Last week, the Central Information Commission (CIC) slammed the Directorate General of Health Services (DCGI) for replying under RTI that the file containing a crucial report pertaining to recommendations made by it in 2013 while granting approval for new drugs and clinical trials, which were adopted by its national regulatory authority, the Central Drugs Standard Control Organisation (CDSCO), was missing. Even more brazen is the fact that, under pressure of a notice sent by the CIC, the DCGI had the audacity to finally email the RTI applicant a copy of the report on 11 May, 2020, "which was neither signed nor certified which indicated their malafide conduct."
CIC Bimal Jhulka, in his order on 26 May, 2020, has directed the DCGI to provide a certified copy of the report within 30 days and "to urgently initiate steps to streamline the process of digitization of records and… to suo motu disclose its reports and other associated documents in the public domain for the benefit of the public at large." And to do so; from time to time. It has also asked this public authority to ensure that “grant of approvals (are made) through a transparent and objective mechanism."
Prashant Reddy, the RTI applicant, way back in May 2018, had sought a copy of the reports and recommendations of the office order issued by the DCGI on 26 March 2013 and review processes adopted by CDSCO in granting approval for new drugs and clinical trials.
This report, called the Dr T N Mahapatra Committee Report, was a sequel to the comments made by the parliamentary standing committee on health and family welfare, early that year, of dubious practices adopted by DCGI and CDSCO while giving approvals to new drugs, allegedly without proper research and clinical trials.
The CPIO of the DCGI office replied that the report was not readily available and therefore refused to provide information. A first appeal to the first appellate authority also brought in the same response. Thereafter, Reddy filed a second appeal way back in September 2018 and the matter came for hearing, a good one and a half year later, that is as recently as 26 May, 2020!
The second appeal, which interestingly was held through WhatsApp due to the lockdown, had the RTI applicant Prashant Reddy, CPIO RG Singh, the FAA on WhatApp (they had also made written submissions to CIC earlier of their stance) while RK Singh, the legal consultant, CDSCO, appeared in person.
Mr Reddy reiterated that he had sought under RTI, the copy of the Mohapatra Committee Report which was denied to him. He argued that the reason was that, the Mohapatra committee had pointed out shocking lapses by the office of the DCGI in the approval of new drugs under the Drugs & Cosmetics Act.
Many of these lapses, he said, border on criminal negligence. Mr Reddy also pointed out that ``there appeared to be a long running problem of missing files at the office of the DCGI’’ as was reported in the 59th report of the parliamentary standing committee on health and family welfare, the Mohapatra Committee Report and the CIC too in its earlier orders had pointed out several previous cases that make a missing file is an offence under the Public Records Act, 1993 and that a legal inquiry must be conducted if a file goes missing.
The CPIO of drugs regulation section of the ministry of health and family welfare, reiterated that they did not have a copy of the report as it was not available with them.
However, they contacted Prof TM Mohapatra personally who provided them with a copy of the “Report of the committee constituted to review the procedures and practices followed by CDSCO for granting approval and clinical trials on certain drugs.” However, Mr Reddy was provided with an uncertified copy through email. At the CIC hearing the CPIO assured the CIC that he would provide him with a certified copy.
However, the CPIO of CDSCO and DGHS defended themselves stating that the department had, from time to time, informed the Parliament about the measures taken, based on regular review of CDSCO and its functioning, to address the various issues highlighted in the 59th report of the department related parliamentary: standing committee.
The CIC observed that the Mohapatra Committee Report has also commented on the issue of poorly maintained records and missing files at the office of the DCGI. It states that in several previous second appeal cases the CIC has pointed out that a missing file is an offence under the Public Records Act, 1993 and a legal inquiry must be conducted if a file goes missing.
There is another CIC decision which states that the public authority should invoke its power under Section 19(8)(iii) of the RTI Act to order DCGI to publish all information regarding approvals of new drugs on its website; invoke its power under Section 19(8)(iv) of the RTI Act to conduct an audit of all files and present a report to the CIC regarding the plan of action for missing files and; to register an FIR under the Public Records Act, 1993 so that an investigation may be conducted into the missing files. The commission thus felt that there was an urgent need to develop a robust system of record keeping in DCGI and to review its efficaciousness periodically, as earlier orders fell on deaf ears.
Jhulka’s CIC decision of 26 May 2020, spurred several activists to tweet the misdoings of the DCGI and CDSCO which go unabated. Dinesh Thakur, public health activist and whistleblower of the Ranbaxy Laboratories fame, had a series of tweets on this issue. One of his tweets aptly stated: “The CIC has taken cognizance of the ministry's conduct and has ordered remedial actions in its order: https://dineshthakur.com/wp-content/uploads/2020/05/Mahapatra-Decision.pdf
… Why is it so difficult to get access to such important reports which have a disproportionate impact on #publichealth
Lawyer and activist, Amit Kumar has tweeted that: " My analysis says that CDSCO in the last four years approved more than 12 drugs in India without any phase III clinical trial and all with a grim violation of their own policy. Four drugs of same company, a UK based MNC were approved in two years without any phase III clinical trial in India."
Frightening, isn’t it?
The CIC Decision
"Keeping in view the facts of the case and the submissions made by both the parties, it was noted by the Commission that on its intervention, a reply was furnished to the appellant. The commission however expressed its serious concern over the record keeping methodology in the office of DCGI / CDSCO due to the fact that an important report relating to the review of procedures and practices followed by CDSCO for granting approval and clinical trials on certain drugs went missing from their office that had to be procured from the author after the receipt of the notice of hearing from the Commission.
“This is despite the fact that the parliamentary standing committee had also taken cognizance of the lapses by the public authority. The intent and the conduct of the public authority should always be above board in matters relating to the grant of approvals through a transparent and objective mechanism. The commission advises the secretary, m/o health and family welfare, govt. of India to examine this matter appropriately for further necessary action at its end."
(Vinita Deshmukh is consulting editor of Moneylife, an RTI activist and 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