IN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES AND SERVICES DURING PANDEMIC versus . on 30 April 2021

(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 issuesrelating to COVID-19 – Unprecedented humanitarian crisis followingoutbreak of COVID-19 pandamic – Issues as regards distributionof essential supplies and services during pandemic – Issuance ofdirections, recommendations and questions to the Government asregards the medical infrastructure, national policy for admission tohospitals, oxygen allocation and availability, vaccines capacity anddisbursal and vaccine pricing, potentiality of compulsory licensingfor vaccines and essential drugs, supply of essential drugs, blackmarketing and augmentation of health care workforce – Directionto Union of India to ensure that the deficit in the supply of oxygento the Government of National Capital Territory of Delhi- GNCTDis rectified within the stipulated period – Direction to CentralGovernment who would in collaboration with the States, prepare abuffer stock of oxygen for emergency purposes and decentralizeits location – Direction to Central Government and StateGovernments that it would notify all Chief Secretaries/Police thatany clampdown on information on social media or harassment causedto individuals seeking/delivering help on any platform would attracta coercive exercise of jurisdiction – Central Government toformulate a national policy on admissions to hospitals which wouldbe followed by all State Governments, and till then no patient to bedenied hospitalization or essential drugs in any State/UT for lackof local residential proof of that State/UT – Issuance of direction toCentral Government to revisit its initiatives and protocols, includingon the availability of oxygen, availability and pricing of vaccines,availability of essential drugs at affordable prices and on all theother 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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SUPREME COURT REPORTS

Aassumed by this Court under Art. 32 did not automatically lead tothe erosion of High Court’s jurisdiction under Article 226 -Jurisdiction under Article 226 is important – High Courts may bebetter 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 inBits entirety – Jurisdiction exercised is merely to facilitate a dialogueof relevant stakeholders, the UOI, the States and this Court, in lightof the pressing humanitarian crisis, and not with a view to usurpthe role of the executive and the legislature – This bounded-deliberative approach is exercised so that the UOI and States canCjustify the rationale behind their policy approach which must bebound by the human rights framework u/Arts. 21 and 14.

Suo Motu vs State of Gujarat Writ Petition (PIL) No 53Of 2021; K.S. Puttaswamy (Privacy-9J.) vs Union ofIndia (2017) 10 SCC 1: [2017] 10 SCR 569 – referredto.

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Sandra Fredman, “Adjudication as Accountability: ADeliberative Approach” in Nicholas Bamforth and PeterLeyland (eds), Accountability in the ContemporaryConstitution (Oxford University Press, 2013) ; TheodoreO. Prosise, ‘The collective memory of the atomicbombings misrecognized as objective history: The caseof the public opposition to the national air and spacemuseum’s atom bomb exhibit’ - (1998) 62 WesternJournal of Communication 3:316-347, pg 318 ; BryanHubbard and Marouf A. Hasian, ‘Atomic Memories ofthe “Enola Gay” : Strategies of Remembrance at theNational Air and Space Museum’ (1998) 1 Rhetoric andPublic Affairs 3:363-385, pg 364; Austin Sarat andThomas R. Kearns, History, Memory, and the Law(University of Michigan Press, 2009) pgs 12-13; NicoleMaurantonio, “The Politics of Memory” in Kate Kenskiand Kathleen Hall Jamieson (eds), The OxfordHandbook of Political Communication (OxfordUniversity Press, 2014); Elena N. Naumova, ‘The trapsof calling the public health response to COVID- 19 “anunexpected 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 IntellectualProperty Rights, Waiver From Certain Provisions Of TheTrips Agreement For The Prevention, Containment AndTreatment Of Covid-19, Communication From India AndSouth Africa, IP/C/W/669, 2[nd] 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: Promotinghealthy behaviours and mitigating the harm frommisinformation and disinformation - Joint statement byWHO, UN, UNICEF, UNDP, UNESCO, UNAIDS, ITU,UN Global Pulse, and IFRC” (WHO, 23 September2020) 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 interactionamong Gen Z and Millennials” (WHO, 23 September2020) 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 wemay forget the pandemic sooner than we think (TheGuardian, 29 January 2021) available at <https://www.theguardian.com/commentisfree/2021/jan/29/history-forget- pandemic- spanish-flu-covid>; LukeShors, ‘Waging Another Public Health “War?” (ThinkGlobal Health, 26 February 2020) available at <https://www.thinkglobalhealth.org/article/waging- another-public-health-war> – referred to.

Case Law Reference

[2017] 10 SCR 569referred to

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ACIVIL 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),BVivek 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, BrijenderChahar, Ms. Sonia Mathur, Vikas Pahwa, Rahul Mehra, Anand Grover,Ms. Indira Jaising, Amarjit Singh Chandiok, S. Niranjan Reddy, YatinCOza, Ranjit Kumar, C.S. Vaidyanathan, Ms. Garima Prashad, Dr. ManishSinghvi, Dr. Menaka Guruswamy, Sr. Advs., Avnish Kumar Sharma,Rajat Nair, Kanu Agrawal, Amit Mahajan, Prashant Singh B, Raj BahadurYadav, Gurmeet Singh Makkar, A P Mayee, Amit Bhandari, SandeepJha, Suhaan Mukerji, Vishal Prasad, Ms. Deepeika Kalia, NikhilDParikshith, Abhishek Manchanda, Kapish Seth, Mrityunjai Singh,Sayandeep Pahari, M/S. Plr Chambers and Co., Arijit Prasad, MeeneshDubey, 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. NandaniGupta, Rahul Kaushik, Satyakam, Gautam Narayan, Ms. Asmita Singh,EAdithya 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, PolankiGowtham, Shaik Mohamad Haneef, T. Vijaya Bhaskar Reddy, AmitabhSinha, Shrey Sharma, Purvish Jitendra Malkan, Ms. Dharita PurvishFMalkan, 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, AishwaryaChoudhary, 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,GMs. Simran Agarwal, Vikram Sharma, K.V. Jagdishvaran, Mrs. G. Indira,Ms. Ruchira Gupta, Shishir Deshpande, Anurag Sharma, Abhishek KumarSrivastava, Dr. A.P. Singh, Sadashiv, V.P. Singh, Ms. Geeta Chauhan,Ms. Richa Singh, Sharwan Kumar Goyal, Jai Gopal Saboo, PashupatiNath Razdan, Sunny Choudhary, Pulkit Agarwal, Sudhanshu Kaushesh,K.P. Jayaram, Astik Gupta, Ms. Maitrayee Jagat Joshi, A.D.N. Rao, A.H

Venkatesh, Rahul Mishra, Ms. Ananya Khandelwal, V.N. Raghupathy,Ms. Siddhesh Kotwal, Ms. Manya Hasija, Ms. Ana Upadhyay, NirnimeshDube, Pukhrambam Ramesh Kumar, Ms. Anupama Ngangom, KarunSharma, Sunny Choudhary, Mrs. K. Enatoli Sema, Amit Kumar Singh,Sameer Abhyankar, Amish Tandon, Ayush Beotra, Varun Tandon, DipinTamang, Uddhav Khanna, Ms. Shafali Jain, Avijit Mani Tripathi, ShauryaSahay, 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, JishnuM.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, HarisBeeran, Mushtaq Salim, Usman Ghani Khan, Azhar Asees, Ms. PallaviPratap, Ms. Astha Sharma, Ms. Manju Jetley, Govind Manoharan, IbadMushtaq, 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 PrasadGoyal, S. Udaya Kumar Sagar, Ms. Sweena Nair, Ms Pragya Baghel,Kumar Anurag Singh, Ms Pallavi Langar, Devashish Bharuka, Mrs. JayaBharuka, Ravi Bharuka, Ms. Sarvshree, Justine George, Ms. SrishtiAgarwal, Ankit Agarwal, Ms. Taniya Bansal, Manoj V George, RanjitPhilip, Ms. Palak Arora, K. Panmei, Ms. Shilpa Liza George, ShuvodeepRoy, Ms. Diksha Rai, Ms. Ninmisha Menon, Deepak A. Masih, Ms.Manreet Kaur, Ms.Kusum, R. N. Keswani, J. Sai Deepak, GuruswamyNataraj, V. Shyamohan, Surya Prakash for M/S KMNP Law, Advs. forthe 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 facilitateanalysis:

AIntroduction

BOutline of the Disaster Management Act

CMedical Infrastructure

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[2021] 4 S.C.R.

AC.1Submissions in UOI’s Affidavits

C.2National Policy for Admission in Hospitals DOxygen allocation and availability EVaccines B

E.1 Vaccine capacity and disbursal

E.2 Vaccine pricing

FPotentiality of Compulsory Licensing for vaccinesand essential drugs GSupply of Essential Drugs C

G.1 Submissions in the Central Government’sAffidavits G.2 Recommendations DG.3 Black Marketing HRecommendations for augmenting healthcareworkforce IEpilogue JConclusion E

A. Introduction

1. The genesis of this suo motu writ petition is in an order dated22 April 2021.This Court took note of the unprecedented humanitariancrisis in the country, following the outbreak of the COVID-19 pandemic.FNotices were issued to the Union of India[1], the Governments of theStates and Union Territories[2], and to several petitioners who were beforethe High Courts. The Court observed:

“the Union Government, the State Governments/Union Territoriesand the parties, who appeared to have approached the High CourtsGto show cause why uniform orders be not passed by this Court inrelation to

a) Supply of oxygen;

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1 “UOI”, referred interchangeably as “Central Government”

2 Collectively referred as “State Government”

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 settingup of a coordinating body that would consider allocation of theabove resources in a consultative manner (with the involvementof concerned States and Union Territories).

2. Consider declaration of essential medicines and medicalequipment including the above articles as essential commoditiesin relation to COVID.

3. In respect of coordination of logistical support for inter-Stateand intra-State transportation and distribution of the aboveresources.”

2. The Court also had appointed an Amicus Curiae to assist it.However, the Amicus Curiae was, on his request, relieved of his positionon 23 April 2021. Hearings in the matter were then conducted on 27April 2021, where the Court appointed two new Amici: Mr Jaideep Guptaand Ms Meenakshi Arora, learned Senior Counsel. They will be assistedby Mr Kunal Chatterjee and Mr Mohit Ram, learned counsel andAdvocate-on-Record. The Court began the hearing by noting that thejurisdiction it assumed under Article 32 did not automatically lead to theerosion of a High Court’s jurisdiction under Article 226. Rather, the Courtstressed on the importance of the jurisdiction under Article 226, and howHigh Courts may be better equipped to deal with issues within their ownStates. However, this Court assumed jurisdiction over issues in relationto COVID-19 which traverse beyond state boundaries and affect thenation in its entirety.

3. The Court noted that it was in receipt of an affidavit dated 23April 2021 filed by the UOI. However, the Court directed the UOI tofile an additional affidavit and the respective governments of the States/Union Territories to file fresh affidavits on four issues. The relevantextract of the order reads thus:

“(i) Supply of oxygen – The Court should be apprised by the Unionof India on A

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(a) The projected demand for oxygen in the country at the presentpoint of time and in the foreseeable future; A

(b) The steps taken and proposed to augment the availability ofoxygen, meeting both the current and projected requirements;

(c) The monitoring mechanism for ensuring the supply of oxygen,Bparticularly to critically affected States and Union Territories aswell as the other areas; (d) The basis on which allocation of oxygen is being made fromthe central pool; and (e) The methodology adopted for ensuring that the requirementsof the States are communicated to the Central Government on adaily basis so as to ensure that the availability of oxygen iscommensurate with the need of each State or, as the case maybe, Union Territory.

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D(ii) Enhancement of critical medical infrastructure, including theavailability of beds, Covid treatment centres with duly equippedmedical personnel on the basis of the projected requirement ofhealthcare professionals and anticipated requirements. The Uniongovernment will consider framing a policy specifying the standardsand norms to be observed for admitting patients to hospitals andEcovid centres and the modalities for admission; D

(iii) The steps taken to ensure due availability of essential drugs,including Remdesivir and Favipiravir among other prescribed drugsand the modalities which have been set up for controlling pricesof essential drugs, for preventing hoarding and for ensuring properFcommunication of the requirements at the level of each Districtby the District health authorities or Collectors to the HealthDepartments of the States and thereafter by the states to theUnion Ministry of Health and Family Welfare so that the projectedrequirements are duly met and effectively monitored on a dailybasis.

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(iv) Vaccination

(a) Presently two vaccinations have been made available in thecountry, namely, Covishield and Covaxin; (b) As of date, the vaccination programme has extended to allHcitizens of the age of 45 years and above;

(c) From 1 May 2021, the vaccination programme is to be openedup also to persons between the age groups of 18 to 45, in additionto the existing age group categories. The Union of India shallclarify (i) the projected requirement of vaccines as a result of theenhancement of coverage; (ii) the modalities proposed for ensuringthat the deficit in the availability of vaccines is met; (iii) stepsproposed for enhancement of vaccine availability by sourcingstocks from within and outside the country; (iv) modalities foradministering the vaccines to meet the requirements of those inthe older age group (forty five and above) who have alreadyreceived the first dose; (v) modalities fixed for administering thevaccine to meet the additional demand of the 18-45 population;(vi) how the supplies of vaccines will be allocated between variousstates if each state is to negotiate with vaccine producers; and(vii) steps taken and proposed for ensuring the procurement ofother vaccines apart from Covishield and Covaxin and the timeframe for implementation; and (d) The basis and rationale which has been adopted by the Uniongovernment in regard to the pricing of vaccines. The governmentshall explain the rationale for differential pricing in regard tovaccines sourced by the Union government on one hand and thestates on the other hand when both sources lead to the distributionof vaccines to citizens.”

4. This Court then received an additional affidavit dated 29 April2021 from the UOI, and fresh affidavits by the various States/UTsaddressing the four issues mentioned in its order dated 27 April 2021. Inthe hearing conducted on 30 April 2021, this Court heard submissions byMr Tushar Mehta, learned Solicitor General of India, who was appearingon behalf of the Central Government. Several other counsels have madebrief interjections, including Mr Vikas Singh, Senior Counsel and Presidentof the Supreme Court Bar Association. This Court also heard apresentation on oxygen supply in India by Ms Sumita Dawra, AdditionalSecretary, 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 theUOI.

5. During the course of the hearing, this Court directed that theindividual States/UTs shall be given an opportunity to discuss their A

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Aaffidavits at a later hearing. Further, the Court also directed the learnedAmici to prepare a tabular compilation in relation to all the InterlocutoryApplications which have been filed in this petition. On the basis of theissues raised, they shall also be considered in a later hearing. Beforedelving into a substantive discussion, we would like to clarify that thejurisdiction exercised in this matter is merely to facilitate a dialogue ofBrelevant stakeholders, the UOI, the States and this Court, in light of thepressing humanitarian crisis, and not with a view to usurp the role of theexecutive and the legislature. This bounded-deliberative approach[3] isexercised so that the UOI and States can justify the rationale behindtheir policy approach which must be bound by the human rightsCframework which presently implicates the right to life under Article 21and right to equality under Article 14 of the Constitution.

B. Outline of the Disaster Management Act

B. Outline of the Disaster Management Act

6. The Disaster Management Act, 2005[4] came into effect on 26December 2005. The DMA provides for the effective management ofDdisasters and matters connected or incidental to such disasters. COVID-19 falls under the definition of a disaster under Section 2(d)[5] of theDMA and the provisions of the DMA were invoked for the first time todeal with the present pandemic. Under Section 6(2)(i) of the DMA, theNational Disaster Management Authority[6] issued an order dated 24EMarch 2020 directing the Ministries, UOI, State/UTs and their authoritiesto take effective measures to prevent the spread of COVID-19 in thecountry. Thereafter, the Home Secretary, Ministry of Home Affairs asthe Chairperson of the National Executive Committee, which assists theNDMA in its functions, in an order dated 24 March 2020 issued guidelinesfor the initial 21 days’ lockdown on account of COVID-19.F

3 Sandra Fredman, “Adjudication as Accountability: A Deliberative Approach” inNicholas Bamforth and Peter Leyland (eds), Accountability in the ContemporaryConstitution (Oxford University Press, 2013)G4 “DMA”

““2… (d) “disaster” means a catastrophe, mishap, calamity or grave occurrence in anyarea, arising from natural or man-made causes, or by accident or negligence whichresults 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 ormagnitude as to be beyond the coping capacity of the community of the affected area;”6 “NDMA”H

7. Section 2(e) defines disaster management as a continuous andintegrated process of planning, organizing, coordinating and implementingmeasures in relation to the disaster. Section 2(e) provides:

“2…

(e) ”disaster management” means a continuous and integratedprocess of planning, organizing, coordinating and implementingmeasures’ 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 orconsequences;

(iii) capacity-building;

(iv) preparedness to deal with any disaster;

(v) prompt response to any threatening disaster situation ordisaster;

(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 fordisaster management for the whole country prepared under Section 11of DMA. Section 3 of the DMA constitutes the NDMA with the PrimeMinister as the Chairperson, ex officio. Section 6 lists down the powersand functions of the NDMA. Under Section 6(2)(b), NDMA has thepower to approve the National Plan. Section 11 of the DMA providesthe procedure for drawing up and implementation of the National Plan inthe following terms:

“11. National Plan

(1) There shall be drawn up a plan for disaster management forthe whole of the country to be called the National Plan.

(2) The National Plan shall be prepared by the National ExecutiveCommittee having regard to the National Policy and in consultationwith the State Governments and expert bodies or organisations inthe field of disaster management to be approved by the NationalAuthority.

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A(3) The National Plan shall include—

(a) measures to be taken for the prevention of disasters, or themitigation of their effects; (b) measures to be taken for the integration of mitigationmeasures in the development plans; B

(c) measures to be taken for preparedness and capacity buildingto effectively respond to any threatening disaster situations ordisaster; (d) roles and responsibilities of different Ministries orCDepartments of the Government of India in respect of measuresspecified in clauses (a), (b) and (c).

(4) The National Plan shall be reviewed and updated annually.

(5) Appropriate provisions shall be made by the CentralGovernment for financing the measures to be carried out underDthe 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 ofthe Government of India and such Ministries or Departments shalldraw up their own plans in accordance with the National Plan.”

E8. A National Plan includes, inter alia, measures for disasterprevention, mitigation, preparedness and roles and responsibilities ofdifferent Ministries in terms of Section 11(3) of DMA. A National Planfor the entire country was prepared in the year 2016 and was revisedand notified in November, 2019. The National Plan, 2019 provides aFframework to the Government agencies to deal with different aspectsof disaster management. Section 11(4) of the DMA provides that theNational Plan is to be revised and updated annually making it a ‘dynamicdocument’. The executive summary of the National Plan succinctlycaptures its purpose and contours in the below extract:

“...The National Disaster Management Plan (NDMP) provides aframework and direction to the government agencies for all phasesof disaster management cycle. The NDMP is a “dynamicdocument” in the sense that it will be periodically improved keepingup with the emerging global best practices and knowledge base indisaster management. It is in accordance with the provisions of G

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the DM Act, 2005, the guidance given in the National Policy onDisaster Management (NPDM) 2009, and the established nationalpractices...”

9. Section 12 of the DMA empowers the NDMA to recommendguidelines for the minimum standard of relief to be provided to personsaffected by disaster. NDMA can create guidelines stipulating minimumstandards of relief for providing ex gratia assistance on account of lossof life and restoration of means of livelihood in terms of Section 12(iii) ofDMA. In light of the human suffering and loss of livelihood that hasaccompanied this pandemic, NDMA may consider laying down minimumstandards of relief in this regard. We clarify that this is not a direction ofthis Court, however a suggestion that can be looked into by the NDMA.Under Section 12(iv) of the DMA, the NDMA has been given widepowers to provide guidelines for any such relief that may be necessary.

10. In addition to the above provisions, Section 35 of the DMAempowers the Central Government to take measures which it deems tobe necessary or expedient for the purpose of disaster management.Section 35(2)(a) provides for coordination of actions between the CentralGovernment and State Governments and their respective authorities inrelation to disaster management. Section 35(2)(e) obliges the CentralGovernment to assist and cooperate with the State Governments asrequested by them or otherwise deemed appropriate by it.

11. Section 36 of DMA provides for the responsibilities that haveto be undertaken by the Ministries or Departments of the CentralGovernment. While Section 36(h) empowers the Central Governmentto take any actions that it may consider necessary for disastermanagement, Section 36(d) specifically enables it to review its policieswith a view to incorporate provisions necessary for prevention of disaster,mitigation or preparedness. Under Section 36(f), it is the responsibilityof every Ministry or Department of Central Government to provideassistance to the State Governments for (i) drawing up mitigation,preparedness and response plans, capacity-building, data collection andidentification 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 rehabilitationand reconstruction. Section 35(g) provides that the Central Governmentis responsible for making available its resources to the National ExecutiveCommittee or a State Executive Committee for the purposes of, inter A

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Aalia, transporting personnel and relief goods to and from the affectedarea.

12. The provisions of Sections 35 and 36 of the DMA that havebeen discussed above have been enacted in the spirit of cooperativefederalism in order to ensure that Central Government can assist andBenable the State Governments to effectively tackle the disaster in question.

13. The learned Solicitor General has submitted that the CentralGovernment is operating under the broad framework of the NationalPlan and the plan is already in force.The plan specifically deals with“Biological and Public Health Emergencies”. Further, different StatesChave their own Disaster Management Plans in place. It has beensubmitted that the National Plan does not and cannot contain step bystep instructions or specific directions for the day to day management ofthe pandemic by the Government agencies. Such aspects are kept openfor executive decision, in view of the dynamic nature of the disaster inquestion. Further, since COVID-19 is a novel virus, the knowledge inDrelation to such a virus is contemporaneous in nature and is subject toconstant development. A three Judge bench of this Court in its judgementin Centre for Public Interest Litigation vs Union of India[7] hadnoted that there was no need to develop a fresh National Plan underSection 11 for COVID-19 since a National Plan was already in place,Ewhich was being supplemented by various orders and measures takenby competent authorities under DMA. Justice Ashok Bhushan, speakingfor this Court, observed that:

“40. The Disaster Management Act, 2005 contain ample powersand measures, which could be taken by the National DisasterFManagement Authority, National Executive Committee and CentralGovernment to prepare further plans, guidelines and StandardOperating Procedure (SOPs), which in respect to COVID-19 hadbeen done from time to time. Containment Plan for NovelCoronavirus, 2019 had been issued by Ministry of Health andFamily Welfare, Government of India. There were no lack ofGguidelines, SOPs and Plan to contain COVID-19, by Nodal Ministryhad been brought on record issued by Ministry of Health andFamily Welfare, Government of India, i.e., Updated ContainmentPlan for Large Outbreaks Novel Coronavirus Disease, 2019(COVID-19).”

H72020 SCC OnLine SC 652

14. Therefore, the National Plan, 2019 can be supplemented bythe issuance of additional guidelines to tackle any aspect of disastermanagement including the issue of admission to hospitals and access toessential 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, theCentral Government begins its affidavit dated 23 April 2021 and additionalaffidavit dated 29 April 2021 by describing its ‘three-tier setup’of CovidCare Centers[8], Dedicated COVID Health Centers[9] and DedicatedCOVID Hospitals[10] which was recommended to the States for tacklingthe COVID-19 pandemic, for which the UOI also provided funds underan emergency response package from the National Health Mission andState Disaster Response Fund.

16. The present status of these is: (i) 2,084 DCH (of which 89 areunder the Central Government and the rest 1,995 with StateGovernments); (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 inDCH. It was also noted that Central Government hospitals have alsobeen converted into DCH.

17. Further, tertiary care hospitals under ESIC, Defence, Railways,paramilitary forces, Steel Ministry, et al, are also being leveraged forcase management. Even as many as 3816 railways coaches spread over16 railway zones have been converted into CCC. Finally, the DRDOhas also set up large field hospitals with capacities ranging from 1,000 to10,000 isolation beds.

18. It was noted that through coordination between CentralGovernment and State Governments, isolation beds (with/without oxygen)were increased to around 15.7 lakhs, as compared to 10,180 before thefirst lockdown; similarly, ICU beds were increased to more than 85,000,as compared to 2,168 before the first lockdown. Similar upgrades wereprovided to necessary equipment such as Ventilators, N95 masks andPPEs.

8 “CCC”

9 “DCHC”10 “DCH”

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A19. The affidavit provides the following details of the efforts takenby UOI to create projections for each State, and how it wascommunicated to them:

(i) It has developed an IT module for projections of expectedcases based on ongoing case load, so as to alert States andBdistricts to be prepared in advance. The projections by theCentral Government were regularly shared in writing withthe States, along with reports containing emergency plans.This tool was also made available to States, to map theirown projections at the State level; C(ii)Details of the meetings conducted by the Prime Minister,the Minister of Health and Family Welfare, the CabinetSecretary, the Secretary (H) and the DGHS were provided;and

(iii) Details of letters(which seem to have been sent on aDmonthly basis) sent by the Central Government to the StateGovernments indicate that theyinformed the StateGovernments of the projected cases for the coming month,along with the number of Oxygen Supported Beds, ICUBeds and of Ventilators that will be required to manage theprojected cases. Thereby, the State Governments whichEwere found lacking in their numbers were directed to rampup their facilities.

20. In relation to the preparedness for the second wave of theCOVID-19 pandemic, the affidavits state that:

F(i)After the first wave, the Central Government has beenconsistently writing to the State Governments from 4December 2020 with numbers of projected cases, alongwith the directions requiring them to arrange the necessaryinfrastructure which will be needed;

(ii) State Governments were requested by the UOI to formulateGa comprehensive plan in relation to:

(a) Bed capacities, ICU beds, further identification ofadditional hospitals, preparation of field hospitalfacilities, ensuring sufficient oxygen supported bedsand oxygen supplies; H

(b) Deployment of requisite HR training and mentoringAof doctors and nurses for management of patients,strengthen ambulance services and centralized callcenter-based services for allocation of beds;

(c) Suitable initiatives for (among other things) achievingand maintaining adequate level of testing, surveillanceBand risk communication for promoting wearing ofmasks, physical distancing, hand hygiene; (d)Sufficient referral linkages for districts with deficitinfrastructure through deployment of additionalambulances, wherever necessary; and C

(iii) On 20 April 2021, the Ministry of Health and FamilyWelfare[11 ]wrote to the State Governments with theirprojections and reminded them also of the funding avenuesbeing made available to all States under NHM funding, StateDisaster Response Fund, and other initiatives.

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21. The affidavits also note that the Central Government haddeveloped a live portal with all the States and districts where they wereasked to feed in their data of cases and details such as people underhome isolation, on isolation beds (with or without oxygen) and on ICUbeds. Further, the State Governments were also directed to feed in detailsof 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 notupload their data regularly enough. Additionally, there was also a ‘FacilityApp’ which could be used by Covid Health facilities to monitor theirpatients as well as the availability of logistics with their health facility.However, the Central Government alleges that States, districts andfacilities did not use this Facility App.

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C.2 National Policy for Admission in Hospitals

22. It has been submitted by the Central Government that healthbeing a state subject, the medical infrastructure is largely created andmaintained by the respective State Governments. Since we are yet tohear from the State Governments, we shall not be issuing any directionsor making comprehensive observations in relation to this issue.

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A23. However, based on the affidavits submitted by the CentralGovernment and the hearings which followed, we have come tounderstand that there is no national policy on how admissions must takeplace in the various tiers of hospitals (CCC, DCHC and DCH). Gainingadmission into a hospital with a bed is one of the biggest challengesbeing faced by most individuals during this second wave of the COVID-B19 pandemic. Left to their own devices, citizens have had to sufferimmeasurable hardship. Different states and local authorities follow theirown protocols. Differing standards for admission in different hospitalsacross the nation leads to chaos and uncertainty. The situation cannotbrook any delay. Accordingly, we direct the Central Government to frameCa policy in this regard, in exercise of its statutory powers under theDMA, which will be followed nationally. The presence of such a policyshall ensure that no one in need is turned away from a hospital, due to nofault of their own. Such a policy should, inter alia, address the followingissues in relation to admission:

D(i)Requirement of a positive test for COVID-19 virus, whichmay become difficult for many individuals since testingfacilities are overwhelmed, test results are takinginordinately long time and the new strain of the COVID-19virus is sometimes not even picked up by a regular RT-PCR test;E

(ii) Some patients are being refused service based on arbitraryfactors. For example, the hospitals in Ahmedabad wereinitially refusing to take in patients who did not arrive in thegovernment-run ‘108’ ambulances. While this rule has nowbeen removed, after objections were noted by the GujaratFHigh Court during hearings in a suo motu public interestlitigation[12], we note that such rules cannot be allowed tocrop up in other places;

(iii) Some reports have also been brought to our attention thathospitals are refusing to admit individuals who cannotGproduce a valid ID card which shows that they belong tothe city where the hospital is located. Given howoverstretched our hospitals are during the second wave ofthe COVID-19 pandemic, it is entirely plausible that H12 Suo Motu vs State of Gujarat, R/Writ Petition (PIL) No 53 of 2021

individuals may travel to other cities in desperation, sincebeds may not be available in their city. The rural healthinfrastructure is seriously deficient. Hence, no hospitalshould be allowed to deny them entry solely based on thisreason or any other issues with identity proofs; A

(iv) A related issue is when individuals often get their familyBmember admitted in a hospital in one city, but have to travelto another city to look for oxygen or essential drugs and aredenied their use because they are to be bought for anindividual admitted in a different city. As was true for theabove such rule, this is also unacceptable and should not beCallowed;

(v) Admissions to hospital must be based on need. The CentralGovernment,in consultation with the respective StateGovernments, must formulate guidelines on the stage atwhich hospitalization is required so as to ensure that scarcehospital beds are not occupied by persons who do not needhospitalization. This aspect should be based on the adviceof medical experts and can be suitably alteredgiven theneeds of each State (or regions within the State) and in thecourse of the experiences gained during the pandemic; and D

(vi) Directions are hereby issued to all States, Union Territories,and all public agencies, to ensure that the above orders areimplemented forthwith. The Central, State and UnionTerritory governments shall issue necessary orders andcirculars, incorporating the above directions, within threedays, which shall be in force till replaced by an appropriateuniform policy, devised by the central government,statutorily.

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D. Oxygen allocation and availability

24. The Central Government has argued the following:

(i) By its order dated 11 September 2020, the Ministry of HomeGAffairs[13], in exercise of its powers under Section 10(2)(h)of the DMA had constituted an Empowered Group-II as aninter-ministerial body to ensure availability of essentialmedical equipment and oxygen management; 13 “MHA”

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[2021] 4 S.C.R.

A(ii)Medical oxygen is critical to treatment of COVID affectedpatients. The entire available capacity of oxygen is usedfor supply for industrial and medical use, which is in theform of Liquid Medical Oxygen[14]. The major suppliers forboth industrial and medical oxygen are steel plants in thepublic and private sectors, and private entities;B

(iii) Oxygen is not produced evenly in India. While some Statesmay be oxygen producing States such as Maharashtra,Rajasthan and Jharkhand; other States/UTs such as Delhi,Goa and Madhya Pradesh, do not have production capacityCand rely on supply of oxygen from oxygen producing States;

(iv) For an estimation of the required oxygen supply, anEmpowered Group I was constituted which categorizedpatients into three categories:

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•Class I comprising of 80% of the cases which are mildand do not require oxygen; E

•Class II comprising of 17% cases which are moderateand can be managed on non-ICU beds and 50% ofthese may require oxygen @10L/min; and •Class III comprising of 3% of cases which are severeICU cases requiring approximately 24L/min oxygen.

(v) On the basis of the categorization provided by EmpoweredGroup I, oxygen requirement of different States on the basisFof active cases is being calculated which is around 8462MT. Based on the trend of active cases, the “doubling rateof cases” is calculated for each State, which implies, thenumber of days in which COVID cases are likely to double.The number of active cases are projected on the basis ofGthe doubling rate and oxygen requirement is calculated.These projections get changed daily on the basis of realtime change;

(vi) In order to ensure supply of oxygen to all States, a mappingAexercise of the sources of supplies with the demand ofmedical oxygen to the critically affected States wasundertaken jointly by the Department of Promotion ofIndustry and Internal Trade, MoHFW, Ministry of Steel,Petroleum and Explosives Safety Organisation, oxygenBmanufacturers etc. During the course of the mappingexercise, States were requested to indicate their projectionsfor requirement of medical oxygen based on expected activecase load. These projections were to be given as on 20April, 25 April, and 30 April 2021. The following was theforecast provided by the major States:C

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(vii) Based on these projections, an indicative mappingframework was drawn up and approved by an order dated15 April 2021, which provided the name of the supply point,Gthe State to which supply was allocated and the quantity tobe supplied. Subsequently, due to continuous changes in thenumber of cases and the need for medical oxygen, a revisedprojection was issued by States for 20 April 2021, whichprovided:

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(viii) Following this, a revised supply plan for medical oxygen to15 States for meeting their demand was issued by an orderdated 18 April 2021. Certain States, such as Delhi, Rajasthan,FPunjab, Uttar Pradesh, Uttarakhand and Madhya Pradesh,faced challenges despite this allocation. Issues such aslogistical bottlenecks in transportation, incidents of localauthorities in disrupting supplies to other states werereported. Due to this, allocation orders were further amendedby orders dated 21 April 2021, 22 April 2021, 24 April 2021,G25 April 2021 and 26 April 2021. The MHA also issuedorders dated 22 April 2021 and 25 April 2021 under theDMA to direct States/UTs to ensure uninterruptedmovement of medical oxygen;

(ix) The major principles on the basis of which the amendmentsHwere made were to: (a) ensure that projected requirement of LMO is allocated as far as possible; (b) allocate sourceslocated within the State or closest to the State whilebalancing requirements from States which have no/lowinternal manufacturing capacity; (c) ensure feasibletransportation; (d) ensure minimum disruptions in existingsupply chains;

(x) As an instance, the allocation summary for 28 April 2021has been placed on record:

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(xi) After the Central Government procures and allocates thequantity of medical oxygen to each State, it is the StateGovernment’s responsibility to arrange transportation to pickup their allotted quantity from the supply point;

(xii) Given the fact that the mapping exercise has to beFcontinuously updated according to the need of the situationacross States, the Central Government also put in aninteractive mechanism called the “Virtual Central ControlRoom” consisting of senior officers of Additional/JointSecretary rank to monitor and find solutions to any problemsthat may arise on a real time basis. We have been apprisedGthat the daily allocation of the supply of oxygen is sanctionedand uploaded on this virtual room, in which the ChiefSecretaries of all States/UTs are members;

(xiii) In addition to the management of supply and demand ofmedical oxygen, the Central Government has also taken H

320SUPREME COURT REPORTS

the following steps to ensure augmentation of supply in thecountry:

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(a) Licenses to industrial gas manufacturers: By anorder dated 7 April 2020, the Drug Controller Generalof India[15] allowed licenses to be issued to industrial gasBmanufacturers for manufacturing medical oxygen within24 hours of receipt of the application by DCGI; (b)Enhanced production of LMO in steel plants andby private manufacturers: Steps have been taken toreduce production of other liquid products which areCrequired for manufacturing steel (such as argon andnitrogen) and enhance the capacity of liquid oxygen.This has resulted in immediate enhancement of 293 MT.Additionally, the steel sector has made available the liquidoxygen in its storage tanks (approx. 16,000 MT as on21 April 2021). Supplies have increased from 1000 MTDin the first week of April 2021 to 2600 MT on 21 April2021. Moreover, private manufacturers have alsoenhanced production of medical oxygen;

(c) Restrictions on use of industrial oxygen: By anorder dated 18 April 2021, the MoHFW restrictedEindustrial use of oxygen. Supply of oxygen for allindustrial use was completely prohibited on 21 April 2021,except for certain industries such as ampoules and vials;pharmaceuticals; petroleum refineries; nuclear energyfacilities; and oxygen cylinder manufacturers. TheseFhave added 1000 MT of additional oxygen; (d)Augmentation in availability of tankers: India has1224 oxygen tankers (16732 MT capacity) and effortsare being made to increase this capacity to 2000 tankersthrough conversion of nitrogen and argon tankers andimport of 138 cryogenic tankers; G

(e) Commissioning of PSA plants: Pressure SwingAbsorption[16 ]is a technology to generate oxygen at alocal level. PSA plants established in hospitals enable 15 “DCGI”H16 “PSA”

self-sufficiency in generation of oxygen. MoHFW is inthe process of commissioning 162 PSA Plants (154 MTcapacity). The following statistics have been furnished:

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(under planning)

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(f) Import of medical oxygen: A global tender wasfloated to import 50,000 MT of medical oxygen to besupplied in 90 days and quotations have been received.As an interim measure, quotations from bidders werecalled within 24 hours as to the quantities they couldoffer, prices etc. Orders have been placed with 2 foreignsuppliers, i.e., SSB Cryogenic Equipment Ltd. for 200MT and Gulf Industrial Gases Abu Dhabi for 1800 MT.Another order is also being placed with M/s Ultra-PureGases India for import of 500-1500 MT; D

E

(g) Augmentation of availability of cylinders: 1,02,400oxygen cylinders were procured in April and May 2020and distributed to States. Orders for additional 1,27,000cylinders were placed on 21 April 2021. The CentralGovernment proposes to address the additional demandthrough regulated portable oxygen system technology; F

(h) Setting up of jumbo container based COVIDhospitals using gaseous oxygen: Apart from LMO,the gaseous oxygen production capacity in the steelsector is 43,000 MT per day against which 26,000 MTper day is being produced. Two private entities, AMNSand JSW are setting up “Jumbo” COVID centres with1000 bed oxygen facilities in Hazira, Vijayanagar andDolvi usinggaseous oxygen; and G

17 As per the affidavit dated 23 April 2021, the UOI has stated that “a further 105plants will be installed by 31.05.2021 and thereafter increasing to 156 plants by30.06.2021.”

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322SUPREME COURT REPORTS

A(i)Transportation by Air & Rail: Railways are beingused for long distance transport of tankers through ‘rollon roll off’ service and an “Oxygen Express”- a doubleengine train which gets a green corridor- is being runfrom supply point to destination. As an instance, thefirst rake with 7 empty tankers reached Mumbai fromBVizag to transport 105 MT from RINL Vizag toKalamboli. In addition to this, defence aircraft forcarrying empty tankers to supply point are beingdeployed. However, it is technically not possible to bringin oxygen filed tankers in an aircraft.C25. During the course of the hearing, the Solicitor General hasalso sought to lay down the facts and figures pertaining to productionand supply of oxygen, daily supply to States and challenges faced insupply chain logistics before the Court by means of a power pointpresentation. We note the submission of the Solicitor General that theDfigures given in the power point presentation are revised on a daily basisand that the presentation is not to be treated as a submission made onoath by the Solicitor General, which may give rise to a cause of actionfor litigation in future either before this Court or the High Courts. MsSumita Dawra, Additional Secretary, Department of Promotion ofIndustry and Internal Trade, Ministry of Commerce and Industry, who isEone of the senior administrative officers in charge of oxygen procurementand supply coordination, has given an overview of these issues and madea presentation before us. We would like to record our appreciation forthe contribution made by Ms Dawra and her team, who despite beinginfected by the COVID-19 virus, has continued to work and manage theFsupply of medical oxygen that the country so desperately needs today. Itis through the earnest contribution of officers such as Ms Dawra, whoare working round the clock, that the country is able to deal with thestorm created by one of the worst humanitarian crises we have seen.

26. Based on the above facts and figures, the Solicitor GeneralGhas stated that there is no dearth of oxygen supply in the country as ondate and steps are being taken continuously to augment the supply ofoxygen. Having said that, the Solicitor General has also admitted thatthere has been a shortage of supply to certain States and has attributedthis shortage to various factors including the failure of State Governmentsto lift the allocated quantity of oxygen from the supply point; transportationH

bottlenecks caused by inter-State movement of tankers; and technicalfailure of certain plants leading to reassessment of allocation on a realtime basis.

27. Submissions have also been made on the issue of supply ofoxygen by Mr Rahul Mehra, learned Senior Counsel appearing for theGovernment of National Capital Territory of Delhi[18]. Mr Rahul Mehrasubmits that the GNCTD is facing an acute shortage of the supply ofoxygen as it had been allocated a substantially lower quantity of oxygenas against its projected demand. Mr Mehra pointed out that initially ason 15 April 2021, the projected demand of GNCTD for 20 April 2021was 300 MT/day, for 25 April 2021 it was 349 MT/day, and for 30 April2021 it was 445 MT/day. However, due to a surge in cases, the projecteddemand was revised by GNCTD on 18 April 2021 to 700MT/day andthis was immediately communicated to the Central Government. Despitethe increase in projected demand, the supply of oxygen to GNCTD hascontinued in terms of the allocation order dated 25 April 2021, in which490 MT/day were allocated. As against this as well, the manufacturershave only been able to supply 445 MT/day. Mr Mehra has clarified thatas on the date of the hearing their demand was 700MT/day, howevertheir projected demand for the coming days is stated to be 976 MT/dayas the GNCTD has planned an increase in medical infrastructure,including beds with oxygen cylinders and beds for patients in intensivecareunit.

28. Opposing his submission, the Solicitor General and MsDawrastated that no revised projections have been received fromGNCTD till date. The Solicitor General has also sought to highlight thatthe government of GNCTD has failed to offtake the allocated quantityof oxygen from the supply point.

29. Having heard the submissions of both counsels on the issuespertaining to supply of oxygen to GNCTD, we note that the CentralGovernment (on page 63) in its affidavit dated 23 April 2021 has admittedthat the projected demand for GNCTD as of 20 April 2021 had increasedby 133% from 300 MT/day to 700 MT/day. According to the figures ofallocation given in the affidavit dated 23 April 2021 and the presentationgiven by Ms Dawra, the existing allocation of GNCTD remains at 490MT/day. This situation must be remedied forthwith. The situation on the AB

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Aground in Delhi is heart rending. Recriminations between the CentralGovernment(which contends that GNCTD has not lifted its allocatedquantity) and GNCTD (which contends that despite its projected demandthe quantity allocated has not been enhanced) can furnish no solace tocitizens whose lives depend on a thin thread of oxygen being available.On the intervention of the Court during the hearing, the Solicitor GeneralBstates that he has instructions to the effect that GNCTD’s demand ofmedical oxygen will be met and that the national capital will not sufferdue 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 ofCcitizens is paramount in times of a national crisis and the responsibilityfalls on both the Central Government and the GNCTD to cooperatewith each other to ensure that all possible measures are taken to resolvethe situation. Learned Senior Counsel for GNCTD has assured the courtafter taking instructions at the ‘highest’ level that the issue will be resolvedcompletely in a spirit of co-operation. During the course of the hearing,Dthe Solicitor General has assured that henceforth he will ensure that thedeficit of oxygen is rectified and supply is made to the GNCTD accordingto their projected demand (which may be revised in the future) on a dayby day basis. We accept his submission and direct compliance within 2days from the date of the hearing, that is, on or before midnight of 3 MayE2021.30. With regard to the issue of the supply and availability of medicaloxygen for the entire country, we have noted that efforts are being madeto augment the availability of oxygen. While the Central and StateGovernments are in the process of managing the supply of oxygen, at Fthe same time, it is critical that a buffer emergency stock of oxygen iscreated so that in the event that the supply chain is disrupted to any oneor more hospitals in an area for any reason, the buffer or emergencystocks can be used to avoid loss of human lives. These emergency stocksmust be so distributed so as to be easily accessible without delay in every local area. We have also seen the situation that has developed inGthe last 24 hours in Delhi where patients, including among them medicalprofessionals, died because of the disruption of supplies and the time lagin the arrival of tankers. This deficit shall be rectified immediately by theCentral Government by creating buffer stocks and collaborating withthe States through the virtual control room on a 24 by 7 basis. In view ofHthe deaths which are being caused daily by the disruption of supplies, this direction is more crucial than ever. We therefore, direct the CentralGovernment in collaboration with the States to prepare a buffer stock ofoxygen to be used for emergency purposes to ensure supply lines continueto function even in unforeseen circumstances. The location of theemergency stocks shall be decentralised so as to be immediately availableif the normal supply chain is disrupted to any hospital for any reason.The emergency stocks shall be created within the next four days. Thereplenishment of the emergency stocks will also be monitored on a realtime basis through the virtual control room in active consultation witheach state/UT. This is in addition to the day to day allocations.

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31. In addition to the above, we direct the Central Government toconsider the following suggestions, which may assist in increasing theavailability of oxygen and ensure transparency of demand-supplymanagement, and provide a clarification to this Court:

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(i) We understand that the Virtual Central Control Room ofthe Central Government displays the allocation of supply ofDoxygen by the Central Government to each State/UT. Byextension of this, a mechanism for displaying real timeupdates of supply of oxygen from each State to hospitals ineach district, along with the remaining stock of oxygen withthe hospitals may be maintained and shared with the citizensto ensure transparency. This will also ensure that citizensEcan easily identify the hospitals where medical aid can beavailed;

(ii) The government shall clarify the steps being taken onplanning on the use of oxygen concentrators to reduce thedemand of LMO, such that LMO is needed only for criticalpatients.A comprehensive plan on augmenting theproduction/import of these oxygen concentrators may beconsidered; F

(iii) The expected supply of oxygen/containersto be receivedfrom outside India should be suitably augmented to cater toanticipated increases in the demand and shortfall of domesticavailability. Pending the early finalization of the global tendera decision may be taken on the need to continue imports tobridge the gap in availability;and G

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A(iv)A review shall be made of any restrictions on inter-Statetravel of trucks or tankers carrying oxygen/other medicalaid equipment (such as GST related issues, documentation)which might cause a hindrance in their movement.TheCentral Government may consider implementing a systemto track and map the supply tankers which would allowBbetter management of resources and allow diversion ofresources from one State to the other in case ofemergencies.

E. VaccinesC32. The previous order of this Court dated 27 April 2021directedthe Central Government to clarify, inter alia: (i) the projected availabilityof vaccines and proposed steps to boost supply and distribution; and (ii)the vaccine pricing and distribution among states. Upon perusing theaffidavits filed by the Central Government and after having the benefitDof oral arguments of the Solicitor General, we have arrived at thefollowing understanding on the two broad issues outlined above. Wewould once again re-iterate that we do not attempt to delve into the roleof the executive in designing policy choices. We are merely seekingtoenter into a dialogue with the relevant stakeholders in order to ensureprobity and transparency of the measures underway.We are cognizantEthat it is ultimately up to the executive to frame and implement policiesthat 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 ofFa National Expert Group on Vaccine Administration for COVID-19[19] on7 August 2020 and operationalization of the immunization programmefrom 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 andpersons who are 45 years of age and higher in the 3 Phases ofGimmunization. It was submitted that these vaccines have been centrallyprocured and administered free of cost to the abovementioned groupswho were identified based on specific vulnerabilities and a higher mortalityrate on account of the COVID-19 infection.

H19 “NEGVAC”

34. On 20 April 2021, the Central Government rolled out a revisedstrategy of COVID-19 vaccination for all persons over 18 years of age,with effect from 1 May 2021. This new age group consists ofapproximately 59 crore people, which would require 122 crore vaccinedosesunder the current two-dose vaccine regime of Covishield andCovaxin which have been authorized for emergency use in India.Thisrevised strategy enables vaccine procurement by State Governmentsand private hospitals, purportedly for accelerating the immunizationprogramme which is critical to curb the pandemic. In response to thequery of this Court on the necessity of the revised strategy, the CentralGovernment furnished the following justification:

“During the ongoing consultation with the states, demands/concerns were raised by the various State Governments to expandthe scope of vaccination drive to include the beneficiaries beyondthe priority groups identified by NEGVAC as approved by CentralGovernment. As a matter of co-operative federalism, it was feltnecessary to allow play in the joints and to de-centralize vaccineprocurement and to enable the States to expand vaccination drivesto other groups between the age of 18-44 years. However, sincethe priority group as identified by Union of India (whichhad more vulnerability) was not fully vaccinated, it wasconsidered imperative to carry out two drives separatelyi.e. in a decentralized manner to achieve higher efficiencyand reach.Thus the States were given a participatory roleto undertake the procurement of vaccine and for vaccinationof any other ‘groups identified drive’ for the 18-44 agegroup. This would also keep the existing drive of criticalgroups unobstructed as the 50 percent of the vaccinesprocured through the GoI channel would continue tosupport and provide free of cost vaccine to the mostvulnerable age groups of 45 years plus in the country healthcare workers and frontline worker identified by the Unionof India who were entitled to get vaccinated under PhaseII.”

(emphasis supplied)

35. In response to the queries of the Court on how the supplies ofvaccines will be allocated between various states if each StateGovernment is to negotiate with vaccine producers, the Central A

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AGovernment has furnished the following justification in order to iron outthe inequities between States:

“For the remaining 50% non-government of India channel,the states and the private hospitals are free to procurevaccine for 18-44 years population, however, to have anBequitable distribution of vaccine across the country, stateshave been allocated the available vaccine quantity inproportion to the population between 18-44 years of age ofthe respective state so as to ensure equitable distributionof vaccine as there is a possibility of some states havingbetter bargaining power due to geographical advantage etc.”C

(emphasis supplied)

(emphasis supplied)

36. During the course of the hearing, this Court has expressed itsreservations prima facie on the validity of the revised policy under whichthe states and private hospitals are to procure 50% of the vaccines inDorder to immunize persons in the 18-44 years age group. For one thing,even this age group would consist of persons who suffer fromvulnerabilities. Once the vaccination programme has been opened upfor persons other than the 45 plus age group, it would not be logical toimpose the obligation to source vaccinations for the 18-44 age group onthe State Governments. This will, inter alia, leave each State GovernmentEto negotiate supply schedules, delivery pointsand other logisticalarrangements with the manufacturers. At present, there are only twomanufacturers for the authorized vaccines (with one other vaccine-Sputnik V, in the process of manufacture). The available stock of vaccinesis not adequate to deal with the requirements of both the categories. TheFCentral Government must take the responsibility of providing guidanceto 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 whocan be covered for vaccination, among other details. Leaving the StateGovernments to negotiate directly with manufacturers will produce chaosand uncertainty. The object of vaccinating the 18-44 age group cannotGbe achieved in the absence of stocks being available.

37. Besides the above issues, the Central Government is directedto clarify the following issues in order to ensure the protection of thefundamental rights to equality and to life and personal liberty for allpersons who will be eligible to take the vaccine from 1 May 2021:H

(i) Whether the Central and State Governments haveintroduced any initiatives for ensuring the immunization ofpersons who do not have access to digital resources asotherwise the mandatory requirement of registration overthe Co-WIN digital portal for persons in the age group of18-44 years will deprive a large class of citizens ofvaccination; A

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(ii) Since the Central Government commits to vaccinatingpersons over 45 years, free of cost, in view of theirvulnerability, whether walk-in facilities for vaccination willcontinue for these persons after 1 May 2021;C(iii)Whether the Central or State Governments propose toundertake targeted vaccination drives for persons who areproviding on-ground assistance during the second wave ofthe pandemic- such as crematorium workers, who werenot considered as Frontline or Healthcare workers for PhaseD1 of the vaccination drive;(iv)Whether, and if so what, steps being undertaken by INYAS,the nation-wide mass awareness campaign for COVID-19vaccination, for ensuring outreach in rural areas and socio-economically underprivileged sections of society includingthe possibility of using mobile vans, vehicles and railwaysEto vaccinate such people as well as those living in remoteareas, near their doorsteps so as to minimize their traveland potential infection with COVID-2019. Efforts must alsobe made that a lack of an identity proof does not create ahindrance in the process of immunization of all individuals,Fspecifically, the underprivileged;(v)Whether the Central government will revisit its policy byprocuring 100% of the doses which can then be equitablydisbursed to the State Governments; and(vi)Since the vaccine administration is now to be a sharedGresponsibility of the Union and the States, the CentralGovernment and the State Governments shall provide- (a)a breakup of the current and projected availability of vaccinestocks for the next 6 months; and (b) a timeline for achieving G

Aimmunization of the newly eligible 59 crore persons whoare aged between 18-44 years.

These issues are of vital importance, since vaccination appears tobe one of the most important strategies to combat further spread of thepandemic, and would also provide a measure of security and assure theBpeople about their health and well-being.

E.2 Vaccine pricing

38. Since the advent of the revised rollout strategy with effectfrom 1 May 2021, only persons aged 45 years and above are guaranteeda free vaccine. The reason of higher efficiency and speed has beenCfurnished as a justification for enabling State Governments and privatehospitals to directly procure vaccines. We have come to understand thata few State Governments have committed to free immunization underthe revised strategy. On specific enquiry on the rationale in regard to thedifferential pricing for procurement by the Central Government and theDState Governments, the Central Government has furnished the followingjustification:

“It is submitted that liberty to decide prices on arm’s lengthbasis by and between the State Government and hospitalsis based on the concept of creating an incentivized demandEfor the private vaccine manufacturers in order to instill acompetitive market resulting in increased production ofvaccines and market driven affordable prices for the same.Simultaneously, the free vaccination by the Central Governmentfor above referred priority age groups would continue and it isalways open for each State Government either to offer freeFvaccination or subsidise it for the additional identified earmarkedpriority group identified by the State Governments [age 18-44years].

63. The new strategy was devised after multiple Inter- Ministerialteams were deputed by Govt. of India to various manufacturingGsites to understand their requirement and to provide pro-activeand customized support to significantly augment vaccine productioncapacities [which is the prime priority of the Central Governmentat this juncture], in the form of advance payments, facilitatingmore sites for production etc. This approach, on the one hand,incentivizes vaccine manufacturers to rapidly scale up their H

production and on the other hand, it would also attract newvaccine manufacturers. It would make pricing, procurementand administration of vaccines more flexible and competitiveand would further ensure augmented vaccine productionas well as wider availability of vaccines in the country.”

(emphasis supplied)

39. Prima facie, there are several aspects of the vaccine pricingpolicy adopted by the Central government which require that policy berevisited. All vaccines, whether in the quantity of 50% purchased by theCentral Government or the remaining 50%, are to be used for vaccinatingcitizens. The end use is the same. The Central Government proposes topurchase half of the total quantity falling within its fifty per cent quotawhile for the rest, the manufacturers would declare in advance the priceto be fixed, allowing the State Governments to negotiate their terms. Asof date, the manufacturers have suggested two different prices, a lowerprice which is applicable to the Central Government and a higher pricewhich is applicable to the quantities purchased by the State Governments.It is likely that compelling the State Governments to negotiate withmanufacturers on the ground of promoting competition and making itattractive for new vaccine manufactures will result in a serious detrimentto those in the age group of 18 to 44 years, who will be vaccinated by theState Governments. The social strata of this age group also comprisespersons who are Bahujans or belong to other under privileged andmarginalized groups, like many in the other population age groups. Theymay not have the ability to pay. Whether or not essential vaccines willbe made available to them will depend upon the decision of each StateGovernment, based on its own finances, on whether or not the vaccineshould be made available free or should be subsidized and if so, to whatextent. This will create disparity across the nation. The vaccinationsbeing provided to citizens constitute a valuable public good. Discriminationcannot be made between different classes of citizens who are similarlycircumstanced on the ground that while the Central government willcarry the burden of providing free vaccines for the 45 years and abovepopulation, the State Governments will discharge the responsibility ofthe 18 to 44 age group on such commercial terms as they may negotiate.Prima facie, the rational method of proceeding in a manner consistentwith the right to life (which includes the right to health) under Article 21would be for the Central Government to procure all vaccines and to A

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Anegotiate the price with vaccine manufacturers. Once quantities areallocated by it to each State Government, the latter would lift the allocatedquantities and carry out the distribution. In other words, while procurementwould be centralized, distribution of the vaccines across India within theStates/UTs would be decentralized. While we are not passing a conclusivedetermination on the constitutionality of the current policy, the manner inBwhich the current policy has been framed would prima facie result in adetriment to the right to public health which is an integral element ofArticle 21 of the Constitution. Therefore, we believe that the CentralGovernment should consider revisiting its current vaccine policy to ensurethat it withstands the scrutiny of Articles 14 and Article 21 of theCConstitution.

40. In light of the justification offered for non-interference in theprices that are set by the manufacturers, irrespective of their variancefrom the prices for procurement of the Central Government, we wouldlike to seek the following clarifications:

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(i) Whether any other alternatives were considered by theCentral Government for ramping up the immunization drivein India, particularly in light of its initial strategy of acentralized free immunization drive;

(ii) The methodology which the Central Government wasEenvisaging to procure adequate vaccine doses for thepopulation prior to the revised strategy which was announcedamidst thesecond wave of COVID-19; and

(iii) Whether any studies and figures were relied upon in orderto arrive at the conclusion that decentralized procurementFwould spur competitive markets to incentivize productionand eventually drive down the prices of the vaccines.Whether these studies are of relevance in a pandemic whenvaccinesare a scarce andessential commodity which is beingproduced by a limited number of manufacturers for a limitednumber of vaccines.G

41. The Central Government has submitted that the FinanceMinistry has sanctioned a credit of Rs 3000 crores for Covishieldmanufacturer- Serum Institute of India[20]and Rs 1500 crores to Covaxin H20 “SII”

manufacturer- Bharat Biotech. Additionally, another Rs 65 crores is statedto have been provided to Bharat Biotech’s production center atBangalore. In bolstering its argument for augmentation of vaccineproduction, the Central Government has provided the Court with furtherinformation on advance funding (of unspecified amounts) that is beingprovided to R&D and manufacturing facilities. In light of this investment,the Central Government should consider revisiting its policy bearing inmind what has been stated above, the following issues and other relevantinformation:

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(i) Whether, and if so, the Finance Ministry or any other fundingorganization of the Government of India havemade anyCgrants/sanctions to Bharat Biotech and the SII in the past,like the current infusion of Rs 1500 crores and Rs 3000crores, respectively. If so, breakup and corelation with thetotal cost of development and production of the twovaccines; D

(ii) Whether the current procurement prices for the CentralGovernment account for infusion of funds for production,infrastructure and other aid provided by it. If so, the basison which the same benefit is denied to procurement by StateGovernments which equally service the needs of citizens;and E

(iii) The full extent of direct and indirect grant/aid provided forresearch, development andmanufacture of all existingvaccines and future vaccines that it proposes to authorize.For instance, the Central Government has submitted in itsaffidavit that the Department of Biotechnology hasfacilitated the trials for Sputnik V.

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F. Potentiality of Compulsory Licensing for vaccines andessential drugs

42. Several drugs that are at the core of the COVID treatmentprotocol are under patents in India including Remdesivir, Tociluzumaband Favipiravir. On 2 October 2020, a communication was issued by theUOI, along with South Africa, to the Council for Trade-Related Aspectsof Intellectual Property which stated that there were several reportsabout intellectual property rights hindering timely provisioning of G

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Aaffordable medical products to patients[21]. The communication alsoreported that some members of the World Trade Organization had carriedout urgent amendments to their national patent laws to expedite theprocess of issuing compulsory/government use licenses.

43. In India, the patent regime is governed by the Patents Act,B1970[22], 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 relevantpatents notified, any person interested in manufacturing the drug canmake an application to the Controller General of Patents who can thenissue a compulsory license. The patentee would be paid a reasonableCroyalty as fixed by the Controller General of Patents. Further, underSection 100 of the Patents Act, the Central Government can authorizecertain companies to use any patents for the “purpose of the government”.Indian companies can begin manufacturing the drugs while negotiatingthe royalties with the patentees. If the Central Government or itsDauthorized 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 thepatentee. Another alternative is for the Central Government to acquirethe patents under Section 102 from the patentees. If the CentralGovernment and the patentee is not able to reach a consensus on theprice of the patents, it is up to the High Court to fix the royalty. Additionally,Eunder Section 66 of the Patents Act, the Central Government is alsoentitled to revoke a patent in the public interest.

44. The utilization of these flexibilities has also been detailed inthe Trade Related Aspects of Intellectual Property Rights Agreement[23].Even as TRIPS obliges countries to ensure a minimum level of patentFprotection, it creates a permissive regime for the carving out of exceptionsand limitations that further public health objectives[24]. This is evident froma 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 FromCertain Provisions Of The Trips Agreement For The Prevention, Containment AndTreatment Of Covid-19, Communication From India And South Africa, IP/C/W/669,G2nd October, 2020, available at https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True22 “Patents Act”23 “TRIPS”

24Report of the United Nations Secretary-General’s High-Level Panel on Access toMedicines Promoting Innovation and Access to Health Technologies, (United NationsHSecretary-General, 2016), p. 16.

the objectives of the TRIPS as being to ensure the effective enforcementof intellectual property in a way that, inter alia, is ‘conducive to socialand economic welfare’. Article 8 gives member countries the freedomto take measures that protect public health and nutrition. Article 8(2)allows for the taking of TRIPS-compatible measures aimed at preventingthe abuse of intellectual property rights. Articles 30 and 31 deal withexceptions to the rights of patent owners, by allowing grant of compulsorylicenses. It leaves countries with significant breathing space to determinehow the compulsory licensing or government-use levers can be triggered.While such determinations must be made on the individual merits ofeach case[25], the aforesaid caveat does not apply when the compulsorylicense grant is for national emergency, extreme urgency or public non-commercial use[26].

45. According to the 2001 Doha Declaration, TRIPS should beinterpreted in a manner supportive of the right of members to protectpublic health and to promote access to medicines[27]. It recognizes theright of WTO members to use the full extent of the TRIPS flexibilities tosecure this objective. Para 5(b) of the Doha Declaration provides thefreedom to each member to grant compulsory licenses and to determinethe grounds on which the licenses are granted. Para 5(c) leaves it up toeach nation to determine what constitutes a national emergency orextreme urgency. In the context of the COVID-19 pandemic, we notethat several countries such as Canada and Germany have relaxed thelegal regimes governing the grant of compulsory licenses[28].

46. Whether and if so, the extent to which these provisions shouldbe utilized is a policy decision for the Central Government. We haveflagged the issue for its consideration. We have only outlined the legalframework within which the Central Government can possibly considercompulsory licensing and government acquisition of patents. The CentralGovernment is free to choose any other course of action that it deems fitto tackle the issue of vaccine requirements in an equitable and expedientmanner, which may involve negotiations with domestic and foreignproducers 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’ (November2001) 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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Ato choose the best possible measures it can undertake during the currentcrisis keeping in mind that public interest is of paramount importance.

G Supply of Essential Drugs

G.1 Submissions in the Central Government’s Affidavits B47. In relation to the broad issue of “Supply of Essentials”, in itsaffidavit dated 23 April 2021 and additional affidavit 29 April 2021, withrespect to Remdesivir, the UOI urged that:

(i) Remdesivir is a patented drug which is being manufacturedin India under licensing agreements between the patentCholder, M/s Gilead, a US based company and seven Indiancompanies. Under such agreements, these Indian companiesare allowed to manufacture Remdesivir for distribution;

(ii) In its affidavit dated 23 April 2021, it was submitted onbehalf of the Central Government that the current productionDis about 74 lakhs vials per month and once the additionalmanufacturing sites of the seven manufacturers becomeoperational by May 2021, the production capacity willincrease to 90 lakhs vials per month. In its additional affidavitdated 29 April 2021, the Central Government has submittedthat as on 23 April 2021, the production capacity hasEincreased to 1.03 crore vials per month;

(iii) The Central Government allocated 11 lakhs vials ofRemdesivir to nineteen States with a high case load between21 to 30 April through a letter issued on 21 April 2021. Thisallocation was revised and expanded to all States and UTsFthrough a letter issued on 24 April 2021;

(iv) The Central Government has directed the States to appointnodal officers to ensure unrestricted and timely movementof Remdesivir. A control room has been set up in this regardby the National Pharmaceutical Pricing Authority[29] whichGis monitoring supplies as allocated. A helpline has been setup by NPPA and manufacturers have been directed toaddress the hindrances in the movement of the drug. AWhatsApp group with nodal officers has also been created to enable coordination and officials of MHA, NPPA andCDSCO are also part of the group; A

(v) Remdesivir, its Active Pharma Ingredients[30] andformulations have been placed under export ban since 11April 2021; B

(vi) The Ministry of Finance has issued a notification on 20 April2021 exempting customs duty on the Remdesivir injection,and API of Remdesivir and Betacyclodexterin, which areused in the manufacture of the injection. All the SEZ/EOUmanufacturing units of M/s Mylan and M/s Honous Lab,who are manufacturing Remdesivir on behalf of some ofthe seven manufacturers have also been directed to startmanufacturing Remdesivir for domestic supply; C

(vii) CDSCO has directed all State Drug Controllers on 10 April2021 to conduct a special investigation drive to preventhoarding and black-marketing of Remdesivir in the country.DCGI and State Drug Controllers have been taking stringentaction against such activities and enforcement action hasbeen taken in thirty-four cases across the country; D

(viii) MHA has issued an advisory on 22 April 2021 to Statesand Union Territories to facilitate smooth movement ofsupplies. A “Covid Drug Management Cell” consisting ofthe Department’s Senior Officers and others has beenconstituted on 26 April 2021 to oversee and identify commonconcerns raised by States in relation to Remdesivir; E

(ix) NPPA has revised the maximum retail price of a 100 mg/Fvial of Remdesivir to Rs 3500; and

(x) The Central Government is also looking at the possibility ofimporting Remdesivir.48. The UOI made the following submissions on the availabilityof Tociluzumab injections:

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(i) Tociluzumab is manufactured by a Swiss Company, M/sRoche, which does not have any manufacturing facility inIndia or any agreementswith domestic pharma companies 30 “API”

338SUPREME COURT REPORTS

Ato manufacture the drug. It is imported in the country byCipla. India is completely dependent on imports;

(ii) It is listed as an investigational therapy drug (off-label) underthe National Clinical Management Protocol for COVID-19for severe cases. There are domestically producedBalternatives which are equivalent to or better thanTociluzumab such as itulizumab, dexamethasone and methylprednisolone. However, an incorrect public perception hasbeen created that only Tociluzumab can treat theinflammatory burst condition in COVID-19 patients sinceit is an imported drug. This has led to the acute shortage inCthe availability of the drug and has created public panic;and(iii)The supply of Tociluzumab is being monitored by NPPAand CDSCO.

49. The UOI has made the following submissions on the availabilityof other drugs:D(i)The National Clinical Management Protocol for COVID-19 does not include Favipirarvir (popularly known as Fabiflu)due to insufficient peer reviewed evidence to substantiateits use in mild to moderate cases of COVID-19. However,it is being prescribed by certain doctors. The clinicalEmanagement protocol is a dynamic document which isreviewed periodically and is subject to further evaluationbased on medical research and evidence that comes up infuture; and

(ii) On 24 April 2021, Department of Pharmaceuticals[31], NPPAand DCGI had reviewed the production and supply of otherFdrugs such as Favipiravir, Enoxaparin, Ivermectin,Methylprednisolone, Paracetamol and Hydroxy-chloroquine.A meeting was conducted on 25 April 2021 by NPPA andDCGI with manufacturers to review stock position,availability and production plans.GG.2 Recommendations

50. In respect of the essential drugs, this Court has been informedthat the Central Government is taking steps to augment the productionof Remdesivir. It has been brought to our notice that seven Indian H31 “DoP”

companies are manufacturing this drug under a licensing agreement witha US based company, M/s Gilead. The current production capacity ason 23 April 2021 is noted to be at 1.03 croresvials per month. The CentralGovernment should provide us with the details of the actual rate ofproduction and a breakup of demand for the drug from different States.Further, while it has been submitted on behalf of the Central Governmentthat it is allocating the stocks based on a rational criterion of equitabledistribution keeping in mind the existing constraints on the availability ofthe drug, this Court should be provided with details of the methodologyused for such allocation.

51. We have been informed by the Central Government in itsaffidavit that NPPA has revised the maximum retail price of Remdesivirto Rs 3500. However, it has come to our notice that several otherdrugs which are being prescribed by doctors for treating COVID-19patients like Favipiravir, Tociluzumab, Enoxaparin, Ivermectin,Methylprednisolone, Paracetamol and Hydroxy-chloroquine are beingpriced at exorbitant rates creating issues of access and affordability.While this is not a direction of this Court, the Central Government canconsider invoking its statutory powers under paragraphs 19 and 20 ofthe Drugs Price Control Order, 2013. Under paragraph 19[32] of the DrugsPrice Control Order, 2013 the Government in extraordinarycircumstances, if it considers necessary in public interest, can fix a ceilingprice or retail price of the drug for a certain period. COVID-19 is acrisis of an unprecedented nature and qualifies as an extraordinarycircumstance. It will be in public interest to ensure that the price ofessential drugs is fixed in such a manner that it is available even to themost marginalized sections of the society. The Government can evenmonitor the prices of the drugs under paragraph 20[33] of the Drugs Price 32 “19: Fixation of the Ceiling Price Under Certain Circumstances: Notwithstandinganything contained in this order, the Government may, in case of extraordinarycircumstances, if it considers necessary to do so in public interest, fix the ceiling priceor retail price of any drug, as it may deem fit and where the ceiling price or retail priceof the drug is already fixed and notified, the Government may allow an increase ordecrease in the ceiling price or the retail price, as the case may be, irrespective of annualwholesale price index of that year.”

33 “20: Monitoring the Prices of Non-Scheduled Formulations: (1) the Governmentshall monitor the maximum retail prices (MRP) of all the drugs, including the non-scheduled formulations and ensure that no manufacturer increases the maximum retailprice of a drug more than ten percent of maximum retail price during preceding twelvemonths and where the increase is beyond ten percent of maximum retail price, it shallreduce the same to the level of ten percent of maximum retail price for next twelvemonths. (2) The manufacturer shall be liable to deposit the overcharged amount alongwith interest thereon from the date of the increase in price in addition to the penalty.”

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AControl Order, 2013 and ensure that no manufacturer increases the pricesof the drugs by more than 10% of the maximum retail price during thepreceding 12 months and where the increase is beyond 10% of themaximum retail price, it can oblige the manufacturer to reduce it to thelevel of 10% for the next 12 months.

B52. The Central Government has submitted that it plans to importRemdesivir. It can also consider importing other essential drugs to meetthe immediate demand of the drug while the production is ramped up.We hasten to clarify that this does not constitute a direction of this Courtand ultimately this decision falls under the domain of the executive.

C53. We note that there are certain medicines which are beingprescribed by doctors which are not mentioned in the National ClinicalManagement Protocol for COVID-19 like Favipiravir. However, sincethese medicines are being prescribed by doctors, people are facingsignificant inconvenience in obtaining them due to their shortage in certainparts of the country. The Central Government should consider whetherDthe production of such medicines should be augmented to meet thedemand or instructions should be given to the doctors to not recommendsuch medicines unless they have been included in the national protocol.

54. It has been submitted on behalf of the Central Governmentthat on 24 April 2021, DoP, NPPA and DGCI reviewed the productionEand supply of drugs such as Favipiravir, Enoxaparin, Ivermectin,Methylprednisolone, Paracetamol and Hydroxy-chloroquine. The supplyof Remdesivir and Tociluzumab is already under the consideration of theCentral Government. A meeting was also held on 25 April 2021 by DoP,NPPA and DGCI with the manufacturers to review stock position,Favailability and production plans. The Central Government should providedetails of estimated demand of essential drugs mentioned above,production capacity, existing stocks, details of allocation and supply ofsuch drugs.

55. As discussed in Section F, the Central Government can alsoconsider using its powers under Sections 92, 100 or 102 of the PatentsGAct to increase production of essential drugs to ensure that it iscommensurate to the demand. The Central Government’s affidavittestifies to existence of capacity of public sector organizations andinstitutes, which can assist in augmenting production of various drugsand formulations. The utilization of these capabilities to augmentHproduction, once licensing is resorted to, will be in the interests of the general public. This Court is further of the opinion that prima facie thepresent circumstance warrant the government’s examination of its theextraordinary powers, meant to be used in extreme situations, such asthe current pandemic, for fixing drug prices, be it vaccines, or patentedformulations, having regard to the provisions of the Drugs and CosmeticsAct, 1940 and other provisions[34].We are cognizant that invocation of theabove provisions, if any, is ultimately a policy decision of the CentralGovernment and may encompass negotiations with the concernedstakeholders. We hope that the Central Government will adopt a routethat best serves the public interest.

G.3 Black Marketing

56. This Court would like to take judicial notice of the fact thatseveral critical drugs, used to treat COVID-19, such as Remdesivir andTocilizumab, are being sold at significantly inflated prices or in fake form.This is a condemnable attempt to exploit people’s miseryand profit fromtheir helplessness.

57. In order to clamp down on this practice, the CentralGovernment can consider constituting a special team to identify andprosecute those who: (a) sell medical grade oxygen/COVID-19 medicinesat exorbitant prices; and (b) sell fake substances and recover theconcerned substances. A protocol for ambulances must also be evolvedto avoid citizens being exploited by extracting unconscionable charges.The Central Government can consider creating a platform for easyreporting and redressal of such cases.

H. Recommendations for augmenting healthcare workforce

58. It is common knowledge that a large number of medical, nursingand pharmacy students, who graduated in 2020 and would be in theprocess of graduating in 2021, would be available to augment theworkforce in the health sector. The Central Government should, wefeel, look into this aspect, and ensure the optimal manner of utilization oftheir services, regard being had, of course, to their safety and well-being.

59. The Central Government should also consider using healthcare workforce available with the armed forces and para military forcesfor the purpose of vaccination.

34 Paragraph 3 and 19 of the Drugs Price Control Order, 2013

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AI.Epilogue

60. The World Health Organisation[35], while discussing the rapidspread 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 disinformation[36]. ThisBhighlights the key role internet and technology currently has in all ourlives, as the COVID-19 pandemic rages on. Indeed, the WHO recentlyalso conducted a study to understand how individuals between the agesof 18-40 years dealt with the ongoing pandemic using social media[37].

61. It is only appropriate then that when many cities in India areCsuffering through the second wave of the COVID-19 pandemic, manyhave turned to the internet, using applications/websites to find criticalsupport. On these platforms, online communities led by members of thecivil society and other individuals, have assisted the needy in multipleways – often by helping them procure oxygen, essential drugs or find ahospital bed through their own networks or by amplifying original requests,Dand even by offering moral and emotional support. However, it is withdeep distress that we note that individuals seeking help on such platformshave been targeted, by alleging that the information posted by them isfalse and has only been posted in social media to create panic, defamethe administration or damage the “national image”. We do not hesitate inEsaying that such targeting shall not be condoned, and the CentralGovernment and State Governments should ensure that they immediatelycease any direct or indirect threats of prosecution and arrest to citizenswho air grievances or those that are attempting to help fellow citizensreceive medical aid. If this does keep happening even after the currentorder, this Court shall be constrained to use the powers available to itFunder it contempt jurisdiction.We also direct that all Directors General 35 “WHO”

36 “Managing the COVID-19 infodemic: Promoting healthy behaviours and mitigatingthe harm from misinformation and disinformation - Joint statement by WHO, UN,UNICEF, UNDP, UNESCO, UNAIDS, ITU, UN Global Pulse, and IFRC” (WHO, 23GSeptember 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 Zand 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-Hinteraction-among-gen-z-and-millennials>

of Police shall ensure compliance down the ranks of the police forceswithin their jurisdictions.

62. In these trying times, those desperately seeking help for theirloved ones on these platforms should not have their misery compoundedthrough the actions of the State and its instrumentalities. Further, thereare two more crucial reasons why such a clampdown on informationsharing must be absolutely stopped immediately.

63. The first reason is because sharing information widely is initself an important tool in combating public tragedies, like the currentCOVID-19 pandemic. In K.S. Puttaswamy (Privacy-9J.) vs Unionof India[38], one of us (DY Chandrachud, J) speaking for four Judges ofa nine-Judge bench of this Court noted academic literature documentingthe widespread availability of information and the resultantacknowledgement of the problem is what prevented the drought inMaharashtra in 1973 from becoming as bad as the Bengal Famine of1943, where the British tried to deny the problem even existed. It wasnoted thus:

“267. Civil and political rights and socio-economic rights do notexist in a state of antagonism. The conditions necessary for realisingor fulfilling socio-economic rights do not postulate the subversionof political freedom. The reason for this is simple. Socio-economicentitlements must yield true benefits to those for whom they areintended. This can be achieved by eliminating rent-seekingbehaviour and by preventing the capture of social welfare benefitsby persons who are not entitled to them. Capture of social welfarebenefits can be obviated only when political systems aretransparent and when there is a free flow of information. Opacityenures to the benefit of those who monopolise scarce economicresources. On the other hand, conditions where civil andpolitical freedoms flourish ensure that governmentalpolicies are subjected to critique and assessment. It is thisscrutiny which subserves the purpose of ensuring that socio-economic benefits actually permeate to the underprivilegedfor whom they are meant. Conditions of freedom and avibrant assertion of civil and political rights promote aconstant review of the justness of socio-economic A

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programmes and of their effectiveness in addressingdeprivation and want. Scrutiny of public affairs is foundedupon the existence of freedom. Hence civil and politicalrights and socio-economic rights are complementary andnot mutually exclusive.

268. Some of these themes have been addressed in the writingsof the Nobel laureate, Amartya Sen. Sen compares the responseof many non-democratic regimes in critical situations such asfamine with the responses of democratic societies in similarsituations. [ Amartya Sen, Development as Freedom (OxfordUniversity Press, 2000) at pp. 178-79.]…

269. In the Indian context, Sen points out that the Bengal famineof 1943 “was made viable not only by the lack of democracy incolonial India but also by severe restrictions on reporting andcriticism imposed on the Indian press, and the voluntary practiceof “silence” on the famine that the British-owned media chose tofollow” [ Amartya Sen, The Idea of Justice (Penguin Books, 2009)at p. 339.] . Political liberties and democratic rights are henceregarded as “constituent components” of development. [Id, at p.347] In contrast during the drought which took place inMaharashtra in 1973, food production failed drastically and theper capita food output was half of that in sub-Saharan Africa. Yetthere was no famine in Maharashtra where five million peoplewere employed in rapidly organised public projects while therewere substantial famines in sub-Saharan Africa. This establisheswhat he terms as “the protective role of democracy”. Sen hasanalysed the issue succinctly:

“The causal connection between democracy and the non-occurrence of famines is not hard to seek. Famines kill millions ofpeople in different countries in the world, but they don’t kill therulers. The kings and the presidents, the bureaucrats and thebosses, the military leaders and the commanders never are faminevictims. And if there are no elections, no opposition parties, noscope for uncensored public criticism, then those in authority don’thave to suffer the political consequences of their failure to preventfamines. Democracy, on the other hand, would spread the penaltyof famines to the ruling groups and political leaders as well. Thisgives them the political incentive to try to prevent any threatening famine, and since famines are in fact easy to prevent (theeconomic argument clicks into the political one at this stage), theapproaching 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 ononline platforms is not just in the interest of individuals sharing theinformation, but the larger democratic structures of our nation. Withoutthe ready availability of such information, it is entirely possible that theCOVID-19 pandemic may turn into a tragedy worse than what it alreadyis.

64. The second reason is because sharing information widely willhelp in the creation of a “collective public memory” of this pandemic.The presence of collective public memory, which refers “to an extantand taken-for-granted group memory”[39], is important for the creationof knowledge of the problems plaguing us today, so they may be passedon across time[40]. This is important since we do not have to travel backtoo 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 worldand killed between 50-100 million individuals (compared to the 17 millionwho died in World War I), has been almost entirely erased from ourcollective public memory[41]. Therefore, the widespread sharing ofinformation by individuals living through the COVID-19 pandemicbecomes crucial. Furthermore, the role of Courts in creating andpreserving 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 inthe following terms[42]:

39 Theodore O. Prosise,

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 bombexhibit’, (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 Rhetoricand Public Affairs 3:363-385, pg 364

41 Jonathan Freedland, ‘History suggests we may forget the pandemic sooner than wethink’ (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 ofMichigan Press, 2009) pgs 12-13

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A“Law in the modern era is, we believe, one of the most importantof our society’s technologies for preserving memory. Just as theuse of precedent to legitimate legal decisions fixes law in aparticular relation to the past, memory may be attached, or attachitself, to law and be preserved in and through law. Where this isthe case, it serves as one way of orienting ourselves to the future.BAs Drucilla Cornell puts it: “Legal interpretation demandsthat we remember the future.” In that phrase, Cornellreminds us that there are, in fact, two audiences for everylegal act, the audience of the present and the audience ofthe future. Law materializes memory in documents,Ctranscripts, written opinions; it re-enacts the past, bothintentionally and unconsciously, and it is one place wherethe present speaks to the future through acts ofcommemoration.

Because the litigated case creates a record, courts canDbecome archives in which that record serves as thematerialization of memory. Due process guarantees anopportunity to be heard by, and an opportunity to speak to,the future. It is the guarantee that legal institutions can beturned into museums of unnecessary, unjust, undeservedpain and death. The legal hearing provides lawyers andElitigants an opportunity to write and record history bycreating narratives of present injustices, and to insist onmemory in the face of denial. By recording such history andconstructing such narratives lawyers and litigants call on animagined future to choose Justice over the “jurispathic” tendenciesFof the moment.”

(emphasis supplied)

Hence, in the present proceedings, we hope to not only initiate adialogue so as to better tackle the current COVID-19 pandemic but alsoto preserve its memory in our public records, so that future generationsGmay evaluate our efforts and learn from them.

65. We speak not only as members of this Court, but also asgrateful citizens of the country, and commend the outstanding work ofour all healthcare professionals (doctors, nurses, healthcare workers,laboratory technicians, ward staff, ambulance drivers, crematoriumH

workers etc.) during this crisis. They have truly gone beyond their callof duty and toiled day in and day out, relentlessly without rest amidstgreat challenges. It is absolutely necessary to take urgent steps for theirwell-being to ensure that our appreciation for their tremendous efforts isnot reduced to rhetoric. This is especially important since another factorwhich affects how collective public memory of any event is created isby the rhetoric surrounding it[43]. As such, our public memory of this publicevent has to transcend its conception as a “war” against the virus ofCOVID-19 itself, but rather to remember that it is “the complexepidemiological circumstances that promote these outbreaks andthe under-resourced health systems that are tasked with diseasecontainment”[44]. While the healthcare professionals have been at theforefront of tackling this crisis, we have to recognize their contributionas medical healthcare professionals who have undertaken “to protectpublic health using proven scientific evidence and best practicesand to serve to community at large”[45], and not just as “CORONAWARRIORS”.

66. We also do not hesitate to note that the treatment meted out tothese public healthcare professional during this COVID-19 pandemichas sometimes been less than ideal. The following are some of the issueswe wish to highlight:

(i) Recently, there were reports that the Pradhan Mantri GaribKalyan Package Insurance Scheme, an insurance schemeof Rs 50 lakhs which had been extended to about 22 lakhhealthcare professionals, was set to expire on 24 March2021 and would not be renewed. While we are happy tonote that UOI’s affidavit of 23 April 2021 states that thisScheme has been extended for one year starting April 2021,we have also been informed that till date only 287 claimshave been settled under it, which includes claims from thefamilies of 168 doctors who died after contracting COVID- 43 Nicole Maurantonio, “The Politics of Memory” in Kate Kenski and Kathleen HallJamieson (eds), The Oxford Handbook of Political Communication (Oxford UniversityPress, 2014)

44 Luke Shors, ‘Waging Another Public Health “War?” ’ (Think Global Health, 26February 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 HealthPolicy (2020) 41:233-237, pg 233

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348SUPREME COURT REPORTS

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19 while treating patients. We direct the CentralGovernment to inform this Court as to how many claimsare pending under the Scheme, and the timeline within whichthe Central Government expects to settle them;

(ii) Healthcare personnel are at an obvious heightened risk ofcontracting the COVID-19 virus. However, we are awareof reports that indicate that infected healthcare personnelare left to fend for themselves without adequate availabilityof beds, oxygen or essential drugs. Further, some of themhave also often been asked to report back to duty within 10days of first testing positive for COVID-19 (provided theyare asymptomatic), even though a longer recuperation periodis often recommended. While we are dealing with a terriblesecond wave of the COVID-19 pandemic, there must bean effective policy to ensure that the nation trulyacknowledges their effort and creates incentives for them.We hope it will be remedied soon by the Central and StateGovernments through theintroduction of appropriateguidelines and measures;

(iii) It is unclear what measures are currently being taken toensure that healthcare personnel can continue to serveothers while not risking the health of their family members.We hope that the respective State Governments, withnecessary assistance from the Central Government, canensure this takes place; and

(iv) The Central Government should, we feel examine andensure that in addition to the schemes it has framed, otherfacilities such as availability of food, resting facilities duringintervals between work, transportation facilities, non-deduction of salary or leave account, if afflicted by COVID2019 or related infection, overtime allowance, in both publicand private hospitals, and a separate helpline for doctors,and healthcare professionals, in cases of COVID 2019related emergencies, is provided. All these, we feel, wouldshow these professionals that we do not show ourappreciation in mere words, but also care for them.

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IN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES ANDSERVICES DURING PANDEMIC

67. The issues mentioned above are only symptomatic of the otherbroader issues thatare being faced by healthcare professionals, who areinstrumental in combating the pandemic. Hence, we hope their welfareis considered seriously by the Central and State Governments. Further,we would wish to use this order toplace on record our sincerestappreciation for all the public healthcare professionals- not just limited tothe doctors, but also nurses, hospital staff, ambulance drivers, sanitationworkers and crematorium workers. It is through their dedicated effortsthat the effect of COVID-19 pandemic is being currently tackled inIndia.

68. In light of the continuing surge of infections in the secondwave of the pandemic, we direct the Central Government and StateGovernments to put on record the efforts taken to curb the spread of thevirus and the measures that they plan on taking in the near future. At thesame time, we would seriously urge the Central and State Governmentsto consider imposing a ban on mass gatherings and super spreader events.They may also consider imposing a lockdown to curb the virus in thesecond wave in the interest of public welfare. Having said that, we arecognizant of the socio-economic impact of a lockdown, specifically, onthe marginalized communities. Thus, in case the measure of a lockdownis imposed, arrangements must be made beforehand to cater to the needsof these communities.

J. Conclusion

69. The present order has primarily considered the submissions(written and oral) ofthe UOI. These submissions have been reproducedhere as a matter of public record and to contextualize the clarificationsthat are being sought by our Court in order to serve its dialogic role. Wereiterate, for abundant caution, that the data and submissions reproducedabove are not its endorsement or acceptance. In terms of the abovediscussion, we hereby pass the following directions:

(i) The UOI shall ensure, in terms of the assurance of theSolicitor General, that the deficit in the supply of oxygen tothe GNCTD is rectified within 2 days from the date of thehearing, that is, on or before the midnight of 3 May 2021;

(ii) The Central Government shall, in collaboration with theStates, prepare a buffer stock of oxygen for emergencypurposes and decentralize the location of the emergency A

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stocks. The emergency stocks shall be created within thenext four days and is to be replenished on a day to daybasis, in addition to the existing allocation of oxygen supplyto the States; A

(iii) The Central Government and State Governments shall notifyBall Chief Secretaries/Directors General of Police/Commissioners of Police that any clampdown on informationon social media or harassment caused to individuals seeking/delivering help on any platform will attract a coerciveexercise of jurisdiction by this Court. The Registrar (Judicial)is also directed to place a copy of this order before allCDistrict Magistrates in the country;

(iv) The Central Government shall, within two weeks, formulatea national policy on admissions to hospitals which shall befollowed by all State Governments. Till the formulation ofsuch a policy by the Central Government, no patient shallDbe denied hospitalization or essential drugs in any State/UTfor lack of local residential proof of that State/UT or evenin the absence of identity proof;

(v) The Central Government shall revisit its initiatives andprotocols, including on the availability of oxygen, availabilityEand pricing of vaccines, availability of essential drugs ataffordable prices and respond on all the other issueshighlighted in this order before the next date of the hearing,that is, 10 May 2021. Copies of all affidavits to be servedupon the Amici in advance; and

F(vi)Several other suggestions have been made before this Courtin IAs and writ petitions filed by diverse parties. In order tostreamline the further course of hearing, we have requestedthe Amici to collate and compile these suggestions whichwould be taken up later. The present order has focused oncertain critical issues in view of the urgency of the situation.

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Nidhi Jain

Directions issued.

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