The 8th hearing of the writ petition filed by Swasthya Adhikar Manch took place yesterday 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 30th September, 2013.
The Hon'ble Supreme Court raised serious concerns over 162 clinicaltrials of Global Clinical Trial (GCT) including New Chemical Entities(NCEs) / New Molecule Entities (NMEs) out of which 157 were approvedbefore 31st December 2012 and 5 between January to August 2013.
Inthe Court it was admitted by Ministry of Health & Family Welfare(MOHFW) and representative of Drug controller General of India (DCGI) that 157 clinical trials were approved by DCGI on recommendations ofNew Drug Advisory Committee (NDAC) and without the approval of Apexand Technical Committee formed after order of Court dated 3rd January2013.
TheHon?ble Supreme Court has ordered GoI to re-examine 157 GCTincluding NCEs by Apex and Technical Committees. Therefore, now Apexand technical committee will have to evaluate these 157 clinicaltrials particularly in terms of - assessment of risk vs. benefits forpatients, innovations to existing therapeutic options and benefits tomedical needs of the country.
The Hon'ble Supreme Court also raised its concern that there is nochecks and balance in the frame work where investigators are paid by sponsors and ethics committees are part of hospital with absence ofproper mechanism to ensure patients safety.
The petitioners have been raising the issue of how NCEs/NMEs are benefiting MNCs at the cost of human life in India. The next hearingis scheduled on 16th December 2013.