Mumbai News

Activist Saket Gokhale petitions Bombay high court; seeks safety info on ‘Covaxin’ – Times of India

MUMBAI: A right to information (RTI) and social activist Saket Gokhale on Saturday filed a petition before Bombay high court for orders to get information he had sought on the vaccine trials and efficacy, on an urgent basis.
He has sought directions to Drug Controller General of India (DCGI) to bring details of the Covid-19 Covaxin’s safety and effectiveness in public domain. The vaccine has been made by is by Bharat Biotech.
Gokhale said he had requested information in an RTI application in what he said is also the general public’s “Right to Know” and also data that would pertain to “life and liberty”.
Gokhale in a petition filed for a hearing via videoconference, said that while the vaccination drive in India begins from January 16 and that Covaxin is safe and provides a “robust immune response”, the data from the company given to the DCGI ought to be made public too.
He said he is compelled to invoke the extraordinary jurisdiction of the HC under Article 226 “to remedy the damage caused to the general public of India through the violation of the fundamental right to life and liberty…by failure to provide information under Sec 7(1) of the Right to Information Act, 2005 within 48 hours in a matter pertaining to life and liberty.”
On January 3 the authorities issued a press release “stating that Covid-19 vaccines of M/s Serum Institute of India (named Covishield) and M/s Bharat Biotech (named Covaxin) have been approved for restricted use in emergency situation.”
The approval was granted based on recommendations of the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO). The committee is a division of the DGCI, said the petition.
Gokhale’s petition said “from the press release” Covaxin was granted “restricted use approval in clinical trial mode while the company’s Phase 3 trials are ongoing.”
It added, “A trial vaccine that has not completed Phase III trials as in the case of M/s Bharat Biotech’s ‘Covaxin’, there remains a great possibility of harm to the life of general people who are being administered this vaccine,” the petition said.
The petition said “while the press release states that M/s Bharat Biotech’s ‘Covaxin’ is safe and provides a robust immune response based on data submitted by the company, this data has not been made available in the public domain”Therefore, on 04/01/2021, Gokhale filed a RTI application to seek “safety, efficacy, and all other relevant data submitted by the Serum Institute of India (SII) for its Covid-19 vaccine ‘Covishield’ to the Drugs Controller General (India) for emergency use approval” and also similar data on covaxin.
He said he has yet to receive reply to his RTI query and hence has petitioned the HC given the launch of the first Phase of Covid-19 vaccination in India beginning on Saturday with an aim to vaccinate 3 crore healthcare and frontline workers.
“Moreover, the NITI Aayog of the Government of India has also said that the vaccines administered under this 1st Phase will include a mix of both M/s Serum Institute of India’s “Covishield” as well as M/s Bharat Biotech’s “Covaxin”.”