The 10th hearing of the writ petition filed by Swasthya Adhikar Manch took place today before a bench of the Supreme Court consisting of Justice R.M Lodha and Justice Kurian Joseph. The case was filed in February, 2012 and the last hearing was held on 31st January , 2014.
Mr. Sanjay Parikh mentioned that in the affidavits filed in December 2012 and on 29th January 2014 along with information provided on 14th Febuary 2014, neither the Technical Committee nor the Apex Committee has given the details of their evaluation as per the three parameters given in the order dated 21-10-2013, instead they have merely rubber stamped their decisions.
Today the court has directed the Ministry of Health and Family Welfare (MoHFW) to provide details of deaths and SAE by the petitioners along with details of 506 cases of SAEs who have not been compensated.
The Respondent-Ministry has admitted that the information regarding deaths/SAEs caused by clinical trials has been provided by drug companies. It has not come on record whether the total number of deaths/ SAEs has been verified by the DCGI and MOHFW.
The Ministry has not been forthcoming about details regarding the approvals, specifically whether the approvals were granted by the Technical Committee and the Apex Committee only after considering the three parameters which were directed to be followed, i.e. (i) safety and efficacy, particularly in terms of risk and benefit to patient; (ii) innovation vis-à-vis existent therapeutic option; (iii) unmet need in the country. Further, the Ministry has not disclosed important details regarding new chemical entities such as for what health purpose were they required to be tested through clinical trials, whether these NCEs were subjected to clinical trials outside India, when did these companies apply for trial, when were they approved by the NDACs and when did the DCGI grant permission?
The Supreme Court directed the MoHFW to file a detailed response within 4 weeks.
The MoHFW had already confirmed that the 215 gas-victims who were subjects of clinical trials were not paid the requisite compensation and that the Serious Adverse Events (SAEs) including death cases were not reported in time.
The Petitioners also raised the point that the Technical Committee includes Dr. Ranjit Roy Choudhary who is the Chairman of Task Force for Research in Apollo Hospital which has conducted 300 clinical trials, including multicentre global trials, on behalf of multinational pharmaceutical companies. In spite of this being a clear case of conflict of interest, he was still selected to be a member of the Technical Committee.
The minutes prepared by the Technical Committee has been followed in toto by the Apex Committee without considering whether clinical trials for NCEs are required in public and national interest.
Neither our country nor citizens are deriving any benefit from clinical trials of new chemical entities; if these new chemical entities were actually efficacious and beneficial, they could easily be used in our country after following due procedure. The question to be asked is why Indian subjects are used for testing new chemical entities by multinational pharmaceutical companies. There is obviously no rational answer which could indicate the existence of any national or public interest.
Mr. Sanjay Parikh mentioned that in the affidavits filed in December 2012 and on 29th January 2014 along with information provided on 14th Febuary 2014, neither the Technical Committee nor the Apex Committee has given the details of their evaluation as per the three parameters given in the order dated 21-10-2013, instead they have merely rubber stamped their decisions.
Today the court has directed the Ministry of Health and Family Welfare (MoHFW) to provide details of deaths and SAE by the petitioners along with details of 506 cases of SAEs who have not been compensated.
The Respondent-Ministry has admitted that the information regarding deaths/SAEs caused by clinical trials has been provided by drug companies. It has not come on record whether the total number of deaths/ SAEs has been verified by the DCGI and MOHFW.
The Ministry has not been forthcoming about details regarding the approvals, specifically whether the approvals were granted by the Technical Committee and the Apex Committee only after considering the three parameters which were directed to be followed, i.e. (i) safety and efficacy, particularly in terms of risk and benefit to patient; (ii) innovation vis-à-vis existent therapeutic option; (iii) unmet need in the country. Further, the Ministry has not disclosed important details regarding new chemical entities such as for what health purpose were they required to be tested through clinical trials, whether these NCEs were subjected to clinical trials outside India, when did these companies apply for trial, when were they approved by the NDACs and when did the DCGI grant permission?
The Supreme Court directed the MoHFW to file a detailed response within 4 weeks.
The MoHFW had already confirmed that the 215 gas-victims who were subjects of clinical trials were not paid the requisite compensation and that the Serious Adverse Events (SAEs) including death cases were not reported in time.
The Petitioners also raised the point that the Technical Committee includes Dr. Ranjit Roy Choudhary who is the Chairman of Task Force for Research in Apollo Hospital which has conducted 300 clinical trials, including multicentre global trials, on behalf of multinational pharmaceutical companies. In spite of this being a clear case of conflict of interest, he was still selected to be a member of the Technical Committee.
The minutes prepared by the Technical Committee has been followed in toto by the Apex Committee without considering whether clinical trials for NCEs are required in public and national interest.
Neither our country nor citizens are deriving any benefit from clinical trials of new chemical entities; if these new chemical entities were actually efficacious and beneficial, they could easily be used in our country after following due procedure. The question to be asked is why Indian subjects are used for testing new chemical entities by multinational pharmaceutical companies. There is obviously no rational answer which could indicate the existence of any national or public interest.