Are multi-national pharmaceutical firms recruiting Indians unethically to conduct clinical trials?
Data from a report in Business Standard seems to suggest so. The report cited confidential government data and said 438 persons died in 2011 during clinical trials of various drugs in India.
According to the report, 57 people died in clinical trials conducted by Novartis, 32 in Quinitles Tech trials, 20 each in Bayer and Pfizer trials, and 19 in Bristol Maer Squibb India.
Contrast this with the death figures in Indian firms' trials: 9 in Sun Pharma trials, 3 in Jubilant Clynsis, and 1 in Dr Reddy's.
A clinical trial is conducted to gauge the effectiveness of a drug in humans before it is marketed.
There have been media reports of companies engaging in unethical methods to get subjects for their trials.
The BS report today quoted experts as saying that absence proper regulations is the key reason for the deaths.
However, companies argue that they conform to global standards while conducting trials.
According to Anoop Mishra, chairman, Fortis-C-DOC centre for diabetes and metabolic diseases, clinical trials can be conducted anywhere in India with a medical supervision.
"There are no minimum criteria for a trial site. Even a doctor in his private clinic is eligible to do a trial," he is quoted as saying in the report.
This is questionable. Consider the way clinical trials are conducted in the US. The US Food and Drugs Administration says on its website that it aims "to ensure that people have reliable information as they decide whether to join a clinical trial".
The government also has guidelines to protect participants from "unreasonable risks".
Though the Drugs Controller General India (DCGI) has made registering on the Clinical Trials Registry - India (CTRI) mandatory to start a clinical trial, a strong guideline is not in place yet.
In case of global trials, the companies have to declare the number of Indian patients involved in the trial.
"There is justifiable concern among Indian regulatory authorities that "global multicentre trials" are just a front and actually a majority of patients, are intended to be recruited from India, raising ethical concerns," a post on the CTRI website says.
It goes on to say that data from the trials by global majors registered on the website shows that there is a bias in recruitment of subjects for trials.
"In these instances it was observed that more than 80 percent of the recruitment took place from India as against the planned equal allocation (globally)," it said.
A report in The Times of India in 2010 said an NGO alleged Bhopal gas victims were duped into signing the consent papers for clinical trials, in which many may have even died. Many of the participants did not even know English, the report said.
It is high time the government puts in place a guideline for clinical trials to contain the influx of multinationals to conduct clinical trials.