Page 53 - Traditional Medicine Systems of BIMSTEC Member States – 2023 Report

BIS established a dedicated standardisation department for TM (Ayush) systems

to deal with the standardisation work in TM (Ayush)-related subjects. Before the creation
of a separate Department, the standardisation work related to Ayush systems was being

done across different departments such as Food and Agriculture Department (FAD),
Medical Equipment & Hospital Planning Department (MHD) and the Service Sector

Department (SSD). Total 58 standards focusing on different topics like single herbs (47),
Ayurveda and Yoga terminologies (6), Panchakarma equipment (2), Yoga mat, Yoga centre

-service requirements and test methods for pesticide residue have been published. Thirty-
three documents related to single herbs are under publication, and more than 50

documents are in different stages of development. Published Standards (AYD). Available
from https://www.services.bis.gov.in/php/BIS_2.0/dgdashboard/published/

subcommtt?depi d=MTA5&aspect=&doe=&dt_from=&dt_to=.

8.8 Good Clinical Practice Guidelines for Clinical Trials in Ayurveda,

Siddha and Unani Medicine: http://siddhacouncil.com/ccrs/wp-content/
uploads/2018/10/GCP-Guidelines.pdf

GCP for ASU guidelines facilitates the researchers and institutions in adopting
a standard way of Good Clinical Practice while conducting the ASU clinical trials. The

guidelines are addressed to investigators and all those, who are interested, concerned,
involved and affected with the conduct of clinical trials on ASU Drugs. Further, Central

Council for Research in Ayurvedic Sciences (CCRAS) had developed three comprehensive
and concise Guidelines focusing on
T raditional Medicine Systems of BIMSTEC Member States – 2023 Report
a) General Guidelines for Drug Development of Ayurvedic Formulations
(Standardisation and quality assurance);

b) General Guidelines of Safety/Toxicity Evaluation of Ayurvedic Formulations
c) General Guidelines for Clinical Evaluation of Ayurvedic Interventions

These Guidelines (available at http://ccras.nic.in/content/general-guideline-series)

encompassed with research practices may be suitably adopted and followed by investigators
in the field of Ayurveda system such as Research organisations, academic institutions

and Investigators seeking grant from schemes of different agencies funding for research
on AYUSH system, would certainly help the investigators while designing and formulating

the proposals and also planning academic industrial research in the field of AYUSH
systems.

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