Saket S Gokhale, an activist has moved the Bombay High Court against the Drugs and Controller General of India (DCGI). Gokhale seeks publication of Phase-3 trial results of Covaxin- an indigenous vaccine developed by Bharat Biotech.
The petition states that the data submitted by Bharat Biotech has not made the results public. As per reports, the Phase-3 trails are underway and the DCGI has given approval to Covaxin for emergency use.
The petitioner has referred to a press note issued by the Government of India on January 3 where the government had approved Covaxin for "restricted use in emergency situation."
Hence, the petitioner has stated the Bharat Biotech has not been granted full approval. The plea states, "every person that is administered M/s Bharat Biotech's Covaxin will technically be seen as a participant in the company's Phase 3 trials and monitored accordingly as per the rules of Phase 3 trial process."
The petitioner had urged in the plea to make the Phase-3 trials public for "Peer-review by independent scientists or evaluation by external subject matter experts."
Gokhale further mentions in his plea that he sought a response under RTI application dated January 4, 2020 but he got no response with respect to the data of Covaxin and Covishield. The response RTI is still awaited, however, it should have been provided within 48 hours of receiving the RTI application.
Gokhale contends that the 'Right to Know' under Article 19 of the constitution of India has been violated by the respondent for not responding to his RTI application.
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