Dipak Misra, J. - (1.) Though the present writ petitions were preferred in the years 2012 and 2013 and the debate had centered around on many an aspect relating to action taken by the Drugs Controller General of India and the Indian Council of Medical Research (ICMR) pertaining to approval of a vaccine, namely, Human Papilloma Virus (HPV) manufactured by the respondent No. 7, M/s. GlaxoSmithKline Asia Pvt. Ltd. and the respondent No.8, MSD Pharmaceuticals Private Limited, respectively for preventing cervical cancer in women and the experimentation of the vaccine was done as an immunization by the Governments of Gujarat and Andhra Pradesh (before bifurcation, the State of Andhra Pradesh, eventually the State of Andhra Pradesh and the State of Telangana) with the charity provided by the respondent No.6, namely, PATH International. The issue also arose with regard to the untimely death of certain persons and grant of compensation. Certain orders were passed by this Court from time to time.
(2.) A stage came in the life span of this litigation, which is still in continuation, when the Court vide order dated 12th August, 2014, had posed the following questions:- "i) Whether before the drug was accepted to be used as a vaccine in India, the Drugs Controller General of India and the ICMR had followed the procedure for said introduction? ii) What is the action taken after the Parliamentary Committee had submitted the 72nd report on 30.08.2013? iii) What are the reasons for choosing certain places in Gujarat and Andhra Pradesh? iv) What has actually caused the deaths and other ailments who had been administered the said vaccine? v) Assuming this vaccine has been administered, regard being had to the nature of the vaccine, being not an ordinary one, what steps have been taken for monitoring the same by the competent authorities of the Union of India, who are concerned with health of the nation as well as the State Governments who have an equal role in this regard? vi) The girls who were administered the vaccine, whether proper consent has been taken from their parents/guardians, as we have been apprised at the Bar that the young girls had not reached the age of majority? vii) What protocol is required to be observed/followed, assuming this kind of vaccination is required to be carried out?"
(3.) In the said order, the Court had also directed as follows:- "At this juncture, we are obligated to state the Union of India, who is required to assist this Court in proper perspective, shall direct its competent authority to produce the file by which the Drugs Controller General of India had approved the vaccine for introduction in India. Mr. Suri, learned senior counsel for the Union of India will produce the said file. Additionally, the relevant documents shall also be provided to the concerned counsel for the petitioners.";