Central Information Commission
Amresh Chandra Mathur vs Central Drugs Standard Control Organis ... 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
ि तीय अपील सं या / Second Appeal No.:- CIC/CDSCH/A/2018/634835-BJ
Mr. Amresh Chandra Mathur
....अपीलकता/Appellant
VERSUS
बनाम
1. CPIO
Ministry of Health & Family Welfare
Office of the Assistant Drugs Controller (India) - Airport
Central Drugs Standard Control Organization
Room No. 402-405, 1st Floor, Phase - III
Airport Authority Building, Air Cargo Complex
Meenambakkam, Chennai - 600027
2. CPIO
Office of Drugs Controller General (India)
CDSCO (HQ), 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 RTI application 13.09.2018
CPIO's response 15.10.2018
Date of the First Appeal 18.10.2018
First Appellate Authority's response 30.10.2018
Date of diarised receipt of Appeal by the Commission Nil
ORDER
FACTS:
The Appellant vide his RTI application sought information on 03 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 8 The CPIO, vide its letter dated 15.10.2018 stated that since the requisite information is related with the third party, their office had asked the importer (third party) for providing the requisite information regarding the bills, as desired in the application. However, the reply is still awaited. As and when the reply would be received by their office, a suitable reply will be provided to him. Dissatisfied with the CPIO's response, the Appellant approached the FAA. The FAA, vide its order dated 30.10.2018 endorsed the CPIO's reply dated 15.10.2018.
HEARING:
Facts emerging during the hearing:
The following were present:
Appellant: 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 Appellant reiterated the contents of the RTI applications and stated that the information sought had been wrongly denied being "third party" information by the CPIO. It was further informed that the First Appellate Authority had also passed an order after a delay of 42 days of filing of Appeal. Furthermore, it was submitted that Section 8 (1) (d) of the RTI Act, 2005, did not attract in his case since he had not asked for any information which was related to commercial confidence, trade secrets or intellectual property. In support of his contention, the Appellant 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. Explaining the background of the matter, the Appellant 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, Air 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) 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 departments were also enclosed. In its reply, the Respondent (Chennai), reiterated the reply of the CPIO and stated that since the information sought pertained to the third party i.e. M/s Alcon Laboratories India Private Limited, Bangalore, they have sought their consent under Section 11 (1) of the RTI Act, 2005, for disclosure of information relating to their import consignment of drug "Alcon Vigamox", vide their letter dated 24.09.2018. Thereafter, the "third party" vide its letter dated 24th October, 2018 at the outset submitted that "Novartis Healthcare Private Limited ('Novartis') is the importer of the drug Vigamox since November 2017 and as such Alcon no longer imports the drug Vigamox in India. Without prejudice to the above, information on import details such as Airway Bills, Invoice comprising of information on the rates and quantities imported, packing list comprising of volume, size, dimensions of the consignment, bill of entry comprising of the assessable value etc. are all in the nature of commercial-in-confidence information and ought not to be disclosed under any circumstances. In addition, detailed information of the manufacturing site and Page 2 of 8 Chemistry Manufacturing & Control (CMC) has also been disclosed in strict confidence to the office of the Drugs Controller General of India (DCGI) as part of the application process. Such information, if disclosed, would compromise, jeopardize and irreparably harm the competitive position of Novartis / Alcon in the market. Most importantly, there is no larger public interest that is sought to be served by disclosure of such confidential information that warrants such disclosure". For all and singular of the aforementioned reasons, they requested not to disclose the information provided by the said company. The Commission was also in receipt of a written submission from the Respondent, O/o ADC (I), Airport, Chennai, dated 26.03.2019 wherein a point wise reply for 2nd Appeal filed under Section 19 (3) was reiterated. While contesting the above averments of the Respondent, the Appellant while referring to Section 4(1) (b) (xiii) of the RTI Act, 2005, submitted that the information relating to customs clearance / permission granted / authorization / license(s) issued / renewed, etc. should be suo-motu disclosed by the Respondent Public Authority under Section 4(1)(b) of the RTI Act, 2005. The Commission was also in receipt of a written submission from the Appellant dated 27.03.2019 wherein while explaining the background of the case, it was submitted that the CDSCO (HQ) approved details of drug permitted for import could not be treated as third party information within the meaning of Section 11 (1) of the RTI Act, 2005. 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. Furthermore, it was submitted that through Chennai Airport, the drug was being regularly imported since 2005 and that in the year 2012-13, 2140980 (twenty one lakh forty thousand nine hundred and eighty) 5 ml packs of the drug were imported through Chennai Air Port. Moreover, the information sought in the RTI application was must for Chennai Air 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. 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 had been permitted for import. Hence, the CPIO as well as the FAA endorsing the information being "third party" had not acted reasonably and diligently while dealing with the RTI application / First Appeal. Therefore, it was inter alia prayed to the Commission to direct the CPIO to provide the requested information and to pass a speaking order about the conduct of CPIO in terms of Section 20 of the RTI Act 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 Page 3 of 8 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 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 Vs. Aditya Bandopadhyay), wherein it was held as under:
Page 4 of 835..... "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, 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."
The Commission referred to the judgment of the Hon'ble Delhi High Court in Mujibur Rehman vs Central Information Commission (W.P. (C) 3845/2007)(Dated 28 April, 2009) wherein it had been held as under:
"14.......The court cannot be unmindful of the circumstances under which the Act was framed, and brought into force. It seeks to foster an "openness culture" among state agencies, and a wider section of "public authorities" whose actions have a significant or lasting impact on the people and their lives. Information seekers are to be furnished what they ask for, unless the Act prohibits disclosure; they are not to be driven away through sheer inaction or filibustering tactics of the public authorities or their officers. It is to ensure these ends that time limits have been prescribed, in absolute terms, as well as penalty provisions. These are meant to ensure a culture of information disclosure so necessary for a robust and functioning democracy."Page 5 of 8
Furthermore, the Hon'ble High Court of Delhi in the matter of R.K. Jain vs Union of India, LPA No. 369/2018, dated 29.08.2018, held as under:
"9................................ That apart, the CPIO being custodian of the information or the documents sought for, is primarily responsible under the scheme of the RTI Act to supply the information and in case of default or dereliction on his part, the penal action is to be invoked against him only. The Appellate Authority is not the custodian of the information or the document. It is only a statutory authority to take a decision on an appeal with regard the tenability or otherwise of the action of the CPIO and, therefore, there is a conscious omission in making the Appellate Authority liable for a penal action under Section 20 of the RTI Act and if that be the scheme of the Act and the legislative intention, we see no error in the order passed by the learned writ Court warranting reconsideration."
Moreover, the Commission observed that information relating to regulatory information held with the Public Authority should be suo motu disclosed on the website of the Public Authority for the sake of transparency and accountability within the public authority and the interest of the public at large so that the citizens are informed about the registration of doctors with the MCI. The Commission observed that a voluntary disclosure of all information that ought to be displayed in the public domain should be the rule and members of public who having to seek information should be an exception. An open government, which is the cherished objective of the RTI Act, can be realised only if all public offices comply with proactive disclosure norms. Section 4(2) of the RTI Act mandates every public authority to provide as much information suo- motu to the public at regular intervals through various means of communications, including the Internet, so that the public need not resort to the use of RTI Act. The Hon'ble Supreme Court of India in the matter of CBSE and Anr. Vs. Aditya Bandopadhyay and Ors 2011 (8) SCC 497 held as under:
"37. The right to information is a cherished right. Information and right to information are intended to be formidable tools in the hands of responsible citizens to fight corruption and to bring in transparency and accountability. The provisions of RTI Act should be enforced strictly and all efforts should be made to bring to light the necessary information under Clause (b) of Section 4(1) of the Act which relates to securing transparency and accountability in the working of public authorities and in discouraging corruption."
The Commission also observes the Hon'ble Delhi High Court ruling in WP (C) 12714/2009 Delhi Development Authority v. Central Information Commission and Another (delivered on:
21.05.2010), wherein it was held as under:
"16.It also provides that the information should be easily accessible and to the extent possible should be in electronic format with the Central Public Information Officer or the State Public Information Officer, as the case may be. The word disseminate has also been defined in the explanation to mean - making the information known or communicating the information to the public through notice boards, newspapers, public announcements, media broadcasts, the internet, etc. It is, therefore, clear from a plain reading of Section 4 of the RTI Act that the information, which a public authority is obliged to publish under the said section should be made available to the public and specifically through the Page 6 of 8 internet. There is no denying that the petitioner is duty bound by virtue of the provisions of Section 4 of the RTI Act to publish the information indicated in Section 4(1)(b) and 4(1)(c) on its website so that the public have minimum resort to the use of the RTI Act to obtain the information."
Furthermore, High Court of Delhi in the decision of General Manager Finance Air India Ltd & Anr v. Virender Singh, LPA No. 205/2012, Decided On: 16.07.2012 had held as under:
"8. The RTI Act, as per its preamble was enacted to enable the citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority. An informed citizenry and transparency of information have been spelled out as vital to democracy and to contain corruption and to hold Governments and their instrumentalities accountable to the governed. The said legislation is undoubtedly one of the most significant enactments of independent India and a landmark in governance. The spirit of the legislation is further evident from various provisions thereof which require public authorities to:
A. Publish inter alia:
i) the procedure followed in the decision making process;
ii) the norms for the discharge of its functions;
iii) rules, regulations, instructions manuals and records used by its employees in discharging of its functions;
iv) the manner and execution of subsidy programmes including the amounts allocated and the details of beneficiaries of such programmes;
v) the particulars of recipients of concessions, permits or authorizations granted. [see Section 4(1) (b), (iii), (iv), (v); (xii) & (xiii)].
B. Suo moto provide to the public at regular intervals as much information as possible [see Section 4(2)]."
With regard to conduct of the CPIO in terms of provisions of Section 20 of the RTI Act, 2005, the Commission referred to the decision of 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..........Page 7 of 8
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."
DECISION:
Keeping in view the facts of the case and the submissions made by both the parties, the Commission directs the Respondent Public Authority to suo motu disclose Regulatory Information in such matters for the benefit of public at large as agreed. No further intervention of the Commission is required in the matter.
The Appeal stands disposed accordingly.
Bimal Julka (िबमल जु का)
Information Commissioner (सूचना आयु )
Authenticated true copy
(अ भ मा णत स या पत त)
K.L. Das (के .एल.दास)
Dy. Registrar (उप-पंजीयक)
011-26182598/ [email protected]
दनांक / Date: 09.04.2019
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