Saket S Gokhale, an activist has moved the Bombay HighCourt against the Drugs and Controller General of India (DCGI). Gokhale seekspublication of Phase-3 trial results of Covaxin- an indigenous vaccinedeveloped by Bharat Biotech.
The petition states that the data submitted by BharatBiotech has not made the results public. As per reports, the Phase-3 trails areunderway and the DCGI has given approval to Covaxin for emergency use.
The petitioner has referred to a press note issued by theGovernment 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 hasnot been granted full approval. The plea states, "every person that isadministered M/s Bharat Biotech's Covaxin will technically be seen as aparticipant in the company's Phase 3 trials and monitored accordingly as perthe rules of Phase 3 trial process."
The petitioner had urged in the plea to make the Phase-3trials public for "Peer-review byindependent scientists or evaluation by external subject matter experts."
Gokhale further mentions in his plea that he sought aresponse under RTI application dated January 4, 2020 but he got no responsewith respect to the data of Covaxin and Covishield. The response RTI is stillawaited, however, it should have been provided within 48 hours of receiving theRTI application.
Gokhale contends that the 'Right to Know' under Article19 of the constitution of India has been violated by the respondent for notresponding to his RTI application.