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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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