Supreme Court has asked the Union Health Ministry to re-examine the approval given to 157 clinical trials in 2012 again by the apex and technical committees set up by the Ministry and ensure proper mechanism before allowing the commencement of five trials approved this year.
The bench consisting Justice R M Lodha and Justice S K Singh made the ruling on Monday when the petition filed by Swasthya Adhikar Manch came up for hearing. This case was filed in February, 2012 and this is the eighth hearing of the case, last hearing was held on 30th September, 2013.
The Court raised serious concern on 162 clinical trials of Global Clinical Trial (GCT) including New Chemical Entities (NCEs)/New Molecule Entities (NMEs) out of which 157 were approved before December 31, 2012 and five between January to August 2013. In the Court it was admitted by Ministry and representative of Drug Controller General of India (DCGI) that 157 clinical trials were approved by DCGI on only recommendation of New Drug Advisory Committee (NDAC) and without the approval of Apex and Technical Committee formed after order of Court dated 3rd January 2013.
The court then directed the Government to reexamine 157 trials including NCEs by Apex and Technical Committees. In case of remaining five clinical trials which have been approved in 2013, the apex court asked the Ministry to allow them only after ensuring proper mechanism and procedure to ensure safety of the patients along with audio-visual recording of participants maintaining principle of confidentially and preservation of documentation.
The bench also raised its concern that there is no checks and balance in the frame work where investigators are paid by sponsors and ethics committees are part of hospital with absence of proper mechanism to ensure patients safety.
Now Apex and technical committee will have to evaluate these 157 clinical trials particularly in terms of - assessment of risk vis-à-vis benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country. It is only after the assessment of apex and technical committee that the question of commencement of 157 approval will be considered.
Sanjay Parikh, Senior Counsel for the petitioner, pointed out contradictions in data given in affidavit filed by Ministry on July 26, 2013 wherein it was stated that only 26 GCT were approved while in current affidavit of October 18, 2013, it is stated that only 5 trials are approved after January 3, 2013 by the apex and the technical committee.