In the past decade India had emerged as a preferred site for drug trials by multinational pharmaceutical companies. India is said to have the largest pool of "naive" patients–i.e., untreated–in many disease areas, including caner and diabetes.
A non-governmental organization filed a public interest lawsuit in February 2012 complaining about unregulated clinical trials of new drugs conducted in India by multinational pharmaceutical companies.
On Thursday, January 3, the Supreme Court heard the complaint and castigated the Union government "for being negligent in curbing illegal clinical trials despite the deaths of at least 2,374 persons who had undergone the dubious testing for unregistered drugs between 2007 and 2012."
A parliamentary report estimated that currently 150,000 people are enrolled in clinical trials in India. It estimates that between 2009 and 2012, there were 352,475 people in India enrolled in pharmaceutical tests. That may change.
The Court stated: "The drug trials are creating havoc to the country."
The Court admonished the government for negligence:
“You have to protect the health of the citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stopped.”
The Court excoriated the government for foot dragging, stating: “You can get back to the court but what about those people who are losing their lives in such clinical trials. People who lost their lives can’t get their lives back. It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues.”
The BMJ reports that in April 2010, the Indian Council of Medical Research suspended a phase V post-licence clinical trial of vaccines against the human papilloma virus (HPV) amid allegations that the trial had violated rules on informed consent. As many as 25 000 girls in Andhra Pradesh and Gujarat received the vaccine.
The violation came to light when seven girls who received the vaccine died.
For in depth investigative reports, see Have India’s Poor Become Human Guinea Pigs? BBCNews, October 31, 2012
"Mrs Bai suffered heart abnormalities after being given the trial drug. She was taken off it and discharged after a few days. Less than a month later, she suffered a cardiac arrest and died at the age of 45.
Drug trials in India Almost 2,000 trials in past seven years
- Tests include drugs made by well-known companies such as Biogen Idec, Astra Zeneca and Glaxo Smith Kline
- 288 deaths in 2008
- 637 deaths in 2009
- 668 deaths in 2010
- 438 deaths in 2011
"The trial, which was registered in the UK by Biogen Idec, was later halted due, say the company, to the number of seizures recorded. The company also says Mrs Bai’s death was not reported to them. Her case is not an isolated incident.
In a different trial with a different company, Narayan Survaiya says neither he nor his late mother Tizuja Bai were asked if she wanted to participate, or even told that she was taking part in one, when she sought treatment for problems with her legs. And, like Mrs Sodey, he claims the family were told that a charity was footing the bill for the care.
A few weeks after taking the drug, Mr Survaiya says his mother’s health deteriorated and she was left unable to walk. His mother died a few weeks later."
See also, Two-part seeries:-The Dark Underbelly of India’s Clinical Trial Business–in LiveMint & The Wall Street Journal , October 10-11, 2012
Between 1990 and 2008, the number of clinical trials conducted largely by US companies shot up about 24 times to 6,465 from 271, according to a 2011 article in Vanity Fair. The 20 largest US-based drug makers conduct about one-third of their phase III clinical trials outside the country, and a majority of their study sites also are elsewhere, according to American Medical News.
“Ethics committees are the front line regulators for clinical trials. If they were functional, they would be a major factor in preventing unethical trials,” said Amar Jasani, a researcher and trainer in the field of bioethics and public health. “The problem is the ethics committees are completely controlled by the institutions—they are not at all independent, the people on the committees are not trained, nor do they have the resources or independence to do their job.”
According to Jasani, Indian law allows for commercial ethics committees to be hired by the very CROs they are meant to monitor. “There’s a double conflict-of-interest,” he said. “They are governed by the CROs or the pharma companies. At the same time they are profit making—so they are more motivated by financial interest than (the safety of participants).”
It would appear that the judiciary is the only institution in India that cares about human rights and inhumane exploitation.
Supreme Court Flays Center for not Stopping Illegal Clinical Trials
Jan 03, 2013
NEW DELHI, India
The Supreme Court on Thursday slammed the Center for its failure to stop illegal clinical trials of untested drugs by multinational companies, saying the drug trials are creating “havoc” in the country and causing death of many citizens.
The apex court said that the government has gone into “deep slumber” on the issue and has failed to put in place proper mechanisms to stop “rackets” of multinational companies, which are conducting illegal clinical trials. A bench of justices R.M. Lodha and A.R. Dave said in its interim order that all clinical trials will be done under the supervision of the Health Secretary at the Center.
“You have to protect health of citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stayed,” the bench said, asking the government to handle the “menace” on an urgent basis. It pulled up the government after it was contended that various committees have been set up to look into the issue and that it will come back to the court after getting suggestions from them.
“You can get back to the court but what about those people who are losing their lives in such clinical trials. People who lost their lives can’t get their lives back,” the bench observed. “It is very easy to form a committee or a commission. It is done just to divert people’s attention on the issue. It is the best way to divert attention on important issues,” the bench said
The court said that the government is “shying away” from responding to its queries while noting that the affidavit filed by the Center was not in consonance with its earlier order. On October 8, last year, the apex court had sought the reply of the Centre and various state governments on the allegation that human beings were being used as guinea pigs for clinical trials by drug companies.
It had directed the Union government to come out with details of the deaths, if any, and the side effects and compensation, if any, paid to the victims or their family members. The court’s direction came during the hearing of a public interest litigation (PIL), filed by NGO Swasthya Adhikar Manch, alleging large-scale clinical drug trials across the country by various pharmaceutical firms using Indian citizens as guinea pigs in those tests
The bench had, however, refrained from passing any blanket ban on the trials and, instead, sought a comprehensive reply from the Center on various issues. The NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states. However, the Madhya Pradesh government had contended that the states cannot be faulted for the tests as the permissions for trials were granted by the Central government without consulting them.
The argument, however, did not impress the bench which had pointed out that the said clinical trials were conducted in state governments’ hospitals whose employees and doctors were under the control of the respective state governments. It had then proceeded to issue notices to all the states, through their chief secretaries, for their responses and posted the matter for further hearing after eight weeks.~~~~~~~~~~~~~~~~~~
DNA (Daily News & Analysis, India)
End illegal drug trials: Supreme courtPublished: Friday, Jan 4, 2013
By Rakesh Bhatnagar | Place: New Delhi | Agency: DNA
The Supreme Court on Thursday castigated the Union government for being negligent in curbing illegal clinical trials despite the deaths of at least 2,374 persons who had undergone the dubious testing for unregistered drugs between 2007 and 2012.
During the resumed hearing of a PIL filed by an NGO Swasthya Adhikar Manch, the court sought an end to illegal clinical trials of untested drugs by multinational companies. The NGO has alleged that massive clinical drug trials, estimated at Rs8,000 crore annually by various pharmaceutical firms, use Indian citizens as guinea pigs.
“The drug trials are creating havoc in the country,” the court said, adding that all clinical trials will be done under the supervision of the Union health secretary. “You have to protect the health of the citizens of the country. It is your obligation. Deaths must be arrested and illegal trials must be stopped,” the bench said and directed the Centre to “handle the menace” in an effective manner.
The judges slammed the government for slipping into “deep slumber” on the issue and for being indifferent in evolving an effective mechanism to stop ‘rackets’ of some multinational drug companies which conduct illegal clinical trials.
In 2004, doctors at the Bhopal Memorial Hospital and Research Centre, an exclusive institute for the victims of the 1984 gas leak disaster, recruited unsuspecting survivors for clinical trials, without their knowledge or consent.
It is said that 14 participants died during the course of the trials. In an Indore-based hospital, 32 people died in clinical trials between 2005 and 2010.
A parliamentary panel says that the Central Drug Standard Control Organisation (CDSCO) is in collusion with drug companies and doctors, and approving at least one drug every month, without conducting clinical trials or seeking expert medical opinion.
A report quoting CDSCO says an estimated 150,000 people are enrolled for clinical trials in India.It has been reported that the number of ‘subjects’ in clinical trials between 2009 and 2012 were 352,475. The government says serious adverse events resulting in deaths “may occur during clinical trials due to various reasons. These deaths could be due to life-threatening diseases like cancer, cardio-vascular conditions like congestive heart failure/stroke and other serious diseases”.
Indian Supreme Court tells government to act on illegal clinical trials
Meera KayCite this as: BMJ 2013; 346:f51 BMJ, 4 January 2013
The Supreme Court of India has said that the government failed to put in place proper mechanisms to stop “rackets” being committed by multinational companies that conduct illegal clinical trials and has asked it to deal with the problem urgently.The court told the health secretary in the Health and Family Welfare Ministry to directly monitor clinical trials of drugs on humans to ensure that statutory procedures were followed. The court order stated that “until further order by this Court, clinical trials of new chemical entity shall be conducted strictly in accord with the procedure prescribed in Schedule ‘Y’ of Drugs & Cosmetics Act, 1940 under the direct supervision of the Secretary, Ministry of Health & Family Welfare, Government of India.”While hearing a petition from the non-governmental organisation Swasthya Adhikar Manch (the Women’s Health Rights Forum), the justices R M Lodha and A R Dave said that unregulated clinical trials of new drugs were causing havoc in the country.Swasthya Adhikar Manch filed a public interest litigation in February 2012 about illegal clinical trials across the country after news surfaced about alleged illegal and unethical drug trials involving mentally challenged patients at the M G M Medical College in Madhya Pradesh.Since June 2009 it has been mandatory to register all clinical trials with the Indian Council of Medical Research. A bill to protect human volunteers in drug trials, the Biomedical Research on Human Participants (Promotion and Regulation) Bill, has been pending for close to eight years.In the past decade India has emerged as a preferred hub for clinical trials. A study by Rabo India Finance, a subsidiary of the Netherlands based Rabo Bank, said that India had the largest pool of naive patients in many disease areas, including cancer and diabetes.1 The report also highlighted the low cost of trials as India’s biggest advantage. Furthermore, the availability of specialist hospitals with state of the art facilities staffed by a high number of clinicians trained in good clinical practice and a large workforce proficient in English all made India suitable for clinical trials.In April 2010 the Indian Council of Medical Research suspended a phase V post-licence clinical trial of vaccines against the human papillomavirus amid allegations that the trial had violated rules on informed consent.2 As many as 25 000 girls in Andhra Pradesh and Gujarat received the vaccine. The violation came to light when seven girls who received the vaccine died.
Cite this as: BMJ 2013;346:f51