Supreme Court Dismisses Plea To Publish Clinical Trial Data Of Rotavac Vaccine

The Supreme Court on Tuesday(August 6) dismissed a PIL seeking publication of the segregated date of the clinical trial (phase III) of the vaccine Rotavac administered to infants to protect against diarrhoea.

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

The petition was filed by S Srinavasan in 2016 seeking the publication of the data of the clinical trial of the vaccine against Rotavirus conducted between 2011-2013.

Advocate Prashant Bhushan, appearing for the petitioner, asked since the clinical trial data was already collected, what was the impediment in releasing it. He submitted that the trial data has to be disclosed to the general public as per Helsinki guidelines, 2015, Bioethics Committee, and ICMR guidelines, 2017.

Senior Advocate Devadatt Kamat, appearing for the Christian Medical College, Vellore (where the clinical trial was done), opposed the petition, saying that it was based on hearsay newspaper reports without proper research. He cited the Supreme Court's judgment in Jacob Puliyel case which turned down the plea to publish the clinical trial data regarding the 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