Delhi High Court Dismisses PIL On Clinical Trials Of Rotavirus Vaccine

The PIL was filed by a member of NTAGI seeking to restrain the government from moving on to phase IV trials in which over one lakh children would be administered the vaccine.

A plea seeking a direction to restrain the Centre from conducting any further clinical trials of rotavirus vaccine in India has been dismissed by the Delhi High Court. The court said that the petition "does not deserve to be taken cognizance as a Public Interest Litigation.”

Rotavirus vaccine protects children from viruses, which are the leading cause of severe diarrhea among infants and young children.

Keeping Rotavirus at Bay
Virus such as influenza via specific characteristics of viral ribonucleic acid can be detected by our immunosensory system.

A bench of Chief Justice G Rohini and Justice Jayant Nath said no case of violation of any statutory provision is made out in the present petition and no case is also made out to show that disclosure of the segregated data of clinical trial is essential in public interest.

"We, therefore, find substance in the submission of the Additional Solicitor General (ASG) that the petition is misconceived and motivated with private interest. For the aforesaid reasons, the petition does not deserve to be taken cognizance as a Public Interest Litigation," the bench said.

The court's order came on a plea filed by Dr Jacob Puliyel, a member of National Technical Advisory Group on Immunization (NTAGI) seeking to restrain the government from moving on to phase IV trials in which over one lakh children would be administered the vaccine.

Novel Treatment to Stop Rotavirus Infection
Rotavirus is transmitted by the faecal-oral route, via contact with contaminated hands, surfaces and objects, and possibly by the respiratory route.

Puliyel in his plea has also sought directions to the government to provide complete data of the multi-center clinical trials of the vaccine.

The bench said NTAGI, which is the highest technical advisory body in the country on immunization on on being satisfied about its efficacy and safety, has recommended to introduce the vaccine in question for National Immunization Program.

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A Georgia State University research team says that activation of the innate immune system with the bacterial protein flagellin could prevent and cure rotavirus infection.

"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 centers, the Government cannot be allowed to proceed to take up Phase-IV study of the vaccine," the bench said.

Source-PTI

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