SC Dismisses PIL Seeking Publication of Segregated Phase III Clinical Trial Data of Rotavac Vaccine

SC Dismisses PIL Seeking Publication of Segregated Phase III Clinical Trial Data of Rotavac Vaccine

The Supreme Court on Tuesday (August 6) dismissed a PIL requesting the publication of segregated data from the phase III clinical trial of the Rotavac vaccine, which is administered to infants to protect against diarrhea.

A bench comprising Justices BR Gavai and KV Viswanathan observed that the Court cannot sit in appeal over the decision made by the expert committee of the National Technical Advisory Group on Immunization (NTAGI).

The petition, filed by S. Srinavasan in 2016, sought the publication of data from the clinical trial of the Rotavac vaccine conducted between 2011 and 2013.

Advocate Prashant Bhushan, representing the petitioner, questioned the impediment in releasing the already collected clinical trial data. He argued that the trial data must be disclosed to the public according to the Helsinki guidelines (2015), Bioethics Committee, and ICMR guidelines (2017).

Senior Advocate Devadatt Kamat, representing the Christian Medical College, Vellore (where the clinical trial was conducted), opposed the petition, asserting it was based on hearsay and newspaper reports without proper research. He referenced the Supreme Court's judgment in the Jacob Puliyel case, which rejected the plea to publish clinical trial data regarding COVID-19 vaccines.

Case title: S. Srinivasan v. Union Of India And Ors. Ministry Of Health And Family Welfare Secretary And Ors.

Citation: W.P.(C) No. 289/2016 PIL-W

 
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