NEW DELHI:
The Delhi High Court on Wednesday refused to put an interim stay on Phase 2-3 clinical trials of Bharat Biotech’s Covaxin for children in the age group of 2 to 18.
Issuing a notice to the Centre, Central Drugs Standard Control Organizations, and others on a petition for quashing the decision of clinical trials, the court sought their responses.
A bench of Justice DN Patel and Justice Jyoti Singh was hearing the Public Interest Litigation (PIL) moved to the court, which sought withdrawal of the Central government’s notification, dated 13 May, that accorded permission to conduct the clinical trial of Covaxin for 2-18 age group to its manufacturer, Bharat Biotec Ltd.
The petition had also sought direction from respondents to place on record the details of the 525 children who will be subjected to Phase 2-3 clinical trial of the Whole Virion inactivated coronavirus vaccine.
The petitioner, Sanjeev Kumar, sought the court’s direction to the state to criminally prosecute the persons involved in such trials, and the persons having authorised conduct of such trials in the event of any death or loss of peaceful and pleasant enjoyment of the life of any toddler or minor children.
The petition stated that the order which requires the conduct of Phase 2-3 clinical trial of Covaxin on 525 healthy volunteers (very young children ranging from 2 years old to 18 years old) is “prima facie unlawful, arbitrary and against the settled principles of law and natural justice” because the term ‘volunteer’ itself means ‘a person who freely offers to do something’.
It further states that a person can offer to do anything only if he/she is capable of understanding the consequences of his/her act.
“In the present case, the subject matter of clinical trials being minors; even toddlers who, for the reason of their age only, are not capable of even speaking and understanding languages in a proper manner, and hence cannot be supposed to ‘Volunteer’ for the aforesaid clinical testing,” read the plea.
