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2015 Supreme(SC) 1315

SUPREME COURT OF INDIA
Dipak Misra, Prafulla C. Pant, JJ.
Kalpana Mehta & Ors. - Petitioners
Versus
U.O.I. & Ors. – Respondents
Writ Petition (Civil) No. 558 of 2012 With W.P.(C) No. 921 of 2013. Decided On : 13-01-2015

Advocates Appeared:
For the Petitioner:- Mr. Colin Gonsalves, Sr. Advocate., Ms. Abhiti Gupta Advocate., Ms. Jyoti Mendiratta, AOR., Mr. Anand Grover, Sr. Adv. Mr. Mihir Samson Advocate Ms. Lorraine Misquith Advocate Mr. Purushottam Sharma Tripathi, AOR Mr. Mukesh Kumar Singh Advocate.
For the Respondent:- Mr. P.S. Patwalia, ASG Mr. Gaurav Goyal Advocate Ms. N. Annapoorani, AOR Mr. R.S. Suri, Sr. Adv. Mr. Charul Sarin Advocate Mr. A. Deb Kumar Advocate Ms. Sushma Suri Advocate Mr. D.S. Mahra, AOR Mr. C.A. Sundaram, Sr. Adv. Ms. Krishna Sarma Advocate Ms. Manisha Singh Advocate Mr. Navnit Kumar Advocate Ms. Vartika Walia Advocate for M/s Corporate Law Group Mr. Shyam Divan, Sr. Adv. Ms. Jaya Krishnan Advocate Mr. Riku Sarma Advocate Ms. Barnali Das Advocate for M/s Corporate Law Group Mr. Gourab banerji, Sr. Adv. Mrs. Nandini Gore Advocate Ms. Aditi Bhatt Advocate Mr. Kartik Bhatnagar Advocate Ms. Tahira Karanjawala Advocate Mr. Abhishek Roy Advocate Mrs. Manik Karanjawala Advocate for M/s. Karanjawala & Co. Ms. Hemantika Wahi, AOR Ms. Swati Vaibhav Advocate Ms. Preeti Bhardwaj Advocate Ms. Sanjana Ramachandran Advocate for M/s. Parekh & Co. Mr. Guntur Prabhakar, AOR Ms. Prerna Singh Advocate Mr. S. Udaya Kumar Sagar, AOR Mr. Krishna Kumar Singh Advocate.

Headnote:

Condo nation of delay – Actually caused the deaths – Acquittal - Compensation - Assuming this vaccine has been administered, regard being had to nature of vaccine, being not an ordinary one what steps have been taken for monitoring same by competent authorities of the Union of India who are concerned with health of nation as well as State Governments who have an equal role in this regard – Held, Next issue that Court intend to address today relates to concept of consent and the resultant deaths - It is submitted that though innovative explanations have been given by stating that some girls in States of Gujarat and have expired due to snake bite and fever yet in actuality it is due to administration of vaccination - It is also urged by that though number of vaccinations that have been carried out for the purpose of experimentation there is no data with regard to adverse effects that have been faced by young girls - Learned senior counsel appearing for Union of India learned counsel appearing for State of Gujarat and learned counsel appearing for the State of, shall state by way of affidavit, what is procedure to be protocol to be followed while obtaining consent - Stand taken by Union of India and the States shall be clear and in consonance with law for affidavit is not expected to be filed in contravention of what has been envisaged in law - At present Court are obliged to state that present public interest litigation has to be perceived from the point of view of rectification, if any, and caution for the future. When we use the word rectification Court mean apart from questions which have been posed earlier factum of consent and procedure followed in consent and sequitur of such consent are to be kept in view learned senior counsel appearing for petitioner in W.P.(C) and learned senior counsel for petitioner in drawn our attention Parliamentary Standing Committee - On a perusal of said Report Court find some defects being noticed and certain suggestions have been given learned senior counsel appearing for Union of India shall obtain instructions from competent authorities of Union of India as to what steps are being thought of on basis of aforesaid Report – Order accordingly

ORDER

On 12th August, 2014, Kalpana Mehta v. Union of India, WP (C) No. 558 of 2012, order dated 12-8-2014 (SC) while dealing with the controversy at length, this Court had posed the following questions:

"(i) Whether before the drug was accepted to be used as a vaccine in India, the Druges 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?"

2. After posing the questions, the Court had proceeded to express thus:

"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. Glaxosmithkline 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.

The Learned counsel for the Union of India shall apprise this Court what steps have been taken by the Union of India on the basis of the Parliamentary Committee Report.

Counsel for the State, who have appeared, shall file their counter affidavits within a period of four weeks. The Union of India shall also file their counter affidavit in W.P.(C) No.921/2013 within four weeks.

Rejoinder affidavit, if any, be filed within two weeks therefrom. By the same time, rejoinder affidavit to the counter affidavit filed by PATH International be filed. Mr. Dipank Yadav, Advocate, who appears for ICMR shall also produce the file of ICMR dealing with this vaccine by the next date.

Let the writ petitions be listed on 28.10.2014."

3. Mr. Colin Gonsalves, learned senior counsel appearing for the petitioner in W.P.(C) 558 of 2012 and Mr. Anand Grover, learned senior counsel for the petitioner in W.P.(C) No.921 of 2013, have drawn our attention to the 81st Report dated 22nd December









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