RTI Reveals ‘Missing File’ a Common Ruse in Health Ministry To Save Dubious Pharma Companies
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
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    COMMENTS

    tillan2k

    4 weeks ago

    Make money while coRONA shines .. make money on Asian Olympics, money from animal fodder, flood relief funds, hea wave funds Pharam cos pile cash on human miseries ...

    glnprasad52

    4 weeks ago

    CIC has powers only as per RTI and all their decisions are just advises and no one really cares for CIC. Believe me, nothing is going to improve in their systems. They just ignore the advice. It is the same case with every Ministry, and this irresponsibility and unaccountability were inherited from the old regime.

    shetyerb

    1 month ago

    This article should be sent to PM Modi office. They mandatorily acknowledge such letters and in many cases also investigate.
    If they have not done anything, after 4 months they should be reminded.

    REPLY

    glnprasad52

    In Reply to shetyerb 4 weeks ago

    Since when PMO commenced investigating such cases. An employee below clerical level sorts out the petitions Ministry wise, a clerk types details of petitioners and lists ministry wise, and a section officer signs the covering letter to Ministry under copy to PMO. This is the general practice. It is not proper to expect PMO to decide on such trivial issues, when such matters are to be handled by officers. A court should take it as suo motu and order investigation through CVC to find out the facts and violations.

    7 Out of 29 State Information Commissions Resume Work amidst Extended Lockdown: Another Study
    A study by the Commonwealth Human Rights Initiative (CHRI), last fortnight, https://www.moneylife.in/article/covid-19-puts-a-brake-on-rti-act-all-28-state-information-commissions-in-limbo/60170.html had reported that only one of the 29 information commissions, from one Central Information Commission (CIC) and none from the state information commissions (SICs) were working since the beginning of the COVID-19 lock-down. Another study conducted this week by the Satark Nagarik Sanghatan (SNS), however, reveals hearteningly that now seven SICs (including the CIC) are functioning.
     
    While one might like to call this progress of sorts, it certainly is still pathetic that three-fourths of the SICs are still hibernating! 
     
    Satark Nagrik Sangathan, which undertook an assessment of the status of information commissions in India during the lock-down due to the COVID-19 pandemic, found that the SICs of Arunachal Pradesh, Haryana, Manipur, Punjab and Telangana and Rajasthan (as also the CIC) have made provision for taking up urgent matters or those related to life and liberty. The SIC of Rajasthan made a provision for hearing such matters, only as recently as on 4th May, nearly six weeks after the lock-down.
     
     
    The SICs, which are not functioning, include those of Assam, Andhra Pradesh, Bihar, Goa, Gujarat, Himachal Pradesh, Jharkhand, Karnataka, Kerala, Madhya Pradesh, Maharashtra, Meghalaya, Mizoram, Nagaland, Odisha, Sikkim, Tamil Nadu, Tripura, Uttar Pradesh, Uttarakhand and West Bengal.
     
    While transparency is the spine of the Right to Information (RTI) Act, the study reveals that 11 information commissions out of 29, have not put up any information or notification about the functioning of their offices during lock-down. These are the commissions of Assam, Bihar, Himachal Pradesh, Kerala, Madhya Pradesh, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim and Tripura. 
     
    The inaccessible websites included the information commissions of Bihar, Madhya Pradesh and Nagaland. Efforts to telephonically reach them were also not successful.  The two information commissions of Jharkhand and Tripura were found to be completely defunct as the serving information commissioners, in both of these, were superannuated during the period of the lock-down. Also, the four information commissions of Bihar, Goa, Rajasthan and Uttar Pradesh are functioning without a SIC.
     
    The report, compiled by Anjali Bhardwaj, Amrita Johri, Indrani Talukdar and Sagarika Ghatak, is based on an analysis of information accessed from the official websites of ICs. For commissions where relevant information was not available on the website, it was obtained telephonically. The assessment examines the functioning of ICs from the commencement of the lock-down on 25 March 2020 till 15 May 2020 (phase 3 of the lock-down ended on 17 May 2020). The website analysis was undertaken between 1st May and 11th May and phone calls were made to ICs between 14th May and 18 May 2020.
     
     
    How Did the Information Commissions Inform the Public? Here’s How:
     
    Central Information Commission: As per an order dated 25 March 2020, the office of the Central Information Commission was closed for a period of 21 days with effect from 25 March 2020 and all cases scheduled for hearing were deferred. Provision was made for hearing matters of urgency through audio conference. For such matters, people were asked to contact the deputy registrars of information commissioners, and their phone numbers were published on the website. 
     
    Andhra Pradesh: As per the notifications issued by the SIC, all hearings scheduled between 25th March to 3rd May were cancelled. The notification stated that from 4 May onwards, all information commissioners will take up only those cases where no reply or decision has been furnished to the applicant by the PIO/FAA or both and will dispose of matters based on available records.
     
    The notification stated that cases where a decision/reply was furnished to the applicant, would be heard after the lock-down is removed. 
     
    Arunachal Pradesh: As per the notice dated 20 March 2020 all hearings from 23rd March to 5 April 2020 were suspended. The notice stated that urgent cases shall be heard as required. As per a press release dated 20 April 2020, provisions were made to hold hearings via video conference through an app.
     
    The Commission suspended receipt of appeals/complaints in physical form and required these to be filed only via email. As per a notification dated 4 May 2020, all pending hearings were resumed through video/audio conferencing. 
     
    Bihar: Vide a notice dated 26 March 2020 all hearings scheduled till 14 April 2020 were adjourned. The notice stated that the SIC would not accept any new appeals/complaints during this period. Further, it clarified that the notice would stand automatically modified in the light of any follow-up orders/instructions issued by the National Disaster Management Authority, the ministry of home affairs, health ministry or the government of Bihar.
     
    Chhattisgarh: As per the information on the homepage of the SIC, all hearings from 23rd March till 3rd May 2020 were suspended. The SIC resumed hearing matters from 4th May onwards. 
     
    Goa: As per the latest order dated 20 April 2020 on the website of the SIC, all hearings have been suspended until further notice. 
     
    Gujarat: All hearings during the period 20th March to 27 March 2020 were adjourned other than the hearing through video conference at Bhavnagar on 23rd March. No further information could be located on the website. 
     
    Haryana: All appeals/complaints scheduled for hearing up to 1 May 2020 were adjourned. Provision was made to bring to the notice of the SIC any matter of urgency or related to life and liberty by contacting the deputy registrar whose contact details were provided on the website. Further, matters listed before commissioners other than the Chief, were adjourned for varying periods of time. Three commissioners adjourned matters till the 15th May and one till 28th May two till 31st May and one till 1 July 2020.
     
     Jharkhand: The initial notice on the SIC website postponed all hearings between 18 March 2020 and 17 May 2020. However, as the acting chief, who was the lone commissioner among the 19, finished his tenure on 8 May 2020, the notice was changed and now states that all scheduled hearings of appeals and complaints shall remain adjourned till the appointment of the chief or an information commissioner. 
     
    Karnataka: As per the notifications on the SIC website, all hearings scheduled till 16 May 2020 were postponed. 
     
    Madhya Pradesh: An order of the SIC dated 1 May 2020 was accessed off line, since the commission’s website is non-functional. It laid down the procedure for staggered working of the staff of the commission but contained no details regarding hearing and disposal of appeals/complaints by the SIC. 
     
    Maharashtra: A document named ‘Sunavani Cancel’ available under the link ‘Important Letters’ on the SIC website states that hearings scheduled for 17th March and 18 March 2020 were cancelled due to the Covid-19 virus. In addition, notices regarding suspension of hearings are available on the link to the cause lists for the Aurangabad and Nasik benches. The notice for the Aurangabad bench states that hearings for 23rd, 24th and 26th were adjourned and the next date of hearing would be informed in due course. The notice for the Nasik bench states that hearings scheduled for 20 April 2020 stand postponed. No further information/notification could be located on the website. 
     
    Manipur: As per the notification dated 16 March 2020, all proceedings regarding appeals/complaints till 31st March were adjourned. Provision was made to look into matters related to life or liberty as per the proviso to section 7(1). As per the notification dated 4 May 2020, the SIC will resume all hearings from 18 May 2020 through audio/video conferencing. 
     
    Odisha: As per the notices available on the SIC website, all matters posted for hearings till 16 May 2020 were adjourned. 
     
    Punjab: As per information on the homepage of the SIC, while appeals/complaints pending in the commission stand adjourned until the duration of the ongoing curfew/lock-down, provision has been made to hear matters of utmost urgency pertaining to ‘Life and Liberty’ by a bench comprising the Chief and an information commissioner. 
     
    Rajasthan: As per notifications all matters posted for hearings between 18th March and 3rd May were adjourned. Subsequently, an order dated 4 May 2020 stated that the SIC would hear only extremely urgent matters. The order also states that if after filing an RTI application under the life and liberty clause and the first appeal, information is not provided or the applicant is dissatisfied, she/he can send the second appeal and all the relevant documents to SIC on a designated mobile number. If the appeal is deemed to be urgent, the SIC will proceed in the matter. No such mechanism for urgent matters was available prior to 4 May 2020. 
     
    Tamil Nadu: As per the notice dated 23 March 2020 all cases posted for enquiry up to 31 March 2020 were adjourned. No further information could be located on the website.
     
    Telangana: As per information on the homepage of the SIC, while all hearings posted till 30th April were postponed due to the lock-down, in case of urgency, the deputy secretary/secretary (law) could be contacted on the numbers listed. Subsequently, the commission decided to hear cases telephonically dispensing with personal appearance of parties. 
     
    Uttar Pradesh: As per orders on the website, all hearings scheduled between 18 March2020 and 17 May 2020 stand adjourned. 
     
    Uttarakhand: As per the notifications on the website, all hearings of second appeals and complaints from 19 March 2020 onwards stand adjourned until further notice. Notification dated 4 May 2020 states that while the SIC has re-opened, it will carry out only administrative work and all hearings will remain adjourned until further notice.
     
    West Bengal: Initially, as per the notice available on the website, the commission decided that between 16 March  and 31 March 2020 only urgent cases which have already been scheduled for this period would be heard and all others would be rescheduled. However from 23 March onwards, the commission decided that the office of the SIC would be closed and all hearings would be rescheduled. The notification did not make any provision for urgent matters or those related to life and liberty. The latest order states that in view of the extension of the nation-wide lock-down for two weeks beyond 3 May 020, the office of the West Bengal information commission will resume its functions after lifting of the restrictive orders, as decided by the full bench of the commission.
     
     
    (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”.) 
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    Myth of Overburden Busted! PIOs Handle only 2 to 6 RTI Applications Per Month!
    For all those political leaders, bureaucrats, judges and heads of public institutions who have been complaining since the inception of the Right to Information (RTI) Act in 2005, that public information officers (PIOs) are overburdened with applications, a study reveals that PIOs of the Central government actually handle only two to six RTI applications per month!
     
    In fact, 7,100 CPIOs are handling the 194 public authorities under the ministry of finance. In 2018-19, they together received 222,000 RTI applications and this amounts to only two RTI applications per CPIO per month. Interestingly, one of the overburdened CPIOs in the entire country is the one in the prime minister’s office (PMO) as he is the lone person working there.
     
    Thus, he has handled 13,816 RTI applications in 2018-19, which works out to the monthly average of 1,151 RTIs.
     
    These statistics are based on a study by the Commonwealth Human Rights Initiative (CHRI), released last week. The inputs were from the Central Information Commission (CIC)’s own annual reports from 2012-13 to 2018-19. CHRI has debunked the "urban myth of the undue burden of RTI on an already overworked bureaucracy." These CIC annual reports carry the work-load of CPIOs and FAAs of central public authorities, from which the analysis was done. As for individual ministries, the statistics of 2018-19 only has been taken into account.
     
    According to the study, the total number of RTI applications has risen from 886,000 per year in 2012-13 to 1.63 million per year in 2018-19.  (This includes the backlog of the previous year and the fresh ones in the current year). The number of CPIOs who handled these RTI applications have risen from 21,204 in 2012-13 to 24,048 in 2018-19 which is a little more than 13% increase.
     
    States Venkatesh Nayak, RTI research scholar and programme head, CHRI, "On an average, a CPIO has handled less than 42 RTIs (41.82) in 2012-13. In 2018-19, this increased to almost 68 RTIs in a year (67.78). Thus, the monthly average number of RTIs per CPIO rose from less than four to less than six RTIs between 2012-13 and 2018-19.  Does handling between four and six RTI applications per month amount to spending 75% of a CPIO's time? While examining the content of the RTI application will reveal the volume of the period for which information is requested, we have in the meantime begun with a study of numbers."
     
    As for the RTI applications received in various Union ministries in 2018-19, the study reveals that the ministry of finance reported a total of 2.22 lakh RTIs in 2018-19 (backlog plus fresh receipts). Says Mr Nayak, "this figure includes not only the RTIs handled by various departments in this ministry but also, public sector banks, tax authorities and insurance companies, debt recovery tribunals among others - a total of 194 public authorities - all of which have a large clientele and therefore high numbers of RTIs are to be expected."
     
    The study states that 7,100 CPIOs are handling this workload in the ministry of finance and so the annual average works out to a little more than 31 RTIs per CPIO (31.27) and a monthly average of just over two RTIs (2.61). When only fresh receipts are taken into account, the annual average per CPIO falls to less than 30 RTIs (29.73) and the monthly average hovers around two RTIs per CPIO (2.48). Asks Mr Nayak, "can handling an average of two RTIs per month be reasonably labelled as an enormous workload on a CPIO? Clearly, the averages are so low because of the large number of designated CPIOs in this ministry and its public authorities."
     
    The study also showed that there are several public authorities that have designated only one CPIO on whom falls the entire year’s burden. For example, the lone CPIO in the prime minister’s office handled 13,816 RTIs in 2018-19 (backlog and fresh receipts), taking the monthly average to 151,000 RTIs. Fresh receipts amounted to an average of almost 1,012 per month.
     
    The study concludes that: 
     
    Where the workload is distributed across multiple PIOs, RTI does not appear to be a burden, at least statistically speaking. 
     
    Where all responsibilities are concentrated in a very small number of PIOs or in just one PIO, the workload appears herculean. 
     
    Another reason why many public authorities and their designated officers think RTI is a burden is because of the mindset that is slow to change. Study after study has demonstrated the inadequacy of implementation of the proactive disclosure provisions of the RTI Act despite the Supreme Court of India declaring this as a mandatory obligation in the CBSE case cited above. 
     
    RTI has been reduced to a request driven process by the public authorities themselves who then complain about the increasing burden of information requests and complaints. 
     
     
    Study of the First appeals workload
     
    More than 9,300 FAAs designated across public authorities under the Central government had a total of 151,000 first appeals to deal with in 2018-19. This works out to an annual average of a little more than 16 appeals per FAA and a monthly average of less than two cases per FAA. Of these 151,000 cases, FAAs actually decided a little over 99,000 cases during this period. So the annual average fell further to less than 11 cases and the monthly average was barely one case per FAA. In fact ever since 2012-13 the monthly average number of cases received has always been less than two per FAA and actual disposal has been less than one case per month;
     
    More than 2,100 FAAs (2,156) designated by various public authorities under the chart topper—ministry of finance- had to deal with more than 25,000 first appeals in 2018-19. The annual average was under 12 first appeals and the monthly average was less than one appeal per FAA. These figures fell even more as the FAAs actually disposed barely 16,000 appeals (15,917) during this period, taking the annual average down to less than 8 per FAA (7.38) and the monthly average fell further to under one case (0.68);
     
    The burden seems enormous in the PMO, President’s secretariat and the Supreme Court which had only one FAA each to dispose of between 400 and 600 appeals in 2018-19. Naturally, the monthly average ranged from 34 tp 167 cases per FAA between them; and
     
    Strangely, actual disposals in the PMO, President’s secretariat and the Supreme Court ranged between 0-16 per month with the PMO reporting that its FAA disposed exactly 10% of the 2,000 first appeals received in 2018-19 (hence the monthly average of 16 cases). Interestingly, the President’s secretariat reported that it did not dispose of any of the 611 appeal cases during the entire year. The Supreme Court reported that its FAA disposed of only three of the 403 first appeals received in 2018-19.  
     
     
    (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”.)
     
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    COMMENTS

    garg0505

    2 months ago

    Great efforts to highlighting the the myths of dealing RTI application by PIOs of various central government office's.
    Since autocratic attitude of officials are negative one in almost 99% office's, therefore having a negative attitudes towards RTI application and information seekers, with the blessings of FAA. Further the controlling authority or head of departments do not have any regards towards the RTI Act. Even in my opinion, the Central Information commission has also lost his relevance towards the implementation of the Act.

    Meenal Mamdani

    2 months ago

    I laud the efforts of Ms Deshmukh and other RTI activists in pushing for this effort to shed light on govt decisions and actions.
    I feel that this effort needs to be combined with organizations focused on specific malfeasance in the public sphere.
    India has an organization ipaidabribe.com but all the complaints that are registered on the website are never followed up.
    Is it because the complaints have no merit? Or is it because the complainant does not have the time and money to follow it up?
    Indians should be focusing on not only exposing wrongdoings but also helping the complainants to take the complaint up the channels till there is a resolution.
    We need an organization with paid staff to follow up and report on these complaints. Surely there are philanthropist who will fund such a body.
    I hope Ms Deshmukh realizes that most ordinary citizens do not have the time, energy, money, etc to push their grievance up the channel until it is resolved.
    Why not allow the aggrieved citizen to pay a subsidized amount for the work involved to push the complaint to its conclusion?

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