ITEM 5 SRINIVASAN

The Supreme Court today in a plea seeking directions to Government to make public the segregated data (result) of Rotavac clinical trial (phase III) involving 6799 infants that was conducted in three centres namely Delhi, Pune and Vellore.

Bench of Justice RF Nariman, Justice KM Joseph and Justice BR Gavai said,

The bench was hearing a plea filed by S. Srinivasan, managing trustee of Low Cost Standard Therapeutics, contended that 6799 infants were administered the said vaccine to ensure its safety of the number of intussusceptions in the two year trial period.

The Supreme Court bench of Justice Arun Mishra and Justice Indira Banerjee had passed a direction to the Union Government on November 8, 2019 to place on record the guidelines framed by the Indian Council of Medical Research, Clinical Trials of Drugs and other interventions as well as the Declaration of Helsinki.

“We do not want to cast any aspersions regarding the vaccine in the public’s minds. That is not our intention. We just want full disclosure of the research data, that’s all,” Srinivasan had then contended.

Senior Advocate Prashant Bhushan, assisted by Advocate Neha Rathi, had made submissions in the made on an earlier occasion.

“So far the respondents have shown complete secrecy in the mater and have not disclosed segregated data from all the centres and have only released aggregated data, that is, the results of all three centres (Delhi, Pune and Vellore) clubbed together. Concealing of this vital data does serve injustice to the thousands of infants who participated in this study, the researchers who painstakingly conducted the trials and the medical/scientific community who depend on this data for their work,” the plea stated.

It was further averred that enforcement of Articles 14&21 calls for the results of clinical trials between 2011 to 2013, preceding the release of Rotovac 5D vaccine.

Case Title: S Srinivasan v. Union of India and Ors