Supreme Court Bench orders it to re-examine 157 GCT, including NCEs, by Apex and Technical Committees

The Supreme Court on Monday allowed the Union government to conduct five clinical trials that were approved this year after ensuring proper mechanism and procedure to ensure the safety of patients along with audio-visual recording of participants maintaining the principle of confidentiality and preservation of documentation.

A Bench of Justices R.M. Lodha and Shiva Kirti Singh passed this interim order on a petition filed by the Swasthya Adhikar Manch challenging the trials.

When the Bench raised serious concern at 162 clinical trials of Global Clinical Trial (GCT), including New Chemical Entities (NCEs)/New Molecule Entities (NMEs), Additional Solicitor General Siddharth Luthra told the Bench that out of 162 clinical trials, 157 were approved before December 31, 2012 and the rest cleared between January and August this year.

Further, it was admitted by the Ministry of Health and Family Welfare (MoHFW) and representative of the Drug Controller General of India (DCGI) that the 157 trials were approved by the DCGI only on the recommendation of the New Drug Advisory Committee (NDAC) and without the approval of the Apex and Technical Committees formed after the order of court dated January 3, 2013.

In the light of this admission, the Bench ordered the Centre to re-examine 157 GCT, including NCEs, by the Apex and Technical Committees. It said the committees would evaluate the 157 trials, particularly in terms of assessment of risk vs. benefits for patients, innovations to existing therapeutic options and benefits to medical needs of the country. It said that only after the assessment of the committees that the question of commencement of the 157 trials would be considered.

Earlier, after counsel Sanjay Parikh and senior counsel Colin Gonsalves made their submissions, Mr. Justice Lodha voiced his concern that there were no checks and balances in the framework, where investigators were paid by sponsors, and ethics committees were part of hospital with the absence of proper mechanisms to ensure patients’ safety.

The Bench posted the matter for further hearing on December 16.