The shocking details of 1,600 casualties in our country during clinical trials of drugs in just last three years reflect the casual approach of multinational companies as well as the DGHS. Even the mandatory norms for providing information on the website of Clinical Trials Registry are not being followed

If the increase in numbers of volunteers for clinical trials of drugs is anything to go by, then India seems to be the hot bed for such trials. What's worse is the high number of deaths during such trials which were kept secret by the Director General of Health Services (DGHS) until Hisar-based activist Ramesh Kumar tenaciously procured the information through an Right to Information (RTI) application. Over the past three years, 1,600 volunteers used as `guinea pigs' by multinational companies (MNCs) for clinical trials have died and so far families of just 22 deceased have been compensated.

(Read:Indians as guinea pigs: Clinical trials killed 1,600 people in the past two years; only 22 compensated for fatalities). This highlights the casual approach of the pharma companies especially the MNCs, towards the life and health of such volunteers as well as the utter negligence by the DGHS in enforcing stringent norms, procedures set by the World Health Organisation (WHO) for such trials.

What is a Clinical Trials Registry (CTR)? As per the WHO guidelines, the CTR means any research or study that assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects of health outcomes and details of such a study should be publicly accessible, online. In our country, the CTR records are maintained by the Clinical Trials Registry India (CTRI) on its site www.ctri.in. It is a free and online system for registration of all clinical trials being conducted in India. As per a notification of the Drugs Controller General (India), registration of clinical trials with the CTRI is also now mandatory.

The Clinical Trials Registry- India (CTRI) has been set up by the ICMR's National Institute of Medical Statistics (NIMS) and is funded by the Department of Science and Technology (DST) through the Indian Council of Medical Research (ICMR). It also receives financial and technical support through the WHO, WHO-SEARO, and the WHO India Country office. However, a search through a series of registrations of clinical trials does not throw up much information in terms of regular progress of the clinical trials. The information available appears to be more like 'selective uploading' than providing complete details in transparent manner.

According to an editorial in a noted medical journal, (http://www.mrcindia.org/journal/issues/452081.pdf) the registration of clinical trials which is meant to improve reliability of data generated, help clinicians interpret research, minimize duplication of trials, and prevent exposure of volunteers to potential risks, has faltered in several ways.

The editorial states: "While participants of clinical trials volunteer with an altruistic motive, it is too well known that still all is not well in experiments involving human subjects. Clearly, there have been reports that trials have failed in their objective to carry out experiments fairly, report honestly and follow the ethical principles in India and abroad.

``There have been several instances of selective reporting or not reporting at all depending upon the outcome of the trial and when financial interests are at stake. Despite best efforts to ensure transparency and honesty, most initiatives to discourage the conduct of unethical trials have largely been unsuccessful.'' (source: K. Satyanarayana, Anju Sharma, Indian Journal of Medical Research and others)
 
Such clinical trials of drugs directly involves health and well being of the public. Therefore it is mandatory for the DGHS to put up every details of clinical trials - both successful and unsuccessful - on the website www.ctri.in under Section 4 of the RTI Act. This makes sure that besides the medical and research fraternity, people too can get an insight into the latest research of drugs.

RTI activist Ramesh Verma, however raises questions about the authenticity of such trials and its outcome. He says, ``There have been several instances wherein pharmaceutical companies have launched their drugs and after ten years or more, the same medicine is declared harmful for people. So, what is the authenticity of such clinical trials?''
 
 Human guinea pigs go cheap in India!

The following information came through Verma's RTI application. It shows the compensation amount paid to 22 volunteers (out of a total 1,600)  who died during clinical research of drugs. Will the DGHS put up details of every case of how each one died, what was the name of the drug on which each one of them was being experimented on? We have the right to know this vital information, which affects the health and life of people.



Statistics of clinical trials procured from  http://www.ijme.in/182ctw127.html
(Note the increase in number of volunteers)
 

Compiled by Deapica Ravindran [email protected] and Sachin Nikarge [email protected] with assistance from Maulik Mavani, Centre for Studies in Ethics and Rights, Mumbai.