Clinical trials of untested drugs is creating "havoc": SC
New Delhi, Jan 3: The Supreme Court today slammed the Centre for its failure to stop illegal clinical trials of untested drugs by multinational companies, saying the drug trials are creating “havoc” in the country
New Delhi, Jan 3: The Supreme Court today slammed the Centre 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 Centre. “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 Centre 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 Centre 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.
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.
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 Centre. “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 Centre 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 Centre 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.
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.