IN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES AND SERVICES DURING PANDEMIC versus .
[2021] 4 S.C.R. 297, Supreme Court of India, 2021
Outcome: Directions issued
Segment: Issues
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(Suo Motu Writ Petition (Civil) No. 03 of 2021)
APRIL 30, 2021
[DR. DHANANJAYA Y CHANDRACHUD,
L. NAGESWARA RAO AND S. RAVINDRA BHAT, JJ.]
COVID-19 Pandemic: Suo Motu cognizance of various issues
relating to COVID-19 – Unprecedented humanitarian crisis following
outbreak of COVID-19 pandamic – Issues as regards distribution
of essential supplies and services during pandemic – Issuance of
directions, recommendations and questions to the Government as
regards the medical infrastructure, national policy for admission to
hospitals, oxygen allocation and availability, vaccines capacity and
disbursal and vaccine pricing, potentiality of compulsory licensing
for vaccines and essential drugs, supply of essential drugs, black
marketing and augmentation of health care workforce – Direction
to Union of India to ensure that the deficit in the supply of oxygen
to the Government of National Capital Territory of Delhi- GNCTD
is rectified within the stipulated period – Direction to Central
Government who would in collaboration with the States, prepare a
buffer stock of oxygen for emergency purposes and decentralize
its location – Direction to Central Government and State
Governments that it would notify all Chief Secretaries/Police that
any clampdown on information on social media or harassment caused
to individuals seeking/delivering help on any platform would attract
a
coercive exercise of jurisdiction – Central Government to
formulate a national policy on admissions to hospitals which would
be followed by all State Governments, and till then no patient to be
denied hospitalization or essential drugs in any State/UT for lack
of local residential proof of that State/UT – Issuance of direction to
Central Government to revisit its initiatives and protocols, including
on the availability of oxygen, availability and pricing of vaccines,
availability of essential drugs at affordable prices and on all the
other issues – Judicial notice – Constitution of India.
Constitution of India: Art. 32 - Suo Motu writ petition –
Unprecedented humanitarian crisis following outbreak of COVID-
19 pandamic – Dialogical role of the bench – Held: Jurisdiction
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assumed by this Court under Art. 32 did not automatically lead to
the erosion of High Court’s jurisdiction under Article 226 -
Jurisdiction under Article 226 is important – High Courts may be
better equipped to deal with issues within their own States – However,
this Court assumed jurisdiction over issues in relation to COVID-
19 which traverse beyond state boundaries and affect the nation in
its entirety – Jurisdiction exercised is merely to facilitate a dialogue
of relevant stakeholders, the UOI, the States and this Court, in light
of the pressing humanitarian crisis, and not with a view to usurp
the role of the executive and the legislature – This bounded-
deliberative approach is exercised so that the UOI and States can
justify the rationale behind their policy approach which must be
bound by the human rights framework u/Arts. 21 and 14.
Suo Motu vs State of Gujarat Writ Petition (PIL) No 53
Of 2021; K.S. Puttaswamy (Privacy-9J.) vs Union of
India (2017) 10 SCC 1: [2017] 10 SCR 569 – referred
to.
Sandra Fredman, “Adjudication as Accountability: A
Deliberative Approach” in Nicholas Bamforth and Peter
Leyland (eds), Accountability in the Contemporary
Constitution (Oxford University Press, 2013) ; Theodore
O. Prosise, ‘The collective memory of the atomic
bombings misrecognized as objective history: The case
of the public opposition to the national air and space
museum’s atom bomb exhibit’ - (1998) 62 Western
Journal
of Communication 3:316-347, pg 318 ; Bryan
Hubbard and Marouf A. Hasian, ‘Atomic Memories of
the “Enola Gay” : Strategies of Remembrance at the
National Air and Space Museum’ (1998) 1 Rhetoric and
Public Affairs 3:363-385, pg 364; Austin Sarat and
Thomas R. Kearns, History, Memory, and the Law
(University of Michigan Press, 2009) pgs 12-13; Nicole
Maurantonio, “The Politics of Memory” in Kate Kenski
and Kathleen Hall Jamieson (eds), The Oxford
Handbook of Political Communication (Oxford
University Press, 2014); Elena N. Naumova, ‘The traps
of calling the public health response to COVID- 19 “an
unexpected war against an invisible enemy” (2020)
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Journal of Public Health Policy (2020) 41:233-237,
pg 233 – referred to.
Council for Trade-Related Aspects of Intellectual
Property Rights, Waiver From Certain Provisions Of The
Trips Agreement For The Prevention, Containment And
Treatment Of Covid-19, Communication From India And
South Africa, IP/C/W/669, 2nd October, 2020,
available at https://docs.wto.org/dol2fe/Pages/SS/
d i r e c t d o c . a s p x ? f i l e n a m e = q : / I P / C /
W669.pdf&Open=True; COVID-19 IP Policy Tracker
(WIPO, 16 July 2020), available at https://www.wipo.int/
covid19-policy- tracker/#/covid19-policy-tracker/
access;“Managing the COVID-19 infodemic: Promoting
healthy behaviours and mitigating the harm from
misinformation and disinformation - Joint statement by
WHO, UN, UNICEF, UNDP, UNESCO, UNAIDS, ITU,
UN Global Pulse, and IFRC” (WHO, 23 September
2020) available at <https://www.who.int/news/item/ 23-
09-2020- managing-the-covid-19-infodemic-promoting-
healthy-behaviours- and-mitigating-the-harm-from-
misinformation- and-disinformation>;“Social media &
COVID-19: A global study of digital crisis interaction
among Gen Z and Millennials” (WHO, 23 September
2020) available at <https://www.who.int/news-room/
feature-stories/detail/social-media-covid-19-a- global-
study-of-digital-crisis-interaction-among-gen-z-and-
millennials>; Jonathan Freedland, ‘History suggests we
may forget the pandemic sooner than we think (The
Guardian, 29 January 2021) available at <https://
www.theguardian.com/commentisfree/2021/jan/29/
history-forget- pandemic- spanish-flu-covid>; Luke
Shors, ‘Waging Another Public Health “War?” (Think
Global Health, 26 February 2020) available at <https:/
/www.thinkglobalhealth.org/article/waging- another-
public-health-war> – referred to.
Case Law Reference
[2017] 10 SCR 569
referred to
Para 63
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CIVIL ORIGINAL JURISDICTION : Suo Motu Writ Petition
(Civil) No. 03 of 2021.
Tushar Mehta, SG, Ms. Aishwarya Bhati, ASG, Anil Grover, Sr.
AAG, Ms. Bansuri Swaraj, Ms. Garima Prashad, Arunabh Chowdhury,
Krishnaraj Thaker, AAGs., Mahendra Singh Singhvi, Adv. Gen., S. C.
Verma, Adv. Gen. (Chhattisgarh), Purushainder Kaurav, Adv. Gen. (MP),
Vivek Kolhi, Adv. Gen. (Sikkim), Amit Kumar, Adv. Gen (Meghalaya),
Atul Nanda, Adv. Gen, (Punjab), Jaideep Gupta, Ms. Meenakshi Arora,
Maninder Singh, Ms. Manisha Lavkumar, Dr. Abhishek Manu Singhvi,
Vikas Singh, Pradeep Kumar Rai, Ms. Mahalakshmi Pavani, Brijender
Chahar, Ms. Sonia Mathur, Vikas Pahwa, Rahul Mehra, Anand Grover,
Ms. Indira Jaising, Amarjit Singh Chandiok, S. Niranjan Reddy, Yatin
Oza, Ranjit Kumar, C.S. Vaidyanathan, Ms. Garima Prashad, Dr. Manish
Singhvi, Dr. Menaka Guruswamy, Sr. Advs., Avnish Kumar Sharma,
Rajat Nair, Kanu Agrawal, Amit Mahajan, Prashant Singh B, Raj Bahadur
Yadav, Gurmeet Singh Makkar, A P Mayee, Amit Bhandari, Sandeep
Jha, Suhaan Mukerji, Vishal Prasad, Ms. Deepeika Kalia, Nikhil
Parikshith, Abhishek Manchanda, Kapish Seth, Mrityunjai Singh,
Sayandeep Pahari, M/S. Plr Chambers and Co., Arijit Prasad, Meenesh
Dubey, Ms. Ritu Bhadwaj, Anupam Mishra, Ms. Nina Gupta, Ms. K.V.
Bharathi Upadhyaya, Mukesh Kumar Singh, Ms. Sasmita Tripathy,
Prashant Singh, Ms. Prerna Kumari, Ms. Seema Patnaha, Ms. Nandani
Gupta, Rahul Kaushik, Satyakam, Gautam Narayan,
Ms. Asmita Singh,
Adithya Nair, Ms. Rajeshwari Hariharan, R. Sathyanarayanan, Ms.
Nupur Kumar, Ms. Mantika Haryani, Ms. Astha Sharma, Nipun Saxena,
Paras Nath Singh, Umang Tyagi, Ms. Serena Sharma, Prashant Kumar,
Ms. Anindita Pujari, Amarjit Singh Bedi, Mahfooz Ahsan Nazki, Polanki
Gowtham, Shaik Mohamad Haneef, T. Vijaya Bhaskar Reddy, Amitabh
Sinha, Shrey Sharma, Purvish Jitendra Malkan, Ms. Dharita Purvish
Malkan, Ms. Deepa Gorasia, Alok Kumar, Ms. Neha Ambashtha, Ms.
Nandini Chhabra, Ms. Bhavna Sarkar, Manish Kumar, Balaji Srinivasan,
Ms. Garima Jain, Ms. Pallavi Sengupta, Ms. Lakshmi Rao, Aishwarya
Choudhary, Ms. Aakriti Priya, Mohammed Shahrukh, Prateek Yadav,
Dr. Monika Gusain, Rahul Chitnis Adv., Sachin Patil, Aaditya A. Pande,
Geo Joseph, M. Yogesh Kanna, Raja Rajeshwaran S., Sumeer Sodhi,
Ms. Simran Agarwal, Vikram Sharma, K.V. Jagdishvaran, Mrs. G. Indira,
Ms. Ruchira Gupta, Shishir Deshpande, Anurag Sharma, Abhishek Kumar
Srivastava, Dr. A.P. Singh, Sadashiv, V.P. Singh, Ms. Geeta Chauhan,
Ms. Richa Singh, Sharwan Kumar Goyal, Jai Gopal Saboo, Pashupati
Nath Razdan, Sunny Choudhary, Pulkit Agarwal, Sudhanshu Kaushesh,
K.P. Jayaram, Astik Gupta, Ms. Maitrayee Jagat Joshi, A.D.N. Rao, A.
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Venkatesh, Rahul Mishra, Ms. Ananya Khandelwal, V.N. Raghupathy,
Ms. Siddhesh Kotwal, Ms. Manya Hasija, Ms. Ana Upadhyay, Nirnimesh
Dube, Pukhrambam Ramesh Kumar, Ms. Anupama Ngangom, Karun
Sharma, Sunny Choudhary, Mrs. K. Enatoli Sema, Amit Kumar Singh,
Sameer Abhyankar, Amish Tandon, Ayush Beotra, Varun Tandon, Dipin
Tamang, Uddhav Khanna, Ms. Shafali Jain, Avijit Mani Tripathi, Shaurya
Sahay, Chetan Joshi, G.M.Kawoosa, Ms. Taruna Ardhendumauli Prasad,
Parth Awasthi, Abhimanyu Tewari, Ms. Eliza Bar, Abhinav Agrawal,
Vishnu Shankar Jain, Rakesh Malhotra, Tungesh, Chirag M. Shroff,
Shibashish Misra, S. Debabrata Reddy, Avnish Kumar Sharma, Jishnu
M.L., Ms. Priyanka Prakash, Ms. Beena Prakash, Sandeep Kumar Jha,
Karan Bharihoke, Ms. Neha Sahai Bharihoke, Siddhant Sharma,
Pashupathi Nath Razdan, Pradeep Kumar Yadav, Ms. Shikha Yadav,
Abhay Singh Yadav, Sanjeev Malhotra, Himanshu Chaubey, Nitin Lonkar,
Ms. Sonali Suryawanshi, Himanshu Chaubey, Shibashish Misra, Haris
Beeran, Mushtaq Salim, Usman Ghani Khan, Azhar Asees, Ms. Pallavi
Pratap, Ms. Astha Sharma, Ms. Manju Jetley, Govind Manoharan, Ibad
Mushtaq, Ms. Aishwarya Murali, Victor Das, Ms. Ambika Mathur, Mrs.
Shally Bhasin, Purvish Jitendra Malkan, Ms. Raushan Tara Jaswal, Ms.
Shobha Gupta, Ms. Medha Garg, Anurag Tomar, Rameshwar Prasad
Goyal, S. Udaya Kumar Sagar, Ms. Sweena Nair, Ms Pragya Baghel,
Kumar Anurag Singh, Ms Pallavi Langar, Devashish Bharuka, Mrs. Jaya
Bharuka, Ravi Bharuka, Ms. Sarvshree,
Justine George, Ms. Srishti
Agarwal, Ankit Agarwal, Ms. Taniya Bansal, Manoj V George, Ranjit
Philip, Ms. Palak Arora, K. Panmei, Ms. Shilpa Liza George, Shuvodeep
Roy, Ms. Diksha Rai, Ms. Ninmisha Menon, Deepak A. Masih, Ms.
Manreet Kaur, Ms.Kusum, R. N. Keswani, J. Sai Deepak, Guruswamy
Nataraj, V. Shyamohan, Surya Prakash for M/S KMNP Law, Advs. for
the appearing parties.
Devasish Garg, Parvesh Sahib Singh Verma, Shashank Deo Sudhi,
G. Prakash, Dr. Ashwani Kumar, Viplav Sharma, Applicants-in-person.
The following Order of the Court was passed:
ORDER
This order has been divided into the following sections to facilitate
analysis:
A
Introduction
B
Outline of the Disaster Management Act
C
Medical Infrastructure
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C.1
Submissions in UOI’s Affidavits
C.2
National Policy for Admission in Hospitals
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Oxygen allocation and availability
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Vaccines
E.1 Vaccine capacity and disbursal
E.2 Vaccine pricing
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Potentiality of Compulsory Licensing for vaccines
and essential drugs
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Supply of Essential Drugs
G.1 Submissions in the Central Government’s
Affidavits
G.2 Recommendations
G.3 Black Marketing
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Recommendations for augmenting healthcare
workforce
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Epilogue
J
Conclusion
A. Introduction
1. The genesis of this suo motu writ petition is in an order dated
22 April 2021.This Court took note of the unprecedented humanitarian
crisis in the country, following the outbreak of the COVID-19 pandemic.
Notices were issued to the Union of India1, the Governments of the
States and Union Territories2, and to several petitioners who were before
the High Courts. The Court observed:
“the Union Government, the State Governments/Union Territories
and the parties, who appeared to have approached the High Courts
to show cause why uniform orders be not passed by this Court in
relation to
a) Supply of oxygen;
1 “UOI”, referred interchangeably as “Central Government”
2 Collectively referred as “State Government”
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b) Supply of essential drugs;
c) Method and manner of vaccination; and
d) Declaration of lockdown”
The Court directed the Central Government to :
“1. Report on the existence or otherwise and requirement of setting
up of a coordinating body that would consider allocation of the
above resources in a consultative manner (with the involvement
of concerned States and Union Territories).
2. Consider declaration of essential medicines and medical
equipment including the above articles as essential commodities
in relation to COVID.
3. In respect of coordination of logistical support for inter-State
and intra-State transportation and distribution of the above
resources.”
2. The Court also had appointed an Amicus Curiae to assist it.
However, the Amicus Curiae was, on his request, relieved of his position
on 23 April 2021. Hearings in the matter were then conducted on 27
April 2021, where the Court appointed two new Amici: Mr Jaideep Gupta
and Ms Meenakshi Arora, learned Senior Counsel. They will be assisted
by Mr Kunal Chatterjee and Mr Mohit Ram, learned counsel and
Advocate-on-Record. The Court began the hearing by noting that the
jurisdiction it assumed under Article 32 did not automatically lead to the
erosion of a High Court’s jurisdiction under Article 226. Rather, the Court
stressed on the importance of the jurisdiction under Article 226, and how
High Courts may be better equipped to deal with issues within their own
States. However, this Court assumed
jurisdiction over issues in relation
to COVID-19 which traverse beyond state boundaries and affect the
nation in its entirety.
3. The Court noted that it was in receipt of an affidavit dated 23
April 2021 filed by the UOI. However, the Court directed the UOI to
file an additional affidavit and the respective governments of the States/
Union Territories to file fresh affidavits on four issues. The relevant
extract of the order reads thus:
“(i) Supply of oxygen – The Court should be apprised by the Union
of India on
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(a) The projected demand for oxygen in the country at the present
point of time and in the foreseeable future;
(b) The steps taken and proposed to augment the availability of
oxygen, meeting both the current and projected requirements;
(c) The monitoring mechanism for ensuring the supply of oxygen,
particularly to critically affected States and Union Territories as
well as the other areas;
(d) The basis on which allocation of oxygen is being made from
the central pool; and
(e) The methodology adopted for ensuring that the requirements
of the States are communicated to the Central Government on a
daily basis so as to ensure that the availability of oxygen is
commensurate with the need of each State or, as the case may
be, Union Territory.
(ii) Enhancement of critical medical infrastructure, including the
availability of beds, Covid treatment centres with duly equipped
medical personnel on the basis of the projected requirement of
healthcare professionals and anticipated requirements. The Union
government will consider framing a policy specifying the standards
and norms to be observed for admitting patients to hospitals and
covid centres and the modalities for admission;
(iii) The steps taken to ensure due availability of essential drugs,
including Remdesivir and Favipiravir among other prescribed drugs
and the modalities which have been set up for controlling prices
of essential drugs, for preventing hoarding and for
ensuring proper
communication of the requirements at the level of each District
by the District health authorities or Collectors to the Health
Departments of the States and thereafter by the states to the
Union Ministry of Health and Family Welfare so that the projected
requirements are duly met and effectively monitored on a daily
basis.
(iv) Vaccination
(a) Presently two vaccinations have been made available in the
country, namely, Covishield and Covaxin;
(b) As of date, the vaccination programme has extended to all
citizens of the age of 45 years and above;
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(c) From 1 May 2021, the vaccination programme is to be opened
up also to persons between the age groups of 18 to 45, in addition
to the existing age group categories. The Union of India shall
clarify (i) the projected requirement of vaccines as a result of the
enhancement of coverage; (ii) the modalities proposed for ensuring
that the deficit in the availability of vaccines is met; (iii) steps
proposed for enhancement of vaccine availability by sourcing
stocks from within and outside the country; (iv) modalities for
administering the vaccines to meet the requirements of those in
the older age group (forty five and above) who have already
received the first dose; (v) modalities fixed for administering the
vaccine to meet the additional demand of the 18-45 population;
(vi) how the supplies of vaccines will be allocated between various
states if each state is to negotiate with vaccine producers; and
(vii) steps taken and proposed for ensuring the procurement of
other vaccines apart from Covishield and Covaxin and the time
frame for implementation; and
(d) The basis and rationale which has been adopted by the Union
government in regard to the pricing of vaccines. The government
shall explain the rationale for differential pricing in regard to
vaccines sourced by the Union government on one hand and the
states on the other hand when both sources lead to the distribution
of vaccines to citizens.”
4. This Court then received an additional affidavit dated 29
April
2021 from the UOI, and fresh affidavits by the various States/UTs
addressing the four issues mentioned in its order dated 27 April 2021. In
the hearing conducted on 30 April 2021, this Court heard submissions by
Mr Tushar Mehta, learned Solicitor General of India, who was appearing
on behalf of the Central Government. Several other counsels have made
brief interjections, including Mr Vikas Singh, Senior Counsel and President
of the Supreme Court Bar Association. This Court also heard a
presentation on oxygen supply in India by Ms Sumita Dawra, Additional
Secretary, Department of Promotion of Industry and International Trade,
Ministry of Commerce and Industry. As such, unless specified otherwise,
the directions and observations in the present order are limited to the
UOI.
5. During the course of the hearing, this Court directed that the
individual States/UTs shall be given an opportunity to discuss their
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affidavits at a later hearing. Further, the Court also directed the learned
Amici to prepare a tabular compilation in relation to all the Interlocutory
Applications which have been filed in this petition. On the basis of the
issues raised, they shall also be considered in a later hearing. Before
delving into a substantive discussion, we would like to clarify that the
jurisdiction exercised in this matter is merely to facilitate a dialogue of
relevant stakeholders, the UOI, the States and this Court, in light of the
pressing humanitarian crisis, and not with a view to usurp the role of the
executive and the legislature. This bounded-deliberative approach3 is
exercised so that the UOI and States can justify the rationale behind
their policy approach which must be bound by the human rights
framework which presently implicates the right to life under Article 21
and right to equality under Article 14 of the Constitution.
B. Outline of the Disaster Management Act
6. The Disaster Management Act, 20054 came into effect on 26
December 2005. The DMA provides for the effective management of
disasters and matters connected or incidental to such disasters. COVID-
19 falls under the definition of a disaster under Section 2(d)5 of the
DMA and the provisions of the DMA were invoked for the first time to
deal with the present pandemic. Under Section 6(2)(i) of the DMA, the
National Disaster Management Authority6 issued an order dated
24
March 2020 directing the Ministries, UOI, State/UTs and their authorities
to take effective measures to prevent the spread of COVID-19 in the
country. Thereafter, the Home Secretary, Ministry of Home Affairs as
the Chairperson of the National Executive Committee, which assists the
NDMA in its functions, in an order dated 24 March 2020 issued guidelines
for the initial 21 days’ lockdown on account of COVID-19.
3 Sandra Fredman, “Adjudication as Accountability: A Deliberative Approach” in
Nicholas Bamforth and Peter Leyland (eds),  Accountability in the Contemporary
Constitution (Oxford University Press, 2013)
4 “DMA”
““2… (d) “disaster” means a catastrophe, mishap, calamity or grave occurrence in any
area, arising from natural or man-made causes, or by accident or negligence which
results in substantial loss of life or human suffering or damage to, and destruction of,
property, or damage to, or degradation of, environment, and is of such a nature or
magnitude as to be beyond the coping capacity of the community of the affected area;”
6 “NDMA”
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7. Section 2(e) defines disaster management as a continuous and
integrated process of planning, organizing, coordinating and implementing
measures in relation to the disaster. Section 2(e) provides:
“2…
(e)”disaster management” means a continuous and integrated
process of planning, organizing, coordinating and implementing
measures’ which are necessary or expedient for—
(i) prevention of danger or threat of any disaster;
(ii) mitigation or reduction of risk of any disaster or its’ severity or
consequences;
(iii) capacity-building;
(iv) preparedness to deal with any disaster;
(v) prompt response to any threatening disaster situation or
disaster;
(vi) assessing the severity or magnitude of effects of any disaster;
(vii) evacuation, rescue and relief;
(viii) rehabilitation and reconstruction;..”
Section 2(n) of DMA defines a “National Plan” as the plan for
disaster management for the whole country prepared under Section 11
of DMA. Section 3 of the DMA constitutes the NDMA with the Prime
Minister as the Chairperson, ex officio. Section 6 lists down the powers
and functions of the NDMA. Under Section 6(2)(b), NDMA has the
power to approve the National Plan. Section 11 of the DMA provides
the procedure for drawing up and implementation of the National Plan in
the following terms:
“11. National Plan
(1) There shall be drawn up a plan for disaster management for
the whole of the country to be called the National Plan.
(2) The National Plan shall be prepared by
the National Executive
Committee having regard to the National Policy and in consultation
with the State Governments and expert bodies or organisations in
the field of disaster management to be approved by the National
Authority.
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(3) The National Plan shall include—
(a) measures to be taken for the prevention of disasters, or the
mitigation of their effects;
(b) measures to be taken for the integration of mitigation
measures in the development plans;
(c) measures to be taken for preparedness and capacity building
to effectively respond to any threatening disaster situations or
disaster;
(d) roles and responsibilities of different Ministries or
Departments of the Government of India in respect of measures
specified in clauses (a), (b) and (c).
(4) The National Plan shall be reviewed and updated annually.
(5) Appropriate provisions shall be made by the Central
Government for financing the measures to be carried out under
the National Plan.
(6) Copies of the National Plan referred to in sub-sections (2) and
(4) shall be made available to the Ministries or Departments of
the Government of India and such Ministries or Departments shall
draw up their own plans in accordance with the National Plan.”
8. A National Plan includes, inter alia, measures for disaster
prevention, mitigation, preparedness and roles and responsibilities of
different Ministries in terms of Section 11(3) of DMA. A National Plan
for the entire country was prepared in the year 2016 and was revised
and notified in November, 2019. The National Plan, 2019 provides a
framework to the Government agencies to deal with different aspects
of disaster management. Section 11(4) of the DMA
provides that the
National Plan is to be revised and updated annually making it a ‘dynamic
document’. The executive summary of the National Plan succinctly
captures its purpose and contours in the below extract:
“...The National Disaster Management Plan (NDMP) provides a
framework and direction to the government agencies for all phases
of disaster management cycle. The NDMP is a “dynamic
document” in the sense that it will be periodically improved keeping
up with the emerging global best practices and knowledge base in
disaster management. It is in accordance with the provisions of
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the DM Act, 2005, the guidance given in the National Policy on
Disaster Management (NPDM) 2009, and the established national
practices...”
9. Section 12 of the DMA empowers the NDMA to recommend
guidelines for the minimum standard of relief to be provided to persons
affected by disaster. NDMA can create guidelines stipulating minimum
standards of relief for providing ex gratia assistance on account of loss
of life and restoration of means of livelihood in terms of Section 12(iii) of
DMA. In light of the human suffering and loss of livelihood that has
accompanied this pandemic, NDMA may consider laying down minimum
standards of relief in this regard. We clarify that this is not a direction of
this Court, however a suggestion that can be looked into by the NDMA.
Under Section 12(iv) of the DMA, the NDMA has been given wide
powers to provide guidelines for any such relief that may be necessary.
10. In addition to the above provisions, Section 35 of the DMA
empowers the Central Government to take measures which it deems to
be necessary or expedient for the purpose of disaster management.
Section 35(2)(a) provides for coordination of actions between the Central
Government and State Governments and their respective authorities in
relation to disaster management. Section 35(2)(e) obliges the Central
Government to assist and cooperate with the State Governments as
requested by them or otherwise deemed appropriate by it.
11. Section 36 of DMA provides for the
responsibilities that have
to be undertaken by the Ministries or Departments of the Central
Government. While Section 36(h) empowers the Central Government
to take any actions that it may consider necessary for disaster
management, Section 36(d) specifically enables it to review its policies
with a view to incorporate provisions necessary for prevention of disaster,
mitigation or preparedness. Under Section 36(f), it is the responsibility
of every Ministry or Department of Central Government to provide
assistance to the State Governments for (i) drawing up mitigation,
preparedness and response plans, capacity-building, data collection and
identification and training of personnel in relation to disaster management;
(iii) carrying out rescue and relief operations in the affected area; (iii)
assessing the damage from any disaster; and (iv) carrying out rehabilitation
and reconstruction. Section 35(g) provides that the Central Government
is responsible for making available its resources to the National Executive
Committee or a State Executive Committee for the purposes of, inter
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alia, transporting personnel and relief goods to and from the affected
area.
12. The provisions of Sections 35 and 36 of the DMA that have
been discussed above have been enacted in the spirit of cooperative
federalism in order to ensure that Central Government can assist and
enable the State Governments to effectively tackle the disaster in question.
13. The learned Solicitor General has submitted that the Central
Government is operating under the broad framework of the National
Plan and the plan is already in force.The plan specifically deals with
“Biological and Public Health Emergencies”. Further, different States
have their own Disaster Management Plans in place. It has been
submitted that the National Plan does not and cannot contain step by
step instructions or specific directions for the day to day management of
the pandemic by the Government agencies. Such aspects are kept open
for executive decision, in view of the dynamic nature of the disaster in
question. Further, since COVID-19 is a novel virus, the knowledge in
relation to such a virus is contemporaneous in nature and is subject to
constant development. A three Judge bench of this Court in its judgement
in Centre for Public Interest Litigation vs Union of India7 had
noted that there was no need to develop a fresh National Plan under
Section 11 for COVID-19 since a National Plan was already in place,
which was being supplemented by various orders and
measures taken
by competent authorities under DMA. Justice Ashok Bhushan, speaking
for this Court, observed that:
“40. The Disaster Management Act, 2005 contain ample powers
and measures, which could be taken by the National Disaster
Management Authority, National Executive Committee and Central
Government to prepare further plans, guidelines and Standard
Operating Procedure (SOPs), which in respect to COVID-19 had
been done from time to time. Containment Plan for Novel
Coronavirus, 2019 had been issued by Ministry of Health and
Family Welfare, Government of India. There were no lack of
guidelines, SOPs and Plan to contain COVID-19, by Nodal Ministry
had been brought on record issued by Ministry of Health and
Family Welfare, Government of India, i.e., Updated Containment
Plan for Large Outbreaks Novel Coronavirus Disease, 2019
(COVID-19).”
72020 SCC OnLine SC 652
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14. Therefore, the National Plan, 2019 can be supplemented by
the issuance of additional guidelines to tackle any aspect of disaster
management including the issue of admission to hospitals and access to
essential drugs and vaccines in respect of COVID-19.
C. Medical Infrastructure
C.1 Submissions in UOI’s Affidavits
15. In relation to the broad issue of medical infrastructure, the
Central Government begins its affidavit dated 23 April 2021 and additional
affidavit dated 29 April 2021 by describing its ‘three-tier setup’of Covid
Care Centers8, Dedicated COVID Health Centers9 and Dedicated
COVID Hospitals10 which was recommended to the States for tackling
the COVID-19 pandemic, for which the UOI also provided funds under
an emergency response package from the National Health Mission and
State Disaster Response Fund.
16. The present status of these is: (i) 2,084 DCH (of which 89 are
under the Central Government and the rest 1,995 with State
Governments); (ii) 4,043 DCHC; and (iii) 12,673 CCC. Cumulatively,
they have 18,52,265 beds in total, out of which 4,68,974 beds are in
DCH. It was also noted that Central Government hospitals have also
been converted into DCH.
17. Further, tertiary care hospitals under ESIC, Defence, Railways,
paramilitary forces, Steel Ministry, et al, are also being leveraged for
case management. Even as many as 3816 railways coaches spread over
16 railway zones have been converted into CCC. Finally, the DRDO
has also set up large
field hospitals with capacities ranging from 1,000 to
10,000 isolation beds.
18. It was noted that through coordination between Central
Government and State Governments, isolation beds (with/without oxygen)
were increased to around 15.7 lakhs, as compared to 10,180 before the
first lockdown; similarly, ICU beds were increased to more than 85,000,
as compared to 2,168 before the first lockdown. Similar upgrades were
provided to necessary equipment such as Ventilators, N95 masks and
PPEs.
8 “CCC”
9 “DCHC”
10 “DCH”
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19. The affidavit provides the following details of the efforts taken
by UOI to create projections for each State, and how it was
communicated to them:
(i)
It has developed an IT module for projections of expected
cases based on ongoing case load, so as to alert States and
districts to be prepared in advance. The projections by the
Central Government were regularly shared in writing with
the States, along with reports containing emergency plans.
This tool was also made available to States, to map their
own projections at the State level;
(ii)
Details of the meetings conducted by the Prime Minister,
the Minister of Health and Family Welfare, the Cabinet
Secretary, the Secretary (H) and the DGHS were provided;
and
(iii)
Details of letters(which seem to have been sent on a
monthly basis) sent by the Central Government to the State
Governments indicate that theyinformed the State
Governments of the projected cases for the coming month,
along with the number of Oxygen Supported Beds, ICU
Beds and of Ventilators that will be required to manage the
projected cases. Thereby, the State Governments which
were found lacking in their numbers were directed to ramp
up their facilities.
20. In relation to the preparedness for the second wave of the
COVID-19 pandemic, the affidavits state that:
(i)
After the first wave, the Central Government has been
consistently writing to the State Governments from 4
December 2020 with numbers of
projected cases, along
with the directions requiring them to arrange the necessary
infrastructure which will be needed;
(ii)
State Governments were requested by the UOI to formulate
a comprehensive plan in relation to:
(a)
Bed capacities, ICU beds, further identification of
additional hospitals, preparation of field hospital
facilities, ensuring sufficient oxygen supported beds
and oxygen supplies;
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(b)
Deployment of requisite HR training and mentoring
of doctors and nurses for management of patients,
strengthen ambulance services and centralized call
center-based services for allocation of beds;
(c)
Suitable initiatives for (among other things) achieving
and maintaining adequate level of testing, surveillance
and risk communication for promoting wearing of
masks, physical distancing, hand hygiene;
(d)
Sufficient referral linkages for districts with deficit
infrastructure through deployment of additional
ambulances, wherever necessary; and
(iii)
On 20 April 2021, the Ministry of Health and Family
Welfare11 wrote to the State Governments with their
projections and reminded them also of the funding avenues
being made available to all States under NHM funding, State
Disaster Response Fund, and other initiatives.
21. The affidavits also note that the Central Government had
developed a live portal with all the States and districts where they were
asked to feed in their data of cases and details such as people under
home isolation, on isolation beds (with or without oxygen) and on ICU
beds. Further, the State Governments were also directed to feed in details
of the COVID dedicated health care infrastructure created by them,
besides the details of containment zones so specified by them. However,
the Central Government has alleged that States and districts did not
upload their data regularly enough. Additionally, there was also a ‘Facility
App’ which could
be used by Covid Health facilities to monitor their
patients as well as the availability of logistics with their health facility.
However, the Central Government alleges that States, districts and
facilities did not use this Facility App.
C.2 National Policy for Admission in Hospitals
22. It has been submitted by the Central Government that health
being a state subject, the medical infrastructure is largely created and
maintained by the respective State Governments. Since we are yet to
hear from the State Governments, we shall not be issuing any directions
or making comprehensive observations in relation to this issue.
11 “MoHFW”
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23. However, based on the affidavits submitted by the Central
Government and the hearings which followed, we have come to
understand that there is no national policy on how admissions must take
place in the various tiers of hospitals (CCC, DCHC and DCH). Gaining
admission into a hospital with a bed is one of the biggest challenges
being faced by most individuals during this second wave of the COVID-
19 pandemic. Left to their own devices, citizens have had to suffer
immeasurable hardship. Different states and local authorities follow their
own protocols. Differing standards for admission in different hospitals
across the nation leads to chaos and uncertainty. The situation cannot
brook any delay. Accordingly, we direct the Central Government to frame
a policy in this regard, in exercise of its statutory powers under the
DMA, which will be followed nationally. The presence of such a policy
shall ensure that no one in need is turned away from a hospital, due to no
fault of their own. Such a policy should, inter alia, address the following
issues in relation to admission:
(i)
Requirement of a positive test for COVID-19 virus, which
may become difficult for many individuals since testing
facilities are overwhelmed, test results are taking
inordinately long time and the new strain of the COVID-19
virus is sometimes not even picked up by a regular RT-
PCR test;
(ii)
Some patients are being refused service based on arbitrary
factors. For example, the hospitals in Ahmedabad were
initially refusing to take in patients who did not arrive in the
government-run ‘108’ ambulances. While this rule has now
been removed, after objections were noted by the Gujarat
High Court during hearings in a suo motu public interest
litigation12, we note that such rules cannot be allowed to
crop up in other places;
(iii)
Some reports have also been brought to our attention that
hospitals are refusing to admit individuals who cannot
produce a valid ID card which shows that they belong to
the city where the hospital is located. Given how
overstretched our hospitals are during the second wave of
the COVID-19 pandemic, it is entirely plausible that
12 Suo Motu vs State of Gujarat, R/Writ Petition (PIL) No 53 of 2021
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individuals may travel to other cities in desperation, since
beds may not be available in their city. The rural health
infrastructure is seriously deficient. Hence, no hospital
should be allowed to deny them entry solely based on this
reason or any other issues with identity proofs;
(iv)
A related issue is when individuals often get their family
member admitted in a hospital in one city, but have to travel
to another city to look for oxygen or essential drugs and are
denied their use because they are to be bought for an
individual admitted in a different city. As was true for the
above such rule, this is also unacceptable and should not be
allowed;
(v)
Admissions to hospital must be based on need. The Central
Government,in consultation with the respective State
Governments, must formulate guidelines on the stage at
which hospitalization is required so as to ensure that scarce
hospital beds are not occupied by persons who do not need
hospitalization. This aspect should be based on the advice
of medical experts and can be suitably alteredgiven the
needs of each State (or regions within the State) and in the
course of the experiences gained during the pandemic; and
(vi)
Directions are hereby issued to all States, Union Territories,
and all public agencies, to ensure that the above orders are
implemented forthwith. The Central, State and Union
Territory governments shall issue necessary orders and
circulars, incorporating the above directions, within three
days, which shall be in force till replaced by an appropriate
uniform policy, devised by the central government,
statutorily. 
D. Oxygen allocation and availability
24. The Central Government has argued the following:
(i)
By its order dated 11 September 2020, the Ministry of Home
Affairs13, in exercise of its powers under Section 10(2)(h)
of the DMA had constituted an Empowered Group-II as an
inter-ministerial body to ensure availability of essential
medical equipment and oxygen management;
13 “MHA”
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(ii)
Medical oxygen is critical to treatment of COVID affected
patients. The entire available capacity of oxygen is used
for supply for industrial and medical use, which is in the
form of Liquid Medical Oxygen14. The major suppliers for
both industrial and medical oxygen are steel plants in the
public and private sectors, and private entities;
(iii)
Oxygen is not produced evenly in India. While some States
may be oxygen producing States such as Maharashtra,
Rajasthan and Jharkhand; other States/UTs such as Delhi,
Goa and Madhya Pradesh, do not have production capacity
and rely on supply of oxygen from oxygen producing States;
(iv)
For an estimation of the required oxygen supply, an
Empowered Group I was constituted which categorized
patients into three categories:
•
Class I comprising of 80% of the cases which are mild
and do not require oxygen;
•
Class II comprising of 17% cases which are moderate
and can be managed on non-ICU beds and 50% of
these may require oxygen @10L/min; and
•
Class III comprising of 3% of cases which are severe
ICU cases requiring approximately 24L/min oxygen.
(v)
On the basis of the categorization provided by Empowered
Group I, oxygen requirement of different States on the basis
of active cases is being calculated which is around 8462
MT. Based on the trend of active cases, the “doubling rate
of cases” is calculated for each State, which implies, the
number of days in which COVID cases are
likely to double.
The number of active cases are projected on the basis of
the doubling rate and oxygen requirement is calculated.
These projections get changed daily on the basis of real
time change;
14 “LMO”

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(vi)
In order to ensure supply of oxygen to all States, a mapping
exercise of the sources of supplies with the demand of
medical oxygen to the critically affected States was
undertaken jointly by the Department of Promotion of
Industry and Internal Trade, MoHFW, Ministry of Steel,
Petroleum and Explosives Safety Organisation, oxygen
manufacturers etc. During the course of the mapping
exercise, States were requested to indicate their projections
for requirement of medical oxygen based on expected active
case load. These projections were to be given as on 20
April, 25 April, and 30 April 2021. The following was the
forecast provided by the major States:
(vii)
Based on these projections, an indicative mapping
framework was drawn up and approved by an order dated
15 April 2021, which provided the name of the supply point,
the State to which supply was allocated and the quantity to
be supplied. Subsequently, due to continuous changes in the
number of cases and the need for medical oxygen, a revised
projection was issued by States for 20 April 2021, which
provided:
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(viii) Following this, a revised supply plan for medical oxygen to
15 States for meeting their demand was issued by an order
dated 18 April 2021. Certain States, such as Delhi, Rajasthan,
Punjab, Uttar Pradesh, Uttarakhand and Madhya Pradesh,
faced challenges despite this allocation. Issues such as
logistical bottlenecks in transportation, incidents of local
authorities in disrupting supplies to other states were
reported. Due to this, allocation orders were further amended
by orders dated 21 April 2021, 22 April 2021, 24 April 2021,
25 April 2021 and 26 April 2021. The MHA also issued
orders dated 22 April 2021 and 25 April 2021 under the
DMA to direct States/UTs to ensure uninterrupted
movement of medical oxygen;
(ix)
The major principles on the basis of which the amendments
were made were to: (a) ensure that projected requirement
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of LMO is allocated as far as possible; (b) allocate sources
located within the State or closest to the State while
balancing requirements from States which have no/low
internal manufacturing capacity; (c) ensure feasible
transportation; (d) ensure minimum disruptions in existing
supply chains;
(x)
As an instance, the allocation summary for 28 April 2021
has been placed on record:
(xi)
After the Central Government procures and allocates the
quantity of medical oxygen to each State, it is the State
Government’s responsibility to arrange transportation to pick
up their allotted quantity from the supply point;
(xii)
Given the fact that the mapping exercise has to be
continuously updated according to the need of the situation
across States, the Central Government also put in an
interactive mechanism called the “Virtual Central Control
Room” consisting of senior officers of Additional/Joint
Secretary rank to monitor and find solutions to any problems
that may arise on a real time basis. We have been apprised
that the daily allocation of the supply of oxygen is sanctioned
and uploaded on this virtual room, in which the Chief
Secretaries of all States/UTs are members;
(xiii) In addition to the management of supply and demand of
medical oxygen, the Central Government has also taken
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the following steps to ensure augmentation of supply in the
country:
(a)
Licenses to industrial gas manufacturers: By an
order dated 7 April 2020, the Drug Controller General
of India15 allowed licenses to be issued to industrial gas
manufacturers for manufacturing medical oxygen within
24 hours of receipt of the application by DCGI;
(b)
Enhanced production of LMO in steel plants and
by private manufacturers: Steps have been taken to
reduce production of other liquid products which are
required for manufacturing steel (such as argon and
nitrogen) and enhance the capacity of liquid oxygen.
This has resulted in immediate enhancement of 293 MT.
Additionally, the steel sector has made available the liquid
oxygen in its storage tanks (approx. 16,000 MT as on
21 April 2021). Supplies have increased from 1000 MT
in the first week of April 2021 to 2600 MT on 21 April
2021. Moreover, private manufacturers have also
enhanced production of medical oxygen;
(c)
Restrictions on use of industrial oxygen: By an
order dated 18 April 2021, the MoHFW restricted
industrial use of oxygen. Supply of oxygen for all
industrial use was completely prohibited on 21 April 2021,
except for certain industries such as ampoules and vials;
pharmaceuticals; petroleum refineries; nuclear energy
facilities; and oxygen cylinder manufacturers. These
have added 1000 MT of additional oxygen;
(d)
Augmentation in availability of tankers: India has
1224 oxygen
tankers (16732 MT capacity) and efforts
are being made to increase this capacity to 2000 tankers
through conversion of nitrogen and argon tankers and
import of 138 cryogenic tankers;
(e)
Commissioning of PSA plants: Pressure Swing
Absorption16 is a technology to generate oxygen at a
local level. PSA plants established in hospitals enable
15 “DCGI”
16 “PSA”
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self-sufficiency in generation of oxygen. MoHFW is in
the process of commissioning 162 PSA Plants (154 MT
capacity). The following statistics have been furnished:
Number of plants installed:
38
Number of plants to be installed by 30 April 2021
21
Number of plants to be installed by 31 May 2021
105
Number of plants to be installed by 30 June 202117
51
Number of PSA Plants for district headquarters
500
(under planning)
(f)
Import of medical oxygen: A global tender was
floated to import 50,000 MT of medical oxygen to be
supplied in 90 days and quotations have been received.
As an interim measure, quotations from bidders were
called within 24 hours as to the quantities they could
offer, prices etc. Orders have been placed with 2 foreign
suppliers, i.e., SSB Cryogenic Equipment Ltd. for 200
MT and Gulf Industrial Gases Abu Dhabi for 1800 MT.
Another order is also being placed with M/s Ultra-Pure
Gases India for import of 500-1500 MT;
(g)
Augmentation of availability of cylinders: 1,02,400
oxygen cylinders were procured in April and May 2020
and distributed to States. Orders for additional 1,27,000
cylinders were placed on 21 April 2021. The Central
Government proposes to address the additional demand
through regulated portable oxygen system technology;
(h)
Setting up of jumbo container based COVID
hospitals using gaseous oxygen: Apart from LMO,
the gaseous oxygen production capacity in the steel
sector is 43,000 MT per day against which 26,000 MT
per day is
being produced. Two private entities, AMNS
and JSW are setting up “Jumbo” COVID centres with
1000 bed oxygen facilities in Hazira, Vijayanagar and
Dolvi using gaseous oxygen; and
17 As per the affidavit dated 23 April 2021, the UOI has stated that “a further 105
plants will be installed by 31.05.2021 and thereafter increasing to 156 plants by
30.06.2021.”
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(i)
Transportation by Air & Rail: Railways are being
used for long distance transport of tankers through ‘roll
on roll off’ service and an “Oxygen Express”- a double
engine train which gets a green corridor- is being run
from supply point to destination. As an instance, the
first rake with 7 empty tankers reached Mumbai from
Vizag to transport 105 MT from RINL Vizag to
Kalamboli. In addition to this, defence aircraft for
carrying empty tankers to supply point are being
deployed. However, it is technically not possible to bring
in oxygen filed tankers in an aircraft.
25. During the course of the hearing, the Solicitor General has
also sought to lay down the facts and figures pertaining to production
and supply of oxygen, daily supply to States and challenges faced in
supply chain logistics before the Court by means of a power point
presentation. We note the submission of the Solicitor General that the
figures given in the power point presentation are revised on a daily basis
and that the presentation is not to be treated as a submission made on
oath by the Solicitor General, which may give rise to a cause of action
for litigation in future either before this Court or the High Courts. Ms
Sumita Dawra, Additional Secretary, Department of Promotion of
Industry and Internal Trade, Ministry of Commerce and Industry, who is
one of the senior administrative officers in charge of oxygen procurement
and supply coordination, has
given an overview of these issues and made
a presentation before us. We would like to record our appreciation for
the contribution made by Ms Dawra and her team, who despite being
infected by the COVID-19 virus, has continued to work and manage the
supply of medical oxygen that the country so desperately needs today. It
is through the earnest contribution of officers such as Ms Dawra, who
are working round the clock, that the country is able to deal with the
storm created by one of the worst humanitarian crises we have seen.
26. Based on the above facts and figures, the Solicitor General
has stated that there is no dearth of oxygen supply in the country as on
date and steps are being taken continuously to augment the supply of
oxygen. Having said that, the Solicitor General has also admitted that
there has been a shortage of supply to certain States and has attributed
this shortage to various factors including the failure of State Governments
to lift the allocated quantity of oxygen from the supply point; transportation
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bottlenecks caused by inter-State movement of tankers; and technical
failure of certain plants leading to reassessment of allocation on a real
time basis.
27. Submissions have also been made on the issue of supply of
oxygen by Mr Rahul Mehra, learned Senior Counsel appearing for the
Government of National Capital Territory of Delhi18. Mr Rahul Mehra
submits that the GNCTD is facing an acute shortage of the supply of
oxygen as it had been allocated a substantially lower quantity of oxygen
as against its projected demand. Mr Mehra pointed out that initially as
on 15 April 2021, the projected demand of GNCTD for 20 April 2021
was 300 MT/day, for 25 April 2021 it was 349 MT/day, and for 30 April
2021 it was 445 MT/day. However, due to a surge in cases, the projected
demand was revised by GNCTD on 18 April 2021 to 700MT/day and
this was immediately communicated to the Central Government. Despite
the increase in projected demand, the supply of oxygen to GNCTD has
continued in terms of the allocation order dated 25 April 2021, in which
490 MT/day were allocated. As against this as well, the manufacturers
have only been able to supply 445 MT/day. Mr Mehra has clarified that
as on the date of the hearing their demand was 700MT/day, however
their projected demand for the coming days is stated to be 976 MT/day
as the GNCTD has planned an increase in medical infrastructure,
including beds with oxygen cylinders and beds for patients in intensive
careunit.
28. Opposing
his submission, the Solicitor General and Ms
Dawrastated that no revised projections have been received from
GNCTD till date. The Solicitor General has also sought to highlight that
the government of GNCTD has failed to offtake the allocated quantity
of oxygen from the supply point.
29. Having heard the submissions of both counsels on the issues
pertaining to supply of oxygen to GNCTD, we note that the Central
Government (on page 63) in its affidavit dated 23 April 2021 has admitted
that the projected demand for GNCTD as of 20 April 2021 had increased
by 133% from 300 MT/day to 700 MT/day. According to the figures of
allocation given in the affidavit dated 23 April 2021 and the presentation
given by Ms Dawra, the existing allocation of GNCTD remains at 490
MT/day. This situation must be remedied forthwith. The situation on the
18 “GNCTD”
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ground in Delhi is heart rending. Recriminations between the Central
Government(which contends that GNCTD has not lifted its allocated
quantity) and GNCTD (which contends that despite its projected demand
the quantity allocated has not been enhanced) can furnish no solace to
citizens whose lives depend on a thin thread of oxygen being available.
On the intervention of the Court during the hearing, the Solicitor General
states that he has instructions to the effect that GNCTD’s demand of
medical oxygen will be met and that the national capital will not suffer
due to lack of oxygen. We issue a peremptory direction in those terms.
In the battle of shifting responsibility of supplying/off-taking of oxygen,
lives of citizens cannot be put in jeopardy. The protection of the lives of
citizens is paramount in times of a national crisis and the responsibility
falls on both the Central Government and the GNCTD to cooperate
with each other to ensure that all possible measures are taken to resolve
the situation. Learned Senior Counsel for GNCTD has assured the court
after taking instructions at the ‘highest’ level that the issue will be resolved
completely in a spirit of co-operation. During the course of the hearing,
the Solicitor General has assured that henceforth he will ensure that the
deficit of oxygen is rectified and supply is made to the GNCTD according
to their projected demand (which may be revised in the future) on a
day
by day basis. We accept his submission and direct compliance within 2
days from the date of the hearing, that is, on or before midnight of 3 May
2021.
30. With regard to the issue of the supply and availability of medical
oxygen for the entire country, we have noted that efforts are being made
to augment the availability of oxygen. While the Central and State
Governments are in the process of managing the supply of oxygen, at
the same time, it is critical that a buffer emergency stock of oxygen is
created so that in the event that the supply chain is disrupted to any one
or more hospitals in an area for any reason, the buffer or emergency
stocks can be used to avoid loss of human lives. These emergency stocks
must be so distributed so as to be easily accessible without delay in
every local area. We have also seen the situation that has developed in
the last 24 hours in Delhi where patients, including among them medical
professionals, died because of the disruption of supplies and the time lag
in the arrival of tankers. This deficit shall be rectified immediately by the
Central Government by creating buffer stocks and collaborating with
the States through the virtual control room on a 24 by 7 basis. In view of
the deaths which are being caused daily by the disruption of supplies,
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this direction is more crucial than ever. We therefore, direct the Central
Government in collaboration with the States to prepare a buffer stock of
oxygen to be used for emergency purposes to ensure supply lines continue
to function even in unforeseen circumstances. The location of the
emergency stocks shall be decentralised so as to be immediately available
if the normal supply chain is disrupted to any hospital for any reason.
The emergency stocks shall be created within the next four days. The
replenishment of the emergency stocks will also be monitored on a real
time basis through the virtual control room in active consultation with
each state/UT. This is in addition to the day to day allocations.
31. In addition to the above, we direct the Central Government to
consider the following suggestions, which may assist in increasing the
availability of oxygen and ensure transparency of demand-supply
management, and provide a clarification to this Court:
(i)
We understand that the Virtual Central Control Room of
the Central Government displays the allocation of supply of
oxygen by the Central Government to each State/UT. By
extension of this, a mechanism for displaying real time
updates of supply of oxygen from each State to hospitals in
each district, along with the remaining stock of oxygen with
the hospitals may be maintained and shared with the citizens
to ensure transparency. This will also ensure that citizens
can easily identify the hospitals where
medical aid can be
availed;
(ii)
The government shall clarify the steps being taken on
planning on the use of oxygen concentrators to reduce the
demand of LMO, such that LMO is needed only for critical
patients.A comprehensive plan on augmenting the
production/import of these oxygen concentrators may be
considered;
(iii)
The expected supply of oxygen/containersto be received
from outside India should be suitably augmented to cater to
anticipated increases in the demand and shortfall of domestic
availability. Pending the early finalization of the global tender
a decision may be taken on the need to continue imports to
bridge the gap in availability;and
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(iv)
A review shall be made of any restrictions on inter-State
travel of trucks or tankers carrying oxygen/other medical
aid equipment (such as GST related issues, documentation)
which might cause a hindrance in their movement.The
Central Government may consider implementing a system
to track and map the supply tankers which would allow
better management of resources and allow diversion of
resources from one State to the other in case of
emergencies.
E. Vaccines
32. The previous order of this Court dated 27 April 2021directed
the Central Government to clarify, inter alia: (i) the projected availability
of vaccines and proposed steps to boost supply and distribution; and (ii)
the vaccine pricing and distribution among states. Upon perusing the
affidavits filed by the Central Government and after having the benefit
of oral arguments of the Solicitor General, we have arrived at the
following understanding on the two broad issues outlined above. We
would once again re-iterate that we do not attempt to delve into the role
of the executive in designing policy choices. We are merely seeking
toenter into a dialogue with the relevant stakeholders in order to ensure
probity and transparency of the measures underway.We are cognizant
that it is ultimately up to the executive to frame and implement policies
that it deems appropriate, with the topmost regard to public interest.
E.1 Vaccine capacity and disbursal
33. The Central
Government has apprised us of its constitution of
a National Expert Group on Vaccine Administration for COVID-1919 on
7 August 2020 and operationalization of the immunization programme
from December 2020. It was further stated that as of 26 April 2021,
over 13.5 crore vaccine doses (approx. 9% of the Indian population)
have been administered to Frontline Workers, Healthcare Workers and
persons who are 45 years of age and higher in the 3 Phases of
immunization. It was submitted that these vaccines have been centrally
procured and administered free of cost to the abovementioned groups
who were identified based on specific vulnerabilities and a higher mortality
rate on account of the COVID-19 infection.
19 “NEGVAC”
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34. On 20 April 2021, the Central Government rolled out a revised
strategy of COVID-19 vaccination for all persons over 18 years of age,
with effect from 1 May 2021. This new age group consists of
approximately 59 crore people, which would require 122 crore vaccine
dosesunder the current two-dose vaccine regime of Covishield and
Covaxin which have been authorized for emergency use in India.This
revised strategy enables vaccine procurement by State Governments
and private hospitals, purportedly for accelerating the immunization
programme which is critical to curb the pandemic. In response to the
query of this Court on the necessity of the revised strategy, the Central
Government furnished the following justification:
“During the ongoing consultation with the states, demands/
concerns were raised by the various State Governments to expand
the scope of vaccination drive to include the beneficiaries beyond
the priority groups identified by NEGVAC as approved by Central
Government. As a matter of co-operative federalism, it was felt
necessary to allow play in the joints and to de-centralize vaccine
procurement and to enable the States to expand vaccination drives
to other groups between the age of 18-44 years. However, since
the priority group as identified by Union of India (which
had more vulnerability) was not fully vaccinated, it was
considered imperative to carry out two drives separately
i.e. in a decentralized manner to achieve higher efficiency
and
reach.Thus the States were given a participatory role
to undertake the procurement of vaccine and for vaccination
of any other ‘groups identified drive’ for the 18-44 age
group. This would also keep the existing drive of critical
groups unobstructed as the 50 percent of the vaccines
procured through the GoI channel would continue to
support and provide free of cost vaccine to the most
vulnerable age groups of 45 years plus in the country health
care workers and frontline worker identified by the Union
of India who were entitled to get vaccinated under Phase
II.”
(emphasis supplied)
35. In response to the queries of the Court on how the supplies of
vaccines will be allocated between various states if each State
Government is to negotiate with vaccine producers, the Central
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Government has furnished the following justification in order to iron out
the inequities between States:
“For the remaining 50% non-government of India channel,
the states and the private hospitals are free to procure
vaccine for 18-44 years population, however, to have an
equitable distribution of vaccine across the country, states
have been allocated the available vaccine quantity in
proportion to the population between 18-44 years of age of
the respective state so as to ensure equitable distribution
of vaccine as there is a possibility of some states having
better bargaining power due to geographical advantage etc.”
(emphasis supplied)
36. During the course of the hearing, this Court has expressed its
reservations prima facie on the validity of the revised policy under which
the states and private hospitals are to procure 50% of the vaccines in
order to immunize persons in the 18-44 years age group. For one thing,
even this age group would consist of persons who suffer from
vulnerabilities. Once the vaccination programme has been opened up
for persons other than the 45 plus age group, it would not be logical to
impose the obligation to source vaccinations for the 18-44 age group on
the State Governments. This will, inter alia, leave each State Government
to negotiate supply schedules, delivery pointsand other logistical
arrangements with the manufacturers. At present, there are only two
manufacturers for the
authorized vaccines (with one other vaccine-
Sputnik V, in the process of manufacture). The available stock of vaccines
is not adequate to deal with the requirements of both the categories. The
Central Government must take the responsibility of providing guidance
to every State on the quantities to be supplied to each State, the vaccine(s)
being allocated, the period of delivery, and the number of persons who
can be covered for vaccination, among other details. Leaving the State
Governments to negotiate directly with manufacturers will produce chaos
and uncertainty. The object of vaccinating the 18-44 age group cannot
be achieved in the absence of stocks being available.
37. Besides the above issues, the Central Government is directed
to clarify the following issues in order to ensure the protection of the
fundamental rights to equality and to life and personal liberty for all
persons who will be eligible to take the vaccine from 1 May 2021:
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(i)
Whether the Central and State Governments have
introduced any initiatives for ensuring the immunization of
persons who do not have access to digital resources as
otherwise the mandatory requirement of registration over
the Co-WIN digital portal for persons in the age group of
18-44 years will deprive a large class of citizens of
vaccination;
(ii)
Since the Central Government commits to vaccinating
persons over 45 years, free of cost, in view of their
vulnerability, whether walk-in facilities for vaccination will
continue for these persons after 1 May 2021;
(iii)
Whether the Central or State Governments propose to
undertake targeted vaccination drives for persons who are
providing on-ground assistance during the second wave of
the pandemic- such as crematorium workers, who were
not considered as Frontline or Healthcare workers for Phase
1 of the vaccination drive;
(iv)
Whether, and if so what, steps being undertaken by INYAS,
the nation-wide mass awareness campaign for COVID-19
vaccination, for ensuring outreach in rural areas and socio-
economically underprivileged sections of society including
the possibility of using mobile vans, vehicles and railways
to vaccinate such people as well as those living in remote
areas, near their doorsteps so as to minimize their travel
and potential infection with COVID-2019. Efforts must also
be made that a lack of an identity proof does not create a
hindrance in the process of immunization of all individuals,
specifically, the underprivileged;
(v)
Whether the Central government will revisit its policy by
procuring 100% of the doses which can then be equitably
disbursed to the State Governments; and
(vi)
Since the vaccine administration is now to be a shared
responsibility of the Union and the States, the Central
Government and the State Governments shall provide- (a)
a breakup of the current and projected availability of vaccine
stocks for the next 6 months; and (b) a timeline for achieving
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immunization of the newly eligible 59 crore persons who
are aged between 18-44 years.
These issues are of vital importance, since vaccination appears to
be one of the most important strategies to combat further spread of the
pandemic, and would also provide a measure of security and assure the
people about their health and well-being.
E.2 Vaccine pricing
38. Since the advent of the revised rollout strategy with effect
from 1 May 2021, only persons aged 45 years and above are guaranteed
a free vaccine. The reason of higher efficiency and speed has been
furnished as a justification for enabling State Governments and private
hospitals to directly procure vaccines. We have come to understand that
a few State Governments have committed to free immunization under
the revised strategy. On specific enquiry on the rationale in regard to the
differential pricing for procurement by the Central Government and the
State Governments, the Central Government has furnished the following
justification:
“It is submitted that liberty to decide prices on arm’s length
basis by and between the State Government and hospitals
is based on the concept of creating an incentivized demand
for the private vaccine manufacturers in order to instill a
competitive market resulting in increased production of
vaccines and market driven affordable prices for the same.
Simultaneously, the free vaccination by the Central Government
for above referred
priority age groups would continue and it is
always open for each State Government either to offer free
vaccination or subsidise it for the additional identified earmarked
priority group identified by the State Governments [age 18-44
years].
63. The new strategy was devised after multiple Inter- Ministerial
teams were deputed by Govt. of India to various manufacturing
sites to understand their requirement and to provide pro-active
and customized support to significantly augment vaccine production
capacities [which is the prime priority of the Central Government
at this juncture], in the form of advance payments, facilitating
more sites for production etc. This approach, on the one hand,
incentivizes vaccine manufacturers to rapidly scale up their
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production and on the other hand, it would also attract new
vaccine manufacturers. It would make pricing, procurement
and administration of vaccines more flexible and competitive
and would further ensure augmented vaccine production
as well as wider availability of vaccines in the country.”
(emphasis supplied)
39. Prima facie, there are several aspects of the vaccine pricing
policy adopted by the Central government which require that policy be
revisited. All vaccines, whether in the quantity of 50% purchased by the
Central Government or the remaining 50%, are to be used for vaccinating
citizens. The end use is the same. The Central Government proposes to
purchase half of the total quantity falling within its fifty per cent quota
while for the rest, the manufacturers would declare in advance the price
to be fixed, allowing the State Governments to negotiate their terms. As
of date, the manufacturers have suggested two different prices, a lower
price which is applicable to the Central Government and a higher price
which is applicable to the quantities purchased by the State Governments.
It is likely that compelling the State Governments to negotiate with
manufacturers on the ground of promoting competition and making it
attractive for new vaccine manufactures will result in a serious detriment
to those in the age group of 18 to 44 years, who will be vaccinated by the
State Governments. The social strata of this age group also comprises
persons who are
Bahujans or belong to other under privileged and
marginalized groups, like many in the other population age groups. They
may not have the ability to pay. Whether or not essential vaccines will
be made available to them will depend upon the decision of each State
Government, based on its own finances, on whether or not the vaccine
should be made available free or should be subsidized and if so, to what
extent. This will create disparity across the nation. The vaccinations
being provided to citizens constitute a valuable public good. Discrimination
cannot be made between different classes of citizens who are similarly
circumstanced on the ground that while the Central government will
carry the burden of providing free vaccines for the 45 years and above
population, the State Governments will discharge the responsibility of
the 18 to 44 age group on such commercial terms as they may negotiate.
Prima facie, the rational method of proceeding in a manner consistent
with the right to life (which includes the right to health) under Article 21
would be for the Central Government to procure all vaccines and to
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negotiate the price with vaccine manufacturers. Once quantities are
allocated by it to each State Government, the latter would lift the allocated
quantities and carry out the distribution. In other words, while procurement
would be centralized, distribution of the vaccines across India within the
States/UTs would be decentralized. While we are not passing a conclusive
determination on the constitutionality of the current policy, the manner in
which the current policy has been framed would prima facie result in a
detriment to the right to public health which is an integral element of
Article 21 of the Constitution. Therefore, we believe that the Central
Government should consider revisiting its current vaccine policy to ensure
that it withstands the scrutiny of Articles 14 and Article 21 of the
Constitution.
40. In light of the justification offered for non-interference in the
prices that are set by the manufacturers, irrespective of their variance
from the prices for procurement of the Central Government, we would
like to seek the following clarifications:
(i)
Whether any other alternatives were considered by the
Central Government for ramping up the immunization drive
in India, particularly in light of its initial strategy of a
centralized free immunization drive;
(ii)
The methodology which the Central Government was
envisaging to procure adequate vaccine doses for the
population prior to the revised strategy which
was announced
amidst thesecond wave of COVID-19; and
(iii)
Whether any studies and figures were relied upon in order
to arrive at the conclusion that decentralized procurement
would spur competitive markets to incentivize production
and eventually drive down the prices of the vaccines.
Whether these studies are of relevance in a pandemic when
vaccinesare a scarce andessential commodity which is being
produced by a limited number of manufacturers for a limited
number of vaccines.
41. The Central Government has submitted that the Finance
Ministry has sanctioned a credit of Rs 3000 crores for Covishield
manufacturer- Serum Institute of India20and Rs 1500 crores to Covaxin
20 “SII”
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manufacturer- Bharat Biotech. Additionally, another Rs 65 crores is stated
to have been provided to Bharat Biotech’s production center at
Bangalore. In bolstering its argument for augmentation of vaccine
production, the Central Government has provided the Court with further
information on advance funding (of unspecified amounts) that is being
provided to R&D and manufacturing facilities. In light of this investment,
the Central Government should consider revisiting its policy bearing in
mind what has been stated above, the following issues and other relevant
information:
(i)
Whether, and if so, the Finance Ministry or any other funding
organization of the Government of India havemade any
grants/sanctions to Bharat Biotech and the SII in the past,
like the current infusion of Rs 1500 crores and Rs 3000
crores, respectively. If so, breakup and corelation with the
total cost of development and production of the two
vaccines;
(ii)
Whether the current procurement prices for the Central
Government account for infusion of funds for production,
infrastructure and other aid provided by it. If so, the basis
on which the same benefit is denied to procurement by State
Governments which equally service the needs of citizens;
and
(iii)
The full extent of direct and indirect grant/aid provided for
research, development andmanufacture of all existing
vaccines and future vaccines that it proposes to authorize.
For instance, the Central Government has submitted in its
affidavit that the Department of Biotechnology has
facilitated the trials for Sputnik V.
F. Potentiality of Compulsory Licensing for vaccines and
essential drugs
42. Several drugs that are at the core of the COVID treatment
protocol are under patents in India including Remdesivir, Tociluzumab
and Favipiravir. On 2 October 2020, a communication was issued by the
UOI, along with South Africa, to the Council for Trade-Related Aspects
of Intellectual Property which stated that there were several reports
about intellectual property rights hindering timely provisioning of
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affordable medical products to patients21. The communication also
reported that some members of the World Trade Organization had carried
out urgent amendments to their national patent laws to expedite the
process of issuing compulsory/government use licenses.
43. In India, the patent regime is governed by the Patents Act,
197022, Section 92 of which envisages the grant of a compulsory license,
inter alia, in circumstances of national emergency and extreme urgency.
Once a declaration of national emergency is made, and the relevant
patents notified, any person interested in manufacturing the drug can
make an application to the Controller General of Patents who can then
issue a compulsory license. The patentee would be paid a reasonable
royalty as fixed by the Controller General of Patents. Further, under
Section 100 of the Patents Act, the Central Government can authorize
certain companies to use any patents for the “purpose of the government”.
Indian companies can begin manufacturing the drugs while negotiating
the royalties with the patentees. If the Central Government or its
authorized company is not able to reach an agreement with the patentee,
the High Court has to fix the reasonable royalty that is to be paid to the
patentee. Another alternative is for the Central Government to acquire
the patents under Section 102 from the patentees. If the Central
Government and the patentee is not able to reach a consensus on
the
price of the patents, it is up to the High Court to fix the royalty. Additionally,
under Section 66 of the Patents Act, the Central Government is also
entitled to revoke a patent in the public interest.
44. The utilization of these flexibilities has also been detailed in
the Trade Related Aspects of Intellectual Property Rights Agreement23.
Even as TRIPS obliges countries to ensure a minimum level of patent
protection, it creates a permissive regime for the carving out of exceptions
and limitations that further public health objectives24. This is evident from
a conjoint reading of Articles 7, 8, 30 and 31 of TRIPS. Article 7 outlines
21 Council for Trade-Related Aspects of Intellectual Property Rights, Waiver From
Certain Provisions Of The Trips Agreement For The Prevention, Containment And
Treatment Of Covid-19, Communication From India And South Africa, IP/C/W/669,
2nd October, 2020, available at https://docs.wto.org/dol2fe/Pages/SS/
directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True
22 “Patents Act”
23 “TRIPS”
24Report of the United Nations Secretary-General’s High-Level Panel on Access to
Medicines Promoting Innovation and Access to Health Technologies, (United Nations
Secretary-General, 2016), p. 16.
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the objectives of the TRIPS as being to ensure the effective enforcement
of intellectual property in a way that, inter alia, is ‘conducive to social
and economic welfare’. Article 8 gives member countries the freedom
to take measures that protect public health and nutrition. Article 8(2)
allows for the taking of TRIPS-compatible measures aimed at preventing
the abuse of intellectual property rights. Articles 30 and 31 deal with
exceptions to the rights of patent owners, by allowing grant of compulsory
licenses. It leaves countries with significant breathing space to determine
how the compulsory licensing or government-use levers can be triggered.
While such determinations must be made on the individual merits of
each case25, the aforesaid caveat does not apply when the compulsory
license grant is for national emergency, extreme urgency or public non-
commercial use26.
45. According to the 2001 Doha Declaration, TRIPS should be
interpreted in a manner supportive of the right of members to protect
public health and to promote access to medicines27. It recognizes the
right of WTO members to use the full extent of the TRIPS flexibilities to
secure this objective. Para 5(b) of the Doha Declaration provides the
freedom to each member to grant compulsory licenses and to determine
the grounds on which the licenses are granted. Para 5(c) leaves it up to
each nation to determine what constitutes a national emergency or
extreme urgency. In the context of the
COVID-19 pandemic, we note
that several countries such as Canada and Germany have relaxed the
legal regimes governing the grant of compulsory licenses28.
46. Whether and if so, the extent to which these provisions should
be utilized is a policy decision for the Central Government. We have
flagged the issue for its consideration. We have only outlined the legal
framework within which the Central Government can possibly consider
compulsory licensing and government acquisition of patents. The Central
Government is free to choose any other course of action that it deems fit
to tackle the issue of vaccine requirements in an equitable and expedient
manner, which may involve negotiations with domestic and foreign
producers of vaccines. We clarify that it is up to the Central Government
25 TRIPS Agreement, Article 31(a).
26 TRIPS Agreement, Article 31(b).
27 World Trade Organization, ‘Ministerial Declaration of 14 November 2001’ (November
2001) WT/MIN(01)/DEC/1, 41 ILM 746, para 4.
28 ‘COVID-19 IP Policy Tracker’ (WIPO, 16 July 2020),  available at https://
www.wipo.int/covid19-policy-tracker/#/covid19-policy-tracker/access.
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to choose the best possible measures it can undertake during the current
crisis keeping in mind that public interest is of paramount importance.
G Supply of Essential Drugs
G.1 Submissions in the Central Government’s Affidavits
47. In relation to the broad issue of “Supply of Essentials”, in its
affidavit dated 23 April 2021 and additional affidavit 29 April 2021, with
respect to Remdesivir, the UOI urged that:
(i)
Remdesivir is a patented drug which is being manufactured
in India under licensing agreements between the patent
holder, M/s Gilead, a US based company and seven Indian
companies. Under such agreements, these Indian companies
are allowed to manufacture Remdesivir for distribution;
(ii)
In its affidavit dated 23 April 2021, it was submitted on
behalf of the Central Government that the current production
is about 74 lakhs vials per month and once the additional
manufacturing sites of the seven manufacturers become
operational by May 2021, the production capacity will
increase to 90 lakhs vials per month. In its additional affidavit
dated 29 April 2021, the Central Government has submitted
that as on 23 April 2021, the production capacity has
increased to 1.03 crore vials per month;
(iii)
The Central Government allocated 11 lakhs vials of
Remdesivir to nineteen States with a high case load between
21 to 30 April through a letter issued on 21 April 2021. This
allocation was revised and expanded to all States
and UTs
through a letter issued on 24 April 2021;
(iv)
The Central Government has directed the States to appoint
nodal officers to ensure unrestricted and timely movement
of Remdesivir. A control room has been set up in this regard
by the National Pharmaceutical Pricing Authority29 which
is monitoring supplies as allocated. A helpline has been set
up by NPPA and manufacturers have been directed to
address the hindrances in the movement of the drug. A
WhatsApp group with nodal officers has also been created
29 “NPPA”
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to enable coordination and officials of MHA, NPPA and
CDSCO are also part of the group;
(v)
Remdesivir, its Active Pharma Ingredients30 and
formulations have been placed under export ban since 11
April 2021;
(vi)
The Ministry of Finance has issued a notification on 20 April
2021 exempting customs duty on the Remdesivir injection,
and API of Remdesivir and Betacyclodexterin, which are
used in the manufacture of the injection. All the SEZ/EOU
manufacturing units of M/s Mylan and M/s Honous Lab,
who are manufacturing Remdesivir on behalf of some of
the seven manufacturers have also been directed to start
manufacturing Remdesivir for domestic supply;
(vii)
CDSCO has directed all State Drug Controllers on 10 April
2021 to conduct a special investigation drive to prevent
hoarding and black-marketing of Remdesivir in the country.
DCGI and State Drug Controllers have been taking stringent
action against such activities and enforcement action has
been taken in thirty-four cases across the country;
(viii) MHA has issued an advisory on 22 April 2021 to States
and Union Territories to facilitate smooth movement of
supplies. A “Covid Drug Management Cell” consisting of
the Department’s Senior Officers and others has been
constituted on 26 April 2021 to oversee and identify common
concerns raised by States in relation to Remdesivir;
(ix)
NPPA has revised the maximum retail price of a 100 mg/
vial of Remdesivir to Rs 3500; and
(x)
The Central Government is also looking
at the possibility of
importing Remdesivir.
48. The UOI made the following submissions on the availability
of Tociluzumab injections:
(i)
Tociluzumab is manufactured by a Swiss Company, M/s
Roche, which does not have any manufacturing facility in
India or any agreementswith domestic pharma companies
30 “API”
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to manufacture the drug. It is imported in the country by
Cipla. India is completely dependent on imports;
(ii)
It is listed as an investigational therapy drug (off-label) under
the National Clinical Management Protocol for COVID-19
for severe cases. There are domestically produced
alternatives which are equivalent to or better than
Tociluzumab such as itulizumab, dexamethasone and methyl
prednisolone. However, an incorrect public perception has
been created that only Tociluzumab can treat the
inflammatory burst condition in COVID-19 patients since
it is an imported drug. This has led to the acute shortage in
the availability of the drug and has created public panic;and
(iii)
The supply of Tociluzumab is being monitored by NPPA
and CDSCO.
49. The UOI has made the following submissions on the availability
of other drugs:
(i)
The National Clinical Management Protocol for COVID-
19 does not include Favipirarvir (popularly known as Fabiflu)
due to insufficient peer reviewed evidence to substantiate
its use in mild to moderate cases of COVID-19. However,
it is being prescribed by certain doctors. The clinical
management protocol is a dynamic document which is
reviewed periodically and is subject to further evaluation
based on medical research and evidence that comes up in
future; and
(ii)
On 24 April 2021, Department of Pharmaceuticals31, NPPA
and DCGI had reviewed the production and supply of other
drugs such as
Favipiravir, Enoxaparin, Ivermectin,
Methylprednisolone, Paracetamol and Hydroxy-chloroquine.
A meeting was conducted on 25 April 2021 by NPPA and
DCGI with manufacturers to review stock position,
availability and production plans.
G.2 Recommendations
50. In respect of the essential drugs, this Court has been informed
that the Central Government is taking steps to augment the production
of Remdesivir. It has been brought to our notice that seven Indian
31 “DoP”
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companies are manufacturing this drug under a licensing agreement with
a US based company, M/s Gilead. The current production capacity as
on 23 April 2021 is noted to be at 1.03 croresvials per month. The Central
Government should provide us with the details of the actual rate of
production and a breakup of demand for the drug from different States.
Further, while it has been submitted on behalf of the Central Government
that it is allocating the stocks based on a rational criterion of equitable
distribution keeping in mind the existing constraints on the availability of
the drug, this Court should be provided with details of the methodology
used for such allocation.
51. We have been informed by the Central Government in its
affidavit that NPPA has revised the maximum retail price of Remdesivir
to Rs 3500. However, it has come to our notice that several other
drugs which are being prescribed by doctors for treating COVID-19
patients like Favipiravir, Tociluzumab, Enoxaparin, Ivermectin,
Methylprednisolone, Paracetamol and Hydroxy-chloroquine are being
priced at exorbitant rates creating issues of access and affordability.
While this is not a direction of this Court, the Central Government can
consider invoking its statutory powers under paragraphs 19 and 20 of
the Drugs Price Control Order, 2013. Under paragraph 1932 of the Drugs
Price Control Order, 2013 the Government in extraordinary
circumstances, if it considers necessary in public interest, can fix
a ceiling
price or retail price of the drug for a certain period. COVID-19 is a
crisis of an unprecedented nature and qualifies as an extraordinary
circumstance. It will be in public interest to ensure that the price of
essential drugs is fixed in such a manner that it is available even to the
most marginalized sections of the society. The Government can even
monitor the prices of the drugs under paragraph 2033 of the Drugs Price
32 “19: Fixation of the Ceiling Price Under Certain Circumstances: Notwithstanding
anything contained in this order, the Government may, in case of extraordinary
circumstances, if it considers necessary to do so in public interest, fix the ceiling price
or retail price of any drug, as it may deem fit and where the ceiling price or retail price
of the drug is already fixed and notified, the Government may allow an increase or
decrease in the ceiling price or the retail price, as the case may be, irrespective of annual
wholesale price index of that year.”
33 “20: Monitoring the Prices of Non-Scheduled Formulations: (1) the Government
shall monitor the maximum retail prices (MRP) of all the drugs, including the non-
scheduled formulations and ensure that no manufacturer increases the maximum retail
price of a drug more than ten percent of maximum retail price during preceding twelve
months and where the increase is beyond ten percent of maximum retail price, it shall
reduce the same to the level of ten percent of maximum retail price for next twelve
months. (2) The manufacturer shall be liable to deposit the overcharged amount along
with interest thereon from the date of the increase in price in addition to the penalty.”
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Control Order, 2013 and ensure that no manufacturer increases the prices
of the drugs by more than 10% of the maximum retail price during the
preceding 12 months and where the increase is beyond 10% of the
maximum retail price, it can oblige the manufacturer to reduce it to the
level of 10% for the next 12 months.
52. The Central Government has submitted that it plans to import
Remdesivir. It can also consider importing other essential drugs to meet
the immediate demand of the drug while the production is ramped up.
We hasten to clarify that this does not constitute a direction of this Court
and ultimately this decision falls under the domain of the executive.
53. We note that there are certain medicines which are being
prescribed by doctors which are not mentioned in the National Clinical
Management Protocol for COVID-19 like Favipiravir. However, since
these medicines are being prescribed by doctors, people are facing
significant inconvenience in obtaining them due to their shortage in certain
parts of the country. The Central Government should consider whether
the production of such medicines should be augmented to meet the
demand or instructions should be given to the doctors to not recommend
such medicines unless they have been included in the national protocol.
54. It has been submitted on behalf of the Central Government
that on 24 April 2021, DoP, NPPA and DGCI reviewed the production
and supply of drugs such
as Favipiravir, Enoxaparin, Ivermectin,
Methylprednisolone, Paracetamol and Hydroxy-chloroquine. The supply
of Remdesivir and Tociluzumab is already under the consideration of the
Central Government. A meeting was also held on 25 April 2021 by DoP,
NPPA and DGCI with the manufacturers to review stock position,
availability and production plans. The Central Government should provide
details of estimated demand of essential drugs mentioned above,
production capacity, existing stocks, details of allocation and supply of
such drugs.
55. As discussed in Section F, the Central Government can also
consider using its powers under Sections 92, 100 or 102 of the Patents
Act to increase production of essential drugs to ensure that it is
commensurate to the demand. The Central Government’s affidavit
testifies to existence of capacity of public sector organizations and
institutes, which can assist in augmenting production of various drugs
and formulations. The utilization of these capabilities to augment
production, once licensing is resorted to, will be in the interests of the
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general public. This Court is further of the opinion that prima facie the
present circumstance warrant the government’s examination of its the
extraordinary powers, meant to be used in extreme situations, such as
the current pandemic, for fixing drug prices, be it vaccines, or patented
formulations, having regard to the provisions of the Drugs and Cosmetics
Act, 1940 and other provisions34.We are cognizant that invocation of the
above provisions, if any, is ultimately a policy decision of the Central
Government and may encompass negotiations with the concerned
stakeholders. We hope that the Central Government will adopt a route
that best serves the public interest.
G.3 Black Marketing
56. This Court would like to take judicial notice of the fact that
several critical drugs, used to treat COVID-19, such as Remdesivir and
Tocilizumab, are being sold at significantly inflated prices or in fake form.
This is a condemnable attempt to exploit people’s miseryand profit from
their helplessness.
57. In order to clamp down on this practice, the Central
Government can consider constituting a special team to identify and
prosecute those who: (a) sell medical grade oxygen/COVID-19 medicines
at exorbitant prices; and (b) sell fake substances and recover the
concerned substances. A protocol for ambulances must also be evolved
to avoid citizens being exploited by extracting unconscionable charges.
The Central Government can consider creating a platform for easy
reporting
and redressal of such cases.
H. Recommendations for augmenting healthcare workforce
58. It is common knowledge that a large number of medical, nursing
and pharmacy students, who graduated in 2020 and would be in the
process of graduating in 2021, would be available to augment the
workforce in the health sector. The Central Government should, we
feel, look into this aspect, and ensure the optimal manner of utilization of
their services, regard being had, of course, to their safety and well-
being.
59. The Central Government should also consider using health
care workforce available with the armed forces and para military forces
for the purpose of vaccination.
34 Paragraph 3 and 19 of the Drugs Price Control Order, 2013
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I.Epilogue
60. The World Health Organisation35, while discussing the rapid
spread of COVID-19 has not only labelled it an epidemic but also an
“infodemic”, due to the overabundance of information on the internet,
which was riddled with misinformation and disinformation36. This
highlights the key role internet and technology currently has in all our
lives, as the COVID-19 pandemic rages on. Indeed, the WHO recently
also conducted a study to understand how individuals between the ages
of 18-40 years dealt with the ongoing pandemic using social media37.
61. It is only appropriate then that when many cities in India are
suffering through the second wave of the COVID-19 pandemic, many
have turned to the internet, using applications/websites to find critical
support. On these platforms, online communities led by members of the
civil society and other individuals, have assisted the needy in multiple
ways – often by helping them procure oxygen, essential drugs or find a
hospital bed through their own networks or by amplifying original requests,
and even by offering moral and emotional support. However, it is with
deep distress that we note that individuals seeking help on such platforms
have been targeted, by alleging that the information posted by them is
false and has only been posted in social media to create panic, defame
the administration or damage the “national image”. We do not hesitate in
saying that such targeting
shall not be condoned, and the Central
Government and State Governments should ensure that they immediately
cease any direct or indirect threats of prosecution and arrest to citizens
who air grievances or those that are attempting to help fellow citizens
receive medical aid. If this does keep happening even after the current
order, this Court shall be constrained to use the powers available to it
under it contempt jurisdiction.We also direct that all Directors General
35 “WHO”
36 “Managing the COVID-19  infodemic: Promoting healthy behaviours and mitigating
the harm from misinformation and disinformation - Joint statement by WHO, UN,
UNICEF, UNDP, UNESCO, UNAIDS, ITU, UN Global Pulse, and IFRC” (WHO, 23
September 2020) available at <https://www.who.int/news/item/23-09-2020-managing-
the-covid-19-infodemic-promoting-healthy-behaviours-and-mitigating-the-harm-from-
misinformation-and-disinformation>
37 “Social media & COVID-19: A global study of digital crisis interaction among Gen Z
and Millennials” (WHO, 23 September 2020) available at <https://www.who.int/news-
room/feature-stories/detail/social-media-covid-19-a-global-study-of-digital-crisis-
interaction-among-gen-z-and-millennials>
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of Police shall ensure compliance down the ranks of the police forces
within their jurisdictions.
62. In these trying times, those desperately seeking help for their
loved ones on these platforms should not have their misery compounded
through the actions of the State and its instrumentalities. Further, there
are two more crucial reasons why such a clampdown on information
sharing must be absolutely stopped immediately.
63. The first reason is because sharing information widely is in
itself an important tool in combating public tragedies, like the current
COVID-19 pandemic. In K.S. Puttaswamy (Privacy-9J.) vs Union
of India38, one of us (DY Chandrachud, J) speaking for four Judges of
a nine-Judge bench of this Court noted academic literature documenting
the widespread availability of information and the resultant
acknowledgement of the problem is what prevented the drought in
Maharashtra in 1973 from becoming as bad as the Bengal Famine of
1943, where the British tried to deny the problem even existed. It was
noted thus:
“267. Civil and political rights and socio-economic rights do not
exist in a state of antagonism. The conditions necessary for realising
or fulfilling socio-economic rights do not postulate the subversion
of political freedom. The reason for this is simple. Socio-economic
entitlements must yield true benefits to those for whom they are
intended. This can be achieved by eliminating rent-seeking
behaviour and by preventing the capture of
social welfare benefits
by persons who are not entitled to them. Capture of social welfare
benefits can be obviated only when political systems are
transparent and when there is a free flow of information. Opacity
enures to the benefit of those who monopolise scarce economic
resources. On the other hand, conditions where civil and
political freedoms flourish ensure that governmental
policies are subjected to critique and assessment. It is this
scrutiny which subserves the purpose of ensuring that socio-
economic benefits actually permeate to the underprivileged
for whom they are meant. Conditions of freedom and a
vibrant assertion of civil and political rights promote a
constant review of the justness of socio-economic
38 (2017) 10 SCC 1
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programmes and of their effectiveness in addressing
deprivation and want. Scrutiny of public affairs is founded
upon the existence of freedom. Hence civil and political
rights and socio-economic rights are complementary and
not mutually exclusive.
268. Some of these themes have been addressed in the writings
of the Nobel laureate, Amartya Sen. Sen compares the response
of many non-democratic regimes in critical situations such as
famine with the responses of democratic societies in similar
situations. [ Amartya Sen, Development as Freedom (Oxford
University Press, 2000) at pp. 178-79.]…
269. In the Indian context, Sen points out that the Bengal famine
of 1943 “was made viable not only by the lack of democracy in
colonial India but also by severe restrictions on reporting and
criticism imposed on the Indian press, and the voluntary practice
of “silence” on the famine that the British-owned media chose to
follow” [ Amartya Sen, The Idea of Justice (Penguin Books, 2009)
at p. 339.] . Political liberties and democratic rights are hence
regarded as “constituent components” of development. [Id, at p.
347] In contrast during the drought which took place in
Maharashtra in 1973, food production failed drastically and the
per capita food output was half of that in sub-Saharan Africa. Yet
there was no famine in Maharashtra where five million people
were employed in rapidly organised public projects while there
were substantial
famines in sub-Saharan Africa. This establishes
what he terms as “the protective role of democracy”. Sen has
analysed the issue succinctly:
“The causal connection between democracy and the non-
occurrence of famines is not hard to seek. Famines kill millions of
people in different countries in the world, but they don’t kill the
rulers. The kings and the presidents, the bureaucrats and the
bosses, the military leaders and the commanders never are famine
victims. And if there are no elections, no opposition parties, no
scope for uncensored public criticism, then those in authority don’t
have to suffer the political consequences of their failure to prevent
famines. Democracy, on the other hand, would spread the penalty
of famines to the ruling groups and political leaders as well. This
gives them the political incentive to try to prevent any threatening
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famine, and since famines are in fact easy to prevent (the
economic argument clicks into the political one at this stage), the
approaching famines are firmly prevented.” [ Amartya Sen,
Development as Freedom (Oxford University Press, 2000) at p.
180.]...””
(emphasis supplied)
As such, preventing clampdowns on sharing of information on
online platforms is not just in the interest of individuals sharing the
information, but the larger democratic structures of our nation. Without
the ready availability of such information, it is entirely possible that the
COVID-19 pandemic may turn into a tragedy worse than what it already
is.
64. The second reason is because sharing information widely will
help in the creation of a “collective public memory” of this pandemic.
The presence of collective public memory, which refers “to an extant
and taken-for-granted group memory”39, is important for the creation
of knowledge of the problems plaguing us today, so they may be passed
on across time40. This is important since we do not have to travel back
too much in our past to realise that the pandemic caused by the “Spanish”
flu of 1918, which is said to have infected every third person in the world
and killed between 50-100 million individuals (compared to the 17 million
who died in World War I), has been almost entirely erased from our
collective public memory41. Therefore, the widespread sharing of
information by individuals living through the COVID-19 pandemic
becomes
crucial. Furthermore, the role of Courts in creating and
preserving this collective public memory cannot be understated.
Professors Austin Sarat and Thomas R. Kearns, in their book History,
Memory, and the Law, describe the function that is played by Courts in
the following terms42:
39 Theodore O. Prosise,
‘The collective memory of the atomic bombings misrecognized as objective history:
The case of the public opposition to the national air and space museum’s atom bomb
exhibit’, (1998) 62 Western Journal of Communication 3:316-347, pg 318
40 Bryan Hubbard and Marouf A. Hasian, ‘Atomic Memories of the  ‘Enola Gay’:
Strategies of Remembrance at the National Air and Space Museum’ (1998) 1 Rhetoric
and Public Affairs 3:363-385, pg 364
41 Jonathan Freedland, ‘History suggests we may forget the pandemic sooner than we
think’ (The Guardian, 29 January 2021) available at <https://www.theguardian.com/
commentisfree/2021/jan/29/history-forget-pandemic-spanish-flu-covid>
42 Austin Sarat and Thomas R. Kearns, History, Memory, and the Law  (University of
Michigan Press, 2009) pgs 12-13
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“Law in the modern era is, we believe, one of the most important
of our society’s technologies for preserving memory. Just as the
use of precedent to legitimate legal decisions fixes law in a
particular relation to the past, memory may be attached, or attach
itself, to law and be preserved in and through law. Where this is
the case, it serves as one way of orienting ourselves to the future.
As Drucilla Cornell puts it: “Legal interpretation demands
that we remember the future.” In that phrase, Cornell
reminds us that there are, in fact, two audiences for every
legal act, the audience of the present and the audience of
the future. Law materializes memory in documents,
transcripts, written opinions; it re-enacts the past, both
intentionally and unconsciously, and it is one place where
the present speaks to the future through acts of
commemoration.
Because the litigated case creates a record, courts can
become archives in which that record serves as the
materialization of memory. Due process guarantees an
opportunity to be heard by, and an opportunity to speak to,
the future. It is the guarantee that legal institutions can be
turned into museums of unnecessary, unjust, undeserved
pain and death. The legal hearing provides lawyers and
litigants an opportunity to write and record history by
creating narratives of present injustices, and to insist on
memory in the face of denial. By recording such history and
constructing
such narratives lawyers and litigants call on an
imagined future to choose Justice over the “jurispathic” tendencies
of the moment.”
(emphasis supplied)
Hence, in the present proceedings, we hope to not only initiate a
dialogue so as to better tackle the current COVID-19 pandemic but also
to preserve its memory in our public records, so that future generations
may evaluate our efforts and learn from them.
65. We speak not only as members of this Court, but also as
grateful citizens of the country, and commend the outstanding work of
our all healthcare professionals (doctors, nurses, healthcare workers,
laboratory technicians, ward staff, ambulance drivers, crematorium
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workers etc.) during this crisis. They have truly gone beyond their call
of duty and toiled day in and day out, relentlessly without rest amidst
great challenges. It is absolutely necessary to take urgent steps for their
well-being to ensure that our appreciation for their tremendous efforts is
not reduced to rhetoric. This is especially important since another factor
which affects how collective public memory of any event is created is
by the rhetoric surrounding it43. As such, our public memory of this public
event has to transcend its conception as a “war” against the virus of
COVID-19 itself, but rather to remember that it is “the complex
epidemiological circumstances that promote these outbreaks and
the under-resourced health systems that are tasked with disease
containment”44. While the healthcare professionals have been at the
forefront of tackling this crisis, we have to recognize their contribution
as medical healthcare professionals who have undertaken “to protect
public health using proven scientific evidence and best practices
and to serve to community at large”45, and not just as “CORONA
WARRIORS”.
66. We also do not hesitate to note that the treatment meted out to
these public healthcare professional during this COVID-19 pandemic
has sometimes been less than ideal. The following are some of the issues
we wish to highlight:
(i)
Recently, there were reports that the Pradhan Mantri Garib
Kalyan Package Insurance Scheme, an insurance scheme
of
Rs 50 lakhs which had been extended to about 22 lakh
healthcare professionals, was set to expire on 24 March
2021 and would not be renewed. While we are happy to
note that UOI’s affidavit of 23 April 2021 states that this
Scheme has been extended for one year starting April 2021,
we have also been informed that till date only 287 claims
have been settled under it, which includes claims from the
families of 168 doctors who died after contracting COVID-
43 Nicole Maurantonio, “The Politics of Memory” in Kate Kenski and Kathleen Hall
Jamieson (eds),  The Oxford Handbook of Political Communication (Oxford University
Press, 2014)
44 Luke Shors,  ‘Waging Another Public Health “War?” ’ (Think Global Health, 26
February 2020) available at <https://www.thinkglobalhealth.org/article/waging-another-
public-health-war>
45 Elena N.Naumova,  ‘The traps of calling the public health response to COVID 19
“an unexpected war against an invisible enemy” ’ (2020) Journal of Public Health
Policy (2020) 41:233-237, pg 233
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19 while treating patients. We direct the Central
Government to inform this Court as to how many claims
are pending under the Scheme, and the timeline within which
the Central Government expects to settle them;
(ii)
Healthcare personnel are at an obvious heightened risk of
contracting the COVID-19 virus. However, we are aware
of reports that indicate that infected healthcare personnel
are left to fend for themselves without adequate availability
of beds, oxygen or essential drugs. Further, some of them
have also often been asked to report back to duty within 10
days of first testing positive for COVID-19 (provided they
are asymptomatic), even though a longer recuperation period
is often recommended. While we are dealing with a terrible
second wave of the COVID-19 pandemic, there must be
an effective policy to ensure that the nation truly
acknowledges their effort and creates incentives for them.
We hope it will be remedied soon by the Central and State
Governments through theintroduction of appropriate
guidelines and measures;
(iii)
It is unclear what measures are currently being taken to
ensure that healthcare personnel can continue to serve
others while not risking the health of their family members.
We hope that the respective State Governments, with
necessary assistance from the Central Government, can
ensure this takes place; and
(iv)
The Central Government should, we feel examine and
ensure that in addition to
the schemes it has framed, other
facilities such as availability of food, resting facilities during
intervals between work, transportation facilities, non-
deduction of salary or leave account, if afflicted by COVID
2019 or related infection, overtime allowance, in both public
and private hospitals, and a separate helpline for doctors,
and healthcare professionals, in cases of COVID 2019
related emergencies, is provided. All these, we feel, would
show these professionals that we do not show our
appreciation in mere words, but also care for them.
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67. The issues mentioned above are only symptomatic of the other
broader issues thatare being faced by healthcare professionals, who are
instrumental in combating the pandemic. Hence, we hope their welfare
is considered seriously by the Central and State Governments. Further,
we would wish to use this order toplace on record our sincerest
appreciation for all the public healthcare professionals- not just limited to
the doctors, but also nurses, hospital staff, ambulance drivers, sanitation
workers and crematorium workers. It is through their dedicated efforts
that the effect of COVID-19 pandemic is being currently tackled in
India.
68. In light of the continuing surge of infections in the second
wave of the pandemic, we direct the Central Government and State
Governments to put on record the efforts taken to curb the spread of the
virus and the measures that they plan on taking in the near future. At the
same time, we would seriously urge the Central and State Governments
to consider imposing a ban on mass gatherings and super spreader events.
They may also consider imposing a lockdown to curb the virus in the
second wave in the interest of public welfare. Having said that, we are
cognizant of the socio-economic impact of a lockdown, specifically, on
the marginalized communities. Thus, in case the measure of a lockdown
is imposed, arrangements must be made beforehand to cater to the needs
of these communities.
J. Conclusion
69. The present order has
primarily considered the submissions
(written and oral) ofthe UOI. These submissions have been reproduced
here as a matter of public record and to contextualize the clarifications
that are being sought by our Court in order to serve its dialogic role. We
reiterate, for abundant caution, that the data and submissions reproduced
above are not its endorsement or acceptance. In terms of the above
discussion, we hereby pass the following directions:
(i)
The UOI shall ensure, in terms of the assurance of the
Solicitor General, that the deficit in the supply of oxygen to
the GNCTD is rectified within 2 days from the date of the
hearing, that is, on or before the midnight of 3 May 2021;
(ii)
The Central Government shall, in collaboration with the
States, prepare a buffer stock of oxygen for emergency
purposes and decentralize the location of the emergency
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stocks. The emergency stocks shall be created within the
next four days and is to be replenished on a day to day
basis, in addition to the existing allocation of oxygen supply
to the States;
(iii)
The Central Government and State Governments shall notify
all Chief Secretaries/Directors General of Police/
Commissioners of Police that any clampdown on information
on social media or harassment caused to individuals seeking/
delivering help on any platform will attract a coercive
exercise of jurisdiction by this Court. The Registrar (Judicial)
is also directed to place a copy of this order before all
District Magistrates in the country;
(iv)
The Central Government shall, within two weeks, formulate
a national policy on admissions to hospitals which shall be
followed by all State Governments. Till the formulation of
such a policy by the Central Government, no patient shall
be denied hospitalization or essential drugs in any State/UT
for lack of local residential proof of that State/UT or even
in the absence of identity proof;
(v)
The Central Government shall revisit its initiatives and
protocols, including on the availability of oxygen, availability
and pricing of vaccines, availability of essential drugs at
affordable prices and respond on all the other issues
highlighted in this order before the next date of the hearing,
that is, 10 May 2021. Copies of all affidavits to be served
upon the Amici in advance; and
(vi)
Several other suggestions have been made before this Court
in IAs and writ petitions filed by diverse parties. In order to
streamline the further course of hearing, we have requested
the Amici to collate and compile these suggestions which
would be taken up later. The present order has focused on
certain critical issues in view of the urgency of the situation.
Nidhi Jain
Directions issued.