Context

• Over the past few years, the Indian judiciary has witnessed a surge in petitions related to vaccine approvals and administration.
• While most of these petitions focus on COVID-19 vaccines, concerns have also been raised regarding the rabies and rotavirus vaccines.
• These legal challenges highlight serious issues such as transparency in regulatory processes, informed consent, adverse event monitoring, and compensation for vaccine-related injuries.
• Addressing these concerns through policy reform rather than prolonged litigation is crucial for maintaining public trust in vaccines.

Concerns Raised in Vaccine-Related Petitions

• Lack of Transparency
  • It is incorrect to categorise these petitions as mere offshoots of the global "anti-vax" movement, which often relies on conspiracy theories.
  • Instead, these cases highlight genuine concerns about vaccine safety and regulatory transparency.
  • For instance, a petition from Kerala brought before the Supreme Court alleged deaths due to the failure of an anti-rabies vaccine.
  • Other petitions challenge the lack of publicly available clinical trial data, insufficient disclosure of side effects, poor adverse event monitoring, and the absence of a structured compensation mechanism for those affected by vaccines.
• Declining Trust in CDSCO
  • A significant issue is the public’s declining trust in the Central Drugs Standard Control Organisation (CDSCO), India’s regulatory authority.
  • This lack of trust is evident from petitioners’ demands for independent committees to reassess clinical trial data rather than relying on the CDSCO’s decisions.
  • Additionally, vaccine manufacturers such as Serum Institute and Bharat Biotech have filed defamation lawsuits against critics, with courts granting ex-parte injunctions in some cases.
  • Such actions undermine public confidence and highlight the urgent need for policy intervention rather than judicial proceedings.

Some Other Factors Driving the Petitions

• Transparency Issues in Vaccine Approval
  • One of the primary concerns driving these petitions is the opaque manner in which the CDSCO approves vaccines. Two key transparency-related issues must be addressed.
  • First, while the CDSCO makes regulatory decisions with input from "independent" experts, the identities of these individuals and any conflicts of interest are not disclosed.
  • To restore public confidence, the government must publish details of these experts and provide transcripts of their deliberations.
  • Second, there is no public access to the clinical trial data that forms the basis of vaccine approvals.
  • Currently, pharmaceutical companies submit trial data to the CDSCO, but this information remains confidential.
  • For transparency, the CDSCO should release raw clinical trial data and its internal evaluations, ensuring that patient privacy is protected through necessary redactions.
• Consent and Adverse Event Monitoring
  • Another significant concern raised in petitions is the lack of adequate disclosure about vaccine side effects.
  • Informed consent requires that individuals receive clear and understandable information before vaccination.
  • However, in India, informed consent laws apply only to clinical trials and not to general vaccination programs.
  • The government’s practice of publishing vaccine-related information on obscure websites is inadequate.
  • Instead, information on potential side effects should be made available in accessible formats at vaccination centres.
• Lack of a Strong Legal Framework
  • Furthermore, India’s system for monitoring vaccine-related adverse events, known as Adverse Event Following Immunisation (AEFI), lacks a strong legal framework.
  • Current AEFI guidelines are not legally binding and suffer from poor implementation.
  • Establishing a robust pharmacovigilance system backed by parliamentary legislation would ensure high-quality data collection, independent of pharmaceutical companies’ influence.

The Issue of Compensation for Vaccine-Related Injuries

• A critical issue that remains unresolved is compensation for individuals who suffered severe side effects or lost family members due to COVID-19 vaccines.
• In the case of Sayeeda v. Union of India (2022), the Kerala High Court directed the government to formulate a compensation policy, but the government challenged this order in the Supreme Court, where final arguments are still pending.
• From a legal standpoint, compensation claims should be directed at vaccine manufacturers, as they developed, sold, and profited from the vaccines.
• The government’s role in compensating victims would depend on whether it had agreed to indemnify vaccine manufacturers, but the lack of transparency regarding vaccine purchase agreements makes this unclear.
• Notably, foreign vaccine manufacturers hesitated to enter the Indian market due to the government’s refusal to provide indemnity, allowing Indian manufacturers to dominate the industry and profit significantly.
• Given this, they should also bear responsibility for vaccine-related risks.

The Way Forward: Need for Policy Intervention

• While the compensation issue remains a matter for the courts, other concerns, such as regulatory transparency, informed consent, and adverse event monitoring, should not be left to legal proceedings.
• These are policy matters with significant long-term implications for public trust in vaccines.
• Instead of allowing these issues to be litigated over years with uncertain outcomes, the Ministry of Health should address them proactively through legislative and policy measures.
• The Health Minister should reassure concerned petitioners that their grievances are being taken seriously and commit to implementing reforms.
• A well-drafted law covering vaccine approval transparency, informed consent, and adverse event reporting would be a step in the right direction.
• Such a policy-driven approach would not only improve public confidence in vaccines but also prevent unnecessary litigation that burdens both the courts and the healthcare system.

Conclusion

• The growing number of vaccine-related petitions in India reflects legitimate concerns rather than unfounded scepticism.
• These petitions underscore the need for greater transparency in vaccine approvals, better disclosure of side effects, robust adverse event monitoring, and a fair compensation mechanism for affected individuals.
• Instead of relying on prolonged and often ineffective litigation, policymakers must take responsibility for addressing these issues through legislative reforms.
• Strengthening regulatory transparency and public trust in vaccines is essential for the success of India’s immunization programs and overall public health.