Legal Document View

Unlock Advanced Research with PRISMAI

- Know your Kanoon - Doc Gen Hub - Counter Argument - Case Predict AI - Talk with IK Doc - ...
Upgrade to Premium
[Cites 13, Cited by 0]

Central Information Commission

Amresh Chandra Mathur vs Asstt. Drugs Controller(I),Chennai on 10 April, 2019

                                         के   ीय सूचना आयोग
                              Central Information Commission
                                    बाबा गंगनाथ माग, मुिनरका
                               Baba Gangnath Marg, Munirka
                                 नई द ली, New Delhi - 110067
िशकायत सं या / Complaint No.:- CIC/ADCCH/C/2018/632962-BJ
Mr. Amresh Chandra Mathur

                                                                    .... िशकायतकता /Complainant
                                            VERSUS
                                             बनाम

1. CPIO & Technical Officer
Ministry of Health & Family Welfare
Central Drugs Standard Control Organization
O/o Asst. Drugs Controller (India)
Room No. 23, IV Floor, Annexe Building, Custom House
Chennai - 600001


2. CPIO
Directorate General of Health Services
Office of DCG (I), RTI Cell
FDA Bhawan, Kotla Road
New Delhi - 110002
                                                                       ... ितवादीगण /Respondent

Date of Hearing       :               03.04.2019
Date of Decision      :               09.04.2019

Date of filing of RTI application                                         13.09.2018
CPIO's response                                                           28.09.2018
Date of filing the First appeal                                           Not on Record
First Appellate Authority's response                                      Not on Record
Date of diarised receipt of Complaint by the Commission                   Nil

                                           ORDER

FACTS:

The Complainant vide his RTI application sought information on 02 points regarding the certified copy of documents available with / officially provided to port officials of CDSCO indicating pack sizes i.e. 3 ml, 5 ml and physicians sample for custom clearance / for permitting / authorizing actual import, certified copy of documents used by port officials of CDSCO that indicate / provide pack sizes of the drug to be permitted / authorized by the port officials of CDSCO for actual import / custom clearance, etc. Page 1 of 7 The CPIO, vide its letter dated 28.09.2018, for points 1 (a), (b), (c), replied with the Comments 'NIL'. Dissatisfied with the CPIO's response, the Complainant approached the Commission.
HEARING:
Facts emerging during the hearing:
The following were present:
Complainant: Mr. Amresh Chandra Mathur along with Mr. Venkatesh Nayak; Respondent: Mr. Jayant Kumar, CPIO & DDC (I), DGHS, Mr. Abhishek Chawardol, DI, DGHS, Mr. S. Kulshrestha, ADC (I) and Mr. R. K. Singh, CDSCO in person; and Ms. P. Priyadharsini, Drug Inspector, CDSCO, Chennai and Mr. J. Ragupathy, CPIO & Technical Officer, Chennai through VC;
The Complainant reiterated the contents of the RTI application and stated that the complete and satisfactory information had not been received by him, till date. In support of his contention, the Complainant referred to a comparative study of label/ insert changes in storage in respect of 5 ml pack of Alcon Vigamox. In addition, he also referred to the label and package insert submitted by the firm for 1st and 2nd, Renewal in the year 2008 and 2011 respectively for 3 ml Alcon. With regard to functions of Port Offices, requirements and check list for import of drugs, documents to be scrutinized by Port Office for Import, and examination of Bill of Entry, a copy of "Activities of the Port Offices" was referred to. Furthermore, a reference was also made to the decision of the Commission in File No. CIC/SA/A/2015/000319 decision dated 03.07.2015 wherein the Appeal was dismissed considering the objections made by the third party i.e. M/s Alcon Laboratories (India) Private Limited. Explaining the background of the matter, the Complainant submitted that the Alcon Company was importing drug Moxifloxacin Ophthalmic Solution 0.5% (Brand Name: Alcon Vigamox), quantum of which should not be permitted to be more than 3 ml as per the standards of FDA, USA. In its reply, the Respondent (New Delhi) stated that the RTI application was transferred to the CPIO, O/o the Assistant Drugs Controller (I) Port, Sea Port Office, CDSCO, Chennai under Section 6 (3) of the RTI Act, 2005 for providing information to the applicant. During the hearing, the Respondent (New Delhi) also handed over a copy of the written submission dated 03.04.2019 wherein a chronological sequences of the replies were reiterated. Several other correspondences held with the department were also enclosed. In its reply, the Respondent (Chennai) submitted that the available information had already been provided to the Complainant. He further endorsed its written submission dated 26.03.2019. The Commission was also in receipt of a written submission from the Respondent, O/o ADC (I), Seaport, Chennai, dated 26.03.2019 wherein a point wise reply for Complaint made under Section 18 (1) of the RTI Act, 2005, was reiterated. On being queried by the Commission, whether the Respondent (Chennai) could furnish an affidavit to the effect of its written submission dated 26.03.2019, it was stated that he would verify with the concerned officials. The Commission was also in receipt of a written submission from the Complainant dated 27.03.2019 wherein while explaining the background of the case, it was submitted that the CDSCO (HQ) has approved details of drug permitted for import and it was unbelievable that port offices were authorized / would permit import of drug without knowing the details of what has been permitted for import. In this context, he also relied upon the several decisions of the Commission in File No. CIC/SA/A/2015/000319; CIC/DTGHS/C/2017/602102;

CIC/LS/C/2013/000085/SS; CIC/YA/C/2015/900281 and the Hon'ble Supreme Court order in Criminal Appeal No. 208 of 2019 (Arising out of SLP (Crl) No. 2328 of 2015 which clearly provides that punishment less than what has been provided in the statute cannot be given. He Page 2 of 7 further submitted that in the year 2011, 463647 (four lakh sixty three thousand six hundred and forty seven) 5 ml packs of the drug were imported through Chennai Sea Port and in view of the CPIO's response that "as per available records of their office, the information for point 1(a), (b),

(c) is NIL w.r.t. CDSCO, Chennai, Sea Port Office" was false. It was further submitted that the information sought in the RTI application was must for Chennai Sea Port Office of CDSCO for permitting import of drug through Chennai Sea Port by CDSCO i.e. to ensure that there was no violation of RC conditions. Therefore, it was inter alia prayed to the Commission to take strict action against the CPIO for malafide denial of information and to pass a speaking order about the conduct of CPIO in terms of provisions of Section 20 of the RTI Act, 2005, for imposing or not imposing a penalty.

The Commission was also in receipt of a synopsis for all CDSCO Cases from the Complainant during the hearing wherein it was stated that it was mandatory that every drug pack approved by CDSCO should contain CDSCO approved insert and label. Explaining the details of information typically contained in an insert and label, the Complainant submitted that the new drug can be approved by CDSCO only after clinical trial was successful and DCGI, CDSCO HQ was only authorized to permit import of drug which gets imported through various port offices of CDSCO. He further stated that the FDA, USA publishes all such information in public domain and that such details were mandatory in nature. It was submitted that he noticed that such information was not put in public domain by CDSCO and that the CPIOs stonewalled every RTI request by using various techniques including giving false information from day 1 regarding import of the drug. While referring to the decision of the Commission in CIC/LS/2013/000085/SS dated 13.01.2014, the Complainant submitted that even after the order of the Commission, the CPIO provided incomplete information on the ground that the file of 2005 containing information regarding import of drug for the first time in India was missing/ not traceable. A Complaint vide diary no. 108023 dated 07.02.2017 regarding successive CPIOs not providing the information on this ground was pending before the Commission. It was further alleged that the CDSCO had permitted import of both 3 ml and 5 ml packs since 2008 (2005-2008 information not provided on the ground of missing file), the Complainant submitted that the FDA, USA continued to permit only 3 ml pack since the research of the drug. Suspecting that there was a likelihood of change in RC conditions during physical import, the Appellant referred to his RTI application dated 11.04.2014 and the action taken thereon as also the decisions of the Commission in Appeal No. CIC/SA/A/2015/000319 and CIC/YA/C/2015/000110. It was submitted that on receipt of notice of hearing in CIC/YA/C/2015/000110, he got to know that Appeal No. CIC/SA/A/2015/000319 was decided on 03.07.2015 dismissing the matter recording the absence of both the parties. The Complaint CIC/YA/C/2015/000110 was also dismissed quoting Appeal No. CIC/SA/A/2015/000319 order dated 03.07.2015. Suspecting a foul play in both the orders mentioned above he inspected both CIC files on 22.09.2016 and found that his address in Notice of hearing was changed in CIC/SA/A/2015/000319 and in CIC/YA/C/2015/000110, the order was issued before completion of pleadings as per file notings. He took photocopies of the documents and submitted a detailed complaint for vigilance inquiry received by the Commission on 27.09.2016. The Vigilance Inquiry Complaint resulted in re-hearing of his case file CIC/SA/A/2015/000319 beginning on 25.10.2016 and in compliance with the order of the Commission, the CPIO, CDSCO vide letter dated 18.11.2016 gave information about the quantity of drug packs imported in India since 2005 but denied part of the information on the ground that the 2005 file was not traceable. It was stated that to his utter surprise the Importer Company did not import a single 3ml pack in spite of continuously taking Registration Certificate of 3 ml pack along with 5 ml pack and only if the information available in 2005 was Page 3 of 7 disclosed will it be known as to what was permitted for import for the first time i.e., 2005 after the clinical trials of the drug in India. He also referred to the decision of the Commission in CIC/YA/C/2015/900281 (Johnson and Johnson case) and submitted that by the time CIC adjudicated the case a lot of patients suffered injury due to illegal imports. Thus, he concluded that the CDSCO stonewalled the information sought in 1st RTI application dated 20.04.2013 falsely on the ground that the information was with State Public Authority i.e., State Drug Controller, denied information on the ground that the 2005 file was missing even after order of the CIC to provide the information and did (did not) not publish the information in public domain like FDA, USA.

The Commission referred to the definition of information u/s 2(f) of the RTI Act, 2005 which is reproduced below:

"information" means any material in any form, including records, documents, memos, e- mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, report, papers, samples, models, data material held in any electronic form and information relating to any private body which can be accessed by a public authority under any other law for the time being in force."

Furthermore, a reference can also be made to the relevant extract of Section 2 (j) of the RTI Act, 2005 which reads as under:

"(j) right to information" means the right to information accessible under this Act which is held by or under the control of any public authority and includes ........"

In this context a reference was made to the Hon'ble Supreme Court decision in 2011 (8) SCC 497 (CBSE and Anr. Vs. Aditya Bandopadhyay and Ors), wherein it was held as under:

35..... "It is also not required to provide 'advice' or 'opinion' to an applicant, nor required to obtain and furnish any 'opinion' or 'advice' to an applicant. The reference to 'opinion' or 'advice' in the definition of 'information' in section 2(f) of the Act, only refers to such material available in the records of the public authority. Many public authorities have, as a public relation exercise, provide advice, guidance and opinion to the citizens. But that is purely voluntary and should not be confused with any obligation under the RTI Act."

Furthermore, the Hon'ble Supreme Court of India in Khanapuram Gandaiah Vs. Administrative Officer and Ors. Special Leave Petition (Civil) No.34868 OF 2009 (Decided on January 4, 2010) had held as under:

6. "....Under the RTI Act "information" is defined under Section 2(f) which provides:
"information" means any material in any form, including records, documents, memos, e- mails, opinions, advices, press releases, circulars, orders, logbooks, contracts, report, papers, samples, models, data material held in any electronic form and information relating to any private body which can be accessed by a public authority under any other law for the time being in force."

This definition shows that an applicant under Section 6 of the RTI Act can get any information which is already in existence and accessible to the public authority under law. Of course, under the RTI Act an applicant is entitled to get copy of the opinions, Page 4 of 7 advices, circulars, orders, etc., but he cannot ask for any information as to why such opinions, advices, circulars, orders, etc. have been passed."

7. "....the Public Information Officer is not supposed to have any material which is not before him; or any information he could have obtained under law. Under Section 6 of the RTI Act, an applicant is entitled to get only such information which can be accessed by the "public authority" under any other law for the time being in force. The answers sought by the petitioner in the application could not have been with the public authority nor could he have had access to this information and Respondent No. 4 was not obliged to give any reasons as to why he had taken such a decision in the matter which was before him."

With regard to the imposition of penalty on the CPIO/PIO under Section 20 of the RTI Act, 2005, the Commission took note of the ruling of Hon'ble Delhi High Court in W.P.(C) 11271/2009 Registrar of Companies & Ors v. Dharmendra Kumar Garg & Anr. (delivered on:

01.06.2012) wherein it was held:
" 61. Even if it were to be assumed for the sake of argument, that the view taken by the learned Central Information Commissioner in the impugned order was correct, and that the PIOs were obliged to provide the information, which was otherwise retrievable by the querist by resort to Section 610 of the Companies Act, it could not be said that the information had been withheld malafide or deliberately without any reasonable cause. It can happen that the PIO may genuinely and bonafidely entertain the belief and hold the view that the information sought by the querist cannot be provided for one or the other reasons. Merely because the CIC eventually finds that the view taken by the PIO was not correct, it cannot automatically lead to issuance of a showcause notice under Section 20 of the RTI Act and the imposition of penalty. The legislature has cautiously provided that only in cases of malafides or unreasonable conduct, i.e., where the PIO, without reasonable cause refuses to receive the application, or provide the information, or knowingly gives incorrect, incomplete or misleading information or destroys the information, that the personal penalty on the PIO can be imposed. This was certainly not one such case. If the CIC starts imposing penalty on the PIOs in every other case, without any justification, it would instill a sense of constant apprehension in those functioning as PIOs in the public authorities, and would put undue pressure on them. They would not be able to ful fill their statutory duties under the RTI Act with an independent mind and with objectivity. Such consequences would not auger well for the future development and growth of the regime that the RTI Act seeks to bring in, and may lead to skewed and imbalanced decisions by the PIOs Appellate Authorities and the CIC. It may even lead to unreasonable and absurd orders and bring the institutions created by the RTI Act in disrepute."

Similarly, the following observation of the Hon'ble Delhi High Court in Bhagat Singh v. CIC & Ors. WP(C) 3114/2007 are pertinent in this matter:

"17. This Court takes a serious note of the two year delay in releasing information, the lack of adequate reasoning in the orders of the Public Information Officer and the Appellate Authority and the lack of application of mind in relation to the nature of information sought. The materials on record clearly show the lackadaisical approach of the second and third respondent in releasing the information sought. However, the Page 5 of 7 Petitioner has not been able to demonstrate that they malafidely denied the information sought. Therefore, a direction to the Central Information Commission to initiate action under Section 20 of the Act, cannot be issued."

Furthermore, the High Court of Delhi in the decision of Col. Rajendra Singh v. Central Information Commission and Anr. WP (C) 5469 of 2008 dated 20.03.2009 had held as under:

"Section 20, no doubt empowers the CIC to take penal action and direct payment of such compensation or penalty as is warranted. Yet the Commission has to be satisfied that the delay occurred was without reasonable cause or the request was denied malafidely.
......The preceding discussion shows that at least in the opinion of this Court, there are no allegations to establish that the information was withheld malafide or unduly delayed so as to lead to an inference that petitioner was responsible for unreasonably withholding it."

The Commission also observed that the Hon'ble High Court of Delhi in the matter of R.K. Jain v. V.P. Pandey, CPIO, CESTAT, New Delhi in W.P. (C) No. 4785/ 2017 dated 10.10.2017 adjudicated on the correctness of an order of the Commission dated 17.04.2017 whereby the Respondent was cautioned to exercise due care in future and to ensure that correct and complete information is furnished to the RTI applicants. It was decided that:

"2. The grievance of the petitioner is that although the CIC had accepted that there was a delay in providing the necessary information to the petitioner, the CIC had not imposed the penalty as required under Section 20(1) of the Right to Information Act, 2005. It is well settled that imposing of the penalty is a discretionary measure. In Anand Bhushan v. R.A. Haritash: ILR (2012) 4 Delhi 657 a division bench of this Court had considered the question whether the levy of penalty was discretionary and held as under..........
3. In this case it is apparent that the CIC had in its discretion considered that a order cautioning the CPIO would be sufficient. This Court is not inclined to interfere with such exercise of discretion."

Furthermore, the Hon'ble High Court in the matter of R.K. Jain v. CIC and Anr. in W.P.(C) 4152/2017 dated 10.10.2017 had held as under:

"5. The question whether the CIC had the discretion to restrict the penalty or whether penalty as provided under Section 20 of the Act is mandatory, is no longer res integra. The said question was considered by a Division Bench of this Court in Anand Bhushan v. R.A. Haritash: ILR (2012) 4 Delhi 657 and the relevant extract of the said decision is set out below....
6. In view of the above, this Court finds no reason to interfere with the discretion exercised by the CIC. The petition is, accordingly, dismissed."

The Complainant could not substantiate his claims regarding malafide denial of information by the Respondent or for withholding it without any reasonable cause.

Page 6 of 7

DECISION:

Keeping in view the facts of the case and the submissions made by both the parties, it was noted that in accordance with Section 2 (f) and (j) of the RTI Act, 2005, a suitable response had been furnished to the Complainant. However, in respect of the submissions made by the Respondent (CPIO and Technical Officer, Chennai), the Commission directs him to furnish an affidavit to the Complainant in respect of his deposition within a period of 15 days from the date of receipt of this order.
The Complaint stands disposed accordingly.
Bimal Julka (िबमल जु का) Information Commissioner (सूचना आयु ) Authenticated true copy (अिभ मािणत स ािपत ित) K.L. Das (के .एल.दास) Dy. Registrar (उप-पंजीयक) 011-26182598/ [email protected] दनांक / Date: 09.04.2019 Page 7 of 7