The main legal point established in the judgment is that public interest necessity or statutory requirement for public disclosure of segregated data from clinical trials must be established to warrant such disclosure.

G. Rohini, J.

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:

“(i) to direct the Department of Biotechnology, Ministry of Science and Technology and Ministry of Health and Family Welfare and the Christian Medical College, Vellore to provide complete segregated data on the clinical trial conducted in 3 centres, namely, Delhi, Pune and Vellore apart from the number of intussusceptions with rotavirus vaccine in the two year trial to the key stakeholders and the petitioner.

(ii) to restrain the respondents from conducting any further trial of rotavirus vaccine in India until the complete data is disclosed to the key stakeholders and the petitioner.

(iii) to 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.”

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.

4. It is submitted by Shri Prashant Bhushan that though Phase-III clinical trials of the ‘rotavirus’ vaccine started in 2011 by the Department of Biotechnology, Ministry of Science and Technology, Government of India at three centres, namely, Pune, Delhi and Vellore, it has now come to light that complete segregated data of different centres of clinical trial has not been disclosed. It is vehemently contended by the learned counsel that Phase-IV trial of vaccine, i.e., post marketing study cannot be allowed without providing evidence of safety from the trials already made in Vellore centre.

5. Shri Sanjay Jain, the learned ASG has brought to the notice of this Court that the vaccine in question has already been approved by the Government after a clinical trial about its efficacy and safety and that the same has also been reviewed by the Global Vaccine Safety Advisory Committee of WHO in June, 2014. Pointing out 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 and that having been satisfied with the efficacy and safety of the vaccine in question, NTAGI recommended that the same be introduced in the National Immunization Programme for all Indian children,