Inadequacies of Clinical Trial Regulations in India
Ashna Ashesh & Zubin Dash
Volume 5 Issue 3 (2012)
Madhya Pradesh has gained its fair share of media attention of late owing to the unethical drug trials being conducted on mentally challenged patients and children in the ‘heart of Incredible India’. In the wake of these trials, the Swasthya Adhikar Manch, 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 future date, the legal limbo surrounding clinical trials needs immediate and serious consideration. According to the public interest petitions, 1727 people have died during drug trials between 2007 and 2010. Art. 21 of the Constitution does not allow for the deprivation of life and personal liberty, except according to the procedure established by law. In the absence of any binding law to regulate 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.