Delhi High Court Issues Notice In Plea Challenging Govt's Permission Given For Conducting Phase II, III Clinical Trials Of Covaxin In Age Group Of 2-18 Years

The Delhi High Court has issued notice in plea challenging the notification issued by the Central Government for conducting phase II and III clinical trials of covaxin in the age group of 2 to 18 years stating them to be "healthy volunteers".

The plea also seeks directions on the State to criminally prosecute persons involved in the trials in the event of death or loss of life of any minor or toddler.

The plea moved by one Sanjeev Kumar makes Union of India, Central Drug Standard Control Organization, Ministry of Women and Child Development and Bharat Biotech Limited as Respondents in the matter.

The petition has been filed seeking quashing of the order passed by the Central Government dated May 13, 2021 giving permission to Bharat Biotech Limited for conducting Covaxin phase II and III clinical trials on 525 "healthy volunteers" falling under the age group of 2 to 18 years.

Stating that the order is prima facie unlawful and arbitrary, the plea states thus:

"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 proper manner) cannot be supposed to Volunteer for the aforesaid clinical testing. This Hon'ble Court is requested to kindly adjudge as to whether the respondents have ensured the 'Voluntariness of the young toddlers' for allegedly volunteering as subject matter of the aforesaid elinical trial which involves very clear possibility of loss of life and/ or loss of peaceful and pleasant enjoyment of life to a toddler/ minor child."

The plea also avers that such a volunteer is also required to enter into a contract with the Institute carrying the clinical trial for various aspects dealing with the compensation, damages in case the clinical trial fails and is also required to give his/her consent that he/she has understood the entire agreement and is willing to volunteer for the clinical trial on the terms and conditions stipulated in the written contract.

"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 volunteers (who are all minors and hence not competent to contract) as the same is in the teeth of sec 2(g), 10, 11 & 12 of the Indian Contract Act, 1872." The plea submits.

In view of this, the plea states that the Order does not provide any details of the parents or legal guardians or persons who have come into contact to such minors amongst the 525 children.

"For that in any view of the matter, the impugned order violates Article 21 of the Constitution of India, Preamble and Article-6 of the United Nations Convention on the Rights of the Child, 1990 to which India is a signatory and hence a State Party, The Principles inherent under the Indian Contract Act 1872 as well as the other settled principles of law and natural justice." The plea submits further.

The plea states the following prayers:

- Quash and set aside the Impugned Order dated 13/05/2021 passed by the respondents for conducting phase II,III clinical trial of Whole Virion Inactivated Coronavirus Vaccine on healthy volunteers from the age group ranging between 2 to 18 years. 

- Direct the respondents to place on record the details of the 525 children who will be subjected to phase II/III clinical trial of Whole Virion Inactivated Coronavirus Vaccines also the records of vaccination of their parents/ legal guardians and family members and other persons who come in close contact of such toddlers/ children for taking their care.

- Direct the respondents to produce the contracts under which the 525 children have been/ would be made Volunteers for the phase II/III clinical trial of Whole Virion Inactivated Coronavirus Vaccine.

- Direct 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 life of any toddler or a minor children.