Even as the Swasthya Adhikar Manch, fighting a case on clinical trials in the Supreme Court, claimed that as many as 3458 people died during the trials in the last nine years including 590 in the year of 2013 alone, the government contented that only 89 deaths could be attributed to clinical trials.
Based on the details given by the government earlier, the NGO pointed out that from January 2005 to December 2012, as many as 2644 people died during the trials, while another 224 died between July 2012 to December 2012. The total number of serious adverse effects since from January 2005 to December 2013 stood at 14320, including 1122 cases during 2013, according to the affidavit by the NGO during the case hearing recently in the Supreme Court.
However, the government claimed that only 506 SAEs and 89 deaths were related to trials while the rest were unrelated. The government also said the compensations were paid in all 89 cases.
Following this huge difference in number, the SC has now asked the Ministry of Health and Family Welfare to provide data related to deaths and SAEs in four weeks, and do detailed review of new chemical entities and global clinical trials as per its earlier order of October 21, 2013.
“Look, it is not a question of one, two or three deaths. The figures say that there were 3,458 deaths. It is a very serious matter and disturbing. We want to know what is the mechanism that you have put in place to prevent it,” says the bench of Justices R M Lodha and Kurien Joseph.
Swasthya Adhikar Manch filed the case in February, 2012, seeking to streamline the clinical trial sector and against the malpractices in the sector by the companies.
Sanjay Parikh, appearing for the petitioner, mentioned that in the affidavits filed in December 2012 and on 29 January 2014 along with information provided on 14th February 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.
The petitioner said the Ministry was not forthcoming about details regarding the approvals, particularly 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.
The counsel also pointed that 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 health ministry had already confirmed that the 215 Bhopal gas victims who were subjects of clinical trials were not paid the requisite compensation and that the SAEs including death cases were not reported on time, the NGO said.