caselaws
Supreme Court of India
Delhi Commission For Protection … vs Union Of India on 25 January, 2022Author: Hon’Ble Dr. Chandrachud
Bench: Hon’Ble Dr. Chandrachud, Sanjiv Khanna
WP(C) 572/2021
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Reportable
IN THE SUPREME COURT OF INDIA
CIVIL ORIGINAL JURISDICTION
Writ Petition (Civil) No 572 of 2021
Delhi Commission for Protection of Child Rights Petitioner(s)
Versus
Union of India and Another Respondents
JUDGMENT
Dr Dhananjaya Y Chandrachud, J
1 These proceedings under Article 32 of the Constitution have been instituted
by the Delhi Commission for Protection of Child Rights 1. The specific reliefs
which have been sought concern the need to provide effective access to
vaccination to pregnant women and lactating mothers. These reliefs can
broadly be summarized as follows:
(i) Categorization of pregnant women and lactating mothers as belonging
to the high risk category to be given priority in vaccination;
1 “DCPCR”
Signature Not Verified
Digitally signed by
DEEPAK SINGH
Date: 2022.02.02
16:44:12 IST
Reason:
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(ii) Their inclusion in the vaccination drives and setting up of a task force to
operationalize a standard operating procedure 2 for monitoring of their
health post vaccination;
(iii) Developing educational materials and SOPs for women belonging to this
group to understand the effects of vaccination and ensure informed
consent;
(iv) Creation of a registry for vaccinated pregnant women and lactating
mothers to allow effective and constant monitoring of their health;
(v) Setting up of separate vaccination centers to protect this class of
persons from untoward infection;
(vi) Engaging Anganwadi centres and ASHA workers for vaccination drives
as a method of outreach particularly for women belonging to
underprivileged socio economic backgrounds; and
(vii) Providing an option on the Co-WIN portal so as to allow pregnant women
and lactating mothers to classify and identify themselves such that they
can be given priority while providing slots for vaccination.
2 Initially, a preliminary affidavit was filed on 2 October 2021 by the Additional
Commissioner in the Union Ministry of Health and Family Welfare 3. The
affidavit has detailed out steps taken for (i) constituting the National
2 “SOP”
3 “MoHFW”
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Technical Advisory Group on Immunization 4 and National Expert Group on
Vaccination Administration for Covid-195; (ii) steps taken for supporting the
vaccination of pregnant women; (iii) steps taken for tracking Adverse Events
Following Immunization6; and (iv) support provided through vaccination
centres and ASHA and Anganwadi workers. The affidavit states that:
(i) Initially, pregnant women and lactating mothers were not eligible for
the COVID-19 vaccination as there was no sufficient evidence regarding
its safety and efficacy. Subsequently, the World Health Organization and
other experts recommended that the benefits of the vaccine for this
group outweigh its potential risks;
(ii) Based on the recommendations of experts, a national consultation was
held on the subject with representatives of State Governments, medical
colleges, Federation of Obstetric and Gynecological Societies of India
(FOGSI), NGOs, among others, to gain consensus on the subject of
vaccinating pregnant women and lactating mothers and spreading
awareness regarding the vaccination drive;
(iii) The MoHFW approved the vaccination of pregnant women on 2 July
2021 and vaccination for lactating mothers was approved on 19 May
2021. Operational guidelines for vaccination of pregnant women were
released on 2 July 2021, which recommended that all pregnant women
visiting for antenatal care should be informed of the risks and benefits
4 “NTAGI”
5 “NEGVAC”
6 “AEFI”
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of COVID-19 vaccines and their likely side effects;
(iv) The MoHFW has directed all States and Union Territories to engage with
professional bodies such as FOGSI, Indian Medical Association, Indian
Academy of Paediatrics, National Neonatology Forum;
(v) Since the full impact of the vaccines on pregnancy outcomes for the
woman and the fetus are unclear, all AEFIs are monitored through a
well-structured and robust surveillance system. For this purpose,
National AEFI Surveillance Operational Guidelines and COVID-19
Operational Guidelines have been formulated;
(vi) A causality assessment is conducted by the designated AEFI committee
and AEFI amongst the beneficiaries of vaccination are reported by the
vaccinator or District Immunization Officer through the Co-WIN portal;
(vii) A multi-centric project to study and document the adverse events
occurring in pregnant women vaccinated with the COVID-19 vaccine is
being initiated across the country;
(viii) All pregnant women who are vaccinated are line-listed on the Co-WIN
portal with their demographic details and any AEFI reported is also
entered on the portal to ensure that a tracking mechanism is
maintained;
(ix) As regards the vaccination drive for pregnant women and lactating
mothers, States/UTs have been advised that they may prioritize
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vaccination through strategies like dedicated time period for
vaccination of pregnant women and lactating mothers, designate
special days for their vaccination, and identify centres for vaccination
of this group;
(x) ASHA and Anganwadi workers form a critical support system as frontline
workers by linking the vaccine beneficiaries and the service providers.
Thus, dedicated Information Education Communication material has
been developed for frontline workers (including ASHA and Anganwadi
workers and vaccinators); and
(xi) An option has been provided on the Co-WIN portal to identify a woman
as pregnant to ensure the woman can get vaccinated at the nearest
centre.
3 On 3 December 2021, this Court directed the petitioner to formulate
concrete suggestions to strengthen the existing framework of vaccination of
pregnant women and lactating mothers and share it with the Union
Government. The petitioner shared these suggestions and thereafter, a
further affidavit dated 13 January 2022 has been filed by the Union
Government which has particularly dealt with AEFIs and the mechanism for
identification of pregnant women and lactating mothers, in response to the
petitioner’s suggestions. The affidavit states that:
(i) Regarding the declaration and identification of pregnant women and
lactating mothers at the time of vaccination, only a verbal declaration,
on a purely voluntary basis, is required regarding the status of
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pregnancy/lactation, which can be verified at the time of vaccination.
Once the declaration is made, the vaccinator provides the beneficiary
with information about risks of COVID-19 infection in pregnancy, the
benefits and side-effects of vaccination;
(ii) The guidelines issued by MoHFW require reporting of any suspected
AEFI irrespective of the time interval between the day of vaccination
and the day of onset of symptoms. Thus, there is no time limitation for
reporting AEFIs;
(iii) The current AEFI surveillance system collects data of all adverse events
related to COVID-19 vaccine beneficiaries, including pregnant women or
lactating mothers. Under this system, (a) the District Immunization
Officers have been instructed to set up a network with private hospitals
to report AEFIs; (b) training has been given to State officers, medical
officers, private practitioners and frontline health workers on their role
in AEFI surveillance; (c) Auxiliary Nurse Midwifes at block/planning unit
have been instructed to notify all AEFIs and medical officers have been
instructed to look for any patterns; (d) pregnant women are being given
antenatal care services through government or private health care
facilities;
(iv) Medical treatment is being provided free of cost to beneficiaries who
suffer AEFIs in all government health institutions. States/UTs have been
asked to identify at least one AEFI management centre in each block.
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Additionally, MoHFW has established a patient to doctor telemedicine
platform;
(v) Regarding the publication of data, the affidavit states that once the
causality assessment is done, the data regarding AEFIs is made
available in public domain on the website of MoHFW. Since all AEFIs
following vaccination may not be causally linked to the vaccination,
publication of data without causality assessment is inappropriate as it
may increase vaccination hesitancy; and
(vi) Regarding the creation of the specific filter on the Co-WIN portal for
pregnant women and lactating mothers, the affidavit states that this
group has to be identified and counselled before the vaccination and
there is no method of verification at the time of booking of slots.
4 We have heard Ms Vrinda Grover, learned counsel appearing on behalf of the
petitioner and Ms Aishwarya Bhati, learned Additional Solicitor General. An
intervention application has been filed by Mr Ambar H Koiri, who is
represented by Mr Nilesh Ojha.
5 During the course of her submissions, Ms Vrinda Grover, learned counsel has
submitted that the affidavits which have been filed by the Union of India
would substantially resolve the concerns which have been raised in the
petition. Learned counsel submitted that DCPCR instituted these
proceedings with the object of ensuring that vaccination for pregnant women
and lactating mothers is taken up on a priority.
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6 The decision to enable vaccination for lactating mothers was taken on 19
May 2021 while the decision to permit vaccination for pregnant women was
announced on 2 July 2021. The Court has been apprised of the fact that in
taking these decisions, the Government has been guided by its own expert
groups as well as by a consensus which has evolved at the international
level through the World Health Organization.
7 Learned counsel appearing on behalf of the petitioners has highlighted three
concerns which, according to the petitioners, remain and which may be
addressed at a suitable level by the government. We shall outline the
concerns which have been presented during the course of the oral
submissions by Ms Vrinda Grover, seriatim:
Firstly, it has been submitted that the framework for vaccination of pregnant
women and lactating mothers envisages a voluntary verbal declaration by
the person who seeks vaccination, at the time of registration. In this context,
it has been submitted that the woman who visits a vaccination centre may
not necessarily be aware of the need to make such a declaration and in the
event that she is not informed by the personnel at the vaccination centre,
the recording of her status either as a pregnant woman or lactating mother
may remain to be incorporated in the data set. Hence, it has been submitted
that if the Co-WIN portal is suitably modified so as to incorporate a
declaration at the time of registration, this would facilitate the monitoring of
the health of the vaccinated woman or mother, as the case may be.
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Secondly, it has been suggested that in order to further support the
surveillance measures which have been instituted by the government for
monitoring AEFIs, targeted tracking of pregnant women and lactating
mothers can be considered so as to bolster the process of monitoring.
Thirdly, it has been emphasized that when adequate data sets become
available, the publication of data will enhance the confidence in the process
of vaccination.
8 Ms Aishwarya Bhati, learned Additional Solicitor General while responding to
the above suggestions submitted that each of the three suggestions has
been carefully evaluated by experts within the Union Government. The
Additional Solicitor General submits that in the ongoing process where
decisions are being continuously evolved, the government has certain
concerns over implementing the suggestions at the present stage but, is
open to further deliberation with the expert bodies.
9 On the first aspect in particular, it has been submitted that with the process
of walk-in-registration, the registration on the Co-WIN portal has become
subsidiary. However, it has been submitted that the reason why it was
believed that a verbal declaration at the time of vaccination would suffice
was to ensure that no person is dissuaded from seeking vaccination by
introducing an additional column at the time of registration. On targeted
tracking, it has been submitted that a robust mechanism has already been
put into place by the Union Government. As regards the publication of data,
it has been submitted that at this stage, such a proposal may be premature,
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but the Union Government is seized of the issue. Moreover, it has been
submitted that the publication of raw data may not be appropriate and the
data is published after due scrutiny and assessment by experts.
10 This Court is cognizant that the suggestions which have been made on
behalf of the petitioners do raise issues of policy. For instance, any mandate
for disclosure at the stage of registration has to factor in and balance
concerns over the privacy of the person. There may well not be one answer
or a single acceptable solution particularly because pregnant women and
lactating mothers belong to different social and economic strata. The
government has to take a decision bearing mind their welfare, safety and
dignity. Likewise, the need to further enhance the existing protocols for
monitoring AEFIs can be carefully evaluated by the expert groups. The
Additional Solicitor General has already stated that data is placed in the
public domain after being scrutinized at an expert level within the
government. The suggestions made before the Court have emanated from a
statutory body. They can be considered with the same sense of cooperation
which has pervaded the judicial process during the hearing of the present
petition.
11 The three suggestions which have been made by the petitioners would
undoubtedly involve an application of domain knowledge by experts in the
area. The Court may not be in the best position to take a decision unaided by
an expert determination. Hence, we are of the view that having regard to the
inclination which has been shown by the Union Government, it would be
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appropriate if the three suggestions which have been outlined earlier are
duly placed before the concerned expert groups as set out in the affidavit of
the Union Government so that the suggestions can be deliberated upon at a
policy level at an appropriate stage. This Court has constituted a National
task Force previously comprised of eminent experts from across the country
and the Union Government may engage with them as well to seek
suggestions for eliciting its views and suggestions in the area. We appreciate
the steps which have been taken by DCPCR in moving these proceedings
and equally, the sense of responsibility with which suggestions have been
made and discussed both by Ms Vrinda Grover appearing for DCPCR and by
Ms Aishwarya Bhati, Additional Solicitor General appearing for the Union
Government in the course of these proceedings.
12 Leaving it open to the Union of India to take a considered view after
evaluating the suggestions, we dispose of the petition.
13 We further note that Mr Nilesh Ojha, counsel appearing on behalf of the
intervenor, has urged before this Court that the intervenor has conducted
studies which reflect that COVID-19 vaccines pose a risk to pregnant women
or the fetus. On this basis, the intervenor has sought a direction from this
Court to stop the administration of vaccination to pregnant women. The
issues raised by the intervenor clearly lie in the policy domain and this Court
cannot take medical decisions regarding the safety of COVID-19 vaccination
among pregnant and lactating persons. The affidavits of the Union of India
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indicate that NTAGI and NEGVAC have taken great care in recommending
vaccination for these groups only after receiving guidance from the World
Health Organization and other domain experts. Thus, we do not find it
necessary to issue any directions to the Union Government as regards this
intervention application.
14 Pending applications, if any, stand disposed of.
……..…………………………………..J.
[Dr Dhananjaya Y Chandrachud]
……..…………………………………..J.
[Sanjiv Khanna]
New Delhi;
January 25, 2022
CKB
WP(C) 572/2021
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ITEM NO.13 Court 4 (Video Conferencing) SECTION PIL-W
S U P R E M E C O U R T O F I N D I A
RECORD OF PROCEEDINGS
Writ Petition (Civil) No.572/2021
DELHI COMMISSION FOR PROTECTION OF CHILD RIGHTS Petitioner(s)
VERSUS
UNION OF INDIA & ANR. Respondent(s)
(With appln.(s) for IA No.63258/2021 – EXEMPTION FROM FILING
AFFIDAVIT)
Date : 25-01-2022 These matters were called on for hearing today.
CORAM :
HON’BLE DR. JUSTICE D.Y. CHANDRACHUD
HON’BLE MR. JUSTICE SANJIV KHANNA
For Petitioner(s) Ms. Vrinda Grover, Adv.
Mr. Kumar Shanu, Adv.
Mr. Soutik Banerjee, Adv.
Ms. Ayushi Rajput, Adv.
Ms. Rangoli Seth, Adv. Mr. Prateek K Chadha, AOR
For Respondent(s) Ms. Aishwarya Bhati, ASG
Mr. Gurmeet Singh Makker, AOR
Mr. Rajat Nair, Adv.
Mr. Kanu Agrawal, Adv.
Ms. Deepabali Dutta, Adv.
Mr. Ketan Paul, Adv.
For Intervener Mr. Nilesh C. Ojha, Adv.
WP(C) 572/2021
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Mr. Prem Sunder Jha, AOR
Mr. Ishwarlal S. Agarwal, Adv.
Ms. Dipali N. Ojha, Adv.
Mr. Pratik Jain Saklecha, Adv.
Mr. Shivam Mehra, Adv.
Mr. Abhishek Mishra, Adv.
Ms. Sidhi A. Dhamnaskar, Adv.
Ms. Snehal S. Surve, Adv.
Ms. Poonam S. Rajbhar, Adv.
Ms. Deepika G. Jaiswal, Adv.
Mr. Mangesh B. Dongre, Adv.
Mr. Pritam Bishwas, Adv.
Mr. Anant Misra, Adv.
UPON hearing the counsel the Court made the following
O R D E R
1 The Petition is disposed of in terms of the signed reportable judgment.
2 Pending applications, if any, stand disposed of.
(CHETAN KUMAR) (SAROJ KUMARI GAUR)
A.R.-cum-P.S. COURT MASTER
(Signed reportable judgment is placed on the file)
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