Delhi HC dismisses PIL demanding guidelines for release of segregated research results in Clinical Trials on Humans [Read Judgment]

The Delhi High Court on Wednesday dismissed a Public Interest Litigation demanding that guidelines be framed regarding publication of complete and segregated research results in clinical trials on humans in accordance with the norms of WHO published in April, 2015 on the issue.

The Bench comprising Chief Justice G. Rohini and Justice Jayant Nath dismissed the Petition observing that "the petition is misconceived and motivated with private interest".

The Court was hearing a petition filed by a Pediatrician, Mr. Jacob Puliyel, seeking a direction to the Government to provide complete data of the results of the Multi Centre Clinical Trial of "Rotavirus" Vaccine done on infants.

As per the petition, a paper had been published in the Journal, 'Vaccine' of August, 2014, raising several questions about the efficacy and the risk associated with the "rotavirus" vaccine on the basis of the findings of Clinical Trial conducted in three centres in India. From that paper, the Petitioner had come to know that the number of cases of intussusceptions in the infants who were administered "rotavirus" vaccine in Vellore centre were the highest.

He therefore claimed that there was a need for disclosure of the segregated data of Vellore Centre so as to ascertain whether a certain section of the population is more susceptible to adverse effects.

His RTI application on the same subject had not received any response. He had also addressed a letter to the Prime Minister's Office, bringing to their notice that the vaccine had been licensed for general use without releasing the segregated data on the Clinical Trials. The Petition further alleged that despite several attempts, the data relating to Vellore centre was not being shared and that without disclosing the said data the Government was proceeding to launch Phase-IV trial (post-marketing study) of the vaccine.

Besides praying for the release of this data, the petition had also demanded that the Court should frame guidelines regarding publication of complete and segregated research results in clinical trials on humans in accordance with the norms of WHO published in April, 2015 on the issue.

Additional Solicitor General, Mr. Sanjay Jain brought to the Court's notice that the Petitioner himself is a member of National Technical Advisory Group on Immunization (NTAGI), which is the highest technical advisory body in the country on immunization. Having been satisfied with the efficacy and safety of the vaccine in question, NTAGI had recommended that the same be introduced in the National Immunization Programme for all Indian children. Hence, he contended that the petition is misconceived and the allegations raised were "without any basis and unwarranted".

Agreeing with the ASG, the Court took note of the fact that the entire segregated data on the clinical trial conducted in all the three centres was available with NTAGI before making its recommendation. "That being so, we are unable to understand the purpose for which the petitioner is insisting on public disclosure of the segregated data. It is not the case of the petitioner that before allowing Phase-IV trial, public disclosure of segregated data is mandatory under the provisions of any statute. No case is made out even to show that such disclosure is necessary in public interest," the Court observed.

Read the Judgment here.