The Delhi High Court on Wednesday issued notice to the Centre on a petition challenging the permission given by the Drugs Controller General of India to Bharat Biotech for conducting the phase II/III clinical trial of its Covaxin COVID-19 vaccine on the 2-18 age group.
A Bench of Chief Justice D.N. Patel and Justice Jyoti Singh gave the order on a petition filed by advocate Sanjeev Kumar against an the May 13 order of the Centre granting permission to conduct the phase II/III clinical trial of Covaxin on 525 healthy volunteers in the age group of 2-18 years.
The plea argued that the clinical trial on Covaxin on minors will in all likelihood have adverse affect on their health - both mental and physical. "These children might even lose their life," the plea said.
It pointed out that the term 'volunteer' cannot be used for these minor children between the age of 2 to 18 as they cannot comprehend the consequences of such clinical trials.
In order for a person to become a subject matter of clinical trial, his or her consent is a pre-requisite. The volunteer is also required to enter into a contract with the institute carrying the clinical trial on various issues including compensation, damages in case the clinical trial fails. The volunteer is also required to give his or her consent that he or she has understood the entire agreement and is willing to volunteer for the clinical trial.
"In this case, since the alleged volunteers belong to the age group between 2 to 18 years, it is crystal clear that no such contract could be signed by the alleged volunteer (who are all minors and hence not competent to contract)," Mr Kumar argued.
Even if the contract is signed by their parents or legal guardian, the same is unlawful as is clearly not for the welfare of the children. Mr Kumar also pointed out that due to the socio-economic scenario of the country, particularly in the lower rungs, the possibility of parent or legal guardian extending their consent out of questionable enticements and monetary considerations cannot be ruled out.
The petition has called for direction to the authorities to place on record the details of all 525 children who will be subjected to the phase II/III clinical trials.
The high court will hear the case again on July 15.