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
"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
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
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
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