Four-year-old Deepak Yadav, a mentally disabled boy from Indore city in the Indian state Madhya Pradesh, was being treated for stomach problems at Chacha Nehru Bal Chikitsalaya, a government hospital for children attached to the M. G. M. Medical College.<\/p>\n
But when repeated administration of the anti-ulcer drug Rabeprazole started to exacerbate his condition, his parents stopped treatment and sought help from the Clinical Trial Victims Association (CTVA), which discovered that the boy had been a lab rat for an untested drug.<\/p>\n
\u201cWe should have been told an unknown drug was being tested on our innocent child and given the choice to say no,\u201d Deepak\u2019s father Sooraj told IPS.<\/p>\n
Deepak is now almost entirely reliant on his mother for survival. The family is poor, yet \u201cdoctors did not take any steps to get us compensation,\u201d his father added.<\/p>\n
This family\u2019s tragic story is just one example of a sinister pattern unfolding across India.<\/p>\n
A spate of deaths over the last four years caused by illegal clinical trials of untested drugs has ignited the wrath of rights activists and prompted prominent legal institutions to consider tightening the country\u2019s drug regulation laws.<\/p>\n
In response to a Right to Information query filed by Indore-based medical rights activist Anand Rai, the Drug Controller General of India (DGCI) disclosed that 2,031 people have died as a result of serious adverse events (SAEs) during drug trials in the past four years.<\/p>\n
SAE-related deaths for 2008, 2009, 2010 and 2011 were 288, 637, 668 and 438 respectively.<\/p>\n
Rai, who is currently spearheading a campaign against unethical drug tests on human beings, has\u00a0urged legal authorities and activists to raise their voices against clinical trials in which desperate people become easy prey for multinational pharmaceutical companies.<\/p>\n
He told IPS that most of the victims were illiterate and poor people.<\/p>\n
\u201cClinical trials on citizens without their consent is considered a violation of basic human rights and often results in the death of innocent persons, who were not even aware of the kind of tests being (performed) on them, since clinical research organisations use roundabout ways of acquiring the consent of patients and their relatives,\u201d he said.<\/p>\n
Many of the institutions involved in the drug trials fail to \u201cprovide the patients with copies of the informed consent form, patient\u2019s information sheet or clinical trial liability insurance policy,\u201d according to the CTVA. As a result,\u00a0very few victims have access to compensation.<\/p>\n
An intervention by the Supreme Court of India last month further exposed the unethical practices of clinical researchers and pharmaceutical companies.<\/p>\n
A division bench headed by Supreme Court Justice R M Lodha stated in early July that it was \u201cunfortunate\u201d that humans are being treated as \u201cguinea pigs\u201d for testing of drugs and vaccines produced by multinational corporations.<\/p>\n
Lax regulations breed impunity<\/strong><\/p>\n Experts on medical law assert that tight regulations in Europe and the U.S. prompt many pharmaceutical companies and research organisations to look to India and other developing countries as cheaper and less restrictive sites for drug trials.<\/p>\n Dr. Mohan Rao, professor at the centre for social medicine and community health at Jawaharlal Nehru University in New Delhi,\u00a0told IPS that India did not have a proper regulatory authority to monitor the trials of\u00a0new drugs.<\/p>\n \u201cWe have unfortunately opened our health sector to global pharmaceutical companies for trials without the infrastructure to monitor and regulate them. It is cheaper for transnationals to locate trials in India, which has a large and captive (drug) market, in addition to doctors not constrained by ethics,\u201d he said.<\/p>\n \u201cThe growth of local clinical research organisations has also contributed to this. Above all, we have a large and unregulated private medical sector with a culture of impunity. For the general public, and the elites, the lives of the poor do not matter,\u201d Rao added.<\/p>\n The CTVA said that many doctors give more importance to their earnings than to the lives of their patients.<\/p>\n