(a) Whether the Government has received any complaints regarding clinical trials on patients without their consent;
(b) If so, the details thereof ;
(c) The action taken by the Government in this regard and the outcome thereof ;
(d) Whether the Government is contemplating to enact a law in regard to the trial of
medicines and compensation to be given due to the harm caused as a result thereof; and
(e) If so, the details thereof ?
THE MINISTER OF STATE IN THE MINISTRY OF HEALTH AND FAMILY WELFARE (SMT. PANABAKA LAKSHMI)
(a)to(e) : A statement is laid on the Table of the House.
STATEMENT REFERRED TO IN REPLY TO LOK SABHA STARRED QUESTION NO. 211
FOR 6TH DECEMBER, 2006
An Anonymous complaint was received in the Central Drugs Standard Control Organisation
on 22.11.2006 wherein it was alleged that two Medical institutions at Salem, namely Sheron
Cancer Research Institution, Yercaud Adivaram and S.K.S. Hospital, Brindavan Road, Salem,
have conducted clinical trials on more than 400 healthy individuals and they were misled as if
the exercise is a medical check up. These clinical trials are stated to have been done under the
banner of Lotus Laboratory, a branch of Sheron Cancer Centre. It also alleged that some of the
subjects for this clinical trial are suffering with problem of pain in the legs of recurrent nature
and loss of sexual desire. They Deputy Drugs Controller (I), South Zone, CDSCO, Chennai, has
been directed to conduct an investigation into the complaint in association with Drug Controller
of Tamil Nadu and Subject Experts and submit a report to this Ministry.
The Drugs and Cosmetics Rules have a provision for monitoring the clinical trials for new
drugs as defined under Rule 122 A to 122 E. Also in Schedule-Y of the Drugs and Cosmetic
Act specifies the requirements and guidelines for clinical trials. One of the requirements of
Schedule-Y is compliance with Good Clinical Practices (GCP). The point 2.4.7 of GCP guidelines
recommends compensation for accidental injuries and makes it obligatory for the sponsors to
pay compensation to the victims.
A proposal to amend the Drug and Cosmetic Act to provide that no person shall conduct
clinical trials in respect of any drug or cosmetic except under, and in accordance with, the
permission granted by the Central Drugs Authority and also to specify the penal action in
term of imprisonment and or fine, which may extend to Twenty Lakh rupees in case of
contravention by any person, is under consideration.