Delhi high court refuses to stay Covaxin clinical trial on children aged 2-18, issues notice to DCGI

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The Delhi high court on Wednesday refused to grant an interim stay on the clinical trial of Covaxin in children in the age group of 2 to 18 years. The court, however, issued notices to the Drugs Controller General of India (DCGI) and others on a plea challenging the DCGI’s nod to Bharat Biotech for conducting clinical trials of Covaxin in children.

The DCGI on May 13 gave permission for the vaccine, developed by Bharat Biotech and the Indian Council of Medical Research, to be used in Phase 2 and Phase 3 trials in people below the age of 18 — the first such trials that will begin in India.

A bench of Chief Justice DN Patel and Justice Jyoti Singh issued notice on a Public Interest Litigation (PIL) filed by Sanjeev Kumar seeking direction to quash the order passed on May 13, giving permission to Bharat Biotech for conducting clinical trials in children aged 2-18. The ministry of women and child development has also been made a party to the proceedings.

In his plea, the petitioner in person Kumar stated that the order for trial rests on the implication that children are signing up as ‘volunteers’, but the term itself means “a person who freely offers to do something”, which children who cannot read or understand a contract are incapable of doing, thus prima facie unlawful, arbitrary and against the settled principles of law and natural justice.

“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 states.

The petitioner states that since the children who will be a part of the trial will be healthy their parents cannot give consent for the trials to be conducted since that would endanger the life of minors.

The plea also drives a separation between parents consenting to life saving surgeries or other medical procedures on their children’s behalf since that is in “purpose of saving the life” of minors.

Kumar seeks invocation of Section 81 of Juvenile Justice Act, 2015, for penalizing parents who volunteer their children in hopes of monetary compensation.

The petitioner also sought directions to the respondents to produce details of all the 525 children who will be enrolled in the trial.

The matter would be heard on July 15.

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