THE MINISTER OF HEALTH AND FAMILY WELFARE (SHRI GHULAM NABI AZAD)
(a)to(e): A statement is laid on the Table of the House.
STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 502 FOR 11th MAY, 2012
(a)to(c): There have been media reports about irregularities in the conduct of
clinical trials. A detail of such cases and action taken thereon during 2010,
2011 and 2012 (till date) is enclosed at Annexure-1.
(d)&(e): Yes, Madam. In order to strengthen the regulation and monitoring of
clinical trials in the country, the following measures have been taken by the
Government:
(i) All clinical trials, the permissions for which have been granted by the
office of DCG(I) on or after 15th June 2009, have to be mandatorily registered
on the clinical trial registry at www.ctri.in of Indian Council of Medical
Research (ICMR).
(ii) CDSCO has issued guidelines for conducting inspection of clinical trial
sites and Sponsor / Clinical Research Organisations (CROs).
(iii) Twelve New Drug Advisory Committees (NDACs) and Six Medica] Device
Advisory Committees (MDACs) have been constituted to evaluate clinical trials
proposals. These committees consist of leading experts from Central and State
Government medical institutions.
(iv) A draft notification has been issued for incorporation of a new rule in
the Drugs & Cosmetics Rules, 1945, which provides the following:
(a) medical treatment and financial compensation to the trial subjects in case
of trial related injury or death;
(b) Procedure for payment of financial compensation;
(c) Enhancement of responsibilities of Ethics Committee (EC), Sponsor & Investigator
to ensure that financial compensation as well as medical care is provided
to the trial subjects who suffer trial related injury or deaths and such information
is provided to DCG(I).
(d) Amendment of the format for obtaining informed consent of trial subjects to
include the details of address, occupation, annual income of the subject so as to
have information regarding socio-economic status of the trial subjects.
