Delhi High Court Calls Merck Vaccine Rollout "Very Serious Matter"
GS2Polity · Governance · IR· Health policy & public health· Prelims + Mains·
Why in news
The Delhi High Court expressed concern over the inclusion of Merck's Gardasil HPV vaccine in the Universal Immunisation Programme following a PIL alleging deaths during previous clinical trials.
Background
A Public Interest Litigation (PIL) was filed by Dr. Sujata Mittal and Jitendra Chouksey regarding the safety of the Gardasil HPV vaccine. The Delhi High Court has sought formal responses from the Ministry of Health and Family Welfare, ICMR, and CDSCO by July 29.
Facts for Prelims
- BodyICMR: Indian Council of Medical Research, the apex body for biomedical research in India.
- BodyCDSCO: Central Drugs Standard Control Organisation, the national regulatory body for cosmetics, pharmaceuticals, and medical devices.
- FactUniversal Immunisation Programme (UIP): A flagship government initiative to provide vaccines against preventable diseases to children and pregnant women.
- PostMinistry of Health and Family Welfare: The nodal ministry responsible for national health policy and vaccine procurement.
For Mains
Q. Discuss the regulatory framework for vaccine safety in India and the importance of clinical trial transparency in public health programs.
Dimensions to cover in your answer
- Regulatory oversight: Balancing rapid vaccine rollout with stringent safety monitoring by CDSCO and ICMR.
- Public trust deficit: Addressing concerns regarding adverse events in clinical trials to ensure vaccine uptake.
- Liability framework: Determining legal accountability for vaccine-related injuries in public health schemes.
Keywords: Public Health Safety · Regulatory Oversight · Clinical Trial Transparency · Universal Immunisation Programme · Adverse Events
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