Human rights groups are raising concern over India turning into a hot spot for drug trials, where hospital patients are being used as guinea pigs for the world's pharmaceutical companies, sometimes without consent.
The groups also say that many of those who sign up do not understand the risks.
NGOs have cited gloomy statistics showing deaths resulting from drug trials in the country have been increasing over the last few years.
For the first six months of this year, nearly 500 deaths have been attributed to trials, which is more than the combined total for 2007 and 2008.
The cost of testing drugs is significantly lower in India, but many say the system needs an overhaul as the human cost is far too high.
India’s government-run hospitals provide low-cost treatment to the poor, but there are increasing claims that patients are being used as guinea pigs in drug trials for western pharmaceuticals without their knowledge.
At the Maharaja Yeshwantrao Hospital in Indore, one of the patients named Vinod has been taking pills for the last six months on the advice of his doctor. He suspects he is being experimented upon.
“I had a pain in my abdomen. They did all sorts of tests, and gave me all sorts of pills to have in the morning, afternoon and at night, but I haven't got any better. Am I a toad or a rat or a cat that they can test any medication on me?” Vinod questioned.
Allegations have surfaced in the media that the Indore hospital is conducting illegal drug trials on patients. Police are investigating the complaint, though hospital officials say any trials are being conducted in accordance with government guidelines. In India, two million people are estimated to be taking part in clinical trials, with or without their consent.
“Drug trials are increasing here because they cost just one-sixth of what they do in the West. The regulatory system here is comparatively corrupt, and pharma companies can easily register patients and begin trials,” explained Dr. Anand Rai, President of Resident Doctors Association of Madhya Pradesh. “In developed countries, it would take six months to register five patients, whereas in India in the same time they can conduct trials on 2,000 people.”
Giving informed consent to be part of an experiment is the golden rule of all clinical trials, yet many patients sign on the dotted line without understanding the nature and the consequences of what is being administered to them.
“Americans are treating Indians as guinea pigs. The patients being used for trials are illiterate and poor. They don't even know details of the drug or that it is a drug trial,” Dr. Anand Rai noted, adding, “To rope patients in without proper consent, without informing them that they are taking part in a drug trial – it is both unethical and illegal.”
Patients sometimes sign up out of desperation. To them, experimental healthcare is better than none at all.
Babita has agreed to let her child be treated with a new drug which she has been told will bring his fever down.
Babita’s reasoning is simple: “The treatment is free, so I'm happy with it.”
There are regulations in place to monitor drug trials, including setting up ethics committees in hospitals to ensure patient safety. However, they are often used by doctors to simply rubberstamp trials.
“The ethics committee has the important responsibility of monitoring drug trials. But it's a very ad hoc system that is misused. For instance, a medical institute in far-away Mumbai gives permission for a drug trial in cities like Indore, Bhopal and Jabalpur,” said Dr. Sumit Shukla, Member of Indore Medical Teachers Association. “How can you use permission from an ethical committee of another institute in another city to justify drug trials in an institute here?”
With over 1,300 drug trials currently being conducted in India, this industry is already said to be worth $1 billion. It is clear that laws against unethical trials are not working, and the government will have come up with other ways to stop the country's poor from being enticed into medical experiments that could potentially have serious side-effects.