New Delhi, October 18: The Delhi HC, on Wednesday, dismissed a Public Interest Litigation demanding for guidelines to be framed regarding publication of complete and segregated research results of clinical trials performed on humans in accordance with the norms of WHO, saying that no case of violation of any statutory provision was made out in the plea and no case was made out to prove that the disclosure of the segregated data of clinical trial was essential in public interest.
The Division Bench of Chief Justice G. Rohini and Justice Jayant Nath dismissed the PIL on the ground that “the petition is misconceived and motivated with private interest.”
The said petition was filed by Mr. Jacob Puliyel, a pediatrician and also member of National Technical Advisory Group on Immunization (NTAGI), seeking a direction to the Union to furnish complete and detailed analysis of the results of the multi-centre clinical trials of “rotavirus” vaccine carried out on infants.
Rotavirus vaccine shields children from viruses causing severe form of diarrhoea.
As per the petition, a paper had been published in the Journal, ‘Vaccine’ in August, 2014, raising several questions regarding the efficacy and risk associated with the “rotavirus” vaccine on the basis of the findings of clinical trials conducted in three centres in India. From that paper, the petitioner had come to know that the number of cases of intussusceptions in infants who were administered “rotavirus” vaccine at the Vellore centre, were the highest.
Puliyel, 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.
The Bench said that NTAGI is the highest technical advisory body on immunization in the country and only after being satisfied with its efficacy and safety, has recommended to introduce the vaccine in question for National Immunization Programme.
Agreeing with Additional Solicitor General, Mr. Sanjay Jain, the Bench was quoted as saying that, “in the circumstances, we do not find any substance in the contention of the petitioner that in the absence of the information about the number of cases of intussusceptions in clinical trial at one of the centres, the Government cannot be allowed to proceed with the Phase-IV study of the vaccine.”