"No Clinical trial on Global clinical trials including New Chemical Entities without proper mechanism -" Supreme Court
The writ petition filed by Swasthya Adhikar Manch came up for hearing today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Mr Singh...... This case was filed in February, 2012 and this is the seventh hearing of the case, last hearing was held on 26th july, 2013.
In the last hearing, the Hon’ble Supreme Court had directed Secretary , Ministry of Health and family Welfare to organise a meeting of all chief Secretaries / Secretary from all states to discuss all the facets and aspects concerning legal framework for strengthening the regulation of clinical trials and other incidental matters. They had also asked the Government to take opinion of Petitioners, National Human Rights Commission and NGOs.
Today Mr. Sanjay Parikh Senior Counsel of Swasthya Adhikar Manch had argued that highlighted the facts contained in the two affidavit filed by the Ministry of health and family welfare. In the additional affidavit filed by the Ministry of Health and Family Affairs it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than 4%. But in these clinical trials 2644, persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11972 SAEs, 506 alone were attributed to clinical trials. He mentioned that total 259 applications regarding NCEs/NMEs have been recommended for approval between 3rd July 2013 to 31st August 2013 out of them 162 have been approved for clinical trials by Drug controller General of India.
The Petitioners in their earlier affidavit had already pointed out that due to Clinical trials of New Chemical Entities/ New Molecular Entities (NCEs/NMEs) though the Ministry of Health and Family Welfare had mentioned 164 deaths in the year 2010, out of which 125 alone had died on account of clinical trial of Rivoroxaben by Bayer but in the letter which was written by Ministry of Health and Family Welfare dated 26.04.2011 to the Lok Sabha Secretariat as many as 671 cases of death occured in the Year,2010 alone, as per Annexure B to the said letter 89 deaths took place in 2010 alone due to clinical trials as against 80 which Ministry of Health and Family Welfare claiming from year 2005 to 2012. The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boahringer, Astrazeneca, Novartis, etc.
Counsel for Swasthya Adhikar Manch- Mr. Sanjay Parikh mentioned that the reason for so many deaths is because NCEs/ NMEs are being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption. It was also urged by the Counsel that the clinical trial of NCEs/ NMEs is not at all beneficial to the Country and therefore, should not be allowed.
As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year, 2005 to 2010 alone 1243 global clinical trials has been permitted.
In the other letter dated 06.06.2011 by DCGI it has been mentioned that out of 645 cases of death response has been received only in 300 cases and out of 300 in only 2 cases compensation and treatment expenses have been paid.
The Court has given 10 weeks time to the MOHFW to come out with the actual implementation of the suggestions given by State Government, NHRC, Petitioner and NGOs to strengthen the regulatory framework of clinical trials in the country.
Mr. Sanjay Parikh also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.
The Supreme court has also issued in the application filed by Swasthya Adhikar Manch where investigation has been sought by facing reliance on 72nd Parliamentary standing Committee on health and family welfare report dated 30th August 2013 where in , it has been recommended that action should be taken against PATH, State Government of Andhra Pradesh and Gujarat, ICMR, and other Government officials including Drug controller General of india. In the said case HPV vaccine was given to 14091 girls in Khammam district of Andhra Pradesh and 10686 girls in Vadodra Gujarat. These girls were between age group of 10-14 and 7 girls were died due to vaccine.
The Court appreciate Mr. Sanjay Parikh, Senior Counsel and Swasthya Adhikar Manch to bring to notice the fact that Indian citizens are being exploited by multinational drug companies and without proper regularatory framework clinical trials happening in the country.
The next hearing scheduled for after 2 weeks.Visit - www.unethicalclinicaltrial.org for more.
The writ petition filed by Swasthya Adhikar Manch came up for hearing today before the bench of the Supreme Court consisting of Justice R.M Lodha and Justice Mr Singh...... This case was filed in February, 2012 and this is the seventh hearing of the case, last hearing was held on 26th july, 2013.
In the last hearing, the Hon’ble Supreme Court had directed Secretary , Ministry of Health and family Welfare to organise a meeting of all chief Secretaries / Secretary from all states to discuss all the facets and aspects concerning legal framework for strengthening the regulation of clinical trials and other incidental matters. They had also asked the Government to take opinion of Petitioners, National Human Rights Commission and NGOs.
Today Mr. Sanjay Parikh Senior Counsel of Swasthya Adhikar Manch had argued that highlighted the facts contained in the two affidavit filed by the Ministry of health and family welfare. In the additional affidavit filed by the Ministry of Health and Family Affairs it was stated that out of 475 New Chemical Entities only 17 were approved for marketing which comes to less than 4%. But in these clinical trials 2644, persons died out of which only 80 deaths were attributed to clinical trials. Similarly, out of 11972 SAEs, 506 alone were attributed to clinical trials. He mentioned that total 259 applications regarding NCEs/NMEs have been recommended for approval between 3rd July 2013 to 31st August 2013 out of them 162 have been approved for clinical trials by Drug controller General of India.
The Petitioners in their earlier affidavit had already pointed out that due to Clinical trials of New Chemical Entities/ New Molecular Entities (NCEs/NMEs) though the Ministry of Health and Family Welfare had mentioned 164 deaths in the year 2010, out of which 125 alone had died on account of clinical trial of Rivoroxaben by Bayer but in the letter which was written by Ministry of Health and Family Welfare dated 26.04.2011 to the Lok Sabha Secretariat as many as 671 cases of death occured in the Year,2010 alone, as per Annexure B to the said letter 89 deaths took place in 2010 alone due to clinical trials as against 80 which Ministry of Health and Family Welfare claiming from year 2005 to 2012. The list of drug companies that conducted the trials included several pharmaceutical companies such Bayer, Eli Lilly, Pfizer, Sanofi Intas, Merck, Boahringer, Astrazeneca, Novartis, etc.
Counsel for Swasthya Adhikar Manch- Mr. Sanjay Parikh mentioned that the reason for so many deaths is because NCEs/ NMEs are being tested on Indian citizens without following the regulations and taking necessary precautions taking advantage of poverty and tardy implementation including corruption. It was also urged by the Counsel that the clinical trial of NCEs/ NMEs is not at all beneficial to the Country and therefore, should not be allowed.
As per the letter dated 26.04.2011 written by the Ministry to Lok Sabha Secretariat, from the year, 2005 to 2010 alone 1243 global clinical trials has been permitted.
In the other letter dated 06.06.2011 by DCGI it has been mentioned that out of 645 cases of death response has been received only in 300 cases and out of 300 in only 2 cases compensation and treatment expenses have been paid.
The Court has given 10 weeks time to the MOHFW to come out with the actual implementation of the suggestions given by State Government, NHRC, Petitioner and NGOs to strengthen the regulatory framework of clinical trials in the country.
Mr. Sanjay Parikh also represented the Bhopal Gas Peedith Mahila Udyog Sangathan (BGPMUS) and the Bhopal Gas Peedith Sangarsh Sahayog Samiti (BGPSSS) who are interveners in this case.
The Supreme court has also issued in the application filed by Swasthya Adhikar Manch where investigation has been sought by facing reliance on 72nd Parliamentary standing Committee on health and family welfare report dated 30th August 2013 where in , it has been recommended that action should be taken against PATH, State Government of Andhra Pradesh and Gujarat, ICMR, and other Government officials including Drug controller General of india. In the said case HPV vaccine was given to 14091 girls in Khammam district of Andhra Pradesh and 10686 girls in Vadodra Gujarat. These girls were between age group of 10-14 and 7 girls were died due to vaccine.
The Court appreciate Mr. Sanjay Parikh, Senior Counsel and Swasthya Adhikar Manch to bring to notice the fact that Indian citizens are being exploited by multinational drug companies and without proper regularatory framework clinical trials happening in the country.
The next hearing scheduled for after 2 weeks.Visit - www.unethicalclinicaltrial.org for more.
