Challenges of Surgical Innovations in India

Abstract

Newer surgical interventions have been planned and conducted over last few decades, but many
of these novel surgical interventions have not been properly assessed before they were introduced
clinically. Indian Council for Medical Research, Ethical Guidelines 2017, have specifically mentioned
regarding surgical interventions and have emphasized proper ethics committee review, need for
animal/modelling data, monitoring during surgical interventional trial as well as provision of compensatory
mechanism. Basic issues with surgical innovations (as developed by IDEAL Collaboration framework) such as
Oversight, Informed Consent and Vulnerable group of patients have been now well emphasized by Indian
Guidelines. Some form of training (Simulations/Animal/ Cadaveric) is necessary for surgeons performing
novel procedures. Surgeon’ s learning curve must be shortened by hands on training on simulated models
preferably in presence of a mentor. Medical devices rules 2017 also necessitate use of new medical device
only after ethical committee review and other statutory permissions. Surgical innovations must be
performed keeping in mind recent guidelines and ethical principles for safety and benefit of
patients.[Agrawal P. Natl J Integr Res Med, 2020; 11(1):88-94]