5 NUJS L. Rev. 379 (2012)
Inadequacies of Clinical Trial Regulations in India

handle is hein.journals/nujslr5 and id is 387 raw text is: INADEQUACIES OF CLINICAL TRIAL
REGULATIONS IN INDIA
Ashna Ashesh & Zubin Dash*
Aadhya Pradesh has gained its fair share of media attention of late ow-
ing to the unethical drug trials being conducted on mentally challenged
patients and children in the 'heart ofIncredible India'. In the wake of these
trials, the Swasthva Adhikar Adanch, an Indore based NGO, has filed a
public interest petition in the Supreme Court. The Court has issued notice
to the Central Government and the Government of Madhya Pradesh and
though the matter has been listed for hearing on a ftture date, the legal
limbo surrounding clinical trials needs immediate and serious considera-
tion. According to the public interest petitions, 17?7 people have died dur-
ing drug trials between 2007 and 2010. Art. 21 of the Constitution does not
allow fbr the deprivation of life and personal liberty, except according to
the procedure established by law. In the absence ofany binding law to regu-
late clinical trials, one would question the safeguards conferred to protect
the rights of the subjects of these clinical trials, who are more often than
not, the impoverished strata of the Indian society.
I. BACKGROUND OF CLINICAL TRIALS IN
INDIA
The process of clinical trials is charted out in four phases,' the
most expensive among these being the third phase., which involves testing the
drug in different stages and in combination with different medicines to ascer-
tain the therapeutic benefits on the patient who is being tested.2 It only stands
to reason that profit-oriented pharmaceutical corporations would want to re-
duce this financial burden by outsourcing the third phase of trials to countries
3r and 2year students respectively, the W.B. National University of Juridical Sciences,
Kolkata. We thank Mr. Saurabh Bhattacharjee, Assistant Professor, NUJS, for his guidance
and inputs in writing this paper. We thank Ms. Nikita Kapoor for her research assistance for
this paper.
See generallv Ankur Paliwal, Ethics on Trial, DowN To EARTH (New Delhi) June 30, 2011,
available at http:/www.downtoearth.org.in/content/ethics-trial (Last visited on September 8,
2012). Phases of clinical trials- phase I: conducted on 8-10 healthy volunteers to estimate the
safety and tolerability of the new drug, phase II: conducted on 100-200 patients to determine
the efficacy and side effects of a new drug. It determines dose and regime for phase III trial;
phase III: conducted on 1,000-3,000 patients to confirm the therapeutic benefits of a new
drug. The drug is tested in different stages of diseases in combination with other medicines:
phase IV: conducted for at least three years after the drug is approved by the Drug Controller
General of India, and launched in the market. Feedback is taken from users to assess its
efficacy.
Id.

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