Tue. Jan 19th, 2021

Jacob Puliyel vs Union Of India & Ors. on 14 October, 2015

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1. This petition, by way of Public Interest Litigation, is filed seeking a
direction to the respondents to provide complete data of the results of the
Multi Centre Clinical Trial of „Rotavirus‟ Vaccine done on infants.
2. It is pleaded by the petitioner,who is a Paediatrician working in
St.Stephen‟s Hospital, Delhi, that a Paper has 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 and
that from the said Paper, he came to know that the number of cases of
intussusceptions in the infants who were administered „rotavirus‟ vaccine

WP(C) No.6913/2015 Page 1 of 5
in Vellore centre were the highest. The petitioner claims that there is 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. It is also pleaded that though the petitioner made an
application under the Right to Information Act seeking information about
the number of cases of intussusceptions in clinical trials at Vellore, there
was no response. It is further pleaded that he also addressed a letter dated
16.06.2015 to the Prime Minister‟s Office bringing to their notice that the
vaccine has been licensed for general use without releasing the segregated
data on the Clinical Trials.Alleging that despite several attempts, the data
relating to Vellore centre is not being shared and that without disclosing
the said data the respondents are proceeding to launch Phase-IV trial of
the vaccine, the present petition is filed with the following prayer:

Source: Indian Kanoon

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