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PIL filed in SC seeking clinical trial data of Covid vaccines

Dr Jacob Puliyel, a former member of the National Technical Advisory Group on Immunisation has filed a PIL in the Supreme Court seeking clinical trial data of Covid vaccines.

Supreme Court
Supreme Court

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Published : May 13, 2021, 6:10 PM IST

Updated : May 13, 2021, 9:22 PM IST

New Delhi: Former member of National Technical Advisory Group on Immunisation (NTGAI), Dr Jacob Puliyel, has filed a PIL in the Supreme Court in a bid to get the government, ICMR, Serum Institute and Bharat Biotech to disclose segregated vaccine trial data for each of the phases and post-vaccination data including information on its adverse effects.

He has sought directions to be given to the Central Drugs Standard Control Organisation to disclose the details of the meeting between the subject expert committee and NTGAI regarding vaccines and reasoned decision of the DCGI approving or rejecting an application for emergency use authorization of vaccines, documents and reports submitted to the DCGI in support of such application.

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"The disclosure of such information is essential to ascertain whether a certain section of the population is more susceptible to adverse effects, to determine what are the adverse effects in various age groups on differing populations, etc. So far, the respondents have practiced complete secrecy in a matter and have not disclosed any data from trials for the vaccines that have been developed in India," read the plea.

Petitioner contends that WHO and ICMR both need to advocate complete disclosure as without it, doctors, patients, medical regulators can not make an informed decision. Section 4 of the Right to Information Act,2005, requires the government to make proactive disclosures of its records through the internet and other means of mass communication to the general public, the plea mentioned.

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"Declare that vaccine mandates, in any manner whatsoever, even by way of making it a precondition for accessing any benefits or services, is a violation of rights of citizens and unconstitutional," prayed the petitioner.

Last Updated : May 13, 2021, 9:22 PM IST

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