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India becomes global drug trial ground for pharmaceuticals

Published: 19 August, 2010, 08:58
Edited: 23 October, 2010, 14:50

In August 2008, the All India Institute of Medical Sciences revealed that 49 children died during 42 trials involving 4,142 patients from the pediatric unit. The hospital blamed the deaths on the children's' underlying illnesses, but the news triggered unease about the largely unregulated drug-testing industry. (Photos by Kathleen Flynn / kflynn.com / St. Petersburg Times / Rapport Syndication)

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TAGS: Health, Scandal, Human rights, India


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.

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ashish (unregistered) January 10, 2012, 20:14
0

 It is not a matter of lower cost of conducting a clinicaltrial in India.It rather represent concern of central government to safeguard Indianpopulation from side effect of drugs discovered outside India by making itmandatory to conduct clinical trial in India before giving a marketing approvalas given on page 503 of Drugs and Cosmetics Rules, 1945 and given below.

"(b) for new drug substances discovered in countries other than India,Phase I data as required under items 1, 2, 3, 4, 5 (data from other countries)and 9 of Appendix I should be submitted along with the application. Aftersubmission of Phase I data generated outside Indiato the Licensing Authority, permission may be granted to repeat Phase I trialsand/or to conduct Phase II trials and subsequently Phase III trialsconcurrently with other global trials for that drug. Phase III trials arerequired to be conducted in Indiabefore permission to market the drug in Indiais granted;"

This is analogous to taking a pilot project in various social schemes, to seethe results and if successful, implementing the scheme nationwide, if notsuccessful, terminating the project.

Just think of the situation, if a drug is allowed to be marketed without doinga clinical trial, and if some serious side effect occurs, that would put wholepopulation at risk. We should not forget story of thalidomide which resulted inbirth of childs with shortened limbs

Dilawar November 07, 2011, 15:07
0

luca Valenzin is absolutely correct.Not just drugs but even organs donation is done by the poor for the sake of  very little money for their livelihood.People from all over the world flock to the hospitals who do transplantation because here is where you get organs replaced cheaply.Unfortunate and shocking but it is there including drug trials on poor. 

abhishek March 20, 2011, 19:18
0

This public health activist "Anand Rai" has this history:
1. Expelled from medical school for criminal charges(a unique distinction for MGM medical college indore)
2. Dean medical school advised psychiatric evaluation
3. Criminal charges still pending in courts of indore.
4. Gained admission in medical school using reservation (belongs to other backward cast)
Characterizes the muck in Indian politics. Corrupt, and criminals only enter politics. Epitomizes "Politics is the last refuge of scoundrels".