SUPREME COURT OF INDIA
Dipak Misra, Rohinton Fali Nariman, JJ.
Kalpana Mehta and Others – Petitioner(s)
Versus
Union of India and Others – Respondent(s)
WRIT PETITION (CIVIL) NO. 558 OF 2012 WITH WRIT PETITION (CIVIL) NO. 921 OF 2013
Decided On : 05-04-2017
(2007) 3 SCC 184; (2011) 10 SCC 529; (1982) 1 SCC 271; AIR 1960 SC 1186; (1992) 4 SCC 506; (2013) 7 SCC 1; (1986) 5 NSWLR 18; [2008] EWHC 737 (Adnin); 1992 Supp (3) SCC 217; (1969) 1 SCC 292; (1971) 2 SCC 779; (1973) 4 SCC 225; (2014) 9 SCC 1; (2009) 10 SCC 564; AIR 1963 SC 1241; AIR 1981 SC 1922; (1996) 1 SCC 130; (2013) 6 SCC 1; (1972) 1 SCC 298; (1976) 3 SCC 108; (1999) 4 SCC 306 – Referred
(b) Interpretation of statute – External aids – Constituent Assembly debates, reports of the Parliamentary Standing Committee and the speeches made in the Parliament or debates held in Parliament – Reference thereto only meant for understanding the Constitution or the legislation – Similarly report of a statutory committee cannot be received as evidence of facts stated in the report. (Para 38, 40)
[1983] 2 All ER 233; (2013) 16 SCC 538 – Referred
(c) Constitution of India – Articles 105, 118, 121, 122 and 32 – Judicial review – Court should exercise restraint in placing reliance on report of Parliamentary Standing Committee – Court, in a lis, should not advert to view of a member of the Parliament or a member of the Parliamentary Standing Committee. (Para 47)
[2001] 1 A.C. 395 – Referred
(d) Constitution of India – Article 32 – Judicial review – Issue of writ of mandamus – Parliamentary Standing Committee report may not be tendered as a document in support of the factual score that a particular activity is unacceptable or erroneous. (Para 51)
Facts of the case:
This case pertains 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.
Finding of the Court:
The issue need s to be referred to Constitution Bench.
Result: Following issues referred to the Constitution Bench under Article 145(3):
(i) Whether in a litigation filed before this Court either under Article 32 or Article 136 of the Constitution of India, the Court can refer to and place reliance upon the report of the Parliamentary Standing Committee?
(ii) Whether such a Report can be looked at for the purpose of reference and, if so, can there be restrictions for the purpose of reference regard being had to the concept of parliamentary privilege and the delicate balance between the constitutional institutions that Articles 105, 121 and 122 of the Constitution conceive?
JUDGMENT
Dipak Misra, J.
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.”
4. In the course of proceedings, affidavits were filed by the Union of India and the State of Gujarat. Learned counsel for the petitioners, Mr. Colin Gonsalves in Writ Petition (C) No. 558 of 2012 and Mr. Anand Grover in Writ Petition (C) No. 921 of 2013 had drawn the attention of this Court to the 81st Report dated 22nd December, 2014 of the Parliamentary Standing Committee. Be it noted, when the report of the Parliamentary Standing Committee was produced, the question arose with regard to the “concept of consent” for administration of vaccine and the resultant illness suffered by the victims and such other issues and the Court had issued certain directions for filing of affidavits pertaining to steps that have been taken by the concerned Governments keeping in view the various instructions given from time to time including what has been stated in the report of the Parliamentary Standing Committee.
5. It is worthy to note here that certain affidavits were filed about the safety measures being undertaken with regard to the
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