Vaccine Safety Concerns in India and Required Policy Reforms

Source: The post Vaccine Safety Concerns in India and Required Policy Reforms has been created, based on the article “A bad omen for public trust in vaccines” published in “The Hindu” on 26 March 2025. Vaccine Safety Concerns in India and Required Policy Reforms.

UPSC Syllabus Topic: GS Paper2- Governance-Issues relating to development and management of Social Sector/Services relating to Health.

Context: In recent years, several petitions have been filed in Indian courts concerning vaccine safety and regulation. While most relate to COVID-19 vaccines, some address issues with the rabies and rotavirus vaccines. These petitions highlight growing concerns over how vaccines are approved, monitored, and administered in India.

For detailed information on Vaccine Regulations In India read this article here

Reasons for Filing Petitions About Vaccines in India

1. Deaths and Adverse Events: A petition in Kerala cited deaths linked to the anti-rabies vaccine.
2. Transparency Issues: Concerns over the opacity in the vaccine approval process by CDSCO and undisclosed conflicts of interest among decision-makers.
3. Inadequate Information Disclosure: Incomplete information on vaccine side-effects and poor public access to clinical trial data.
4. Compensation for Harm: Legal action, like in Sayeeda v. Union of India (2022), seeks government policies on compensating vaccine-related harms.
5. Ineffective Monitoring: Weak implementation of the system for tracking adverse events following immunization (AEFI).

Problem highlighted by these petitions

1. Courts are poorly equipped to address vaccine issues due to their complex scientific nature.
2. Legal proceedings are lengthy and often result in unsatisfactory and poorly reasoned orders.
3. For example, courts have granted exparte interim injunctions to vaccine manufacturers against critics, which can stifle necessary public debate.
4. Judicial handling can detract from the credibility of vaccine manufacturers and does not resolve underlying public health concerns.
5. Effective resolution of these issues lies in policy reform and regulation by health authorities, not litigation.

Steps Needed to Ensure Informed Consent and Public Safety

1. Clear and Timely Information: Ensure that information about vaccine side-effects is provided clearly and directly to recipients at the time of vaccination, not merely posted on websites.
2. Strengthening AEFI Guidelines: Transition the current Adverse Event Following Immunization (AEFI) guidelines into a robust legal framework to enhance data collection and transparency.
3. Public Disclosure of Trial Data: Mandate the public disclosure of all clinical trial data and the CDSCO’s internal analysis to build public trust in vaccine approvals.
4. Compensation Policy: Implement a government policy for compensating those adversely affected by vaccines, as directed by the Kerala High Court in Sayeeda v. Union of India (2022). This policy should clarify the circumstances under which vaccine manufacturers or the government is liable, depending on indemnity clauses which are currently not public.

Conclusion

Except for compensation, most vaccine-related concerns are policy matters. The Health Ministry should respond with legal and regulatory reforms instead of leaving them to be settled in courts.

Question for practice:

Examine the concerns raised in recent petitions regarding vaccine safety and regulation in India and suggest policy measures to address them.