Central Information Commission
Puneet Bhasin vs Central Drugs Standard Control ... on 18 June, 2024
Author: Heeralal Samariya
Bench: Heeralal Samariya
के न्द्रीय सूचना आयोग
Central Information Commission
बाबा गंगनाथ मागग, मुननरका
Baba Gangnath Marg, Munirka
नई दिल्ली, New Delhi - 110067
नितीय अपील संख्या / Second Appeal No. CIC/CDSHQ/A/2023/651086
Shri Puneet Bhasin ... अपीलकताग/Appellant
VERSUS/बनाम
PIO, ...प्रनतवािीगण /Respondent
Central Drugs Standard Control Organization,
HQ, New Delhi
Date of Hearing : 13.06.2024
Date of Decision : 13.06.2024
Chief Information Commissioner : Shri Heeralal Samariya
Relevant facts emerging from appeal:
RTI application filed on : 12.06.2023
PIO replied on : 19.07.2023
First Appeal filed on : 10.08.2023
First Appellate Order on : 03.10.2023
2 Appeal/complaint received on
nd : 14.11.2023
Information soughtand background of the case:
The Appellant filed an RTI application dated 12.06.2023 seeking information on following points:-
"1. The name of Stake Holders involved in finalizing of GSR 78 (E) at 31-01- 2017.
2. Copy of file notings & minutes of meeting(s) with above Stake Holders for the purpose of finalizing of GSR 78 (E) at 31-01-2017.
3. Copy of public notices issued for the above stakeholder meetings.
4. Comparison of Fee Structure of other countries Vis-à-vis those prescribed in MDR 2017 as done while finalizing the fee structure for the purpose of finalizing of GR 78(E) dt. 31-01-2017.
5. No. of licenses issued till date for class A, class B, class C, class D non IVD medical devices till date for both import and manufacturing for each risk class separately."
The CPIO vide letter dated 19.07.2023 replied as under:-
"Point No. 1 to 5: To have a comprehensive regulatory provisions for import, manufacture, Clinical investigation, sale and distribution of medical devices based on risk based criteria, the Ministry of Health & Family Welfare, Government of India has notified the Medical Devices Rules, 2017 vide G.S.R. 78(E) dated 31.01.2017 as per procedure prescribed under the Drugs and Cosmetics Act, 1940. The Drafts Rules was published on Gazette vide notification number G.S.R. 983(E), dated 17.10.2016 for stakeholders Page 1 of 4 comments. The Ministry of Health & Family Welfare has published final notification as Medical Devices Rules, 2017 on 31.07.2017. The details of the license(s) issued is available on Online System for Medical Devices portal i.e. cdscomdonline.gov.in."
Dissatisfied with the response received from the CPIO, the Appellant filed a First Appeal dated 10.08.2023. The FAA vide order dated 03.10.2023 stated as under:-
"Point 1 to 4:
The details of representatives / stake holders, regulators etc called for consultation in the matter as available with CDSCO are as follow:
Date Subject Venue
23.05.2016 Public notice regarding FICCI Auditorium
interactive meeting with the House, Tansen
medical devices and Merg, New Delhi
diagnostic stakeholders on
proposed regulatory
framework of Medical
Devices and In-vitro
diagnostics stakeholders on
24.05.2016.
24.05.2016 List of the stakeholders of FICCI Auditorium
the meeting on regulatory House, Tansen
framework of Medical Merg, New Delhi
Devices and In-vitro
diagnostics with the medical
devices and diagnostic
stakeholders.
02.07.2016 Meeting with the Nirman Delhi
stakeholders of medical Bhawan, New
devices and diagnostics for
deciding the fee structure for
Medical Devices as well as
Medical Devices Draft Rules,
2016.
15.07.2016 Meeting-Revision of Drugs CDSCO, Mumbai
and Cosmetics Act and West Zone
Rules & Draft Medical
Rules.
The Ministry of Health and Family Welfare published the said draft/final notification and before publication of final notification, various meeting with stake holders were held on dated 23rd May 2016, 24th May 2016 02nd July 2016, 15th July 2016 etc. Your RTI Appeal is being transferred to the CPIO, DRS Section, Ministry of Health and Family Welfare under section 6(3) of the RTI Act, 2005 for the available information (if any).
Point 5:
The list of approved Medical Devices is available on online system for Medical Device Portal at:
https://cdscomdonline.gov.in/NewMedDev/ListOfApproved Devices"
Aggrieved and dissatisfied, the Appellant approached the Commission with the instant Second Appeal.
Page 2 of 4Written submission dated 05.06.2024 has been received from the CPIO and same has been taken on record for perusal.
Facts emerging in Course of Hearing:
Appellant: Present in person, along with Mr. Harpreet Singh Respondent: Ms. Kavita Sharma, CPIO, CDSCO(HQ) and Ms. Aniruddh Negi, DPIO, CDSCOC (HQ) participated in the hearing.
The Appellant stated that the relevant information has not been furnished to him till date. He stated that the PIO has not furnished minutes of the meetings as sought in the instant RTI Application. He further stated that the information sought at point No. 5 of the RTI Application was related to the number of licenses issued till date for different classes of medical devices but same has not been provided by the PIO.
The Respondent reiterated the averments made in their written submission and stated that the relevant information from their official record has been duly provided to the Appellant. He further stated that the minutes of the meetings as available in their record have been duly provided to the Appellant at this stage. They further stated that information related to list of approved medical devices is available on online system for medical device Portal and the details of the licenses issued for the medical devices can be easily accessed online. The Respondent furnished a copy of their written submission along with annexures to the Appellant during course of proceedings.
Decision:
In the light of the above submissions, the Commission observes that that an appropriate response as per the provisions of the RTI Act, 2005 has been provided by the Respondent. Furthermore, written submission filed by the Respondent is comprehensive and self-explanatory. Commission notes that 'information' as defined in the section 2(f) of the Act, only refers to such material as is already available in the records of the public authority. Further, the RTI Act, 2005 does not cast an obligation upon the public authority, to collect or collate such non-available information and then furnish it to an applicant Hence, no further intervention of the Commission is required in the instant matter Appeal is disposed of accordingly.
Heeralal Samariya (हीरालाल सामररया) Chief Information Commissioner (मुख्य सूचना आयुक्त) Page 3 of 4 Authenticated true copy (अनिप्रमानणत सत्यानपत प्रनत) S. K. Chitkara (एस. के . नचटकारा) Dy. Registrar (उप-पंजीयक) 011-26186535 Page 4 of 4 Recomendation(s) to PA under section 25(5) of the RTI Act, 2005:-
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