RECOGNITION OF AYURVEDIC PHARMACOPOEIA OF INDIA (API) AND AYURVEDIC FORMULARY OF INDIA (AFI) BY SWISSMEDIC
22-Jul-23 05:44:49
MESMERIZING MOMENT - RECOGNITION OF AYURVEDIC PHARMACOPOEIA OF INDIA (API) AND AYURVEDIC FORMULARY OF INDIA (AFI) BY SWISSMEDIC
Pharmacopoeia Commission for Indian Medicine & Homoeopathy (PCIM&H) through Ministry of Ayush, Govt. of India is working with Govt. of Switzerland to accord recognition to Ayurvedic drugs. As a first step, inclusion of 41 substances from Ayurvedic Medicine in the list of Traditional Asian Substances (TAS) has been recently achieved. Now any company having a (Co-)seat in Switzerland can develop and sell Ayurvedic pharmaceuticals out of those 41 substances listed.
Swissmedic (Swiss Agency for Therapeutic Products) is the central Swiss supervisory authority for medicinal products. It is a Bern-based institution affiliated with the Federal Department of Home Affairs and works in accordance with Therapeutic Products Act and federal corporate governance.
The Complementary and Phytomedicine Ordinance, KPAV; SR 812.212.24 has recently been reviewed in view of simplified authorization and reporting procedure for complementary and herbal medicines and revised with effect from 1st July, 2023. The list of documented TAS according to Annex 10 of the ordinance includes substances that are common and established in Asian medicine and that serve as starting materials for medicinal products of the corresponding therapeutic directions without an indication. They have an official pharmacopoeial monograph on quality. In this latest revision, a new distinction is made and a total of 41 substances, for which the use in Ayurvedic medicine is sufficiently documented have been added as second part of this list, taking into account the respective Sanskrit designation.
Further, Appendix 9 of the said ordinance i.e. list of standard works which has references that contain traditional and established classic formulations and recipes for the approval of fixed drug combinations in Asian medicine in a simplified procedure and based on a notification has also been revised. The revised list now recognises The Ayurvedic Pharmacopoeia of India, Part-II (Formulations), Volume-I (2007) to Volume-IV (2017) and The Ayurvedic Formulary of India, Part-I (2003) to Part-III (2010) as standard works from Ayurvedic medicine that meet the requirements for inclusion. Thus, 202 pharmacopoeial monographs and 985 Formulary specifications of classical Ayurvedic Formulations get a place in the recognition by Swissmedic.