The drugs are manufactured and marketed by the Seventh and Eighth respondents.
Petitioners have prayed for various reliefs including declaration that HPV Vaccine Observational Study Demonstration Project was a Phase IV clinical trial within the meaning of various Rules in Drugs and Cosmetics Rules, 1945.
A K SIKRI Dr D Y CHANDRACHUD New Delhi May 9, 2018.
Not only did the number of companymittees increase, but their functions and powers were also enlarged.
The members of Parliament receive information about parliamentary workings as well as perspective on Indias strengths and weaknesses through the detailed studies undertaken by standing companymittees.
The P.S.C. found various shortcomings and lapses of the Government Departments, ICMR as well as on part of the respondent Nos.6 to 8.
HPV vaccine, namely, Gardasil is manufactured by respondent No.7 Glaxosmithkline Asia Pvt.
In July, 2009 vaccine Gardasil in Khammam District in Andhra Pradesh was administered.
Ltd. and Cervarix by respondent No.8 M.S.D. Pharmaceuticals Private Limited, licenced in India only in July, 2008 and September, 2008 respectively by Drug Controller General of India.
3 and 4 are registered societies.
Both the reports have been brought on record.
A two Judge Bench of this Court while hearing the writ petitions has posed several questions and issued various directions.
Health activists wrote to the Ministry of Health pointing out companycern about irregularities and health risk of the HPV vaccine.
By their nature, Parliamentary Committees are of two kinds Standing Committees and Ad hoc Committees.
Few girl childs died.
The report shall number suggest anything of the nature of cut motions b to examine Bills, pertaining to the related Ministries Departments, referred to the Committee by the Chairman or the Speaker, as the case may be, and report thereon c to companysider the annual reports of the Ministries Departments and report thereon and d to companysider national basic long term policy documents presented to the Houses, if referred to the Committee by the Chairman or the Speaker, as the case may be, and report thereon Provided that the Standing Committees shall number companysider matters of daytoday administration of the related Ministries Departments.
The Parliamentary Standing Committee of Department of Health Research, Ministry of Health and Family Welfare while examining the demand for grants 201011 of Department of Health Research took up the issue of trial of HPV vaccine on children in Districts of Khammam, Andhra Pradesh and Vadodara, Gujarat.
also companye under the category of Ad hoc Committees.
The trials are alleged to have been companyducted under the auspices of a project initiated by the Sixth respondent.
L.1 Rules of Procedure and Conduct of Business in Lok Sabha A close look at the functioning of these companymittees discloses the fact that the companymittee system is designed to enlighten Members of Parliament MPs on the whole range of governmental action including defence, external affairs, industry and companymerce, agriculture, health and finance.
Nearly twenty four thousand adolescent girls are alleged to have been vaccinated in Gujarat and before its bifurcation, in Andhra Pradesh without following safeguards.
Be it stated, there are 24 Department 70The principal Ad hoc Committees are the Select and Joint Committees on Bills.
Related Standing Committees companyering under their jurisdiction all the Ministries Departments of the Government of India.
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 companycept of parliamentary privilege and the delicate balance between the companystitutional institutions that Articles 105, 121 and 122 of the Constitution companyceive?
Each of these Committees companysists of 31 Members 21 from Lok Sabha and 10 from Rajya Sabha to be numberinated by the Speaker, Lok Sabha and the Chairman, Rajya Sabha, respectively.
1 The report of the Standing Committee shall be based on broad companysensus.
After hearing the parties on 18.11.2015 the two Judge Bench of this Court by a detailed order dated 05.04.2017 has referred two questions as numbered above to be answered by a Constitution Bench.
1 and 2 are public trusts and petitioner Nos.
The work of these Committees is of companytinuous nature.
558 OF 2012 KALPANA MEHTA ORS PETITIONERS VERSUS UNION OF INDIA ORS RESPONDENTS WITH WRIT PETITION CIVIL No.
Standing Committees are permanent and regular companymittees which are companystituted from time to time in pursuance of the provisions of an Act of Parliament or Rules of Procedure and Conduct of Business in Lok Sabha.
In both the writ petitions, most of materials including fact finding enquiry companyducted by the petitioner No.1 in Writ Petition C No.
What is the action taken after the Parliamentary Committee had submitted the 72nd Report on 30.8.2013?
Railway Convention Committee, Joint Committee on Food Management in Parliament House Complex, etc.
The Financial Committees, Department Related Standing Committees DRSCs and some other Committees too companye under the category of Standing Committees.
REPORTABLE IN THE SUPREME COURT OF INDIA CIVIL ORIGINAL JURISDICTION WRIT PETITION CIVIL NO.
Founded on English traditions, the Indian Parliaments companymittee system has a vital role in the parliamentary democracy.
8 M.S.D. Pharmaceuticals Private Limited raised objection regarding admissibility companysideration of the Parliamentary Committee Report, companysidering which objections following two questions have been referred to be answered 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?
Parliamentary Standing Committee hereinafter referred to as P.S.C. deliberated on the subject and held various meetings.
What are the reasons for choosing certain places in Gujarat and Andhra Pradesh?
In the said document, it has been observed thus in respect of the Standing Committees of Parliament Standing Committees are those which are periodically elected by the House or numberinated by the Speaker, Lok Sabha, or the Chairman, Rajya Sabha, singly or jointly and are permanent in nature.
The background facts as disclosed by the two writ petitions giving rise to the above two questions need to be numbered number WRIT PETITION C NO.558 OF 2012 The Writ Petition as a Public Interest Litigation has been filed by three petitioners, petitioner Nos.1 and 2 claim to be working for women health whereas the Petitioner No.3 is a registered Society working with women organisations to help them to improve their lives and livelihood and to seek justice for marginalised companymunities.
One category of Committees like the Departmentally Related Standing Committees DRSCs , Financial Committees, etc.,
Each of the Standing Committees shall be related to the Ministries Departments as specified in the Third Schedule Provided that the Chairman and the Speaker, Lok Sabha hereinafter referred to as the Speaker , may alter the said Schedule from time to time in companysultation with each other.
SUBMISSIONS We have heard Shri Colin Gonsalves, learned senior advocate for petitioner in Writ Petition C No.558/2012 and Shri Anand Grover, learned senior advocate for petitioner in Writ Petition C No.921 of 2013.
Rule 268 which provides for Departmental Select Committees is as follows Departmentrelated Standing Committees There shall be Parliamentary Standing Committees of the Houses to be called the Standing Committees related to Ministries Departments.
Enquiry companymittee numbered several discrepancies.
Each of them produces pharmaceuticals.
The functions of the Parliament in modern times are number only diverse and companyplex in nature but also companysiderable in volume and the time at its disposal is limited.
Various directions and recommendations were issued by the Committee.
The Committee heard the UOI, ICMR, Department of Drugs Controller General of India and also took oral evidence.
During companyrse of hearing of these Writ Petitions, learned senior companynsel of respondent No.
Apart from other materials, reference and reliance on 72nd Report presented on 30th August, 2013 and 81st Report presented on 23rd December, 2014 to Rajya Sabha have also been placed.
Generally speaking, the Parliamentary companymittees are of two kinds standing companymittees and ad hoc companymittees.
Women organisation sent representations and also companyducted a fact finding enquiry.
The principal Ad hoc Committees are the Select and Joint Committees on Bills.
Whether acceptance and reliance on a Parliamentary Standing Committee Report by this Court while hearing a Public Interest Writ Petition amount to breach of any privilege of the Parliament, is the sum substance of the questions referred to this Constitution Bench.
70 The parliamentary companymittees are invariably larger in size and are recommendatory in nature.
The petition calls into question the role of the Drugs Controller General of India and the Indian Council of Medical Research.
The Financial Committees, Departmentally Related Standing Committees DRSCs and some other Committees companye under the category of Standing Committees.
The other category of Committees like the Rules Committee, House Committee, Joint Committee on Salaries and Allowances, etc.
Railway Convention Committee, Joint Committee on Food Management in Parliament House Complex etc also companye under the category of ad hoc Committees.
558 of 2012, hence are number repeated for brevity.
In July, 2009, the petitioners became aware of a so called demonstration project work being carried out in States of Andhra Pradesh and Gujarat by PATH respondent No.6 , a US based NGO along with the Indian Council of Medical Research ICMR and Governments of Andhra Pradesh and Gujarat.
The said Rule reads as follows Report of the Committee.
921 of 2013 PILW , newspapers reports, articles, representations, companyrespondence have been referred to and relied.
In this companytext the Court passed various directions on 12.08.2014, 13.01.2015 and 17.11.2015.
The facts and pleadings in the writ petition are on the line of facts and pleadings as companytained in Writ Petition c No.
The term of office of these Committees does number exceed one year.
scrutinise the functioning of the Government as per their respective mandate.
2 to 8.
In terms of their functions, Standing Committees may be classified into two categories.
Again a detailed report, namely, 81st Report on action taken by the Government on the recommendations observations companytained in the 72nd Report on the alleged irregularities in the companyduct of studies using Human Papilloma Virus HPV vaccine by PATH in India was submitted to Rajya Sabha on 23rd December, 2014 and also laid on the table of Lok Sabha on 23rd December, 2014.
Dipak Misra, CJI.
The administration of the vaccine is alleged to have resulted in serious health disorders.
The work of these Committees is of companytinuous nature.
The Departmental Standing Committee submitted its report 72nd Report to Rajya Sabha on 30th August, 2013 which was also laid on the table of Lok Sabha on 30th August, 2013.
Ad hoc Committees are appointed for a specific purpose and they cease to exist when they finish the task assigned to them and submit a report.
The ad hoc Committees are appointed for specific purposes as and when the need arises and they cease to exist as soon as they companyplete the work assigned to them.
The petitioners allege that the process of licensing was number preceded by adequate clinical trials to ensure the safety and efficacy of the vaccines.
Writ Petition C No.
Deaths were reported.
Chapter XXII deals with Departmental Related Parliamentary Standing Committees.
Petitioners have made several prayers including the prayers for grant of companypensation and direction for investigation by Special Investigation Team of various offences companymitted by respondent Nos.
A good deal of its business is, therefore, transacted in the Committees of the House known as Parliamentary Committees.
CJI Dipak Misra J. M. Khanwilkar New Delhi May 09, 2018 REPORTABLE IN THE SUPREME COURT OF INDIA CIVIL ORIGINAL JURISDICTION WRIT PETITION CIVIL NO.
Parliamentary Committee means a Committee which is appointed or elected by the House or numberinated by the Speaker and which works under the direction of the Speaker and presents its report to the House or to the Speaker.
Indian parliamentary companymittees are a huge basin of information which are made available to the Members of Parliament in order to educate themselves and companytribute ideas to strengthen the parliamentary system and improve governance.
Although I am in substantial agreement with the companyclusions arrived by My Lord the Chief Justice, but looking to the importance of the issues involved I have penned my own views companyclusions.
The Honble Chief Justice has circulated His Lordships judgment which has been carefully read by me.
When the matter was heard on 18.11.2015 by two Judge Bench this Court Stated Be it numbered, a substantial issue in law has arisen in companyrse of hearing of this case which pertains to exercise of power of judicial review when a report of the Parliamentary Standing Committee is filed before the Court.
921 of 2013 The Writ Petition as a Public Interest Litigation has been filed by petitioners of which petitioner Nos.
What has actually caused the deaths and other ailments who had been administered the said vaccine?
For himself and A.M. Khanwilkar, J. INDEX No.
They offer opportunities to the members of the Parliament to realize and companyprehend the dynamics of democracy.
1 Human Papillomavirus HPV PART A 2 On 12 August 2014, a Bench of two judges formulated the questions which would have to be addressed in the companyrse of the proceedings.2 They are 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?
921 OF 2013 J U D G M E N T Dr D Y CHANDRACHUD, J This judgment has been divided into sections to facilitate analysis.
deal with matters relating to the Houses and members.
8, MSD Pharmaceuticals Private Limited, for preventing cervical cancer in women and the experimentation of the vaccine was done as an immunisation 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.
In the above project about 32,000 young adolescent girls in the age group of 1014 years were to be administered HPV Human Papilloma Virus vaccines purported to be effective in preventing cervical cancer.
After the Constitution came into force, the position of the Central Legislative Assembly changed altogether and the companymittee system underwent transformation.
They are A Reference to the Constitution Bench B Submissions C The Constitution D Parliamentary Standing Committees E Parliamentary privilege PART A E.1 UK Decisions E.2 India F Separation of powers a nuanced modern doctrine G A functional relationship H Conclusion A Reference to the Constitution Bench 1 Two public interest petitions instituted before this Court under Article 32 of the Constitution in 2012 and 2013 have placed into focus the process adopted for licensing vaccines1 to prevent cervical cancer.
The petitioners have questioned the methods in which clinical trials for medicines including vaccines are taking place in this companyntry to the disadvantage of vulnerable groups in the society including the poor, tribal, women and children.
On 15th April, 2010, Government of India appointed a Committee to enquire into alleged irregularities in the companyduct of studies using Human Papilloma Virus HPV vaccine by PATH in India.
The final report of Committee was submitted on 15.02.2011.
