India: SC blasts Govt over MN Drug trials' serious side-effects in the poor & illiterate Print E-mail

 Thursday January 03, 2013

Illegal Clinical Trial of Drugs by MNCs Creating 'Havoc': SC

Scroll down to final item to also read  "211 people died in six months during clinical trials in India"

(File photo: Jitender Gupta)

New Delhi: The Supreme Court today said uncontrolled clinical trial of drugs on humans by multinational companies was creating "havoc" in the country and slammed the Centre for failing to stop the "rackets" which has caused deaths.

Observing that the Government has slipped into "deep slumber" in addressing this "menace", the court ordered that all drug trials will be done under the supervision of the Union Health Secretary.

The apex court said the government has failed to put in place proper mechanisms to stop "rackets" of multinational companies, which are conducting illegal clinical trials, and asked it handle the problem on an urgent basis.

"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 comprising R M Lodha and A R Dave said.

"You have slipped into deep slumber. It pains us that children of the country are being uses as guinea pigs by the companies. You do not have even respect of the Parliamentary Committee which has said that the companies are running racket and you are showing just draft rules," the bench said when the Additional Solicitor General Siddhath Luthra contended that Centre is considering to frame rules.

"Uncontrolled clinical trial is creating havoc in country. There has to be some some semblance of responsibility on your part," the bench said.

It pilloried 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.

"Give us performance of even one committee during the last 21 months. We gave you many opportunities," it said adding, "Your officials are not working in a manner they should work. If there is foolproof mechanism then we would not have interfered in the matter".

The apex court said the government is "shying away" from responding to its queries, noting that the affidavit filed by the Centre was not in consonance with its earlier order.

It rejected the affidavit filed on behalf of the Centre by deputy director of Central Drugs Standard Control Organisation (CDSCO) saying that it had asked the Health Secretary or the director general of CDSCO to file the response.

The ASG submitted that there was communication gap among officers and fresh affidavit would be filed.

"You are not taking our orders seriously. No senior officer wants to take responsibility and they pass the buck on junior officers," the bench said asking the Centre to "put your house in order."

It directed the Centre and all the state governments to file their responses within four weeks.

On October 8 last year, the apex court had sought the replies of the Centre and various state governments to 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 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 NGO had alleged that the clinical trials by several pharmaceutical companies were going on indiscriminately in various states.

On allegation that the clinical trials by pharmaceutical firms were going on in various states, the Madhya Pradesh government had earlier contended that the states cannot be faulted for the tests as the permissions for trials were given 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 government 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.

Prior to introduction of a new drug for use by humans, a company is required to conduct clinical trials to study its effects on people.

Detailing several cases of alleged illegal drug trials in Indore, the NGO has said in its petition, "Over 3,300 patients were used for the tests. Approximately 15 government doctors were involved. About 40 private doctors in 10 private hospitals were involved.

"Clinical trials were conducted on 233 mentally-ill patients, 1,833 children in the age group of one day to 15 years.. Approximately Rs 5.5 crore were paid to the government doctors alone. In 2008, there were 288 deaths, in 2009, there were 637 deaths, and in 2010, there were 597 deaths," it has alleged.

It has claimed there was lack of transparency in clinical trials as the subjects were not aware of their rights.

According to it, majority of people on whom the tests were performed were poor and illiterate, came from marginalised communities and suffered serious adverse effects.

Friday January 4, 2013

Supreme Court pans government for denying data on clinical trials

By ET Bureau

NEW DELHI: The Supreme Court on Tuesday severely criticised the Union government for failing to submit a proper status report on clinical trials of new chemical entities in the country and directed that these henceforth be held under the direct supervision of health secretary.

A two-judge bench, led by Justice R M Lodha, directed that such trials be conducted as per Schedule Y of the Drugs and Cosmetics Rules, which make it mandatory for those seeking to conduct trials to seek approval of the licensing authority and maintain data on the trials.

"He can then be held responsible," Justice Lodha said justifying his order. Hitherto, clinical trials were conducted under a senior official of the Drugs Controller General (India).

The DGCI has a host of committees to deal with clinical trials. But acting on a PIL by Swasthya Adhikar Manch, which has alleged several deaths due to such clinical trials, the top court had asked the health ministry to submit a status report on them.
 October 27, 2012

NHRC to intervene in drug trial case pending before Supreme Court


INDORE: National Human Rights Commission (NHRC) on Friday decided to intervene in the case related to the clinical trials of drugs pending before the Supreme Court. The case has been filed as public interest litigation by two Indore-based NGOs.

In addition to this, the Clinical Trial Welfare Society has also decided to intervene in the case on the grounds that people who had been affected by the clinical trials should be given a chance to express their views before the court. "Most of the people of our organization are those whose names have figured in the list of 81 people, who were affected by clinical trials, submitted by EOW to the government. We are the victims and we should be given a chance to express our views before court," said vice-president of the Society, Ashish Jatav.

Dr Anand Rai, who has been raising the issues of clinical trials of drugs for years, said that a series of unethical and illegal clinical trials were conducted on psychiatric patients by several government and private doctors in Indore. Psychiatric patients have been made clinical guinea pigs for drug trials sponsored by multinational and Indian pharmaceutical companies. Now matter is pending before the Supreme Court and victims have decided to put forth their views before it.

In his complaints to NHRC, Rai had stressed that clinical trials had been conducted in flagrant violation of article 21 of the Constitution; whereby human rights of psychiatric patients have been overlooked. "Psychiatric patients are often not in a position to give their informed consent for participating in such clinical trials and the trials have also violated the Indian Council of Medical Research guidelines and provision of the Drug and Cosmetic Act 1940," he said.

Taking cognizance of the complaints over clinical drug trials NHRC on Friday has constituted an expert committee for framing guidelines of drug trials in the country; it was said in an official communique of NHRC.

The committee will comprise Dr D C Doval, director of research and director, medical oncology, Rajiv Gandhi Cancer Institute and Research Centre, New Delhi, Prof Vivekananda Jha from department of Nephrology, PGIMER, Chandigarh, Prof B N Dhawan, former director of Central Drug Research Institute, Lucknow, Dr Subhash Yadav, additional professor, department of Endocrinology and member secretary, IEC, SGPGI, Lucknow, Dr Nilima Kshirsagar from national chair in clinical pharmacology, Indian Council of Medical Research and dean ESI-PGIMER, MGM Hospital, Mumbai Law Division. The meetings of the committee will be coordinated by NHRC.
 August 18, 2012

211 people died in six months during clinical trials in India

By Kounteya Sinha, TNN
(As many as 211 people died)

NEW DELHI: As many as 211 people died between January and June 2012 due to serious adverse events (SAE) during clinical trials. Investigations are now on to ascertain how many of the deaths were caused by drugs administered to the trial subjects.

Union health minister Ghulam Nabi Azad said on Friday that the deaths could be related to diseases such as cancer or administration of drugs and their side-effects. In 2011, 438 cases of SAE were reported, of which 16 were found to be due to clinical trials. The previous year, 668 cases of SAE were reported, of which 22 were caused due to the trials.

The Union health ministry says approval for conducting clinical trials now includes a condition in the consent form that in case of a study-related injury or death, the applicant will provide medical care and pay compensation. All trials are now compulsorily registered with the Indian Council of Medical Research.

The compensation, however, is so far, "according to the will" of pharmaceutical companies. This could change as the Central Drugs Standard Control Organization has for the first time proposed a formula "on the basis of age of the deceased, income, seriousness and severity of the disease the subject was suffering at the time of his/her participation in the trial and percentage of permanent disability."

'Young patients must get higher compensation'
The Central Drugs Standard Control Organization has for the first time proposed a formula to curb serious adverse events (SAE) during clinical trials.

The CDSCO formula stipulates that the younger the patient, the higher will be the compensation.

Families of the 22 people who died during clinical trials in 2010 were paid around Rs 50 lakh in all by 10 pharmaceutical companies, including well-known names such as Wyeth, Quintiles, Lilly, Amgen, Bayer, Bristol Mayer, Sanofi, PPD and Pfizer. The individual compensation ranged from Rs 1.08 lakh to Rs 10 lakh. Most of the families received Rs 1.5 lakh and Rs 2.5 lakh as a one-time settlement. This, after companies initially refused to pay compensation for majority of the deaths.

"When a 70-year-old patient who is terminally ill dies during a clinical trial due to an adverse reaction of the drug, the compensation should be less than that given to a 22-year-old man in the first stage of the same disease who dies of the same drug," said a CDSCO official. "The youth could be the sole bread-winner of the family and would have lived longer but for the adverse drug reaction. So, the guidelines quantify accordingly who should get how much compensation. At present, both could get the same amount and it could be abysmally low if decided by the pharmaceutical company."

CDSCO says a research-related injury is that which occurs to a subject as a result of research participation. Injuries may be relatively minor (such as bruises or infected wounds), major (such as organ damage or temporary disability) or catastrophic (such as permanent disability). An injury may require only acute or emergency care, or it may require continuing care. Injuries can be physical or psychological/emotional. The Drug Technical Advisory Board on October 10, 2011 had given its nod to the CDSCO to put in place a "compensation chart" or extensive guidelines that will specify amount to be paid.