IN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES AND SERVICES DURING PANDEMIC versus . on 31 May 2021

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SUPREME COURT REPORTS

[2021] 5 S.C.R.

AIN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES ANDSERVICES DURING PANDEMIC

(Suo Motu Writ Petition (Civil) No. 3 of 2021)

MAY 31, 2021

[DR. DHANANJAYA Y CHANDRACHUD,BL NAGESWARA RAO AND S RAVINDRA BHAT, JJ.]

COVID-19 pandemic:

Suo Motu writ petition – Cognizance of the Management ofthe Covid -19 pandemic during the second wave –Gradual recessionof the second wave – In view thereof, issues as regards CentralCGovernment’s Liberalised Vaccination Policy, vaccine distribution,vaccine procurement process, and the augmentation of vaccineavailability, taken up – With respect to the vaccine distributionbetween different age-groups, the policy of the Central Governmentconducting free vaccinations for persons above age of 45 yearsDand frontline/healthcare workers, and paid vaccinations by the State/UT Governments and private hospitals for persons between 18-44years, prima facie arbitrary and irrational – With regard toprocurement process, the Liberalised Vaccination Policy, may notbe able to yield the desired results, and the basis of pro rata allocationto State Governments also not clear, thus, Central Government toEspecify as to how they would deal with the concern – As regardsaugmentation of vaccine production/availability, Union of India toundertake a fresh review of its vaccination policy – In view thereof,issuance of direction to Union of India to file affidavit addressingthe issues with regard to the vaccination policy: vaccine procurementFand distribution among different categories of the population, effectsof vaccination by private hospitals under the liberalized vaccinationpolicy, basis and impact of differential pricing, vaccine logistics,digital divide – Affidavit to provide information on the percentageof population that has been vaccinated with one dose and bothdoses; complete data on purchase of COVID-19 vaccines till dateG(Covaxin, Covishield and Sputnik V), and an outline for vaccinatingthe remaining population in phases 1, 2 and 3; and the steps takenby the Central Government to ensure availability of drug formucormycosis – Further, direction to Union of India to attach copiesof relevant papers and file notations perused while preparingH

vaccination policy – Also, the State/UT governments to clarify theirposition and policies as regards providing free vaccination to thepopulation within their territories.

Judicial review – Exercise of, over the management of theCOVID-19 pandemic – Held: Policy-making continues to be in thesole domain of the executive – However, separation of powers doesnot result in courts lacking jurisdiction in conducting a judicialreview of these policies – Constitution does not envisage courts tobe silent spectators when constitutional rights of citizens areinfringed by executive policies – Judicial review and solicitingconstitutional justification for policies formulated by the executiveis an essential function, which the courts are entrusted to perform –Judiciary has also recognized that constitutional scrutiny istransformed during such public health emergencies – In grapplingwith the second wave of the pandemic, this Court does not intend tosecond-guess the wisdom of the executive – However, it continuesto exercise jurisdiction to determine if the chosen policy measureconforms to the standards of reasonableness, militates againstmanifest arbitrariness and protects the right to life of all persons –Court is presently assuming a dialogic jurisdiction – Hence, theCourt would, under the auspices of an open court judicial process,conduct deliberations with the executive where justifications forexisting policies would be elicited and evaluated to assess whetherthey survive constitutional scrutiny.

Union of India vs Rakesh Malhotra and another SLP (Civil)(Diary) No 11622 of 2021; DDA v. Joint Action Committee(2008) 2 SCC 672 : [2007] 13 SCR 811; Gujarat MazdoorSabha v. State of Gujarat AIR 2020 SC 4601 – referredto.

Jacobson v. Massachusetts 197 U.S. 11 (1905); RomanCatholic Diocese of Brooklyn, New York v. Cuomo, 592U.S., 141 S. Ct. 63; Calvary Chapel Dayton Valley v.Steve Sisolak, Governor of Nevada, et al, 140 S.Ct.2603 – referred to.

Sandra Fredman, “Adjudication as Accountability: ADeliberative Approach” in Nicholas Bamforth and PeterLeyland (eds), Accountability in the Contemporary AB

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AConstitution (Oxford University Press, 2013) – referredto.

< h t t p s : / / w w w . m o h f w . g o v . i n / p d f /GuidancedocCOWIN2.pdf>; <https://pib.gov.in/PressReleseDetail.aspx?PRID=1701549>; <https://Bpib.gov.in/PressReleseDetail.aspx?PRID=1712710>;< h t t p s : / / w w w . m o h f w . g o v . i n / p d f /LiberalisedPricingandAcceleratedNationalCovid19VaccinationStrategy2042021.pdf.; <https://www.pib.gov.in/PressReleasePage.aspx?PRID=1721225\;<https://www.indiabudget.gov.in/doc/Budget_Speech.pdf>; <http:/C/mospi.nic.in/sites/default/files/publication_reports/Report_585_75th_round_Education_final_1507_0.pdf; <https://www.trai.gov.in/sites/default/files/Wireless_Data_Service_Report_21082019_0.pdf>;<https://csc.gov.in/assets/events-report/Annual-Report-D2019-20.pdf> - referred to.

Case Law Reference

[2007] 13 SCR 811Referred toPara 14AIR 2020 SC 4601Referred toPara 16

Referred toPara 16

ECIVIL ORIGINAL JURISDICTION : Suo Motu Writ Petition(Civil) No. 3 of 2021.

(Under Article 32 of The Constitution of India)

Tushar Mehta, SG., Ms. Aishwarya Bhati, K. M. Natraj, ManinderSingh, ASGs., Anil Grover, Sr. AAG., Ms. Prachi Mishra, ArunabhFChowdhury, Krishnaraj Thaker,, Ms. Bansuri Swaraj, Ajay Bansal,AAGs., Amit Kumar Adv. Gen. (Meghalaya), Ashok Parija(Odisha),Vivek Kohli, Advs. Gen.(Sikkim), Rajiv Rangan, Mahendra Singh Singhvi,Ashok Sharma, Atul Nanda, Purushendra Kaurav, Advs. Gen., SanatKumar, Dy. Adv. Gen., Jaideep Gupta, Ms. Meenakshi Arora, Ms. ManishGLavkumar, Anand Grover, Ms. Indira Jaising, Sidharth Luthra, S.K.Rungta, Dr. Maneka Guruswamy, Yatin Oza, Dr. Abhishek Manu Singhvi,Bikash Ranjan Bhattacharya, P.S. Patwalia, Manish Tewari, ManinderSingh, C.S. Vaidyanathan, Rahul Mehra, Salman Khurshid, Tarun Gulati,Vikas Singh, Pradeep Kumar Rai, Ms. Mahalakshmi Pavani, ArijitPrasad, Brijender Chahar, Ms. Sonia Mathur, Vikas Pahwa, Dr. AshwaniHKumar, Sr. Advs., Kunal Chatterjee, Mohit D. Ram, Rajat Nair, Kanu

Agrawal, Digvijay Dam, Amit Sharma, B.V. Balaram Das, GurmeetSingh Makker, Amit Mahajan, Prashant Singh, Raj Bahadur Yadav, A.P.Mayee, Ms. Rajeshwari Hariharan, R. Sathyanarayanan, Ms. NupurKumar, Ms. Mantika Haryani, Ms. Astha Sharma, Nipun Saxena, ParasNath Singh, Umang Tyagi, Ms. Serena Sharma, Adit S. Pujari, Ms. KajalDalal, Simranjeet Singh Rekhi, Sridhar Potaraju, Ms. Petal Chandhok,Gaichangpou Gangmei, M/S. Trust Legal, Avijit Mani Tripathi, ShauryaSahay, Ms. Rekha Bakshi, Prashant Bhushan, Ms. Cheryl D’souza,Deepak Masih, Ms. Manreet Kaur, R.N. Keswani, Mrs. KetakiGoswami, Nitin Saluja, Ayush Kaushik, Anjag Gautam, Mahfooz AhsanNazki, Polanki Gowtham, Shaik Mohamad Haneef, T. Vijaya BhaskarReddy, Amitabh Sinha, K.V. Girish Chowdary, Shrey Sharma, SumitPragal, Ms. Amita Singh Kalkal, Vishnu Shankar Jain, Ms. Manju Jetley,Ms. Shobha Gupta, Ms. Medha Garg, Summer Sodhi, Ms. SimranAgarwal, Chaitanya, Anilendra Pandey, Ms. Suchita Dixit, Sandeep,Manish Kumar, Ms. Pragya Baghel, Kumar Anurag Singh, Ms. PallaviLangar, Govind Manoharan, Ibad Mushtaq, Ms. Aishwarya Murali, VictorDas, Ms. Ambika Mathur, Mrs. Shally Bhasin, Ms. Charu Ambwani,Purvish Jitendra Malkan, Rasesh Parikh, Masoom Shah, Ms. DharitaPurvish Malkan, Ms. Deepa Gorasia, Alok Kumar, Ms. Neha Ambashtha,Ms. Nandini Chhabra, Ms. Bhavna Sarkar, J. Sai Deepak, GuruswamyNataraj, Ms. Pooja Dhar, V. Shyamohan, Surya Prakash, M/s. KmnpLaw, Amarjit Singh Bedi, Raj Bahadur Yadav, Amit Bhandari, SandeepKumar Jha, Abhay Nevagi, Amit Singh, Dhiraj Abraham Philip,Pukhrambam Ramesh Kumar, Ms. Anupama Ngangom, Karun Sharma,Ms. Anindita Mitra, Samim Ahammed, Ms. Supratik Sarkar, Arnab Sinha,Ms. Sayanti Sengupta, Jamir Khan, S.P.M. Tripathi, Ms. Swagoti Batchas,Satish Kumar, Karan Bharihoke, Ms. Neha Sahai Bharihoke, Yajur Bhalla,Deepak Samota, Rohit Kumar Pihal, Ashish Vajpayee, SiddharthSrivastava, Shubham Bhalla, Pashupathi Nath Razdan, Palav Agarwal,Sudhanshu Kaushesh, K.P. Jayaram, Astik Gupta, Ms. Maitrayee JagatJoshi, Arjun Garg, Aakash Nandolia, Ms. Shrutika Garg, Sunny Choudhary,Pradeep Kumar Yadav, Abhay Singh, Ms. Shikha Yadav, ShreekantVerma, Virender Kumar Mumwalia, Sanjeev Malhotra, Ramesh BabuM. R., Abhay Panday, Ms. Manisha Singh, Varun Singh, K. V.Jagdishvaran, Ms. G. Indira, Saurabh Kansal, Vikas Jain, Aviral Saxena,Ashu Choudhary, Shantanu Kumar, Mohd. Azhar, Manjeet Rathor, Ms.Ruchira Gupta, Shishir Deshpande, Anurag Sharma, Himanshu Chaubey,Shuvodeep Roy, Ms. Diksha Rai, Ms. Ninmisha Menon, Gautam Narayan, AB

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ASatyakam, Ms. Asmita Singh, Adithya Nair, Avinash B. Amarnath, G.M. Kawoosa, Ms. Taruna Ardhendumauli Prasad, Parth Awasthi, Ms.Lubna Naaz, Ms. Kunika, Zafar Khurshid, Akhand Pratap Singh Chauhan,Tungesh, Ms. Nupur Kumar, Chirag M. Shroff, Ms. Disha Jham, Ms. B.Vijayalakshmi Menon, Devashish Bharukha, Rajiv Shankar Dvivedi, NirajKumar, Mrs. Jaya Bharukha, Ravi Bharuka, Ms. Sarvshree, JustineBGeorge, Ms. Shrishti Agarwal, Ankit Agarwal, Ms. Taniya Bansal, RohitAnil Rathi, Balaji Srinivasan, Ms. Garima Jain, Ms. Pallavi Sengupta,Ms. Lakshmi Rao, Ms. Aishwarya Choudhary, Ms. Aakriti Priya,Mohammed Sharukh, Prateek Yadav, Ankit Goel, Shibashish Misra,Deepak Prakash, Manoj V. George, Ms. Shilpa Liza George, Panmei,CAmit Kumar, Sriram P., Ms. Pallavi Pratap, Dr. Monika Gusain, SuhaanMukerji, Vishal Prasad, Ms. Deepeika Kalia, Nikhil Parikshith, AbhishekManchanda, Kapish Seth, Mrityanjai Singh, Savandeep Pahari, M/s. PLRChambers & Co., Annam D. N. Rao, Dr. A. P. Singh, Sadashiv, V. P.Singh, Ms. Geeta Chauhan, Ms. Richa Singh, Sharwan Kumar Goyal,Jai Gopal Saboo, Jaswant Singh Rawat, Meenesh Dubey, Ms. RituDBhardwaj, Anupam Mishra, Ms. Nina Gupta, Ms. K.V. BharathiUpadhyaya, Mukesh Kumar Singh, Ms. Sasmita Tripathy, Prashant Singh,Ms. Prerna Kumari, Ms. Seema Patnaha, Ms. Nandini Gupta, RahulKaushik, Sameer Abhyankar, S. Udaya Kumar Sagar, Ms. Sweena Nair,Abhimanyu Tewari, Ms. Eliza Bar, V. N. Raghupathy, Sharath Nambiar,EP. Venkat Reddy, Prashant Tyagi, P. Srinivas Reddy, M/S. Venkat PalwaiLaw Associates, Mrs. K. Enatoli Sema, Amit Kumar Singh, ApratimAnimesh Thakur, Ms. Prachi Hasija, Siddhesh Kotwal, Ms. Manya Hasija,Ms. Ana Upadhyay, Nirnimesh Dubey, Gaurav Yadava, Ms. VeenaBansal, Sushil Kumar Anand, Sanjay Kumar Visen, Ms. Raushan TaraJaswal. Advs. for Appearing Parties.FSachit Jolly, In-person, Devasish Garg, Parvesh Sahib Singh Verma-Applicants-in-Person.

The following Order of the Court was passed:

ORDERG

This order has been divided into the following sections to facilitateanalysis:

AIntroduction

BSubmission by CounselH

CNational Vaccination Policy

DSeparation of Powers

EIssues with the Liberalized Vaccination Policy E.1 Vaccine Procurement and Distribution amongDifferent Categories of the Population E.2 Effects of Vaccination by Private Hospitalsunder the Liberalized Vaccination Policy E 3 Basis and Impact of Differential Pricing E.4 Vaccine Logistics E.5 Digital Divide FConclusion

A. Introduction

1. Proceedings in the present suo motu writ petition were initiatedon 22 April 2021, when this Court took cognizance of the managementof the COVID-19 pandemic during the second wave. Subsequently,hearings were conducted on 23 April 2021, 27 April 2021 and 30 April2021 when submissions were heard on behalf of the Union of India[1],States/Union Territories[2], learned Amici appointed by this Court and someof the intervenors.

2. On 30 April 2021, this Court passed a detailed order in relation,inter alia, to the following issues: vaccination policy, supply of essentialdrugs, supply of medical oxygen, medical infrastructure, augmentationof healthcare workforce and the issues faced by them, and issues offreedom of speech and expression during the COVID- 19 pandemic. Inits order, this Court had noted that its observations and directions werein consonance with a bounded-deliberative approach[3] and hence, theUoI was directed to re-consider its policies on the above issues, takinginto account this Court s observations.

1 “UoI”/interchangeably referred to as the “Central Government”

2 “UTs”

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

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A3. Following the order dated 30 April 2021, another two judgeBench of this Court heard a Special Leave Petition[4] against an order ofthe High Court of Delhi in relation to the supply of medical oxygen to theNational Capital Territory[5] of Delhi. During the course of the proceedingsin that matter, the Bench primarily issued directions in relation to thesupply of medical oxygen to the NCT of Delhi. However, through itsBorder dated 6 May 2021, it also constituted a National Task Force toprovide a public heath response to the COVID-19 pandemic on the basisof a scientific approach. The terms of reference of this National TaskForce included, inter alia, assessing and making recommendations forthe need, availability and distribution of medical oxygen; devising aCmethodology for allocation of medical oxygen and periodical review ofthe allocation based on the stage of the pandemic; providingrecommendations for augmenting the supplies of oxygen; facilitating auditsin each State/UT to determine whether oxygen supplies had reached itsdestination; efficacy, transparency and efficiency of the distributionnetworks within the State/UT; providing recommendations for ensuringDavailability of essential drugs, augmentation of medical and paramedicalstaff, management of the pandemic and treatment of cases.

4. During the course of the proceedings on 31 May 2021, we hadthe benefit of perusing the details provided in the affidavit filed by theUoI on 9 May 2021. The submissions contained in the affidavit wereEsupplemented and updated in the hearing by Mr Tushar Mehta, learnedSolicitor General of India, appearing on behalf of the CentralGovernment. We have further heard the learned Amici, Mr Jaideep Guptaand Ms Meenakshi Arora, learned Senior counsel.

5. Since the last hearing in this matter, the second wave of theFCOVID-19 pandemic has started receding across the nation and thesituation appears to have become more manageable. Hence, some ofthe issues discussed in the previous orders can await further deliberation.However, the issue of vaccination is absolutely crucial, since healthexperts globally agree that vaccination of the nation’s entire eligibleGpopulation is the singular most important task in effectively combatingthe COVID-19 pandemic in the long run. Hence, during the course ofthe proceedings on 31 May 2021, this Court has limited itself to hearingsubmissions on the UoI s vaccination policy and its roadmap for the 4 Union of India vs Rakesh Malhotra and another, SLP (Civil) (Diary) No 11622of 2021H5 “NCT”

future. By way of abundant clarification, we note that all of the issuescontained in this Court’s previous orders still retain their overallimportance, and this Court shall continue to monitor them alongside theNational Task Force and intervene whenever necessary.

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6. It is also important to note that numerous interlocutoryapplications and affidavits by individual State/UT Governments andmembers of civil society have been filed before us in this matter. Wehave perused them to understand the key issues being raised there, alongwith the helpful notes provided by the Amici.

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7. Mr Tushar Mehta, learned Solicitor General, relying on the UoIs affidavit dated 9 May 2021, has made the following submissions tosupplement it, in view of the recent updates:

(i) The vaccination drive will be complete by the end ofDecember 2021, and the Central Government is in activetalks with foreign vaccine manufacturers at the highestpolitical and diplomatic levels, to ensure the adequate supplyof vaccines; D

(ii) It would be incorrect to state that a consequence of theUoI s updated policy on vaccination of those in the 18-44age group is that there will be competition amongst theEStates/UTs; and

(iii) Everyone above the age of 45 years can continue to getvaccinated at a facility through on-site registration, withoutpreviously having to book an appointment through CoWIN.

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8. Mr Jaideep Gupta and Ms Meenakshi Arora, learned Seniorcounsel and Amici, have raised the following issues relating to vaccinationdistribution, augmentation of vaccine production and differential pricingof vaccines and the future preparedness for dealing with the COVID-19 pandemic:

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(i) With respect to the procurement of vaccines, reportssuggest that foreign vaccine manufacturers are generallynot receptive or open to a dialogue with State/UTGovernments on the basis that, as a matter of corporatepolicy, they only deal with federal governments of differentnations; H

A(ii)Since 1978 till 1 May 2021, the UoI has implemented theUniversal Immunization Programme[6] under which essentialvaccines were procured by the UoI and were distributed toStates/UTs free of cost for administering them to the endbeneficiary. The said policy has held the test of times. Evenduring the vaccination drive for COVID-19 in phases 1 andB2 for vaccination of healthcare workers[7], frontline workers[8]and persons above the age of 45 years, the UoI procuredall the vaccines and distributed them to State/UTGovernments for administration. The single procurementmodel has also been followed by other nations for ensuringCfast and effective administration of vaccines againstCOVID-19;

(iii) The UIP has been replaced by the Liberalized Pricing andAccelerated National COVID-19 Vaccination Strategy[9]from 1 May 2021 in phase 3 of the vaccination drive,Dwhereby State/UT Governments or private hospitals arerequired to procure vaccines for persons between the agegroup of 18-44 years from the private manufacturers onthe basis of a pro rata quota set by the UoI;

(iv) The Liberalized Vaccination Policy leaves the State/UTEGovernments to fend for themselves, rather than the CentralGovernment acting on behalf of the entire nation. As aconsequence, the vaccine manufacturers are free toimplement a differential procurement price for the UoI forvaccinating persons above 45 years of age, and for the State/UT Governments and private hospitals for vaccinating theFpersons between 18-44 years of age;

(v) While the Liberalized Vaccination Policy has been introducedto spur competitive prices, there are multiple States/UTscompeting to purchase a scarce commodity from a fewvaccine manufacturers. Consequently, the manufacturersGhave the advantage of creating a monopoly and selling it atany price that they desire to private healthcare institutions.

6 “UIP”7 “HCWs”8 “FLWs”H9 “Liberalized Vaccination Policy”

The State/UT Governments do not enjoy the unique positionof the UoI, which has the advantage of being a monopolisticbuyer and can negotiate an appropriate price for the vaccineson behalf of the entire population of India;

(vi) The Liberalized Vaccination Policy puts an undue burdenon persons between the age group of 18-44 years,specifically persons belonging to a poor socio- economicbackground, who have to purchase two doses of vaccineseither from the State/UT Governments or private hospitals;

(vii) In the alternative, the UoI has stated that all State/UTGovernments have agreed to vaccinate their population freeof cost and have undertaken to bear the burden of thevaccines which are available at a higher purchase pricethan the one available to the UoI. Thus, the end beneficiaryis not impacted by the differential pricing in the LiberalizedVaccination Policy. With regard to this submission, the Amicihave raised the following concerns:

(a) While some States/UTs have announced that theywill vaccinate their population for free, this policystatement must be confirmed by the State/UTGovernments on affidavit before this Court. TheLiberalized Vaccination Policy as it stands today, doesnot incorporate a condition whereby the cost ofvaccination is imposed on the State/UT Governments.Instead, the end beneficiary is liable to pay the cost.There is a necessity for the State/UT Governmentsto place their decisions on record and for it to be partof the formal policy, such that persons can enforcetheir right to free vaccination, including before thecourts; (b)Although the State/UT Governments may haveannounced free vaccination for their population, someof them are contesting the Liberalized VaccinationPolicy before this Court and have advancedsubmissions for universal vaccination by the CentralGovernment. Thus, it cannot conclusively be statedthat State/UT Governments have agreed to the policy A

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Adecision taken by the Central Government of deviatingfrom the single procurement model;

(c) The Liberalized Vaccination Policy, as a consequenceof its differential pricing, treats individuals livingacross India residing in different States/UTsunequally, as States/UTs that are financially distressedmay not be able to afford to purchase the vaccinesat the prices set by the vaccine manufacturers or tolift the quantity allocated to them; and B

(d) The end result of the Liberalized Vaccination Policyis that the UoI can purchase vaccines at Rs 150 perdose for Covishield and Covaxin, while the State/UTGovernments have to pay Rs 300 and Rs 400 perdose respectively. If the UoI were to be the singleprocurement agency for all vaccines at a fixed cost,then the cost of vaccination to the public exchequerwould be substantially lower. Thus, it is incorrect tosuggest that the end beneficiary, who contributes tothe public exchequer, will not be unduly impacted; C

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(viii) Although public health is a subject under Entry 6 of List II(State List) of the Seventh Schedule to the Constitution,EEntry 81 of List I (Union List) deals with inter-Statemigration and inter-State quarantine and Entry 29 of ListIII (Concurrent List) deals with prevention of extension fromone State to another of infectious or contagious diseases.Thus, the management of the pandemic, control of theFspread of COVID-19, vaccination policy and pricing, arethe responsibility of the Central Government, which mustwork in tandem with the State/UT Governments. TheLiberalized Vaccination Policy, by putting the burden ofvaccination of persons between 18-44 years of age on theState/UT Governments, conflicts with this constitutionalGbalance of responsibilities between the Centre and States/UTs;

(ix) With regard to the vaccine distribution, the LiberalizedVaccination Policy has created a quota of 50:25:25 for the18-44 age group. The quota of 25% that is available to State/

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UT Governments, which is equivalent to the privatehospitals, is extremely disproportionate and not in touch withsocietal realities, as a large number of persons may not beable to afford two doses of a vaccine from a privatehospital. Thus, if State/UT Governments are to bear theburden of vaccinating a majority of the persons in theirStates/UTs, the quota available to the private hospitals mustbe reduced;

(x) The Liberalized Vaccination Policy does not provide anyclarity on the basis of the pro rata allotment of the doses toeach State/UT (available for purchase by the State/UTGovernment and private hospitals). The Policy does notindicate whether such apportionment will be on the basis ofpopulation; state of the pandemic in each State/UT; or thenumber of persons with co- morbidities between 18-44 yearsof age, among others. Further, the Policy does not indicatewhether the pro rata allotment will be made by the UoI orthe private vaccine manufacturer;

(xi) It is reported that UoI on certain occasions has stated thatit will refrain from interfering in the issue of vaccinedistribution. Contrarily, UoI has also been stated that it maydecide to redistribute the vaccines procured by it amongState/UT Governments. The basis on which the re-distribution of vaccines will take place among States/UTshas not been provided in the policy document;

(xii) The Liberalized Vaccination Policy does not provide forprioritizing of persons with co-morbidities; persons withdisabilities or suffering from other illnesses; care-givers forthe elderly and sick; teachers and others in the age groupof 18-44 years. Further, the CoWIN application is not builtwith functions which prioritize a certain category of persons,as it only books appointments on a first-cum-first-servedbasis;

(xiii) News reports indicate that crematorium workers have eithernot been vaccinated, or are unaware that they are eligiblefor vaccination in phases 1 and 2; A

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A(xiv) With regard to preparedness, the UoI has claimed that itwill be able to vaccinate a substantial number of persons(around 100 crore persons requiring 200 crore doses) byDecember 2021. However, no projections have been sharedwith this Court regarding how this target would be achieved.Based on reports, it appears that the UoI has factored aBnumber of vaccines that are currently in their developmentstages to reach its projected number of 200 crore doses.This approach would be misguided as the success andefficacy of vaccines that are currently in the stage of clinicaltrials is uncertain and cannot be guaranteed;C(xv)There is material to suggest that the augmentation of vaccineproduction will be inadequate to vaccinate the populationbetween 18-44 years of age. The total population of thisage group is 59 crores, which would require around 122crore doses. Based on reports, the existing manufacturersD(Serum Institute of India[10] and Bharat Biotech IndiaLimited[11]) will be able to produce less than 10 crore dosesper month. Optimistically, around 15-20 crores doses ofSputnik V will be available per month. At this rate, it wouldtake around 12 months for the population in this age groupto be inoculated, by which time the virus may have mutated,Ecausing further waves of the pandemic;

(xvi) Meanwhile, there is a necessity to ensure that guidelinesregarding standardization of masks are formulated andpublicized. Thus, medical guidance is necessary to ensurethat masks of appropriate quality are produced andFdistributed free of cost to curb the spread of the infection;and

(xvii) It has been reported that due to dearth of electriccrematoria, persons who have succumbed to COVID-19are not dignified with a proper cremation and are crematedGwithout any rituals. The UoI and State/UT Governmentsmay consider forming appropriate guidelines which augmentthe creation of infrastructure for electric crematoria and a protocol for cremation of the dead.

C. National Vaccination Policy

9. Phase 1 of the National COVID-19 Vaccination Strategy waslaunched on 16 January 2021 and 1 February 2021 and was targetedtowards protecting HCWs and FLWs. Phase 2 was initiated on 1 March2021 and 1 April 2021, and was directed towards protecting the mostvulnerable population in the age group of persons above 45 years ofage. In phase 1 and 2, the UoI was procuring the vaccines and distributingthem to the States/UTs free of cost for disbursal through governmentand private COVID-19 vaccination centres. The private facilities werenot allowed to charge a sum above Rs 250 per person per dose (Rs 150for vaccines and Rs 100 as operational charges) from a beneficiary.

10. During phase 2, eligible beneficiaries could register and bookappointments for vaccination on the CoWIN 2.0 portal or other ITapplications such as Aarogya Setu. From 1 March 2021 onwards, thepopulation aged 60 years or which would attain the age of 60 years ormore as on 1 January 2022 was eligible to register on the CoWINplatform. Further, persons who were aged 45 years or would attain theage of 45 years to 59 years as on 1 January 2022 and had any of the 20specified co-morbidities were also eligible to register on the CoWINplatform. From 1 April 2021 onwards, all persons who were aged 45years or would attain the age of 45 years to 59 years as on 1 January2022 were eligible to register on the CoWIN platform. On-site registrationfacility was also made available at vaccination centres in this phase.

11. In phase 3, a Liberalized Vaccination Policy was introducedby the UoI, which came into effect on 1 May 2021. We have perusedthe documents available in the public domain (guidance note[12], pressreleases[13] and policy document[14]) issued by the Central Government tounderstand the written policy of the Central Government with regard tophase 3. Based on such documents, the main elements of the LiberalizedVaccination Policy can be identified as:

12 Guidance Note For COWIN 2.0 dated 28 February 2021, available at <https://www.mohfw.gov.in/pdf/GuidancedocCOWIN2.pdf>

13 Press releases dated 28 February 2021 and 19 April 2021, available at <https://pib.gov.in/PressReleseDetail.aspx?PRID=1701549>and <https://pib.gov.in/PressReleseDetail.aspx?PRID=1712710>

14 Liberalized Pricing and Accelerated National Covid-19 Vaccination Strategy dated24 April 2021, available at <https://www.mohfw.gov.in/pdfLiberalisedPricingandAcceleratedNationalCovid19VaccinationStrategy 2042021.pdf>

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A(i)Vaccine manufacturers are required to supply 50% of theirmonthly Central Drugs Laboratory[15] doses to the UoI andwould be free to supply the remaining 50% doses to State/UT Governments and in „other than Government of Indiachannel [16]; B(ii)Manufacturers were required to make a declaration of theprice of the 50% supply that would be available to State/UT Governments and in the „other than GoI channel before1 May 2021. Based on this price, States/UTs, privatehospitals and industrial establishments through their hospitalsmay procure vaccines from the manufacturers. PrivateChospitals would be able to procure their supplies only fromthe 50% supply earmarked for ‘other than GoI channel’ ;

(iii) The prices charged for vaccination by private hospitalswould be monitored. As a result, the earlier dispensationwhere private COVID-19 vaccination centres whichDreceived doses from the UoI could charge up to Rs 250 perdose ceased to exist;

(iv) The population which is now eligible to obtain vaccines atUoI s vaccination centres is limited to HCWs, FLWs andthose above 45 years of age. The population between 18-E44 years is eligible to obtain vaccines from ‘other than GoIchannel;’

(v) The vaccination would continue to be available for free foreligible population groups in those vaccination centres whichreceive their vaccine doses from UoI;F

(vi) The vaccination would continue to be a part of the NationalVaccination Programme and would follow all existingguidelines. The CoWIN platform would capture thevaccination, stocks and price per vaccination applicable inall vaccination centres. The vaccination drive would complyGwith ‘Adverse Event Following Immunization’ managementand reporting, digital vaccination certificate and all otherprescribed norms; 15 “CDL”H16 “other than GoI channel”

(vii) The division of 50% supply to UoI and 50% to ‘other thanGoI channel’ would be applicable uniformly across all thevaccine manufactures in the country;

(viii) The fully ready to use imported vaccines are allowed to beutilized entirely in the ‘other than GoI channel’ ; and

(ix) The UoI from its share will allocate vaccines to States/UTs based on criteria of performance (speed ofadministration, average consumption) and extent of infection(number of COVID-19 cases). Wastage of vaccines wouldalso be considered in the criteria and would affect theallocation negatively. Based on the above criteria, a State-wise quota would be decided and communicated to theStates/UTs in advance.

12. The facility of only online appointment on the CoWIN portalwas initially introduced for the entirety of the population between theages of 18-44 years. Later, on 24 May 2021[17], the UoI announced thaton-site registration will be made available for the 18-44 years age group.However, this is contingent on: (i) the State/UT Government enablingthis policy; and (ii) only in cases of wastage at a particular governmentCOVID-19 vaccination centre due to a no-show by an online appointee.Further, this facility has not been expanded to private COVID-19vaccination centres.

D. Separation of Powers

13. At the outset, we seek to clarify the nature of this Court sjurisdiction in the exercise of the power of judicial review over themanagement of the COVID-19 pandemic in India. In its affidavit dated9 May 2021, the UoI has highlighted a few concerns which are detailedbelow:

(i) The executive is battling an unprecedented crisis and thegovernment needs discretion to formulate policy in largerinterest and its wisdom should be trusted;

(ii) The current vaccine policy conforms to Articles 14 and 21of the Constitution, and requires no interference from thecourts as the executive has “room for free play in the joints”

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Awhile dealing with a pandemic of this magnitude;

(iii) The current steps are thoughtfully undertaken to tide overan imminent crisis, which may turn out to be imprudent inthe long run. However, they need to be appreciated from ashort-term and holistic perspective; B

(iv) Judicial review over executive policies is permissible onlyon account of manifest arbitrariness. No interference fromjudicial proceedings is called for when the executive isoperating on expert medical and scientific opinion to tacklea medical crisis; and C

(v) Any over-zealous judicial intervention, though well-meaning,in the absence of expert advice or administrative experiencemay lead to unintended circumstances where the executiveis left with little room to explore innovative solutions.

14. It is trite to state that separation of powers is a part of theDbasic structure of the Constitution. Policy-making continues to be in thesole domain of the executive. The judiciary does not possess the authorityor competence to assume the role of the executive, which isdemocratically accountable for its actions and has access to the resourceswhich are instrumental to policy formulation. However, this separationEof powers does not result in courts lacking jurisdiction in conducting ajudicial review of these policies[18]. Our Constitution does not envisagecourts to be silent spectators when constitutional rights of citizens areinfringed by executive policies. Judicial review and soliciting constitutionaljustification for policies formulated by the executive is an essentialfunction, which the courts are entrusted to perform.F

15. We had clarified in our order dated 30 April 2021, that in thecontext of the public health emergency with which the country is currentlygrappling, this Court appreciates the dynamic nature of the measures.Across the globe, the executive has been given a wider margin in enactingmeasures which ordinarily may have violated the liberty of individuals,Gbut are now incumbent to curb the pandemic. Historically, the judiciaryhas also recognized that constitutional scrutiny is transformed duringsuch public health emergencies, where the executive functions in rapidconsultation with scientists and other experts. In 1905, the Supreme Court 18 DDA vs Joint Action Committee, (2008) 2 SCC 672H

of the United States in Jacobson vs Massachusetts[19] considered aconstitutional liberty challenge to a compulsory vaccination law that wasenacted to combat the smallpox epidemic. Justice Harlan had noted thecomplex role of the government in battling public health emergencies inthe following terms:

“..the State may invest local bodies called into existence forpurposes of local administration with authority in some appropriateway to safeguard the public health and the public safety... Whilethis court should guard with firmness every right appertaining tolife, liberty or property as secured to the individual by the SupremeLaw of the Land, it is of the last importance that it should notinvade the domain of local authority except when it is plainlynecessary to do so in order to enforce that law. The safety andthe health of the people of Massachusetts are, in the first instance,for that Commonwealth to guard and protect……So far as theycan be reached by any government, they depend, primarily, uponsuch action as the State in its wisdom may take, and we do notperceive that this legislation has invaded any right secured by theFederal Constitution.”

The Supreme Court of United States, speaking in the wake of thepresent COVID-19 pandemic in various instances, has overruled policiesby observing, inter alia, that “Members of this Court are not publichealth experts, and we should respect the judgment of those withspecial expertise and responsibility in this area. But even in apandemic, the Constitution cannot be put away and forgotten”[20]and “a public health emergency does not give Governors and otherpublic officials carte blanche to disregard the Constitution for aslong as the medical problem persists. As more medical and scientificevidence becomes available, and as States have time to craft policiesin light of that evidence, courts should expect policies that more”[21]carefully account for constitutional rights.

16. Similarly, courts across the globe have responded toconstitutional challenges to executive policies that have directly or 19 197 U.S. 11 (1905)

20 Roman Catholic Diocese of Brooklyn, New York vs Cuomo, 592 U.S., 141 S. Ct.63

21 Calvary Chapel Dayton Valley vs Steve Sisolak, Governor of Nevada, et al, 140S.Ct. 2603 (Mem) (Justice Alito Dissenting Opinion)

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Aindirectly violated rights and liberties of citizens. Courts have oftenreiterated the expertise of the executive in managing a public healthcrisis, but have also warned against arbitrary and irrational policies beingexcused in the garb of the “wide latitude” to the executive that isnecessitated to battle a pandemic. This Court in Gujarat Mazdoor SabhaBvs State of Gujarat[22], albeit while speaking in the context of labourrights, had noted that policies to counteract a pandemic must continue tobe evaluated from a threshold of proportionality to determine if they,inter alia, have a rational connection with the object that is sought to beachieved and are necessary to achieve them.C17. In grappling with the second wave of the pandemic, this Courtdoes not intend to second-guess the wisdom of the executive when itchooses between two competing and efficacious policy measures.However, it continues to exercise jurisdiction to determine if the chosenpolicy measure conforms to the standards of reasonableness, militatesDagainst manifest arbitrariness and protects the right to life of all persons.This Court is presently assuming a dialogic jurisdiction where variousstakeholders are provided a forum to raise constitutional grievances withrespect to the management of the pandemic. Hence, this Court would,under the auspices of an open court judicial process, conduct deliberationswith the executive where justifications for existing policies would beEelicited and evaluated to assess whether they survive constitutionalscrutiny.

E. Issues with the Liberalized Vaccination Policy E.1 Vaccine Procurement and Distribution among DifferentFCategories of the Population

18. In our order dated 30 April 2021, the UoI was directed toclarify its vaccination procurement and distribution policy, especially afterthe introduction of the Liberalized Vaccination Policy. We had alsodirected the UoI to apprise this Court regarding the projected numbersGof vaccinations that would be made available in the coming months tothe public and the efforts being taken to augment vaccine production. Inits affidavit dated 9 May 2021, UoI has made the following submissions:

(i) The vaccination policy for COVID-19 that was adoptedprior to 1 May 2021 in phases 1 and 2, was designed as aH22 AIR 2020 SC 4601, para 9

system of prioritization. After vaccinating the HCWs andFLWs, vaccination was opened up for age groups onaccount of their heightened vulnerability and mortality toCOVID-19, in consonance with the WHO guidelines andinternational practice;

(ii) In phase 1, HCWs (starting from 16 January 2021) andFLWs (starting from 2 February 2021) were vaccinated. Inphase 2, persons above 60 years of age and persons over45 years of age with certain co-morbidities (starting from 1March 2021) and all persons over 45 years of age (startingfrom 1 April 2021) were eligible for vaccination. This prioritywas accorded in view of the fact that COVID-19 deathsacross the world demonstrate that over 85% of all deathsoccurred in the age group over 45 years;

(iii) FLWs such as municipal workers (including crematoriumworkers) and panchayat workers were also vaccinated inphase 1 of the vaccination drive;

(iv) With effect from 1 May 2021, the Liberalized VaccinationPolicy was implemented as a response to repeated requestsby State/UT Governments, and after detailed deliberationswith domain experts. The parallel decentralized policy aimsto achieve higher efficiency and reach;

(v) Currently, vaccine manufacturers are obligated to supply50% of their monthly CDL released doses to the UoI andthe remaining 50% doses to the “other than GoI channel”which can be procured by State/UT Governments, privatehospitals and hospitals of industrial establishments tovaccinate persons in the age group of 18-44 years;

(vi) The priority of the UoI remains vaccinating persons aged45 years and above for free since they are more vulnerable.The simultaneous vaccinations for persons aged between18-44 years has been introduced to respect the wishes ofthe State/UT Governments. In view of the differentialvulnerability and mortality rates, the Liberalized VaccinationPolicy conforms to the mandate of Articles 14 and 21 ofthe Constitution; A

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A(vii)In order to eliminate disparity in bargaining powers, “theCentral Government has, in consultation with thevaccine manufacturers determined the pro-ratapopulation of each State in the age group of 18-44 andeach State will procure only that quantity”; B(viii) The Central Government will notify States/UTs, everyfortnight, on the quantity of vaccines that will be distributedfor vaccinating persons aged 45 years and above;

(ix) With regard to the augmentation of production of vaccines,it is stated that the National Expert Group on VaccineCAdministration for COVID-19[23] had procured 6.6 croredoses for the initial phases. Support for other vaccinecandidates under clinical development is being provided bythe ‘Mission COVID Suraksha the Indian COVID-19Vaccine Development Mission’ ; D(x)The Central Government is in talks with several vaccinedevelopers/manufacturers outside India and is seeking tofacilitate imports. The Drugs Controller General of India[24]has already approved import of 1.5 lakh doses of the SputnikV vaccine by Dr Reddy s Laboratories ; E(xi)The availability of vaccines for the next 6 months would bedifficult to project as it is dynamic and contingent on foreignprocurement and successful ramping of production by thetwo existing manufacturers;

(xii) However, it is also stated that manufacturing capacity isFbeing increased in the following terms:

(a) SII: from 5 crore doses/month to 6.5 crore doses/month by July 2021; (b)BBIL: from 90 lakh doses/month to 2 crore doses/month, and further increase to 5.5 crore doses/monthGby July 2021; and

(c) Sputnik V: from 30 lakh doses to 1.2 crore doses/month by July 2021; and 23 “NEGVAC”H24 “DCGI”

(xiii) The regulatory and testing process for foreign vaccines hasbeen simplified by the NEGVAC which now allows bridgingtrials (a nearly 4-month long process) of foreign vaccinesto occur simultaneously with market development.

19. Based on the response of the UoI and the submissions madeby the Amici, we understand that there are three broad issues that are ofconcern: (i) vaccine distribution between different age groups; (ii) vaccineprocurement process; and (iii) the augmentation of the vaccine availabilityin India.

20. The affidavit of the UoI sufficiently clarifies the prioritizationof the groups in phases 1 and 2 for obtaining the COVID-19 vaccines.These include HCWs, FLWs and persons above the age of 45 years.The prioritization of these groups was based on the experience of Indiaand other countries during the first wave of the pandemic in 2020. Itwas largely observed that these groups faced a higher risk of infectionand thus, it was necessary to inoculate them free of cost and on a prioritybasis by the Central Government. During the vaccination for these groups,the Central Government had allowed on-site registration and there wasno prior requirement for booking an appointment on CoWIN. Havingsaid that, the vaccination policy has been substantially changed for personsbetween 18-44 years of age. The Liberalized Vaccination Policy requiressome of these persons to pay for the vaccines; limited vaccines aremade available for this category with the State/UT Governments/privatehospitals and an additional requirement of mandatory digital registrationand booking an appointment through CoWIN has been imposed, amongothers. Unlike the prior policy, the Liberalized Vaccination Policy doesnot prioritize persons with co- morbidities and other diseases, personswith disabilities, or any other vulnerable groups. This is especially atissue because the experience of the second wave of the pandemic hasprovided an experiential learning that the COVID-19 virus is capable ofmutation and now poses a threat to persons in this age group as well.Reports indicate that persons between 18-44 years of age have not onlybeen infected by COVID-19, but have also suffered from severe effectsof the infection, including prolonged hospitalization and, in unfortunatecases, death. Due to the changing nature of the pandemic, we are nowfaced with a situation where the 18-44 age group also needs to bevaccinated, although priority may be retained between different age groupson a scientific basis. Hence, due to the importance of vaccinating A

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Aindividuals in the 18-44 age group, the policy of the Central Governmentfor conducting free vaccination themselves for groups under the first 2phases, and replacing it with paid vaccination by the State/UTGovernments and private hospitals for the persons between 18-44 yearsis, prima facie, arbitrary and irrational.

B21. With regard to the procurement process for vaccinations whichis to be followed in view of the Liberalized Vaccination Policy, there area number of issues that need to be addressed. The Amici have indicatedthat many State/UT Governments and local municipal bodies have issuedtenders and attempted to negotiate with foreign manufacturers but theyhave largely been unsuccessful, as foreign manufacturers are not inclinedCto negotiate with individual State/UT Governments and prefer negotiatingwith federal governments of countries. Additionally, it has been urgedthat Central Government is also better placed to use its monopoly as abuyer (India being the second most populous country) to bargain forhigher quantities of vaccines at reasonable prices. We find that theDsubmissions urged by the Amici are extremely pertinent and haveindicated that in practice, the Liberalized Vaccination Policy may not beable to yield the desired results of spurring competitive prices and higherquantities of vaccines.

22. Additionally, the Liberalized Vaccination Policy seeks to removeEthe issue of bargaining disparities by stating that each State/UT wouldhave a prefixed pro rata quota based on their population in the 18-44age group, 50% of which will be available to the State/UT Governmentsand 50% to the private hospitals. The Amici have raised concerns thatthere is a lack of clarity regarding whether the UoI will intervene in thedistribution process. Given that inter-State barriers in India are porousFand persons are free to migrate and work in different parts of the country,it is essential to understand if the pro rata allotment will take into accountsuch migration to more densely populated industrial and urban States/UTs. Other concerns, such as the stage of the pandemic, the healthcareinfrastructure and existing capacities of a State/UT, the literacy rate,Gage and overall health condition of its population, may also be relevantfactors in making such a pro rata determination. The UoI should thusspecify whether it seeks to address these concerns within the vaccinationpolicy such that the State/UT Governments have a realistic assessmentof the assistance they can anticipate from the UoI.

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23. We shall now address the issue related to augmentation ofvaccine production/availability. We have noted the submissions of theUoI in its affidavit dated 9 May 2021, that it is difficult to predict theprojections for vaccines given that it depends on variable factors suchas introduction of new foreign vaccines, capability of increased productionby existing manufacturers, among others. Mr Tushar Mehta has duringthe course of his oral submissions stated that he is in a position to addressthese concerns of this Court and that the UoI aims to vaccinateapproximately 100 crore persons by the end of December 2021. MrMehta has agreed to provide a detailed roadmap regarding projectedavailability of vaccines from the various vaccine manufacturers. It hasalso been highlighted that the Central Government is in active negotiationswith various private foreign manufacturers to augment the availability ofvaccines in the near future.

24. In view of the above, we direct the UoI to undertake a freshreview of its vaccination policy addressing the concerns raised. Further,we direct the UoI to provide the following clarifications:

•As noted above, the UoI is directed to place on record aroadmap of projected availability of vaccines till 31December 2021; •The preparedness with respect to specific needs of childrenin the event of a third wave of the pandemic in terms ofmedical infrastructure, vaccination trials and regulatoryapproval, and compatible drugs;

•Whether under the policy of the UoI, it is permissible forState/UT Governments or individual local bodies to accessvaccine supplies of foreign manufacturers; •The number of crematorium workers vaccinated in phase1. A targeted drive can be conducted for vaccination of theremaining crematorium workers; •The State/UT Governments are diverting the vaccines(procured by them at a higher price than CentralGovernment) for the persons in the age group of 18- 44years to vaccinate persons above 45 years of age, due to ashortage of vaccines being supplied by the CentralGovernment. The manner in which the Central Government A

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will factor this quantity and price differential into theirsubsequent allocation and disbursal of vaccines to States/UTs for the persons above 45 years of age; and A

•The mechanism for redistribution, if the 25:25 quota in aparticular State/UT is not picked up by the State/UTBGovernment or the private hospitals.

E.2 Effects of Vaccination by Private Hospitals under theLiberalized Vaccination Policy

25. Under the Liberalized Vaccination Policy covering persons inthe age group of 18-44 years, the total vaccines produced will be dividedCin a ratio of 50:25:25 between the Central Government, State/UTGovernments and private hospitals. In its affidavit dated 9 May 2021,the UoI notes the following salient features of this Liberalized VaccinationPolicy, in relation to vaccination by private hospitals:

(i) Out of the 50% quota allocated for the ‘other than GoIDchannel’, 50% will go to the State/UT Governments,calculated on a pro rata basis as per the population. Thebalance 50% would be open for private hospitalsprocurement, based on contracts with the manufacturers.As such, the State/UT Governments and private hospitalswould each end up with 25% of the total CDL doses; E

(ii) Vaccination through the private sector of 25% of the totalCDL quantity would reduce the operational stress ongovernment facilities and help with issues of crowding atvaccination centres; and F(iii)Paid vaccination through private hospitals has beenintroduced for persons who can afford to pay, therebyreducing the operational stress on the Government.However, it has also been submitted that this policy mayundergo a change based on performance and futureavailability of vaccines.

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26. As a consequence of this Liberalized Vaccination Policy, 50%of the population of any State/UT in the 18-44 age group is expected topay for its vaccination. From the UoI’s affidavit, we understand that thishas been done while taking into account the ability of a certain section ofthe population to pay for their vaccination. However, the present systemH

of allowing only digital registration and booking of appointment onCoWIN, coupled with the current scarcity of vaccines, will ultimatelyensure that initially all vaccines, whether free or paid, are first availed bythe economically privileged sections of the society. As such, even thosewho may have been able to afford a vaccine, may opt for a free vaccinesimply because of issues of availability, even if it would entail travellingto far-flung rural areas. Hence, any calculations of the economic abilityof a given individual may not directly correspond to the vaccination route(paid/unpaid) they opt for. Consequently, it is plausible that privatehospitals may have vaccine doses left over with them because everyonewho could afford them has either already bought it or availed of a freevaccine, while those who need it may not have the ability to pay for it.

27. Further consequences of the vaccination by private hospitalsunder the Liberalized Vaccination Policy relate to a simple issue at thecore of their existence: that while they provide a public health service,they still remain private, for-profit entities. Consequently, they may sellthe vaccine doses procured at a higher price, unless regulated stringently.Private hospitals also may not sell all their vaccine doses publicly throughappointments on CoWIN, but rather sell them for lucrative deals directlyto private corporations who wish to vaccinate their employees. Finally,private hospitals are not equally spread out across a State/UT and areoften limited to bigger cities with large populations. As such, a largerquantity will be available in such cities, as opposed to the rural areas.

28. It is pertinent to clarify here that we are not opposed to theinvolvement of private hospitals in the vaccination drive. Private healthcare institutions have an important role as well. The UoI has correctlynoted in its affidavit that these hospitals will reduce the burden ongovernment facilities. This was also happening earlier for the vaccinationof those above 45 years of age, where the Central Government wasproviding these hospitals with vaccines and they were allowed to chargepatients a nominal fee (Rs 250). However, the issue is about the effectof privatizing 50% of all vaccines available for the 18-44 age group. Inview of the above concerns, we direct the UoI to provide the followingclarifications:

•The manner in which Central Government will monitor thedisbursal of vaccines to private hospitals, specifically thosewho have hospital chains pan India. Further, whether (i)private hospitals are liable to disburse vaccines pro rata A

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the population of States/UTs; and (ii) the mechanism todetermine if private players are genuinely administering thelifted quota in that State/UT alone. The UoI shall place onrecord any written policy in relation to this.

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•Whether the Central Government conducted a “means-test”Bof the demographic of a State/UT to assert that 50% of thepopulation in the 18-44 age group would be able to affordthe vaccine. If not, the rationale for private hospitals beingprovided an equal quota for procurement as the State/UTGovernments.

C•The manner in which the Centre and States/UTs shall ensurean equitable distribution of vaccines across sections of thesociety, and how this factors into the rationale of equalapportionment between State/UT Governments and privatehospitals.

•The nature of the intervention with respect to the final, end-user price that is being charged by private hospitals,especially when a cap on procurement by the privatehospitals has been set.

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E.3 Basis and Impact of Differential PricingEImpact of differential pricing

29. In our order dated 30 April 2021, we had elicited the UoI’sjustification for enabling decentralized procurement where a pre-fixedand differential price was set for the Central Government, States/UTsand private hospitals. The UoI through its affidavit dated 9 May 2021,Fhas submitted the following:

(i) The Liberalized Vaccination Policy was introduced toincentivize existing manufacturers and invite moremanufacturers, which will ensure fastest vaccination of themajority of the population. Differential pricing has beenGintroduced in order to instill a competitive market whichwould drive the market towards affordability and attractoffshore vaccine manufacturers;

(ii) Vaccine manufacturers are mandated to transparentlydeclare the price in advance for procurement by State/UT

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Governments and private hospitals. The price for the CentralGovernment is pre-fixed and declared; A

(iii) Extensive consultations with the manufacturers were heldto ensure that pricing is uniform and reasonable. The UoIstated that these were “due to consultations and persuasion”by the Central Government; B

(iv) On the differential pricing of the vaccines, it is stated that“the Central Government by nature of its largevaccination programme, places large purchase ordersfor vaccines as opposed to the State Governments and/or Private Hospitals and therefore, this reality has someCreflection in the prices negotiated”; and

(v) In any event, all persons of all age groups will get freevaccination throughout the country since all State/UTGovernments have announced free vaccination for personsaged 18-44 years, in addition to the Central Governmentvaccinating persons over 45 years for free.

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30. The current Liberalized Vaccination Policy enables State/UTGovernments and private hospitals to procure 50% of the monthly CDLapproved doses in the country at a pre-fixed price. The justification forthis Policy has been adduced in a bid to spur competition which wouldattract more private manufacturers that could eventually drive downprices. Prima facie, the only room for negotiation with the two vaccinemanufacturers was on price and quantity, both of which have been pre-fixed by the Central Government. This casts serious doubts on UoI sjustification for enabling higher prices as a competitive measure.Furthermore, the Central Government justifying its lower prices onaccount of its ability to place large purchase orders for vaccines, raisesthe issue as to why this rationale is not being employed for acquiring100% of the monthly CDL doses. The Union Budget for Financial Year2021-2022 had earmarked Rs 35000 crores for procuring vaccines[25]. Inlight of the Liberalized Vaccination Policy, the Central Government isdirectedto clarify how these funds have been spent so far and why theycannot be utilized for vaccinating persons aged 18-44 years.

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31. In response to our questions on the poor and marginalizedsuffering on account of the vaccine prices, the Central Government in 25 Available at <https://www.indiabudget.gov.in/doc/Budget_Speech.pdf>, page 7

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Aits affidavit stated that the eventual beneficiary of the vaccine would notbe affected by the Liberalized Vaccination Policy since every State/UThas promised to vaccinate its residents free of cost. Nevertheless, it isreiterated that the UoI should consider utilizing its position as themonopolistic buyer in the market and pass down the benefit to all persons.Even if the States/UTs were to fund the higher-priced vaccines, a burdenBthey were not discharging before the Liberalized Vaccination Policy wasintroduced and potentially may not have planned in advance for, thesefunds are expended at the behest of the public exchequer. The Centreand States/UTs, both operate in the service of the Indian population, andraise and disburse funds in their name. The additional funds expendedCon procuring vaccines against a deadly pandemic are necessaryexpenditure for any State/UT Government which has battled the publichealth emergency for over 15 months now. However, an avoidableexpense would eventually hurt the welfare of individuals residing withinthose States/UTs, who may potentially be benefitted by the differentialfunds being utilized for ramping up the health infrastructure in the State/DUT, which is equally important to combat the pandemic. If the CentralGovernment s unique monopolistic buyer position is the only reason for itreceiving vaccines at a much lower rate from manufacturers, it isimportant for us to examine the rationality of the existing LiberalizedVaccination Policy against Article 14 of the Constitution, since it couldEplace severe burdens, particularly on States/UTs suffering from financialdistress.

Basis of pricing

32. In our order dated 30 April 2021, we had requested for dataon government funding and support, direct or indirect, into the twoFvaccines that are currently authorized for public use – SII’s Covishieldand BBIL s Covaxin. Additionally, in order to evaluate the bottlenecks invaccine scarcity, we had sought the UoI’s stance on invoking its powersof compulsory licensing under the Patents Act, 1970 in order to ramp upmanufacturing and other statutory provisions to drive down costs. TheGUoI has adduced the following justifications in its affidavit dated 9 May2021:

(i) SII and BBIL have taken a financial risk in developing andmanufacturing these vaccines and prudence dictates pricingthrough a transparent and consultative negotiation, andHstatutory provisions must be invoked in the last resort;

(ii) Covaxin is developed under a public-private partnershipAthrough a formal MoU between Indian Council of MedicalResearch[26] and BBIL. ICMR would receive a 5% royaltyon net sales, the intellectual property is shared betweenICMR and BBIL and clauses such as prioritization of in-country supplies have been included. Phase 3 trials ofBCovaxin have been funded by the ICMR to the tune of Rs35 crores; A

(iii) Covishield is manufactured by SII. The Central Governmenthas directly transferred Rs 11 crores to 14 clinical trialssites for conducting phase 3 trials of over 1600 participants;Cand

(iv) Covaxin production is being augmented with governmentsupport to the tune of Rs 200 crores to one privatemanufacturer and 3 public sector manufacturing facilities– Bharat Biotech, Hyderabad; Indian Immunologicals,Hyderabad; Haffkine Biopharmaceuticals, Mumbai; andBharat Immunologicals and Biologicals, Bulandshar. Thisis projected to enhance Covaxin s current manufacturingof 1 crore doses/month to nearly 10 crore doses/month inthe next 8-10 months. Grant-in-aids have beenrecommended, but the disbursements are yet to be made.

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33. We commend the co-operative efforts of the UoI and theprivate manufacturers in developing and distributing vaccines which arecritical to mitigate the pandemic. The import of our further line ofquestioning is to facilitate a better understanding of the process ofdevelopment and augmentation of vaccine production and its pricing forStates/UTs and private hospitals. Hence, we direct that the UoI to providethe following clarifications:

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•Since the Central Government has financed (officially, Rs35 crores to BBIL and Rs 11 crore to SII for phase 3 clinicaltrials) and facilitated the production (or augmentation ofGproduction) of these vaccines through concessions orotherwise, it may not be accurate to state that the privateentities have alone borne the risk and cost of manufacture.Additionally, the Central Government would have minimized Athe risks of the manufacturers by granting Emergency UseAuthorization to the vaccines, which should factor into itspricing.

•The manner in which public financing is reflected in theprocurement price for the Central Government, which isBsignificantly lower than price for the State/UT Governmentsand private hospitals. Given that the R&D cost and IP haveeither been shared between the Central Government andthe private manufacturer (in case of Covaxin) or themanufacturer has not invested in R&D of the vaccine (incase of Covishield), the manner in which the pricing ofCvaccines has been arrived at, with the Central Governmentrefusing to intervene statutorily. The justification forintervening in pre-fixing procurement prices and quantitiesfor States/UTs and private hospitals, but not imposingstatutory price ceilings.

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•Comparison between the prices of vaccines being madeavailable in India, to their prices internationally.

•Whether ICMR/BBIL formally invited contracts forvoluntary licensing and if so, whether they have they receivedviable offers. The manner in which the UoI is independentlyEtrying to assist manufacturers for developing BSL3 labswhich are essential for Covaxin production.

E.4 Vaccine Logistics

34. We have already noted that as a consequence of the LiberalizedFVaccination Policy, the responsibility for the vaccination in phase 3 isbeing divided between the Central Government (for those above 45 yearsof age, HCWs and FLWs) and the State/UT Government along with theprivate hospitals (for the age group of 18-44 years). This would meanthat the limited vaccine logistics available in a State/UT would have tobe shared between the State/UT Government and the CentralGGovernment. This is different from the situation under the UIP, wherethe Central Government buys and allocates vaccines to States/UTs, inorder to ensure that their cold storage facilities are not overwhelmed.Hence, we direct the UoI to provide the following clarifications:

•The manner in which cold storage equipment capacity isbeing balanced between the Central and State/UTGovernments. The manner in which the States/UTs aremanaging the logistical burden for vaccinating persons agedbetween 18-44 years, along with persons aged over 45years.

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•Whether cold storage facilities in India have increased forthe COVID-19 vaccination drive; the present numbers, andcomparison with the numbers prior to March 2020; •Whether the cold storage equipment is indigenouslymanufactured or is imported. If it is imported, the stepsCwhich have been taken to start indigenous manufacturing.

•The steps being taken to improve the cold storagemanagement for vaccines which may require lowertemperature to be stored, compared to the ones whichcurrently have approval in India.

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E.5 Digital Divide

35. In our order dated 30 April 2021, we had highlighted theconcerns relating to the ability of the marginalized members of societyto avail of vaccination, exclusively through a digital portal in the face ofa digital divide. The UoI’s affidavit made the following submissions inrelation to the accessibility of the CoWIN portal:

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(i) The CoWIN portal enables one person to register 4 personsusing the same mobile number;

(ii) All gram panchayats in the country have Common ServiceFCentres[27] which can effectively enable people residing inrural areas to register online for the vaccination;

(iii) Citizens who do not have access to digital resources couldtake help from family, friends, NGOs and CSCs;

(iv) Walk-ins cannot be permitted due to the scarcity of vaccinesGand fears of over-crowding at centres. The onlineregistration requirement counters this fear and alsoeffectively monitors the administration of the second dose.The policy may be re-considered subsequently when morevaccines are available; H

[2021] 5 S.C.R.

A(v)Identity proofs are required for the purpose of determiningage and keeping a track of persons who are due for thesecond dose. However, in recognizing the issues arising withthe insistence of one of the seven prescribed photo-IDproofs, the Central Government issued an SoP dated 23April 2021 which enables bulk registration of certainBidentifiable groups, such as homeless persons, who wouldbe identified and registered by the District ImmunizationTask Force; and

(vi) It is clarified that walk-in vaccination facilities will continuefor persons over the age of 45 years in separate, designatedCvaccination centres. This is because vaccinations have beenunderway for this age group for a while and over- crowdinghas not been experienced so far.

36. A survey on ‘Household Social Consumption : Education’ wasconducted by National Statistics Office (July 2017-June 2018)[28] whichDrevealed the following:

(i) Around 4% of the rural households and 23% of the urbanhouseholds possessed a computer. In the age group of 15-29 years, around 24% in rural households and 56% in urbanareas were able to operate a computer; and E

(ii) Nearly 24% of the households in the country had internetaccess during the survey year 2017-18. The proportion was15% in rural households and 42% in urban households.Around 35% of persons in the age group of 15-29 yearsreported use of internet during the 30 days prior to the dateFof survey. The proportions were 25% in rural areas and58% in urban areas.

37. The Telecom Regulatory Authority of India in its reporttitled ‘Wireless Data Services in India’ [29] noted that:

(i) Out of the total population of 1.3 billion, only 578 millionGpeople in India (less than 50%) have subscription to wirelessdata services. The wireless tele density in rural areas is 27 “CSC”

28 Available at <http://mospi.nic.in/sites/default/files/publication_reports/Report_585_75th_round_Education_final_15 07_0.pdf>

29 Available at <https://www.trai.gov.in/sites/default/filesHWireless_Data_Service_Report_21082019_0.pdf>

57.13% as compared to 155.49% in urban areas as on 31March 2019. The report stated that:

“[this] reflects the rural-urban divide in terms of telecomservices penetration. Since, the number of wireless datasubscribers are less than 50% of the total wirelessaccess subscribers, the number of wireless datasubscribers in rural areas would be much lower”.

(ii) The report also noted that in a few Indian States like Bihar,Uttar Pradesh and Assam the tele density is less than 75%;and

(iii) The monthly income of persons living below the povertyline in urban areas and rural areas is Rs 1316 and Rs 896,respectively. However, to access internet data services, aminimum tariff plan would cost around Rs 49, which includes1 GB data every 28 days. This would constitute 4-5% ofthe month s income of such persons accessing data. Assuch, the report notes that this would bear a considerablecost for persons living below the poverty line.

38. According to the Annual Report of CSC for 2019-20, publishedby the Ministry of Electronics and Information Technology, while thereare 2,53,134 Gram Panchayats in India, as on 31 March 2020 only 2,40,792Gram Panchayats are covered with at least one registered CSC[30]. Hence,approximately 13,000 Gram Panchayats in India do not have a CSC.

39. It is clear from the above statistics that there exists a digitaldivide in India, particularly between the rural and urban areas. The extentof the advances made in improving digital literacy and digital accessfalls short of penetrating the majority of the population in the country.Serious issues of the availability of bandwidth and connectivity posefurther challenges to digital penetration. A vaccination policy exclusivelyrelying on a digital portal for vaccinating a significant population of thiscountry between the ages of 18-44 years would be unable to meet itstarget of universal immunization owing to such a digital divide. It is themarginalized sections of the society who would bear the brunt of thisaccessibility barrier. This could have serious implications on the 30 Available at <https://csc.gov.in/assets/events-report/Annual-Report-2019-20.pdf>,at page 8

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Afundamental right to equality and the right to health of persons within theabove age group. In this regard, we direct that the UoI to provide thefollowing clarifications:

•It may not be feasible to require the majority of ourpopulation to rely on friends/NGOs for digital registrationsBover CoWIN, when even the digitally literate are finding ithard to procure vaccination slots.

•The issue of over-crowding may also arise at CSCs in ruralareas where people would have to visit constantly in hopeof a vaccine slot opening up.

C•Certain vaccination centres may be earmarked for on-siteregistrations for the population aged between 18-44 yearswithout the existing conditions prescribed in the circulardated 24 May 2021, potentially with a view to prioritize thosewith co-morbidities/disabilities/other socio-economicDvulnerabilities. Alternatively, whether specific daily quotasmay be introduced for on-site registration at each centre orspecific centres.

•This policy may not allay the issue of hesitancy which mayarise from approaching a State authority (such as the DistrictEImmunization Task Force) to obtain registration for thevaccination. Whether on-site registration with self-attestation of age to ensure widespread vaccination can beprovided.

•The CoWIN platform and other IT applications like AarogyaFSetu should be made available in regional languages. Thetimeline for ensuring the availability of the platform inmultiple regional languages.

•Conducting a disability audit for the CoWIN website andother IT application like Aarogya Setu to ensure that theyare accessible to persons with disabilities.G

40. It has been brought to our notice that the CoWIN platform isnot accessible to persons with visual disabilities. The website suffersfrom certain accessibility barriers which should be addressed. Theseinclude:

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(i) Audio or text captcha is not available;

(ii) The seven filters, which inter alia, include age group, nameof vaccine and whether the vaccine is paid or free, are notdesigned accessibly. This issue can be addressed by creationof a drop-down list;

(iii) While visually challenged persons can determine the numberof available vaccine slots, one cannot find out the day thoseslots correspond to. This can be resolved by ensuring thattable headers correspond to associated cells;

(iv) Keyboard support for navigating the website is absent;

(v) Adequate time should be given to disabled users to scheduletheir appointment without the possibility of beingautomatically logged off; and

(vi) Accessibility protocols, such as use of appropriate colourcontrasts, should be adhered to.

F. Conclusion

41. We direct the UoI to file an affidavit, which shall address theissues and questions raised in Section E, wherein it shall ensure thateach issue is responded to individually and no issue is missed out. Wealso direct that the affidavit should provide the following information:

•The data on the percentage of populationthat has beenvaccinated (with one dose and both doses), as against eligiblepersons in the first three phases of the vaccination drive.This shall include data pertaining to the percentage of ruralpopulation as well as the percentage of urban population sovaccinated; •The complete data on the Central Government s purchasehistory of all the COVID-19 vaccines till date (Covaxin,Covishield and Sputnik V). The data should clarify: (a) thedates of all procurement orders placed by the CentralGovernment for all 3 vaccines; (b) the quantity of vaccinesordered as on each date; and (c) the projected date of supply;and •An outline for how and when the Central Government seeksto vaccinate the remaining population in phases 1, 2 and 3.

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A•The steps being taken by the Central Government to ensure drug availability for mucormycosis.

42. While filing its affidavit, UoI shall also ensure that copies ofall the relevant documents and file notings reflecting its thinking andculminating in the vaccination policy are also annexed on the vaccinationBpolicy. Hence, we direct the UoI to file its affidavit within 2 weeks.

43. We also note that UoI’s stated position in its affidavit dated 9May 2021 is that every State/UT Government shall provide vaccinationfree of cost to its population. It is important that individual State/UTGovernments confirm/deny this position before this Court. Further, ifCthey have decided to vaccinate their population for free then, as a matterof principle, it is important that this policy is annexed to their affidavit, sothat the population within their territories can be assured of their right tobe vaccinated for free at a State vaccination centre. Hence, we directeach of the State/UT Governments to also file an affidavit within 2 weeks,where they shall clarify their position and put on record their individualDpolicies.

Nidhi Jain

Directions issued.

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