The Union health ministry has made it mandatory for the clinical research organisations (CROs), clinical trial sponsors, medical institutions and other stakeholders involved in the conduct of clinical trials to provide information on assessment of risk versus benefit to the patients; innovation vis-à-vis existing therapeutic option; and unmet medical need in the country.

A directive in this connection has been issued by the Drugs Controller General of India (DCGI).

The DCGI's action in this regard comes in the backdrop of the Supreme Court order.  In the case of W.P. (C) No. 33/2012 of Swasthya Adhikar Manch, Indore & Anr Vs Ministry of Health and Family Welfare & Ors with WP © No.779/2012 regarding clinical trials, the Supreme Court had passed an order dated 21/10/2013. As per the said order, all the Global Clinical Trials (GCTs)/New Clinical Trials (NCEs) should be evaluated having regard to three parameters, namely assessment of risk versus benefit to the patients; innovation vis-à-vis existing therapeutic option; and unmet medical need in the country.

“In view of the above, it has been decided with the approval of the ministry of health and family welfare, all the applications for the conduct of clinical trials of new drugs in India should invariably provide the information on (i) assessment of risk versus benefit to the patients, innovation vis-à-vis existing therapeutic option and unmet medical need in the country” the DCGI in his directive said.

All the sponsors/CROs/medical institutions and other stakeholders involved in the conduct of clinical trials in the country are hereby directed to adhere to the above requirement of inclusion of the three parameters in their clinical trial applications with immediate effect, the DCGI directive further said.