India, along with the African and some impoverished Latin American and Central American Countries leads the list of clinical deaths due to the drug trials.
These are the official figures.
I doubt whether this constitutes even 10 % of the actual deaths.
One has to take into account that many drug trials are conducted in India on the sly., with the active connivance of doctors and Pharmacists.
More than 2,500 Indians have died in the course of clinical trials in recent years, government figures reveal.
According to an affidavit filed by the health ministry in the Supreme Court in response to a petition by health NGOs, there were 80 deaths due to clinical trials between January 2005 and June 2012. Between July 2012-August 2013 nine more such reported deaths occurred, making this total 89, according to the petitioner Swasthya Adhikar Manch (SAM), a health rights forum. Compensation was paid in 82 cases.
The ministry also admitted that 2,644 people died during clinical trials of 475 new drugs from 2005 to 2012.
SAM challenges this number of 80 deaths said to have been caused by clinical trials – among the rest who are said only to have died during the course of the trials and not as a result of the trials.
“No standard protocol was followed, there were no post-mortems; so how can they arrive at this figure?” Amulya Nidhi of SAM told IPS. Compensation is paid only if a death was said to have been caused by the clinical trial.
Government documents also say that around 11,972 “serious adverse events” (excluding death) were reported from Jan. 1, 2005 to Jun. 30, 2012, of which 506 were said to have been caused by clinical trials.
These figures have raised new opposition to the prevailing practices for conducting clinical trials.
India has become a hub of clinical trials for drugs over the last few years, mostly by pharmaceutical companies from abroad. Allegations of short-changing participants and of unethical practices have been rampant.
Responding to growing concerns by health activists, the ministry of health and family welfare set up a six-member expert panel under the Central Drugs Standard Control Organisation (CIDSCO) in February this year. The panel has recommended that these trials should only be carried out in accredited centres.
“ Despite clinical trials coming under scrutiny in various courts, little has changed on the ground. At least 370 deaths have been reported during clinical trials in India since February 2013, but compensation has been paid in only 21 cases, according to government data. The amount ranged from Rs 4 lakh to Rs 40 lakh, a senior official told TOI. “