Case: IN RE:  Vs. DISTRIBUTION OF ESSENTIAL SUPPLIES AND SERVICES DURING PANDEMIC

This order has been divided into the following sections to facilitate analysis: A. Introduction B. Outline of the Disaster Management Act C. Medical Infrastructure C.1 Submissions in UOIs 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 Governments Affidavits G.2 Recommendations G.3 Black Marketing H. Recommendations for augmenting healthcare workforce I. Epilogue J. Conclusion A. Introduction 1. The genesis of this suo motu writ petition is in an order dated 22 April 2021. This Court took note of the unprecedented humanitarian crisis in the country, following the outbreak of the COVID-19 pandemic. Notices were issued to the Union of India(UOI, referred interchangeably as Central Government), the Governments of the States and Union Territories(Collectively referred as State Government), 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 Amid: 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 Courts 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 approach(Sandra Fredman, Adjudication as Accountability: A Deliberative Approach in Nicholas Bamforth and Peter Leyland (eds), Accountability in the Contemporary Constitution (Oxford University Press, 2013)) is exercised so that the UOI and States can justify the rationale behind their policy approach which must be bound by the human rights framework which presently implicates the right to life under Article 21 and right to equality under Article 14 of the Constitution. B. Outline of the Disaster Management Act 6. The Disaster Management Act, 2005(DMA) 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) 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 Authority( NDMA) 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 nota 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 India, 2020 SCC OnLine SC 652 had noted that there was no need to develop a fresh National Plan under Section 11 for COVID-19 since a National Plan was already in place, which was being supplemented by various orders and measures taken by competent authorities under DMA. Justice Ashok Bhushan, speaking for this Court, observed that: 40. The Disaster Management Act, 2005 contain ample powers and measures, which could be taken by the National Disaster Management Authority, National Executive Committee and Central Government to prepare further plans, guidelines and Standard Operating Procedure (SOPs), which in respect to COVID-19 had been done from time to time. Containment Plan for Novel Coronavirus, 2019 had been issued by Ministry of Health and Family Welfare, Government of India. There were no lack of guidelines, SOPs and Plan to contain COVID-19, by Nodal Ministry had been brought on record issued by Ministry of Health and Family Welfare, Government of India, i.e., Updated Containment Plan for Large Outbreaks Novel Coronavirus Disease, 2019 (COVID-19). 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 UOIs 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 Centers(CCC), Dedicated COVID Health Centers(DCHC) and Dedicated COVID Hospitals(DCH) 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 Welfare( MoHFW) 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.

Decision reasoning: 1[ds]A three Judge bench of this Court in its judgement in Centre for Public Interest Litigation vs. Union of India, 2020 SCC OnLine SC 652 had noted that there was no need to develop a fresh National Plan under Section 11 for COVID-19 since a National Plan was already in place, which was being supplemented by various orders and measures taken by competent authorities under DMA. Justice Ashok Bhushan, speaking for this Court, observed that:40. The Disaster Management Act, 2005 contain ample powers and measures, which could be taken by the National Disaster Management Authority, National Executive Committee and Central Government to prepare further plans, guidelines and Standard Operating Procedure (SOPs), which in respect to COVID-19 had been done from time to time. Containment Plan for Novel Coronavirus, 2019 had been issued by Ministry of Health and Family Welfare, Government of India. There were no lack of guidelines, SOPs and Plan to contain COVID-19, by Nodal Ministry had been brought on record issued by Ministry of Health and Family Welfare, Government of India, i.e., Updated Containment Plan for Large Outbreaks Novel Coronavirus Disease, 2019 (COVID-19).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-19.23. 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.We note the submission of the Solicitor General that the figures given in the power point presentation are revised on a daily basis and that the presentation is not to be treated as a submission made on oath by the Solicitor General, which may give rise to a cause of action for litigation in future either before this Court or the High Courts. Ms Sumita Dawra, Additional Secretary, Department of Promotion of Industry and Internal Trade, Ministry of Commerce and Industry, who is one of the senior administrative officers in charge of oxygen procurement and supply coordination, has given an overview of these issues and made a presentation before us. We would like to record our appreciation for the contribution made by Ms Dawra and her team, who despite being infected by the COVID-19 virus, has continued to work and manage the supply of medical oxygen that the country so desperately needs today. It is through the earnest contribution of officers such as Ms Dawra, who are working round the clock, that the country is able to deal with the storm created by one of the worst humanitarian crises we have seen.29. Having heard the submissions of both counsels on the issues pertaining to supply of oxygen to GNCTD, we note that the Central Government (on page 63) in its affidavit dated 23 April 2021 has admitted that the projected demand for GNCTD as of 20 April 2021 had increased by 133% from 300 MT/day to 700 MT/day. According to the figures of allocation given in the affidavit dated 23 April 2021 and the presentation given by Ms Dawra, the existing allocation of GNCTD remains at 490 MT/day. This situation must be remedied forthwith. The situation on the ground in Delhi is heart rending. Recriminations between the Central Government (which contends that GNCTD has not lifted its allocated quantity) and GNCTD (which contends that despite its projected demand the quantity allocated has not been enhanced) can furnish no solace to citizens whose lives depend on a thin thread of oxygen being available.30. With regard to the issue of the supply and availability of medical oxygen for the entire country, we have noted that efforts are being made to augment the availability of oxygen. While the Central and State Governments are in the process of managing the supply of oxygen, at the same time, it is critical that a buffer emergency stock of oxygen is created so that in the event that the supply chain is disrupted to any one or more hospitals in an area for any reason, the buffer or emergency stocks can be used to avoid loss of human lives. These emergency stocks must be so distributed so as to be easily accessible without delay in every local area. We have also seen the situation that has developed in the last 24 hours in Delhi where patients, including among them medical professionals, died because of the disruption of supplies and the time lag in the arrival of tankers. This deficit shall be rectified immediately by the Central Government by creating buffer stocks and collaborating with the States through the virtual control room on a 24 by 7 basis. In view of the deaths which are being caused daily by the disruption of supplies, this direction is more crucial than ever.32. The previous order of this Court dated 27 April 2021 directed the Central Government to clarify, inter alia: (i) the projected availability of vaccines and proposed steps to boost supply and distribution; and (ii) the vaccine pricing and distribution among states. Upon perusing the affidavits filed by the Central Government and after having the benefit of oral arguments of the Solicitor General, we have arrived at the following understanding on the two broad issues outlined above. We would once again re-iterate that we do not attempt to delve into the role of the executive in designing policy choices. We are merely seeking to enter into a dialogue with the relevant stakeholders in order to ensure probity and transparency of the measures underway. We are cognizant that it is ultimately up to the executive to frame and implement policies that it deems appropriate, with the topmost regard to public interest.33. The Central Government has apprised us of its constitution of a National Expert Group on Vaccine Administration for COVID-19(NEGVAC) on 7 August 2020 and operationalization of the immunization programme from December 2020. It was further stated that as of 26 April 2021, over 13.5 crore vaccine doses (approx. 9% of the Indian population) have been administered to Frontline Workers, Healthcare Workers and persons who are 45 years of age and higher in the 3 Phases of immunization. It was submitted that these vaccines have been centrally procured and administered free of cost to the abovementioned groups who were identified based on specific vulnerabilities and a higher mortality rate on account of the COVID-19 infection.36. During the course of the hearing, this Court has expressed its reservations prima facie on the validity of the revised policy under which the states and private hospitals are to procure 50% of the vaccines in order to immunize persons in the 18-44 years age group. For one thing, even this age group would consist of persons who suffer from vulnerabilities. Once the vaccination programme has been opened up for persons other than the 45 plus age group, it would not be logical to impose the obligation to source vaccinations for the 18-44 age group on the State Governments. This will, inter alia, leave each State Government to negotiate supply schedules, delivery points and other logistical arrangements with the manufacturers. At present, there are only two manufacturers for the authorized vaccines (with one other vaccine - Sputnik V, in the process of manufacture). The available stock of vaccines is not adequate to deal with the requirements of both the categories. The Central Government must take the responsibility of providing guidance to every State on the quantities to be supplied to each State, the vaccine(s) being allocated, the period of delivery, and the number of persons who can be covered for vaccination, among other details. Leaving the State Governments to negotiate directly with manufacturers will produce chaos and uncertainty. The object of vaccinating the 18-44 age group cannot be achieved in the absence of stocks being available.38. Since the advent of the revised rollout strategy with effect from 1 May 2021, only persons aged 45 years and above are guaranteed a free vaccine. The reason of higher efficiency and speed has been furnished as a justification for enabling State Governments and private hospitals to directly procure vaccines. We have come to understand that a few State Governments have committed to free immunization under the revised strategy.39. Prima facie, there are several aspects of the vaccine pricing policy adopted by the Central government which require that policy be revisited. All vaccines, whether in the quantity of 50% purchased by the Central Government or the remaining 50%, are to be used for vaccinating citizens. The end use is the same. The Central Government proposes to purchase half of the total quantity falling within its fifty per cent quota while for the rest, the manufacturers would declare in advance the price to be fixed, allowing the State Governments to negotiate their terms. As of date, the manufacturers have suggested two different prices, a lower price which is applicable to the Central Government and a higher price which is applicable to the quantities purchased by the State Governments. It is likely that compelling the State Governments to negotiate with manufacturers on the ground of promoting competition and making it attractive for new vaccine manufactures will result in a serious detriment to those in the age group of 18 to 44 years, who will be vaccinated by the State Governments. The social strata of this age group also comprises persons who are Bahujans or belong to other under privileged and marginalized groups, like many in the other population age groups. They may not have the ability to pay. Whether or not essential vaccines will be made available to them will depend upon the decision of each State Government, based on its own finances, on whether or not the vaccine should be made available free or should be subsidized and if so, to what extent. This will create disparity across the nation. The vaccinations being provided to citizens constitute a valuable public good. Discrimination cannot be made between different classes of citizens who are similarly circumstanced on the ground that while the Central government will carry the burden of providing free vaccines for the 45 years and above population, the State Governments will discharge the responsibility of the 18 to 44 age group on such commercial terms as they may negotiate. Prima facie, the rational method of proceeding in a manner consistent with the right to life (which includes the right to health) under Article 21 would be for the Central Government to procure all vaccines and to negotiate the price with vaccine manufacturers. Once quantities are allocated by it to each State Government, the latter would lift the allocated quantities and carry out the distribution. In other words, while procurement would be centralized, distribution of the vaccines across India within the States/UTs would be decentralized. While we are not passing a conclusive determination on the constitutionality of the current policy, the manner in which the current policy has been framed would prima facie result in a detriment to the right to public health which is an integral element of Article 21 of the Constitution. Therefore, we believe that the Central Government should consider revisiting its current vaccine policy to ensure that it withstands the scrutiny of Articles 14 and Article 21 of the Constitution.42. Several drugs that are at the core of the COVID treatment protocol are under patents in India including Remdesivir, Tociluzumab and Favipiravir. On 2 October 2020, a communication was issued by the UOI, along with South Africa, to the Council for Trade-Related Aspects of Intellectual Property which stated that there were several reports about intellectual property rights hindering timely provisioning of affordable medical products to patients(Council for Trade-Related Aspects of Intellectual Property Rights, Waiver From Certain Provisions Of The Trips Agreement For The Prevention, Containment And Treatment Of Covid-19, Communication From India And South Africa, IP/C/W/669, 2nd October, 2020, available at https://docs.wto.org/dol2fe/Pages/SS/directdoc.aspx?filename=q:/IP/C/W669.pdf&Open=True). The communication also reported that some members of the World Trade Organization had carried out urgent amendments to their national patent laws to expedite the process of issuing compulsory/government use licenses.43. In India, the patent regime is governed by the Patents Act, 1970(Patents Act), Section 92 of which envisages the grant of a compulsory license, inter alia, in circumstances of national emergency and extreme urgency. Once a declaration of national emergency is made, and the relevant patents notified, any person interested in manufacturing the drug can make an application to the Controller General of Patents who can then issue a compulsory license. The patentee would be paid a reasonable royalty as fixed by the Controller General of Patents. Further, under Section 100 of the Patents Act, the Central Government can authorize certain companies to use any patents for the purpose of the government. Indian companies can begin manufacturing the drugs while negotiating the royalties with the patentees. If the Central Government or its authorized company is not able to reach an agreement with the patentee, the High Court has to fix the reasonable royalty that is to be paid to the patentee. Another alternative is for the Central Government to acquire the patents under Section 102 from the patentees. If the Central Government and the patentee is not able to reach a consensus on the price of the patents, it is up to the High Court to fix the royalty. Additionally, under Section 66 of the Patents Act, the Central Government is also entitled to revoke a patent in the public interest.44. The utilization of these flexibilities has also been detailed in the Trade Related Aspects of Intellectual Property Rights Agreement( TRIPS). Even as TRIPS obliges countries to ensure a minimum level of patent protection, it creates a permissive regime for the carving out of exceptions and limitations that further public health objectives(Report of the United Nations Secretary-Generals High-Level Panel on Access to Medicines Promoting Innovation and Access to Health Technologies, (United Nations Secretary-General, 2016), p. 16.). This is evident from a conjoint reading of Articles 7, 8, 30 and 31 of TRIPS. Article 7 outlines the objectives of the TRIPS as being to ensure the effective enforcement of intellectual property in a way that, inter alia, is conducive to social and economic welfare. Article 8 gives member countries the freedom to take measures that protect public health and nutrition. Article 8(2) allows for the taking of TRIPS-compatible measures aimed at preventing the abuse of intellectual property rights. Articles 30 and 31 deal with exceptions to the rights of patent owners, by allowing grant of compulsory licenses. It leaves countries with significant breathing space to determine how the compulsory licensing or government-use levers can be triggered. While such determinations must be made on the individual merits of each case(TRIPS Agreement, Article 31 (a).), the aforesaid caveat does not apply when the compulsory license grant is for national emergency, extreme urgency or public non-commercial use(TRIPS Agreement, Article 31 (b).).45. According to the 2001 Doha Declaration, TRIPS should be interpreted in a manner supportive of the right of members to protect public health and to promote access to medicines(World Trade Organization, Ministerial Declaration of 14 November 2001 (November 2001) WT/MIN(01)/DEC/1, 41 ILM 746, para 4.) It recognizes the right of WTO members to use the full extent of the TRIPS flexibilities to secure this objective. Para 5(b) of the Doha Declaration provides the freedom to each member to grant compulsory licenses and to determine the grounds on which the licenses are granted. Para 5(c) leaves it up to each nation to determine what constitutes a national emergency or extreme urgency. In the context of the COVID-19 pandemic, we note that several countries such as Canada and Germany have relaxed the legal regimes governing the grant of compulsory licenses(COVID-19 IP Policy Tracker (WIPO, 16 July 2020), available at https://www.wipo.int/covid19-policy-tracker/#/covid19-policy-tracker/access.).46. Whether and if so, the extent to which these provisions should be utilized is a policy decision for the Central Government. We have flagged the issue for its consideration. We have only outlined the legal framework within which the Central Government can possibly consider compulsory licensing and government acquisition of patents. The Central Government is free to choose any other course of action that it deems fit to tackle the issue of vaccine requirements in an equitable and expedient manner, which may involve negotiations with domestic and foreign producers of vaccines. We clarify that it is up to the Central Government to choose the best possible measures it can undertake during the current crisis keeping in mind that public interest is of paramount importance.50. In respect of the essential drugs, this Court has been informed that the Central Government is taking steps to augment the production of Remdesivir. It has been brought to our notice that seven Indian companies are manufacturing this drug under a licensing agreement with a US based company, M/s Gilead. The current production capacity as on 23 April 2021 is noted to be at 1.03 crores vials per month. The Central Government should provide us with the details of the actual rate of production and a breakup of demand for the drug from different States. Further, while it has been submitted on behalf of the Central Government that it is allocating the stocks based on a rational criterion of equitable distribution keeping in mind the existing constraints on the availability of the drug, this Court should be provided with details of the methodology used for such allocation.51. We have been informed by the Central Government in its affidavit that NPPA has revised the maximum retail price of Remdesivir to Rs 3500. However, it has come to our notice that several other drugs which are being prescribed by doctors for treating COVID-19 patients like Favipiravir, Tociluzumab, Enoxaparin, Ivermectin, Methylprednisolone, Paracetamol and Hydroxy-chloroquine are being priced at exorbitant rates creating issues of access and affordability. While this is not a direction of this Court, the Central Government can consider invoking its statutory powers under paragraphs 19 and 20 of the Drugs Price Control Order, 2013. Under paragraph 19 of the Drugs Price Control Order, 2013 the Government in extraordinary circumstances, if it considers necessary in public interest, can fix a ceiling price or retail price of the drug for a certain period. COVID-19 is a crisis of an unprecedented nature and qualifies as an extraordinary circumstance. It will be in public interest to ensure that the price of essential drugs is fixed in such a manner that it is available even to the most marginalized sections of the society. The Government can even monitor the prices of the drugs under paragraph 20 of the Drugs Price Control Order, 2013 and ensure that no manufacturer increases the prices of the drugs by more than 10% of the maximum retail price during the preceding 12 months and where the increase is beyond 10% of the maximum retail price, it can oblige the manufacturer to reduce it to the level of 10% for the next 12 months.52. The Central Government has submitted that it plans to import Remdesivir. It can also consider importing other essential drugs to meet the immediate demand of the drug while the production is ramped up. We hasten to clarify that this does not constitute a direction of this Court and ultimately this decision falls under the domain of the executive.53. We note that there are certain medicines which are being prescribed by doctors which are not mentioned in the National Clinical Management Protocol for COVID-19 like Favipiravir. However, since these medicines are being prescribed by doctors, people are facing significant inconvenience in obtaining them due to their shortage in certain parts of the country. The Central Government should consider whether the production of such medicines should be augmented to meet the demand or instructions should be given to the doctors to not recommend such medicines unless they have been included in the national protocol.The supply of Remdesivir and Tociluzumab is already under the consideration of the Central Government. A meeting was also held on 25 April 2021 by DoP, NPPA and DGCI with the manufacturers to review stock position, availability and production plans. The Central Government should provide details of estimated demand of essential drugs mentioned above, production capacity, existing stocks, details of allocation and supply of such drugs.55. As discussed in Section F, the Central Government can also consider using its powers under Sections 92, 100 or 102 of the Patents Act to increase production of essential drugs to ensure that it is commensurate to the demand. The Central Governments affidavit testifies to existence of capacity of public sector organizations and institutes, which can assist in augmenting production of various drugs and formulations. The utilization of these capabilities to augment production, once licensing is resorted to, will be in the interests of the general public. This Court is further of the opinion that prima facie the present circumstance warrant the governments examination of its the extraordinary powers, meant to be used in extreme situations, such as the current pandemic, for fixing drug prices, be it vaccines, or patented formulations, having regard to the provisions of the Drugs and Cosmetics Act, 1940 and other provisions(Paragraph 3 and 19 of the Drugs Price Control Order, 2013). We are cognizant that invocation of the above provisions, if any, is ultimately a policy decision of the Central Government and may encompass negotiations with the concerned stakeholders. We hope that the Central Government will adopt a route that best serves the public interest.56. This Court would like to take judicial notice of the fact that several critical drugs, used to treat COVID-19, such as Remdesivir and Tocilizumab, are being sold at significantly inflated prices or in fake form. This is a condemnable attempt to exploit peoples misery and profit from their helplessness.57. In order to clamp down on this practice, the Central Government can consider constituting a special team to identify and prosecute those who: (a) sell medical grade oxygen/COVID-19 medicines at exorbitant prices; and (b) sell fake substances and recover the concerned substances. A protocol for ambulances must also be evolved to avoid citizens being exploited by extracting unconscionable charges. The Central Government can consider creating a platform for easy reporting and redressal of such cases.58. It is common knowledge that a large number of medical, nursing and pharmacy students, who graduated in 2020 and would be in the process of graduating in 2021, would be available to augment the workforce in the health sector. The Central Government should, we feel, look into this aspect, and ensure the optimal manner of utilization of their services, regard being had, of course, to their safety and well-being.59. The Central Government should also consider using health care workforce available with the armed forces and para military forces for the purpose of vaccination.60. The World Health Organisation(WHO), while discussing the rapid spread of COVID-19 has not only labelled it an epidemic but also an infodemic, due to the overabundance of information on the internet, which was riddled with misinformation and disinformation. This highlights the key role internet and technology currently has in all our lives, as the COVID-19 pandemic rages on. Indeed, the WHO recently also conducted a study to understand how individuals between the ages of 18-40 years dealt with the ongoing pandemic using social media.61. It is only appropriate then that when many cities in India are suffering through the second wave of the COVID-19 pandemic, many have turned to the internet, using applications/websites to find critical support. On these platforms, online communities led by members of the civil society and other individuals, have assisted the needy in multiple ways - often by helping them procure oxygen, essential drugs or find a hospital bed through their own networks or by amplifying original requests, and even by offering moral and emotional support. However, it is with deep distress that we note that individuals seeking help on such platforms have been targeted, by alleging that the information posted by them is false and has only been posted in social media to create panic, defame the administration or damage the national image. We do not hesitate in saying that such targeting shall not be condoned, and the Central Government and State Governments should ensure that they immediately cease any direct or indirect threats of prosecution and arrest to citizens who air grievances or those that are attempting to help fellow citizens receive medical aid. If this does keep happening even after the current order, this Court shall be constrained to use the powers available to it under it contempt jurisdiction. We also direct that all Directors General of Police shall ensure compliance down the ranks of the police forces within their jurisdictions.62. In these trying times, those desperately seeking help for their loved ones on these platforms should not have their misery compounded through the actions of the State and its instrumentalities. Further, there are two more crucial reasons why such a clampdown on information sharing must be absolutely stopped immediately.63. The first reason is because sharing information widely is in itself an important tool in combating public tragedies, like the current COVID-19 pandemic. In K.S. Puttaswamy (Privacy-9J.) vs. Union of India, (2017) 10 SCC 1 one of us (DY Chandrachud, J) speaking for four Judges of a nine-Judge bench of this Court noted academic literature documenting the widespread availability of information and the resultant acknowledgement of the problem is what prevented the drought in Maharashtra in 1973 from becoming as bad as the Bengal Famine of 1943, where the British tried to deny the problem even existed. It was noted thus:267. Civil and political rights and socio-economic rights do not exist in a state of antagonism. The conditions necessary for realising or fulfilling socio-economic rights do not postulate the subversion of political freedom. The reason for this is simple. Socio-economic entitlements must yield true benefits to those for whom they are intended. This can be achieved by eliminating rent-seeking behaviour and by preventing the capture of social welfare benefits by persons who are not entitled to them. Capture of social welfare benefits can be obviated only when political systems are transparent and when there is a free flow of information. Opacity enures to the benefit of those who monopolise scarce economic resources. On the other hand, conditions where civil and political freedoms flourish ensure that governmental policies are subjected to critique and assessment. It is this scrutiny which subserves the purpose of ensuring that socio-economic benefits actually permeate to the underprivileged for whom they are meant. Conditions of freedom and a vibrant assertion of civil and political rights promote a constant review of the justness of socio-economic programmes and of their effectiveness in addressing deprivation and want. Scrutiny of public affairs is founded upon the existence of freedom. Hence civil and political rights and socio-economic rights are complementary and not mutually exclusive.268. Some of these themes have been addressed in the writings of the Nobel laureate, Amartya Sen. Sen compares the response of many non-democratic regimes in critical situations such as famine with the responses of democratic societies in similar situations. [Amartya Sen, Development as Freedom (Oxford University Press, 2000) at pp. 178-79.]...269. In the Indian context, Sen points out that the Bengal famine of 1943 was made viable not only by the lack of democracy in colonial India but also by severe restrictions on reporting and criticism imposed on the Indian press, and the voluntary practice of silence on the famine that the British-owned media chose to follow [Amartya Sen, The Idea of Justice (Penguin Books, 2009) at p. 339.] . Political liberties and democratic rights are hence regarded as constituent components of development. [Id, at p. 347] In contrast during the drought which took place in Maharashtra in 1973, food production failed drastically and the per capita food output was half of that in sub-Saharan Africa. Yet there was no famine in Maharashtra where five million people were employed in rapidly organised public projects while there were substantial famines in sub-Saharan Africa. This establishes what he terms as the protective role of democracy. Sen has analysed the issue succinctly:The causal connection between democracy and the non-occurrence of famines is not hard to seek. Famines kill millions of people in different countries in the world, but theydont kill the rulers. The kings and the presidents, the bureaucrats and the bosses, the military leaders and the commanders never are famine victims. And if there are no elections, no opposition parties, no scope for uncensored public criticism, then those in authority dont have to suffer the political consequences of their failure to prevent famines. Democracy, on the other hand, would spread the penalty of famines to the ruling groups and political leaders as well. This gives them the political incentive to try to prevent any threatening famine, and since famines are in fact easy to prevent (the economic argument clicks into the political one at this stage), the approaching famines are firmly prevented. [Amartya Sen, Development as Freedom (Oxford University Press, 2000) at p. 180.]...As such, preventing clampdowns on sharing of information on online platforms is not just in the interest of individuals sharing the information, but the larger democratic structures of our nation. Without the ready availability of such information, it is entirely possible that the COVID-19 pandemic may turn into a tragedy worse than what it already is.64. The second reason is because sharing information widely will help in the creation of a collective public memory of this pandemic. The presence of collective public memory, which refers to an extant and taken-for-granted group memory(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 museums atom bomb exhibit, (1998) 62 Western Journal of Communication 3:316-347, pg 318), is important for the creation of knowledge of the problems plaguing us today, so they may be passed on across time(Bryan Hubbard and Marouf A. Hasian, Atomic Memories of the Enola Gay: Strategies of Remembrance at the National Air and Space Museum (1998) 1 Rhetoric and Public Affairs 3:363-385, pg 364). This is important since we do not have to travel back too much in our past to realise that the pandemic caused by the Spanish flu of 1918, which is said to have infected every third person in the world and killed between 50-100 million individuals (compared to the 17 million who died in World War I), has been almost entirely erased from our collective public memory(Jonathan Freedland, History suggests we may forget the pandemic sooner than we think (The Guardian, 29 January 2021) available at <https://www.theguardian.com/commentisfree/2021/jan/29/history-forget-pandemicspanish-flu-covid>). Therefore, the widespread sharing of information by individuals living through the COVID-19 pandemic becomes crucial. Furthermore, the role of Courts in creating and preserving this collective public memory cannot be understated. Professors Austin Sarat and Thomas R. Kearns, in their book History, Memory, and the Law, describe the function that is played by Courts in the following terms(Austin Sarat and Thomas R. Kearns, History, Memory, and the Law (University of Michigan Press, 2009) pgs 12-13):Law in the modern era is, we believe, one of the most important of our societys technologies for preserving memory. Just as the use of precedent to legitimate legal decisions fixes law in a particular relation to the past, memory may be attached, or attach itself, to law and be preserved in and through law. Where this is the case, it serves as one way of orienting ourselves to the future. As Drucilla Cornell puts it: Legal interpretation demands that we remember the future. In that phrase, Cornell reminds us that there are, in fact, two audiences for every legal act, the audience of the present and the audience of the future. Law materializes memory in documents, transcripts, written opinions; it re-enacts the past, both intentionally and unconsciously, and it is one place where the present speaks to the future through acts of commemoration.Because the litigated case creates a record, courts can become archives in which that record serves as the materialization of memory. Due process guarantees an opportunity to be heard by, and an opportunity to speak to, the future. It is the guarantee that legal institutions can be turned into museums of unnecessary, unjust, undeserved pain and death. The legal hearing provides lawyers and litigants an opportunity to write and record history by creating narratives of present injustices, and to insist on memory in the face of denial. By recording such history and constructing such narratives lawyers and litigants call on an imagined future to choose Justice over the jurispathic tendencies of the moment.Hence, in the present proceedings, we hope to not only initiate a dialogue so as to better tackle the current COVID-19 pandemic but also to preserve its memory in our public records, so that future generations may evaluate our efforts and learn from them.65. We speak not only as members of this Court, but also as grateful citizens of the country, and commend the outstanding work of our all healthcare professionals (doctors, nurses, healthcare workers, laboratory technicians, ward staff, ambulance drivers, crematorium workers etc.) during this crisis. They have truly gone beyond their call of duty and toiled day in and day out, relentlessly without rest amidst great challenges. It is absolutely necessary to take urgent steps for their well-being to ensure that our appreciation for their tremendous efforts is not reduced to rhetoric. This is especially important since another factor which affects how collective public memory of any event is created is by the rhetoric surrounding it(Nicole Maurantonio, The Politics of Memory in Kate Kenski and Kathleen Hall Jamieson (eds), The Oxford Handbook of Political Communication (Oxford University Press, 2014)). As such, our public memory of this public event has to transcend its conception as a war against the virus of COVID-19 itself, but rather to remember that it is the complex epidemiological circumstances that promote these outbreaks and the under-resourced health systems that are tasked with disease containment(Luke Shors, Waging Another Public Health War? (Think Global Health, 26 February 2020) available at <https://www.thinkglobalhealth.org/article/waging-another-public-health-war>). While the healthcare professionals have been at the forefront of tackling this crisis, we have to recognize their contribution as medical healthcare professionals who have undertaken to protect public health using proven scientific evidence and best practices and to serve to community at large(Elena N. Naumova, The traps of calling the public health response to COVID-19 an unexpected war against an invisible enemy (2020) Journal of Public Health Policy (2020) 41:233-237, pg 233), and not just as CORONA WARRIORS.