Prepare buffer stock of oxygen for emergency purposes, formulate national policy: SC

In Re Distribution of Essential Supplies And Services During Pandemic (Supreme Court of India)

In light of the continuing surge of infections in the second wave of the pandemic, we direct the Central Government and State Governments to put on record the efforts taken to curb the spread of the virus and the measures that they plan on taking in the near future. At the same time, we would seriously urge the Central and State Governments to consider imposing a ban on mass gatherings and super spreader events. They may also consider imposing a lockdown to curb the virus in the second wave in the interest of public welfare. Having said that, we are cognizant of the socio-economic impact of a lockdown, specifically, on the marginalized communities. Thus, in case the measure of a lockdown is imposed, arrangements must be made beforehand to cater to the needs of these communities”

Hon’ble Supreme Court has passes the following directions:-

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

(ii) The Central Government shall, in collaboration with the States, prepare a buffer stock of oxygen for emergency purposes and decentralize the location of the emergency stocks. The emergency stocks shall be created within the next four days and is to be replenished on a day to day basis, in addition to the existing allocation of oxygen supply to the States;

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

(iv) The Central Government shall, within two weeks, formulate a national policy on admissions to hospitals which shall be followed by all State Governments. Till the formulation of such a policy by the Central Government, no patient shall be denied hospitalization or essential drugs in any State/UT for lack of local residential proof of that State/UT or even in the absence of identity proof;

This order has been divided into the following sections to facilitate analysis:

FULL TEXT OF THE SUPREME COURT JUDGMENT/ORDER

A Introduction

B Outline of the Disaster Management Act

C Medical Infrastructure

C.1 Submissions in UOI’s Affidavits

C.2 National Policy for Admission in Hospitals

D Oxygen allocation and availability

E Vaccines

E.1 Vaccine capacity and disbursal

E.2 Vaccine pricing

F Potentiality of Compulsory Licensing for vaccines and essential drugs

G Supply of Essential Drugs

G.1 Submissions in the Central Government’s Affidavits

G.2 Recommendations

G.3 Black Marketing

H Recommendations for augmenting healthcare workforce

I Epilogue

J Conclusion

PART A

A Introduction

1. The genesis of this suo motu writ petition is in an order dated 22 April 2021. This Court took note of the unprecedented humanitarian crisis in the country, following the outbreak of the COVID-19 pandemic. Notices were issued to the Union of India¹, the Governments of the States and Union Territories², and to several petitioners who were before the High Courts. The Court observed:

“the Union Government, the State Governments/Union Territories and the parties, who appeared to have approached the High Courts to show cause why uniform orders be not passed by this Court in relation to

a) Supply of oxygen;

b) Supply of essential drugs;

c) Method and manner of vaccination; and

d) Declaration of lockdown”

The Court directed the Central Government to :

“1. Report on the existence or otherwise and requirement of setting up of a coordinating body that would consider allocation of the above resources in a consultative manner (with the involvement of concerned States and Union Territories).

2. Consider declaration of essential medicines and medical equipment including the above articles as essential commodities in relation to COVID.

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

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

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

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

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

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

(c) The monitoring mechanism for ensuring the supply of oxygen, particularly to critically affected States and Union Territories as well as the other areas;

(d) The basis on which allocation of oxygen is being made from the central pool; and

(e) The methodology adopted for ensuring that the requirements of the States are communicated to the Central Government on a daily basis so as to ensure that the availability of oxygen is commensurate with the need of each State or, as the case may be, Union Territory.

(ii) Enhancement of critical medical infrastructure, including the availability of beds, Covid treatment centres with duly equipped medical personnel on the basis of the projected requirement of healthcare professionals and anticipated requirements. The Union government will consider framing a policy specifying the standards and norms to be observed for admitting patients to hospitals and covid centres and the modalities for admission;

(iii) The steps taken to ensure due availability of essential drugs, including Remdesivir and Favipiravir among other prescribed drugs and the modalities which have been set up for controlling prices of essential drugs, for preventing hoarding and for ensuring proper communication of the requirements at the level of each District by the District health authorities or Collectors to the Health Departments of the States and thereafter by the states to the Union Ministry of Health and Family Welfare so that the projected requirements are duly met and effectively monitored on a daily basis.

(iv) Vaccination

(a) Presently two vaccinations have been made available in the country, namely, Covishield and Covaxin;

(b) As of date, the vaccination programme has extended to all citizens of the age of 45 years and above;

(c) From 1 May 2021, the vaccination programme is to be opened up also to persons between the age groups of 18 to 45, in addition to the existing age group categories. The Union of India shall clarify (i) the projected requirement of vaccines as a result of the enhancement of coverage; (ii) the modalities proposed for ensuring that the deficit in the availability of vaccines is met; (iii) steps proposed for enhancement of vaccine availability by sourcing stocks from within and outside the country; (iv) modalities for administering the vaccines to meet the requirements of those in the older age group (forty five and above) who have already received the first dose; (v) modalities fixed for administering the vaccine to meet the additional demand of the 18-45 population; (vi) how the supplies of vaccines will be allocated between various states if each state is to negotiate with vaccine producers; and (vii) steps taken and proposed for ensuring the procurement of other vaccines apart from Covishield and Covaxin and the time frame for implementation; and

(d) The basis and rationale which has been adopted by the Union government in regard to the pricing of vaccines. The government shall explain the rationale for differential pricing in regard to vaccines sourced by the Union government on one hand and the states on the other hand when both sources lead to the distribution of vaccines to citizens.”

4. This Court then received an additional affidavit dated 29 April 2021 from the UOI, and fresh affidavits by the various States/UTs addressing the four issues mentioned in its order dated 27 April 2021. In the hearing conducted on 30 April 2021, this Court heard submissions by Mr Tushar Mehta, learned Solicitor General of India, who was appearing on behalf of the Central Government. Several other counsels have made brief interjections, including Mr Vikas Singh, Senior Counsel and President of the Supreme Court Bar Association. This Court also heard a presentation on oxygen supply in India by Ms Sumita Dawra, Additional Secretary, Department of Promotion of Industry and International Trade, Ministry of Commerce and Industry. As such, unless specified otherwise, the directions and observations in the present order are limited to the UOI.

5 During the course of the hearing, this Court directed that the individual States/UTs shall be given an opportunity to discuss their affidavits at a later hearing. Further, the Court also directed the learned Amici to prepare a tabular compilation in relation to all the Interlocutory Applications which have been filed in this petition. On the basis of the issues raised, they shall also be considered in a later hearing. Before delving into a substantive discussion, we would like to clarify that the jurisdiction exercised in this matter is merely to facilitate a dialogue of relevant stakeholders, the UOI, the States and this Court, in light of the pressing humanitarian crisis, and not with a view to usurp the role of the executive and the legislature. This bounded-deliberative approach³ is exercised so that the UOI and States can justify the rationale behind their policy approach which must be bound by the human rights framework which presently implicates the right to life under Article 21 and right to equality under Article 14 of the Constitution.

PART B

B Outline of the Disaster Management Act

6. The Disaster Management Act, 2005⁴ came into effect on 26 December 2005. The DMA provides for the effective management of disasters and matters connected or incidental to such disasters. COVID-19 falls under the definition of a disaster under Section 2(d)⁵ of the DMA and the provisions of the DMA were invoked for the first time to deal with the present pandemic. Under Section 6(2)(i) of the DMA, the National Disaster Management Authority⁶ issued an order dated 24 March 2020 directing the Ministries, UOI, State/UTs and their authorities to take effective measures to prevent the spread of COVID-19 in the country. Thereafter, the Home Secretary, Ministry of Home Affairs as the Chairperson of the National Executive Committee, which assists the NDMA in its functions, in an order dated 24 March 2020 issued guidelines for the initial 21 days‟ lockdown on account of COVID-19.

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

“2…

(e)”disaster management” means a continuous and integrated process of planning, organizing, coordinating and implementing measures’ which are necessary or expedient for–

(i) prevention of danger or threat of any disaster;

(ii) mitigation or reduction of risk of any disaster or its’ severity or consequences;

(iii) capacity-building;

(iv) preparedness to deal with any disaster;

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

(vi) assessing the severity or magnitude of effects of any disaster;

(vii) evacuation, rescue and relief;

(viii) rehabilitation and reconstruction;..”

Section 2(n) of DMA defines a “National Plan” as the plan for disaster management for the whole country prepared under Section 11 of DMA. Section 3 of the DMA constitutes the NDMA with the Prime Minister as the Chairperson, ex officio. Section 6 lists down the powers and functions of the NDMA. Under Section 6(2)(b), NDMA has the power to approve the National Plan. Section 11 of the DMA provides the procedure for drawing up and implementation of the National Plan in the following terms:

“11. National Plan

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

(2) The National Plan shall be prepared by the National Executive Committee having regard to the National Policy and in consultation with the State Governments and expert bodies or organisations in the field of disaster management to be approved by the National Authority.

(3) The National Plan shall include–

(a) measures to be taken for the prevention of disasters, or the mitigation of their effects;

(b) measures to be taken for the integration of mitigation measures in the development plans;

(c) measures to be taken for preparedness and capacity building to effectively respond to any threatening disaster situations or disaster;

(d) roles and responsibilities of different Ministries or Departments of the Government of India in respect of measures specified in clauses (a), (b) and (c).

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

(5) Appropriate provisions shall be made by the Central Government for financing the measures to be carried out under the National Plan.

(6) Copies of the National Plan referred to in sub-sections (2) and (4) shall be made available to the Ministries or Departments of the Government of India and such Ministries or Departments shall draw up their own plans in accordance with the National Plan.”

8. A National Plan includes, inter alia, measures for disaster prevention, mitigation, preparedness and roles and responsibilities of different Ministries in terms of Section 11(3) of DMA. A National Plan for the entire country was prepared in the year 2016 and was revised and notified in November, 2019. The National Plan, 2019 provides a framework to the Government agencies to deal with different aspects of disaster management. Section 11(4) of the DMA provides that the National Plan is to be revised and updated annually making it a ^„dynamic document‟. The executive summary of the National Plan succinctly captures its purpose and contours in the below extract:

“…The National Disaster Management Plan (NDMP) provides a framework and direction to the government agencies for all phases of disaster management cycle. The NDMP is a “dynamic document” in the sense that it will be periodically improved keeping up with the emerging global best practices and knowledge base in disaster management. It is in accordance with the provisions of the DM Act, 2005, the guidance given in the National Policy on Disaster Management (NPDM) 2009, and the established national practices…”

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

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

11. Section 36 of DMA provides for the responsibilities that have to be undertaken by the Ministries or Departments of the Central Government. While Section 36(h) empowers the Central Government to take any actions that it may consider necessary for disaster management, Section 36(d) specifically enables it to review its policies with a view to incorporate provisions necessary for prevention of disaster, mitigation or preparedness. Under Section 36(f), it is the responsibility of every Ministry or Department of Central Government to provide assistance to the State Governments for (i) drawing up mitigation, preparedness and response plans, capacity-building, data collection and identification and training of personnel in relation to disaster management; (iii) carrying out rescue and relief operations in the affected area; (iii) assessing the damage from any disaster; and (iv) carrying out rehabilitation and reconstruction. Section 35(g) provides that the Central Government is responsible for making available its resources to the National Executive Committee or a State Executive Committee for the purposes of, inter alia, transporting personnel and relief goods to and from the affected area.

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

13. The learned Solicitor General has submitted that the Central Government is operating under the broad framework of the National Plan and the plan is already in force. The plan specifically deals with “Biological and Public Health Emergencies”. Further, different States have their own Disaster Management Plans in place. It has been submitted that the National Plan does not and cannot contain step by step instructions or specific directions for the day to day management of the pandemic by the Government agencies. Such aspects are kept open for executive decision, in view of the dynamic nature of the disaster in question. Further, since COVID-19 is a novel virus, the knowledge in relation to such a virus is contemporaneous in nature and is subject to constant development. A three Judge bench of this Court in its judgement in Centre for Public Interest Litigation vs Union of India⁷ had noted that there was no need to develop a fresh National Plan under Section 11 for COVID-19 since a National Plan was already in place, which was being supplemented by various orders and measures taken by competent authorities under DMA. Justice Ashok Bhushan, speaking for this Court, observed that:

PART C

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

14. Therefore, the National Plan, 2019 can be supplemented by the issuance of additional guidelines to tackle any aspect of disaster management including the issue of admission to hospitals and access to essential drugs and vaccines in respect of COVID-19.

C Medical Infrastructure

C.1 Submissions in UOI’s Affidavits

15. In relation to the broad issue of medical infrastructure, the Central Government begins its affidavit dated 23 April 2021 and additional affidavit dated 29 April 2021 by describing its ^„three-tier setup‟ of Covid Care Centers⁸, Dedicated COVID Health Centers⁹ and Dedicated COVID Hospitals¹⁰ which was recommended to the States for tackling the COVID-19 pandemic, for which the UOI also provided funds under an emergency response package from the National Health Mission and State Disaster Response Fund.

16. The present status of these is: (i) 2,084 DCH (of which 89 are under the Central Government and the rest 1,995 with State Governments); (ii) 4,043 DCHC; and (iii) 12,673 CCC. Cumulatively, they have 18,52,265 beds in total, out of which 4,68,974 beds are in DCH. It was also noted that Central Government hospitals have also been converted into DCH.

17. Further, tertiary care hospitals under ESIC, Defence, Railways, paramilitary forces, Steel Ministry, et al, are also being leveraged for case management. Even as many as 3816 railways coaches spread over 16 railway zones have been converted into CCC. Finally, the DRDO has also set up large field hospitals with capacities ranging from 1,000 to 10,000 isolation beds.

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

19. The affidavit provides the following details of the efforts taken by UOI to create projections for each State, and how it was communicated to them:

(i) It has developed an IT module for projections of expected cases based on ongoing caseload, so as to alert States and districts to be prepared in advance. The projections by the Central Government were regularly shared in writing with the States, along with reports containing emergency plans. This tool was also made available to States, to map their own projections at the State level;

(ii) Details of the meetings conducted by the Prime Minister, the Minister of Health and Family Welfare, the Cabinet Secretary, the Secretary (H) and the DGHS were provided; and

(iii) Details of letters (which seem to have been sent on a monthly basis) sent by the Central Government to the State Governments indicate that they informed the State Governments of the projected cases for the coming month, along with the number of Oxygen Supported Beds, ICU Beds and of Ventilators that will be required to manage the projected cases. Thereby, the State Governments which were found lacking in their numbers were directed to ramp up their facilities.

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

(i) After the first wave, the Central Government has been consistently writing to the State Governments from 4 December 2020 with numbers of projected cases, along with the directions requiring them to arrange the necessary infrastructure which will be needed;

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

(a) Bed capacities, ICU beds, further identification of additional hospitals, preparation of field hospital facilities, ensuring sufficient oxygen supported beds and oxygen supplies;

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

(c) Suitable initiatives for (among other things) achieving and maintaining adequate level of testing, surveillance and risk communication for promoting wearing of masks, physical distancing, hand hygiene;

(d) Sufficient referral linkages for districts with deficit infrastructure through deployment of additional ambulances, wherever necessary; and

(iii) On 20 April 2021, the Ministry of Health and Family Welfare¹¹ wrote to the State Governments with their projections and reminded them also of the funding avenues being made available to all States under NHM funding, State Disaster Response Fund, and other initiatives.

21. The affidavits also note that the Central Government had developed a live portal with all the States and districts where they were asked to feed in their data of cases and details such as people under home isolation, on isolation beds (with or without oxygen) and on ICU beds. Further, the State Governments were also directed to feed in details of the COVID dedicated health care infrastructure created by them, besides the details of containment zones so specified by them. However, the Central Government has alleged that States and districts did not upload their data regularly enough. Additionally, there was also a ^„Facility App‟ which could be used by Covid Health facilities to monitor their patients as well as the availability of logistics with their health facility. However, the Central Government alleges that States, districts and facilities did not use this Facility App.

C.2 National Policy for Admission in Hospitals

22. It has been submitted by the Central Government that health being a state subject, the medical infrastructure is largely created and maintained by the respective State Governments. Since we are yet to hear from the State Governments, we shall not be issuing any directions or making comprehensive observations in relation to this issue.

23. However, based on the affidavits submitted by the Central Government and the hearings which followed, we have come to understand that there is no national policy on how admissions must take place in the various tiers of hospitals (CCC, DCHC and DCH). Gaining admission into a hospital with a bed is one of the biggest challenges being faced by most individuals during this second wave of the COVID-19 pandemic. Left to their own devices, citizens have had to suffer immeasurable hardship. Different states and local authorities follow their own protocols. Differing standards for admission in different hospitals across the nation leads to chaos and uncertainty. The situation cannot brook any delay. Accordingly, we direct the Central Government to frame a policy in this regard, in exercise of its statutory powers under the DMA, which will be followed nationally. The presence of such a policy shall ensure that no one in need is turned away from a hospital, due to no fault of their own. Such a policy should, inter alia, address the following issues in relation to admission:

(i) Requirement of a positive test for COVID-19 virus, which may become difficult for many individuals since testing facilities are overwhelmed, test results are taking inordinately long time and the new strain of the COVID-19 virus is sometimes not even picked up by a regular RT-PCR test;

(ii) Some patients are being refused service based on arbitrary factors. For example, the hospitals in Ahmedabad were initially refusing to take in patients who did not arrive in the government-run ^„108‟ ambulances. While this rule has now been removed, after objections were noted by the Gujarat High Court during hearings in a suo motu public interest litigation¹², we note that such rules cannot be allowed to crop up in other places;

(iii) Some reports have also been brought to our attention that hospitals are refusing to admit individuals who cannot produce a valid ID card which shows that they belong to the city where the hospital is located. Given how overstretched our hospitals are during the second wave of the COVID-19 pandemic, it is entirely plausible that individuals may travel to other cities in desperation, since beds may not be available in their city. The rural health infrastructure is seriously deficient. Hence, no hospital should be allowed to deny them entry solely based on this reason or any other issues with identity proofs;

(iv) A related issue is when individuals often get their family member admitted in a hospital in one city, but have to travel to another city to look for oxygen or essential drugs and are denied their use because they are to be bought for an individual admitted in a different city. As was true for the above such rule, this is also unacceptable and should not be allowed;

(v) Admissions to hospital must be based on need. The Central Government, in consultation with the respective State Governments, must formulate guidelines on the stage at which hospitalization is required so as to ensure that scarce hospital beds are not occupied by persons who do not need hospitalization. This aspect should be based on the advice of medical experts and can be suitably altered given the needs of each State (or regions within the State) and in the course of the experiences gained during the pandemic; and

(vi) Directions are hereby issued to all States, Union Territories, and all public agencies, to ensure that the above orders are implemented forthwith. The Central, State and Union Territory governments shall issue necessary orders and circulars, incorporating the above directions, within three days, which shall be in force till replaced by an appropriate uniform policy, devised by the central government, statutorily.

PART D

D Oxygen allocation and availability

24 The Central Government has argued the following:

(i) By its order dated 11 September 2020, the Ministry of Home Affairs¹³, in exercise of its powers under Section 10(2)(h) of the DMA had constituted an Empowered Group-II as an inter-ministerial body to ensure availability of essential medical equipment and oxygen management;

(ii) Medical oxygen is critical to treatment of COVID affected patients. The entire available capacity of oxygen is used for supply for industrial and medical use, which is in the form of Liquid Medical Oxygen¹⁴. The major suppliers for both industrial and medical oxygen are steel plants in the public and private sectors, and private entities;

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

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