A bad omen for public trust in vaccines, Pg 7

Legal & Regulatory Concerns

• Multiple petitions filed regarding COVID-19, rabies, and rotavirus vaccines.
• Allegations include lack of trial data transparency, monitoring of side-effects, and biased regulatory decisions by CDSCO.

Issues in Approval Process

• CDSCO decisions rely on "independent" experts, but details are undisclosed.
• No public clinical trial data, hampering informed consent and public confidence.

Issue of Compensation

• Kerala High Court in X v. Union of India (2022) demanded a clear compensation policy for vaccine side-effects.
• Govt appealed; compensation remains unresolved.

Defamation by Pharma Giants

• Companies like Serum Institute and Bharat Biotech have sued critics, worsening perception of opacity.

AEFI Monitoring Gaps

• India's current Adverse Event Following Immunisation (AEFI) setup lacks implementation force.

Analysis & Way Forward

• Build transparency, make trial and conflict data public, and establish a compensation law.
• The Health Ministry must acknowledge genuine concerns, not dismiss them as anti-science.

Mains Mock Question:

"Discuss the implications of lack of transparency in drug and vaccine regulation in India. Suggest measures to rebuild public trust in the regulatory process."