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The Union Health Ministry has refused to furnish the data based on which the vaccines–Serum Institute of India's Covishield and Bharat Biotech's Covaxin–received the formal clearance for its emergency use authorisation.
The ministry refused to make the documents public under Right To Information (RTI), citing the reasons of commercial confidence, trade secrets, intellectual property rights, and that the information being sought is with the regulatory agency in 'fiduciary relationship'.
The ministry responded to the RTI filed by transparency activist and independent journalist Saurav Das on January 3, seeking information about the considerations and approval of each company's vaccines.
Das filed the application with the Central Drugs Standard Control Organisation (CDSCO), under threat to 'Life or Liberty' clause, and demanded information be provided within 48 hours before the second phase of vaccination drive begins in the next week.
After both the vaccines received emergency use approval from the Drug Controller General of India (DCGI), Das sought the certified copies of the evidence, data and studies provided by both the firms that suggested the efficacy of their vaccines, under which the medical body gave the clearance to each company.
He had also requested to furnish the details of the file notings, internal communications, correspondences, OMs, and the minutes of the meetings/discussions to provide the approval.
Details of the records related to the internal communications between the health ministry and the concerned officers and the inter-ministerial communications related to the approval were also requested.
Das also sought the data/evidence based on which Dr VG Somani had claimed 110 per cent efficacy of the vaccines, during a press conference on January 3.
He had also sent a notice to the DCGI and the Central Public Information Officer regarding the same.
Speaking to The Logical Indian, Das said the officer he connected with claimed that the information did not fall under the 'Life or Liberty' clause. After much resistance, the officer forwarded the matter to the concerned team.
The response received on Thursday, January 21 stated that the clarification is not covered under the RTI. It further read that the 'sought information is exempted under section 8 (1) (d) and (e) of the RTI Act, 2005.
On a query seeking details of the data based on which DCGI Dr Somani claimed vaccines are '110 per cent safe', the CDSCO replied saying that the Subject Expert Committee (SEC) recommendations are available in CDSCO.
It is to be noted that Bharat Biotech was granted approval for the emergency of Covaxin in the 'clinical trial mode'.
"How is denying the data serving any public interest? It is only serving the interests of private companies. The CDSCO has simply claimed a blanket exemption without giving specific details like who is the third party, what exact harm would be caused to them, how they will be affected, etc, which they are required to furnish under the law," Das said.
Das said the RTI Act provides for overriding any exemptions if there is significant public interest involved. "However, it seems the Government thinks there is no public interest involved and seeks to protect the interests of only these private companies. This is absolutely shocking and insensitive, to say the least. The Government wants us to 'trust the vaccine' but when we ask for the data to see if we can really trust it, they deny it. It doesn't work this way."
Das said that denying the data of approvals is a long-standing problem with the Health Ministry. "Foreign regulators like the FDA and others regularly release the data based on which they approve/reject medicines/vaccines. But here in India, the situation is like 'wild west'. This has to change and now is the right time. I am in touch with my lawyers and apart from going to the Central Information Commission against this order, I am pondering over the possibility of moving the Court."
According to the health ministry's report, the country has reported over 500 adverse events following immunisation (AEFI) out of 381,305 people vaccinated for COVID-19 till Monday, along with four fatalities. Three of them, the ministry claims, are not related to the vaccine.
The number of adverse events and deaths reported does convey the need for the information.
Another RTI Activist, Saket Gokhale, had also applied with CDSCO, demanding the information about the data and the studies taken into consideration for the approval of the Covaxin. They refused to disclose it because 'disclosure would harm the competitive position of Bharat Biotech.' Gokhale has filed a petition in the Bombay High Court.
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