1. PRESENTATION OF BREAKAWAY SESSION THEME – I HARMONIZATION AND INTERNATIONAL COOPERATION IN TM SHIV BASANT Joint Secretary Department of AYUSH, India

2. GLOBAL SCENARIO Increasing demand for natural health products. Global Market – US $ 60 billion annually. 80-90% of population in many countries relies on TM. TM encompasses extreme diversity – 100 different TM practices in vogue in the world. Global resurgence in TM raising concerns regarding their quality, safety and efficacy.

3. CHALLENGES & ISSUES Underlying principles of different TM systems are similar and have many common medicinal plants. Need for information sharing and collaborative R&D for harmonization of herbal pharmacopoeia. Sharing of knowledge regarding chemical/ biological markers/chromatogram fingerprints. Common approach for regulation of education and practice of TM. Mutual recognition of TM qualifications. Developing a common regulatory approach regarding quality, safety and efficacy parameters for TM. Contd…

4. Need for greater dialogue and interaction between regulatory authorities of participating countries and with regulatory authorities in developed countries on issues relating to non-tariff trade barriers like 15 year of usage in Europe for fast track registration of herbal products and inclusion of otherwise safe medicinal plants in the negative list. Common strategy for protection of TM against misappropriation. Need for bringing together APTMNET and other Regional fora on TM at our platform under the aegis of WHO for evolving a common approach to regulation of TM products and services across frontiers.

5. RECOMMENDATIONS Participating countries should develop a consensus on regulatory approach to Traditional Medicine. Exchange of information between countries with strong TM traditions regarding Pharmacopoeial Standards/Standardization and Quality Control Parameters/Good Agro-Technology practices etc. Development of a common strategy for protection of both codified and uncodified traditional medicinal knowledge. Contd…

6. Participating countries should consider grant of mutual recognition of degrees and allow practice of codified systems of traditional medicines in their countries. Exchange of students and experts. Common approach to non-tariff technical barriers to trade of TM products like 15 year usage in Europe for registration/otherwise safe medicinal plants on negative list of various countries. Explore the possibility of organizing training programmes on agro technology/manufacturing technology/standardization and quality control techniques/collaborative R&D for scientific validation and development of new drugs for prioritized disease conditions based on TM knowledge.

7. THANKS