Jacob Puliyel vs Union of India & Ors.

Public health – Immunisation – Adverse Events Following Immunisation (AEFI) – Central Drugs Standard Control Organisation (CDSCO) – Sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines, not acceptable – Role of the Pharmacovigilance Programme of India – CDSCO, as elaborated upon by Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration – Union of India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs.

Public health – Immunisation – Adverse effects following immunisation – Information relating to – Held: Such information is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic – Imperative need for collection of requisite data of adverse events and wider participation in terms of reporting – Union of India directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform – These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest.

Public health – Vaccination – Paediatric vaccination – Policy decision – Scope of review – Held: Decision taken by Union of India to vaccinate children in the country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC – It is beyond the scope of review for the Court to second-guess expert opinion, on the basis of which the Government has drawn up its policy – Keeping in line with the WHO Statement on Clinical Trials and the extant statutory regime, Union of India directed to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done.

Public Health – Policy decisions based on expert opinion – Judicial review – Scope – Held: Court would be slow in interfering with matters of policy, especially those connected to public health – Wide latitude is provided to the executive in matters involving policy decisions based on expert opinion – Court does not have the expertise to appreciate and decide on merits of scientific issues on the basis of divergent medical opinion – However, this does not bar the Court from scrutinising whether the policy in question can be held to be beyond the pale of unreasonableness and manifest arbitrariness and to be in furtherance of the right to life of all persons, bearing in mind the material on record – Constitution of India, 1950 – Art. 14.

Evidence – News item published in newspaper – Admissibility – Held: The courts cannot take judicial notice of facts stated in a news item published in a newspaper – A statement of fact contained in a newspaper is merely hearsay and therefore, inadmissible in evidence, unless proved by the maker of the statement appearing in court and deposing to have perceived the fact reported – Judicial Notice.

Public interest litigation – Public interest litigation moved by a person having knowledge in the subject-matter of the lis and, thus, having an interest therein, as contradistinguished from a busybody, in the welfare of people – Maintainability of. Disposing the writ petition, the Court

HELD: Judicial review of public policies relating to health - Ambit of

1.1. The Courts, in exercise of their power of judicial review, do not ordinarily interfere with the policy decisions of the executive unless the policy can be faulted on grounds of mala fide, unreasonableness, arbitrariness or unfairness etc. Indeed, arbitrariness, irrationality, perversity and mala fide will render the policy unconstitutional. It is neither within the domain of the courts nor the scope of judicial review to embark upon an enquiry as to whether a particular public policy is wise or whether better public policy can be evolved. Nor are the courts inclined to strike down a policy at the behest of a petitioner merely because it has been urged that a different policy would have been fairer or wiser or more scientific or more logical. Courts do not and cannot act as appellate authorities examining the correctness, suitability and appropriateness of a policy, nor are courts advisors to the executive on matters of policy which the executive is entitled to formulate. The scope of judicial review when examining a policy of the Government is to check whether it violates the fundamental rights of the citizens or is opposed to the provisions of the Constitution, or opposed to any statutory provision or manifestly arbitrary. [Para 21][497-B-E]

1.2. The courts should not rush in where even scientists and medical experts are careful to tread. The rule of prudence is that courts will be reluctant to interfere with policy decisions taken by the Government, in matters of public health, after collecting and analysing inputs from surveys and research. Nor will courts attempt to substitute their own views as to what is wise, safe, prudent or proper, in relation to technical issues relating to public health in preference to those formulated by persons said to possess technical expertise and rich experience. Where expertise of a complex nature is expected of the State in framing rules, the exercise of that power not demonstrated as arbitrary must be presumed to be valid as a reasonable restriction on the fundamental right of the citizen and judicial review must halt at the frontiers. The Court cannot re-weigh and substitute its notion of expedient solution. Within the wide judge-proof areas of policy and judgment open to the government, if they make mistakes, correction is not in court but elsewhere. That is the comity of constitutional jurisdictions in our jurisprudence. One cannot evolve a judicial policy on medical issues. All judicial thought, Indian and Anglo-American, on the judicial review power where rules under challenge relate to a specialised field and involve sensitive facets of public welfare, has warned courts of easy assumption of unreasonableness of subordinate legislation on the strength of half- baked studies of judicial generalists aided by the ad-hoc learning of counsel. However, the Court certainly is the constitutional invigilator and must act to defend the citizen in the assertion of his fundamental rights against executive tyranny draped in disciplinary power. [Para 22][497-E-G; 498-A-D]

1.3. The Court would be slow in interfering with matters of policy, especially those connected to public health. There is also no doubt that wide latitude is given to executive opinion which is based on expert advice. However, it does not mean that this Court will not look into cases where violation of fundamental rights is involved and the decision of the executive is manifestly arbitrary or unreasonable. It is true that this Court lacks the expertise to arrive at conclusions from divergent opinions of scientific issues but that does not prevent this Court from examining the issues raised in this Writ Petition, especially those that concern violation of Article 21 of the Constitution of India. [Para 25][499-E-F]

Vaccine mandates – If violative of Art.21 of the Constitution

2.1. Bodily integrity is protected under Article 21 of the Constitution of India and no individual can be forced to be vaccinated. Personal autonomy of an individual involves the right of an individual to determine how they should live their own life, which consequently encompasses the right to refuse to undergo any medical treatment in the sphere of individual health. Persons who are keen to not be vaccinated on account of personal beliefs or preferences, can avoid vaccination, without anyone physically compelling them to be vaccinated. However, if there is a likelihood of such individuals spreading the infection to other people or contributing to mutation of the virus or burdening of the public health infrastructure, thereby affecting communitarian health at large, protection of which is undoubtedly a legitimate State aim of paramount significance in this collective battle against the pandemic, the Government can regulate such public health concerns by imposing certain limitations on individual rights that are reasonable and proportionate to the object sought to be fulfilled. [Para 49][516-B-F]

2.2. The Union of India is justified in centering its vaccination policy around the health of the population at large, with emphasis on insulating the weaker and more vulnerable sections from the risk of severe infection and its consequences, as opposed to basing its decision keeping in mind the interests of a healthy few. Given the considerable material filed before this Court reflecting the near-unanimous views of experts on the benefits of vaccination in dealing with severe disease, reduction in oxygen requirement, hospital and ICU admissions and mortality and stopping new variants from emerging, this Court is satisfied that the current vaccination policy of the Union of India, formulated in the interest of public health, is informed by relevant considerations and cannot be said to be unreasonable. [Para 56] [520-D-F]

2.3. While there is abundant data to show that getting vaccinated continues to be the dominant expert advice even in the face of new variants, no submission nor any data has been put forth to justify restrictions only on unvaccinated individuals when emerging scientific evidence appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. To put it differently, neither the Union of India nor the State Governments have produced any material before this Court to justify the discriminatory treatment of unvaccinated individuals in public places by imposition of vaccine mandates. No doubt that when COVID-19 vaccines came into the picture, they were expected to address, and were indeed found to be successful in dealing with, the risk of infection from the variants in circulation at the time. However, with the virus mutating, one has seen more potent variants surface which have broken through the vaccination barrier to some extent. While vaccination mandates in the era of prevalence of the variants prior to the Delta variant may have withstood constitutional scrutiny, in light of the data presented by the Petitioner, which has not been controverted by the Union of India as well as the State Governments, the restrictions on unvaccinated individuals imposed through vaccine mandates cannot be considered to be proportionate, especially since both vaccinated and unvaccinated individuals presently appear to be susceptible to transmission of the virus at similar levels. [Para 58][522-D-G; 523-A-B]

2.4. Till the infection rate and spread remains low, as it is currently, and any new development or research finding comes to light which provides the Government due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals in furtherance of the continuing efforts to combat this pandemic, it is suggested that all authorities in this country, including private organisations and educational institutions, review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources. [Para 59][523-D-F]

2.5. However, given the rapidly-changing nature of the virus and the clear purpose served by the approved vaccines in terms of restoration and protection of public health, the suggestions with respect to review of vaccine mandates are limited to the present situation alone. This judgment is not to be construed as impeding, in any manner, the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus in public interest, which may also take the form of restrictions on unvaccinated people in the future, if the situation so warrants. Such restrictions will be subject to constitutional scrutiny to examine if they meet the threefold requirement for intrusion into rights of individuals. [Para 61] [524-C-E]

Judicial notice of news item published in a newspaper

3. The courts cannot take judicial notice of facts stated in a news item published in a newspaper. A statement of fact contained in a newspaper is merely hearsay and therefore, inadmissible in evidence, unless proved by the maker of the statement appearing in court and deposing to have perceived the fact reported. In the absence of anything on record in the present case to substantiate the statement made by a member of the NTAGI, this Court is not inclined to take judicial notice of the news article reported in The Wire, even more so in light of the affidavit filed on behalf of the Union of India stating that the relevant data was examined by the expert bodies at all stages before granting emergency use approval to the vaccines. Also, the evidence relating to the approval process of the Rotavac vaccine has no relevance to the dispute in this case. On the basis of the said two incidents, it cannot be concluded that the emergency use approval to COVISHIELD and COVAXIN recommended by the SEC are not in accordance with the statutory regime. [Para 70][530-G-H; 531-A-B]

Non-disclosure of segregated clinical trial data in public domain

4. It is seen that there is a strict statutory regime in force for grant of approvals to vaccines. Specialist bodies established under the provisions of the Drugs and Cosmetics Act, 1940 and the rules framed thereunder comprise of domain experts in the relevant field, who conduct a thorough scrutiny of the material produced by the manufacturers before granting approval. The information provided on behalf of the Union of India substantiates that the data provided by the vaccine manufacturers was considered by the SEC over a period of time and several conditions were imposed at the time of recommending approvals, which have been modified or lifted subsequently on availability of further data arising from the clinical trials before the SEC, as can be seen from the minutes of the meetings of the SEC, available on the website of the MoHFW. It cannot be said that emergency approvals to the vaccines were given in haste, without properly reviewing the data from clinical trials. Also, the Parliamentary Standing Committee report relied upon by the Petitioner is not relevant and the lapses pointed out therein pertain to the year 2011, which have no obvious connection to the grant of approval to Respondent Nos. 4 and 5 for the restricted emergency use of their respective vaccines. As long as the relevant information relating to the minutes of the meetings of the regulatory bodies and the key outcomes and findings of the trials are available in public domain, the Petitioner cannot contend that every minute detail relating to clinical trials be placed in public domain to enable an individual to take an informed, conscious decision to be vaccinated or not. Given the widespread affliction caused by the virus, there was an imminent need of manufacturing vaccines which would keep the infection at bay. Both the vaccines have been approved by the WHO as well. A perusal of the material placed on record would show that there is material compliance with the procedure prescribed under the Drugs and Cosmetics Act, 1940 and the New Drugs and Clinical Trials Rules, 2019 framed under the said Act, before grant of approval for the emergency use of the two vaccines. However, it is made clear that subject to the protection of privacy of individual subjects and to the extent permissible by the 2019 Rules, the relevant data which is required to be published under the statutory regime and the WHO Statement on Clinical Trials shall be made available to the public without undue delay, with respect to the ongoing post-marketing trials of COVAXIN and COVISHIELD as well as ongoing clinical trials or trials that may be conducted subsequently for approval of other COVID-19 vaccines / vaccine candidates. [Para 76][535-E-H; 536-A-D]

Improper collection and reporting of Adverse Events Following Immunisations (AEFIs).

5. There should be a mechanism by which individuals and private doctors should be permitted to report suspected adverse events. Information relating to adverse effects following immunisation is crucial for the purpose of understanding the safety of the vaccines that are being administered, apart from being instrumental in further scientific studies around the pandemic. There is an imminent need for collection of requisite data of adverse events and wider participation of people in reporting the adverse events is necessary for the purpose of gathering correct information. Thus, the Union of India is directed to facilitate the reporting of suspected adverse events by individuals and private doctors on a virtual platform and the reports so made shall be publicly accessible after being given unique identification numbers, without listing any personal or confidential data of the persons reporting. All necessary steps to create awareness of, and to navigate, this platform for selfreporting shall be effectuated by the Government, roping in and training relevant participants right from the ground level of vaccine administration. [Para 84][541-F-H; 542-A] Vaccination of children

6.1. This Court cannot sit in judgment of leading scientific analysis relating to the safety of paediatric vaccination. Experts in science may themselves differ in their opinions while taking decisions on matters related to safety and allied aspects, but that does not entitle the Court to second-guess expert opinion, on the basis of which the Government has drawn up its policies. The decision taken by the Union of India to vaccinate paediatric population in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC have also advised paediatric vaccination. It would not only be beyond jurisdiction of this Court but also hazardous if this Court were to examine the accuracy of such expert opinion, based on competing medical opinions. The scope of judicial review does not entail the Court embarking upon such misadventures. Therefore, the contention of the Petitioner, that this Court has to intervene in paediatric vaccination on the ground that it is unscientific, is rejected. [Para 87][543-C-F]

6.2. With respect to results of clinical trials, it is noted that the Union of India has stated that the results of clinical trials of COVAXIN for paediatric population have already been published. It is further noted that for the age group of 12 to 14 years, Biological E’s Corbevax is being administered. Keeping in line with the WHO Statement on Clinical Trials, the Declaration of Helsinki and the GCP guidelines, the Union of India is directed to ensure that key findings and results of the clinical trials of Corbevax be published at the earliest, if not already done. Neither vaccine is an mRNA vaccine and to this extent, the apprehensions of the Petitioner with respect to the associated risks of mRNA vaccines are unfounded in the present situation. [Para 88] [543-F-H]

7. Conclusion

(i) Given the issues urged by the Petitioner have a bearing on public health and concern the fundamental rights of individuals in this country, this Court is not inclined to entertain any challenge to the maintainability of the Writ Petition.

(ii) As far as judicial review of policy decisions based on expert opinion is concerned, there is no doubt that wide latitude is provided to the executive in such matters and the Court does not have the expertise to appreciate and decide on merits of scientific issues on the basis of divergent medical opinion. However, this does not bar the Court from scrutinising whether the policy in question can be held to be beyond the pale of unreasonableness and manifest arbitrariness and to be in furtherance of the right to life of all persons, bearing in mind the material on record.

(iii) With respect to the infringement of bodily integrity and personal autonomy of an individual considered in the light of vaccines and other public health measures introduced to deal with the COVID-19 pandemic, this Court is of the opinion that bodily integrity is protected under Article 21 of the Constitution and no individual can be forced to be vaccinated. Further, personal autonomy of an individual, which is a recognised facet of the protections guaranteed under Article 21, encompasses the right to refuse to undergo any medical treatment in the sphere of individual health. However, in the interest of protection of communitarian health, the Government is entitled to regulate issues of public health concern by imposing certain limitations on individual rights, which are open to scrutiny by constitutional courts to assess whether such invasion into an individual’s right to personal autonomy and right to access means of livelihood meets the threefold requirement as laid down in K.S. Puttaswamy case, i.e., (i) legality, which presupposes the existence of law; (ii) need, defined in terms of a legitimate State aim; and (iii) proportionality, which ensures a rational nexus between the objects and the means adopted to achieve them.

(iv) On the basis of substantial material filed before this Court reflecting the near-unanimous views of experts on the benefits of vaccination in addressing severe disease from the infection, reduction in oxygen requirement, hospital and ICU admissions, mortality and stopping new variants from emerging, this Court is satisfied that the current vaccination policy of the Union of India is informed by relevant considerations and cannot be said to be unreasonable or manifestly arbitrary.

(v) However, no data has been placed by the Union of India or the States, controverting the material placed by the Petitioner in the form of emerging scientific opinion which appears to indicate that the risk of transmission of the virus from unvaccinated individuals is almost on par with that from vaccinated persons. In light of this, restrictions on unvaccinated individuals imposed through various vaccine mandates by State Governments / Union Territories cannot be said to be proportionate. Till the infection rate remains low and any new development or research finding emerges which provides due justification to impose reasonable and proportionate restrictions on the rights of unvaccinated individuals, it is suggested that all authorities in this country, including private organisations and educational institutions, review the relevant orders and instructions imposing restrictions on unvaccinated individuals in terms of access to public places, services and resources, if not already recalled. It is clarified that in the context of the rapidly-evolving situation presented by the COVID-19 pandemic, the suggestion to review the vaccine mandates imposed by States / Union Territories, is limited to the present situation alone and is not to be construed as interfering with the lawful exercise of power by the executive to take suitable measures for prevention of infection and transmission of the virus. The suggestion also does not extend to any other directions requiring maintenance of COVID-appropriate behaviour issued by the Union or the State Governments.

(vi) As regards non-disclosure of segregated clinical data, it is found that the results of Phase III clinical trials of the vaccines in question have been published, in line with the requirement under the statutory regime in place, the GCP guidelines and the WHO Statement on Clinical Trials. The material provided by the Union of India, comprising of minutes of the meetings of the SEC, do not warrant the conclusion that restricted emergency use approvals had been granted to COVISHIELD and COVAXIN in haste, without thorough review of the relevant data. Relevant information relating to the meetings of the SEC and the NTAGI are available in public domain and therefore, challenge to the procedures adopted by the expert bodies while granting regulatory approval to the vaccines on the ground of lack of transparency cannot be entertained. However, subject to the protection of privacy of individual subjects, with respect to ongoing clinical trials and trials that may be conducted subsequently for COVID-19 vaccines, all relevant data required to be published under the extant statutory regime must be made available to the public without undue delay.

(vii) One cannot accept the sweeping challenge to the monitoring system of AEFIs being faulty and not reflecting accurate figures of those with severe reactions or deaths from vaccines. The role of the Pharmacovigilance Programme of India and the CDSCO, as elaborated upon by the Union of India, collates and studies previously unknown reactions seen during monitoring of AEFIs at the time of vaccine administration and one trusts the Union of India to ensure that this leg of the AEFI surveillance system is not compromised with, while meeting the requirements of the rapid review and assessment system followed at the national level for AEFIs.

(viii) Information relating to adverse effects following immunisation is crucial for creating awareness around vaccines and their efficacy, apart from being instrumental in further scientific studies around the pandemic. Recognising the imperative need for collection of requisite data of adverse events and wider participation in terms of reporting, the Union of India is directed to facilitate reporting of suspected adverse events by individuals and private doctors on an accessible virtual platform. These reports shall be made publicly accessible, without compromising on protecting the confidentiality of the persons reporting, with all necessary steps to create awareness of the existence of such a platform and of the information required to navigate the platform to be undertaken by the Union of India at the earliest.

(ix) On paediatric vaccination, this Court recognises that the decision taken by the Union of India to vaccinate children in this country is in tune with global scientific consensus and expert bodies like the WHO, the UNICEF and the CDC and it is beyond the scope of review for this Court to second-guess expert opinion, on the basis of which the Government has drawn up its policy. Keeping in line with the WHO Statement on Clinical Trials and the extant statutory regime, the Union of India is directed to ensure that key findings and results of the relevant phases of clinical trials of vaccines already approved by the regulatory authorities for administration to children, be made public at the earliest, if not already done. [Para 89 (ii) to (ix)][544-A-H; 545A-H; 546-A-H; 574-A-E]

Delhi Development Authority v. Joint Action Committee, Allottee of SFS Flats (2008) 2 SCC 672 : [2007]

13 SCR 811; In re: Distribution of Essential Supplies and Services During Pandemic, (2021) 7 SCC 772; Ugar Sugar Works Ltd. v. Delhi Administration (2001)

3 SCC 635; Villianur Iyarkkai Padukappu Maiyam v. Union of India (2009) 7 SCC 561; Directorate of Film Festivals v. Gaurav Ashwin Jain (2007) 4 SCC 737: [2007] 5 SCR 7; Pyarali K.Tejani v. Mahadeo

Ramchandra Dange (1974) 1 SCC 167 : [1974]

2 SCR 154; Union of India v. Dinesh Engineering Corporation (2001) 8 SCC 491; Common Cause (A Registered Society) v. Union of India (2018) 5 SCC 1 : [2018] 6 SCR 1; K. S. Puttaswamy v. Union of India (2017) 10 SCC 1 : [2017] 10 SCR 569 and Ashwani Kumar v. Union of India (2019) 2 SCC 636 : [2018]

13 SCR 1286 – relied on

Indian Banks’ Association, Bombay v. Devkala

Consultancy Service (2004) 11 SCC 1 : [2004] 1 Suppl. SCR 225; Academy of NutritionImprovement v. Union of India, (2011) 8 SCC 274: [ 2011] 8 SCR 680; G. Sundarrajan v. Union of India (2013) 6 SCC 620 : [2013] 8 SCR 631; Shri Sitaram Sugar Company Ltd. v. Union of India (1990) 3 SCC 223 : [1990] 1 SCR 909; Aruna Ramachandra Shanbaug v. Union of India (2011) 4 SCC 454 : [2011] 4 SCR 1057; National Legal Services Authority v. Union of India (2014) 5 SCC

438 : [2014] 5 SCR 119; X v. Hospital ‘Z’ (1998) 8 SCC 296 : [1998] 1 Suppl. SCR 723; Kharak Singh v State of U.P., [1964] 1 SCR 332; Gobind v. State of M.P. (1975) 2 SCC 148 : [1975] 3 SCR 946;

Association of Medical Super Speciality Aspirants and Residents v. Union of India (2019) 8 SCC 607 : [2019]

12 SCR 1011; Vincent Panikurlangara v. Union of India (1987) 2 SCC 165; ArunaRodrigues (4) v. Union of India (2011) 12 SCC 481; and Laxmi Raj Shetty v. State of Tamil Nadu (1988) 3 SCC 319 : [1988] 3 SCR

706 – referred to.

Henning Jacobson v. Commonwealth of Massachusetts

197 US 11 (1905); Zucht v. King, 260 US 174 (1922); Henry v. Hazzard [2021] NSWSC 1320; Ryan Yardley v. Minister for Workplace Relations and Safety [2022] NZHC 291; Roman Catholic Diocese v. Cuomo 141 S. Ct. 63 (2020); South Bay United Pentecostal Church v. Newsom 140 S. Ct. 1613 (2020); Kassam v. Hazzard; Henry v. Hazzard [2021] NSWCA 299; Ministry of Health v. Atkinson [2012] NZCA 184; Jane Roe v. Henry Wade 410 US 113 (1973); Four Aviation Security Service Employees v. Minister of COVID-19 Response [2021] NZHC 3012 and Spencer v. Attorney General of Canada [2021] FC 361 – referred to.