Drugs & Cosmetics Act,
1940 contains enabling provisions for regulating and ensuring quality,
safety and efficacy of drugs. The Act, therefore, contains inherent
enabling powers for regulating the clinical trials. Accordingly, under
the inherent plenary powers vested in the Act, necessary rules,
procedures and guidelines have been framed under the Drugs and Cosmetics
Rules, 1945. Regulatory provisions for clinical trials in the country
are prescribed under Rule-122DA, 122DAA, 122E and Schedule-Y to the Drug
and Cosmetics Rules, 1945. The said Rules also provide specific
Application Form and relevant documents required for seeking permission
to conduct clinical trials in India. Schedule Y also mandates the
clinical trial to be conducted as per Good Clinical Practices (GCP)
Guidelines issued by Central Drugs Standard Control Organisation (CDSCO).
Clinical trials can be initiated only after the approval of CDSCO and
respective Ethics Committee. In all trials, a freely given informed
written consent is required to be obtained from the persons
participating in the study trial. The Serious Adverse Events (SAEs) of
deaths may occur during clinical trials due to various reasons. These
deaths could be due to life-threatening diseases like cancer,
cardio-vascular conditions like congestive heart failure / stroke and
other serious diseases. They could also be due to the side-effects of
the drugs or their administration to critically or terminally ill
patients. Such deaths are investigated to arrive at the causal
relationship, if any. As per available data, the number of Serious
Adverse Events of deaths in clinical trials reported during 2011 were
438. But SAEs of death due to clinical trials were 16.
Out of 438 deaths approximately 55% are in clinical trials conducted by
foreign Pharmaceutical companies and rest are in clinical trials
conducted by Clinical Research Organizations (CROs), domestic pharma
The following concrete steps have been taken to strengthen the approval
procedures, monitoring mechanism for clinical trials as well to ensure
that safety, rights and well-being of clinical trial subjects are
(1) 12 New Drug Advisory Committees (NDAC) consisting of leading experts
from the government medical colleges, institutes from all over the
country have been constituted to advise CDSCO in matters related to
approval of clinical trials and new drugs.
(2) Applications of Investigational New Drugs (IND) ; i.e, New Drug
Substances which have never earlier been used in human beings, are
evaluated by the IND committee, chaired by the Director General, Indian
Council of Medical Research.
(3) Registration of clinical trial in ICMR registry at www.ctri.in has
been made mandatory since 15.6.2009.
(4) Every approval / permission for conducting clinical trials now
includes a condition that in case of study related injury or death,
applicant will provide complete medical care as well as compensation for
the injury or death and statement to this effect would be incorporated
in the informed consent form.
(5) Guidelines for conducting inspection of Clinical Trial sites and
sponsor /Clinical Research Organizations (CROs) have been prepared and
posted on CDSCO website.
(6) Draft rules have been notified to provide for the following:
(i) Medical treatment and financial compensation to the trial subjects
in case of trial related injury or death;
(ii) Procedure for payment of financial compensation;
(iii) 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 the Drugs Controller
General (India) [DCG(I)].
(iv) 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.
(7) Draft rules have been notified to incorporate Rules to have
authority for clinical trials inspections by CDSCO and to take
administrative actions like restriction on investigators/ sponsors /
CROs from conducting future clinical trials in case of non-compliance.
(8) Draft rules have been notified to incorporate Rules and Schedule Y-1
specifying requirements and guidelines for registration of Ethics
This information was given by Minister for Health & Family Welfare Shri
Ghulam Nabi Azad in written reply to a question in the Rajya Sabha