IN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES AND SERVICES DURING PANDEMIC versus .
[2021] 5 S.C.R. 268, Supreme Court of India, 2021
Outcome: Directions issued
Segment: Issues
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IN RE: DISTRIBUTION OF ESSENTIAL SUPPLIES AND
SERVICES DURING PANDEMIC
(Suo Motu Writ Petition (Civil) No. 3 of 2021)
MAY 31, 2021
[DR. DHANANJAYA Y CHANDRACHUD,
L NAGESWARA RAO AND S RAVINDRA BHAT, JJ.]
COVID-19 pandemic:
Suo Motu writ petition – Cognizance of the Management of
the Covid -19 pandemic during the second wave –Gradual recession
of the second wave – In view thereof, issues as regards Central
Government’s Liberalised Vaccination Policy, vaccine distribution,
vaccine procurement process, and the augmentation of vaccine
availability, taken up – With respect to the vaccine distribution
between different age-groups, the policy of the Central Government
conducting free vaccinations for persons above age of 45 years
and frontline/healthcare workers, and paid vaccinations by the State/
UT Governments and private hospitals for persons between 18-44
years, prima facie arbitrary and irrational – With regard to
procurement process, the Liberalised Vaccination Policy, may not
be able to yield the desired results, and the basis of pro rata allocation
to State Governments also not clear, thus, Central Government to
specify as to how they would deal with the concern – As regards
augmentation of vaccine production/availability, Union of India to
undertake a fresh review of its vaccination policy – In view thereof,
issuance of direction to Union of India to file affidavit addressing
the issues
with regard to the vaccination policy: vaccine procurement
and distribution among different categories of the population, effects
of vaccination by private hospitals under the liberalized vaccination
policy, basis and impact of differential pricing, vaccine logistics,
digital divide – Affidavit to provide information on the percentage
of population that has been vaccinated with one dose and both
doses; complete data on purchase of COVID-19 vaccines till date
(Covaxin, Covishield and Sputnik V), and an outline for vaccinating
the remaining population in phases 1, 2 and 3; and the steps taken
by the Central Government to ensure availability of drug for
mucormycosis – Further, direction to Union of India to attach copies
of relevant papers and file notations perused while preparing
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vaccination policy – Also, the State/UT governments to clarify their
position and policies as regards providing free vaccination to the
population within their territories.
Judicial review – Exercise of, over the management of the
COVID-19 pandemic – Held: Policy-making continues to be in the
sole domain of the executive – However, separation of powers does
not result in courts lacking jurisdiction in conducting a judicial
review of these policies – Constitution does not envisage courts to
be silent spectators when constitutional rights of citizens are
infringed by executive policies – Judicial review and soliciting
constitutional justification for policies formulated by the executive
is an essential function, which the courts are entrusted to perform –
Judiciary has also recognized that constitutional scrutiny is
transformed during such public health emergencies – In grappling
with the second wave of the pandemic, this Court does not intend to
second-guess the wisdom of the executive – However, it continues
to exercise jurisdiction to determine if the chosen policy measure
conforms to the standards of reasonableness, militates against
manifest arbitrariness and protects the right to life of all persons –
Court is presently assuming a dialogic jurisdiction – Hence, the
Court would, under the auspices of an open court judicial process,
conduct deliberations with the executive where justifications for
existing policies would be elicited and evaluated to
assess whether
they 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 Mazdoor
Sabha v. State of Gujarat AIR 2020 SC 4601 – referred
to.
Jacobson v. Massachusetts 197 U.S. 11 (1905); Roman
Catholic Diocese of Brooklyn, New York v. Cuomo, 592
U.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: A
Deliberative Approach” in Nicholas Bamforth and Peter
Leyland (eds), Accountability in the Contemporary
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Constitution (Oxford University Press, 2013) – referred
to.
< 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://
pib.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 /
LiberalisedPricingandAcceleratedNationalCovid19VaccinationStrategy
2042021.pdf.; 
<https://www.pib.gov.in/
PressReleasePage.aspx?PRID=1721225\;<https://
www.indiabudget.gov.in/doc/Budget_Speech.pdf>; <http:/
/mospi.nic.in/sites/default/files/publication_reports/
Report_585_75th_round_Education_final_15
07_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-
2019-20.pdf> - referred to.
Case Law Reference
[2007] 13 SCR 811
Referred to
Para 14
AIR 2020 SC 4601
Referred to
Para 16
CIVIL 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, Maninder
Singh, ASGs., Anil Grover, Sr. AAG., Ms. Prachi Mishra, Arunabh
Chowdhury, 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., Sanat
Kumar, Dy. Adv. Gen.,
Jaideep Gupta, Ms. Meenakshi Arora, Ms. Manish
Lavkumar, 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, Maninder
Singh, C.S. Vaidyanathan, Rahul Mehra, Salman Khurshid, Tarun Gulati,
Vikas Singh, Pradeep Kumar Rai, Ms. Mahalakshmi Pavani, Arijit
Prasad, Brijender Chahar, Ms. Sonia Mathur, Vikas Pahwa, Dr. Ashwani
Kumar, Sr. Advs., Kunal Chatterjee, Mohit D. Ram, Rajat Nair, Kanu
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Agrawal, Digvijay Dam, Amit Sharma, B.V. Balaram Das, Gurmeet
Singh Makker, Amit Mahajan, Prashant Singh, Raj Bahadur Yadav, A.P.
Mayee, Ms. Rajeshwari Hariharan, R. Sathyanarayanan, Ms. Nupur
Kumar, Ms. Mantika Haryani, Ms. Astha Sharma, Nipun Saxena, Paras
Nath Singh, Umang Tyagi, Ms. Serena Sharma, Adit S. Pujari, Ms. Kajal
Dalal, Simranjeet Singh Rekhi, Sridhar Potaraju, Ms. Petal Chandhok,
Gaichangpou Gangmei, M/S. Trust Legal, Avijit Mani Tripathi, Shaurya
Sahay, Ms. Rekha Bakshi, Prashant Bhushan, Ms. Cheryl D’souza,
Deepak Masih, Ms. Manreet Kaur, R.N. Keswani, Mrs. Ketaki
Goswami, Nitin Saluja, Ayush Kaushik, Anjag Gautam, Mahfooz Ahsan
Nazki, Polanki Gowtham, Shaik Mohamad Haneef, T. Vijaya Bhaskar
Reddy, Amitabh Sinha, K.V. Girish Chowdary, Shrey Sharma, Sumit
Pragal, Ms. Amita Singh Kalkal, Vishnu Shankar Jain, Ms. Manju Jetley,
Ms. Shobha Gupta, Ms. Medha Garg, Summer Sodhi, Ms. Simran
Agarwal, Chaitanya, Anilendra Pandey, Ms. Suchita Dixit, Sandeep,
Manish Kumar, Ms. Pragya Baghel, Kumar Anurag Singh, Ms. Pallavi
Langar, Govind Manoharan, Ibad Mushtaq, Ms. Aishwarya Murali, Victor
Das, Ms. Ambika Mathur, Mrs. Shally Bhasin, Ms. Charu Ambwani,
Purvish Jitendra Malkan, Rasesh Parikh, Masoom Shah, Ms. Dharita
Purvish Malkan, Ms. Deepa Gorasia, Alok Kumar, Ms. Neha Ambashtha,
Ms. Nandini Chhabra, Ms. Bhavna Sarkar, J. Sai Deepak, Guruswamy
Nataraj, Ms. Pooja Dhar, V. Shyamohan, Surya Prakash, M/s. Kmnp
Law, Amarjit Singh Bedi, Raj Bahadur Yadav,
Amit Bhandari, Sandeep
Kumar 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, Siddharth
Srivastava, Shubham Bhalla, Pashupathi Nath Razdan, Palav Agarwal,
Sudhanshu Kaushesh, K.P. Jayaram, Astik Gupta, Ms. Maitrayee Jagat
Joshi, Arjun Garg, Aakash Nandolia, Ms. Shrutika Garg, Sunny Choudhary,
Pradeep Kumar Yadav, Abhay Singh, Ms. Shikha Yadav, Shreekant
Verma, Virender Kumar Mumwalia, Sanjeev Malhotra, Ramesh Babu
M. 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,
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Satyakam, 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, Niraj
Kumar, Mrs. Jaya Bharukha, Ravi Bharuka, Ms. Sarvshree, Justine
George, Ms. Shrishti Agarwal, Ankit Agarwal, Ms. Taniya Bansal, Rohit
Anil 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,
Amit Kumar, Sriram P., Ms. Pallavi Pratap, Dr. Monika Gusain, Suhaan
Mukerji, Vishal Prasad, Ms. Deepeika Kalia, Nikhil Parikshith, Abhishek
Manchanda, Kapish Seth, Mrityanjai Singh, Savandeep Pahari, M/s. PLR
Chambers & 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. Ritu
Bhardwaj, Anupam Mishra, Ms. Nina Gupta, Ms. K.V. Bharathi
Upadhyaya, Mukesh Kumar Singh, Ms. Sasmita Tripathy, Prashant Singh,
Ms. Prerna Kumari, Ms. Seema Patnaha, Ms. Nandini Gupta, Rahul
Kaushik, Sameer Abhyankar, S. Udaya Kumar Sagar, Ms. Sweena Nair,
Abhimanyu Tewari, Ms. Eliza Bar, V. N. Raghupathy,
Sharath Nambiar,
P. Venkat Reddy, Prashant Tyagi, P. Srinivas Reddy, M/S. Venkat Palwai
Law Associates, Mrs. K. Enatoli Sema, Amit Kumar Singh, Apratim
Animesh Thakur, Ms. Prachi Hasija, Siddhesh Kotwal, Ms. Manya Hasija,
Ms. Ana Upadhyay, Nirnimesh Dubey, Gaurav Yadava, Ms. Veena
Bansal, Sushil Kumar Anand, Sanjay Kumar Visen, Ms. Raushan Tara
Jaswal. Advs. for Appearing Parties.
Sachit Jolly, In-person, Devasish Garg, Parvesh Sahib Singh Verma-
Applicants-in-Person.
The following Order of the Court was passed:
ORDER
This order has been divided into the following sections to facilitate
analysis:
A
Introduction
B
Submission by Counsel
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C
National Vaccination Policy
D
Separation of Powers
E
Issues with the Liberalized Vaccination Policy
E.1 Vaccine Procurement and Distribution among
Different Categories of the Population
E.2 Effects of Vaccination by Private Hospitals
under the Liberalized Vaccination Policy
E 3 Basis and Impact of Differential Pricing
E.4 Vaccine Logistics
E.5 Digital Divide
F
Conclusion
A. Introduction
1. Proceedings in the present suo motu writ petition were initiated
on 22 April 2021, when this Court took cognizance of the management
of the COVID-19 pandemic during the second wave. Subsequently,
hearings were conducted on 23 April 2021, 27 April 2021 and 30 April
2021 when submissions were heard on behalf of the Union of India1,
States/Union Territories2, learned Amici appointed by this Court and some
of 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 essential
drugs, supply of medical oxygen, medical infrastructure, augmentation
of healthcare workforce and the issues faced by them, and issues of
freedom of speech and expression during the COVID- 19 pandemic. In
its order, this Court had noted that its observations and directions were
in consonance with a bounded-deliberative approach3 and hence, the
UoI was directed to re-consider its policies on the above issues, taking
into 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” in
Nicholas Bamforth and Peter Leyland (eds), Accountability in the Contemporary
Constitution (Oxford University Press, 2013)
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3. Following the order dated 30 April 2021, another two judge
Bench of this Court heard a Special Leave Petition4 against an order of
the High Court of Delhi in relation to the supply of medical oxygen to the
National Capital Territory5 of Delhi. During the course of the proceedings
in that matter, the Bench primarily issued directions in relation to the
supply of medical oxygen to the NCT of Delhi. However, through its
order dated 6 May 2021, it also constituted a National Task Force to
provide a public heath response to the COVID-19 pandemic on the basis
of a scientific approach. The terms of reference of this National Task
Force included, inter alia, assessing and making recommendations for
the need, availability and distribution of medical oxygen; devising a
methodology for allocation of medical oxygen and periodical review of
the allocation based on the stage of the pandemic; providing
recommendations for augmenting the supplies of oxygen; facilitating audits
in each State/UT to determine whether oxygen supplies had reached its
destination; efficacy, transparency and efficiency of the distribution
networks within the State/UT; providing recommendations for ensuring
availability of essential drugs, augmentation of medical and paramedical
staff, management of the pandemic and treatment of cases.
4. During the course of the proceedings on 31 May 2021, we had
the benefit of perusing the details provided in the
affidavit filed by the
UoI on 9 May 2021. The submissions contained in the affidavit were
supplemented and updated in the hearing by Mr Tushar Mehta, learned
Solicitor General of India, appearing on behalf of the Central
Government. We have further heard the learned Amici, Mr Jaideep Gupta
and Ms Meenakshi Arora, learned Senior counsel.
5. Since the last hearing in this matter, the second wave of the
COVID-19 pandemic has started receding across the nation and the
situation appears to have become more manageable. Hence, some of
the issues discussed in the previous orders can await further deliberation.
However, the issue of vaccination is absolutely crucial, since health
experts globally agree that vaccination of the nation’s entire eligible
population is the singular most important task in effectively combating
the COVID-19 pandemic in the long run. Hence, during the course of
the proceedings on 31 May 2021, this Court has limited itself to hearing
submissions on the UoI s vaccination policy and its roadmap for the
4 Union of India vs Rakesh Malhotra and another, SLP (Civil) (Diary) No 11622
of 2021
5 “NCT”
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future. By way of abundant clarification, we note that all of the issues
contained in this Court’s previous orders still retain their overall
importance, and this Court shall continue to monitor them alongside the
National Task Force and intervene whenever necessary.
6. It is also important to note that numerous interlocutory
applications and affidavits by individual State/UT Governments and
members of civil society have been filed before us in this matter. We
have perused them to understand the key issues being raised there, along
with the helpful notes provided by the Amici.
B. Submission by Counsel
7. Mr Tushar Mehta, learned Solicitor General, relying on the UoI
s affidavit dated 9 May 2021, has made the following submissions to
supplement it, in view of the recent updates:
(i)
The vaccination drive will be complete by the end of
December 2021, and the Central Government is in active
talks with foreign vaccine manufacturers at the highest
political and diplomatic levels, to ensure the adequate supply
of vaccines;
(ii)
It would be incorrect to state that a consequence of the
UoI s updated policy on vaccination of those in the 18-44
age group is that there will be competition amongst the
States/UTs; and
(iii)
Everyone above the age of 45 years can continue to get
vaccinated at a facility through on-site registration, without
previously having to book an appointment through CoWIN.
8. Mr Jaideep Gupta and Ms Meenakshi Arora, learned Senior
counsel and
Amici, have raised the following issues relating to vaccination
distribution, augmentation of vaccine production and differential pricing
of vaccines and the future preparedness for dealing with the COVID-
19 pandemic:
(i)
With respect to the procurement of vaccines, reports
suggest that foreign vaccine manufacturers are generally
not receptive or open to a dialogue with State/UT
Governments on the basis that, as a matter of corporate
policy, they only deal with federal governments of different
nations;
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(ii)
Since 1978 till 1 May 2021, the UoI has implemented the
Universal Immunization Programme6 under which essential
vaccines were procured by the UoI and were distributed to
States/UTs free of cost for administering them to the end
beneficiary. The said policy has held the test of times. Even
during the vaccination drive for COVID-19 in phases 1 and
2 for vaccination of healthcare workers7, frontline workers8
and persons above the age of 45 years, the UoI procured
all the vaccines and distributed them to State/UT
Governments for administration. The single procurement
model has also been followed by other nations for ensuring
fast and effective administration of vaccines against
COVID-19;
(iii)
The UIP has been replaced by the Liberalized Pricing and
Accelerated National COVID-19 Vaccination Strategy9
from 1 May 2021 in phase 3 of the vaccination drive,
whereby State/UT Governments or private hospitals are
required to procure vaccines for persons between the age
group of 18-44 years from the private manufacturers on
the basis of a pro rata quota set by the UoI;
(iv)
The Liberalized Vaccination Policy leaves the State/UT
Governments to fend for themselves, rather than the Central
Government acting on behalf of the entire nation. As a
consequence, the vaccine manufacturers are free to
implement a differential procurement price for the UoI for
vaccinating persons above 45 years of age, and for the State/
UT Governments
and private hospitals for vaccinating the
persons between 18-44 years of age;
(v)
While the Liberalized Vaccination Policy has been introduced
to spur competitive prices, there are multiple States/UTs
competing to purchase a scarce commodity from a few
vaccine manufacturers. Consequently, the manufacturers
have the advantage of creating a monopoly and selling it at
any price that they desire to private healthcare institutions.
6 “UIP”
7 “HCWs”
8 “FLWs”
9 “Liberalized Vaccination Policy”
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The State/UT Governments do not enjoy the unique position
of the UoI, which has the advantage of being a monopolistic
buyer and can negotiate an appropriate price for the vaccines
on behalf of the entire population of India;
(vi)
The Liberalized Vaccination Policy puts an undue burden
on persons between the age group of 18-44 years,
specifically persons belonging to a poor socio- economic
background, who have to purchase two doses of vaccines
either from the State/UT Governments or private hospitals;
(vii)
In the alternative, the UoI has stated that all State/UT
Governments have agreed to vaccinate their population free
of cost and have undertaken to bear the burden of the
vaccines which are available at a higher purchase price
than the one available to the UoI. Thus, the end beneficiary
is not impacted by the differential pricing in the Liberalized
Vaccination Policy. With regard to this submission, the Amici
have raised the following concerns:
(a)
While some States/UTs have announced that they
will vaccinate their population for free, this policy
statement must be confirmed by the State/UT
Governments on affidavit before this Court. The
Liberalized Vaccination Policy as it stands today, does
not incorporate a condition whereby the cost of
vaccination 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 Governments
to place their decisions on record and for it to be part
of
the formal policy, such that persons can enforce
their right to free vaccination, including before the
courts;
(b)
Although the State/UT Governments may have
announced free vaccination for their population, some
of them are contesting the Liberalized Vaccination
Policy before this Court and have advanced
submissions for universal vaccination by the Central
Government. Thus, it cannot conclusively be stated
that State/UT Governments have agreed to the policy
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decision taken by the Central Government of deviating
from the single procurement model;
(c)
The Liberalized Vaccination Policy, as a consequence
of its differential pricing, treats individuals living
across India residing in different States/UTs
unequally, as States/UTs that are financially distressed
may not be able to afford to purchase the vaccines
at the prices set by the vaccine manufacturers or to
lift the quantity allocated to them; and
(d)
The end result of the Liberalized Vaccination Policy
is that the UoI can purchase vaccines at Rs 150 per
dose for Covishield and Covaxin, while the State/UT
Governments have to pay Rs 300 and Rs 400 per
dose respectively. If the UoI were to be the single
procurement agency for all vaccines at a fixed cost,
then the cost of vaccination to the public exchequer
would be substantially lower. Thus, it is incorrect to
suggest that the end beneficiary, who contributes to
the public exchequer, will not be unduly impacted;
(viii) Although public health is a subject under Entry 6 of List II
(State List) of the Seventh Schedule to the Constitution,
Entry 81 of List I (Union List) deals with inter-State
migration and inter-State quarantine and Entry 29 of List
III (Concurrent List) deals with prevention of extension from
one State to another of infectious or contagious diseases.
Thus, the management of the pandemic, control of the
spread of COVID-19, vaccination policy and pricing, are
the responsibility of the Central Government, which must
work in tandem with the State/UT Governments. The
Liberalized Vaccination Policy, by putting the burden of
vaccination of persons between 18-44 years of age on the
State/UT Governments, conflicts with this constitutional
balance of responsibilities between the Centre and States/
UTs;
(ix)
With regard to the vaccine distribution, the Liberalized
Vaccination Policy has created a quota of 50:25:25 for the
18-44 age group. The quota of 25% that is available to State/
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UT Governments, which is equivalent to the private
hospitals, is extremely disproportionate and not in touch with
societal realities, as a large number of persons may not be
able to afford two doses of a vaccine from a private
hospital. Thus, if State/UT Governments are to bear the
burden of vaccinating a majority of the persons in their
States/UTs, the quota available to the private hospitals must
be reduced;
(x)
The Liberalized Vaccination Policy does not provide any
clarity on the basis of the pro rata allotment of the doses to
each State/UT (available for purchase by the State/UT
Government and private hospitals). The Policy does not
indicate whether such apportionment will be on the basis of
population; state of the pandemic in each State/UT; or the
number of persons with co- morbidities between 18-44 years
of age, among others. Further, the Policy does not indicate
whether the pro rata allotment will be made by the UoI or
the private vaccine manufacturer;
(xi)
It is reported that UoI on certain occasions has stated that
it will refrain from interfering in the issue of vaccine
distribution. Contrarily, UoI has also been stated that it may
decide to redistribute the vaccines procured by it among
State/UT Governments. The basis on which the re-
distribution of vaccines will take place among States/UTs
has not been provided in the policy document;
(xii)
The Liberalized Vaccination Policy does not provide for
prioritizing of persons with co-morbidities;
persons with
disabilities or suffering from other illnesses; care-givers for
the elderly and sick; teachers and others in the age group
of 18-44 years. Further, the CoWIN application is not built
with functions which prioritize a certain category of persons,
as it only books appointments on a first-cum-first-served
basis;
(xiii) News reports indicate that crematorium workers have either
not been vaccinated, or are unaware that they are eligible
for vaccination in phases 1 and 2;
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(xiv) With regard to preparedness, the UoI has claimed that it
will be able to vaccinate a substantial number of persons
(around 100 crore persons requiring 200 crore doses) by
December 2021. However, no projections have been shared
with this Court regarding how this target would be achieved.
Based on reports, it appears that the UoI has factored a
number of vaccines that are currently in their development
stages to reach its projected number of 200 crore doses.
This approach would be misguided as the success and
efficacy of vaccines that are currently in the stage of clinical
trials is uncertain and cannot be guaranteed;
(xv)
There is material to suggest that the augmentation of vaccine
production will be inadequate to vaccinate the population
between 18-44 years of age. The total population of this
age group is 59 crores, which would require around 122
crore doses. Based on reports, the existing manufacturers
(Serum Institute of India10 and Bharat Biotech India
Limited11) will be able to produce less than 10 crore doses
per month. Optimistically, around 15-20 crores doses of
Sputnik V will be available per month. At this rate, it would
take around 12 months for the population in this age group
to be inoculated, by which time the virus may have mutated,
causing further waves of the pandemic;
(xvi) Meanwhile, there is a necessity to ensure that guidelines
regarding standardization of masks are formulated and
publicized. Thus, medical guidance is necessary to ensure
that masks of appropriate quality are produced and
distributed free of cost to curb the spread of the infection;
and
(xvii) It has been reported that due to dearth of electric
crematoria, persons who have succumbed to COVID-19
are not dignified with a proper cremation and are cremated
without any rituals. The UoI and State/UT Governments
may consider forming appropriate guidelines which augment
the creation of infrastructure for electric crematoria and a
10 “SII”
11 “BBIL”
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protocol for cremation of the dead.
C. National Vaccination Policy
9. Phase 1 of the National COVID-19 Vaccination Strategy was
launched on 16 January 2021 and 1 February 2021 and was targeted
towards protecting HCWs and FLWs. Phase 2 was initiated on 1 March
2021 and 1 April 2021, and was directed towards protecting the most
vulnerable population in the age group of persons above 45 years of
age. In phase 1 and 2, the UoI was procuring the vaccines and distributing
them to the States/UTs free of cost for disbursal through government
and private COVID-19 vaccination centres. The private facilities were
not allowed to charge a sum above Rs 250 per person per dose (Rs 150
for vaccines and Rs 100 as operational charges) from a beneficiary.
10. During phase 2, eligible beneficiaries could register and book
appointments for vaccination on the CoWIN 2.0 portal or other IT
applications such as Aarogya Setu. From 1 March 2021 onwards, the
population aged 60 years or which would attain the age of 60 years or
more as on 1 January 2022 was eligible to register on the CoWIN
platform. Further, persons who were aged 45 years or would attain the
age of 45 years to 59 years as on 1 January 2022 and had any of the 20
specified co-morbidities were also eligible to register on the CoWIN
platform. From 1 April 2021 onwards, all persons who were aged 45
years or would attain the age of 45 years to 59 years as on 1 January
2022 were eligible to register on the CoWIN platform.
On-site registration
facility was also made available at vaccination centres in this phase.
11. In phase 3, a Liberalized Vaccination Policy was introduced
by the UoI, which came into effect on 1 May 2021. We have perused
the documents available in the public domain (guidance note12, press
releases13 and policy document14) issued by the Central Government to
understand the written policy of the Central Government with regard to
phase 3. Based on such documents, the main elements of the Liberalized
Vaccination 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 dated
24 April 2021, available at <https://www.mohfw.gov.in/pdf
LiberalisedPricingandAcceleratedNationalCovid19VaccinationStrategy 2042021.pdf>
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(i)
Vaccine manufacturers are required to supply 50% of their
monthly Central Drugs Laboratory15 doses to the UoI and
would be free to supply the remaining 50% doses to State/
UT Governments and in „other than Government of India
channel 16;
(ii)
Manufacturers were required to make a declaration of the
price of the 50% supply that would be available to State/
UT Governments and in the „other than GoI channel before
1 May 2021. Based on this price, States/UTs, private
hospitals and industrial establishments through their hospitals
may procure vaccines from the manufacturers. Private
hospitals would be able to procure their supplies only from
the 50% supply earmarked for ‘other than GoI channel’ ;
(iii)
The prices charged for vaccination by private hospitals
would be monitored. As a result, the earlier dispensation
where private COVID-19 vaccination centres which
received doses from the UoI could charge up to Rs 250 per
dose ceased to exist;
(iv)
The population which is now eligible to obtain vaccines at
UoI s vaccination centres is limited to HCWs, FLWs and
those above 45 years of age. The population between 18-
44 years is eligible to obtain vaccines from ‘other than GoI
channel;’
(v)
The vaccination would continue to be available for free for
eligible population groups in those vaccination centres which
receive their vaccine doses from UoI;
(vi)
The vaccination would continue to be a part of the National
Vaccination
Programme and would follow all existing
guidelines. The CoWIN platform would capture the
vaccination, stocks and price per vaccination applicable in
all vaccination centres. The vaccination drive would comply
with ‘Adverse Event Following Immunization’ management
and reporting, digital vaccination certificate and all other
prescribed norms;
15 “CDL”
16 “other than GoI channel”
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(vii)
The division of 50% supply to UoI and 50% to ‘other than
GoI channel’ would be applicable uniformly across all the
vaccine manufactures in the country;
(viii) The fully ready to use imported vaccines are allowed to be
utilized 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 of
administration, average consumption) and extent of infection
(number of COVID-19 cases). Wastage of vaccines would
also be considered in the criteria and would affect the
allocation negatively. Based on the above criteria, a State-
wise quota would be decided and communicated to the
States/UTs in advance.
12. The facility of only online appointment on the CoWIN portal
was initially introduced for the entirety of the population between the
ages of 18-44 years. Later, on 24 May 202117, the UoI announced that
on-site registration will be made available for the 18-44 years age group.
However, this is contingent on: (i) the State/UT Government enabling
this policy; and (ii) only in cases of wastage at a particular government
COVID-19 vaccination centre due to a no-show by an online appointee.
Further, this facility has not been expanded to private COVID-19
vaccination centres.
D. Separation of Powers
13. At the outset, we seek to clarify the nature of this Court s
jurisdiction in the exercise of the power of judicial review over the
management of the COVID-19 pandemic in India.
In its affidavit dated
9 May 2021, the UoI has highlighted a few concerns which are detailed
below:
(i)
The executive is battling an unprecedented crisis and the
government needs discretion to formulate policy in larger
interest and its wisdom should be trusted;
(ii)
The current vaccine policy conforms to Articles 14 and 21
of the Constitution, and requires no interference from the
courts as the executive has “room for free play in the joints”
17 Available at <https://www.pib.gov.in/PressReleasePage.aspx?PRID=1721225>
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while dealing with a pandemic of this magnitude;
(iii)
The current steps are thoughtfully undertaken to tide over
an imminent crisis, which may turn out to be imprudent in
the long run. However, they need to be appreciated from a
short-term and holistic perspective;
(iv)
Judicial review over executive policies is permissible only
on account of manifest arbitrariness. No interference from
judicial proceedings is called for when the executive is
operating on expert medical and scientific opinion to tackle
a medical crisis; and
(v)
Any over-zealous judicial intervention, though well-meaning,
in the absence of expert advice or administrative experience
may lead to unintended circumstances where the executive
is left with little room to explore innovative solutions.
14. It is trite to state that separation of powers is a part of the
basic structure of the Constitution. Policy-making continues to be in the
sole domain of the executive. The judiciary does not possess the authority
or competence to assume the role of the executive, which is
democratically accountable for its actions and has access to the resources
which are instrumental to policy formulation. However, this separation
of powers does not result in courts lacking jurisdiction in conducting a
judicial review of these policies18. Our Constitution does not envisage
courts to be silent spectators when constitutional rights of citizens are
infringed by executive
policies. Judicial review and soliciting constitutional
justification for policies formulated by the executive is an essential
function, which the courts are entrusted to perform.
15. We had clarified in our order dated 30 April 2021, that in the
context of the public health emergency with which the country is currently
grappling, this Court appreciates the dynamic nature of the measures.
Across the globe, the executive has been given a wider margin in enacting
measures which ordinarily may have violated the liberty of individuals,
but are now incumbent to curb the pandemic. Historically, the judiciary
has also recognized that constitutional scrutiny is transformed during
such public health emergencies, where the executive functions in rapid
consultation with scientists and other experts. In 1905, the Supreme Court
18 DDA vs Joint Action Committee, (2008) 2 SCC 672
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of the United States in Jacobson vs Massachusetts19 considered a
constitutional liberty challenge to a compulsory vaccination law that was
enacted to combat the smallpox epidemic. Justice Harlan had noted the
complex role of the government in battling public health emergencies in
the following terms:
“..the State may invest local bodies called into existence for
purposes of local administration with authority in some appropriate
way to safeguard the public health and the public safety... While
this court should guard with firmness every right appertaining to
life, liberty or property as secured to the individual by the Supreme
Law of the Land, it is of the last importance that it should not
invade the domain of local authority except when it is plainly
necessary to do so in order to enforce that law. The safety and
the health of the people of Massachusetts are, in the first instance,
for that Commonwealth to guard and protect……So far as they
can be reached by any government, they depend, primarily, upon
such action as the State in its wisdom may take, and we do not
perceive that this legislation has invaded any right secured by the
Federal Constitution.”
The Supreme Court of United States, speaking in the wake of the
present COVID-19 pandemic in various instances, has overruled policies
by observing, inter alia, that “Members of this Court are not public
health experts, and we should respect the judgment of those with
special expertise and responsibility
in this area. But even in a
pandemic, the Constitution cannot be put away and forgotten”20
and “a public health emergency does not give Governors and other
public officials carte blanche to disregard the Constitution for as
long as the medical problem persists. As more medical and scientific
evidence becomes available, and as States have time to craft policies
in light of that evidence, courts should expect policies that more
carefully account for constitutional rights”21.
16. Similarly, courts across the globe have responded to
constitutional 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, 140
S.Ct. 2603 (Mem) (Justice Alito Dissenting Opinion)
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indirectly violated rights and liberties of citizens. Courts have often
reiterated the expertise of the executive in managing a public health
crisis, but have also warned against arbitrary and irrational policies being
excused in the garb of the “wide latitude” to the executive that is
necessitated to battle a pandemic. This Court in Gujarat Mazdoor Sabha
vs State of Gujarat22, albeit while speaking in the context of labour
rights, had noted that policies to counteract a pandemic must continue to
be evaluated from a threshold of proportionality to determine if they,
inter alia, have a rational connection with the object that is sought to be
achieved and are necessary to achieve them.
17. In grappling with the second wave of the pandemic, this Court
does not intend to second-guess the wisdom of the executive when it
chooses between two competing and efficacious policy measures.
However, it continues to exercise jurisdiction to determine if the chosen
policy measure conforms to the standards of reasonableness, militates
against manifest arbitrariness and protects the right to life of all persons.
This Court is presently assuming a dialogic jurisdiction where various
stakeholders are provided a forum to raise constitutional grievances with
respect to the management of the pandemic. Hence, this Court would,
under the auspices of an open court judicial process, conduct deliberations
with the executive where justifications
for existing policies would be
elicited and evaluated to assess whether they survive constitutional
scrutiny.
E. Issues with the Liberalized Vaccination Policy
E.1 Vaccine Procurement and Distribution among Different
Categories of the Population
18. In our order dated 30 April 2021, the UoI was directed to
clarify its vaccination procurement and distribution policy, especially after
the introduction of the Liberalized Vaccination Policy. We had also
directed the UoI to apprise this Court regarding the projected numbers
of vaccinations that would be made available in the coming months to
the public and the efforts being taken to augment vaccine production. In
its affidavit dated 9 May 2021, UoI has made the following submissions:
(i)
The vaccination policy for COVID-19 that was adopted
prior to 1 May 2021 in phases 1 and 2, was designed as a
22 AIR 2020 SC 4601, para 9
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system of prioritization. After vaccinating the HCWs and
FLWs, vaccination was opened up for age groups on
account of their heightened vulnerability and mortality to
COVID-19, in consonance with the WHO guidelines and
international practice;
(ii)
In phase 1, HCWs (starting from 16 January 2021) and
FLWs (starting from 2 February 2021) were vaccinated. In
phase 2, persons above 60 years of age and persons over
45 years of age with certain co-morbidities (starting from 1
March 2021) and all persons over 45 years of age (starting
from 1 April 2021) were eligible for vaccination. This priority
was accorded in view of the fact that COVID-19 deaths
across the world demonstrate that over 85% of all deaths
occurred in the age group over 45 years;
(iii)
FLWs such as municipal workers (including crematorium
workers) and panchayat workers were also vaccinated in
phase 1 of the vaccination drive;
(iv)
With effect from 1 May 2021, the Liberalized Vaccination
Policy was implemented as a response to repeated requests
by State/UT Governments, and after detailed deliberations
with domain experts. The parallel decentralized policy aims
to achieve higher efficiency and reach;
(v)
Currently, vaccine manufacturers are obligated to supply
50% of their monthly CDL released doses to the UoI and
the remaining 50% doses to the “other than GoI channel”
which can be procured by State/UT Governments, private
hospitals and hospitals of industrial establishments to
vaccinate persons in
the age group of 18-44 years;
(vi)
The priority of the UoI remains vaccinating persons aged
45 years and above for free since they are more vulnerable.
The simultaneous vaccinations for persons aged between
18-44 years has been introduced to respect the wishes of
the State/UT Governments. In view of the differential
vulnerability and mortality rates, the Liberalized Vaccination
Policy conforms to the mandate of Articles 14 and 21 of
the Constitution;
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(vii)
In order to eliminate disparity in bargaining powers, “the
Central Government has, in consultation with the
vaccine manufacturers determined the pro-rata
population of each State in the age group of 18-44 and
each State will procure only that quantity”;
(viii) The Central Government will notify States/UTs, every
fortnight, on the quantity of vaccines that will be distributed
for 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 Vaccine
Administration for COVID-1923 had procured 6.6 crore
doses for the initial phases. Support for other vaccine
candidates under clinical development is being provided by
the ‘Mission COVID Suraksha the Indian COVID-19
Vaccine Development Mission’ ;
(x)
The Central Government is in talks with several vaccine
developers/manufacturers outside India and is seeking to
facilitate imports. The Drugs Controller General of India24
has already approved import of 1.5 lakh doses of the Sputnik
V vaccine by Dr Reddy s Laboratories ;
(xi)
The availability of vaccines for the next 6 months would be
difficult to project as it is dynamic and contingent on foreign
procurement and successful ramping of production by the
two existing manufacturers;
(xii)
However, it is also stated that manufacturing capacity is
being 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/month
by July 2021; and
(c)
Sputnik V: from 30 lakh doses to 1.2 crore doses/
month by July 2021; and
23 “NEGVAC”
24 “DCGI”
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(xiii) The regulatory and testing process for foreign vaccines has
been simplified by the NEGVAC which now allows bridging
trials (a nearly 4-month long process) of foreign vaccines
to occur simultaneously with market development.
19. Based on the response of the UoI and the submissions made
by the Amici, we understand that there are three broad issues that are of
concern: (i) vaccine distribution between different age groups; (ii) vaccine
procurement process; and (iii) the augmentation of the vaccine availability
in India.
20. The affidavit of the UoI sufficiently clarifies the prioritization
of 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 India
and other countries during the first wave of the pandemic in 2020. It
was largely observed that these groups faced a higher risk of infection
and thus, it was necessary to inoculate them free of cost and on a priority
basis by the Central Government. During the vaccination for these groups,
the Central Government had allowed on-site registration and there was
no prior requirement for booking an appointment on CoWIN. Having
said that, the vaccination policy has been substantially changed for persons
between 18-44 years of age. The Liberalized Vaccination Policy requires
some of these persons to pay for the vaccines; limited vaccines are
made available for this
category with the State/UT Governments/private
hospitals and an additional requirement of mandatory digital registration
and booking an appointment through CoWIN has been imposed, among
others. Unlike the prior policy, the Liberalized Vaccination Policy does
not prioritize persons with co- morbidities and other diseases, persons
with disabilities, or any other vulnerable groups. This is especially at
issue because the experience of the second wave of the pandemic has
provided an experiential learning that the COVID-19 virus is capable of
mutation 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 only
been infected by COVID-19, but have also suffered from severe effects
of the infection, including prolonged hospitalization and, in unfortunate
cases, death. Due to the changing nature of the pandemic, we are now
faced with a situation where the 18-44 age group also needs to be
vaccinated, although priority may be retained between different age groups
on a scientific basis. Hence, due to the importance of vaccinating
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individuals in the 18-44 age group, the policy of the Central Government
for conducting free vaccination themselves for groups under the first 2
phases, and replacing it with paid vaccination by the State/UT
Governments and private hospitals for the persons between 18-44 years
is, prima facie, arbitrary and irrational.
21. With regard to the procurement process for vaccinations which
is to be followed in view of the Liberalized Vaccination Policy, there are
a number of issues that need to be addressed. The Amici have indicated
that many State/UT Governments and local municipal bodies have issued
tenders and attempted to negotiate with foreign manufacturers but they
have largely been unsuccessful, as foreign manufacturers are not inclined
to negotiate with individual State/UT Governments and prefer negotiating
with federal governments of countries. Additionally, it has been urged
that Central Government is also better placed to use its monopoly as a
buyer (India being the second most populous country) to bargain for
higher quantities of vaccines at reasonable prices. We find that the
submissions urged by the Amici are extremely pertinent and have
indicated that in practice, the Liberalized Vaccination Policy may not be
able to yield the desired results of spurring competitive prices and higher
quantities of vaccines.
22. Additionally, the Liberalized Vaccination Policy seeks to remove
the issue of bargaining
disparities by stating that each State/UT would
have a prefixed pro rata quota based on their population in the 18-44
age group, 50% of which will be available to the State/UT Governments
and 50% to the private hospitals. The Amici have raised concerns that
there is a lack of clarity regarding whether the UoI will intervene in the
distribution process. Given that inter-State barriers in India are porous
and 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 account
such migration to more densely populated industrial and urban States/
UTs. Other concerns, such as the stage of the pandemic, the healthcare
infrastructure and existing capacities of a State/UT, the literacy rate,
age and overall health condition of its population, may also be relevant
factors in making such a pro rata determination. The UoI should thus
specify whether it seeks to address these concerns within the vaccination
policy such that the State/UT Governments have a realistic assessment
of the assistance they can anticipate from the UoI.
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23. We shall now address the issue related to augmentation of
vaccine production/availability. We have noted the submissions of the
UoI in its affidavit dated 9 May 2021, that it is difficult to predict the
projections for vaccines given that it depends on variable factors such
as introduction of new foreign vaccines, capability of increased production
by existing manufacturers, among others. Mr Tushar Mehta has during
the course of his oral submissions stated that he is in a position to address
these concerns of this Court and that the UoI aims to vaccinate
approximately 100 crore persons by the end of December 2021. Mr
Mehta has agreed to provide a detailed roadmap regarding projected
availability of vaccines from the various vaccine manufacturers. It has
also been highlighted that the Central Government is in active negotiations
with various private foreign manufacturers to augment the availability of
vaccines in the near future.
24. In view of the above, we direct the UoI to undertake a fresh
review 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 a
roadmap of projected availability of vaccines till 31
December 2021;
•
The preparedness with respect to specific needs of children
in the event of a third wave of the pandemic in terms of
medical infrastructure, vaccination trials and regulatory
approval, and compatible
drugs;
•
Whether under the policy of the UoI, it is permissible for
State/UT Governments or individual local bodies to access
vaccine supplies of foreign manufacturers;
•
The number of crematorium workers vaccinated in phase
1. A targeted drive can be conducted for vaccination of the
remaining crematorium workers;
•
The State/UT Governments are diverting the vaccines
(procured by them at a higher price than Central
Government) for the persons in the age group of 18- 44
years to vaccinate persons above 45 years of age, due to a
shortage of vaccines being supplied by the Central
Government. The manner in which the Central Government
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will factor this quantity and price differential into their
subsequent allocation and disbursal of vaccines to States/
UTs for the persons above 45 years of age; and
•
The mechanism for redistribution, if the 25:25 quota in a
particular State/UT is not picked up by the State/UT
Government or the private hospitals.
E.2 Effects of Vaccination by Private Hospitals under the
Liberalized Vaccination Policy
25. Under the Liberalized Vaccination Policy covering persons in
the age group of 18-44 years, the total vaccines produced will be divided
in a ratio of 50:25:25 between the Central Government, State/UT
Governments and private hospitals. In its affidavit dated 9 May 2021,
the UoI notes the following salient features of this Liberalized Vaccination
Policy, in relation to vaccination by private hospitals:
(i)
Out of the 50% quota allocated for the ‘other than GoI
channel’, 50% will go to the State/UT Governments,
calculated on a pro rata basis as per the population. The
balance 50% would be open for private hospitals
procurement, based on contracts with the manufacturers.
As such, the State/UT Governments and private hospitals
would each end up with 25% of the total CDL doses;
(ii)
Vaccination through the private sector of 25% of the total
CDL quantity would reduce the operational stress on
government facilities and help with issues of crowding at
vaccination centres; and
(iii)
Paid vaccination through private hospitals
has been
introduced for persons who can afford to pay, thereby
reducing the operational stress on the Government.
However, it has also been submitted that this policy may
undergo a change based on performance and future
availability of vaccines.
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 to
pay for its vaccination. From the UoI’s affidavit, we understand that this
has been done while taking into account the ability of a certain section of
the population to pay for their vaccination. However, the present system
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of allowing only digital registration and booking of appointment on
CoWIN, coupled with the current scarcity of vaccines, will ultimately
ensure that initially all vaccines, whether free or paid, are first availed by
the economically privileged sections of the society. As such, even those
who may have been able to afford a vaccine, may opt for a free vaccine
simply because of issues of availability, even if it would entail travelling
to far-flung rural areas. Hence, any calculations of the economic ability
of a given individual may not directly correspond to the vaccination route
(paid/unpaid) they opt for. Consequently, it is plausible that private
hospitals may have vaccine doses left over with them because everyone
who could afford them has either already bought it or availed of a free
vaccine, while those who need it may not have the ability to pay for it.
27. Further consequences of the vaccination by private hospitals
under the Liberalized Vaccination Policy relate to a simple issue at the
core of their existence: that while they provide a public health service,
they still remain private, for-profit entities. Consequently, they may sell
the vaccine doses procured at a higher price, unless regulated stringently.
Private hospitals also may not sell all their vaccine doses publicly through
appointments on CoWIN, but rather sell them for lucrative deals directly
to private corporations who wish to vaccinate their employees. Finally,
private hospitals
are not equally spread out across a State/UT and are
often limited to bigger cities with large populations. As such, a larger
quantity 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 the
involvement of private hospitals in the vaccination drive. Private health
care institutions have an important role as well. The UoI has correctly
noted in its affidavit that these hospitals will reduce the burden on
government facilities. This was also happening earlier for the vaccination
of those above 45 years of age, where the Central Government was
providing these hospitals with vaccines and they were allowed to charge
patients a nominal fee (Rs 250). However, the issue is about the effect
of privatizing 50% of all vaccines available for the 18-44 age group. In
view of the above concerns, we direct the UoI to provide the following
clarifications:
•
The manner in which Central Government will monitor the
disbursal of vaccines to private hospitals, specifically those
who have hospital chains pan India. Further, whether (i)
private hospitals are liable to disburse vaccines pro rata
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the population of States/UTs; and (ii) the mechanism to
determine if private players are genuinely administering the
lifted quota in that State/UT alone. The UoI shall place on
record any written policy in relation to this.
•
Whether the Central Government conducted a “means-test”
of the demographic of a State/UT to assert that 50% of the
population in the 18-44 age group would be able to afford
the vaccine. If not, the rationale for private hospitals being
provided an equal quota for procurement as the State/UT
Governments.
•
The manner in which the Centre and States/UTs shall ensure
an equitable distribution of vaccines across sections of the
society, and how this factors into the rationale of equal
apportionment between State/UT Governments and private
hospitals.
•
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 private
hospitals has been set.
E.3 Basis and Impact of Differential Pricing
Impact of differential pricing
29. In our order dated 30 April 2021, we had elicited the UoI’s
justification for enabling decentralized procurement where a pre-fixed
and differential price was set for the Central Government, States/UTs
and private hospitals. The UoI through its affidavit dated 9 May 2021,
has submitted the following:
(i)
The Liberalized Vaccination Policy was introduced to
incentivize existing
manufacturers and invite more
manufacturers, which will ensure fastest vaccination of the
majority of the population. Differential pricing has been
introduced in order to instill a competitive market which
would drive the market towards affordability and attract
offshore vaccine manufacturers;
(ii)
Vaccine manufacturers are mandated to transparently
declare the price in advance for procurement by State/UT
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Governments and private hospitals. The price for the Central
Government is pre-fixed and declared;
(iii)
Extensive consultations with the manufacturers were held
to ensure that pricing is uniform and reasonable. The UoI
stated that these were “due to consultations and persuasion”
by the Central Government;
(iv)
On the differential pricing of the vaccines, it is stated that
“the Central Government by nature of its large
vaccination programme, places large purchase orders
for vaccines as opposed to the State Governments and/
or Private Hospitals and therefore, this reality has some
reflection in the prices negotiated”; and
(v)
In any event, all persons of all age groups will get free
vaccination throughout the country since all State/UT
Governments have announced free vaccination for persons
aged 18-44 years, in addition to the Central Government
vaccinating persons over 45 years for free.
30. The current Liberalized Vaccination Policy enables State/UT
Governments and private hospitals to procure 50% of the monthly CDL
approved doses in the country at a pre-fixed price. The justification for
this Policy has been adduced in a bid to spur competition which would
attract more private manufacturers that could eventually drive down
prices. Prima facie, the only room for negotiation with the two vaccine
manufacturers was on price and quantity, both of which have been pre-
fixed by the Central Government. This casts serious doubts on UoI s
justification for
enabling higher prices as a competitive measure.
Furthermore, the Central Government justifying its lower prices on
account of its ability to place large purchase orders for vaccines, raises
the issue as to why this rationale is not being employed for acquiring
100% of the monthly CDL doses. The Union Budget for Financial Year
2021-2022 had earmarked Rs 35000 crores for procuring vaccines25. In
light of the Liberalized Vaccination Policy, the Central Government is
directed to clarify how these funds have been spent so far and why they
cannot be utilized for vaccinating persons aged 18-44 years.
31. In response to our questions on the poor and marginalized
suffering 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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its affidavit stated that the eventual beneficiary of the vaccine would not
be affected by the Liberalized Vaccination Policy since every State/UT
has promised to vaccinate its residents free of cost. Nevertheless, it is
reiterated that the UoI should consider utilizing its position as the
monopolistic 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 burden
they were not discharging before the Liberalized Vaccination Policy was
introduced and potentially may not have planned in advance for, these
funds are expended at the behest of the public exchequer. The Centre
and States/UTs, both operate in the service of the Indian population, and
raise and disburse funds in their name. The additional funds expended
on procuring vaccines against a deadly pandemic are necessary
expenditure for any State/UT Government which has battled the public
health emergency for over 15 months now. However, an avoidable
expense would eventually hurt the welfare of individuals residing within
those States/UTs, who may potentially be benefitted by the differential
funds being utilized for ramping up the health infrastructure in the State/
UT, which is equally important to combat the pandemic. If the Central
Government s unique monopolistic buyer position is the only reason for it
receiving vaccines at a much lower rate from manufacturers, it is
important for us to
examine the rationality of the existing Liberalized
Vaccination Policy against Article 14 of the Constitution, since it could
place severe burdens, particularly on States/UTs suffering from financial
distress.
Basis of pricing
32. In our order dated 30 April 2021, we had requested for data
on government funding and support, direct or indirect, into the two
vaccines that are currently authorized for public use – SII’s Covishield
and BBIL s Covaxin. Additionally, in order to evaluate the bottlenecks in
vaccine scarcity, we had sought the UoI’s stance on invoking its powers
of compulsory licensing under the Patents Act, 1970 in order to ramp up
manufacturing and other statutory provisions to drive down costs. The
UoI has adduced the following justifications in its affidavit dated 9 May
2021:
(i)
SII and BBIL have taken a financial risk in developing and
manufacturing these vaccines and prudence dictates pricing
through a transparent and consultative negotiation, and
statutory provisions must be invoked in the last resort;
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(ii)
Covaxin is developed under a public-private partnership
through a formal MoU between Indian Council of Medical
Research26 and BBIL. ICMR would receive a 5% royalty
on net sales, the intellectual property is shared between
ICMR and BBIL and clauses such as prioritization of in-
country supplies have been included. Phase 3 trials of
Covaxin have been funded by the ICMR to the tune of Rs
35 crores;
(iii)
Covishield is manufactured by SII. The Central Government
has directly transferred Rs 11 crores to 14 clinical trials
sites for conducting phase 3 trials of over 1600 participants;
and
(iv)
Covaxin production is being augmented with government
support to the tune of Rs 200 crores to one private
manufacturer and 3 public sector manufacturing facilities
– Bharat Biotech, Hyderabad; Indian Immunologicals,
Hyderabad; Haffkine Biopharmaceuticals, Mumbai; and
Bharat Immunologicals and Biologicals, Bulandshar. This
is projected to enhance Covaxin s current manufacturing
of 1 crore doses/month to nearly 10 crore doses/month in
the next 8-10 months. Grant-in-aids have been
recommended, but the disbursements are yet to be made.
33. We commend the co-operative efforts of the UoI and the
private manufacturers in developing and distributing vaccines which are
critical to mitigate the pandemic. The import of our further line of
questioning is to facilitate a better understanding of the process of
development and augmentation of vaccine production and its pricing for
States/UTs and private hospitals. Hence, we direct that the UoI to provide
the following clarifications:
•
Since the Central Government has financed (officially, Rs
35 crores to BBIL and Rs 11 crore to SII for phase 3 clinical
trials) and facilitated the production (or augmentation of
production) of these vaccines through concessions or
otherwise, it may not be accurate to state that the private
entities have alone borne the risk and cost of manufacture.
Additionally, the Central Government would have minimized
26 “ICMR”
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the risks of the manufacturers by granting Emergency Use
Authorization to the vaccines, which should factor into its
pricing.
•
The manner in which public financing is reflected in the
procurement price for the Central Government, which is
significantly lower than price for the State/UT Governments
and private hospitals. Given that the R&D cost and IP have
either been shared between the Central Government and
the private manufacturer (in case of Covaxin) or the
manufacturer has not invested in R&D of the vaccine (in
case of Covishield), the manner in which the pricing of
vaccines has been arrived at, with the Central Government
refusing to intervene statutorily. The justification for
intervening in pre-fixing procurement prices and quantities
for States/UTs and private hospitals, but not imposing
statutory price ceilings.
•
Comparison between the prices of vaccines being made
available in India, to their prices internationally.
•
Whether ICMR/BBIL formally invited contracts for
voluntary licensing and if so, whether they have they received
viable offers. The manner in which the UoI is independently
trying to assist manufacturers for developing BSL3 labs
which are essential for Covaxin production.
E.4 Vaccine Logistics
34. We have already noted that as a consequence of the Liberalized
Vaccination Policy, the responsibility for the vaccination in phase 3 is
being divided between the Central Government (for those above
45 years
of age, HCWs and FLWs) and the State/UT Government along with the
private hospitals (for the age group of 18-44 years). This would mean
that the limited vaccine logistics available in a State/UT would have to
be shared between the State/UT Government and the Central
Government. This is different from the situation under the UIP, where
the Central Government buys and allocates vaccines to States/UTs, in
order to ensure that their cold storage facilities are not overwhelmed.
Hence, we direct the UoI to provide the following clarifications:
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•
The manner in which cold storage equipment capacity is
being balanced between the Central and State/UT
Governments. The manner in which the States/UTs are
managing the logistical burden for vaccinating persons aged
between 18-44 years, along with persons aged over 45
years.
•
Whether cold storage facilities in India have increased for
the COVID-19 vaccination drive; the present numbers, and
comparison with the numbers prior to March 2020;
•
Whether the cold storage equipment is indigenously
manufactured or is imported. If it is imported, the steps
which have been taken to start indigenous manufacturing.
•
The steps being taken to improve the cold storage
management for vaccines which may require lower
temperature to be stored, compared to the ones which
currently have approval in India.
E.5 Digital Divide
35. In our order dated 30 April 2021, we had highlighted the
concerns relating to the ability of the marginalized members of society
to avail of vaccination, exclusively through a digital portal in the face of
a digital divide. The UoI’s affidavit made the following submissions in
relation to the accessibility of the CoWIN portal:
(i)
The CoWIN portal enables one person to register 4 persons
using the same mobile number;
(ii)
All gram panchayats in the country have Common Service
Centres27 which can effectively enable people residing in
rural areas to register online for the vaccination;
(iii)
Citizens who do not have access to digital resources could
take help from family, friends, NGOs and CSCs;
(iv)
Walk-ins cannot be permitted due to the scarcity of vaccines
and fears of over-crowding at centres. The online
registration requirement counters this fear and also
effectively monitors the administration of the second dose.
The policy may be re-considered subsequently when more
vaccines are available;
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(v)
Identity proofs are required for the purpose of determining
age and keeping a track of persons who are due for the
second dose. However, in recognizing the issues arising with
the insistence of one of the seven prescribed photo-ID
proofs, the Central Government issued an SoP dated 23
April 2021 which enables bulk registration of certain
identifiable groups, such as homeless persons, who would
be identified and registered by the District Immunization
Task Force; and
(vi)
It is clarified that walk-in vaccination facilities will continue
for persons over the age of 45 years in separate, designated
vaccination centres. This is because vaccinations have been
underway for this age group for a while and over- crowding
has not been experienced so far.
36. A survey on ‘Household Social Consumption : Education’ was
conducted by National Statistics Office (July 2017-June 2018)28 which
revealed the following:
(i)
Around 4% of the rural households and 23% of the urban
households possessed a computer. In the age group of 15-
29 years, around 24% in rural households and 56% in urban
areas were able to operate a computer; and
(ii)
Nearly 24% of the households in the country had internet
access during the survey year 2017-18. The proportion was
15% in rural households and 42% in urban households.
Around 35% of persons in the age group of 15-29 years
reported use of internet during the 30 days prior to the date
of survey. The
proportions were 25% in rural areas and
58% in urban areas.
37. The Telecom Regulatory Authority of India in its report
titled ‘Wireless Data Services in India’ 29 noted that:
(i)
Out of the total population of 1.3 billion, only 578 million
people in India (less than 50%) have subscription to wireless
data 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/files
Wireless_Data_Service_Report_21082019_0.pdf>
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57.13% as compared to 155.49% in urban areas as on 31
March 2019. The report stated that:
“[this] reflects the rural-urban divide in terms of telecom
services penetration. Since, the number of wireless data
subscribers are less than 50% of the total wireless
access subscribers, the number of wireless data
subscribers 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 poverty
line in urban areas and rural areas is Rs 1316 and Rs 896,
respectively. However, to access internet data services, a
minimum tariff plan would cost around Rs 49, which includes
1 GB data every 28 days. This would constitute 4-5% of
the month s income of such persons accessing data. As
such, the report notes that this would bear a considerable
cost for persons living below the poverty line.
38. According to the Annual Report of CSC for 2019-20, published
by the Ministry of Electronics and Information Technology, while there
are 2,53,134 Gram Panchayats in India, as on 31 March 2020 only 2,40,792
Gram Panchayats are covered with at least one registered CSC30. 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 digital
divide in India, particularly between the rural and urban areas. The extent
of the advances made in improving digital
literacy and digital access
falls short of penetrating the majority of the population in the country.
Serious issues of the availability of bandwidth and connectivity pose
further challenges to digital penetration. A vaccination policy exclusively
relying on a digital portal for vaccinating a significant population of this
country between the ages of 18-44 years would be unable to meet its
target of universal immunization owing to such a digital divide. It is the
marginalized sections of the society who would bear the brunt of this
accessibility 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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fundamental right to equality and the right to health of persons within the
above age group. In this regard, we direct that the UoI to provide the
following clarifications:
•
It may not be feasible to require the majority of our
population to rely on friends/NGOs for digital registrations
over CoWIN, when even the digitally literate are finding it
hard to procure vaccination slots.
•
The issue of over-crowding may also arise at CSCs in rural
areas where people would have to visit constantly in hope
of a vaccine slot opening up.
•
Certain vaccination centres may be earmarked for on-site
registrations for the population aged between 18-44 years
without the existing conditions prescribed in the circular
dated 24 May 2021, potentially with a view to prioritize those
with co-morbidities/disabilities/other socio-economic
vulnerabilities. Alternatively, whether specific daily quotas
may be introduced for on-site registration at each centre or
specific centres.
•
This policy may not allay the issue of hesitancy which may
arise from approaching a State authority (such as the District
Immunization Task Force) to obtain registration for the
vaccination. Whether on-site registration with self-
attestation of age to ensure widespread vaccination can be
provided.
•
The CoWIN platform and other IT applications like Aarogya
Setu should be made available in regional languages. The
timeline for ensuring the availability of the platform
in
multiple regional languages.
•
Conducting a disability audit for the CoWIN website and
other IT application like Aarogya Setu to ensure that they
are accessible to persons with disabilities.
40. It has been brought to our notice that the CoWIN platform is
not accessible to persons with visual disabilities. The website suffers
from certain accessibility barriers which should be addressed. These
include:
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(i)
Audio or text captcha is not available;
(ii)
The seven filters, which inter alia, include age group, name
of vaccine and whether the vaccine is paid or free, are not
designed accessibly. This issue can be addressed by creation
of a drop-down list;
(iii)
While visually challenged persons can determine the number
of available vaccine slots, one cannot find out the day those
slots correspond to. This can be resolved by ensuring that
table headers correspond to associated cells;
(iv)
Keyboard support for navigating the website is absent;
(v)
Adequate time should be given to disabled users to schedule
their appointment without the possibility of being
automatically logged off; and
(vi)
Accessibility protocols, such as use of appropriate colour
contrasts, should be adhered to.
F. Conclusion
41. We direct the UoI to file an affidavit, which shall address the
issues and questions raised in Section E, wherein it shall ensure that
each issue is responded to individually and no issue is missed out. We
also direct that the affidavit should provide the following information:
•
The data on the percentage of population that has been
vaccinated (with one dose and both doses), as against eligible
persons in the first three phases of the vaccination drive.
This shall include data pertaining to the percentage of rural
population as well as the percentage of urban population so
vaccinated;
•
The complete data on the Central Government s purchase
history of all the
COVID-19 vaccines till date (Covaxin,
Covishield and Sputnik V). The data should clarify: (a) the
dates of all procurement orders placed by the Central
Government for all 3 vaccines; (b) the quantity of vaccines
ordered as on each date; and (c) the projected date of supply;
and
•
An outline for how and when the Central Government seeks
to vaccinate the remaining population in phases 1, 2 and 3.
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•
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 of
all the relevant documents and file notings reflecting its thinking and
culminating in the vaccination policy are also annexed on the vaccination
policy. 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 9
May 2021 is that every State/UT Government shall provide vaccination
free of cost to its population. It is important that individual State/UT
Governments confirm/deny this position before this Court. Further, if
they have decided to vaccinate their population for free then, as a matter
of principle, it is important that this policy is annexed to their affidavit, so
that the population within their territories can be assured of their right to
be vaccinated for free at a State vaccination centre. Hence, we direct
each of the State/UT Governments to also file an affidavit within 2 weeks,
where they shall clarify their position and put on record their individual
policies.
Nidhi Jain
Directions issued.