Standardization of Ayurveda medical devices: A new initiative by Bureau of Indian Standards

Ayurveda has employed a variety of medical devices and equipment in its therapeutic practices. In ancient times, Ayurveda relied on medical devices that were considerably less sophisticated than those available today. However, ancient Ayurvedic seers were clearly aware of the potential drawbacks and harmful effects that could arise from substandard devices, emphasizing the need for adherence to strict quality parameters during manufacturing, medicine processing, and therapeutic applications. This concern is amplified in the contemporary context where the World Health Organization (WHO) document on “Benchmarks for the practice of Ayurveda” emphasize the role of standard Ayurveda medical devices in success of treatment. In Ayurveda, Pharmacovigilance (PV) is a well-established framework that records and manages adverse drug reactions from medicine consumption. Similarly, materiovigilance pertains to the monitoring of medical devices used for the diagnosis, prevention, monitoring, and treatment of diseases. Currently, there is a significant gap in the standardization of guidelines for medical devices used in Ayurveda, resulting in uncontrolled manufacturing processes and a lack of quality and usage data. As Ayurveda continues to expand into global markets, there is an urgent need to standardize therapeutic equipment to ensure consistent quality and patient-centric service delivery. In response to this need, the Bureau of Indian Standards (BIS) has set up a new Technical Department for Standardization in the field of Ayush systems including traditional and modern aspects of products and services of these systems. Under this Department, Ayurveda Sectional Committee (AYD 01) which deals with standards development in the field of Ayurveda has undertaken the task of formulating Indian Standards for Ayurvedic medical devices. BIS has already published standards for specific devices such as the Droni and Shirodhara yantra , and is actively working on developing standards for other devices. This initiative by BIS is an important step towards achieving uniformity in the standards of equipment used in prophylactic and therapeutic procedures, thereby promoting the global dissemination of Ayurvedic knowledge and practices while ensuring patient safety and efficacy in treatment.