Plea To Publish Clinical Trials Data Of Rotavac Vaccine : Supreme Court To Hear After 3 Weeks

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

A bench comprising Justices AS Bopanna and MM Sundresh was hearing a petition filed by S Srinavasan in 2016 seeking publication of the data of the clinical trial of the vaccine against Rotavirus conducted between 2011-2013. 

Advocate Prashant Bhushan, appearing on behalf of the petitioner, submitted that the trial data has to be disclosed to the general public as per Helsinki guidelines, 2015, Bioethics Committee, and ICMR guidelines, 2017.

He particularly referred to Helsinki guidelines and quoted “all researchers have ethical obligations with respect to the publication of the results of research. There is a duty to make public research on the human subject and accountability for the accuracy of reports. It must be made publicly available.”

Justice Bopanna asked “But now the vaccine has been tested, used worldwide?"

Prashant Bhushan replied, "In the US, the same Rotavac(vaccine) was introduced in Universal Immunization program but was then withdrawn when it was found to have side effects. Therefore, once trials are over, it has to be released for the scientists to scrutinize".

Additional Solicitor General Aishwarya Bhati submitted that the issue is covered in Union's favour by the judgment of the Supreme Court in Dr.Jacob Puliyel case in relation to COVID vaccine.

The bench decided to post the matter after three weeks.

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