On 31st January 2014 at the 9th hearing of the writ petition filed by Swasthya Adhikar Manch took place today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice S.K. Singh. The case was filed in February, 2012 and the last hearing was held on 16th December , 2013.
In compliance of the last order dated 16th December 2013 the MOHFW did not filed further affidavit within three weeks granted by the Hon’ble Supreme Court. The Affidavit was filed only on 29th Jan 2014 and a copy of the same was given to the petitioners on 30th January 2014.
In view of the fact that serious and important question arise for consideration as the issue relates to New chemical entities / Global clinical trials. The Petitioners sought for four weeks time to give their response. The Supreme Court allowed this time and also directed the Ministry of Health and Family Welfare to supply the documents within 2 weeks to the Petitioner which have been asked for by the Petitioners from the Ministry.
In the earlier affidavits filed on the issue of NCEs, the stand of Ministry was that DCGI had granted approval to 475 NCEs between 1.1.2005 to 30.6.2012 and out of them only 17 were approved for marketing. in the subsequent affidavits filed in December 2012 and on 29th January 2014 the Ministry of health and family welfare had said that out of 285 clinical trials which were approved by NDACs, DCGI had approved 157 clinical trials by 31.12.2012 and 5 after 3.1.2013 making it a total of 162 clinical trials.
It is not clear how many applications were moved after 30.6.2012 which were approved by NDACs and to whom approvals were granted by DGCI by 31.12.2012. It was also not clear from the earlier affidavit that whether 162 clinical trials which were approved, how many trials are ended and how many trials are ongoing. in the affidavit filed in December 2013.
The Ministry has not provided any document to show that approvals have been granted by the technical committee and by the apex committee by looking into the three parameters which were directed to be followed. (i) safety and efficacy, particularly in terms of risk and benefit to patient; (ii) innovation vis-a-vis existent therapeutic option; (iii) unmet need in the country. Unfortunately the technical committee consists of Dr Ranjit Roy Choudhary who is the chairman of task force for research in Appolo Hospital which has conducted 300 clinical trial including multicentre global trials on behalf of multinational Pharmaceutical Companies. Inspite of Dr Chaudhary having conflict of interest, he has been taken in the technical committee. The minutes prepared by Technical Committee have been followed in totol by the apex committee without considering whether NCE clinical trials are required in public and National interest.
The MOHFW has totally followed the recommendation of Ranjit Roy Choudhary and has not considered the suggestions given by other stake holders. Because of the presence of Dr Ranjit Roy Choudhary, the technical committee went to the extent of suggesting that certain drugs should be approved for marketing and use in India without conducting any clinical trial, which suggestion is in total contradiction of the recommendations made in 59th port in the Parliamentary standing committee. Both the technical committee and apex committee have also succumb to the representation of M/s Glen mark Pharmaceuticals limited that 50% trial in Government and Hospitals and medical colleges will not be mandatory.
The Ministry has not disclosed the details of new chemical entities for what health purpose they are required to be tested in clinical trials. Whether these NCEs were subjected to the clinical trials outside India, when these companies applied for trial, when they were approved by the NDACs and when the DCGI granted permission. it is also not mention when the clinical trial started which were the places for conducting clinical trial, how many persons suffered serious adverse impact, how many persons have been died and whether any compensation have been paid to them.
It is also significant that the charges leveled against the Bhopal Memorial Hospital & Research Centre (BMHRC) by the Bhopal Gas Peedith Mahila Udyog Sanghathan (BGPMUS) and the Bhopal Gas Peedith Sangharsh Sahayog Samiti (BGPSSS) in their application dated 14.12.2012 have been confirmed in the Reply Affidavit filed by the Ministry of Health & Family Welfare (MOHFW) on 12.12.2013. The MOHFW has 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 However, the MOHFW has merely issued warning letters to the Principal Investigators and the concerned drug companies instead of initiating appropriate civil and criminal proceedings against the guilty. In the Rejoinder Affidavit filed by BGPMUS & BGPSSS on 29.01.2014, the demand for initiating appropriate civil and criminal proceeding against the guilty Principal Investigators and the concerned drug companies has been raised. BGPMUS & BGPSSS has also asked the BMHRC to file details of how the Rs.10085100/- that it had received from drug companies were utilized by them.
Swasthya Adhikar Manch shall be filing a comprehensive reply after getting information from the Ministry as the clinical trial of NCEs /GCTs which are conducted by multinational pharmaceutical companies in third world countries including in India for obvious reasons result in serious adverse impacts and deaths for which even compensation is not paid. Our country or people are not benefitted by these clinical trials of new chemical entities because if the new chemical entities are efficacious and beneficial it can always be used in our country after following the 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 there is no rational answer which support the National / public interest.
In compliance of the last order dated 16th December 2013 the MOHFW did not filed further affidavit within three weeks granted by the Hon’ble Supreme Court. The Affidavit was filed only on 29th Jan 2014 and a copy of the same was given to the petitioners on 30th January 2014.
In view of the fact that serious and important question arise for consideration as the issue relates to New chemical entities / Global clinical trials. The Petitioners sought for four weeks time to give their response. The Supreme Court allowed this time and also directed the Ministry of Health and Family Welfare to supply the documents within 2 weeks to the Petitioner which have been asked for by the Petitioners from the Ministry.
In the earlier affidavits filed on the issue of NCEs, the stand of Ministry was that DCGI had granted approval to 475 NCEs between 1.1.2005 to 30.6.2012 and out of them only 17 were approved for marketing. in the subsequent affidavits filed in December 2012 and on 29th January 2014 the Ministry of health and family welfare had said that out of 285 clinical trials which were approved by NDACs, DCGI had approved 157 clinical trials by 31.12.2012 and 5 after 3.1.2013 making it a total of 162 clinical trials.
It is not clear how many applications were moved after 30.6.2012 which were approved by NDACs and to whom approvals were granted by DGCI by 31.12.2012. It was also not clear from the earlier affidavit that whether 162 clinical trials which were approved, how many trials are ended and how many trials are ongoing. in the affidavit filed in December 2013.
The Ministry has not provided any document to show that approvals have been granted by the technical committee and by the apex committee by looking into the three parameters which were directed to be followed. (i) safety and efficacy, particularly in terms of risk and benefit to patient; (ii) innovation vis-a-vis existent therapeutic option; (iii) unmet need in the country. Unfortunately the technical committee consists of Dr Ranjit Roy Choudhary who is the chairman of task force for research in Appolo Hospital which has conducted 300 clinical trial including multicentre global trials on behalf of multinational Pharmaceutical Companies. Inspite of Dr Chaudhary having conflict of interest, he has been taken in the technical committee. The minutes prepared by Technical Committee have been followed in totol by the apex committee without considering whether NCE clinical trials are required in public and National interest.
The MOHFW has totally followed the recommendation of Ranjit Roy Choudhary and has not considered the suggestions given by other stake holders. Because of the presence of Dr Ranjit Roy Choudhary, the technical committee went to the extent of suggesting that certain drugs should be approved for marketing and use in India without conducting any clinical trial, which suggestion is in total contradiction of the recommendations made in 59th port in the Parliamentary standing committee. Both the technical committee and apex committee have also succumb to the representation of M/s Glen mark Pharmaceuticals limited that 50% trial in Government and Hospitals and medical colleges will not be mandatory.
The Ministry has not disclosed the details of new chemical entities for what health purpose they are required to be tested in clinical trials. Whether these NCEs were subjected to the clinical trials outside India, when these companies applied for trial, when they were approved by the NDACs and when the DCGI granted permission. it is also not mention when the clinical trial started which were the places for conducting clinical trial, how many persons suffered serious adverse impact, how many persons have been died and whether any compensation have been paid to them.
It is also significant that the charges leveled against the Bhopal Memorial Hospital & Research Centre (BMHRC) by the Bhopal Gas Peedith Mahila Udyog Sanghathan (BGPMUS) and the Bhopal Gas Peedith Sangharsh Sahayog Samiti (BGPSSS) in their application dated 14.12.2012 have been confirmed in the Reply Affidavit filed by the Ministry of Health & Family Welfare (MOHFW) on 12.12.2013. The MOHFW has 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 However, the MOHFW has merely issued warning letters to the Principal Investigators and the concerned drug companies instead of initiating appropriate civil and criminal proceedings against the guilty. In the Rejoinder Affidavit filed by BGPMUS & BGPSSS on 29.01.2014, the demand for initiating appropriate civil and criminal proceeding against the guilty Principal Investigators and the concerned drug companies has been raised. BGPMUS & BGPSSS has also asked the BMHRC to file details of how the Rs.10085100/- that it had received from drug companies were utilized by them.
Swasthya Adhikar Manch shall be filing a comprehensive reply after getting information from the Ministry as the clinical trial of NCEs /GCTs which are conducted by multinational pharmaceutical companies in third world countries including in India for obvious reasons result in serious adverse impacts and deaths for which even compensation is not paid. Our country or people are not benefitted by these clinical trials of new chemical entities because if the new chemical entities are efficacious and beneficial it can always be used in our country after following the 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 there is no rational answer which support the National / public interest.
