PIL In SC Seeks The Release Of Result Of Clinical Trial Involving 6799 Infants For Rotavac Vaccine [Read Petition]

The Petition was filed on behalf of Mr. S. Srinivasan, the (Managing Trustee of "Low Cost Standard Therapeutics"). He is a Graduate and Post Graduate of IIT Kharagpur & IIM Bangalore & has previously filed petitions in the Supreme Court inter alia irrational medicines, drug pricing policy, vaccine PSU's closure and HPV vaccine related deaths.

Before a Bench comprising Justices Arun Mishra & Indira Banerjee, Senior Advocate Prashant Bhushan submitted that as per the last order dated 8th November 2019, the Respondents had placed certain documents on record which entailed guidelines framed by the Indian Council of Medical Research as well as the Declaration of Helsinki which were required to be looked at from his end. The Bench adjourned the matter for next week.

The Petition has averred that the enforcement of rights under Article 14 & 21 calls for the results of the clinical trials conducted between 2011 and 2013 preceding the release of Rotavac 5D vaccine to be disclosed for the public and the Government must be willing to do so.

It has been contended that 6799 infants were administered the said vaccine to ensure its safety in terms of the number of intussusceptions in the 2 year trial period.

"Intussusceptions are intestinal obstructions that may need an urgent surgery to prevent death among infants and is diagnosed by ultra sound examination" the Petition elucidates.

Moreover, the Petition states that the disclosure of segregated data of all three centres clubbed together is not relevant as access to segregated data would be relevant to ascertain whether a certain section of the population is more susceptible to adverse effects.

"So far the respondents have shown complete secrecy in the matter and have not disclosed segregated ( meaning dis-aggregated) data from all the centres and have only released aggregated data i.e. the results of all three centres clubbed together. Concealing of this vital data does severe 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."

Urging that the administration of the vaccine in 4 states requires that the Government discloses the safety data, the Petition contends that it would be unethical to proceed with immunization without informing the public of any risks observed with previous use of the vaccine.

"We don't 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 it" said Mr. Srinivasan.

Senior Advocate Prashant Bhushan appeared for the Petitioner & was assisted by Advocate Neha Rathi.