Summary
A public-interest petition challenged COVID-19 vaccination mandates, trial-data disclosure, adverse-event reporting and vaccination of children. The Court upheld the expert-led vaccination policy and regulatory approvals while recognising bodily autonomy. On the evidence and conditions then prevailing, restrictions on unvaccinated persons’ access to public places and services were disproportionate and called for review. It directed improved public reporting of suspected adverse events and timely disclosure of required trial results, protecting privacy.
Issues
- Whether vaccination policy and access restrictions violated bodily autonomy and proportionality.
- Whether approval, trial disclosure and adverse-event surveillance required judicial intervention.
- Whether the policy of vaccinating children warranted interference.
Provisions considered
- Articles 14 and 21, Constitution of IndiaScientific policy remained reviewable for arbitrariness and infringement of fundamental rights; bodily autonomy and public-health restrictions required constitutional proportionality. (¶¶ 21-25, 48-61)
- Rules 19 and 25(vi), read with the First Schedule, New Drugs and Clinical Trials Rules, 2019The approval and trial framework, including ethical safeguards and good clinical practice, informed the finding of substantial regulatory compliance and directions for required public disclosure. (¶ 63-76)
Held
- Judicial restraint in scientific matters did not exclude review of arbitrary policy or violations of fundamental rights. The vaccination policy rested on relevant expert material; the Court would not substitute its scientific assessment or determine that natural immunity was superior. (¶¶ 21-25, 39-40, 54-56)
- Bodily integrity and personal autonomy under Article 21 protected refusal of medical treatment, and no person could be physically forced to receive a vaccine. Public-health measures affecting individual choice nevertheless remained possible if supported by law, a legitimate aim and proportionality. (¶¶ 41, 48-50, 89)
- On the material produced, the governments had not rebutted the evidence concerning transmission by vaccinated and unvaccinated persons sufficiently to justify the challenged access restrictions. Authorities, including private and educational institutions, were called upon to review such restrictions while infection levels remained low and until further research justified them. This conclusion depended on the then prevailing evidence and conditions; it neither displaced COVID-appropriate behaviour nor foreclosed constitutionally valid future restrictions. (¶¶ 58-61, 89)
- The material did not establish hasty or unlawful approval of Covaxin and Covishield. Transparency required publication of relevant findings and results under the applicable framework, rather than compulsory disclosure of every primary or segregated dataset. Required data for ongoing post-marketing and future trials had to be made public without undue delay, preserving participants’ privacy. (¶¶ 62-76, 89)
- The general challenge to adverse-event surveillance failed. An adverse event following vaccination did not itself establish causation. The Union was directed to facilitate public and private-practitioner reporting of suspected events through an accessible virtual mechanism, assign identifiers, publish reports without personal confidential information and promote awareness and training. (¶¶ 77-84, 89)
- The expert-supported policy of vaccinating children did not warrant interference. Relevant key findings and results for approved paediatric vaccines were to be made public at the earliest if not already disclosed. (¶ 85-89)
Result
Writ petition disposed of with directions for review of the challenged access restrictions in the conditions then prevailing, improved reporting and publication of suspected adverse events, and timely disclosure of required clinical-trial findings and results subject to privacy safeguards.