The government has requested the Supreme Court to dismiss a petition filed jointly by the parents of two young women who died allegedly after they took a Covid vaccine.
In a 276-page reply to a court notice seeking its response to the petition, the government said the vaccine, Covishield, had gone through a rigorous safety review and regulatory approval process before it got the clearance.
The parents of the women, meanwhile, said they were going to counter every point of the government’s response.
The government, which also provided details of the approval procedure, said the regulatory approval process of vaccines under the Drugs and Cosmetics Act and Rules was a “well-established”, “internationally recognised system” with “several layers of independent expert review for safety and efficacy”.
Detailing the process for Covid-19 vaccines, the government said once a vaccine was approved for use by the Central Drugs Standard Control Organisation, a detailed examination of scientific evidence and data would be conducted by the National Immunisation Technical Advisory Group (NTAGI).
Further, it said, the recommendations of the NTAGI would undergo another layer of expert review by the National Expert Group on Vaccine Administration for Covid-19. The final recommendations on use and administration would then be placed before the Ministry of Health for its approval. In September this year, the Supreme Court had admitted a writ petition filed jointly by the families of the two women and issued notice to the government.