC Ethiopia, 90% Benin, 70% India, 70% Rwanda, 70% Tanzania, 60% Population in developed countries who have used CAM at least once Uganda, 70% Canada, 70% Australia, 48% France, 49% USA, 42% Belgium, 31%

United States David Kessler, FDA Commissioner threatens to remove botanicals, 1993 Congress receives more mail since Vietnam war Congress passes DSHEA in Oct, 1994

DSHEA 1994 Major Findings benefits of DS in health promotion and disease prevention link between the ingestion of certain nutrients or DS and the prevention of chronic diseases DS are safe within a broad range of intake

DSHEA 1994 Dietary Supplements Herbs, vitamins, minerals & amino acids Burden of proof on FDA Commission on Dietary Supplements Office of Dietary Supplements

19.5 50 68.7 89.2 104.6 128 128.8 121 122 117.7 114.1 2012 2010 2008 2006 2004 2002 2000 1998 1996 1994 1992

FDA GMP Guidelines Proposed 1997 Final announcement 2007 Effective Date 2010 Preparation time 13 years

Europe Some Trends Germany biggest market, regularly prescribed France 49% use CAM UK 90% prevalence of CAM Belgium 40% of the population use CAM Medical practitioners 59%

Germany Herbal medicines equivalent to regular medicines Imperial Decree of 1901 First Medicine Act (AMG) 1961 Second Medicine Act (AMG) 1976 Products to be reviewed by committee

Germany Minister of Health 1978 Commission E 24 members Physicians, pharmacists, non medical practitioners, pharmacologists, toxicologists, biostatisticians and representatives of the industry Commission E Monographs

India heritage Rich of traditional medicine which has been developed as a parallel health care system since 1940 s. Ayurveda Sidha Unani Yoga & Naturopathy Homeopathy Indian System of Medicine & Homeopathy

India heritage Rich of traditional medicine which has been developed as a parallel health care system since 1940 s. Ayurveda Sidha Unani Yoga & Naturopathy Homeopathy Indian System of Medicine & Homeopathy

India Dept of AUSH Budget IR 11.78 Billion Secretary, Joint Secretary & 4 directors

India Dept of AUSH Budget IR 11.78 Billion Secretary, Joint Secretary & 4 directors

India Drugs & Cosmetic Act 1940 Chapter IV A Applicable only Ayurvedic, Sidha & Unani drugs Ayurvedic & Unani Drugs Technical Advisory Board Ayurvedic, Siddha and Unani Drug Consultative Committee

India GMP

India GMP

India GMP First publication 1995 Revision 2003 Preparation time 8 years

STRATEGY FOR DOUBLING EXPORTS IN NEXT THREE YEARS (2011-12 to 2013-14) Govt. Of India Firstly, as suggested in the Task Force Report, we need to focus our attention on twenty five more important traditional medicine products selected purely on the considerations of their acceptance in the export markets and then work around those products for pharmacopeia development, marketing tie-ups and regulatory facilitation.

India heritage Rich of traditional medicine which has been developed as a parallel health care system since 1940 s.

China traditional Chinese medicine is a great treasury Mao Zedong

China To develop TCM Chapter 21 The Constitution of the People s Republic of China1982

Key Messages 1 Own your HERITAGE

Key Messages 2 EXPERTS committee needs to work on regulations

Key Messages 3 Regulations require TIME

Thank you!