JACOB PULIYEL Vs. UNION OF INDIA AND ORS.

JUDGEMENT

(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 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:

(3.) We have heard Shri Prashant Bhushan, the learned counsel appearing for the petitioner as well as Shri Sanjay Jain, the learned ASG who appeared on advance notice on behalf of the respondents No.1 and 2.