In what can be termed as a brutal assault on the Right to Information (RTI) Act, the Central Drug Standard Control Organisation (CDSCO), which is the nodal authority for drug clearance, says it has no information on the World Health Organisation’s (WHO) suspension of the supply of Covaxin (Bharat Biotech) after the latter’s inspection between 14th–22 March 2022 had identified deficiencies in good manufacturing practices (GMP).
In a hard-hitting report, WHO has recommended that countries using the vaccine take 'action as appropriate’. Despite WHO having confirmed that the inspection was conducted along with the CDSCO authorities and a report was promptly submitted to them, the central public information officer (CPIO) of CDSCO has replied under the RTI Act, “No such information is available.”
Thanks to the effort of two young investigative journalists, Saurav Das and Priyanka Pulla, who are pursuing this explosive story, we are able to gauge the dangerous level to which public authorities are denying crucial information that is mandatory under Section 4 of the RTI Act. For, this information pertains to the lives of the people as the vaccine is going to be injected into their bodies, possibly with life-threatening results.
On being denied information, Mr Das has submitted a complaint under Section 18 of the RTI Act before the central information commission (CIC) Delhi, asking for urgent hearing of this COVID-19 related matter. This is on the basis of a Madras High Court order which had ordered CICs to take up the hearing of such second appeals on a priority basis. States Mr Das, “CPIO Sushanta Sarkar’s claim that he has no information is absolutely false and deceitful. It has been provided so as to withhold and suppress vital information of larger public interest, and the same is equivalent to malafide denial of information.’’
Mr Das has asked for the following information:
1. Whether the CDSCO has taken cognizance of the inspection done by the WHO. If so, kindly provide the date when the matter was put up before the competent authority.
2. Kindly furnish the action taken if any, on this matter.
3. Kindly furnish whether Bharat Biotech has been asked for a report or explanation on the matter. If so, the details thereof and a copy of the communication thereof.
4. Kindly furnish whether the CDSCO or its attached offices has inspected the sites of Bharat Biotech till date. If so, the dates be provided.
5. Furnish whether any further action is being taken to investigate the claims made in the WHO report, including any site inspections of Bharat Biotech. If so, furnish the details thereof, including the details of the team that will carry out such an inspection.
6. Whether this public authority has written to the WHO on this matter. If so, furnish the copies of such communication and the reply received, if any.
Meanwhile, journalist Ms Pulla, who communicated with WHO on this issue, has established that CDSCO indeed has the required information which has been denied to Mr Das and her. The email reply sent to Ms Pulla by Tarik Jašarević, spokesperson, media relations, WHO, states, “As per WHO procedure, the National Medicines Regulatory Authority of India, the CDSCO was informed and invited to join the inspection. Inspector from CDSCO joined the team inspecting Bharat (Biotech) for the last two days of the inspection (21 and 22 March 2022).’’
The email ([email protected]
) further states, “A draft inspection report was shared with Bharat (Biotech) on 22 March 2022 immediately after the closing meeting of the site inspection. This email was also copied to the representative of CDSCO. Acknowledgments of receipt of the draft inspection report were received by email from the representative of Bharat Biotech and also from the CDSCO inspector, both on 23.03.22. Subsequently, a meeting was held by WHO with CDSO and the Drug Controller-General of India in late March 2022 to discuss the findings in the report and agree on the next steps. The final inspection report was sent by the WHO PQT Inspection Team to Bharat (Biotech) on 30.03.22, with the confirmations of receipt received from Bharat (Biotech)’s CEO.’’
Ms Pulla, who had also used RTI to procure information but was denied, emailed the WHO spokesperson, for the information, stating, “After I wrote this story for Science Mag, I asked the CDSCO under India's RTI Act for a copy of the WHO inspection report. They responded saying they didn't have any such document. Subsequently, I filed a second RTI asking for a copy of any written communication from the WHO to CDSCO, or any report prepared internally by CDSCO following the inspection. The CDSCO responded saying they didn't have any such documents either. So, I would like to know from the WHO if it shared its inspection report with the CDSCO, or sent any form of written communication about the inspection to the agency related to the inspection? Please do clarify.
Mr Das, in his complaint to central information commission (CIC), has appealed for the CPIO “to be punished with nothing less than a recommendation for disciplinary action for acting in the most malafide manner by providing, deliberately, false information. And that all associated deemed CPIOs be also punished in the same manner.’’
He is rightly aggrieved that CDSCO has repeatedly denied information on Covaxin when asked under RTI.
As per the 2019-CT Rules and the Hdbk-ClinTrial, CDSCO is the regulatory authority responsible for clinical trial oversight, approval and inspections in India. CDSCO is headed by the drugs controller general of India (DCGI). Therefore, it is difficult to accept the submission of CDSCO that the WHO report on Covaxin relevant to the present case was never received by CDSCO and that it has no information whatsoever on the matter. It reeks of malice and is utter lies.
(Vinita Deshmukh is consulting editor of Moneylife. She is also the convener of the Pune Metro Jagruti Abhiyaan. She is the recipient of prestigious awards like the Statesman Award for Rural Reporting, which she won twice in 1998 and 2005 and the Chameli Devi Jain award for outstanding media person for her investigation series on Dow Chemicals. She co-authored the book “To The Last Bullet - The Inspiring Story of A Braveheart - Ashok Kamte” with Vinita Kamte and is the author of “The Mighty Fall”