ORDER On 12.08.2014, Kalpana Mehta v. Union of India, WP (C)No. 558 of 2012, order dated 12.8.2014 (SC) after hearing the learned counsel for the parties at length, this Court had stated that the questions that really cause concern are : "(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 the 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?" 2. After so stating, the Court has proceeded to direct as follows: "Regard being had to the aforesaid concerns, which are posed in the aforesaid questions, we think it apposite that the State of Gujarat, State of Andhra Pradesh and State of Telangana be impleaded as parties. Hence, liberty is granted to the petitioners to take steps to serve standing counsel for the State of Gujarat, Andhra Pradesh and Telangana in both the petitions. Dasti, in addition, is permitted. Be it stated, their appearance shall be in respect of both the petitions. At this juncture, a submission was made to the effect that manufacturing companies, M/s. Glaxo Smith Kline Asia Pvt. Ltd. and MSD Pharmaceuticals Pvt. Ltd. (Respondent no.7 and 8 respectively in W.P.(C) No. 558/2012) should be served. Mr. Jyoti Mendiratta, Advocate, undertakes to take appropriate steps to effect service on the said companies. Dasti, in addition, is permitted. At this juncture, a submission was made to the effect that manufacturing companies, M/s. Glaxo Smith Kline Asia Pvt. Ltd. and MSD Pharmaceuticals Pvt. Ltd. (Respondent no.7 and 8 respectively in W.P.(C) No. 558/2012) should be served. Mr. Jyoti Mendiratta, Advocate, undertakes to take appropriate steps to effect service on the said companies. Dasti, in addition, is permitted. Learned counsel for the petitioners are also granted liberty to effect service on the concerned Ethics Committee of the all the three States. This Court hopes and trust that on the next date of hearing, the Standing Counsel of all the States shall remain present and argue the matter. 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." After the said order came to be passed, an additional affidavit has been filed by the Union of India and the reply thereto has also been filed. It is submitted by Mr. Tushar Mehta, learned Additional Solicitor General that the two files, as directed by this Court, shall be filed before this Court by tomorrow, i.e. 18.11.2015. 3. It is also submitted by Mr. Mehta, that the Rules in question have been amended and the detailed safeguards have been provided prior to taking consent of the person who has expressed her consent for accepting vaccination. Be it noted, learned Additional Solicitor General has further clarified that the Rules do not specifically pertain to vaccination but to all kinds of trial of any drug. Needless to say, learned counsel shall apprise us about the steps taken on the basis of the Parliamentary Committee Report submitted on 30.08.2013. 4. The other aspects shall also be dealt with in accordance with the Rules that have been amended after the affidavit has been filed. 5. Let the matter be listed for hearing on 18.11.2015. It shall be taken at 11.00 a.m. Mr. Gonsalves, learned senior counsel, has taken the burden of arguing first.