Quash notification allowing phase 2/3 trials of Covaxin in 2-18 years age group: PIL in Delhi HC
May 18, 2021
By Sushil Batra
New Delhi [India], May 18 : A Public Interest Litigation (PIL) has been moved in Delhi High Court seeking quashing of Centre's "notification" of May 13, which has accorded permission for conduct of phase two/three clinical trials of Covaxin in the age group 2 to 18 years to its manufacturer Bharat Biotech.
The petition also seeks directions from respondents to place on record details of the 525 children who will be subjected to phase two/three clinical trial of the whole-virion inactivated coronavirus vaccine.
Covaxin is the vaccine developed by Bharat Biotech in collaboration with ICMR against COVID-19
The petitioner Sanjeev Kumar also seeks court's directions to the state to criminally prosecute the persons involved in such trials and the persons having authorized 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 states that the order, which requires the conduct of phase two/three clinical trial of Covaxin by the Bharat Biotech Ltd. on 525 healthy volunteers (very young children ranging from 2 year-old to 18 year-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".
"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) cannot be supposed to volunteer for the aforesaid clinical testing," the petition said.
The plea also said that in case the contract for the alleged volunteers has been signed by their parents/legal guardians, even then it is unlawful as it is clearly not for the welfare of the said children.
It is trite in law that nobody can enter into a contract the execution of which could endanger the life of minors, the petition said.
The petition is scheduled to be heard by the Bench of Justice DN Patel and Justice Jyoti Singh on Wednesday.
The Drugs Controller General of India (DCGI) had last week approved phase two and three clinical trial of Covaxin in the age group of 2 to 18 years, Health Ministry had said.
