India Seeks New Regulations Amid Rising Clinical Trial Deaths
The Supreme Court of India is attempting to enact new clinical trial regulations following rising deaths and continued reports of unethical practices and corruption.
Corruption and Deaths in Indian Clinical Trials
With loose regulations and a lack of enforcement, India has become a haven for pharmaceutical companies looking to conduct clinical trials quickly, cheaply and with as little regulatory interference as possible.
However, such practices do carry a human cost. According to Inter Press Service News, it is now estimated by India’s health ministry that 2,644 people have died in 475 clinical trials for new drugs between 2005 and 2012. These trials were testing “new chemical entities” not used as drugs anywhere else in the world.
In addition to the 2,644 deaths, the ministry recorded another 11,972 “serious adverse events” in connection to the drug trials.
The human rights group Swasthya Adhikar Manch (SAM) claims that it is essentially impossible to tell how many of the deaths and which adverse events are actually linked to the experimental drugs as no standard procedure was followed during the trials and there were no post-mortem reports, effectively nullifying the primary reason for conducting the trials in the first place.
The group also claims that the pharmaceutical companies are taking advantage of poverty, illiteracy and lack of awareness in order to recruit trial participants, and then connive along with doctors in order to deny the participants compensation when the trials are completed.
India Supreme Court Tightens Regulations
In response to the claims made by SAM and other activist organizations, the India’s Supreme Court and ministry of health have begun to take steps towards addressing unethical clinical trial practices.
The ministry of health set up a six-member expert panel under the Central Drug Standard Control Organization (CIDSCO) in February. In efforts to ensure proper procedure is followed, the panel is currently recommending clinical trials should only be carried out at accredited sites by accredited investigators and institutes.
The panel has ordered that informed consent must be obtained by each participant before they can be permitted to the clinical trial. They also plan to better address concerns of companies taking advantage of illiterate participants.
In regards to the patient compensation issues, the directive clarifies compensation practices stating that compensation must be paid unless an injury or death is proven to not be connected to the clinical trial being conducted.
Unfortunately, with vast sums of money being exchanged and India’s reliance on the pharmaceutical industry as a source of financial stability, some groups have little faith that these new policies will be properly enforced.
Contact an Experienced Clinical Trial Attorney
Thomas J. Henry are leaders in the area clinical trial litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. Our Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects while participating in a clinical trial, contact Thomas J. Henry immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.
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