Concerns Raised in Petitions
Petitions in India have raised concerns over the approval, transparency, and side effects of vaccines, especially COVID-19 vaccines.
Issues include alleged failures in vaccines (like anti-rabies), lack of transparency in clinical trial data, and the monitoring of adverse vaccine reactions.
Petitioners have called for independent committees to review vaccine data and greater transparency in the approval process by the Central Drugs Standard Control Organisation (CDSCO).
Transparency and Regulatory Issues
CDSCO’s decision-making process is opaque, and details about doctors and their conflicts of interest are not disclosed.
Clinical trial data is not released to the public, making it difficult for the public to trust the approval process.
There’s a need for clearer communication about vaccine side effects to ensure informed consent from citizens at the time of vaccination.
Informed Consent and Pharmacovigilance
Current laws do not provide a clear framework for 'informed consent' outside clinical trials.
A stronger pharmacovigilance system to track vaccine-related adverse events, known as an ‘adverse event following immunisation’ (AEFI) is needed
with better implementation to ensure accurate data collection and prevent pharmaceutical companies from controlling information.
Compensation Issues
The issue of compensation for those harmed by vaccine side effects, particularly for COVID-19 vaccines, is unresolved.
The government’s role in providing compensation is unclear unless vaccine manufacturers are indemnified.
The government should address these concerns through policy discussions, rather than relying on court decisions, to improve public trust and create a clearer framework for accountability.
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