Congress leaders question ‘modification’ of protocols to approve Covaxin

Health Ministry needs to give proper reasons for dispensing with the mandatory protocols, says Anand Sharma.

Updated - January 03, 2021 10:58 pm IST

Published - January 03, 2021 12:37 pm IST - New Delhi

Deputy leader of the Congress in the Rajya Sabha Anand Sharma on Sunday expressed concern over the Drug Controller General of India (DCGI) granting permission for restricted use of Bharat Biotech’s COVID-19 vaccine by “dispensing” with mandatory protocols and verification of data.

On Sunday, the DGCI, India’s drug regulator, approved Oxford University’s Covishield, and Bharat Biotech’s Covaxin for “restricted emergency use”.

Also read: Drug Controller General approves Covishield and Covaxin in India for ‘emergency use’

IMr. Sharma, who heads the Parliamentary Panel on Home Affairs that extensively dealt with the issue, said no country had dispensed with mandatory Phase-3 trials and verification of data, and the issue of granting authorisation needs to be taken carefully.

He said that going by the submission made to the expert panel, Phase-3 trials have not been completed and, therefore, the data on safety and efficacy has not been reviewed.

Also read: COVID-19 vaccine rollout possible in 10 days, says NITI Aayog member V.K. Paul


“Verification of data and Phase-3 trials are mandatory requirements. The Health Ministry needs to give proper reasons for dispensing with the mandatory protocols and requirements in this case, since it involves the health and safety of those frontline workers who will be vaccinated under the restricted category,” Mr. Sharma told The Hindu .


“The DCGI statement is puzzling and the government must reveal the final data on global efficacy trials and the final trials in the U.K., which has been shared officially by the U.K.’s MHRA (Medicines and Healthcare products Regulatory Authority) following a government-to-government agreement signed between the two countries, which should be put in the public domain to avoid any confusion on the proven efficacy of the vaccine,” he added.

The Congress leader, however, said that the news of the imminent arrival and roll-out of the nation-wide vaccination drive is “truly uplifting and reassuring” for a country paralysed by the pandemic.

Also read: Coronavirus | Why people with prior infection still need COVID-19 vaccination

“It is also a tribute to our scientists, researchers and institutions, who have established India as the largest vaccine manufacturer of the world,” he said.

Mr. Sharma’s colleague in the Rajya Sabha, Jairam Ramesh, asked Health Minister Harsh Vardhan to clarify why internationally-accepted protocols on Phase-3 trials are being modified.

Also read: Experts raise questions over ‘hasty’ approval for COVID-19 vaccines


“Bharat Biotech is a first-rate enterprise, but it is puzzling that internationally-accepted protocols relating to phase 3 trials are being modified for Covaxin. Health Minister Harsh Vardhan should clarify,” Mr. Ramesh said on Twitter.

When Bharatiya Janata Party (BJP) leaders, including party president J.P. Nadda and Union Minister Hardeep Singh Puri, accused Congress leaders of being unhappy with “Made in India” vaccines , the Congress hit back.

“Congress party has full belief in our scientific community. Whatever they decide, we are going to follow them, but we want that the best vaccine [be provided] after completing all protocols,” party spokesperson Gourav Vallabh said at a press conference.

Earlier, the Parliamentary Standing Committee on Home Affairs, in a report submitted to Rajya Sabha Chairman M. Venkaiah Naidu on December 21, had noted that the Central Drugs Standard Control Organisation has given no emergency use authorisation in the past and suggested that “all necessary and mandatory requirements must be duly fulfilled and all trial phases completed”.

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